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MEDICINES POLICY Guidelines for use of medicines 2009 Updated February 2014 Version 1.9 Trust Medicines Policy Policy Number EHT/DTG/018/2014 Ratifying Committee Date Ratified Next Review Date Accountable Director Policy Author Policy Updated by Drug and Therapeutics Group 04 March 2014 04 March 2015 Medical Director/Assistant Chief Executive Paulette Main, Principal Pharmacist Paulette Main, Principal Pharmacist Gobi Manoharan, Medicines Information Pharmacist Trust-wide Controlled and restricted Drugs Policy Cytotoxic Drugs Policy The Intrathecal Drug Policy Pharmaceutical Cold Chain Policy All Policy Application Related Policies List of Staff for Circulation -2- Equality Impact Assessment [EIA] Policy or service being assessed : Medicines Policy Summary of Policy / Service: Local guidance on the management of all aspects of the handling, storage and administration of medicines throughout Ealing Hospital NHS Trust. Lead Person: Stuart Richardson, Chief Pharmacist Person (s) responsible for carrying out the assessment [if not the lead] : Stuart Richardson, Chief Pharmacist Date of assessment : August 2009 Stage 1 Question 1. Is this a new or existing policy or service? Please tick to indicate Existing 2. What is the expected outcome of the policy / service? [ e.g. aims, objectives and purpose of the policy / service ] 3. Does the Policy / Service link to others? If Yes please state below 4. Who is intended to benefit from the Policy / Service and in what way? 5. How is the Policy / Service to be put into practice? Who is responsible? 6. How and where is information about this policy / service published [e.g. through groups, forums, committees / the Trust’s intranet / internet ] 7. What regular consultation is carried out with different communities and groups regarding the Policy / Service [e.g. groups or forums within the Trusts’ external groups & communities ] -3- To ensure clear guidance is in place for the management, storage, handling and administration of medicines throughout the Trust Yes All Healthcare Professionals employed by the Trust involved with the handling of medicines at EHT The Policy is to be launched jointly by the Pharmacy Department and the Drug and Therapeutics group for the Trust. Trust Intranet. Hyperlinked to Trust Controlled and Restricted Drugs policy for cross referencing. N/A 8. Are there any concerns that this Policy / Service provision could have an impact with regard to equality legislation, that has not been addressed as part of the policy, specifically in relation to: Age Yes No No No No No No No No Disability Gender Ethnicity ( Race) Sexual orientation Religion / Belief Dignity and Human Rights 9. If YES to one or more of the above please state evidence 10. Do the difference amount to discrimination 11. If YES could it be justifiable e.g. on grounds of promoting equality of opportunity for one group? Indirect discrimination can sometimes be justifiable when it is target at a particular or ‘hard to reach group’. 12. If YES please give reasons N/A Yes No 13. From the initial EIA at stage 1, should there be a full Equality impact assessment carried out, ensure you addressed those areas identified in question 8? - Please note reasons No 14. Please indicate who will be responsible for leading on the undertaking of the full EIA being conducted, and the expected date of completion [e.g. action plan, indicated end dates for actions] N/A -4- N/A In developing this policy the following legislation has been duly considered: Data Protection Act 1998 Data Protection issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with the Data Protection Act 1998 and internal Data Protection Policies. Diversity Policies Equality issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with Equal Opportunity legislation and internal Equal Opportunity policies. Freedom of Information Act 2000 Freedom of Information issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with the Freedom of Information Act 2000 legislation and internal Freedom of Information policies. Health and Safety Act 1974 Health and Safety issues have been considered with regards to this policy. Adherence to this policy will therefore ensure compliance with Health and Safety legislation and internal Health and Safety policies. Human Rights Act 1998 The Human Rights Act 1998 has been considered with regards to this policy. Proportionally has been identified as the key to Human Rights compliance. This means striking a fair balance between the rights of the individuals and those of the rest of the community. There must be a reasonable relationship between the aim to be achieved and the means used. Race Relations Amendment Act 2000 The Race Relations Amendment Act 2000 has been considered with regards to this policy. Adherence to this policy means that the Trust will eliminate discrimination on the grounds of race and will promote race equality and good race relations. Equalities Act 2006 The Equalities Act 2006 requires all public sector bodies to have a general duty in the exercise of their public functions to pay due regard to the need to eliminate unlawful discrimination. The Mental Capacity Act 2005 The Mental Capacity Act provides a statutory framework to empower and protect vulnerable people who are not able to make their own decisions. Bribery Act 2010 -5- The Act repeals all previous statutory and common law provisions in relation to bribery, instead replacing them with the crimes of bribery, being bribed, the bribery of foreign public officials, and the failure of a commercial organisation to prevent bribery on its behalf. -6- Document History Date Action Person May 2009 Updated (Version 1.3) Paulette Main Jan 2010 Updated (Version 1.4) Paulette Main August 2011 Updated (Version 1.5) Paulette Main July 2012 Updated (Version 1.6) Paulette Main January 2013 Updated (Version 1.7) Paulette Main July 2013 Updated (Version 1.8) February 2014 Updated (Version 1.9) Paulette Main Gobi Manoharan Paulette Main Ratification dates Sent to Version Date Drug &Therapeutics Group 1.3 09 June 2009 Drug &Therapeutics Group 1.4 January 2010 Drug &Therapeutics Group 1.5 August 2011 Drug &Therapeutics Group 1.6 18 July 2012 Drug &Therapeutics Group 1.7 29 January 2013 Drug &Therapeutics Group 1.8 30 July 2013 Drug &Therapeutics Group 1.9 04 March 2014 -7- Actions taken as a result CONTENTS Page INTRODUCTION GLOSSARY 9 14 1. MAINTAINING A REGISTER OF NAMES OF STAFF 18 2. ORDERING A. Stock medicines B. Non-stock medicines C. Discharge medicines D. Intravenous fluids E. Medical gases F. Emergency medicines boxes G. Medicines prepared in pharmacy production unit TPN CIVAS H. Controlled stationery 19 19 20 22 28 29 31 32 32 32 33 3. SUPPLY, TRANSPORT AND RECEIPT A. Out-of-hours advice and supply B. Supply from Emergency Drugs Cupboard C. Obtaining supplies of medicines from another ward or clinical area D. Transport of medicines E. Transport of medical gases F. Delivery & receipt of medicines G. Patients’ own medicines H. Checking the identity of patient’s own medicines I. Supply of medicines to patients for use outside the hospital 36 36 36 37 38 39 39 42 43 44 4. STORAGE AND SECURITY A. General requirements B. Medical gases C. Intravenous fluids & sterile topical fluids D. Keys E. Emergency medicines boxes F. Medicines no longer required G. Total Parenteral Nutrition (TPN) and Cytotoxic items H. The medicines trolley and other systems I. Order and record books J. Action to be required if threatened K. Closure of a ward or department L. Medicines requiring refrigeration M. Disposal of medicines 47 47 49 50 50 51 51 52 53 53 54 55 56 57 -8- 5. PRESCRIBING Writing prescriptions Medical Prescribers Non Medical Prescribers Patient Group Directions Approved forms Writing prescription for In Patients & Day Cases Review & Cancellation of In Patient prescriptions Out Patient Prescribing Doctors Self Prescribing Gifts & Benefits Home Oxygen 58 58 58 58 60 61 61 63 64 65 65 66 6. PREPARATION A. Oral medicines B. Injections and infusions C. Suppositories, enemas and vaginal pessaries D. Bladder instillations E. Other medicines 67 67 67 69 69 70 7. ADMINISTRATION A. General guidance B. Patient consent Covert administration of medicines C. Non-oral medicines D. Nebulised medicines E. Self Administration F. Further notes on administration 71 71 74 8. ADDITIONAL PROFESSIONAL PRACTICES A. Issue of pre-packed or over-labelled medicines from ward / clinical areas B. Controlled Drugs – See CD Policy 2009 C. Unlicensed medication and licensed medication for unlicensed Indication D. Intravenous medicines E. Storage and use of I/V potassium F. Cytotoxic Medicines Administration Documentation Chemotherapy Sub-committee of D&TG Prescribing Chemotherapy Authorised locations for administration Storage & Transportation of Cytotoxics Pharmacy Cytotoxic Reconstitution Service Safe Handling Spillage of Cytotoxic drugs Oral Methotrexate G. Reporting Adverse Reactions to medicines 80 80 81 812 82 85 90 75 75 75 75 -9- 9. ERRORS IN ADMINISTRATION OR CUSTODY OF MEDICINES A. Dealing with medicines errors B. Changing names from BANs to rINNs 105 105 105 10. MEDICINES DEFECTS A. 24 Hour recall procedure for defective medicinal products 109 109 POLICY FOR DISSEMINATION 110 APPENDIX 1 APPENDIX 2 APPENDIX 3 111 112 113 MEADOW HOUSE VERBAL ORDERS GP REFERRAL LETTER NORTH WEST LONDON RED LIST (December 2013) - 10 - INTRODUCTION TO THE MEDICINES POLICY The Medicines Policy has been prepared in a ‘stand alone’ loose leaf format to aid retrieval of and facilitate updating of the information. The latest version of the policy must be available to all staff in all clinical areas. The latest version is also available via the Trust intranet. The procedures are filed in sections relating to specific functions. Each section can be easily identified by the section dividers. Significant changes may be made when the policy is next reviewed. Always ensure you refer to the most recent version. Feedback on the Policy to ensure it reflects current best practice is encouraged. All medicines are potentially hazardous to someone This document is intended to be used as a guide to good practice for all healthcare staff involved, in any aspect, of the use of medicines. It defines the mandatory requirements of Ealing Hospital NHS Trust, the employing authority. The policies and procedures aim to provide a framework for the safe use of medicines by all staff involved and at each stage of the medicines process and ensure that: o Medicines are correctly and appropriately prescribed by an authorised practitioner o Medicines are correctly and appropriately dispensed or supplied by an authorised practitioner o Medicines are accurately and appropriately administered o Medicines are correctly stored o Recording and control of medicines is correctly performed to prevent the loss, inappropriate access to and misuse of medicines by patient/clients, residents, staff or any member of the general public o Practitioners involved in the delivery of care carry responsibility for their actions. Signatures and initials must be capable of identification o Medicines are correctly disposed of when no longer required o All aspects of handling medicines comply with current legislation and guidance issued by the Department of Health o Risks associated with medicines are identified and minimised Scope of the Medicines Policy The use of medicines is the most common intervention in hospital patients. Adverse events associated with medicines can result in patient harm. Safe medicines use depends on healthcare professionals working as a team to consistently high professional standards and understanding their own and others contributions to this outcome. This policy: o describes regular practice o recognises that Healthcare professionals have the right to exercise their professional judgement and act within their competence, however, the policy should be followed at all times except in exceptional circumstances when, in the judgement of the professional a deviation is justified in the interest of the patient. This must be document in the patient record. o only considers the processes associated with the physical handling of medicines The clinical elements of the management of medicines (choice, dose, route of administration, frequency and duration of treatment) should be appropriate to the patient’s - 11 - condition, taking into account allergies, metabolic limitations etc. and are beyond the scope of the policy. Resources which should be used in conjunction with the Medicines Policy o The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) o British National Formulary (Current) o British National Formulary for Children – BNF-C (Current) o Ealing Hospital NHS Trust Formulary (Current) o Ealing Hospital NHS Trust Intravenous Drug Administration Guide (Current – Intranet) o Ealing Hospital Controlled and Restricted drugs Policy (current) o Ealing Hospital Pharmaceutical Cold Chain Policy(current) o Nurse Prescribers Formulary (Current) o Ealing Hospital NHS Trust Cytotoxics Policy (current) o Ealing Hospital NHS Trust Blood Products administration Policy o RCN Standards for infusion therapy (current) o EHT Patient Group Directions by Emergency Nurse Practitioners & Paediatric Nurse Practitioners. Accident & Emergency Department – (current) o Hazardous Waste (England & Wales) Regulations (current) o Standards of proficiency for Nurse and Midwife Prescribers. NPC. (current) o The emergency medical treatment of anaphylactic reactions for first medical responders and for community nurses- Resuscitation council UK (current) o EHT Non-Medical Prescribing guidelines (current) o Policy for administration of nebulised therapies to adult patients (current) o EDS Operational Procedure (current) Sources referred to throughout the compilation were: o UKCC Code of Professional Conduct for the Nurse, Midwife and Health Visitor, Second Edition (1984) and Third Edition (1992) o UKCC Administration of Medicines Advisory Paper (1992) o UKCC Exercising Accountability Advisory Document (1989) o UKCC The Scope of Professional Practice (1992) o UKCC Standards for Records and Record Keeping (1993) o UKCC Standards for the Administration of Medicines (1992) o RCN Standards for infusion therapy – October 2003 o Guidelines for the Safe and Secure Handling of Medicines - Duthie 1988 o The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) o Medicines Act – (1968) o Misuse of Drugs Act – (1971) o The West Middlesex Hospital. Medicines Policy (2002) o King’s College Hospital Medicines Management Policy (2008) o St Mary’s NHS Trust. Drug administration policy and guidelines (Dec 2004) o North West London Hospitals NHS Trust. Drug Policy (Aug 2003) o EHT Patient Group Directions by Emergency Nurse Practitioners & Paediatric Nurse Practitioners. Accident & Emergency Department – January 2005 o Changes in the CDs affecting pharmacists. RPSGB V2 June 2006. www.rpsgb.org - 12 - o o Nursing & Midwifery Council. Statement on Covert administration of medicines 2007. http://www.nmc-uk.org/ EDS Operational Procedure (2010) Ratification and Review of Policies and Procedures All policies and procedures relating to the use of medicines must be ratified by the Drug & Therapeutics Group (D&TG), who act on behalf of the Trust. This includes new and amended procedures, both in general use and for specific locations. The Group will also have an ongoing responsibility for The Medicines Policy and will carry out an annual review of all policies and procedures. This Medicines Policy Document was reviewed by a Trust-wide, multidisciplinary working party and representatives from Ealing Care Commission Group (CCG). - 13 - GLOSSARY ABPI: The Association of the British Pharmaceutical Industry Appointed Nurse in Charge: The nurse in charge carries continuing responsibility for a ward, department or clinic. At times when he/she is not on duty, delegated responsibility is carried by another qualified nurse. Authorised Staff/Practitioner: Individual practitioners/members of staff are authorised in one or more of the following ways: o By terms and conditions of appointment and as defined in the job description. o By possession of a recognised professional qualification necessary to carry out the duties defined in the job description o By being recognised as competent to carry out specific functions. o With authority of first-line Manager and/or Senior Manager o By definition within individual procedures. BNF: British National Formulary (The latest edition must always be used). BNF-C: British National Formulary for Children (Latest edition) Clinical Trial: An investigation or series of investigations consisting of the administration of one or more medicinal products, by one or more doctors or dentists for the purpose of ascertaining what effects, beneficial or harmful, the products have. Community Pharmacy: A retail pharmacy in the private sector, i.e. not attached to an NHS hospital. Complementary Therapies: Homeopathic and herbal medicines for the purposes of this document will be considered as medicines Controlled Drugs (CDs): Medicines which are subject to the prescription requirements of the Misuse of Drugs Regulations 1985, Schedules 2 and 3 Controlled Stationery: All stationery which could be used to obtain medicines fraudulently. Cytotoxic: As defined by BNF codes – Chapter 8.1 Designated Manager: The person who carries managerial responsibility for a specific area. This may be a first-line manager or a senior manager depending on the level of responsibility DOH: Department of Health Drug: This term is interchangeable with the term medicine eBNF: The Trust Medicines Formulary information can be accessed on the intranet. It is supported by an electronic version of the current BNF. - 14 - ePro: The system used to prescribe patient TTAs and transfer information to GPs at discharge Healthcare Staff: Any Trust, ICO or CCG staff who are involved in the care of patients ICO: Integrated Care Organisation. The Trust which is an organisation combining the staff and services of Ealing Hospital and Ealing, Harrow & Brent Community Services ISO Standards: Standards set by the International Standards Organisation Locally Agreed/Approved: Policies and procedures for local use that have been agreed/approved by the Drug and Therapeutics Committee. The term 'local' may apply to a small work unit (e.g. a ward) or to a large healthcare setting (e.g. a hospital) Matron: Senior Nurse Manager Medical Practitioner: This covers all pre-registration and post-registration doctors and dental practitioners who have clinical responsibility for the patient/client at any given time Medicine: This term describes all medicinal products i.e. a substance administered by mouth, applied to the body or introduced into the body for the purpose of treating or preventing disease; diagnosing disease; ascertaining the existence, degree or extent of a physiological condition; contraception; inducing anaesthesia or otherwise preventing or interfering with the normal operation of a physiological function. Medicine Defect: This term covers the following areas: o Visual evidence of deterioration e.g. colour, smell, taste, physical damage, bacterial/fungal contamination o Unexplained lack of action or adverse reaction to a medicinal product o Packaging errors Medicine Error: Any occurrence that contravenes the policies and procedures laid down in this document MHRA : Medicines and Healthcare products Regulatory Agency. Formerly known as the MCA (Medicines Control Agency) and incorporates the CSM (Committee for Safety in Medicines). See www.mca.gov.uk Nursing & Midwifery Council (NMC): Regulatory body and register of nurses, midwives and health visitors registered and/or working in the UK (Previously UKCC). NPSA: A Special Health Authority created to co-ordinate the efforts of the entire country to report, and more importantly to learn from mistakes and problems that affect patient safety. See www.npsa.nhs.uk ODA: Operating Department Assistants (also called ODPs - Operating Department Practitioners). Theatres staff who assist anaesthetists during surgical procedures. - 15 - Patient: May otherwise be referred to as ‘Service users’, ‘Clients’, ‘Consumers’ or ‘Customers’ PGD: Patient Group Direction. Standardised guideline to allow appropriately trained and accredited staff to administer or supply (or both) and agreed range of medicines for specified indications to individual patients in line with agreed criteria. Pharmacist: A practitioner registered with the General Pharmaceutical Council. PODs: Patients’ Own Drugs or Medicines. Medicines which belong to a patient, that have been brought into the hospital setting. Medicines dispensed by EHT pharmacy that have left a clinical area and later returned must also be treated as PODs. PODs must be assessed suitable for use by a pharmacist. Prescriber: Person who is responsible for the writing the prescriptions for a patient. Would usually be a medical practitioner but could also be a qualified Independent prescriber who is a nurse, midwife or pharmacist. Prescription: A signed order for the supply of medicine for a specific patient. Prescriptions are written on in-patient prescription charts, out-patient prescriptions or on Epro (electronic discharge system). Private prescriptions are written on letter headed paper. Private Patient: A patient who is not funded by the NHS Private Prescription: A prescription written for a private patient (non-NHS) or a prescription for an NHS patient for a drug not available on the NHS eg. Malaria prophylaxis Qualified Nurse: A qualified nurse is either a Registered nurse or an Enrolled nurse listed in the second level part of the Nursing & Midwifery Council (NMC) Register. Currently, that part of the Register includes the following: Part 2 Enrolled nurse, general Part 4 Enrolled nurse, mental Part 6 Enrolled nurse, mental handicap Part 7 Enrolled nurse Registered Nurse: A nurse who is listed in the first level part of the NMC Register. Currently, that part of the Register includes the following: Part 01 Registered general nurse Part 03 Registered mental nurse Part 05 Registered nurse of the mentally handicapped Part 08 Registered sick children's nurse Part 10 Registered midwife Part 11 Registered health visitor Part 12 Registered nurse, adult health Part 13 Registered nurse, mental health Part 14 Registered nurse, mental handicap Part 15 Registered nurse, care of the child - 16 - Registered Medical Practitioner: A medical practitioner with full General Medical Council registration Restricted Drugs: Prescription only medicines which are known to have the potential to be subject to abuse. Local policy restricts quantities ordered, method of ordering and storage requirements SI Units: Systems International units TTA: ‘To Take Away’. Medicines supplied to inpatients on discharge from the hospital. The term may be used to describe both the ‘Discharge medicines letter’ used to order the supply, or the supply itself. Other hospital trusts may use an alternative term ‘TTO’ – ‘To Take Out’ UKCC: UK Central Council for Nursing, Midwifery and Health Visiting. Now known as NMC - 17 - 1. MAINTAINING A REGISTER OF NAMES OF STAFF A. REGISTER OF STAFF NAMES All healthcare settings involved in the direct delivery of care shall have a Register of staff. Signatures and initials of staff must be capable of identification A1 A1.1 Register All staff involved in the handling of medicines, including custody, ordering, prescribing and administration of medicines, shall be required to provide a register entry A1.2 A register will be maintained by: - The designated Manager in each Clinical area. - The Dispensary manager, for Pharmacy staff and relevant portering and transport staff. - Medical staffing, for medical practitioners A1.3 Permanent staff shall make an entry on their first day of appointment. A1.4 Temporary staff (including students) shall make an entry preferably on their first day at the commencement of their shift, or the next week day if this should fall on a weekend. This part of the register shall be maintained chronologically A1.5 The register entry shall comprise: - date - full printed name - designation - signature (in full) - signature (initials) - name of agency (if applicable) - contact details A1.6 The designated managers have the authority to request a register entry from any member of staff working within their area. A1.7 Details should be kept current. Staff should inform the manager of any change in details or name and a new entry should be made. - 18 - 2. ORDERING A. ORDERING STOCK MEDICINES FROM PHARMACY Each ward, department or clinical area which uses medicines routinely holds a stock of medicines suitable for the common types of conditions being treated in those areas. All stock orders are dealt with by Distribution and Stores section in pharmacy. Stock medicines can be ordered in four ways: A1. Top-up – in agreed Clinical areas A1.1 An agreed list of medicines to be held as stock is drawn up by the Ward Manager and the Ward Pharmacist. This list specifies standard quantities of each medicine to be held. This list must be reviewed on at least an annual basis A1.2 A member of the pharmacy technical staff is assigned to visit the clinical area on a pre-arranged number of days A1.3 On each designated day, the technician/pharmacy assistant visits the clinical area and systematically checks each storage area, noting the amount of each medicine required to return the stock to the level required on the list. In some clinical areas a ward staff member will perform this task A1.4 If extra supplies of any item are required, the nurse in charge shall inform the technician/pharmacy assistant at the time of handing over the keys A1.5 Where extra supplies of stock medicines are required on a regular basis, the stock holding shall be reviewed and the list amended. A2. Written, Signed Orders A2.1 Stock medicines, for all wards and most clinics, may be ordered using the ‘Stock Requisition’ order book. Some clinics have a standard pre-printed ‘Stock Requisition’ order form A2.2 Orders should only be written for items which are on the agreed stock list. Medicines shall only be supplied against such orders if it has been previously agreed with the pharmacy that these medicines may be held as stock or if the Distribution Manager feels it is appropriate to supply the medicines against a stock order A2.3 The order must state clearly: - Ward or clinic name - Generic name of the medicine - Strength - Form required e.g. tabs, injection etc. - Quantity required The order must be signed (using full signature) by an authorised practitioner, with the name and designation printed clearly under the signature A2.4 - 19 - A2.5 Additional stocks should not be ordered after 5pm weekdays, at weekends or over Bank Holidays unless need for the supplies is urgent. If ordered outside Distribution opening hours, orders would be processed by the dispensary staff working the weekend or Bank Holiday A2.6 Orders for Controlled Drugs – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. A3. Telephone or Fax Orders A3.1 Telephone Orders A3.1.1 Orders for stock medicines may be telephoned to the Distribution section on weekdays and only in emergencies A3.1.2 The caller must state: - their name - designation - location - medicines required (form, strength) - quantity required - reason for request A3.1.3 A written, signed order must be sent to Distribution within 24 hours. A3.2 Fax orders A3.2.1 Orders for stock medicines may be faxed to the Pharmacy office on weekdays and only in emergencies (0208 5742975) A3.2.2 A fax of a written signed order is acceptable (see above), but must be marked 'For the attention of Pharmacy Distribution'. A3.2.3 The original order must be sent to Distribution within 24 hours B. ORDERING NON-STOCK MEDICINES FROM PHARMACY Medicines which are not routinely used in a clinical area, but may be required for an individual patient are designated 'non-stock'. All non-stock medicines are labelled with the patient's name and are charged either to the ward/clinical area or to the consultant caring for the patient. Controlled or Restricted drugs must be ordered as stock items. Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. Non-stock medicines may be ordered in two ways: B1. Ordering via the Ward Pharmacist B1.1 The pharmacist responsible for the ward/clinical area, visits on an agreed number of days, at times agreed with the nurse in charge B1.2 Requests for non-urgent supplies may be ordered via the ward pharmacist by noting requirements on a ‘Pharmacy request slip’ attached to the patients’ drug chart or another locally agreed place, such as a ward diary where messages for the ward pharmacist may also be recorded B1.3 At each ward visit, the ward pharmacist shall check the prescription charts or diary and supply appropriate quantities of the required items. - 20 - B2. Ordering via the Pharmacy Dispensary This method must only be used for items that cannot wait for the next ward pharmacist visit B2.1 Sending a prescription chart to pharmacy B2.1.1 Ward staff should contact the regular ward pharmacist to obtain advice. The Ward pharmacist may ask that the chart be forwarded to pharmacy dispensary for their attention, may agree to visit the ward to pick it up or may ask that the chart remain on the ward until the next scheduled visit B2.1.2 If the chart is to go to dispensary ward staff should ensure that the prescription chart has been completed in full, signed and that the patient name, hospital number, consultant and ward name are printed clearly on the front of the chart and that these details are correct B2.1.3 Complete a 'Pharmacy Request slip' for each prescription chart. The order must state clearly: - the patient name, hospital number and consultant - the name, form and strength of each medicine required and directions if applicable - the ward - attention ‘Ward Pharmacist Name’ if appropriate B2.1.4 The order must be signed (using full signature) and dated by an authorised practitioner, with the name printed clearly under the signature B2.1.5 Attach the order slip to the prescription chart using a paper clip. Send to the pharmacy dispensary via: - routine ‘Pharmacy Green bag (Envopak®)’ collection - a porter - a member of the ward staff - the pneumatic tube system (if available) B2.1.6 If the medicine is required immediately, the porter/ward staff must be requested to wait for the medicine to be dispensed so that he/she can return it to the ward. Ensure pharmacy staff knows the person is waiting B2.1.7 Charts will be returned to the ward as soon as possible on the next porter’s round. If the chart is required immediately, the porter/ward staff must be requested to wait for the chart to be checked against the request slip so that he/she can return it to the ward. Ensure pharmacy staffs know the person is waiting. Ordered items will be sent once dispensed and may be sent later, separately to the chart. Small items might be sent via the pneumatic tube if requested - 21 - B2.2 Telephone request without a drug chart A telephone request may only be made in the event of urgency and the need to retain the drug chart on the ward. B2.2.1 A telephone request must be made by a doctor or a senior nurse and may only be accepted by the relevant ward pharmacist B2.2.2 The pharmacist must ask for the reason for the urgency and the reason for retaining the drug chart on the ward B2.2.3 The pharmacist must be told what else is prescribed on all sections of the drug chart B2.2.4 The pharmacist must record the name, formulation, dose and frequency of the medicine required on a ‘Ward Pharmacy dispensing record sheet’, together with the names of other medicines prescribed B2.2.5 The pharmacist retains the right to refuse to supply medicines without seeing the drug chart if not satisfied with information supplied and has concerns about treatment regimen. The ward pharmacist may agree to visit the ward to view the chart but if this is not possible the drug chart must be sent to the dispensary for review before the medicine can be supplied B2.2.6 The pharmacist is responsible for endorsing the chart with the quantity and date of any medicines supplied, as soon as possible C. DISCHARGE MEDICINES (TTAs) C1.0 Overview of System ‘Workflow’ and processes Please also see EDS Operational Procedure and intranet page on ePro (under systems) in conjunction with this policy. All information contained in the electronic discharge summary must be complete and accurate at the time of completion. The separate stages of the system based workflow are summarised below, noting each of the “status” types as the discharge summary progresses from “Draft” to “Complete”. Once the patient’s admission has been recorded on PAS, the electronic discharge summary can start to be authored – this is referred to as “Draft” status. When the decision to discharge the patient is made the clinical author can complete the discharge summary – status is changed to “Written”. A member of the medical team or nursing staff should then inform the ward pharmacist. A pharmacist will clinically screen the discharge summary - status changed to “Screened”. The pharmacy team will then dispense the discharge medication – status changed to “Dispensed” – and check it (“Checked”). The discharge medication is then “Ready” for collection and the nursing staff can issue the medication to the patient and “Complete” the process. A Discharge summary (DS) is written by the discharging doctor, summarising all the relevant clinical details of patient’s in-patient stay. It is primarily intended for the GP. A DS will also - 22 - contain a list of drugs on discharge. A TTA (To Take Away) or TTO (To Take Out) refers to the discharge medication. C2.0 Pharmacy Screening – Standard Process Pharmacists must clinically screen all discharge prescriptions prior to the supply of discharge medicines. The pharmacist will query any clinical concerns, e.g. unexplained or unexpected changes found on the discharge prescription when matched against the medication chart. Once clinically screened, the pharmacist will indicate this on the electronic discharge system and will also sign and date the TTA section of the printed drug chart. Please note that drug charts do not need to be taken to Pharmacy if a pharmacist has clinically checked the discharge prescription on the ward. The pharmacist or a Medicines Management Technician (MMT) must ensure that the bedside medicines locker contents, fridge and or controlled drug cabinet have been checked, to ensure that all medicines labelled for discharge are included in the completed discharge summary. The pharmacist or the MMT must endorse on the electronic discharge system (and/or the pharmacy dispensing sheet) to indicate which medicines are already labelled for discharge, along with those medicines which must either be dispensed from Pharmacy, require relabelling or are the patient’s own supply from home. If the drug chart is sent to Pharmacy for screening, then the contents of the medicines locker (and any fridge item) must also be sent to Pharmacy. If there are patient’s own controlled drug(s), then a member of pharmacy team must deal with them as appropriate. The Screening pharmacist should make sure appropriate blood results are recorded, appropriate follow up arrangements made and counselling and treatment booklets are given for high risk drugs such as methotrexate. The screening pharmacist must make sure that their contact and/or bleep number is included on the electronic discharge summary. C2.2 Amending a discharge summary Clinician Authors If any amendments are required after the initial discharge prescription has been written, it is the responsibility of the clinician making the amendment to inform their team, the ward pharmacist, the patient’s nurse and/or pharmacist in the dispensary, as required. Pharmacists Any amendments to the prescription should be discussed with the prescriber or another doctor from the same medical team before a change is made. A pharmacist is authorised to amend a discharge prescription following a verbal instruction from a doctor. The name of the prescriber authorising the change must be recorded on the discharge prescription, along with their contact bleep. The details of the pharmacist making the amendment will be automatically recorded on the electronic discharge system. - 23 - A pharmacist may use their discretion to make a change without contacting the prescriber (e.g. amending an inhaler device). Where a prescriber has not been contacted, the pharmacist must indicate this on the discharge summary (recorded as ‘PNC’ i.e. prescriber not contacted). C2.3 Dispensing and Supply Requesting Discharge Medication Once the clinical author has typed up the electronic discharge summary (i.e. status is “written”), it is the responsibility of nursing staff to provide the ward based pharmacist with the patient’s medication chart and any medication dispensed for that patient, including fridge items and the patient’s own medication. A Pharmacy request slip should be filled-out and attached to the medication chart, together with any controlled drugs prescription, to indicate to the pharmacist that discharge medicines are required. If the discharge prescription is written after the pharmacist’s regular visit time - and is required before the next pharmacist visit time - the ward pharmacist will be bleeped. The ward pharmacist may then either return to the ward or ask for the prescription and medication chart to be sent to pharmacy. C2.4 Pharmacy Dispensing If all required medicines are already available on the ward, in sufficient quantities and labelled appropriately, the pharmacist and/or MMT will assemble the TTA on the ward, check it and mark the discharge summary status as “Ready” on the system. If medicines are required from Pharmacy, the TTA will be sent to Pharmacy for dispensing. The screening pharmacist will print a TTA dispensing sheet for dispensary staff to dispense the TTA from. The TTA dispensing sheet will already have some endorsements such as patient’s own drugs (POD) on it. The dispenser and checker will manually endorse on the form. Once checked by the Pharmacist (or accredited checking technician) the discharge summary status will be set to “Dispensed” and “Ready”. When the TTA is checked it is placed into specific TTA bags, with a label including patient details affixed to the bag. These TTA bags have two forms; please refer to Appendix 3 for details. Once the TTA is ready, the nursing staff or the pharmacy porter can collect or deliver the TTA as applicable. C2.5 Nurse Dispensing – Variations to Standard Process It is recognised that for a small number of clinical areas there are agreed variations to the standard workflow, e.g. Maternity (Lammas), Endoscopy Unit, Ward 3 North. In these areas, nursing staff (including midwives) are able to “direct supply” some prescriptions following a strict protocol, allowing for the completion of TTAs on the ward. In order to do this they must have completed the relevant accreditation process. - 24 - Nursing and midwifery staff must only carry out this process when they can “direct supply” all medications on that discharge summary. If any of the medications require pharmacy input, then the entire discharge summary will be screened, dispensed and checked by Pharmacy staff, as per the standard process. C2.6 Discharge Co-ordination Nursing and midwifery staff (as applicable) must print a copy of the final electronic discharge summary and ensure that this is provided to the patient at the point of discharge, along with the correct medication and relevant instructions. Discharge medicines must be matched against the details included on the printed discharge summary. Directions for use on each labelled medicine must also be identical to those on the prescription. Where a patient has sufficient medication supply at home, this is to be indicated on the printed discharge summary and the medication will not be in the TTA bag. Once the relevant member of nursing/midwifery staff is assured that no discrepancies exist, they must sign on to the PAS/Bed-Web system and discharge the patient. They must then also sign on to the electronic discharge system and mark as the discharge summary status as “Complete”. This will result in two actions: 1. Two copies of the completed discharge summary will be printed, i.e. one for the patient and one for the patient’s medical record; 2. An electronic copy of the completed summary will be sent to the GP by secure email. The nurse-in-charge on the relevant ward is responsible for ensuring that these actions are completed in a timely manner, for all inpatient/day case episodes. C3.0 User Roles and Responsibilities The following general rules should be followed by all in all situations; o Users must always use their own log-in details. o Passwords must never be shared. Failure to comply with this instruction may result in disciplinary action, as per the Trust’s Information Security Policy. C3.1 Ward Pharmacist It is the ward pharmacist’s responsibility to; 1) Screen discharge summaries (DS) on the ward as much as possible. They should arrange the time of the visit which best suits the area they are working in and their ward’s requirement. Liaise with ward staff to arrange how ward staff will communicate when DS are written, and, how and when ward staff should send down discharge medication/drug chart for dispensing to pharmacy. - 25 - 2) ‘Clinically screen’ DS from their ward. (Clinical screening involves carefully assessing the need for each drug, checking transcribing, checking for interactions etc). After screening they should endorse electronically that this has been done. 3) Resolve any prescribing errors/problems, ensure that CDs are written correctly (& signed), and cytotoxic guidelines are followed. 4) Screening Pharmacist must ensure that Dietary Supplements have been initiated by or on the advice of a Dietician and have been indicated to continue on discharge. See Prescribing Food Supplements Guide. 5) Take ownership of DS from their ward (until 17:30). If the pharmacist is unable to do this (in the case of meetings or other commitments), they must ensure that an appropriate handover has taken place; in order of preference to their team, dispensary pharmacist or the on-call pharmacist. 6) Engage with the prescribing doctor and other multidisciplinary team members and provide appropriate pharmaceutical input in authoring DS. 7) Initial on drug chart to indicate that DS has been screened. 8) Where appropriate collect, assess & count labelled medication for the patient, PODs, fridge items etc and electronically endorse on the system. 9) Dispense discharge medication & check discharge summaries where appropriate. 10) Print ‘TTA dispensing form’ if further dispensing is needed (it is recommend that TTA dispensing forms are only printed when in pharmacy). 11) Mark “In Pharmacy” on ePro when TTA in Pharmacy. 12) Liaise with MMT and dispensary team as appropriate. 13) Place checked drugs into pharmacy bags allocated for discharge (please see appendix 2), affix bag label and place into appropriate pigeon hole. 14) Monitor DS progress from their ward via discharge tracker. This must be performed throughout the working day at intervals of no more than 3 hours (i.e. before and after lunch and 5pm). A final check must occur at approximately 5pm to ensure that there are no outstanding DS on the system form their ward so they must either take ownership or liaise with / handover to on-call pharmacist. 15) Communicate with nursing staff regarding collection of TTA with CD(s). 16) Follow Trust guidelines & policies with respect to the management of unlicensed drugs, non-formulary drugs, controlled drugs and cytotoxics. 17) Ensure up to date contact details such as bleep numbers are held within the electronic system and ensure that ward staff know how to contact them. C3.2 Dispensary Pharmacist Responsibilities of a dispensary pharmacist include; 1) All responsibilities of the ward pharmacist described in 3.1. 2) To manage workflow via discharge tracker. 3) To liaise with ward pharmacists, MMTs and dispensary staff in managing workflow. 4) Endorse appropriate section on the TTA dispensing sheet manually and/or electronically where appropriate. Cytotoxics will need two checking signatures. 5) File ‘TTA dispensing form’ and any CD prescription. 6) All other current responsibilities. C3.3 Discharge Team - 26 - Discharge Team usually consists of one or more pharmacist(s) and technician(s). This team will visit 4S, 5S, 5N, 6S, 6N, 7S & 7N to screen and dispense TTO. This service is only be provided between 14:00 – 17:00. C3.4 On-call Pharmacist Responsibilities of an on-call pharmacist include; 1) All responsibilities of the ward pharmacist as appropriate. 2) To manage workflow via discharge tracker. 3) All responsibilities of a dispensary pharmacist as appropriate. 4) To check discharge tracker for outstanding TTA/DS before close. C3.5 Medicines Management Technician (MMT) It is the responsibility of the MMT to; 1) Work closely with ward pharmacist and dispensary team in managing workflow. 2) Manage workflow via the discharge tracker. 3) Collect, count, assess and electronically endorse PODs, fridge items etc. as appropriate. 4) Print ‘TTA dispensing form’ and endorse manually where appropriate. 5) Hand over TTA to appropriate nurse on ward where appropriate. 6) Communicate with nursing staff regarding collection of TTA with CD(s). 7) Follow Trust guidelines & policies with respect to the management of unlicensed drugs, non-formulary drugs, controlled drugs and cytotoxics. 8) All other current responsibilities. C3.6 Accredited Checking Technician (ACT) It is the responsibility of the ACT to; 1) Liaise with ward pharmacist, dispensary pharmacist, on-call pharmacist & MMT as appropriate to manage workflow 2) Count, assess and electronically endorse PODs, fridge items etc. as appropriate. 3) Dispense & check where appropriate. 4) Endorse electronically that DS has been dispensed & checked where appropriate. 5) Print ‘TTA dispensing form’ and endorse manually where appropriate. 6) Place checked drugs into pharmacy bags allocated for discharge (please see appendix), affix bag label and place into appropriate pigeon hole. 7) File ‘TTA dispensing form’ and any CD prescription. 8) Communicate with nursing staff regarding collection of TTA with CD(s). 9) Follow Trust guidelines & policies with respect to the management of unlicensed drugs, non-formulary drugs, controlled drugs and cytotoxics. C3.7 Technicians, Pre-registration Pharmacists & Student Technicians It is the responsibility of the technician, pre-registration pharmacist and/or student technician to; 1) Liaise with ward pharmacist, dispensary pharmacist, on-call pharmacist, MMT & ACT as appropriate to manage workflow. 2) Print ‘TTA dispensing form’ and dispense any items that need dispensing & endorse manually. 3) Count, assess and electronically endorse PODs, fridge items etc. as appropriate. 4) Communicate with nursing staff regarding collection of TTA with CD(s). - 27 - 5) Follow Trust guidelines & policies in handling unlicensed drugs, non-formulary drugs, controlled drugs and cytotoxics. C3.8 Pharmacy Assistants & reception staff It is the responsibility of the pharmacy assistant to; 1) Dispense items against ‘TTA dispensing form’ and endorse manually. 2) Communicate with nursing staff regarding collection of TTA with CD(s). 3) Follow Trust guidelines & policies with respect to the management of unlicensed drugs, non-formulary drugs, controlled drugs and cytotoxics. It is the responsibility of the reception staff to; 1) Set status of DS as “In Pharmacy” on receipt of a drug chart/PODs and/or a TTA dispensing sheet. 2) Monitor the discharge tracker and facilitate pharmacist/MMT awareness of DS in written status. D. ORDERING INTRAVENOUS (IV) FLUIDS FROM PHARMACY Intravenous fluids are treated as stock items and may be ordered from the Distribution and Stores section in pharmacy. Intravenous fluids can be ordered in three ways: D1. Top-up D1.1 Some clinical areas are visited by a pharmacy technician or pharmacy assistant on a regular basis D1.2 On the designated day, they will visit the clinical area and systematically checks the IV fluid stocks against an agreed list (see procedure for ordering stock items) D1.3 If any extra supply of an item is required, above the agreed maximum, the nurse in charge must inform the pharmacy staff at the time of the visit D1.4 All IV fluids shall be supplied to the clinical area after 15:00 on the designated delivery day – usually the following day D1.5 The supply to each area is enough to last until the next top-up, usually in 7 days. Pharmacy stores do not keep large quantities of these bulky items and additional supplies required between top-ups may not be readily available D2. Written signed orders Clinical areas with a high usage of IV fluids may require additional supplies before the next ‘top-up’ delivery is due D2.1 Check the IV fluid stocks systematically and indicate in the ‘Stock Requisition’ order book the quantity required. Ensure that the correct units are used (e.g. bags or boxes) D2.2 Ensure that sufficient stocks are ordered. eg. stock ordered on a Friday should be in sufficient quantities to last the whole weekend - 28 - D2.3 Sign (using full signature), print the name and designation clearly underneath, date the order and send to the Distribution section in pharmacy before 13.00 hours D2.4 Orders would usually be supplied to the clinical area after 15:00 the same day D2.5 Pharmacy stores do not keep large quantities of these bulky items and additional supplies required between top-ups may not be readily available, or available in limited quantities. D3. Telephone or Fax Orders D3.1 Telephone Orders D3.1.1 Urgent or extra orders for IV fluids may be telephoned to the Distribution section on week days only D3.1.2 The caller must state: - their name - grade - location - IV fluid required - quantity required - reason for request D3.1.3 A written copy of the order must be sent to Distribution using the ‘Stock Requisition’ order book the same day D3.1.4 Orders received by 1pm will be delivered to the clinical areas after 15:00 the same day D3.2 Fax orders D3.2.1 A fax of a written signed order is acceptable on week days but must be marked for 'The attention of Pharmacy Distribution' D3.2.2 The original order must be sent to Distribution by the end of the next weekday. E. ORDERING MEDICAL GASES See EHT Medical Gas Policy 2008 for further advice. Medical gases are 'prescription only medicines' and are subject to the same strict legal controls as other medicines. They are either piped to the clinical area or supplied as free- standing cylinders. Medical gases can be ordered in three ways: E1. Top-up This applies to Theatres, Maternity Unit, ITU and A&E only E1.1 An agreed list of medical gases to be held as stock is drawn up by the Ward manager and a pharmacist. This list specifies quantities of each gas to be held and must be reviewed on at least an annual basis E1.2 The pharmacy porter is assigned to visit the clinical area on a pre-arranged number of days - 29 - E1.3 On each designated day, the porter visits the clinical area and systematically checks the quantity required on the list E1.4 If extra supplies of any item are required, the nurse in charge shall inform the porter during his visit E1.5 Where extra supplies of medical gases are required on a regular basis, the maximum stock holding shall be reviewed and the list amended The porter shall remove all empty cylinders and replace them with full containers on the same day E1.6 E2. Written, Signed Orders For the majority of clinical areas, medical gases are ordered on an 'as required' basis via the Pharmacy Stores or Portering Department (Medirest) E2.1 Medical gases must be ordered on an approved order form. Medical gases will not be supplied without this form E2.2 The written order must be dated and indicate the location E2.3 The order must state clearly: - the type of gas - the cylinder size - the quantity required E2.4 The order must be signed (using full signature) by an authorised practitioner, with the name and designation printed clearly under the signature E2.5 Medical gases shall only be supplied against such orders on a full for empty basis E2.6 Completed order forms to be sent to pharmacy at the end of the week. E3. Telephone Orders Telephone orders may be placed with a Duty Porter prior to the provision of a signed order E3.1 When a replacement cylinder is required, the Duty porter must be contacted E3.2 The caller must state their location E3.3 A written signed order must be given to the porter when collecting the empty cylinder from the ward / department For supplies of Home Oxygen see policy Chapter 5 Section A - 30 - F. ORDERING EMERGENCY MEDICINES BOXES Medicines for the emergency treatment of cardiac arrest must be immediately available in all clinical areas. - Emergency medicines for use in ADULTs are stored in blue, black or red emergency boxes (depending on contents). - Emergency medicines for use in CHILDREN(P) or INFANTS(N) are pale blue(P) or green(N) The paper seal around the box lists the contents of the box and shows the expiry date of the shortest dated medicine. Ward staff must check the expiry date of the emergency box on a weekly basis. The emergency boxes may be obtained in two ways: F1. Pharmacy Distribution Section F1.1 One week prior to the expiry of the box or following the use of any item from the box an authorised member of the ward staff shall telephone the pharmacy distribution section or notify the technician/assistant completing the top-up and request a replacement box. Pharmacy staff will also check the expiry of the boxes and identify ‘expiring’ boxes for replacement F1.2 The used or ‘expiring’ box should be returned to the pharmacy distribution for replacement during Pharmacy opening hours. It should be returned by a ward staff member. A replacement box shall be sent to the ward on the next porters round (or if required immediately the ward staff member may wait for a new box to be issued). F2. Outside normal pharmacy hours F2.1 Spare ADULT blue and black boxes can be obtained from the ‘Emergency Drug Cupboard (EDC)’ located in the pharmacy outpatient waiting area. Contact Site Manager (218 bleep) and Security for access. This method of supply should only be necessary to replace boxes that have been used in an emergency and the ward does not have enough complete boxes available until Pharmacy is open again F2.2 Boxes must never be ‘borrowed’ from other clinical areas F2.3 Leave the used box for return to pharmacy Distribution by the Pharmacy porter or a staff member on the next working week-day - 31 - G. ORDERING MEDICINES PREPARED IN THE PHARMACY PRODUCTION UNIT The pharmacy Production Unit is able to prepare a range of patient specific medicinal products such as Total Parenteral Nutrition (TPN), Cytotoxics, IV additives (CIVAS), dermatologicals and oral liquid preparations G1. TPN G1.1 Referrals to commence new patients on TPN must be directed to the TPN team, by a doctor, before 12:00 Monday - Friday only (Dietician bleep 099 or Pharmacist bleep 493) G1.2 The team visit the patients and order the required regimen based on each patients' daily nutritional requirements G1.3 Any queries regarding the supply of TPN should be directed to the pharmacy Production Unit (Ext: 5699) G1.4 The Infection Control Nurse may be contacted for advice on all nursing aspects of TPN e.g. dressings, line care G1.5 TPN is not an emergency, hence will not be dealt with outside normal pharmacy opening times G1.6 Prepared TPN bags will be delivered to the ward and left in the refrigerator before 17:00 hours each weekday G1.7 TPN infusion should be started within 6 hours of delivery and must not run for longer than 24 hours unless it is clearly stated on the label that the bag is to run over a period longer than 24 hours G1.8 TPN will be prepared for named patients and must be administered only to that patient G2. CIVAS G2.1 Some antibiotics are prepared by the pharmacy Production unit staff under aseptic conditions and are ready to be administered directly to patients by nursing staff G2.2 The ward pharmacist will advise nursing staff of which preparations are made by pharmacy and will ensure that the order is placed. G2.3 CIVAS preparations are delivered to the wards and left in the fridge before 17:00 hours each weekday. G2.4 Antibiotics prepared for a named patient must be administered only to that patient - 32 - G3. All other preparations, including Cytotoxics & extemporaneously prepared medicines G3.1 As products may take some time to prepare, items must be ordered on a weekday at least 24 hours in advance of administration wherever possible G3.2 The procedure for ordering non-stock medicines must be followed G3.3 The manufacturing service is only available weekdays. Weekend orders will not be able to be filled until the next working day G3.4 Medicines prepared for a named patient must not be administered to other patients H. ORDERING CONTROLLED STATIONERY This includes all stationery which could be used to obtain medicines fraudulently. Such stationery may only be ordered by authorised staff H1. Pharmacy Request Slips H1.1 A new pad must be ordered when ten slips are left on the current pad H1.2 A new pad must be ordered using a request slip H1.3 The order must be signed (using full signature) and dated by an authorised practitioner, with the name and designation printed clearly under the signature H1.4 The request slip may be given to the ward pharmacist/technician or sent to the pharmacy dispensary in a pharmacy Envopak® H2. Stock Requisition Books for ordering stock medicines H2.1 A new book will be issued on completion of the final page of the existing book. The used book will be returned to the ward and this must be stored on the ward for at least 12 months before being discarded H2.2 Lost or spoiled books may be replaced by contacting pharmacy distribution H3. Controlled Drugs Order Books H3.1 Pharmacy will issue a new order book when no order sheets are left in the book. Speak