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DRUGS AND THERAPEUTIC COMMITTEE - ROLE OF HOSPITAL PHARMACISTS DRUGS AND THERAPEUTIC COMMITTEE A drugs and therapeutics committee (DTC), also called a pharmacy and therapeutics committee, is a committee designated to ensure the safe and effective use of medicines in the facility or area under its jurisdiction Promotes rational and cost-effective use of medicines in hospitals Members represents all the major specialties and the administration in the hospital A senior doctor would usually be the chairperson and the chief pharmacist, the secretary www.who.int/entity/medicines/.../01-TG_DTC-Overview_final-08.pdf NEED FOR DRUGS AND THERAPEUTIC COMMITTEE In the absence of DTC following areas of inefficiency and drug use problems occurs: Poor selection of medicines, without consideration for relative efficacy, costeffectiveness or local availability Inefficient procurement practices, resulting in non-availability, inadequate quality, wastage, or use of unnecessarily expensive medicines http://apps.who.int/medicinedocs/en/d/Js4882e/3.1.html NEED FOR DRUGS AND THERAPEUTIC COMMITTEE Prescribing not in accordance with standard treatment protocols Poor dispensing practices resulting in medication errors, and patients’ lack of knowledge about dosing schedules Patients not adhering to dosing schedules and treatment advice http://apps.who.int/medicinedocs/en/d/Js4882e/3.1.html ROLE OF PHARMACIST IN HOSPITAL Interact closely with the prescriber to promote the rational prescribing and use of drugs Having access to medical records, Pharmacist can • Influence the selection of drugs and dosage regimens • Monitor patient compliance and therapeutic response to drugs • Recognize and report adverse drug reactions Assessment and monitoring patterns of drug usage and thus recommend changes where necessary http://apps.who.int/medicinedocs/en/d/Jh2995e/1.6.3.html ROLE OF PHARMACIST IN HOSPITAL Serves as a member of policy-making committees (Drug and Therapeutics Committee) and thereby influences the preparation and composition of an essential-drug list or formulary Educate other health professionals about the rational use of drugs Participates in studies to determine the beneficial or adverse effects of drugs, and is involved in the analysis of drugs in body fluids Controlling hospital manufacture and procurement of drugs to ensure the supply of high-quality products Planning and implementation of clinical trials http://apps.who.int/medicinedocs/en/d/Jh2995e/1.6.3.html ROLE OF PHARMACIST AS A MEMBER OF DTC Chief Pharmacist of the hospital is the secretary of Drugs and Therapeutic committee (DTC ) so he is actively involved in the following responsibilities of DTC: Developing and adopting clinical guidelines for the health institution under its jurisdiction Electing cost-effective and safe medicines Implementing and evaluating strategies to improve medicine use www.who.int/entity/medicines/.../01-TG_DTC-Overview_final-08.pdf ROLE OF PHARMACIST AS A MEMBER OF DTC Providing on-going staff education Controlling access to staff by pharmaceutical industry with promotional activities the its Monitoring and taking action to prevent adverse drug reactions and medication errors Providing advice about other drug management issues, such as quality and expenditure www.who.int/entity/medicines/.../01-TG_DTC-Overview_final-08.pdf ROLE AS ADVISORY COMMITTEE DTC provides advice to medical staff, nurses, administration, pharmacy and other departments and groups within the hospital DTC can advise on all issues, policies and guidelines concerning the selection, distribution and use of medicines. DTC will provide advice and an executive body, usually the pharmacy or hospital management, will implement it http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html DEVELOPMENT OF DRUG POLICIES It develops concerning: the specific policies • Criteria for inclusion of medicines on the formulary list (essential medicines list (EML) • Standard treatment guidelines and treatment algorithms, which should be the basis of formulary selection • Drug representatives promotional literature and http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html DEVELOPMENT OF DRUG POLICIES Periodic use of medicines not on the formulary list (only allowing 10% of the hospital medicines budget to be spent on them) Expensive or dangerous medicines, such as oncological drugs, which are restricted to certain practitioners, departments or patients Drugs that are under investigation for safety or efficacy Generic substitution and therapeutic interchange http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html FORMULARY DEVELOPMENT Most important function of a DTC is the evaluation and selection of medicines for the essential medicines list or formulary list Drugs should be selected on the basis of the standard treatment guidelines The evaluation of medicines requires significant expertise and time commitment and a rigorous, transparent approach http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html FORMULARY DEVELOPMENT Documented evidence for the efficacy, safety, quality and cost of all drugs under consideration for inclusion in the formulary list must be examined Periodic review is necessary because of changing costs and indications, new information on safety, and the emergence of new medicines http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html MEDICATION USE EVALUATION(MUE) MUE is a quality-improvement activity, but it can also be considered a formulary system management technique MUE activities should be conducted to examine the effect of medication-use policy decisions MUE often focuses on medications which are : High risk High-cost DTC should be involved in the MUE process by establishing a systematic plan to monitor, evaluate, and improve medication use ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System DRUG PRODUCT SHORTAGE Drug product shortages disrupt patient care and the processing of medication orders DTC needs to develop strategies to address shortages in a timely manner by • Including designating appropriate alternatives • Identifying strategies for rationing available drug product • Establishing use restrictions • Implementing evidence-based review procedures Therapeutic interchange can be useful in dealing with critical drug product shortages ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System STANDARD TREATMENT GUIDELINES Standard treatment guidelines (STGs) or protocols are a proven way to promote rational use of medicines STGs provide a benchmark of optimum treatment in the monitoring and audit