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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. Dispensing 5/31/2015WHO GPP: A clinical approach16
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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. National GPP Facilities Premises Personnel Equipments
Quality policy Service strategy Training Complaints and recalls
Documentation systems Procurement and inventory control Storage
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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. 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
32. 5/31/2015WHO GPP: A clinical approach32
33. Todays pharmacists 5/31/2015WHO GPP: A clinical
approach33
34. The End 5/31/2015WHO GPP: A clinical approach34
35. Any questions??? 5/31/2015WHO GPP: A clinical
approach35