to the dispensary manager to order a new book before the current book is finished discussing reason for request. The used book will be returned to the ward and this must be stored on the ward, in a secure place, for at least 24 months before being destroyed. - Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. H3.2 The new book must not be used for ordering drugs until all orders in the old book have been completed. - 33 - H4. Controlled Drugs Registers H4.1 These can be requested by contacting the dispensary manager. The used Register must be stored on the ward, in a secure place, for at least 24 months before being destroyed H4.2 Theatres use a Controlled Drugs Register specifically designed to record administration of part ampoules and wastage. The appropriate CD register must be used in individual theatres. H5. In-patient Prescription Charts H5.1 In-patient prescription charts must be ordered from the Supplies Department on an approved order form H5.2 The order must be signed (using full signature) and dated by an authorised member of staff. H6. FP 10(HP) & FP 10(PCD) H6.1 Requests to hold supplies of FP 10(HP) or FP 10(PCD) prescription forms must, in the first instance, be made in writing to the Chief Pharmacist (Head of Department) stating: - the location of the clinical area - the reason for requiring FP10(HP) or FP10(PCD) prescriptions - an estimate of the monthly usage H6.2 Supplies shall only be approved if the Chief Pharmacist is satisfied that patients will suffer undue inconvenience if their medicines cannot be prescribed in this way H6.3 If the criteria for supply are met, the Chief Pharmacist shall confirm, in writing, that a designated number of FP 10(HP) or FP 10(PCD) forms may be supplied to the clinical area per month. A copy of the letter shall also be sent to the dispensary manager H6.4 When the first supply of the forms is required an authorised member of staff must take the clinical area copy of the letter to the Pharmacy dispensary and sign for receipt H6.5 Each set of prescriptions is issued with an accompanying form which must be completed each time an FP10(HP) or FP 10(PCD) is issued. Once all the prescriptions have been issued, the form must be signed (using full signature) and dated by an authorised practitioner, with the name and grade printed clearly under the signature and taken to the Pharmacy dispensary for a further supply. Receipt must be signed for by the authorised practitioner who is responsible for Controlled Stationery in the Clinical area. H7. Out-patient Prescription Forms & GP referral letters H7.1 Out-patient prescription forms & GP referral letters must be ordered from the Pharmacy Distribution on headed note paper H7.2 The order must state clearly: - the location of use - 34 - - the quantity required the date H7.3 The order must be signed (using full signature) by an authorised practitioner, with the name and grade printed clearly under the signature H7.4 The prescription forms must be collected by an authorised practitioner, or delivered by Pharmacy Distribution staff, and receipt must be signed for For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) Changes in the Management of CDs affecting Pharmacists. RPSGB June 2006 - 35 - 3. SUPPLY, TRANSPORT AND RECEIPT A. OBTAINING SUPPLIES OF, OR ADVICE ON, THE USE OF MEDICINES OUTSIDE NORMAL WORKING HOURS An on-call pharmacist is available via an air-call bleep outside normal Pharmacy opening times. The pharmacist is available for advice on all aspects of the use of medicines and to supply urgently required medicines, which are not otherwise available - On weekdays the hours are - before 08:30 and after 18:00 hours. - On weekends and Bank Holidays the hours are – before 10:30 and after 13:30 hours. A1. To obtain advice on the use of medicines A1.1 Contact the Site Manager (218 bleep) for initial advice. If the pharmacist is required contact Switchboard and ask them to air-call the duty pharmacist A1.2 On receipt of a call, the pharmacist must ring the hospital and ask to be connected to the caller A2. To obtain emergency supplies of medicines A2.1 Check whether the medicine is stored in any of the emergency storage areas in the hospital (see procedure for obtaining medicines from the emergency cupboard) A2.2 If the medicine is not kept in one of these locations or there are insufficient quantities, contact the Site Manager who will provide information on alternate locations A2.3 If the medicine cannot be located then the Site Manager will recommend Nurse in Charge of the ward contact the on-call pharmacist via switchboard for advice on how to obtain supplies of the medicine A2.4 If the medicine is a Controlled Drug refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. B. OBTAINING SUPPLIES OF MEDICINES FROM THE EMERGENCY DRUGS CUPBOARD Small stocks of medicines which may be required outside normal working hours are kept in the emergency drugs cupboard (EDC) located in the Pharmacy outpatients waiting area or the emergency drugs refrigerator, located in A&E. It is the responsibility of the ward requiring the medicine to arrange supply. Records must be kept of issues to ensure that the stocks are replenished promptly by pharmacy staff. Complete the log, kept in the EDC, of what is taken giving details of ward, patient information, hospital number and consultant. - 36 - B1. Obtaining supplies of drugs or IV fluids from the EDC or ED- fridge B1.1 Check whether the medicine is stored in either the EDC or ED-fridge by referring to the stock lists in the Pharmacy Information File which is kept on every ward. Contact the Site Manager (218 bleep) for advice on other clinical areas a drug may be kept B1.2 A qualified member of the ward staff (not a porter) shall then proceed to contact Security and request access to the EDC or ED-fridge. The security officer should satisfy him/herself of the identity of the person collecting the medicines and if in doubt check with the relevant ward B1.3 Locate the medicine in the cupboard and remove the required quantity of full containers. A second person should check the correct item is taken and suitable checkers would be another qualified nurse from the ward or the Site Manager (218 bleep) B1.4 Record the details of what has been removed in the record logs which are kept in the EDC and ED-fridge. Ensure full details including patient name, hospital number, consultant and ward are recorded B1.5 Relock the EDC or ED-fridge and return the keys to the security officer. B1.6 On the next working day, a member of the pharmacy staff shall check the cupboard/refrigerator and replenish stocks. On the following morning ensure all further supplies necessary for continued care of the patient(s) are obtained from the pharmacy during opening hours. C. OBTAINING MEDICINES FROM ANOTHER WARD OR CLINICAL AREA Obtaining supplies of medicines from another ward or clinical area is only permitted outside normal pharmacy hours and if the medicine is not available from the EDC or ED-fridge. At all other times, medicines must be obtained from the pharmacy. Non-stock medicines must not be supplied to another ward but obtained from the EDC or via the on-call pharmacist. Supply of single doses may be permitted in emergency situations. C1. Obtaining supplies of medicines from another ward/clinical area C1.1 Identify a ward from which the medicine may be obtained. The Site Manager would be available for advice C1.2 Contact the nurse in charge of the supplying ward/clinical area to ascertain whether sufficient stocks are available. They may ask to see the drug chart. C1.3 Send an authorised member of the ward staff (with the drug chart) to collect the medicine from the supplying ward/clinical area C1.4 The nurse in charge of the ward requiring the drug must inform the ward pharmacist or pharmacy distribution the on next weekday, giving details of the transfer of stocks, to ensure replacement stock is charged appropriately Controlled Drugs – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. C1.5 - 37 - D. TRANSPORT OF MEDICINES FROM PHARMACY TO CLINICAL AREAS AND OFFSITE UNITS The safe and secure transport of medicines is essential to minimise risks to the handler and reduce the likelihood of damage to or abuse/unauthorised use of the medicines. Transport in sealed containers is intended to remove, from the messenger, the responsibility for the contents D1. Transport from pharmacy to clinical areas D1.1 All medicines shall be transported in sealed containers manufactured from a material suitable for this purpose D1.2 Liquids in glass bottles shall be placed in a sealed plastic bag to minimise contamination of other products, if damaged. Large quantities of glass bottles transported in ward stock boxes do not need to be placed in sealed plastic bags D1.3 Toxic medicines shall be transported in a separate, sealed container, which indicates the type of hazard D1.4 Items requiring refrigeration shall be transported in a sealed plastic bag marked 'Medicines for refrigeration', ‘Fridge item enclosed’ or similar. See the Pharmaceutical Cold Chain Policy for further information. D1.5 Controlled Drugs – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. D2. Transport from pharmacy to off-site units D2.1 All medicines shall be transported in sealed containers manufactured from a material suitable for this purpose D2.2 Liquids in glass bottles shall be placed in a sealed plastic bag to minimise contamination of other products, if damaged. Large quantities of glass bottles transported in ward stock boxes do not need to be placed in sealed plastic bags D2.3 Toxic medicines shall be transported in a separate, sealed container, which indicates the type of hazard D2.4 If necessary, items requiring refrigeration shall be transported in cool boxes packed with freezer packs. The cool boxes will be marked 'Medicines for refrigeration'. The items shall either be placed in the cool box in a sealed container or the cool boxes shall be sealed with tape prior to issue. See the Cold chain policy for further information. - 38 - E. TRANSPORT OF MEDICAL GASES See EHT Medical Gas Policy (Current) for further advice Handling of Medical Gases during transport Medical gas cylinders contain highly pressurised gases which may explode if handled inappropriately - Cylinders must, at all times, be handled in a manner which prevents damage to the cylinder and/or risk of explosion - Smoking is not permitted at any time when transporting cylinders. - Individual cylinders must be transported in the designated trolleys. - A trolley of the appropriate size must be selected. - Bulk quantities of cylinders must be transported in a way which prevents rolling and knocking. They must not be transported in an upright position unless the securing method prevents them from falling over. - When transported in a car or van, cylinders must be secured firmly using straps or chains, preferably in the back of the van or in the boot of the car. - All transport vehicles must display a sign indicating that they are carrying compressed gases. - Cylinders must not be left unattended at any time during transport unless they are stored in a transport vehicle. F. DELIVERY & RECEIPT OF MEDICINES All delivered medicines must be checked and stored in their appropriate areas, as soon as possible, after delivery. Envopak® bags must be opened immediately by an authorised person on a ward to ensure: - Items which are urgently required are received by those who need them - Patients waiting for TTAs, before discharge, can be discharged and transport ordered as soon as possible, to avoid any delays - Refrigerated or Cytotoxic drugs are stored appropriately - Controlled Drugs are signed for and locked away appropriately – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. F1. Stock Medicines Upon receipt of stock medicines, the delivery note must be checked against the order received. Any discrepancies must be recorded on the delivery note and pharmacy distribution must be informed, to correct any discrepancies. After the checks, the delivery note is to be signed and filed in a designated place and stored for 24 months before being destroyed. F2. Discharge Medicines (TTAs) F2.1 Upon receipt of a patients’ completed TTA supply, the nurse caring for the patient must check the medicines supplied against the discharge letter. F2.2 - In some cases some or all of the discharge medicines prescribed may not be supplied against a TTA. eg. The patient has a sufficient quantity at home. The patient has their own supply (POD) in their bedside locker. This must be returned to them with the rest of the dispensed items - 39 - - The patient is being discharged to a facility which keeps stocks of bulky items (ie lactulose) The item is not available at the time of discharge but an arrangement has been made to obtain further supplies Such variations should be clearly endorsed by the pharmacist on Epro which will be reflected on the discharge letter printed by nursing staff. F2.3 If the patient is not leaving immediately the medicines must be stored in a secure area – either a locked cupboard or a locked bedside locker F2.4 Controlled Drugs must be secured in the Ward CD Cupboard until the patient is discharged refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. F3. Delivery to a ward/clinical area by the Pharmacy porter F3.1 A record of all medicines, delivered by the Pharmacy porter, must be kept on ‘The Ward Delivery Signature log’ detailing: - The date - Ward/clinic name - Description (i.e. number of sealed Envopak® bags or CDs) - ‘Received for delivery by’ F3.2 When the sealed containers reach the ward/clinical area, an authorised person must complete the: - Time received - ‘Received on ward by’ sections of the delivery log F3.3 The Delivery log must be returned to Pharmacy Dispensary at the end of each porters delivery round, where it will be stored in the designated place for 24 months. F4. Transport and receipt of Certain Categories of Medicines - Controlled drugs (CDs) – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. - Cytotoxic preparations – See Chapter 8 Section F F4.1 Porters/messengers must sign that they are taking receipt of CDs for transport from Pharmacy to another area. A signature is required on the white copy of the CD requisition. F4.4 Wards or clinical areas receiving supplies from the porter/messenger must sign for receipt of delivery on the delivery log and on the pink copy of the CD requisition once the delivery is checked. F4.5 It is NOT the responsibility of the porter/messenger to wait whilst deliveries of drugs that are not CDs are checked, however they must ensure that the delivery log is appropriately signed so an audit trail can be maintained. F4.6 Cytotoxic preparations must be transported in clearly labelled, sealed, containers. Warning labels must be applied to the container to alert the porter/messenger and - 40 - the recipients, to the nature of the contents, to ensure appropriate measures can be made for safe transport and cleaning in case of spillage F5. Delivery to an off-site hospital or clinical area by hospital transport F5.1 All medicines delivered to off-site hospitals or clinical areas shall be received by an authorised member of staff who shall sign for receipt F5.2 It is the responsibility of the person receiving these categories of medicine to check the medicines for correctness and suitability for use (i.e. no physical damage in transit) and to contact the pharmacy if there is an error F5.3 The driver shall be asked to sign for receipt of the medicines for transport in a book kept in the Pharmacy F5.4 On receipt of the medicines an authorised practitioner must sign the 'received by' section of the delivery note and return it to pharmacy within 24 hours F6. Collection from pharmacy by ward/clinical area staff. - Cytotoxic preparations – See Chapter 8 Section F F6.1 The 'messenger' must be a member of staff (or regular volunteer) with clearly displayed identification badge. They may be asked to sign for receipt of the medicines F6.2 Staff collecting Controlled Drugs for supply to the ward will sign the white copy of the CD requisition to indicate they accept the drugs for transport. Once on the ward the pink copy should be signed by an authorised member of staff to indicate receipt on the ward. The CDs should then be entered into the CD register. – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. F6.3 Staff collecting TTA or Outpatient supplies of medicines for a patient, which includes a Controlled Drug, must be a member of staff (or regular volunteer) who works in the clinical area and they must clearly display their identification badge. The person should be ‘known’ to the pharmacy staff and they may be asked to sign for receipt of the medicines. Pharmacy may refuse to supply the medicines if there is any doubt about the identity of the messenger F7. Samples F7.1 No samples of medicinal products or clinical trial materials may be accepted in clinical areas other than via the pharmacy department or with pharmacy approval F7.2 Pharmaceutical company representatives who wish to leave samples must be asked to contact pharmacy F8. Defective or broken items F7.1 All goods must be checked for physical damage by an authorised member of staff. The section of pharmacy where the supplies came from should be contacted if there is a problem and to arrange a replacement - 41 - F7.2 The medicine should be returned to pharmacy if found to be defective. If damaged, it can be disposed of in accordance with the Hazardous Waste (England & Wales) Regulations 2005. G. DEALING WITH MEDICINES BROUGHT INTO THE HEALTHCARE SETTING BY PATIENTS OR CARERS G1. General principles G1.1 Medicines brought in by patients are the property of the patient and must not be destroyed or disposed of without the agreement of the patient or their representative. Supplies of these Medicines, which have been appropriately checked, are administered to the patient during their stay and if there are sufficient supplies, may be returned to them on discharge as part of their TTA supply G1.2 - However, there are situations where it may be potentially harmful to the patient to return their medicines to them: the medicines cannot be positively identified and cannot, therefore be regarded as safe to use. the patient's therapy has changed and continued custody of their previous medication could lead to confusion and possible inappropriate therapy. In these circumstances, following discussion between a pharmacist and a medical practitioner/nurse, the medicines may be destroyed. The patient/carer must be informed and consent given. (See Ch.4 - Section M on disposal of medicines) G2. Receiving ‘Patients’ Own Medicines’ (PODs) G2.1 All medicines received by the admitting doctor/nurse must be placed in a plastic bag labelled with the name of the patient and stored in an area designated for patients' own medicines. All Controlled drugs must be stored in the CD cupboard – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. G2.2 If any of the medicines are not available within the healthcare setting, the patient's own medicine may be used, provided it can be positively identified. (See ‘Procedure for identifying and checking suitability of patients own medicines’) G2.3 On the next ward visit, the ward pharmacist will check all patients' own medicines. If the medicines are suitable for use they will be labelled accordingly and are then able to be administered to the patient while on the ward. G3. Storage of patients own medicines As a result of the above action, the medicines may be dealt with in one of six ways: G3.1 Store in the Clinical Area: Store the medicines in the designated secure storage area in the ward/clinical setting until returned to the patient/carer prior to or upon discharge or send with patients to transferring ward G3.2 Store in a locked bedside cabinet for administration to patient on ‘Dispensing for discharge wards’. This applies only to medicines which will be used in the healthcare setting in the circumstances outlined in Chapter 3 Section G4 - 42 - G3.3 Store in the medicines trolley or medicines fridge. This applies only to medicines which will be used in the healthcare setting in the circumstances outlined in Chapter 3 Section G4 G3.4 Return Medicines to home. The medicines may be returned home via an identified adult (older than 16 years) if the patient declines the use of suitable PODs G3.5 Destruction on ward in accordance with the Hazardous Waste (England & Wales) Regulations 2005. The patient/care-giver must give consent before medicines are destroyed and this permission must be noted in the nursing or medical notes. Send to pharmacy medicines which cannot be positively identified for appropriate destruction G3.6 Store in a Controlled Drugs cupboard. Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. G4. Use of Patient's own medicines (PODs) in the clinical setting G4.1 PODs may be used once they have been checked by a Clinical Pharmacist and labelled accordingly. On evenings and weekends, if a pharmacist has not checked the PODs and an alternative supply is not available in the ward or clinical area, doses may be administered to patient provided they can be positively identified (See ‘Procedure for checking the identity and suitability of medicines brought into the healthcare setting by patients’) G4.2 PODs remain the patient’s property and under no circumstances should they be administered to other patients G4.3 The permission of the patient must be sought before the medicines are used G4.4 Upon discharge, the medicines are returned to the patient, if appropriate, and further supplies may be issued, if required, as part of the TTA supplies H. CHECKING THE IDENTITY AND SUITABILITY OF MEDICINES BROUGHT INTO THE HEALTHCARE SETTING BY PATIENTS/CARERS Patients' own medicines must only be used in healthcare settings if they can be positively identified. A Clinical Pharmacist assigned to the ward will check the PODs and label supplies as able to be safely administered. Prescription charts will be endorsed with an indication of quantity. It is essential that the patient’s confidence in their GP or Community Pharmacist is not undermined by this process. If medicines cannot be positively identified, the patient must receive a clear explanation of the reasons why. Permission should be sought to destroy these medicines. H1. Assessment of patient's own medicines Medicines may be designated as suitable for use if: H1.1 The container is labelled with the patient’s name - 43 - H1.2 The name, strength and form can be positively confirmed H1.3 They are presented in a clearly labelled container issued from a community pharmacy or hospital pharmacy with a date of dispensing not more than 3 months ago and all medicines in the container are identical H1.4 Medicine presented in a foil or strip pack with the name of the medicine and an expiry date marked on the strip may only be used after confirmation that they are still appropriate. Loose strips may be re-labelled and boxed by pharmacy if necessary H1.5 Open sterile products (eg eye drops) can only be used if confirmation can be obtained that the seal has been broken for no longer than the manufacturer’s recommendation H1.5 The medicine is in good condition with no evidence of deterioration H2. Outside normal working hours If there is any doubt as to the identity or suitability for use of the medicine then it should not be administered. The on-call pharmacist may be contacted for advice. I. SUPPLY OF MEDICINES TO PATIENTS FOR USE OUTSIDE THE HOSPITAL Patients often require a supply of medicines to continue or initiate treatment outside the hospital or clinical setting I1. Giving TTA supplies to in-patients before discharge I1.1 Medicines will be dispensed against a discharge letter by pharmacy. Quantities of medicines supplied against a TTA would be: - Regular medicines; Two weeks although often up to a month is given - Short courses; Total course supplies of courses of drugs such as antibiotics or steroids - ‘When Required’ Meds: Small supply of a single packet of drugs such as analgesics I1.2 The TTA supply must have been FINAL checked by a pharmacist. All TTA supplies which come from pharmacy have been FINAL checked. If the patient is on a Dispensing for Discharge ward the supply may have been FINAL checked on the ward. Under no circumstances must any supply of medicines be made to a patient against a discharge letter unless it has been dispensed and labelled for that patient AND this has been FINAL CHECKED I1.3 When a patient is due to be discharged a trained staff member must counsel the patient and/or carer, on the appropriate use of the medicines. The staff member would usually be a Registered Nurse but may also be a Pharmacist, Pharmacy Technician, Nursing student (under direct supervision) or Medical Practitioner I1.4 If any of the medicines are Controlled Drugs the staff member must be sure of the identity of the person taking possession of the medicine. If the patient is not known - 44 - to them or the person collecting the CD is a relative or carer the staff member must ask to see proof of identity– Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. I1.5 The staff member should work down the list of medication on discharge letter, checking the medicine supplied matches what is written on the letter and all are correct and available. Correct use, common adverse effects and what to do if there are problems should be discussed. I1.6 Upon nursing staff ‘issuing’ the discharge medication on ePro two copies of the discharge letter will be printed: one for the patient and one for the medical notes. Nursing staff must attach the relevant discharge to appropriate section of the medical notes. One copy will also be sent electronically to the GP. I2. Supply of medicines on an Outpatient prescription I2.1 Outpatient prescriptions may be written by authorised prescribers, for supply of medicines to outpatients, in appropriate clinical settings: - Outpatient clinics - A&E See Chapter 5 I2.2 The Outpatient prescription form is designed to be used in one of two ways: - A letter to the General Practitioner (GP) requesting them to prescribe the medication recommended. GP referral letters are also available for this purpose - A prescription for dispensing and supply by the Ealing Hospital Pharmacy department I2.3 All patients should be referred back to their GP for their medication unless one of these reasons applies: - It is essential that Treatment must start immediately e.g. antibiotics, steroids - It is a Specialist drug and not readily available in primary care e.g. antiretrovirals - It is an Unlicensed drug – a drug without a UK product license e.g. extemporaneously prepared creams or ointments - It is a licensed drug used for an unlicensed indication (off-licensed use) e.g. - Hospital only drug or Ealing CCG ‘red list’ drug. See Appendix 3 I2.4 The patient should present the prescription to Pharmacy for dispensing (during Pharmacy opening times). Prescription charges will be charged, where appropriate, for all outpatient prescriptions. ‘Exempt’ patients will be asked to provide evidence that they are exempt from prescription charges I2.5 A pharmacist or member of the pharmacy staff who has received appropriate training, will counsel the patient or carer on the use of the medicine, possible adverse effects and drug interactions as the medicine is being given to the patient. If the supply has been sent from Pharmacy to a clinic or to A&E for supply to a patient, a Registered Nurse or Medical practitioner must appropriately counsel the patient on the appropriate use of the medicine, adverse effects and drug interactions - 45 - I2.6 If the medicine is a Controlled drug the staff member must be sure of the identity of the person taking possession of the medicine by asking for proof of identity of the patient or carer. If identification cannot be verified the staff member may refuse to supply the medicine – Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. I3. Supply of medicines according to Patient Group Directions (PGDs) Medical staff and appropriately qualified Nurses or Nurse Practitioners may supply medicines directly to patients in accordance with locally agreed and D&TG approved PGDs, which are specific to defined clinical areas. I3.1 The staff member must be authorised to supply and/or administer the medicine in accordance with the PGD I3.2 The PGDs apply to specific medicines used in defined indications. The PGD must be complied with entirely I3.3 The patient must comply with the criteria for inclusion written in the PGD. See individual PGD documents for further information. I4. Supply of Pre-packs A limited range of pre-labelled packs of medicines are available in A&E and some clinics. Guidelines are specific to the individual clinical setting and must be approved by the D&TG. I4.1 TTA packs may be supplied directly to patients by approved staff in accordance with a PGD. I4.2 TTA packs may be supplied by a doctor, or appropriately trained nurse, in accordance with a written prescription I4.3 Only pre-labelled packs can be used to supply