of drug use DTC should either develop STGs from scratch or adapt them from elsewhere for use in their own hospital http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html STANDARD TREATMENT GUIDELINES Development of STGs from scratch will result in greater local ownership and acceptance, but is difficult and will consume time and resources Adaptation of STGs from elsewhere is much easier and quicker, but will result in less local ownership and acceptance STGs should be • Developed in a participatory way involving end-users • Easy to read and up to date • Introduced with an official launch, training, supervision and wide dissemination http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html CONDUCTING EFFECTIVE INTERVENTIONS The DTC is the main body within a hospital responsible for conducting interventions to promote more rational drug use Some important interventions are: Monitoring and supervision Audit and feedback Educational programs In-service training Use of standard treatment guidelines Provision of unbiased drug information Prescribing restrictions and automatic stop orders http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html MANAGING ADVERSE DRUG REACTIONS Adverse drug reactions may be due to the unknown effects of new (or older) drugs, unknown drug combinations and interactions, or poor drug quality DTCs are responsible for ensuring that patients are treated as safely as possible Monitoring and minimizing adverse drug reactions is an essential part of this function http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html MANAGING MEDICATION ERRORS Medication errors occurs due to lack of knowledge, tiredness of staff, careless work attitudes, poor procedures, lack of policies, unfamiliar dosage forms and human error DTCs can reduce such errors by monitoring, analyzing, reporting errors and implementing corrective action http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html INFORMATION DISSEMINATION AND TRANSPARENCY The DTC must disseminate information about its activities, decisions and recommendations to the staff who must implement the DTC’s decisions Members should either have no relationship with pharmaceutical companies or declare it openly so that conflicts of interest can be avoided The only acceptable contact with pharmaceutical companies is to ensure the flow of information about their drug products in a way that is as unbiased as possible http://apps.who.int/medicinedocs/en/d/Js4882e/3.3.html ASSESSING NEW MEDICINES The assessment of new medicines is critical in order to manage a formulary list It involves adding new medicines and deleting old ones DTCs evaluates and compares the drug on the basis of: • • • • • Efficacy, comparative efficacy Effectiveness, comparative effectiveness Safety, comparative safety Cost of use Quality http://apps.who.int/medicinedocs/en/d/Js4882e/6.html ASSESSING NEW MEDICINES Efficacy, effectiveness and safety can be evaluated from a critical assessment of the literature Much of the information may be biased so it is important that the members of DTCs evaluating new medicines have the necessary skills and time to assess the literature critically Once efficacy and safety are established, medicines should be compared according to cost of use and cost-effectiveness http://apps.who.int/medicinedocs/en/d/Js4882e/6.html GENERIC EQUIVALENTS The DTC must establish policies and procedures governing the dispensing of generic equivalents These policies and procedures should include the following points: • The pharmacist is responsible for selecting from available generic equivalents • The prescriber has the option, at the time of prescribing, to specify the brand of the drug to be dispensed for that particular medication order if considered clinically justified • The prescriber’s decision should be based on pharmacologic or therapeutic considerations (or both) relative to that patient ASHP Guidelines on the Pharmacy and Therapeutics Committee and the Formulary System ENSURING MEDICINE SAFETY AND QUALITY A significant amount of harm to patients and wastage of resources is caused through the use of unsafe, poor-quality medicines The DTC has a role to ensure that all medicines prescribed and dispensed to patients are safe and of good quality A DTC may have a significant impact on preventing and managing drug safety problems http://apps.who.int/medicinedocs/en/d/Js4882e/7.html ENSURING MEDICINE SAFETY AND QUALITY This involves: Monitoring and addressing medication errors Ensuring medicine quality through ensuring good practices concerning procurement, storage and distribution and monitoring and addressing drug quality problems Monitoring and addressing adverse drug reactions, which may be caused by the chemical entity itself or may be due to medication errors or poor drug quality http://apps.who.int/medicinedocs/en/d/Js4882e/7.html PROMOTING THE RATIONAL USE OF MEDICINES Aim of DTC is to ensure that medicines are used in the most effective way Strategies to promote the rational use of medicines: • Educational strategies that aim to inform prescribers • Managerial strategies that aim to guide the decisions of prescribers • Regulatory strategies that aim to restrict the decisions of prescribers http://apps.who.int/medicinedocs/en/d/Js4882e/9.html ANTIMICROBIALS AND INJECTIONS Antimicrobials and injectable drugs are amongst the most expensive of all drugs The use of antimicrobials contributes to the development of antimicrobial resistance Poor infection control contributes to the spread of resistant pathogens Unsafe injections can transmit blood-borne diseases such as hepatitis B and C and HIV/AIDS http://apps.who.int/medicinedocs/en/d/Js4882e/10.html ANTIMICROBIALS AND INJECTIONS Drug and therapeutic committees (DTCs) should: Monitor the use of antimicrobials and injections to ensure appropriate and safe use Ensure that appropriate infection control policies and practices are implemented, through an infection control committee or team Ensure that appropriate surveillance antimicrobial resistance is conducted of http://apps.who.int/medicinedocs/en/d/Js4882e/10.html CONCLUSION Irrational use of medicines is a widespread problem at all levels of health care, but especially in hospitals A drugs and therapeutic committee(DTC) provides a forum, allowing all the relevant people to work together to improve health care delivery Hospital pharmacists being a part DTC serves in an evaluative, educational, and advisory capacity to the medical staff and organizational administration in all matters pertaining to the use of medications http://archives.who.int/tbs/rational/s4882e.pdf