1. 1. T/Maj. Dr. Sitaram Khadka (Pharmacist) Doctor of Pharmacy(Pak), PGDDM (Ind), R.Ph. T/Capt. Dr. Mahesh Khatri (Pharmacist) Doctor of Pharmacy(Pak), R.Ph. 5/31/2015WHO GPP: A clinical approach1 WHO Good Pharmacy Practice(GPP): A Clinical Approach
2. 2. Contents of the Presentation 5/31/2015WHO GPP: A clinical approach2 Background Introduction to GPP; Global and SBH scenario Clinical Pharmacy Practice Rational prescribing and dispensing Pharmacovigilance; Adverse Drug Reactions(ADR) Drug Information Centre(DIC) National GPP Questions/Answers session
3. 3. They just count a few tablets Perception s of Pharmacis ts -How do others see pharmacists? 5/31/2015WHO GPP: A clinical approach3 They just weigh and measure th A bunch of shop-keepers Tell me how and when to use the Medi
4. 4. 5/31/2015WHO GPP: A clinical approach4 Counter-prescribing Not really health care practitioners theyre businessmen Do you need a degree to be a pharmacist?
5. 5. Background In 1992 the International Pharmaceutical Federation (FIP) developed standards for pharmacy services under the heading Good pharmacy practice in community and hospital pharmacy settings. 5/31/2015WHO GPP: A clinical approach5
6. 6. 5/31/2015WHO GPP: A clinical approach6 Knowledge of Drug Therapy Knowledge of Drug Therapy Knowledge of Disease Knowledge of communication skill Communication skill Patient monitoring skill Physical Assessment skill Drug Information skill Therapeutic Planning Skill Knowledge of laboratory and diagnostic skill Philosophy of Pharmacy Pharmacoeconomics Drug Information Efficacy Assurance Health Promotion Pharmacovigilance Patient care
7. 7. Good Pharmacy Practice 5/31/2015WHO GPP: A clinical approach7 GPP is the practice of pharmacy that responds to the needs of the people who use the pharmacists services to provide optimal, evidence-based care. To support this practice it is essential that there be an established national framework of quality standards and guidelines. Source: WHO FIP
8. 8. GPP Framework 5/31/2015WHO GPP: A clinical approach8 A legal framework that: defines who can practice pharmacy; defines the scope of pharmacy practice; ensures the integrity of the supply chain and the quality of medicines A workforce framework that: ensures the competence of pharmacy staff through continuing professional development (CPD or continuing education (CE)) programs; defines the personnel resources needed to provide GPP. An economic framework that: provides sufficient resources and incentives that are effectively used to ensure the activities undertaken in GPP.
9. 9. Clinical Pharmacy; 5/31/2015WHO GPP: A clinical approach9 The discipline that embodies the application and development (by pharmacist) of scientific principles of pharmacology, toxicology, therapeutics, and clinical pharmacokinetics, pharmacoeconomics, pharmacogenomics and other allied sciences for the care of patients (Reference: American college of clinical pharmacy)
10. 10. History and Development 5/31/2015WHO GPP: A clinical approach10 Traditional role Sedentary practice Clinical pharmacy services in Community/Hospitals Ward pharmacy Bedside pharmacy
11. 11. In context of Nepal 5/31/2015WHO GPP: A clinical approach11 Education: Diploma level/Bachelor/Post Bacc PharmD/Master/PhD The clinical pharmacy practice in Nepal is still in embryonic stage. Efforts are being made by pharmacists in different parts of country. A milestone for Pharmacy practice in Nepal: Hospital Pharmacy Directive 2070 : Accepted from the minister level of Nepal Govt on 2070.07.14 Execution; not till now/in process Competency/Patience/ IPC needed
12. 12. Clinical Pharmacy: A Shift in Practice Philosophy and Education 5/31/2015WHO GPP: A clinical approach12 Drug Product Pharmacy Dispenser Solo Knowledge As ordered Drug Therapy Bedside Caregiver Team Information As best prescribed From To
13. 13. Level of Action of Clinical Pharmacists 5/31/2015WHO GPP: A clinical approach13 Clinical pharmacy activities may influence the correct use of medicines at three different levels: Before the prescription During the prescription After the prescription "If your medicine is not working it may not be your medicine, it may be you"
14. 14. What we are doing in SBH??? 5/31/2015WHO GPP: A clinical approach14 Formulary Yes Drug Information No* Clinical Trail No Drug Policy No Counseling NO Counseling Yes Outcome Research No Personalized Formulation Yes* Pharmacoeconomic studies No Before the prescription During the prescription Afterthe Prescription
15. 15. Aims of Clinical Pharmacy Practice Effective drug therapy Safe drug therapy Economic drug therapy Improve quality of life 5/31/2015WHO GPP: A clinical approach15
16. 16. Dispensing 5/31/2015WHO GPP: A clinical approach16
17. 17. High Profile Examples A patient with leukaemia received Intrathecal vincristine instead of intravenously. Died beginning of February 2001. 14th such case over the last 16 years. Patient being operated for a AAA received bupivacaine intravenously rather than epidurally. Patient died 3 days later. A 3 year old girl, who had a convulsion post flu vaccine. Attended hospital to get checked out. Received nitrous oxide instead of oxygen in casualty. Elderly lady was prescribed Methotrexate (1997) for her rheumatoid arthritis. Dose increased to 17.5mg weekly over a 6 month period. A patient undergoes right TKR in hospital (2000). MTX given as one tablet a week (only 2.5mg).Prescription for MTX 10mg/daily written and dispensed. 30th April patient5/31/2015WHO GPP: A clinical approach17
18. 18. Deaths from medicines in the UK 1999 - 2000 (ICD9 & 10 data) 5/31/2015WHO GPP: A clinical approach18 "Every drug is poison, its the dose that differentiate poison or drug the substance is.