medicines for patients to take away For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) EHT Patient Group Directions by Emergency Nurse Practitioners & Paediatric Nurse Practitioners. Accident & Emergency Department – January 2005 Changes in the management of CDs affecting pharmacists. RPSGB June 2006 - 46 - 4. STORAGE AND SECURITY OF MEDICINES IN A HEALTHCARE SETTING It is essential that all medicines are stored in designated medicine storage areas with access restricted to authorised persons only. All storage areas must be clean and approved as suitable for use by a senior member of the pharmacy staff. Responsibility for storage and security rests with the designated manager of the ward or department. All employees of Ealing Hospital ICO NHS Trust, working in either a permanent or non-permanent capacity are NOT PERMITTED to take drugs from hospital stocks for their own personal use. This also applies to intended use by working colleagues, family members or friends and relatives or visitors to Ealing Hospital NHS Trust Staff, who require access to medication during work time, should attend Occupational Health. Outside Occupational Health opening hours, staff will need to attend Accident & Emergency Relatives/visitors should be referred to Accident & Emergency also. Failure to comply with Trust policy will be viewed as a serious breach of policy and will result in disciplinary action A. GENERAL REQUIREMENTS A1.1 There shall be lockable cupboards with separately identified and segregated storage areas for the following categories of medicines: - Controlled Drugs - Internal medicines - oral medicines (tablets/capsules/oral liquids) - Rectal medicines - Injectables - External medicines and dressings - Discharge medicines to take home - Patients' own medicines - Epidural medicines - The National Patient Safety Agency (NPSA) recommends that “storage of epidural infusions is in a separate cupboard or refrigerator to reduce the risk of the wrong medicine being selected”, NPSA audit checklist for epidural medicines, March 2007. Under no circumstances should medicines be stored outside designated areas A1.2 Cold Chain Storage. A specially designed medicines Fridge (or freezer if appropriate) must be used for medicines stored below 8oC. They must be lockable and kept locked when not being accessed. Fridges should be fitted with a lock and fan-assisted cooling and have a temperature range of 2 to 8ºC. For Freezers the temperature range is -30 to -18 ºC. Fridges or Freezers must be monitored with a calibrated digital thermometer with maximum and minimum recording. Ideally the fridge should have an integrated thermometer and an audible alarm. - 47 - The DOH recommends Drug fridges are at least 500 mm × 600 mm × 900 mm and for large use areas e.g. wards using TPN, a larger fridge would be more suitable. Nominal size: 1900 × 600 × 650. Steps must be taken to ensure that the fridge/freezer is not switched off accidentally (i.e. wired directly into the socket) or labelled “Do not switch off”. On in-patient wards that store cytotoxic drugs a separate ‘Cytotoxic Fridge’ should be used. High turnover areas should consider using fridges with glass doors to improve efficiency in product selection and reduce time the door is open. See EHT Pharmaceutical Cold Chain Policy (2012) for additional information. A1.3 Medicines must be stored appropriately in lockable treatment rooms or cupboards. Cupboards must be locked when not being accessed. Cupboards when unlocked must not be left unattended for any reason. Metal cupboards (which comply with BS 2881) are recommended for the storage of medicines in areas which are not staffed 24 hours a day. Trays and baskets are considered unsuitable for storing medicines (except external medicines and dressings and IV fluids) because they do not allow medicines to be adequately segregated and clearly displayed and hence may increase the risk of incorrect medicines selection. A1.4 Separate storage must be provided for the following categories of medicines: - Intravenous fluids and sterile topical fluids - Inflammable fluids and gases; Flammable medicines should be stored in lockable metal cupboards. A risk assessment should be undertaken to ascertain whether a fire resisting cabinet is required. This will depend on the quantity and flammability of the medicines. The smallest recommended cupboard size: 400 × 400 × 300. - Epidural and intrathecal infusions and other high-risk medicines; Epidural and intrathecal infusions must be stored in a separate cupboard or refrigerator to reduce the risk of the wrong medicines being selected. See NPSA recommendations and Practice Safety Alert 21 – ‘Epidural injections and infusions’ (NPSA, 2007). As some epidural and intrathecal infusions are CDs, it is recommended that cupboards used to store these medicines be constructed to the same standard as CD cupboards. - Diagnostic reagents including urine testing - Patients Own Drugs (PODs); PODs must not be stored with ward or clinic stock medicines (or in a way where they could be confused (or mixed) with stock medicines). PODs may be stored in medicines cabinets beside the patients’ beds. Where a patient is self administering medicines (after appropriate risk assessment) the patient should have a key to their own bedside medicines cabinet to facilitate self administration of their medicines. - 48 - A1.5 Where practicable, the categories of medicines in A1.4 shall be stored in areas away from the general public or thoroughfares A1.6 Within each storage area, medicines shall be stored in alphabetical order (by generic name), where possible, and in a manner which aids location and identification A1.7 Storage areas must be kept clean and tidy at all times A1.8 Rotation of stock shall occur such that containers with the earliest expiry date are used first. This is the responsibility of the ward staff with assistance from the pharmacy distribution top-up staff A1.9 Medicines must not be transferred from an original dispensing container to another for the purposes of storage. Only pharmacy staff may dispense medicines from one container to another for the purpose of supply A1.10 Systems for delivering drugs to the patient’s bedside must be locked and immobilised when not in use A1.11 DISPOSAL AND SPILLAGE Policies and procedures on the disposal of medicines and action to be taken in the event of a spill are covered in the Health and Safety Manual and the Hazardous Waste (England & Wales) Regulations, which must be available in every healthcare setting. For Cytotoxic spills also see Chapter 8 Section F B.MEDICAL GASES See EHT Medical Gas Policy 2012 (current update) for full details B1.1 Medical gases must be kept away from stocks of combustible materials and sources of heat, in a well ventilated area where smoking and naked flames are prohibited B1.2 Wherever possible, they shall be placed in an area near to an exit to allow rapid removal in an emergency B1.3 Large cylinders (Size F and above, except ENTONOX®) must be stored vertically B1.4 Small cylinders must be stored on shelves that will not damage the surface paintwork of the cylinders B1.5 All ENTONOX® cylinders must be stored horizontally at a temperature above 10oC. If this is not possible, the cylinder must be allowed to warm up and be inverted several times prior to use. B1.6 All cylinders must be stored in a secure manner either in stands or by securing to a wall with chains or straps. C. INTRAVENOUS (IV) FLUIDS AND STERILE TOPICAL FLUIDS C1.1 The storage area must be clearly labelled to distinguish between IV and topical fluids. C1.2 The containers of fluids must be stored off the floor, either on pallets, shelves, or in specially designed storage boxes. Lockable closed storage units with trays or baskets - 49 - or open shelving can be used for bulk storage of IV fluids (for example boxes of 20 or 50 bags). Where open shelving is used, it should be located in a locked room. Ensure there is adequate protection from light C1.3 Fluids must not be stored above head height to prevent possible injury to handlers D. KEYS D1.1 Keys for each lock should be kept as part of a set ‘in use’ on a ward at any time (except for bedside drug storage lockers – see D1.7). The keys should be kept on the person in charge of the ward or a nominated deputy at all times. Stock medicines cupboards (except CD cupboards) on each in-patient ward should have locks that use identical keys. Multiple key copies may be available, to reduce the time needed for authorised staff to unlock the cupboards. Locking mechanisms other than keys may be used, except for CD cupboards, provided they comply with BS 3621, where appropriate. Where keypads, electronic keys or swipe cards are used to open medicines cupboards, systems should be in place to ensure codes are regularly changed or swipe cards updated (for example following an incident or staff dismissal) and dissemination of codes are restricted on a ‘need to know’ basis. Doors should lock automatically on closing. Locks for metal cupboards must comply with BS 3621. D1.2 The keys should never leave the ward except in an emergency e.g. evacuation or when the ward is closed D1.3 Drug keys (medicine cupboards and medicine trolley) must be kept on the person of a qualified nurse at all times unless an alternative local procedure has been agreed D1.4 Controlled Drug cupboard keys – a number of stipulations exist. Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy D1.5 Controlled drug keys may be given to other authorised staff, when required, for legitimate purposes but responsibility for the custody of the keys and the medicines remains with the nurse in charge D1.6 A student nurse must not accept custody of the Drug keys or the Controlled Drugs keys, except in exceptional circumstances agreed between the local manager and the educational body D1.7 Keys for bedside drug storage lockers may be kept separate from the rest of the keys, according to locally agreed procedure, if necessary for ease of use. Each bedside medicines cabinet should have a unique key, within that ward, with a master key for that ward required for nursing (and visiting pharmacy) staff. The qualified nurse in charge of each ward bay is responsible for the security of the keys. The Ward Pharmacist may also be permitted to hold a key to open the bedside drug storage lockers. - 50 - D1.8 Spare keys, if kept, should be locked in the Ward Managers office and not accessible to ward staff D1.9 Loss of Keys The loss of keys must be immediately investigated by the nurse in charge who must, in turn, report the loss at once to the senior nurse/manager. (This includes situations where it is believed that keys have been taken home, in error, by a nurse on a previous shift and that nurse cannot be contacted). If the keys cannot be located, contact Estates to arrange for locks to be changed. A Clinical incident (DATIX) form, describing the situation, should be completed. Pharmacy should be informed at the beginning of the next working day. If the loss of keys is related to theft of Controlled Drugs, Pharmacy should be informed immediately by contacting the Chief Pharmacist (or Acting head of department) or bleeping the on-call pharmacist, if out-ofhours. E. EMERGENCY MEDICINES BOXES E1.1 The contents of these boxes are determined by the Resuscitation Committee E1.2 The boxes must be stored in an area which is readily accessible to users, but out of the immediate view of the general public E1.3 They are supplied with a tamper-evident seal. Each time the seal is broken, the box, any unused contents and the internal packing, must be returned to pharmacy E1.4 It is the responsibility of the ward staff to ensure that the boxes are in date. Expired boxes are to be returned to pharmacy distribution for replacement. See Chapter 2 Section F For further information see ‘The emergency medical treatment of anaphylactic reactions for first medical responders and for community nurses- Resuscitation council UK – 2010’ http://www.resus.org.uk/pages/guide.htm F. MEDICINES NO LONGER REQUIRED Medicines dispensed for individual patients who have been discharged; expired stock medicines and unused discharge medicines must be stored in a secure place prior to return to pharmacy. F1.1 Medicines no longer required in the clinical area must be stored in a designated restricted-access area prior to return to pharmacy F1.2 Ask the pharmacy technician to remove the medicines and return them to pharmacy or arrange for a porter to collect any bulky items (inform pharmacy distribution of the arrangements) F1.3 Medicines no longer required must not be returned to pharmacy using the Envopak® collection or over weekends or Bank Holidays - 51 - F1.4 Medicine for return to pharmacy must not be stock-piled in clinical areas. F1.5 Some medicines may be destroyed on the ward, on instruction of Pharmacy staff. Destruction must comply with the Hazardous Waste (England & Wales) Regulations 2005. F1.6 Controlled drugs must always be kept in a locked CD cupboard. Ask the pharmacist to return the CDs to dispensary stocks or to the dispensary for destruction. Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. G. STORAGE AND SECURITY OF TOTAL PARENTERAL NUTRITION (TPN) ADMIXTURES AND CYTOTOXICS C. It is essential that these medicines are stored in designated storage areas with access restricted to authorised persons only. D. All storage areas must be approved as suitable for use by a senior pharmacist. E. Storage areas must be kept clean and tidy at all times. F. Rotation of doses shall occur such that containers with the earliest expiry date are used first. G1. TPN Bags G1.1 These must be stored in a designated medicines refrigerator, or in an area designated for TPN within the medicines refrigerator G1.2 The TPN bag must be allowed to reach room temperature prior to use G1.3 Unused TPN bags must be returned to the refrigerator immediately and the pharmacy production unit informed the next working day. Under no circumstances should unused TPN bags be left out of the refrigerator or disposed of on the ward G1.4 The balance of partially used bags should be disposed of in an appropriate ‘sharps’ bin. Sealing the bag inside another plastic bag is recommended to stop spillage G2. Injectable Cytotoxic Drugs G2.1 These must be stored in either: - an area designated for cytotoxic drugs requiring refrigeration, within the medicines refrigerator or - an area designated for cytotoxic drugs within a lockable medicines cupboard G2.2 All unused cytotoxic preparations must be kept in the correct storage area then returned to pharmacy the next working day G2.3 The storage of intrathecal cyctotoxic doses is governed by the stipulations in the Trust Intrathecals Policy (see the intranet). H. STORAGE AND SECURITY OF MEDICINES IN THE MEDICINES TROLLEY OR BEDSIDE DRUG STORAGE LOCKERS Medicines stored in the medicines trolley or bedside drug storage lockers should consist of the working stock for the clinical area plus any medicines dispensed for individual patients. - 52 - It is the responsibility of the ward staff to ensure the following: H1.1 The medicines trolley or bedside drug storage lockers must be locked and immobilised, when not in use, to prevent access by unauthorised persons H1.2 They must not be left unattended at any time during use H1.3 The 'trolley' must be of adequate size and design to allow storage of all medicines required on a medicines administration round. Bedside drug storage lockers must be adequate to contain the medicines required by most patients. In unusual cases it may be necessary to store additional medicines for patients using many medicines or ‘bulky’ medicines in a designated locked cupboard H1.4 Medicines must not be stored underneath, or in any non-lockable part of the trolley. Bedside drug storage lockers are fixed to bedside cabinets used for storage of clothes and personal items. Medicines must not be stored in these parts of the cabinet H1.5 The medicines shall be stored in a manner which aids location and identification H1.6 The trolley must be kept clean and tidy at all times. Bedside drug storage lockers must be thoroughly emptied and cleaned between patients I. STORAGE AND RETENTION OF ORDER AND RECORD BOOKS USED IN CONNECTION WITH MEDICINAL PRODUCTS Any order books or record charts which could be misused by unauthorised persons must be stored in a secure manner in clinical areas. In addition, completed order and record books must be stored for a period 24 months, prior to destruction I1. Controlled stationery The term controlled stationery includes: - Medicines administration charts - Controlled drugs order books - Controlled drugs registers - FP 10(HP) & FP 10(PCD) prescriptions - Discharge medicines letters - Out-patient prescription forms - GP Referral letters I1.1 Unused controlled stationery must always be stored in a locked secure area in a manner which aids location and identification I1.2 It is the responsibility of the clinical area manager to ensure no unauthorised persons have access to controlled stationery I2. In Use Controlled Stationery I2.1 Medicines administration charts to be stored in a central file or end of patient’s bed I2.2 Controlled drugs order books and registers must be stored within the controlled drugs cupboard - 53 - I2.3 Discharge medicines letters and out-patient prescription forms in a secure and staffed area, out of view of the general public I3. Completed order books and administration books I3.1 All completed CD order books and CD registers must be stored in a designated locked area on the ward for a period of 24 months I.2 At the end of the 24 month period, they shall be disposed of in accordance with the procedure for disposal of Confidential Waste I4. FP 10(HP) & FP 10(PCD) Prescriptions I4.1 All full and part used FP 10(HP) or FP10 (PCD) prescriptions must be stored in a locked cupboard I4.2 When required, only the quantity of sheets needed should be removed from the cupboard. The patient’s name must be recorded against the sheet number on the form attached to the book J. ACTION TO BE TAKEN BY STAFF WHEN PERSONAL SAFETY IS THREATENED WHILST THEY HAVE RESPONSIBILITY FOR MEDICINES The safety of staff is paramount at all times. Staff should not risk their personal safety if confronted by threatening behaviour. J1.1 Assess the situation carefully J1.2 If threatened physically in any way one or all of three courses of action may be taken: - Shout for help - Depart rapidly from the scene - Hand over the medicines J1.3 In all cases, report the incident to your line manager and Security immediately. Security will inform the Police, as appropriate J1.4 The line manager must then inform senior managers, as appropriate K. STORAGE AND SECURITY OF MEDICINES DURING WARD AND DEPARTMENTAL CLOSURES A ward or department may close for a very short period of time e.g. over a weekend, for a longer period when there is a schedule for re-opening, or when there is no schedule for reopening. If a ward, or clinical area, is closing for refurbishment or building work then the closure must be treated as a ‘Closure for more than 7 days with a re-opening schedule’ regardless of the actual length of closure K1. Closure up to 7 days - 54 - The area must be locked and secure. No access by any persons, to any area, is permitted during the time the ward is closed K1.1 Controlled Drugs Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. K1.2 Other Medicines K1.2.1 Other medicines may be left in locked medicine cupboards if ward security is satisfactory to the nurse in charge and ward pharmacist K1.2.2 Medicine cupboards must be checked to ensure that they are securely locked and the keys are locked in the appropriate key cupboard or in accordance with local procedures relating to key security. K2. Closure for more than 7 days with a re-opening schedule K2.1 Controlled Drugs Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. K2.2 Other Medicines K2.2.1 Other medicines must be sealed in the ward stock box or another suitable container supplied by pharmacy K2.2.2 The medicines must be stored in pharmacy until the ward re-opens K2.2.3 If a ward is to re-open at a weekend the medicines, including Controlled Drugs, may be returned to the ward on the nearest available weekday providing the security of the ward is satisfactory to the nurse in charge and the ward pharmacist K3. Closure with no re-opening schedule K3.1 Controlled Drugs Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. K3.2 Other Medicines 3.2.1 All other medicines must be returned to pharmacy where, if appropriate, they will be credited to the appropriate cost centre and returned to pharmacy stock. L. MEDICINES REQUIRING REFRIGERATION Refer to Ealing Hospital NHS Trust Cold chain Policy 2010 for further information L1. Storage L1.1 Manufacturers’ recommendations on storage must be observed and care should be taken to ensure that, on receipt, medicines needing cool storage are immediately placed under the required storage conditions - 55 - L1.2 Medicines received from pharmacy which need to be stored in a fridge will be labelled “Store in a refrigerator” L1.3 The designated manager in each area is responsible for the safe storage of medicines requiring cool storage. L2. Storage conditions L2.1 Only pharmaceuticals and blood products should be stored in the medicines fridge. L2.2 All fridges must be maintained between 2 - 8°C L3. Recording of fridge temperature L3.1 A maximum/minimum thermometer must be used in all fridges. The designated manager must ensure temperature of the fridge is read and recorded. a. every day when the fridge is first opened, b. when the fridge has been accidentally switched off, c. when the fridge has been defrosted, to check the correct temperature has been reached before medicines are replaced in it L3.2 Follow manufacturer’s instructions to reset thermometer, after reading L4. What to do if the temperature is not within the recommended range L4.1 Identify all affected medicines and length of time out of range. Contact Distribution or Medicines Information in Pharmacy for advice. L5 Defrosting fridges L5.1 Where appropriate it is important that fridges are defrosted every three months to ensure they function properly. Medicines should either be: a. transferred to another fridge, which is within the temperature ranges for storing the medicines b. returned to pharmacy for temporary refrigeration When the fridge has been defrosted make sure that the correct temperatures have been reached before medicines are returned. For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) M. DISPOSAL OF MEDICINES Refer to the ‘EHT Waste Management Policy’ for full information on disposal of pharmaceuticals Medicines for disposal The majority of drugs which require destruction should be disposed of in clinical areas. These are medicines which have expired, are no longer suitable for use, damaged or are unrequired patients’ own drugs. Most medicines which need to be disposed of can be placed in the Blue bins specifically for the disposal of medicines. Blue bins are available in clinical - 56 - areas and are sent for incineration when full. Remove all packaging and place the tablets, strips of tablets/capsules or ampoules (or other dose administration form) in the Blue bin. Sharps If the waste is a ‘sharp’ it should be disposed of in a Yellow waste/sharps bin. Examples of sharps include: - Needles used for reconstitution or administration of injectable medicines - Glass ampoules which have been broken/open - Glass vials with stoppers which have been used - Insulin pens which have been used - Single use syringes eg. erythropoietin, vaccines Unopened/unbroken vials may be disposed of in blue medicines bins. Cytotoxic and Cytostatic agents Pharmaceutical waste is classed as Hazardous if cytotoxic, cytostatic or if it meets any other ‘hazardous’ criteria as stated in the regulations. All materials used in the preparation and administration of Cytotoxic drugs, all empty containers and exposed unused drugs MUST be treated as cytotoxic waste. All drug containers, giving sets, urotainers, needles and other sharps MUST be placed in the dedicated sharps bin. This should be clearly marked using "Cytotoxic Warning Tape" (this is available from Pharmacy). A bin should be available in all areas where cytotoxic drugs are being handled and administered. Gloves, masks, aprons and other non-sharp items used during the reconstitution and/or the administration process must be disposed of by "Double Bagging" in yellow clinical waste bags which must then be sealed and marked with cytotoxic warning tape. All waste may then be sent for incineration following the procedure for all clinical waste within the Trusts. Recyclables Patient specific data, such as names on medicine labels must be removed from pharmaceutical containers sent for recycling. Any recyclable waste such as paper, cardboard (cardboard boxes must be flattened after use), plastic bottles and metal (not aerosols) should be disposed of into the recycling containers provided. Bottles All glass bottles should be separated from other rubbish and placed in a box or special strength paper bags. Empty medicine bottles should be rinsed with warm water and detergent before disposal. Glass bottles should NEVER be put in plastic black bags. Aerosols containing pharmaceuticals (eg inhalers, povidone iodine spray) Aerosols containing pharmaceuticals must not be sent with other pharmaceutical waste for incineration. Separate these items, place in a plastic bag marked ‘For Destruction’, and return to Pharmacy for disposal. Controlled Drugs & Restricted medicines (CDs) (eg Opiates) See the EHT Controlled and Restricted Medicines Policy and/or speak to a pharmacist. Disposal of ‘Patients Own’ Medicines (PODs) - 57 - POD’s must never be used for other patients. PODs must be treated as the property of the patient at all times and their permission must be sought before the medicine is to be destroyed. If a patient no longer requires a medicine it should be destroyed promptly to minimise the risk of error due to inappropriate administration or re-introduction after discharge. Always ask the permission of the patient or their carer before disposing of POD’s. Advise the patient/carer to dispose of further supplies kept at home. Usually it is recommended the medicines are returned to their community pharmacy for destruction. PODs when the patient has died It is recommended that all PODs be destroyed when a patient has died. Permission must be sought from the ‘Next of Kin’ to destroy the PODs. With the exception of Controlled Drugs, the ‘Next of Kin’ may take the PODs away with the patient’s other possessions. In these cases the ‘Next of Kin’ should be advised that the PODs should not be used and of the most appropriate way to dispose of further supplies kept at home. For CD’s see EHT Controlled and Restricted Medicines Policy and/or speak to a pharmacist. Environmental Agency The Environmental Agency is charged with ensuring the Hazardous Waste Regulations are enforced and to ensure that all waste classified as Hazardous is going to a suitable site and to prevent the dumping of Hazardous material. www.environment-agency.gov.uk The Hazardous Waste Regulations 2005 require the Hospital to register with the Environmental Agency and Consignment notes for each load of waste removed must be issued by the Agency. It is therefore essential that Hazardous waste is segregated from all other waste, placed in the required receptacle and labelled so as to identify the contents. Grundon Waste Management Ltd deal with the removal and disposal of all Hazardous waste generated by the Trust. Queries about removal of waste from the Trust should be referred to: Grundon Waste Management Lakeside Rd Colnbrook Slough SL3 0EG Ph. 01753 686777 - 58 - 5. PRESCRIBING A. WRITING PRESCRIPTIONS This procedure is intended to help ensure that medicines are prescribed accurately and safely, and that prescriptions comply with all legal requirements Verbal orders are SPECIFICALLY PROHIBITED* * Meadow House – see Appendix 1 For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) EHT Non medical Prescribing Policy July 2006 - Cytotoxic preparations – See Chapter 8 Section F A1. Medical Prescribers Prescriptions for the treatment of In-patients may be written by Medical staff (pre and post registration) employed by the Trust Prescriptions for Out-patients must be written by post-registration Medical staff A2. Non Medical Independent practitioners & Supplementary Prescribers A2.1 Nurse/Pharmacist Independent Prescribers (IPs) Independent Prescribing is prescribing by a practioner responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing. Changes to regulations from May 1st 2006 enable suitably trained nurses and pharmacists to qualify as independent prescribers A2.2 Supplementary Prescribers (SPs) Supplementary prescribing is a voluntary partnership between an independent prescriber (doctor or dentist) and a supplementary prescriber, to implement an agreed patient specific Clinical Management Plan (CMP) with the patient’s agreement. There are no legal restrictions on the clinical