1. MEDICATION MANAGEMENT P&T COMMITTEE AND FORMULARY MANAGEMENT EMTENAN ALHARBI, Msc CLINICAL PHARMACIST

2. Learning Objectives  Discuss the organization and role of the pharmacy and therapeutic committee.  Explain how formulary management works.

3. Introduction Safety Cost Efficacy  Medication use management describe the process used to assure the safe and effective use of drugs in a cost conscious manner.  The key to medication management is the formulary system.

4. Formulary system  Formulary system defined as an ongoing process which methodically evaluate medications for inclusion\exclusion, establishing guidelines and developing policy and procedures.  The formulary system is managed by pharmacy and therapeutic committee.

5. Pharmacy and Therapeutic committee(P&T committee) Definition. Committee membership. Responsibilities.

6. P&T committee-definition  P &T committee is a group responsible for overseeing all aspects of drug therapy in an institution.  Because drug products and medical literature are continually changing,meeting should occur at lease 4-6 times per year.  Generally, monthly meetings are needed to keep the meeting time to 60-90 minutes.

7. P&T committee-definition P&T subcommittees Medication safety Review ADRs and medication errors. Drug review panel Focus on a particular specialty such as cardiology and review drug products and guidelines. Medication use review Monitor one or more medications to optimize specific drug use.

8. P&T committee membership Physicians. Pharmacists. Nurses. Quality improvement mangers.

9. P&T committee membership  Therefore, Medication management is a multidisciplinary process.  The voting members of the P&T committee in many hospitals remains to physicians only. this is changing as the committee membership is evolving.

10. P&T committee-responsibilities P&T committee Formulary system maintenance. Medication selection and review. MUE Medication safety evaluation. Drug therapy guidelines. Policy& procedure development. Education.

11. Formulary system maintenance  The committee develop a list of medication for use on regular basis to assure that the current need of patents and staff are met.  They also develop guidelines for the optimal use of medication for specific disease management.

12. Medication selection and review  A written medication review is prepared from available literature.  The review should be unbiased, and committee members should discuss any conflict of interest prior to discussion of drug or drug class.  Medication selection criteria should be based on efficacy, safety and cost.

13. Medication selection and review  Other issues that should be considered in medication selection process such as duplication, method of administration and targeted population.  Barriers to optimal formulary decision include : 1. physicians experience and preference. 2. detailing by pharmaceutical company representatives.

14. Medication use evaluation (MUE)  MUE is the method for evaluating and improving medication use process with the goal of optimal patient outcome.  Medication considered for review are based on efficacy,safety and cost or a combination of factors.  E.g. antibiotics

15. Medication safety evaluation  Medication safety is evaluated through ADRs and medication errors reports.  Such reports may be local i.e SFDA or global i.e literature or press release.

16. Drug therapy guidelines  Are listing of the indications, dosage regimen, duration, route of administration,monitoring parameter and special consideration.  These guidelines are often put into via pre-printed physician order sheet placed in the patient chart.

17. Policy& procedure development  Guidelines development on pharmacy related topics such as narcotics,IV preparation and chemotherapy handling.

18. Education  Newsletters are often employed to include clinical information on drug added to the formulary, medication safety alerts and new guidelines.  The newsletter should be visually pleasing, easy to follow and limited to 2-4 pages.  Presentations are also employed to educate staff and awareness days are held to educate patients.

19. Formulary management

20. Formularies (by access to medications) Open Generally large. Closed Limited list of medication to certain physicians or indications.

21. Formulary restrictions  Do not necessarily translate to optimal medication management.  Some authors suggested that restricting formularies has resulted in increased health care cost and hospitalization i.e. antimicrobial resistance.

22. Therapeutic equivalent and interchange  Drug products with different chemical structure and same pharmacological \therapeutic use  E.g. 1 st generation cephalosporin.  Histamine -2 blocker.  Is the authorized exchange of therapeutic alternative in accordance to previously established guidelines. This should include dose strength,frequency and route.  E.g. cimetdine 300 mg q 6 hour is as effective as ranitidine 50 mg q 8 hours. Therapeutic equivalentTherapeutic interchange

23. Formulary maintenance  New product evaluation.  Non-formulary drug use review.

24. New product evaluation  Development of slandered format for new drug evaluation is useful in facilitating P&T committee discussions.  The slandered element include the following: Generic nameIndication\uses Trade nameAdverse events Pharmacological classDrug interaction PharmacologyDosing PharmacokineticsCost Clinical studiesSummary, recommendation and references. leuprolide acetate

25. Non-formulary drug use review  Unique patients needs may require the use of non- formulary agent.  the process includes the completion of non- formulary request form by the prescribing physician.  This may take up to 24 hours delivery time. it also permit the use of patient own medications.

26. Non-formulary drug use review  P&T committee frequently assess the non-formulary requests.critical information such number of times used in the last 6-12 months, patient safety and cost should be considered.  Understanding this information will allow the committee to take an action plan such as reconsidering the agent for formulary addition or adding the drug with restrictions.