19. 19. So drugs are safe ? Photosensitivity from Amiodarone Severe extravasation of amiodarone infusion 5/31/2015WHO GPP: A clinical approach19 NSAID induced peptic ulcer Goitre Hypothyroidism Secondary to Amiodarone Bleeding due to anticoagulation Erythemal rash from penicillin in patient with a previous Known allergy/ ADR
20. 20. Some considerations for Rational prescribing 5/31/2015WHO GPP: A clinical approach20 Interdisciplinary collaboration: Inter-professional collaboration Intra-professional collaboration Effective and safe use of pharmaceuticals Economic and effective use of pharmaceuticals "Medicine is for those who need them, not for those who want them."
21. 21. Some facts 5/31/2015WHO GPP: A clinical approach21 Over time, participation in medical ward rounds, medication history taking, drug therapy selection,TDM services, provisin of drug information,ADR monitoring, and prevention,DUE, research and teaching have become activities that now form the basis of contemporary clinical pharmacy practice (Wilson 2000, Rahel 2000) Studies have clearly shown that clinical pharmacy improves drug therapy and overall patient health outcomes (Gattis 1999, Leape 1999, Stewarr 1999, Bond 1999), and reduces both drug costs and total health costs (Stewart 1999, McMullin 1999) The publication of editorial by Lundberg entitled The clinical pharmacist in the Journal of the American Medical Association in 1983 was an important milestone in the history of clinical pharmacy development in USA.
22. 22. Human Error in clinical practice (Mistakes, Slips, Lapses) 5/31/2015WHO GPP: A clinical approach22 Error is inevitable due to our limitations We all make errors all the time Patients suffer adverse events much more often than previously realized Types of errors that can be accounted: Prescribing error/Dispensing error/Administration error/Lack of user education The same error, even a minor one, can have quite different consequences in different circumstances.
23. 23. I assumed the brown glass ampoule was frusemide 5/31/2015WHO GPP: A clinical approach23 The System: Only as safe as its designed to be!
24. 24. Formulary Prescribing protocols Prospective review Clinical pharmacy Admission medication history Allergy check Drug distribution system Opportunity For Error Administration instructions Clinical Pharmacist Role in Reducing Risks 5/31/2015WHO GPP: A clinical approach24
25. 25. Formulary Prescribing protocols Prospective review Clinical pharmacy Admission medication history Allergy check Drug distribution system Opportunity For Error Administration instructions What if we are not there! 5/31/2015WHO GPP: A clinical approach25
26. 26. Pharmacovigilance 5/31/2015WHO GPP: A clinical approach26 The WHO defines pharmacovigilance as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug related problems.
27. 27. 5/31/2015WHO GPP: A clinical approach27 Regional Pharmacovigilance Centers : TUTH NMCH KIST Medical College Manipal TH BPKIHS Civil Hospital Fig: Pyramid of ADR reporting system in N
28. 28. Drug Information Center 5/31/2015WHO GPP: A clinical approach28 Drug information centers (DICs) in general, are service providers, which provide drug information relating to therapies, pharmacoeconomics, education, and research programs. Drug Information Centers in Nepal Department of Drug Administration (DDA), Ministry of Health Drug Information Unit(DIU), Tribhuvan University Teaching Hospital Resource Centre for Primary Health Care (RECPHEC) Nepal Chemists and Druggists Association (NCDA)
29. 29. National GPP Facilities Premises Personnel Equipments Quality policy Service strategy Training Complaints and recalls Documentation systems Procurement and inventory control Storage 31/05/201529
30. 30. National GPP Contd Prescription handling Dispensing Extemporaneous preparations Patient information Patient counseling Medicine records and patients F/U Self care Health promotion Enhancement and development of professional role Pharmacovigilance Audit 31/05/201530
31. 31. Recommendations Technical manpower required in sufficient number Skill enhancement trainings Quality control lab establishment Centralized store room for drugs and related items with centralized AC system Surgical and other drug related items list (similar to formulary) to be prepared Clinical pharmacy practice New and advanced technology needed 31/05/201531
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33. 33. Todays pharmacists 5/31/2015WHO GPP: A clinical approach33
34. 34. The End 5/31/2015WHO GPP: A clinical approach34
35. 35. Any questions??? 5/31/2015WHO GPP: A clinical approach35