condition that may be treated under supplementary prescribing. The Supplementary Prescriber will have completed accredited training through a higher education institution (HEI) and meet the conditions set out in the EHT Non Medical Prescribing Policy 2006 A2.3 Medicines prescribed by Non-Medical prescribers IP/SP prescribers must adhere to the Ealing Hospital NHS Trust Formulary and Good Prescribing guidelines. There is no specific formulary for supplementary prescribing. Provided medicines are prescribable by a doctor or dentist, available on the EHT Formulary and that they are referred to in the patient’s Clinical Management Plan, Non-Medical prescribers are able to prescribe: o All GSL and P and POM medicines o Appliances and devices prescribable by GP’s o Food and other borderline substances which are approved - 59 - o Medicines for use outside their licensed indications (i.e. ‘off label’ prescribing) ‘black triangle’ drugs and drugs marked ‘less suitable for prescribing’ in the BNF or BNF-C. Unlicensed drugs may not be prescribed unless they are part of a clinical trail that has a clinical trail certificate or exemption. Both out patient and in patient prescription sheets should be marked clearly with the IP/SP details e.g. (‘A Nurse IP/SP’). An individual cost code will be assigned to allow ease of identification by pharmacists and GP’s. An IP/SP can only prescribe for a patient who they have personally assessed or for whom there is a CMP. A2.4 Legal Requirements for IPs & SPs To be legally eligible to prescribe IPs or SPs must fulfil all of the following: - Be a registered nurse, midwife, pharmacist or other approved AHP - Be employed by Ealing Hospital NHS Trust - Have a valid registration on the relevant professional register (eg. NMC, RPSGB) - Successfully complete a Non-Medical Prescribing course, or appropriate course relevant to profession, including all assessments and the period of learning in practice and have registered this qualification with the relevant professional register - Be registered with the Trust as a prescriber - Their job description must clearly state that prescribing is required as part of their duties - IPs must complete the ‘Scope of Practice’ document and have it approved by the DTG In addition to fulfilling the legal criteria for eligibility to prescribe, nurses who are selected for prescribing preparation will have: - The ability to study at Level 3 (degree level) - At least three years post-registration clinical nursing experience working at Band 7 or above. In addition to fulfilling the legal criteria for eligibility to prescribe, pharmacists & approved AHPs who are selected for prescribing preparation will have: - At least two years post-registration clinical experience in Hospital and currently working at Band 6 level or above All candidates who are selected for prescribing preparation will also have the support of their line manager to confirm that: - Their post is one in which they will have the need and opportunity to act as a supplementary or independent prescriber and that prescribing should form part of their professional responsibilities - They have identified within the Trust systems to access prescription pads or other mechanisms for prescribing which are appropriate to the setting (for example patients’ drug charts in hospitals) - They will have access to a budget to meet the costs of their prescriptions on completion of the course - 60 - - They will have access to continuing professional development (CPD) opportunities on completion of the course Arranged clinical support with the supervising medical practitioner before applying for the relevant Non-Medical Prescribing course. The supervising medical practitioner must be willing to mentor them throughout the programme and work within a prescribing partnership following approval to commence prescribing. A2.5 Non Medical Prescribing Committee The Non Medical Prescribing Committee includes the Deputy Director of Nursing, the Chief Pharmacist, the Principal Pharmacist – Clinical Services, IP/SP Nurse Prescribers, and representatives from the local PCT/AHPs. Their role is to: - Advise the Drugs and Therapeutics Group (DTG) on changes in legislation in prescribing and the implications for the Trust. - Develop a trust wide framework to support and co-ordinate the development of new prescribing initiatives within the Trust - Ensure consideration is given to areas where Independent and Supplementary Prescribing could be of benefit - To ensure staff working in the Trust are familiar with changes in the legal status of prescribing, supply and administration of medicines by disseminating information throughout the Trust - To review all applicants for the IP/SP course - e.g. discuss how applications will be supported during training, how successful candidates will operate once qualified - To develop local guidance on the responsibilities of the mentor supervising the training of IP/SP - To keep a register/updated list of IP/ SPs in the Trust - Liaise with the Clinical Governance committees of the Trust to ensure practice is monitored, supported and reviewed - e.g. regular review of prescribing practice, expenditure and Clinical Management Plans (CMPs) A3. Patient Group Directions (PGDs) PGDs are written instructions for the supply and administration of medicines to groups of patients who may not be individually identified before presentation for treatment. Such patients may be supplied with or have medicines administered in the absence of a prescription written by a doctor provided that all criteria within the PGD are met. The supply and administration of medicines under a PGD should be reserved for those limited situations where this offers an advantage for patient care (without compromising its safety), and where it is consistent with appropriate professional relationships and accountability. PGDs are developed with Nursing, Medical and Pharmacy input. PGDs must be approved by the Consultant responsible for the area, Senior &/or Practice Development Unit Nursing staff and the Divisional support pharmacist before submission for D&TC approval. PGDs are be utilised once final approval has been given by the D&TC. Records of supply/administration must be made according to the requirements of the PGD. - 61 - A4. Approved forms All prescriptions must be on an approved prescription sheet or administration record card. Approved forms are:- Inpatient Drug chart and Administration Record - Out-patient prescription - GP referral letter - Discharge letter on Epro(TTA) - FP 10(HP) - FP 10(PCD) - Accident & Emergency record - Anaesthetic record - Day case record - Day clinic prescription - ITU infusion chart - Chemotherapy prescription - Doctors Prescription (for self-prescribing) A5. Writing prescriptions for In-patients & Day-patients A5.1 A new prescription chart must be used for each in-patient admission. If more than one drug chart is required then each chart must be numbered e.g. 1 of 2 etc. A5.2 Prescriptions must be written on the appropriate section of drug charts. For In- patient charts these are: - Once only drugs and Pre-medication - Oral anti-coagulants - Regular medication - When required drugs (PRN) - Oxygen - Nebulised drugs - Insulin Sliding scale - Regular Insulin section - Syringe Driver infusions - Intravenous infusions of drugs, fluids and blood products - Antimicrobial Prescription Chart A5.3 The following patient details must be included on every prescription: - Name of the hospital - Patients name - Ward or Clinic identity - Age or Date of birth - Hospital number - Consultant treating the patient - Known drug sensitivities - Weight – in children - In-patient prescriptions should also include: o any special diets o weight - 62 - A5.4 When writing In-patient prescriptions the prescriber must: - Write legibly, in blue or black ink, in CAPITAL LETTERS - Use the generic name of the drug wherever possible and avoid abbreviations - Complete all the appropriate sections for each prescription - Fill in the ‘Frequency box’ – nursing or pharmacy staff may ring times - Complete the ‘Start date’ with the date the drug was first prescribed - Cancel prescriptions with a definite line through both the item and the vacant administration record. Cancellations must be initialled and dated - Any changes in drug therapy must be ordered with a new prescription. NEVER ALTER EXISTING INSTRUCTIONS (this includes additions to instructions) - Doses of less than 1mg (milligram) must be written in micrograms Small S.I. units must be written in full to avoid errors Acceptable indicators of units are: o G (grams) o mg (milligrams) o micrograms o nanograms o units o L (litres) o ml (millilitres) - Specify the driving gas for nebulisers - Prescribe the drugs in the appropriate sections of the chart - Specify route of administration. Drugs which may be given by multiple routes, where the dose is the same, may have one or more routes indicated when first prescribed. e.g. PO/PR. Addition of other routes of administration, at a later time, requires the prescription to be rewritten. - For ‘When Required’ (PRN) medicines specify the maximum frequency or dose - For single doses indicate the date and time of administration - For infusions indicate the rate or duration of infusion A5.5 Prescriptions for private patients must be clearly marked 'PRIVATE PATIENT'. A5.6 Prescriptions must be signed in full by an authorised prescriber. Initials must not be used alone. Bleep or extension numbers must also be included. A5.7 Medicines which are restricted for use to a single speciality must only be prescribed by medical practitioners currently working in that speciality. Prescribers may be required to indicate their current post on the prescription, to validate the prescription. A5.8 The date the medication is to start must be entered on all prescriptions A5.9 The prescribing of Controlled drugs will be in accordance with the Misuse of Drugs Act, 1971 and subsequent regulations/guidance including the Safer Management of Controlled Practice. A guide to good practice in Secondary Care (England) October 2007. Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. - 63 - A5.10 Medical gases must always be prescribed by a medical practitioner. If a patient is likely to be discharged requiring home Oxygen ensure it is ordered at least THREE DAYS in advance of their discharge. See Section A9 A5.11 It is the responsibility of the prescriber or medical practitioner to indicate, clearly, any oral medications that must not be administered to patients who are 'nil by mouth' A6. Review and Cancellation of In-patient or Day-patient prescriptions A6.1 All dose or prescription cancellations must be signed and dated A6.2 When one or more doses are to be omitted (e.g. when a patient is 'nil-by-mouth') the prescriber must indicate this by putting a cross in the appropriate box and signing A6.3 Prescriptions for inpatients must be reviewed regularly in conjunction with their condition and plan of care. Courses of treatment must be clearly indicated with a Start and Stop date A6.4 Administration of some medicines may be dependent on the acceptability of blood drug levels. It is accepted practice to indicate a blood sample should be taken by putting a square around the time to remind nursing/medical staff to take the blood sample at the correct time. The acceptable/ideal blood drug level (required range) should be clearly indicated on the chart and in the patients’ notes. When the blood drug level is known it can be written in the square in addition to the notes. If a dose is to be omitted, as a result of an unacceptably high blood dug level, the attending medical practitioner must be informed at the time of the omission. A6.5 A pharmacist may clarify a prescription for the purpose of ensuring the safe and effective administration of medicines. Endorsements made by a pharmacist must be signed and dated by them. A pharmacist may ask for a prescription to be rewritten by the prescriber if they are dissatisfied with it because it is difficult to read, ambiguous or a source of potential error A6.6 Where a local drug substitution policy exists, a pharmacist may rewrite a prescription. A re-written prescription must be countersigned by an authorised prescriber within 24 hours A6.7 When any aspect of therapy is changed, the prescription must be REWRITTEN. Prescriptions must never be altered. This is a potential source of error. A6.8 Prescriptions must be cancelled by a line through the drug name and across the unused part of the administration record. This must be signed and dated with the stop date written in the appropriate box A6.9 Medication should be condensed to one drug chart when possible. Only medical practitioners associated with the patient’s care can re-write prescriptions. A pharmacist may re-write a prescription, after communicating with a medical practitioner and this prescription must be countersigned by the medical practitioner within 24 hours - 64 - A6.10 Prescription charts which have been re-written or are no-longer to be used for any other reason must be cancelled: - Cross a line through each page of the whole chart - Sign and date the prescription cancellation on the front of the chart and endorse with the words ‘Chart re-written’ A6.11 Any cancelled charts must be kept with current medical records. Medical notes have a section where used charts should be added A7 Writing Prescriptions for Out-patients A7.1 There are two forms available for prescribing for Outpatients. The Out-patient prescription form and the GP referral letter (See Appendix 2) All out-patients should be referred back to their GPs for medication via the GP referral letter unless there is a specific need for the patient to obtain the medicine from the hospital pharmacy. In exceptional cases the Out-patient prescription form may be used. The only exceptions will be: - Specialist drugs e.g. anti-TNFs, Imatinib - Hospital only/Red list drugs (see Appendix 3) - Treatment must start immediately i.e. within 3 working days A7.2 In all other circumstances the GP referral letter should be completed and the patient advised to take this to their GP. As therapy recommended in this way is not urgent, it is not necessary for the patient to obtain a prescription from the GP immediately. This GP referral letter must be LEGIBLE & IN CAPITAL LETTERS with a clear diagnosis and name/contact number of the person filling in the form. Without this the GP may quite legitimately refuse to prescribe A7.3 Controlled Drugs Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. A7.4 FP 10(HP) prescriptions are available for prescribing in some clinics. Refer patient to Community pharmacies for supply as the hospital dispensary is unable to dispense against these prescriptions. A7.5 FP 10(PCD) prescriptions are available for supply of Controlled drugs from a Community pharmacy. Use is restricted to palliative care in emergency situations. Maximum period of supply is 28 days. A8 Writing prescriptions for Controlled Drugs Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. - 65 - A9 Doctors Self Prescribing This service is provided to help doctors obtain essential medicines in emergency. Prescriptions for medical staff will only be dispensed in situations where it is difficult for the doctor to obtain supplies from their GP. A9.1 Doctors employed by Ealing Hospital NHS Trust may prescribe short term treatment for themselves for an acute illness however it is recommended they seek advice from their GP or Occupational Health A9.2 Long term maintenance prescriptions will not be provided by the Trust A9.2 Prescriptions for members of the Doctors’ immediate family will be dispensed only in emergency (Immediate family = Spouse/Partner, Children, Parents & younger Siblings who live with Parents) A9.3 Prescriptions are subject to NHS prescription tax except where exemptions apply A9.4 Doctors Prescription forms are kept in Pharmacy Reception. Doctors must show Staff Identification badge to the receptionist in order to prescribe. This service is available only during Pharmacy opening hours A9.5 Prescriptions for Controlled and Restricted Drugs (including Temazepam), Benzodiazepines or Cytotoxic drugs (including Methotrexate) are not allowed to be self prescribed A9.6 Prescriptions are limited to drugs allowed by the Ealing Hospital NHS Trust Formulary A9.7 Doctors who want to obtain medicines to administer in private practice should obtain these outside the hospital wherever possible. If this is not possible such medicines will only be supplied by prior arrangement and will be charged as private prescriptions A10 Gifts and benefits A10.1 The advertising and promotion of medicines is strictly regulated under the Medicines (Advertising) Regulations 1994, and it is important that all health professionals make their choice of medicinal product for their patients on the basis of clinical suitability and value for money alone. Any complaints about promotional practices should be referred to the MHRA or ABPI A10.2 As part of the promotion of a medicine or medicines, suppliers may provide inexpensive gifts and benefits, e.g. pens, diaries, mouse mats. Personal gifts are prohibited, and it is an offence to solicit or accept a prohibited gift or inducement. See ABPI Code of Practice www.abpi.org.uk A10.3 Companies may also offer hospitality at a professional meeting or at meetings held to promote medicines, but such hospitality should be reasonable in level and subordinate to the main purpose of the meeting. See ABPI Code of Practice www.abpi.org.uk - 66 - A11 Supply of Home Oxygen After 1st February 2006 oxygen can no longer be prescribed on FP 10 prescriptions. A Home Oxygen Order Form (HOOF) must be used. This HOOF is ongoing and will remain valid unless a further HOOF supersedes it. Patients should be reviewed regularly to determine whether they still require oxygen. The supply of home oxygen for North West London is provided by Air Products A11.1 Ordering Home Oxygen Supplies: - The oxygen order must be in place for a patient 3 DAYS prior to discharge - Fill out a Home Oxygen Ordering Form (HOOF) and a Home Oxygen Consent Form (HOCF). These can be downloaded from http://www.primarycarecontracting.nhs.uk/118.php. Paper copies of these forms can be found on Level 6 wards of the hospital and in Meadow House. Please note that a copy of the consent form must be given to the patient and one must be filed away in the patient’s medical notes. - Please ensure all sections are filled out concisely. Patient’s GP and PCT details can be found on PAS under patient enquiries - The PIN requested on the bottom right hand corner of the HOOF refers to the clinician’s professional registration number - Once the form has been completed please fax directly to Air Products on 6288. This number should be accessible from all fax machines within Ealing Hospital - If oxygen is being initiated by anyone other than the Respiratory team please ensure a copy of the HOOF is sent to the Respiratory Consultant as the patient must be reviewed regularly under this new system - Any enquiries can be answered by phoning Air Products on 0800 373 580 (dial 9 for an outside line) - In some palliative care cases Emergency oxygen can be ordered. This service runs 24 hours a day with a maximum response time of 4 hours. This is an expensive option and must be reserved to URGENT PALLIATIVE CASES - Patients are responsible for their oxygen supplies. If they have any trouble with existing supplies they should contact the company directly on 0800 373 580. - 67 - 6. PREPARATION OF MEDICINES PRIOR TO ADMINISTRATION - Hands must always be washed prior to preparation of medicines Only suitably trained and authorised staff may prepare medicines All medicines must be prepared in an environment which protects both the medicine and the member of staff from possible contamination. Where medicines are prepared, smooth, impervious work surfaces should be provided. All medicines must be prepared in a manner which is suitable for the intended route of administration Manufacturers' and/or pharmacists' instructions for the preparation of medicines must be complied with Only one patient's medication may be prepared at a time Cytotoxic preparations – See Chapter 8 Section F A. PREPARATION OF ORAL MEDICINES A1.1 Ensure that the medicine trolley or cabinet is clean and tidy A1.2 Ensure that the following are available: - all medicines required for the patient - current editions of British National Formulary (BNF or BNF-C) and EHT Formulary (on-line) - jug of fresh water and tumblers, by each bed - graduated measures and/or oral syringes for liquid medicines - receptacle for used medicine pots B. PREPARATION OF INJECTIONS AND INFUSIONS B1. Preparation of equipment B1.1 Follow the principles of aseptic technique B1.2 Prepare the injections in a designated preparation area B1.3 Clean the work surface prior to and following use B1.4 Check and follow the instructions for reconstitution or dilution in the EHT Intravenous Administration Guide (if the drug is not included, use the manufacturers instructions) B1.5 Ensure that equipment is available as follows: - clean trays or receivers in which to place medication and equipment - syringes of appropriate size - needles of appropriate size (see A2.2) - sterile alcohol impregnated swabs (if indicated) - required medicine and diluents - patient prescription chart or administration record - suitable administration equipment with instructions for use e.g. syringe driver - sharps bin - 68 - B2. Selection of needle size - White (19G) for ease of reconstitution and drawing up of certain solutions & liquids - Green (21G) for the administration of IM injections to adults - Blue (23G) for the administration of IV injections to children and adults and IM injections to children and to adults with very reduced muscle mass. The use of a blue needle in adults with normal muscle mass will actually cause greater pain than the use of a green needle - Orange (25G) for the administration of SC injections B3. Preparation of medicines in ampoules Prior to commencing preparation of the actual medicine, ensure that the packaging of any sterile equipment is intact and that liquid medicines or diluents have no visible particulate contamination or cloudiness. When reconstituting or drawing up a medicine, observe the following principles: B3.1 Ensure that all the solution is in the main body of the ampoule B3.2 Always cover the neck of an ampoule with an alcohol impregnated swab whilst snapping it open. After breaking open an ampoule check that no glass particles are present in the solution B3.3 Ensure that the contents of ampoules are completely dissolved/mixed after reconstitution B3.4 After withdrawing the required amount of solution remove the air bubble and any excess liquid by aspirating the syringe on a sterile swab to prevent contamination of the preparation area with drug solution. NEVER RE-SHEATH NEEDLES. B3.5 Always change the needle prior to administration. Remove the old needle and immediately put it into the sharps bin. Attach the new needle (inside the guard) or syringe bung to the end of the syringe as appropriate B3.6 If appropriate, clean the patient's skin with a sterile alcohol impregnated swab and allow to dry prior to administration, unless specifically contra-indicated by the manufacturer of the medicine - 69 - B4. Preparation of medicines in vials Prior to commencing preparation of the actual medicine, ensure that the packaging of sterile equipment is intact and that liquid medicines or diluents have no visible particulate contamination, or cloudiness. When reconstituting or drawing up a medicine, observe the following principles: B4.1 Prior to inserting a needle, clean the rubber bung of a vial with a sterile alcohol impregnated swab and allow the area to dry B4.2 After inserting a needle through the rubber bung of a vial check that no rubber particles are present in the solution B4.3 Ensure that the contents of vials are completely dissolved/mixed after reconstitution B4.4 After withdrawing the required amount of solution remove the air bubble and any excess liquid by aspirating the syringe on a sterile swab to prevent contamination of the preparation area with drug solution. NEVER RE-SHEATH NEEDLES. B4.5 Always change the needle prior to administration. Remove the old needle and immediately put it into the sharps bin. Attach the new needle (inside the guard) or syringe bung to the end of the syringe as appropriate B4.6 If appropriate, clean the patient's skin with a sterile alcohol impregnated swab and allow the area to dry prior to administration (unless specifically contra-indicated by the manufacturer of the medicine) C. PREPARATION OF SUPPOSITORIES, ENEMAS AND VAGINAL PESSARIES C.1 The following items are required: - clean tray or receiver in which to place medication - prescribed medication - patient prescription chart or administration record - gauze swabs or tissues - disposable gloves - suitable applicator if necessary C.2 A lubricating agent suitable for the medicine must be selected (see the manufacturers' recommendations) D. PREPARATION OF BLADDER INSTILLATIONS D.1 The following items are required: - the prescribed solution - a suitable delivery and collection system - patient prescription chart or administration record - disposable gloves D.2 Principles of aseptic technique must be observed throughout - 70 - E. PREPARATION OF OTHER MEDICINES Particular items of equipment need to be prepared for other specific medicines E.1 Topical Applications - The prescribed medicine - Disposable gloves - Flat wooden spatula or other applicator E.2 Inhalations - The prescribed solution - Recommended diluent - Syringe(s) and needle(s) for drawing up the solutions - Administration equipment (e.g. nebuliser, face mask, connecting tubing) E.3 Ear, eye and nasal drops/ointments - The prescribed medicine - Gauze swabs or tissues - Applicator, if appropriate E.4 Mouthwashes and gargles - The prescribed solution - Tumbler - Receiver for "spitting out" - Tissues For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) Standards for infusion therapy (RCN 2003) Ealing Hospital NHS Trust Intravenous Drug Administration Guide (Latest edition) - 71 - 7. ADMINISTRATION OF MEDICINES A. GENERAL GUIDANCE It is the responsibility of the member of staff administering a medicine to ensure that the correct medicine is administered to the correct patient/client, in the correct form, by the correct route, at the correct dose, at the times specified by the prescriber. A1.1 A registered nurse, medical practitioner or other authorised practitioner may undertake single-person administration of medicines with the following exceptions in the hospital setting: - a second authorised person must be involved in all stages of the checking process for Controlled Drugs - a second authorised person must be involved with the administration of all medicines prescribed for children - a second authorised person must be involved in the administration of all Cytotoxic drugs. At least one person must be a suitably trained staff member who is on the Cytotoxic drug administration register - a second authorised person must be involved in the administration of all parenteral drugs - a second authorised person must be involved in all situations where calculations are required Student nurses may administer medicines under the close supervision of an appropriately experienced registered nurse who is responsible for their training. A1.2 The correct procedure for the administration of medicines is as follows: 1. Wash hands prior to commencing preparation and administration and at such other times as are necessary, to minimise the likelihood of cross-infection (e.g. before and after administering eye preparations and after administering suppositories and pessaries) 2. The medicines trolley or other suitable delivery system must be used whilst administering oral medicines to more than one patient 3. Injections, external applications and rectal or vaginal preparations must not be administered at the same time as oral medicines 4. Prior to administration, check each prescription chart or administration record for all of the following: - Patient's full name, hospital number and ward - Any recorded allergy or dietary restrictions - Name of medicine - Dose and Strength - Formulation - Route - Special instructions - Date that therapy is due to commence - Duration of therapy, if specified - Signature of prescriber - 72 - 5. Read ALL SECTIONS of the chart/prescription. Do not proceed if there is any suspected clinical contra-indication or the prescription is incomplete or illegible. In such instances, contact the medical practitioner responsible for the patient or the ward pharmacist for clarification 6. Check the prescribed administration time and that the dose has not already been given. Ensure the maximum dose is not exceeded on ‘when required’ prescriptions. 7. Identify the patient by checking full name and hospital number on the patient's identity band. Patients who are able to respond must also be asked to state their name. Medicines must not be given to patients who cannot be positively identified. 