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Your Surgery Name Protocol for the Administration of Hydroxocobalamin (B12) to adults by Health Care Assistants (HCA) Purpose of Protocol To enable suitably trained Health Care Assistants working within Your surgery name who have undertaken relevant training (as outlined below), to administer hydroxocobalamin as a duty delegated by the General Practitioner (GP employer) or registered nurse (PCT employee). Characteristics of staff Staff group (s) Health Care Assistants Additional Requirements Completion of relevant training (as outlined below) Knowledge of PCT policy on management Anaphylaxis in the Community and basic life support. Training and competence in the correct procedure of administering medication via intra-muscular injection. Continuing Training Requirement Annual updates in Basic Life Support and 1 yearly updates in the treatment of Anaphylaxis. Demonstration of competence in relation to this medication within the PDP and appraisal process. Clinical Condition Clinical Condition to be treated Megaloblastic anaemias –lack of B12 due to: o Food – Cobalamin malabsorption (i.e. dietary deficiency) o Cobalamin malabsorption (e.g. total gastrectomy, Crohn’s disease, Coeliac disease, Whipple’s disease, chronic pancreatitis, TB etc.) Pernicious anaemia – lack of gastric intrinsic factor resulting from autoimmune gastritis. Drug induced - ( e.g. Prolonged nitrous oxide anaesthesia etc) Hereditary Cobalamin Metabolism diseases (Congenital Transcobalamin II Deficiency etc) Criteria for inclusion Any adult (i.e. any person aged 18 years or over) who has received first dose following diagnosis and now requires maintenance doses. Criteria for exclusion Patients with an unconfirmed diagnosis of pernicious or other macrocytic anaemia. Recently diagnosed patients who are receiving the initial two weeks of treatment. Any person less than 18 years of age. Adverse reactions Health Care Assistants must ensure the availability of an Anaphylaxis shock pack containing Adrenaline 1:1000. If a general adverse reaction does occur: Record in patient’s notes Inform patient’s General Practitioner as soon as possible Local reactions should be seen by either the general practitioner or practice nurse or qualified Registered Nurse within the district nursing team. If anaphylactic reaction occurs Give treatment in accordance with the PCT policy on the Management of Anaphylaxis in the community, including ensuring patient is transferred to Accident and Emergency. Record in patient’s notes Inform patient’s General Practitioner as soon as possible Relevant training 1) The Health Care Assistants will attend a training session covering the following aspects of the administration of hydroxocobalamin Appropriate anatomy and physiology Correct procedure for the administration of hydroxocobalamin by intramuscular injection Drug store requirements Cautions and side effects related to the administration of hydroxocobalamin Documentation Legal aspects of drug administration 2) The Health Care Assistant will have successfully completed and passed the Injection Training Course. This includes an assessment of competence at performing basic life support and underpinning knowledge of consent issues. 3) The HCA will undergo a period of supervised practice and to be directly observed administering 5x intramuscular injections of hydroxocobalamin either by the general practitioner or the practice nurse (GP employee) providing this duty has been delegated in writing by the general practitioner or by a registered nurse (if employed by Croydon PCT). Assessment of competence Assessment of competence will be undertaken following the period of supervised practice as outlined above. In the GP Practice, this will be undertaken by the general practitioner (or by the practice nurse providing that this duty has been delegated in writing) in order to comply with the specific requirements of the company providing medical indemnity. If employed by the Croydon PCT, assessment of competence will be undertaken by an occupationally competent registered nurse. Competence will be assessed by direct observation of the HCA’s ability to: Prepare the patient for the procedure Safe administration of the medication (including choice of site and needle technique) Correct disposal of clinical waste Correct documentation The Health Care Assistant will also be assessed (via oral questioning) on issues relating to the therapeutics of hydroxocobalamin. Clinical Aspects The following will be required: 1. Patient specific direction – written by the General Practitioner or other authorised prescriber 2. Patient identification - required prior to the administration of medication (confirmed by the patient declaring his or her name, date of birth and home address). 3. Consent – informed consent must be obtained from the patient. 4. Record keeping – The following should be recorded in the patient’s notes, either according to the GP practice system, or within the district nursing documentation drug administration records Name of drug, dose route and site of administration Date administered Batch No and expiry date Signature of person administering Significant Events Any significant event which occurs during or as the result of administration of medication must be reported to the Practice Manager/General Practitioner (GP employee) or Registered Nurse/Manager (PCT employee), and the incident reported via the PCT significant event reporting framework. Audit: The HCA will be expected to participate in audit in relation to patient outcomes and the development of this role. The HCA must be familiar with the following documents or own PCT equivalent: Your CCG Medicines Policy Your CCG Consent Policy Your CCG Records Management Policy Your CCG Adverse Incident/Reporting & Managing Policy NMC Standards for Medicine Management This protocol has been revised by Francina Hyatt, Clinical Nurse Trainer and Barbara Adie Principle Pharmacist Acknowledgement is given to the following people from Salford PCT Mrs Barbara Jackson Workforce Modernisation Co-ordinator Ms Sue Harris Non-medical Prescribing Lead Review: It is the responsibility of the lead of the staff group (s) to whom this protocol applied to ensure the review process takes place. This protocol becomes valid on 1st February 2016 Protocol for Hydroxocobalamin Agreement for Health Care Assistants This protocol is to be read, agreed and signed by all Health Care Professionals it applies to: Approved base: __________________________________ Staff Name: __________________________________ Designation: __________________________________ Signature: __________________________________ Date: __________________________________ Signature of Team __________________________________ Leader: Date: __________________________________ The Health Care Professionals should retain a copy of the document after signing and the original retained in their personal file. Expires 1st February 2018 Protocol for Hydroxocobalamin Agreement for Health Care Assistants This protocol is to be read, agreed and signed by all Health Care Professionals it applies to: Practice: __________________________________ Staff Name: __________________________________ Designation: __________________________________ Signature: __________________________________ Date: __________________________________ Approved by Lead GP: __________________________________ Date: __________________________________ The Health Care Professionals should retain a copy of the document after signing and the original retained in their personal file. Expires 1st February 2018 8