8. Select the required medicine and check that the strength and form are the same as on the prescription. Check the medicine has been stored correctly and the expiry date. If there is no expiry date (e.g. tablets) then only administer drugs dispensed from the hospital pharmacy within the last 6 months 9. Measure out, or draw up, the correct dose. For oral medicines, use a separate medicine pot for each patient and do not mix liquid medicines 10. Do not interfere with a medicine in its prepared form (e.g. by crushing) unless this has been discussed with a pharmacist and they have endorsed on the prescription chart that it is safe to do so 11. Take the medicine and the prescription chart/administration record to the patients’ bedside 12. Re-check the patient’s identity and any known allergies. The nature of the allergy must be established before proceeding 13. Ensure that the patient has an understanding of the medicine about to be administered and offer appropriate explanation if necessary 14. Ensure that the patient and environment have been appropriately prepared with regard to positioning and privacy 15. Administer the medicine 16. Do not leave any medicine at the patient's bedside. It is the responsibility of the person administering the medicine to ensure the patient takes the medicine. A student nurse, ATO or carer/parent may help in encouraging patients to take medicines however the responsibility remains with the qualified nurse 17. Record the completed administration on the prescription chart/administration record, using clear initials. Ensure the year, month and day are recorded at the top of the drug chart - 73 - 18. If the medicine is not administered at the prescribed time then record the time of administration on the chart 19. For "as required" medicines, also record the dosage, date and time of administration 20. If a medicine is not administered indicate the reason as stated on the prescription chart / administration record and clearly document this in the patient record. Inform prescriber or medical practitioner responsible for the patient that the drug has not been administered and the reasons why, so they may take appropriate action as necessary. See F1.12 To reduce harm from omitted and delayed medicines in hospital, if a critical medicine is not available on the ward contact your ward pharmacist or for ward stock items, contact pharmacy distribution team. If a critical medicine is not available out of hours, inform nurse in charge and if appropriate, contact the duty manager (218) to obtain medicine from another ward or emergency drug cupboard/ fridge. When advised by duty manager, contact on-call pharmacist via switch board. If unsure if the unavailable medicine is critical, refer to “Critical list of medicines” guide available on the Medication Safety Intranet site. If unsure contact the ward manger, duty manager, prescriber or on-call pharmacist. 21. All batch numbers and expiry date of Vaccines and Blood products, such as Human Albumin or Immunoglobulins, administered to patients must be recorded in the patients’ health care record and on the drug chart. Records must also be kept in Pharmacy for Blood products. Immunoglobulins must only be given to the patient named on the label to comply with Department of Health regulations. See Immunoglobulin management plan 2008. 22. In areas where Human Albumin is a Stock item ensure the patient details are recorded on the label attached to the bottle and that this label is returned to the Distribution manager so a record can be made - 74 - B. PATIENT CONSENT B.1.1 In most circumstances treatment may only be given with the patients consent. ‘Consent’ is defined as ‘the voluntary and continuing permission of the patient to receive a particular treatment, based on a adequate knowledge of the purpose, nature, likely effects and risks of that treatment including the likelihood of its success and any alternatives to it’. Medical, Pharmacy and Nursing staff have a duty to give patients an explanation of the nature, purpose, effects and risk of medical treatment and to obtain the patients consent before administering such treatment. The patients must be allowed to consent voluntarily to the treatment and must not be subject to coercion. The patient must have the capacity to understand the information that has been given and be able to make a decision. B1.2 The exceptions to this are: - Emergency situations where to withhold treatment would endanger a patients’ life or health - Where the patient lacks the capacity to give consent, is in need of medical care and where medical treatment is in the patients’ best interests (i.e. to save life, prevent deterioration or ensure an improvement in a person’s health). If a patient is unable to give consent the responsibility for decision making falls to the attending physician who, in discussion with the relevant colleagues, is required to act in the patients’ best interest In the case of adult patients, family and carers do not have the right to consent on the patients behalf B1.3 - - Covert administration of medicines - Disguising medicine in food and drink. By disguising medication in food or drink, the patient is being led to believe that they are not receiving medication, when in fact they are. Covert administration of medicines must be deemed necessary in order to save life, prevent deterioration or ensure an improvement in the patient’s physical or mental health. In other words, it must be in the best interest of the patient. All healthcare professionals involved in the practice of administering medicines covertly should be fully aware of the aims, intent and implications this practice and be accountable for their actions. The healthcare professionals will need to be certain they have the support of the multi-professional team. Healthcare professionals should not make a decision to administer medication in this way in isolation. Records must be made in the patient notes. Summaries of discussions documenting all views and resulting actions/decisions must be documented in the current care plan. In some cases, the only proper course of action may be to seek the permission of the court to administer medicines covertly. If a person is lawfully detained under a section of the relevant mental health legislation the practice of administration of disguised medication may be recognised by law. Such approvals must be documented clearly including relevant dates as these provisions are subject to review. - 75 - C. ADMINISTRATION OF NON-ORAL MEDICINES The general principles outlined in the ‘Procedure for the Administration of Medicines’ applies to all dosage forms. However, for the groups of medicines listed below, clinical practice may differ from one healthcare setting to another. In these instances, reference must be made to locally approved Clinical Procedures Groups of medicines: - Ear drops - Eye Drops/Eye Ointment - Inhalations - Injections (IV,IM,SC) - Medical Gases - Mouthwashes - Suppositories and enemas - Topical preparations - Vaginal pessaries - Bladder instillations Refer to local procedures for information relating to infusion devices D. ADMINISTRATION OF NEBULISED DRUGS The general principles outlined in the procedure for the Administration of Medicines apply. Refer to: Policy for administration of Nebulised therapies to adult patients (current). For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) E. SELF ADMINISTRATION Refer to the Self Administration policy (Current) F. FURTHER NOTES ON ADMINISTRATION F1.1 The responsibility for the administration of medicines usually rests with the Registered nurse F1.2 Other healthcare staff may have responsibility for the administration of medicines delegated to them in accordance with locally agreed procedures or Patient Group Directions F1.3 Nursing Auxiliaries and Care Assistants Nursing auxiliaries and care assistants are not permitted to verify or dispense any Medication (in any form), for administration, within the acute hospital setting The task of aiding oral administration by encouraging patients to take tablets or liquids may be delegated to nursing auxiliaries and care assistants by a Senior Nurse. The authorised nurse practitioner is responsible for the administration and must sign the chart. - 76 - F1.4 Nurses in Training For learning purposes, a nurse in training may be involved, with an authorised nurse practitioner, in the administration of medicines. However, the responsibility for the administration of the medicines still attaches to the authorised nurse practitioner F1.5 Single Nurse Drug Administration F1.5.1 Qualified Nurses Single Nurse Drug Administration can be carried out by individual, appropriately qualified nurses with the agreement of the Ward/Department Manager and of the individual practitioner. The hospital procedure relating to Single Nurse Drug Administration must always be adhered to. In preparing to undertake this procedure, the qualified nurse must: 1. Be aware of their accountability 2. Have read the Medicines Policy and Procedure file 3. Have read the NMC documents - Standards for the Administration of Medicines - Code of Professional Conduct - Accountability - Standards for Records and Record Keeping - Standards for infusion therapy F1.5.2 Criteria - Registered nursing staff who undertake Single Nurse Drug Administration, must be assessed as competent by the Ward/Department Manager. - A record of competencies achieved needs to be maintained and kept on record. Attendance and passing requirements of a study day or course may be necessary according to local procedures - Registered Nursing Staff who undertake single nurse drug administration should be qualified for at least three months. This is an area which should be considered within the preceptorship period and could be identified as a learning outcome F1.5.3 Supervision/Assessment - Supervision for newly qualified staff should be carried out by an identified preceptor. When the individual and preceptor feel that the nurse is competent, they should be assessed by a qualified assessor, and cover all aspects of administration of medicines - Staff who are not newly qualified should be assessed by the Ward/Department Manager. Areas covered should follow the format of the Bank/Agency Nurse Drug Administration as set out in the Medicines Policy/Procedure file - 77 - F1.5.4 Administration - The nurse will understand the nature of the drug administered and the side effects or have available a current British National Formulary to refer to. - The Medicines Policy and Procedures will be adhered to at all times. - It will automatically occur that double check of administration will be reintroduced at the request of any individual practitioner, enabling him/her to maintain practice in a safe professional environment. - Learners, at the appropriate stages in their training, should be involved in drug administration to enable them to develop the appropriate skills F1.6 Medical Practitioners Trained medical practitioners (not medical students) can administer medicines according to agreed procedures. On certain occasions it is the sole responsibility of the medical practitioner to administer particular medicines (see IV Administration guide and Cytotoxic policies) F1.7 Other disciplines Chiropodists, podiatrists, dieticians, pharmacists, registered dental nurses, radiographers and physiotherapists may be responsible and accountable for the administration of medicines within their designated sphere of practice. Such administration must be in accordance with procedures approved for that speciality and PGDs F1.8 Self-administration of medicines by patients Self-administration of medicines by patients is allowed in designated healthcare settings in accordance with approved local procedures. See Self Administration Policy. F1.9 Single-Person Administration (in hospitals) A registered nurse, authorised enrolled nurse, medical practitioner or other authorised practitioner may undertake single-person administration of medicines, in the hospital setting, with the following exceptions: - a second authorised person must be involved in all stages of the checking process for Controlled Drugs - a second authorised person must be involved with the administration of all medicines prescribed for children - a second authorised person must be involved with the administration of all parenterally administered medicines - a second authorised person must be involved in the administration of all blood and blood products - a second authorised person must be involved in all situations where the dose, concentration or rate of administration have to be calculated - 78 - F1.10 Bank and agency staff Qualified, 'Bank' and agency staff may be authorised for single-nurse administration only in the following circumstances: - They are a Registered Nurse already in permanent employment with the Trust - Written authorisation has been given by the appointed nurse in charge or a line manager. Such authorisation shall be given only if the 'Bank' or agency nurse has: o been made familiar with the Policies & Procedures relating to the administration of medicines. o been judged competent by the appointed nurse in charge or a line manager and a record of competency is o expressed willingness to undertake single-nurse administration F1.11 The responsibility of the member of staff administering medicines - It is the responsibility of the member of staff administering a medicine to ensure that the correct medicine is administered to the correct patient/client, in the correct form, by the correct route, at the correct dose, at the times specified by the prescriber - Where there is any doubt as to the accuracy, completeness or appropriateness of an individual prescription, it is the responsibility of the member of staff to confirm the details with the prescriber and/or a pharmacist before administering the medicine - If the member of staff is still not satisfied, their line manager must be notified immediately. Any concerns and details of the action taken must be recorded in the nursing record or case notes - If the medical practitioner insists that the medicine must be given, that medical practitioner shall be responsible for administration and any resulting consequences F1.12 Non-administration of medicines In certain situations it may not be possible to administer a medicine to a patient at the prescribed time. - The reason for non administration must be recorded on the medication record and the nurse in charge informed. - The nurse in charge shall then contact the prescriber to verify whether nonadministration will compromise patient care F1.13 Nil by Mouth - Patients who are ‘nil by mouth’ may be given oral medicines with a small amount of water unless the prescriber has clearly indicated administration is not necessary - The person responsible for administering the medicine(s) shall administer all doses as prescribed, unless the prescriber indicates clearly on the medication record that a dose(s) of a medicine(s) must not be administered to a patient who is 'nil by mouth' - 79 - F1.14 Condition of patient Depending on the condition of a patient, it may be deemed necessary to withhold the medicine at the time when it is due to be administered. In this case, further verification must be obtained from a medical practitioner For further reference see: The Safe and Secure handling of medicines. A team approach – Duthie 2005 (Revised) - 80 - 8. ADDITIONAL PROFESSIONAL PRACTICES A. ISSUE OF PRE-PACKED OR OVERLABELLED MEDICINES FROM WARD/ CLINICAL AREAS A1 Supply against a prescription In certain healthcare settings, small supplies of discharge medicines are made available for supply, against a prescription and given to patients. These medicines should only be issued where it is essential that the patient receives immediate therapy. A1.1 The independent prescriber, responsible for the patient, must write a prescription according to the written procedure for prescription writing A1.2 Medicines may only be issued from the healthcare setting if they are labelled with the following details: - name of the medicine - form - strength - quantity - directions for use - space to write the patient's name and date of issue - name and address of the hospital A1.3 A maximum of one container may be given for each medicine. A1.4 An independent prescriber must write the patient's name and date of issue in the space provided on the label. A1.5 The person issuing the medicine must indicate on the prescription the quantity supplied and must countersign (using full signature) the prescription with the name and designation printed clearly underneath. This person must have been trained and accredited to perform this task by the nurse/midwifery manager and Pharmacy. A1.6 The dispensed medicine must be checked against the prescription by a second authorised person. This person must have been trained and accredited to perform this task by the nurse/midwifery manager and Pharmacy. A1.7 The medicine may then be given to the patient A1.8 The prescriptions must be sent to pharmacy on the next working day A1.9 A record of trained nurses and midwives involved in the supply of medicines to patients against prescriptions and clinical areas where this supply may occur, must be kept and regularly updated by the Senior Nurse Manager for each, relevant, clinical area. A2 Supply according to a PGD A2.1 The independent prescriber must write a directive for supply in the patient notes for a specific medicine in a specific indication that an approved PGD is valid for. A2.2 The supplier must be appropriately trained and authorised to supply the medicine in accordance with the PGD. A record of valid PGDs, who may administer or supply medicines against these PGDs and clinical areas where this supply may occur, must be kept and regularly updated by the Senior Nurse Manager for each, relevant, clinical area. For further reference see: Clinical area specific, local, relevant PGDs and PGD guidance. - 81 - B. CONTROLLED AND RESTRICTED DRUGS Refer to Ealing Hospital NHS Trust Controlled and Restricted Drugs Policy. C UNLICENSED MEDICINAL PRODUCTS (UMPs) USE OF LICENSED MEDICATIONS FOR UNLICENSED INDICATIONS This section is under revision. Speak to a pharmacist for advice if required. D. MEDICINES WHICH MAY BE ADMINISTERED BY AUTHORISED PRACTITIONERS BY INTRAVENOUS ROUTES D1. Practitioners authorised to administer intravenous medicines The following people may prepare and administer intravenous medicines: o All medical practitioners, including pre-registration house officers o Qualified nurses who are recognised as professionally competent - Intravenous medicines may be administered by nursing staff who have: a) Attended a course of study on the administration of intravenous medicines and associated risks Achieved competencies necessary to complete course, as assessed by course organisers Passed the courses’ Calculation test, including IV calculations AND b) Been assessed as competent by a nurse manager at the unit/ward in which the nurse is currently working. A written record of the assessment must be kept on file - Before administering any medicine the nurse must ensure they are familiar with any specialist monitoring and/or equipment required. Any required equipment must also be available before administering the medicine There is no restriction on the doses of medicines which may be administered by suitably qualified nurses except in situations where the nurse is concerned on grounds of safety to the patient. See section on Administration of Medicines Before being allowed to give intravenous medicines to children, a qualified nurse who is recognised as competent to administer intravenous medicines must additionally be assessed as competent by the Senior Nurse Paediatrics or the paediatric ward sister/charge nurse. A written record of the assessment must be kept on file - - D2. Intravenous administration It is the responsibility of the qualified nurse or medical practitioner when setting up any drug or fluid for intravenous administration to: - Check the prescription is valid and complies with the ‘EHT Intravenous Drug Administration Guide’ (Latest edition available in clinical areas and on Trust Intranet) - Check the container and fluid show no obvious faults or contamination - Check the correct medicine is administered to the correct patient - Observe whether the administration line remains patent - Inspect the site of injection for signs of abnormality - Control the rate of administration - 82 - - Observe the condition of the patient Report and/or solve any problems appropriately Maintain all necessary records - 83 - D3. Intravenous fluids which may be administered by any qualified nurse D3.1 Intravenous Infusions These medicines may only be administered in accordance with a legitimate prescription. An established and patent line must be used. D3.1.1 Fluids Via a Peripheral or Central line o Glucose 5%, 10% o Sodium Chloride 0.9% o Glucose 4% and Sodium Chloride 0.18% (Dextrose/Saline) o Glucose 10% and Sodium Chloride 0.18% o Glucose 2.5% and Sodium Chloride 0.45% o Volplex® or Gelatin solutions o Hartmann's - Compound Sodium Lactate o Potassium 0.15% or 0.3% in glucose or saline or dextrose/saline prepared by a pharmaceutical manufacturer Via a Central line o Glucose 20%, 50% The list is not exhaustive. Check with Pharmacy Medicines Information (ext 5303) for help with appropriate use of fluids not listed in the ‘EHT Intravenous Drug Administration Guide’ (Latest edition) D3.1.2 Blood and blood products Common Blood products o Blood, Packed red cells, Platelets and other blood fractions o Human Immunoglobulin (IVIG) o Human Albumin o Anti-D Immunoglobulin The list is not exhaustive. Check with Pharmacy Medicines Information for help. A second person must be involved in all stages of checking and at the commencement of administration of all blood and blood products Staff must complete accredited training and competent to administer blood and blood products. A record of staff accredited to administer blood and blood products must be kept and updated by the Senior Nurse Manager for each clinical area. Refer to the current ‘Blood transfusion policy’ See NPSA & MHRA recommendations - www.mhra.gov.uk D3.1.3 Flushing of peripheral intravenous cannulae o Sodium Chloride 0.9% injection - up to 5ml per dose o Water for injection – up to 5ml per dose - 84 - E. POLICY FOR THE STORAGE AND USE OF IV POTASSIUM E1. Introduction Intravenous administration of concentrated potassium solutions is associated with deaths when used improperly. NPSA (National Patient Safety Agency) requirements were published in July 2002 (Patient Safety Alert 01. July 2002. www.npsa.nhs.uk ) and include the introduction of local controls to reduce the risks associated with concentrated intravenous potassium solutions. Ealing Hospital NHS Trust clinical areas and all units served by the Ealing Hospital NHS Trust Pharmacy Department are required to comply with this policy. E1.1 Aim To ensure the safe storage, handling, preparation, prescribing, checking and administration of intravenous potassium solutions in order to minimise the risk of associated errors and adverse events and to meet the requirements of the NPSA Patient Safety Alert (July 2002). E1.2 Definition For the purposes of this policy “concentrated” intravenous potassium solutions used in the Trust are: o Potassium chloride 15% injection o Potassium phosphate 17.42% injection o Potassium chloride 40mmol in sodium chloride 0.9% 100ml. Other intravenous solutions of potassium (strengths and/or salts) introduced subsequently may also be included. Prior to the introduction of such preparations, the necessity of including them in this policy will be considered. (Further advice should be obtained from the Chief Pharmacist) E2. Potassium Chloride 15% injection and Potassium Phosphate 17.42% injection E2.1 Availability These preparations will be supplied and should only be used in the following clinical areas: o ITU o 10 North o SCBU. ITU - - Potassium chloride 15% injection is available on ITU to enable the addition of potassium to haemodiafiltration fluids. It should not be used on ITU for intravenous potassium supplementation for which an alternative preparation is available Potassium phosphate 17.42% injection is available on ITU for use when there is a clinical need for intravenous supplementation of both potassium and phosphate. It must be appropriately diluted before administration and must be administered via a central venous catheter N.B. Sodium phosphate injection is the preparation of choice if there is a clinical need for intravenous supplementation of phosphate only - 85 - 10N & SCBU - Potassium chloride 15% injection is available on 10 North and SCBU to enable the addition of potassium to intravenous fluids for the purpose of supplementation where there is no suitable commercially manufactured dilute solution. See E2.3 N.B. A comprehensive range of commercially manufactured intravenous infusion solutions containing potassium are stocked in the hospital and these must be used preferentially in all areas whenever practicable. E2.2 Ordering, Storage and Handling of Potassium Chloride 15% injection and Potassium Phosphate 17.42% injection. - Both the above injections must be ordered, stored, handled and administered in accordance with full Controlled Drugs regulations and must not be transferred between clinical areas unless authorised by a pharmacist. All supplies out of hours must be discussed with the on-call pharmacist - Stocks in Pharmacy are stored, handled and supplied subject to Controlled Drugs regulations - Potassium Chloride 15% injection and Potassium Phosphate 17.42% injection are only available for use in the clinical areas outlined above for the indications outlined above. They are not to be supplied to other clinical areas. Neither should they be used in the permitted clinical areas for alternative indications. The use of such solutions outside the clinical areas agreed above or for alternative indications must be approved and/or reported to the Principal Pharmacist Patient Services or Chief Pharmacist. Outside normal hours any issues should be discussed with the on-call pharmacist in the first instance. E2.3 Administration In rare circumstances, when it is necessary to use concentrated potassium injections, the concentrated solution must be diluted, by addition to a large volume infusion bag (see current Ealing Hospital Trust Intravenous Drug Administration Guide for details). - The following steps must be followed to minimise the risk of incomplete mixing which has resulted in rapid administration of potassium with serious clinical consequences. o Hold the additive port of the infusion bag upwards o Inject potassium injection downwards o Mix the contents thoroughly by gently inverting the bag on at least five occasions o Do not inject potassium injection into a hanging bag or the burette of a giving set under any circumstances o A second practitioner must always check the preparation and administration of a solution of potassium made up in clinical areas. o The checks undertaken must include: 1. That there is a genuine need for the use of a concentrated potassium solution and there is not a suitable commercially manufactured preparation available 2. Prescriptions should be written to enable the use of pre-mixed solutions and nursing staff should query prescriptions with prescribers where this does not appear to be the case. 3. That the correct products were chosen to make the dilution i.e. the correct ampoule of potassium injection and the correct bag of infusion fluid 4. That the dosage prescribed is appropriate for the patient - 86 - - 5. That the dilution carried out is as prescribed on the drug chart 6. That thorough mixing has taken place as described above 7. That the diluted solution is labelled, correctly with a fully completed IV additive label All of these checks must be carried out during the preparation of the solution and again immediately prior to beginning administration All potassium containing intravenous infusions must be administered through an infusion pump E3. Potassium chloride 40mmol in sodium chloride 0.9% 100ml This commercially prepared low volume (100ml) sodium chloride infusion containing 40mmol potassium is supplied to a limited number of clinical areas where there is a clinical need for the availability of an intravenous potassium infusion with a concentration of potassium greater than 40mmol per litre. It is not subject to Controlled Drug regulations although careful handling is required to minimise risk. E3.1 Availability This preparation will be supplied and should only be used in the following clinical areas: o ITU o Theatres o 4South o Wilmot ward (8South) E3.2 Ordering, Storage & Handling of Potassium chloride 40mmol in sodium chloride 0.9% 100ml - This preparation will be supplied only to the listed clinical areas - Stocks must never be transferred to any other clinical area, other than those listed - This preparation must not be used in any other clinical area - It must only be used for intravenous potassium supplementation when there is not a suitable, commercially available dilute solution - In the clinical areas above : o Stocks will be supplied via the pharmacy distribution top-up service o It is not available for use in any other clinical area and must not be transferred to other clinical areas unless authorised by a pharmacist. (This must be discussed with the on-call pharmacist in out-of-hours situations). o It is not subject to Controlled Drug regulations o It must be stored in lockable designated areas, separate from other intravenous infusion fluids, in order to minimise the risks of inadvertent administration - 87 - E3.3 Administration of Potassium chloride 40mmol in sodium chloride 0.9% 100ml - Infusion must be via a central venous catheter - The maximum rate of administration should not exceed 20mmol potassium per hour - Continuous ECG monitoring must be performed during the infusion The use of ‘concentrated’ intravenous Potassium solutions outside of the stipulated clinical areas or indications must be reported to the Principal Pharmacist Patient Services or Chief Pharmacist as a ‘Clinical incident’ on the relevant form E4. Large volume IV infusions containing potassium E4.1 Recommendations for use General recommendations for the concentration, route and rate of administration of potassium infusions - 20mmol of potassium should usually be administered in at least 500ml of the appropriate fluid - The usual maximum rate of infusion of potassium is 20mmol per hour - ECG monitoring is essential when administering more than 20mmols potassium/hour to an adult or more than 0.5mmol/kg/hour to a child. - Intravenous potassium solutions up to a concentration of 40mmols per litre can be administered peripherally. (Potassium solutions more concentrated than this should be administered via a central intravenous cannula) - Pain or phlebitis may occur during administration of solutions containing 30mmol or more of potassium per litre - Administration of concentrations exceeding 40mmol/100ml over a period of less than one hour poses a serious risk of serious adverse cardiac effects e.g. asystole - All potassium infusions must be administered through an infusion pump E4.2 Availability of large volume IV infusions containing potassium The range of intravenous infusion solutions containing potassium that are available in the trust is outlined in the table on page 119: - Such solutions must be used for patients requiring intravenous potassium supplementation in all circumstances in most clinical areas. The exceptions are outlined in E2 and E3 - If a commercially manufactured preparation is available this should be used whenever possible. Prescriptions should be written to enable the use of such premixed solutions and nursing staff should query prescriptions with prescribers where this does not appear to be the case - These solutions must be stored in a lockable storage area, separate from other infusion fluids in clinical areas. This is to minimise the risk of inadvertent administration of unnecessary potassium solutions - Pharmacy should be contacted to obtain any of these fluids which may not be ordinarily stocked in a specific clinical area. Outside normal working hours the on-call pharmacist should be contacted for advice on how a particular infusion can be obtained - 88 - - If the solutions listed are considered unsuitable for a particular patient, pharmacy should be contacted for advice. Outside normal hours the on-call pharmacist should be contacted E4.3 Potassium containing infusion solutions stocked at Ealing Hospital NHS Trust Fluid Volume (ml) 1000 1000 Potassium (mmol) 20 40 Glucose 5% + potassium chloride 0.15% Glucose 5% + potassium chloride 0.3% 1000 500 20 20 Sodium chloride 0.18% & Glucose 4% + potassium chloride 0.15% Sodium chloride 0.18% & Glucose 4% + potassium chloride 0.3% 1000 20 1000 40 Glucose 10% + potassium chloride 0.15% 500 10 Glucose 2.5% & Sodium Chloride 0.45% + potassium chloride 0.15% 500 10 Sodium chloride 0.9% + potassium chloride 0.15% Sodium chloride 0.9% + potassium chloride 0.3% N.B. It is acceptable for a proportion of a bag to be infused if the exact volume prescribed in unavailable e.g. if a 500ml bag containing 10mmols potassium is required, 500ml of a 1000ml bag containing 20mmol may be used. Further advice can be obtained from Medicines Information (ext 5303) in the pharmacy or outside normal working hours from the on-call pharmacist. E5. Training The risks associated with the storage, prescribing, preparation and administration of concentrated intravenous potassium chloride solutions must be included in: o IV training days o Nursing staff induction training, including agency / bank staff o Medical staff induction training, including locum staff o Pharmacy staff induction training, including locum staff o Site Managers / Night Practitioners induction training The medical, nursing and pharmacy professional leads have each nominated a lead person to ensure appropriate delivery of this training. For further reference see: The Safe and secure handling of Potassium Chloride – NPSA Alert July 2002 - 89 - F. CYTOTOXIC MEDICINES Refer to full guidance in the EHT Cytotoxic Policy 2008(Current) which has been authorised by the Chemotherapy Sub-group of the Drug and Therapeutics Group. F1. Administration F1.1 Main Routes F1.1.1 Intravenous. Three methods can be used; IV push, rapid IV infusion via a fast running drip, IV pumpcontrolled IV infusion. Administration may be via a peripheral line or a central venous catheter F1.1.2 Intramuscular This technique is rarely used for the administration of cytotoxics. Methotrexate is the most commonly prescribed drug by this route. F1.1.3 Sub-cutaneous Reserved for the least irritant drugs and small volumes e.g. methotrexate, asparaginase (not a cytotoxic) F1.1.4 Oral Tablets, suspensions or solutions e.g. Methotrexate, Hydroxycarbamide, Cyclophosphamide, Chlorambucil F1.2 Other Routes F1.2.1 Intrathecal This involves the insertion of a needle into the lumbar region and the injection of the drug through the dura and arachnoid into the sub-arachnoid space, thereby allowing direct access to the CNS by drugs which normally only cross the blood-brain barrier in small amounts. The only agents used are, cytarabine and methotrexate. Drugs for intrathecal administration MUST be prescribed on the relevant intrathecal chemotherapy prescription form. Intrathecal doses must be administered at different times from other parenteral doses and in a designated location. Refer to the Trust Intrathecals Policy for the full guidance. F1.2.2 Intraperitoneal Use reserved for treatment of tumours that have invaded the peritoneal lining. Agents that have been used include: bleomycin, carboplatin, cisplatin, fluorouracil, mitomycin C, mitoxantrone. F1.2.3 Intravesical This technique allows a high concentration of the antineoplastic agent to come into contact with the urothelium in the bladder over a relatively long time. Typically, the agent is instilled into the bladder through a urinary catheter, and retained for about 1 to 3 hours. Agents that have been used include: doxorubicin, epirubicin, mitomycin C, mitoxantrone, BCG (not cytotoxic) - 90 - F1.2.4 Intrapleural This route can deliver drugs to a site where systemic penetration is poor. It can alleviate symptoms of pleural disease associated with some malignancies. Agents which have been used include: bleomycin, BCG, doxorubicin, mitoxantrone, mustine, and fluorouracil. Other routes of administration can be used. Further information should be sought from clinician/pharmacy if required. The method of administration chosen will depend on a number of factors such as: 1. Site of intended action 2. Vesicant properties of drug 3. Potential for vein irritation 4. Potential for immediate or delayed complications of the drugs 5. Logistics of specific treatment protocol 6. Pharmaceutical considerations of stability and compatibility F2. DOCUMENTATION Documents for inclusion in the Cytotoxic Policy will be authorised by the Chemotherapy Subgroup of the Drug and Therapeutics Group after full consultation with all relevant parties e.g. Cancer Board, Drug and Therapeutics Group of West London Cancer Network. F2.1 Location The master copy of the Cytotoxic Policy will be kept in the Pharmacy department, Technical Services. There will be one complete copy in; o Haematology Day Unit o Wilmot ward (8S) o Robert Dann unit (8N) o Consultant Haematologist’s office o Consultant Oncologist’s office o Princess Amelia ward (10S) o Charlie Chaplin ward (10N) F2.1.1 Review The whole document will be reviewed annually, and changes made to specific sections, as required. F2.2 Register of Chemotherapy Authorised Staff The master copies of all registers are retained in the Pharmacy department. Other copies are also available in: o Haematology Day Unit o 8S o 8N o 10S o 10N - 91 - The list of registers kept is: - Chemotherapy Prescribers - - Haematology - Other Parenteral Chemotherapy Administrators - Medical - Nursing Intrathecal – Prescribers Intrathecal – Dispensers Intrathecal – Issuers Intrathecal – Checkers Intrathecal – Administrators The Principal Pharmacist – Haematology/Oncology, as the Lead Trainer is responsible for distribution of the most recent copy of each register to the designated areas, as delegated by the Trust Designated Lead (Consultant Haematologist). F2.2.1 Review Each register will be reviewed annually, by the person listed below and the Trust Designated Lead. (The Designated Lead has overall responsibility for induction, training and CPD related to intrathecal chemotherapy) Changes to the register can be made as below: Register 1. Prescribers - Intrathecal Authorise Additions/Deletions Lead Trainer Annual review by Haematology Consultant 2. Dispensers - Intrathecal Principal Pharmacist,Tech.Serv. Chief Pharmacist 3. Issuers – Intrathecal Lead Trainer Chief Pharmacist 4. Checkers - Intrathecal 5. Administers - Intrathecal Chemotherapy Nurse Practitioner & Lead Trainer Lead Trainer Chemotherapy Nurse Practitioner Haematology Consultant 6. Chemotherapy prescribers Lead Trainer Haematology Consultant 7. Parenteral chemotherapy, to administer Chemotherapy Nurse Practitioner & Lead Trainer Haematology Consultant, Chemotherapy Nurse Practitioner - 92 - F3. F3.1 - CHEMOTHERAPY SUB-GROUP OF D&TG Composition Haematology Consultant Oncology Consultant Principal Pharmacist, Haem/Onc Lead Chemotherapy Nurse Practitioner F3.2 - Functions Review and authorisation of new chemotherapy and protocols, and production of submission documents for Drug and Therapeutics Group, Division of Medicine, Cancer Board and West London Cancer Network. Review of Cytotoxic policies annually. Production of new policies related to chemotherapy F4. F4.1 PRESCRIBING CHEMOTHERAPY Cytotoxic drugs This policy applies to all medication in BNF categories: 8.1.1 8.1.2 8.1.3 8.1.4 8.1.5 Busulphan, Carmustine, Chlorambucil, Mustine, Cyclophosphamide, Estramustine, Ifosphamide, Lomustine, Melphalan, Thiotepa, Treosulfan Aclarubicin, Bleomycin, Dactinomycin, Daunorubicin, Doxorubicin, Epirubicin, Idarubicin, Mitomycin, Mitoxantrone Capecitabine, Cladribine, Cytarabine, Fludarabine, Fluorouracil, Gemcitabine, Mercaptopurine, Methotrexate, Raltritrexed, Tegafur +uracil, Etoposide, Vinblastine, Vincristine, Vindesine, Vinorelbine Amsacrine, Altretamine, Asparginase, Dacarbazine, Temozolamide, Hydroxyurea, Pentostatin, Carboplatin, Cisplatin, Oxaliplatin, Porfimer, Procarbazine, Razoxane This list is not exhaustive F4.1.1 Who may prescribe Cytotoxic drugs for PARENTERAL administration (includes IV, SC, IM) - Haematology Consultants - Oncology Consultants - Rheumatology Consultants - Dermatology Consultants - Specialist Registrars, authorised at Ealing Hospital NHS Trust They are responsible for the choice of protocol, accurate dosing, appropriate time intervals being allowed between treatments, correct administration details and the evaluation of whether the patient can safely be given treatment (e.g. bloods, U&Es, liver function) F4.1.2 Who may prescribe Cytotoxic drugs for INTRATHECAL administration - Haematology Consultants, authorised at Ealing Hospital NHS Trust - Oncology Consultants, authorised at Ealing Hospital NHS Trust - Specialist Registrars, authorised at Ealing Hospital NHS Trust - 93 - F4.1.3 Who may prescribe Cytotoxic drugs for INTRAVESICAL/INTRAPLEURAL administration - Consultants - Specialist Registrars Prescriptions on In-patient drug charts for oral Cytotoxic drugs must be signed, by an Authorised prescriber, usually the Consultant. When rewritten the new prescription must also be signed by the Authorised prescriber. See Prescribing Oral Methotrexate pg. 130 F4.1.4 Who may prescribe Cytotoxic drugs for ORAL administration - Consultants - Specialist Registrars, authorised at Ealing Hospital NHS Trust - Senior House Officers, authorised at Ealing Hospital NHS Trust F4.1.5 Authorisation Authorised Registrars or Senior House Officers will have attended the Chemotherapy training session, as in F4.1.6 and received a certificate. Their names are included on the relevant register of accredited prescribers. They are responsible for the choice of protocol, accurate dosing, appropriate time intervals being allowed between treatment, correct administration details and the evaluation of whether the patient can safely be given treatment (e.g. bloods, U&Es, liver function) - A junior house officer must NEVER prescribe cytotoxics. - All prescriptions for cytotoxics must be written to the usual standards. They must include patient’s name, address, DOB, dose, form and length of treatment. If another team initiated the treatment, then specialist review must be sought from the clinical team who were originally responsible for the patient’s therapy in order to check the dose, frequency and duration of therapy. If possible written prescribing protocols should be available for all oral cytotoxic regimes. F4.1.6 Training Session All new Medical staff who will be involved in the prescribing and / or administration of chemotherapy, will receive the general induction training and will sign the log. - To become accredited for prescribing and / or administering intrathecal chemotherapy new Haematology/Oncology Consultants must, in addition, read the National Guidance on the Safe Administration of Intrathecal Chemotherapy. New Consultants should also familiarise themselves with the whole contents of the Cytotoxic Policy and sign the log accordingly. - Haematology/Oncology Registrars must fulfil the above requirements and complete the general induction training satisfactorily before receiving a certificate accrediting them to prescribe and / or administer chemotherapy. - The Haematology Consultant will assess and give written confirmation of the Registrar’s competence to administer intrathecal chemotherapy before their name may be added to the registers for prescribing and administering them. - Senior House Officers and House Officers CANNOT PRESCRIBE, DISPENSE, CHECK OR ADMINISTER INTRATHECAL CHEMOTHERAPY, and are made aware of this during the training program. - 94 - - F4.2 - - To remain on the register of accredited personnel, each doctor will read the National Guidance on safe administration of intrathecal chemotherapy and Ealing Hospital NHS Trust policy on Intrathecal chemotherapy ANNUALLY, and sign the log as designated. Protocols A copy of all chemotherapy treatment protocols in use at Ealing Hospital NHS Trust should be available in pharmacy. If a treatment protocol is being used for the first time, a copy must be sent to pharmacy with the initial prescription. Pharmacy staff will need to check the dose against the protocol before dispensing the medication. Any deviation from the standard protocol must be highlighted on the prescription, with the reason given, and pharmacy informed. Deviations from the standard protocol must be authorised by / confirmed with the consultant in charge of the case. F4.3 Prescription Forms Standard Chemotherapy Prescription forms are available. (Contact Pharmacy for current list) - Chemotherapy Prescription,General - Fludarabine - ABVD - CHOP - R-CHOP - FMD - VAD - Etoposide mobilization - Cyclophosphamide mobilization - Intrathecal cytarabine - Intrathecal methotrexate F4.3.1 Parenteral chemotherapy Parenteral chemotherapy should be prescribed on a Chemotherapy Prescription Form (see the list) ALL sections of the form MUST be completed so that the prescription can be accurately checked before preparation of the drugs. Drugs will NOT be dispensed if details are missing. This is a separate document from the usual in-patient chart F4.3.2 Intrathecal chemotherapy Intrathecal doses must be prescribed on either the Intrathecal Methotrexate or Cytarabine Prescription Form Intrathecal doses will not be issued from pharmacy until all parenteral chemotherapy doses for the same day have been administered, and the signed Chemotherapy Prescription Form confirming this has been received. See latest guidelines. Reference to intrathecal doses must be noted on the Chemotherapy Prescription form in the relevant section - 95 - F4.3.3 Intravesical/intrapleural chemotherapy Intravesical/intrapleural doses and adjuvant therapy should be prescribed on the standard inpatient prescription chart F4.4 Timing - All requests for parenteral and intrathecal chemotherapy MUST be sent to Pharmacy Technical Services (Ext. 5699) at least 24 hours prior to the planned administration. This is to ensure that stock is available and allow time for it to be ordered in if necessary. - Courses of chemotherapy should be started so that dispensing and administration can occur during normal working hours Monday to Friday, except in special circumstances (see ‘Out of hours’ policy F4.5). F4.5 Supply & Administration ‘Out of hours’ and at Weekends - Whenever possible, chemotherapy courses should be prescribed and planned to allow reconstitution and administration during normal working hours (Monday to Friday) - Outside of normal pharmacy opening hours, the on-call pharmacist should be contacted for advice (via switchboard) if a cytotoxic is requested. The Lead Haematology/Oncology Pharmacist may need to be involved in the decision-making. - The same applies at weekends, when only urgent requests from an authorised consultant may be accepted. - Intrathecal doses MUST be given during normal working hours, except in emergencies as decided and prescribed by the Consultant Haematologist. - The ‘Designated Lead’ must be informed of any intrathecal chemotherapy administered out-of-hours and receive written justification for the departure from agreed practice. F5. AUTHORISED LOCATIONS FOR ADMINISTRATION OF CHEMOTHERAPY F5.1.1 Intravenous chemotherapy may only be administered in the following locations, by authorised personnel - Princess Amelia ward (10 South) - Charlie Chaplin ward (10 North) - Wilmot ward (8 South) - Robert Dann Unit (8 North) - Haematology Day Unit - ITU F5.1.2 Intrathecal chemotherapy may only be administered in the following locations, by authorised personnel - Wilmot ward (8 South) - Haematology Day Unit, treatment room F5.1.3 Subcutaneous and intramuscular chemotherapy No specific locations, but must only be administered by authorised personnel. F5.1.4 Intravesical/intrapleural chemotherapy There are no specific locations. F5.1.5 Oral or topical chemotherapy There are no specific locations. - 96 - F6 STORAGE AND TRANSPORTATION OF CYTOTOXICS F6.1 Storage - Prepared/dispensed doses will always be packed into a sealed outer package. - All packages will be identified as cytotoxic by the yellow ‘CYTOTOXIC’ tape on it. - Doses requiring refrigeration must be stored at the bottom of the fridge or in a separate designated fridge. They should be placed inside a tray to avoid contamination of the area in the event of a leak. - Doses stored at room temperature must also be stored in a tray in a designated location. - Intrathecal doses will be stored in pharmacy in a designated box in the pharmacy fridge, reserved for this purpose alone, until required for administration. Intrathecal doses will not be stored in any other location. The dose will only be issued by an authorised pharmacist to the doctor who will administer the dose, as per policy 07.03.01, AT A DIFFERENT TIME FROM ALL OTHER CHEMOTHERAPY DOSES. - Oral/topical cytotoxic medication will have a label identifying them as such, whether being sent to an in-patient ward or for outpatient use. - There are no special storage requirements for these. F6.2 Transport - Parenteral chemotherapy doses prepared in pharmacy will normally be delivered to the designated location by pharmacy staff who has received chemotherapy induction training. They may also be collected from pharmacy by nursing unit staff who have had chemotherapy induction training. - Intrathecal chemotherapy doses may only be issued by a pharmacist authorised and on the register, to a doctor authorised and on the register for administering intrathecal chemotherapy. - Oral/topical cytotoxics are treated as regular medication, for the purposes of transportation. F7 PHARMACY CYTOTOXIC RECONSTITUTION SERVICE All requests for chemotherapy MUST be sent to Pharmacy Technical Services (Ext. 5699) as far in advance as possible. This is to ensure that stock is available and allow time for it to be ordered in if necessary. Courses of chemotherapy should be started so that reconstitution and administration can occur during normal working hours Monday to Friday, whenever possible. F7.1 Hours The Pharmacy Department provides a Cytotoxic Reconstitution Service Monday to Friday 9am to 3.30pm. If ordered during these hours, drugs may also be supplied for administration at weekends and in the evenings depending on the stability of the requested chemotherapy. F7.2 Out of Hours ALL doses of cytotoxic drugs required should be ordered from the Technical Services section of the Pharmacy Department, extension 5699. Outside of normal opening hours, if a cytotoxic is requested then the on-call pharmacist should be called (via switchboard) to advise on how to proceed. - 97 - There is a very limited service available at the weekends for urgent requests only. This should be discussed in advance with Pharmacy. Whenever possible, courses of chemotherapy should be started so that reconstitution and administration can occur during normal working hours. There are very few occasions when chemotherapy will be required urgently. F7.3 Preparation outside Pharmacy Medical or nursing staff are not involved in the routine reconstitution of cytotoxic drugs. Very occasionally, in extremely exceptional circumstances, it may be necessary for a dose of chemotherapy to be prepared outside the pharmacy. If this happens, it is essential that this is done safely - in order to protect the operator, the patient and the environment from contamination with the drug and the drug from microbial contamination. In order for this to be achieved the procedures detailed in ‘The Cytotoxics Policy’ must be followed fully. F7.4 Pharmacy Information or Advice Any queries regarding any aspect of cytotoxic therapy e.g. the dose, method of administration or side-effects can be addressed either to the pharmacist in Pharmacy Technical Services (Ext 5699) or to Medicines Information (Ext 5303, Bleep 215). Out of hours the on-call pharmacist should be contacted via the hospital switchboard. F8 SAFE HANDLING OF CYTOTOXIC DRUGS F8.1 Handling of Cytotoxic Drugs at Ward Level It is well recognised that most cytotoxic drugs are potentially hazardous to staff involved in their handling and administration. This is due to: - Local effects caused by direct contact with the skin, eyes or mucous membrane - Potentially harmful long or short term effects due to inhalation, ingestion or injection of the cytotoxic agents during preparation or administration. - Women who are pregnant, breast-feeding or actively seeking pregnancy should not be involved in the preparation or administration of cytotoxic drugs. - It is also necessary to remember that patient’s body fluids also represent a potential significant source of contamination to staff. - All necessary measures must be taken to protect staff from occupational exposure. The guidelines provided in ‘The Cytotoxics Policy’ give the information required to achieve this F8.2 Monitoring of staff handling Cytotoxic Drugs - Staff members regularly involved in the preparation and administration of cytotoxics should have a full blood count every 12 months. The Occupational Health department will co-ordinate this. - It is the responsibility of the managers of sections preparing and administering these drugs to inform Occupational Health which staff members require monitoring. - 98 - F9 SPILLAGE OF CYTOTOXIC DRUGS F9.1 Equipment The following items should be readily available, in the form of a ‘Cytotoxic Spill Kit’, in all areas where cytotoxics are being handled and administered: - disposable apron - overshoes - gloves (latex and PVC) - surgical face mask - safety goggles - dedicated cytotoxic sharps bin - paper towels - sterile water - sodium chloride 0.9% eye-wash - plastic bags - labelled “cytotoxic waste - for incineration” - sharps bin - plastic tweezers F9.2 Action in event of spillage F9.2.1 All spills In the event of a cytotoxic spillage the following procedure should be followed: - Act immediately - do not leave spills to be cleared up later - Ensure that all staff are aware of the spillage and therefore avoid inadvertent spread. - Collect together the necessary equipment and put on protective clothing - If there is a powder spill ensure that the face mask is worn F9.2.2 Spillages on yourself or other people - On clothing - remove the affected clothing as soon as possible and send to laundry as “soiled linen” - On skin - wash contaminated area liberally with soap and cold water - In eyes - irrigate affected eye(s) with 0.9% sodium chloride Eye Wash and seek medical advice immediately - Report incident to Occupational Health F9.2.3 Spillages on hard surfaces - Put on surgical gloves, apron (and overshoes if necessary) If the spillage is:o LIQUID - mop up liquids which have been spilled on hard surfaces with paper towels and dispose of them in yellow “high risk” waste bags immediately and label it as ‘Cytotoxic Waste’ o POWDER - put on surgical face mask to avoid inhalation as well as the rest of the protective clothing. Wipe up powder spill carefully with well dampened paper towels and dispose of them in yellow “high risk” waste bags immediately - Wash all hard surfaces well with copious amounts of cold, soapy water and dry well with paper towels. All cloths and towels used should be placed in the plastic disposal bag immediately after use. F9.2.4 Spillages on bed linen If spillage is on bed linen, change it immediately and send to laundry as “soiled linen”. The mattress or pillow affected should be cleaned as for liquid spills on hard surfaces. - 99 - F9.3 Incident Reporting Any accident or spillage involving direct skin / eye contact with a cytotoxic drug must be reported to Occupational Health Department through the Hospital’s Accident Report Procedure. F10 ORAL METHOTREXATE Refer to: ‘The Cytotoxic prescribing policy’ and the ‘Methotrexate dispensing policy’ for further information. F10.1 Prescribing To comply with the NPSA alert on oral Methotrexate and to prevent inappropriate daily administration which is classed as a “Never Event” by the Department of Health, Hospital Physicians need to ensure the following take place: - All Consultants may prescribe oral methotrexate. They are all on the Trust Oral Methotrexate Prescribing Register kept in pharmacy. - Only Registrars (FY3) and above whose names are on the Trust Oral Methotrexate Prescribing Register may prescribe oral methotrexate. This register will be updated regularly to include staff new to the Trust. - House Officers MUST NEVER prescribe cytotoxic drugs 1. Initiate prescribing of oral methotrexate, making sure that; the dose is written both in milligrams and number of 2.5mg or 10mg tablets to be taken for each dose, it is emphasized that the dose must be taken WEEKLY, on the same day of each week. For in-patients days when a dose is not to be administered must be crossed out (X) on the prescription chart. this information is recorded in the patient-held monitoring and dosage record(PMDR) card (available from pharmacy department). 2. Agree on shared care arrangements with the GP of the patient, for continuing supplies and for routine monitoring. 3. Ensure patient is made aware of each point covered in the ‘Patient Information Leaflet’ (available from pharmacy department). Why it is being prescribed How to take the dose Safe handling Why regular bloods are needed Possible side effects Which symptoms to alert the doctor to. 4. Ensure that the patient has a PMDR card; With the correct dose recorded With the monitoring results updated and explained 5. Ask to see the PMDR card at every consultation or in-patient admission and update it on discharge. 6. Enquire about side effects signs and symptoms - 100 - 7. When patients present at the pharmacy department, all of the above points will be reiterated and the PMDR card will be examined. If the patient does not have a card they will be asked to go back to the clinic to have this remedied. Patients admitted to hospital normally on oral methotrexate; Confirm the dose from patient-held monitoring and dosage record card. Only prescribe once confirmation has been received. Consider the reason for admission and whether the methotrexate should be withheld during admission. Ensure that it is prescribed by a Registrar or above, on the drug chart and/or on the TTA. Ensure that the dose is prescribed as WEEKLY, on the same day of each week on the drug chart or TTA. F10.2 Supply Process See the Methotrexate Dispensing Policy for further information. F10.2.1 Screening of Out-Patient Prescription - Check Patient-held Dosage and Monitoring Record (PDMR) to confirm o Dose o Strength o Frequency of dose (ONCE A WEEK) - If patient does not have a PDMR ask them to return to the clinic doctor. - Check that the prescription has been signed by an authorised prescriber (See F10.1) - Assess individual patient needs o Packaging o Labeling o PIL requirements. - Patients may have reduced manual dexterity and larger containers, or ribbed easy-togrip lids may reduce the likelihood of patients decanting the tablets into an unsuitable container once at home - The strength of tablet supplied to the patient must remain consistent to prevent any confusion for the patient over the number of tablets they need to take - Confirm with patient that they have had a recent blood test. - Endorse prescription with specific information required for dispensing, gained from consultation with patient (e.g. tablet strength must be specified). F10.2.2 Screening of In-Patient Prescriptions The Ward pharmacist must carry out a thorough drug history with the patient - Check the Patient-held Dosage and Monitoring Record (PDMR) to confirm dose, strength and frequency (including day of the week) of methotrexate. If the patient has not brought their PDMR into hospital with them, the pharmacist should ask for it to be brought into hospital. - Confirm dose, tablet strength and frequency from at least two different sources if PDMR is not available e.g. patient, GP, community pharmacist, out-patient clinic etc. - Doses may change according to blood test results and thus it is imperative that the most recent information regarding dosage is obtained. - 101 - - - Document dose, tablet strength, frequency and any other important information on the front of the drug chart, along with the source of the information Appropriate endorsements must be made inside the drug chart against any prescribed methotrexate, including a ‘cytotoxic’ warning for nursing staff. Days were methotrexate is not to be administered should be crossed off (X). Ward pharmacists should be vigilant of methotrexate patients presenting with signs of methotrexate toxicity or intolerance e.g. breathlessness, dry persistent cough, vomiting or diarrhoea In-patient supplies for oral methotrexate should be made either on the day before or on the morning the dose is due. This should be done on a weekly basis with only enough tablets for one dose supplied. F10.2.3 TTA Supply on Discharge - Ward pharmacists must ensure that the dose, tablet strength and frequency (including day of the week) are all specified for methotrexate TTAs. - If the TTA is sent to Dispensary the pharmacist must check that the drug history section on the front of the drug chart is complete (it is not practical for the PDMR to be sent to pharmacy with the drug chart, but the pharmacist must be sure that thorough checks have been made by the ward pharmacist). If the drug history section on the front of the drug chart is not complete then the dispensary pharmacist will not know if the PDMR has been checked on admission. The ward pharmacist should be asked to check this and screen the TTA personally before the methotrexate on the TTA can be dispensed. - Clinically screen prescription in the usual way, checking the entry for methotrexate against the entry inside the drug chart and finally, check that this correlates with the information on the front of the drug chart. Any discrepancies should be queried with the prescribing doctor. - Endorse details regarding dose, tablet strength and frequency (including day of the week) of oral methotrexate on the TTA. - Four weeks supply will be given unless otherwise specified. F10.2.4 Labeling - Standardise dosing instructions as follows o Methotrexate tablets 2.5mg Take 2.5mg (one tablet) ONCE a week on X day Take 5mg (two tablets) ONCE a week on X day. o Methotrexate tablets 10mg Take 10mg (one tablet) ONCE a week on X day - For all oral methotrexate products this caution will appear on the computer screen: tablets usually taken ONCE A WEEK as a single dose, use this as an additional warning on the label. Warning: Methotrexate is a Cytotoxic. Handle tablets carefully (disposable gloves are available) and use only designated ‘Cytotoxic’ counting triangle and tweezers. Wash equipment after use. - 102 - F10.2.5 Dispensing - Check label against prescription. Dispense from prescription, not label. - Ensure additional instructions are followed regarding suitable containers etc.(see 10.2.1) - Ensure that packaging of oral methotrexate is different to folic acid (if prescribed) e.g. blister pack and bottle or highlight methotrexate drug name and frequency on label. (Both methotrexate 2.5mg tablets and folic acid are round yellow tablets) - Include suitable PIL. F10.2.6 Checking - TWO final checks of dispensing are required - Dispenser to check as per usual checking procedure taking note of any additional instructions on prescription - Second check of dispensing must be carried out by accredited checking technician or pharmacist as per usual checking procedure F10.2.7 Counselling - Counselling of In-Patients by the Ward pharmacist should occur before the patient is ready for discharge. Further counselling by the ward pharmacist or nurse should occur at the point of discharge. - Handing out of oral methotrexate, in the dispensary, must only be carried out only by a senior technician or pharmacist familiar with this procedure and the use of oral methotrexate. - Identity of patient must be ascertained by matching docket to that on the prescription or wrist band. Name and address or date of birth must be asked for as final confirmation. - Check PDMR card against prescription to confirm correct dosage and tablet strength have been issued. Ask patient to carry their PDMR with them and ensure that their doctor, pharmacist and dentist know that they take methotrexate. - Check if patient has taken methotrexate before and knows how to take it. - Discuss dosage and tablet strengths for both methotrexate and folic acid if prescribed. - Ask if the patient takes any other medication – check for interactions. - Confirm that patient understands rationale for use of methotrexate and possible sideeffects (use PDMR as aide memoire if necessary). - In particular tell patient to report signs of: o infection e.g. sore throat, o bleeding / bruising (signs of blood dyscrasias / bone marrow damage) o breathlessness, cough or fever (signs of pulmonary toxicity) - Advise patient to take the methotrexate after food. - Issue appropriate PIL. Warning: Methotrexate is a Cytotoxic. Handle tablets carefully (disposable gloves are available) and use only designated ‘Cytotoxic’ counting triangle and tweezers. Wash equipment after use. - 103 - G REPORTING ADVERSE REACTIONS TO MEDICATION If a patient suffers a suspected adverse reaction to a medicine it should be reported immediately to the Consultant responsible for the patient. If there has been any detrimental effect on the patient a Clinical incident form should also be completed and it is recommended a Yellow Card is also completed and forwarded to the MCA - The Yellow Card Adverse Drug Reaction (ADR) Reporting Scheme is a voluntary scheme through which doctors, pharmacists, nurses, AHPs and patients notify the Medicines Control Agency (MCA) / Committee on the Safety of Medicines (CSM) of suspected adverse drug reactions. The Yellow Card is found in the back of the BNF & BNF-C or online on the web BNF at http://www.bnf.org/bnf/bnf/current/openat/0.htm - 104 - 9. ERRORS IN ADMINISTRATION OR CUSTODY OF MEDICINES A. DEALING WITH MEDICINES ERRORS Medicines errors may occur for a variety of reasons. As part of providing high quality care and managing risk, it is essential that all medicines incidents and near misses are reported in line with the Trust’s Incident and Near Miss Reporting Policy. This includes omission of doses and loss of any medication previously supplied. The accurate reporting of incidents will aid the detection of patterns or types of errors to which there may be an easy solution. An annual report of incidents will be prepared for the Trust Boards. - The person identifying the error should o Immediately report it to a senior member of staff (if appropriate) - The senior member of staff should o Identify the nature of the error o Identify possible adverse effects o Take all immediate action necessary to ensure the patient's safety is maintained o Complete a Clinical incident report form (or Medicines Incident report form) and forward to the designated person in the Clinical area within 24 hours, who will lead an investigation o Send a copy of the completed form to the Chief Pharmacist and Clinical Governance for recording and follow up B. CHANGING NAMES FROM BANs TO rINNs Some errors occur due to the drug name not being written clearly or spelt correctly. Some drugs have changed their names and this may be a cause of error. The following is a list of medicinal substances for which the British Approved Names (BANs) have been changed to match the corresponding recommended International Non-Proprietary Names (rINNs). These changes were published in the ‘British Pharmacopoeia 2003’, which became effective on 1 December 2003. BANs have been changed to match rINNs where the names differ to achieve consistency in the names of medicines available in the UK and ensure compliance with EC legislation. Former BAN Acrosoxacin Amethocaine Amoxycillin Amylobarbitone Amylobarbitone sodium Beclomethasone Bendrofluazide Benorylate Benzhexol Benztropine Busulphan Butobarbitone Carticaine New BAN (rINN) Rosoxacin Tetracaine Amoxicillin Amobarbital Amobarbital sodium Beclometasone Bendroflumethiazide Benorilate Trihexyphenidyl Benzatropine Busulfan Butobarbital Articaine - 105 - Cephalexin Cephamandole Nafate Cephazolin Cephradine Chloral betaine Chlorbutol Chlormethiazole Chlorpheniramine Chlorthalidone Cholecalciferol Cholestyramine Clomiphene Colistin Sulphomethate Sodium Corticotrophin Cyclosporin Cysteamine Danthron Desoxymethasone Dexamphetamine Dibromopropamidine Dicyclomine Dienoestrol Dimethicone(s) Dimethyl sulphoxide Dothiepin Doxycycline Hydrochloride (Hemihydrate Hemiethanolate) Eformoterol Ethamsylate Ethinyloestradiol Ethynodiol Flumethasone Flupenthixol Flurandrenolone Frusemide Gestronol Guaiphenesin Hexachlorophane Hexamine Hippurate Hydroxyurea Indomethacin Lignocaine Lysuride Methimazole Cefalexin Cefamandole Nafate Cefazolin Cefradine Cloral betaine Chlorobutanol Clomethiazole Chlorphenamine Chlortalidone Colecalciferol Colestyramine Clomifene Colistimethate Sodium Corticotropin Ciclosporin Mercaptamine Dantron Desoximetasone Dexamfetamine Dibrompropamidine Dicycloverine Dienestrol Dimeticone Dimethyl sulfoxide Dosulepin Doxycycline Hyclate Formoterol Etamsylate Ethinylestradiol Etynodiol Flumetasone Flupentixol Fludroxycortide Furosemide Gestonorone Guaifenesin Hexachlorophene Methenamine Hippurate Hydroxycarbamide Indometacin Lidocaine Lisuride Thiamazole - 106 - Methotrimeprazine Methyl Cysteine Methylene Blue Mitozantrone Mustine Nicoumalone Oestradiol Oestriol Oestrone Oxpentifylline Phenobarbitone Pipothiazine Polyhexanide Potassium Clorazepate Pramoxine Procaine Penicillin Prothionamide Quinalbarbitone Riboflavine Salcatonin Sodium Calciumedetate Sodium Cromoglycate Sodium Ironedetate Sodium Picosulphate Sorbitan Monostearate Stibocaptate Stilboestrol Sulphacetamide Sulphadiazine Sulphamethoxazole Sulphapyridine Sulphasalazine Sulphathiazole Sulphinpyrazone Tetracosactrin Thiabendazole Thioguanine Thiopentone Thymoxamine Thyroxine Sodium Tribavirin Trimeprazine Urofollitrophin Levomepromazine Mecysteine Methylthioninium Chloride Mitoxantrone Chlormethine Acenocoumarol Estradiol Estriol Estrone Pentoxifylline Phenobarbital Pipotiazine Polihexanide Dipotassium Clorazepate Pramocaine Procaine Benzylpenicillin Protionamide Secobarbital Riboflavin Calcitonin (salmon) Sodium Calcium Edetate Sodium Cromoglicate Sodium Feredetate Sodium Picosulfate Sorbitan Stearate Sodium Stibocaptate Diethylstilbestrol Sulfacetamide Sulfadiazine Sulfamethoxazole Sulfapyridine Sulfasalazine Sulfathiazole Sulfinpyrazone Tetracosactide Tiabendazole Tioguanine Thiopental Moxisylyte Levothyroxine Sodium Ribavirin Alimemazine Urofollitropin - 107 - All drugs which have changed their names will now be labelled with the new name. Some presentations/packaging may show both names. - 108 - 10. MEDICINES DEFECTS A. 24 HOUR RECALL PROCEDURE FOR DEFECTIVE MEDICINAL PRODUCTS A1. Procedure for recalling a suspected defective medicine London Regional Health Authority, Pharmaceutical Service operates a 24 hour recall system for defective medicinal products. All recalls are coordinated through the Regional Quality Control Laboratory. They disseminate the information to all hospital pharmacies in the Region using a cascade system. - On receipt of a recall alert, Pharmacy staff must follow an agreed procedure which determines: o the urgency of the recall o whether the medicinal product is or has been stocked in the pharmacy o where the drug may have been issued to. - If the medicine is in use in any of the ward/clinical areas, pharmacy staff will contact all ward/clinical areas to ensure completion of the action required by the recall alert In cases where information needs to reach health professionals especially quickly, the Chief Medical Officer (CMO) issues urgent advice electronically via the 'Public Health Link System'. There may be useful information on current and previous medicines defects available on www.dh.gov.uk A2. Procedure for reporting a suspected medicine defect - On identification of a suspected medicine defect, all medical, nursing and paramedical staff must report it to the most senior pharmacist on site, as soon as practical - Ensure that whatever remains of the medicine / medical device in question and packaging, is retained and returned to pharmacy. This will preserve evidence for future need as enquiries progress. - Complete a clinical incident reporting form giving full details of what happened and who was involved and affected. o to distinguish events caused by defective products from those due to adverse drug reactions, accidents or errors o to differentiate between events relating to medicinal products from those relating to non-medicinal plant, and equipment, and medical and non-medical supplies - Discontinue use of batch of medicine in question unless advised otherwise, to prevent the use of a defective or possibly defective medicinal product and if samples are required for analysis or other purposes, they should ideally be obtained from another part of the same batch - The pharmacist will require as much information about the defect as possible to allow a full assessment of the seriousness of the defect and what is to be reported. When reporting a serious defect, it is important to report it to the MHRA as soon as possible and there must be sufficient detail to determine if national action is be required. - 109 - POLICY FOR DISSEMINATION Medicines Policy Ealing Hospital NHS Trust April 2009 Who should read the objectives of this policy/procedure All staff who are involved with the prescribing, handling or administration of medicines The objectives of this policy/procedure are To ensure that all medicines are dealt with in a legal, ethical and safe manner Director responsible for ensuring this document is implemented Chief Pharmacist / ADO CLINICAL SUPPORT SERVICES MEDCAL DIRECTOR For further information contact Drugs and Therapeutics Group Medicines Information - Pharmacy The formal/legal documents forming the basis of this document are: Duthie Report (Revised March 2005) Medicines Act Misuse of Drugs Act NMC RPSGB Medicines, Ethics and Practice Training and communication plan: Communication to: Chief Executive All Executive Directors All Assistant Directors All Medical Consultants All Ward/Clinical Departmental Managers Training for all staff as a workshop style seminar Equal Opportunities statement: This policy / procedure has been developed taking the following points into account: Promotion of good relations between people of different racial groups Elimination of unlawful discrimination based on someone’s race, gender or disability Elimination of all other forms of discrimination such as age, marital status or sexual orientation promotion of equality of opportunity - 110 - Appendix 1 Verbal prescription orders at Meadow House There is a list of drugs on the Meadow House chart which may be administered by designated nurses after a verbal order from a Medical practitioner if required out of hours. The standard list of medicines (located at the top of the last page on the chart) needs to be checked and signed by a doctor at admission or if there is a possibility the drugs may be required in the near future. This list must be signed before any of the drugs can be administered. Any of the medicines not appropriate for the patient should be crossed off the list at this time. There are two lists of medicines. The first where a Single dose of the drug may be given and the second, where up to 3 doses can be given at different times. In extreme circumstances, single doses of drugs which are not prescribed may be given against a verbal order. The verbal order must be confirmed by a faxed note (containing patient details, dose and drug details and the prescribers’ signature) which must be referred to at the time of administration. The faxed note should be kept in the patients records. The administration should be recorded on the drug chart by the prescriber as soon as possible. Controlled drugs may not be prescribed by a verbal order under any circumstances. - 111 - Appendix 2 GP referral letter EALING HOSPITAL NHS TRUST Uxbridge Road, Southall, Middlesex UB1 3HW Tel: 020 8967 5000 To the patient THIS IS NOT A PRESCRIPTION PLEASE TAKE THIS LETTER TO YOUR GP He/she will write a prescription for you in the normal way. The treatment does not need to be started immediately so you do not need to call out the doctor for this or seek an urgent appointment. Date _____________________________ Dear Doctor _____________________________ Re: Patient __________________________________ Date of Birth ____________ Address __________________________________ Unit No: ____________ ___________________________________ ___________________________________ Clinic ____________ Thank you for referring this patient, who was seen in clinic today. This note is sent to avoid delay in essential information reaching you and to request that you prescribe the medication recommended below: The diagnosis / clinical impression is: __________________________________________________________________________ __________________________________________________________________________ I recommend the following treatment (PLEASE PRINT CLEARLY) MEDICATION DOSAGE & FREQUENCY DURATION PLEASE NOTE: Only medication from the Ealing Formulary can be recommended with this form. Thank you for your co-operation Yours sincerely Signature of Hospital Clinician _____________________________________ PRINT NAME Bleep or Hospital Extension _________________________________________ _________________________________________ Updated Feb 2006 - 112 - Appendix 3 NWL Red List version 25; 6.12.13 Ensure you are using the most recent version. See Trust Intranet North West London Red List Medicines that Hospital Doctors should not ask GPs to prescribe 1.0 Background Hospital New Drugs Panels or Drug and Therapeutics Committees (NDP or D&TC) consider published evidence on the effectiveness of a new medicine and its cost-effectiveness before deciding whether to add it to the hospital’s formulary. All such committees in North West London (NWL) have representation from local Clinical Care Groups (CCGs). When a medicine is added to a hospital formulary, the committee will also consider whether it is reasonable for a hospital doctor to ask a GP to prescribe the medicine, or whether it should be added to the red list. The NWL Medicines Management Pharmacy Network (NWLMMPN) is a network of Clinical Commissioning Group/ Commissioning Support Unit Senior Pharmacists from NWL, Acute and Mental Health Trust Chief Pharmacists from all Trusts in NWL and Community Health Care Pharmacists representatives from NWL. It meets at least 4 times a year to provide a mechanism for formal liaison in order: To work together to improve prescribing of medicines at the interface between primary, secondary/tertiary care and be involved in service redesign. To share ideas on cost improvement programmes (CIP) for drugs and QIPP plans To share information about the managed entry of new drugs To keep all parties informed and aligned with regard to prescribing priorities and local policies for primary and secondary care To respond to NHS policies including NICE guidance that affect prescribing and medicines management across the interface To identify ways of improving medicines management in both sectors To maintain the North West London red list and shared care tracker and make recommendations to the NWLIF NDP and to Trust New Drugs Panels To share information on medicines expenditure To share ideas on cost improvement programmes (CIP) for drugs/QIPP. The NWLMMPN has an advisory role on whether medicines are suitable for addition to or removal from the ‘red list’ and makes recommendations to the relevant decision making bodies. 2.0 Criteria for adding a medicine to or removing from the red list: The following criteria are used by NDPs, D&TCs and the NWLMMPN in deciding whether a change to the red list should be made: Safe or effective use of the medicine, throughout its use, requires expertise or facilities that a GP will not normally have. Medicines added to the red list will normally be ‘specialist medicines’ that a GP will see infrequently. Relevant changes to a medicine’s licensing or to national policy (e.g. NICE guidance). - 113 - PART A: Red list GPs should not be asked to take on the prescribing of any of the following drugs. It relates to all formulations unless a specific formulation is given. BNF BNF Section Title Generic Name Section 2.1.2 Phosphodiesterase Enoximone, milrinone inhibitors 2.5.1 Vasodilator Ambrisentan, bosentan, iloprost, sildenafil, antihypertensive drugs sitaxentan, tadalafil 2.8.1 Parenteral anticoagulants Dalteparin sodium, enoxaparin sodium, tinzaparin sodium, bivalirudin, epoprostenol, fondaparinux 2.10.2 Fibrinolytic drugs Alteplase, reteplase, streptokinase, tenecteplase, urokinase 3.3.3 Phosphodiesterase type-4 Roflumilast inhibitors 3.4.2 Allergen immunotherapy Grass pollen extract (Grazax®), omalizumab, 3.4.3 Allergic emergencies C1-Esterase inhibitor, conestat alfa, icatibant 4.1.1 Hypnotics Sodium oxybate 4.2.1 Antipsychotic drugs Clozapine 4.6 Drugs used in nausea and vertigo Control of epilepsy Nabilone Apomorphine 5.1 Dopaminergic drugs used in parkinsonism Drugs used in essential tremor, chorea, tics and related disorders Antibacterial drugs 5.1.7 5.2 5.3.1 Other antibacterials Antifungal drugs HIV infection 5.3.2.2 Cytomegalovirus 5.3.3 Viral hepatitis 4.8.1 4.9.1 4.9.3 Rufinamide Botulinum toxins type A and B All IV antibacterials (or according to locally agreed primary care services – contact your local CCG for further information) Linezolid Posaconazole, voriconazole, IV antifungals All antiretroviral drugs for treatment/prophylaxis of HIV infection Lamivudine (for chronic hep B) Cidofovir, ganciclovir, foscarnet, valganciclovir Adefovir, boceprevir, entecavir, interferon alpha, peginterferon alfa, ribavirin ,lamivudine, telaprevir, telbivudine, tenofovir - 114 - 5.3.5 Respiratory syncytical virus Palivizumab, ribavirin 5.4.8 Drugs for pneumocystis pneumonia Hypothalamic and anterior pituitary hormones and anti-oestrogens Corifollitropin alfa, follitropin alfa and beta, human menopausal gonadotrophins, lutropin alfa, urofollitrophin Pegvisomant Pentamidine Calcitonin and parathyroid hormone Bisphosphonates and other drugs affecting bone metabolism Drugs affecting gonadotrophins Teriparatide 6.7.4 Somatomedins Mecasermin 7.4.5 Drugs for Erectile Dysfunction 8.1 Cytotoxic Drugs 8.2.1 Antiproliferative immunosuppressants Corticosteroids and other immunosuppressants Alprostadil, apomorphine, sildenafil, tadalafil, vardenafil (unless for indications in Schedule 2). Oncology use of all I.V, intracavitary and oral cytotoxics; all use if injectables Mycophenolate mofetil 6.5.1 Infertility treatments Growth hormone receptor antagonists 6.6.1 6.6.2 6.7.2 8.2.2 Chorionic gonadotropin, choriogonadotropin alfa Disodium pamidronate, ibandronic acid (injection), zoledronic acid Cetrorelix, ganirelix Basiliximab, belatacept, ciclosporin, sirolimus, tacrolimus 8.2.3 Rituximab and alemtuzumab Alemtuzumab, ofatumumab, rituximab 8.2.4 Other immunomodulating drugs Interferon alfa, peginterferon alfa, interferon beta, interferon gamma, aldesleukin, BCG bladder installation, canakinumab, fingolimod, glatiramer, histamine, lenalidomide, thalidomide, mifamurtide, natalizumab 8.3.4 Hormone Antagonists Fulvestrant - 115 - 9.1.3 Drugs used in hypoplastic, haemolytic, and renal anaemias Darbepoetin alfa, epoetin alpha, beta, theta and zeta, methoxy polyethylene glycol-epoetin beta, deferasirox, deferiprone, desferrioxamine, eculizumab 9.1.4 Drugs used in platelet disorders Drugs used in neutropenia Eltrombopag, romiplostim, anagrelide 9.1.7 Drugs used to mobilise stem cells Plerixafor 9.4.1 Foods for special diets Saproterin dihydrochloride 9.5.1.2 Hypercalcaemia and hypercalciuria 9.8.1 Drugs Used in metabolic disorders 9.8.2 Acute porphyrias Cinacalcet (secondary hyperparathyroidism in patients with endstage renal disease) Agalsidase alfa and beta, imiglucerase, velaglucerase alpha, galsulfase, idursulfase, laronidase, mercaptamine, algucosidase alpha, nitisinone, carglumic acid, sodium phenylbutyrate, betaine, miglustat Haem arginate 10.1.3 Drugs that suppress the rheumatic disease process 10.2.1 Drugs that enhance neuromuscular transmission Tetrahydrocannabinol/cann abidiol 9.1.6 10.2.2 Filgrastim, lenograstim, pegfilgrastim Abatacept, adalimumab, anakinra, belimumab, certolizumab, etanercept, golimumab, infliximab, leflunomide, methotrexate injections, tocilizumab Amifampridine, fampridine Sativex 11.4.1 Corticosteroids Dexamethasone intravitreal implant 11.8.2 Ocular diagnostic and perioperative preparations and photodynamic treatment Aflibercept, ranibizumab, pegaptanib, verteporfin, bevacizumab (unlicensed indication) 13.5.1 13.5.2 13.5.3 Alitretinoin Acitretin Ustekinumab 13.6.2 Preparations for eczema Preparations for psoriasis Drugs affecting the immune response Oral preparations for acne 14.5 N/A Immunoglobulins Anabolic steroid Normal immunoglobulin Oxandrolone (not in BNF) Isotretinoin - 116 - Template Request for the North West London Medicines Management Pharmacy Network to Consider Adding a Medicine to the ‘Red List’ of Medicines The following criteria are used to decide whether a change to the red list should be made: Criteria for adding a medicine to the red list Safe or effective use of the medicine, throughout its use, requires expertise or facilities that a GP will not normally have. Medicines added to the red list will normally be ‘specialist medicines’ that a GP will see infrequently. Relevant changes to a medicine’s licensing or to national policy (e.g. NICE guidance). Criteria for removing a medicine from the red list Guidance from NICE states that it is reasonable for GPs to prescribe the medicine, perhaps in the context of a shared care agreement. New trial evidence or a change in licence has made the medicine easier to use than at the time it was added to the red list (e.g. by demonstrating that less monitoring is needed than previously thought). A medicine will not be added to the red list: If, although the medicine should only be initiated by a hospital specialist, it is reasonable for a GP to continue to prescribe it once the patient and treatment are stable (e.g. monitoring, dose changes and stopping treatment require no specialist expertise or facilities). Simply because it is expensive, if the criterion for adding a medicine to the red list (above) is not met. - Name of medicine Presentation Indication Specialist expertise needed to prescribe safely Special facilities required to prescribe safely Details of recent change to license or national policy Form completed by Date of completion - 117 -