Putative role of pharmacist in reporting adr and contributing into the national pharmacovigilance system of india

1. Putative Role of Pharmacist in reporting ADR and
contributing into the national Pharmacovigilance
system of India
Anindya Banerjee
Patient Safety-Pharmacovigilance Associate
Dept of Pharmacology
NRS Medical College & Hospital
And
National Coordination Centre-Pharmacovigilance program of India
Indian pharmacopoeia Commission
Ministry of Health & Family Welfare
Govt of India

2. Pharmacy as a Profession
• A Pharmacist is a custodian of medicines who
handles, prepares, dispenses, distributes, and
provides counseling to patient and other HCPs on
appropriate use of drug.
• To become a Pharmacist a degree of D.Pharm,
B.Pharm and M.Pharm must have to be there
alongwith a registration number from the country.
E.g., Pharmacy Council of India (PCI)

3. Pharmaceutical Care and Pharmacist
The role of pharmacist is an integral part of the
healthcare system. WHO explains pharmaceutical
care as “a philosophy of practice in which the
patient is the primary beneficiary of the
pharmacist’s actions. Pharmaceutical care focuses
on the attitudes, behaviours, commitments,
concerns, ethics, functions, knowledge,
responsibilities and skills of the pharmacist on the
provision of drug therapy with the goal of achieving
definite therapeutic outcomes toward patient health
and quality of life.
-The Word “pharmaceutical care,” coined by C. D.
Hepler and L. M. Strand.
-“Pharmacist”: All efforts of rational prescribing
will be nullified if dispensing is inappropriately
carried out. The Pharmacist is the last person the
patient comes in contact with before leaving the
hospital or health facility.

5. Role of Pharmacist
• The prescription must be read and interpreted
correctly so as to ensure that the right drug is
delivered in the correct dose, correct dosage form,
with clear direction to the right person and that
patient is counselled on the rational use of his/her
drugs.

6. Contd..
• Hospital Pharmacist – who
dispenses prescribed drugs,
procures, keep records,
provides counsel and drug
information to the patients
and other HCPs
• Community Pharmacist -
who Possess a drug outlet
such as retail or wholesale
pharmacy stores where
drugs are sold; dispenses
prescription brought by
patients provides counsel
and information.

7. Newer Concept - role of a Pharmacist
Vijay Venkatraman, et al.: Pharmacist as Pharmacovigilance Practitioner

8. Pharmacist as ADR reporter
Pharmacists have an important
responsibility in monitoring the
ongoing safety of medicines as part
of their professional practice.
A drug needs to be considered as a
concept, with benefit-risk profile,
applied to treat patients through
proven or commonly agreed
measures where benefits outweigh
risks.
Here comes the role of pharmacists on
a global perspective called
Pharmacovigilance.

10. Contd..
• It would be prudent to say pharmacovigilance deals with the
collection of adverse drug reaction (ADR) reports from various
stakeholders responsible for monitoring the safety profile of the
drug.
• Safety can be defined as “relative absence of harm”.
• In pharmacovigilance, safety means collection of reports of adverse
effects of drug. Safety can mean generating data and arriving upon a
solution to decide further usage of drug.
• A Pharmacist must also be involved in the collection of data that
might be useful in longitudinal pharmacoepidemiological studies

11. Opportunity of a Pharmacist as Vigilare
• Pharmacists play a key role in management and prevention of
the adverse events associated with the drug.
• Safety concerns are often considered to be implied when drugs
are approved or authorized.
• The scope has widened now. It includes all safety-related
activity right from the moment humans are first exposed to the
new drug. It should be noted that the pharmacists has an added
advantage of getting in direct contact with the patients.
• hospital pharmacists can play a significant role in ADR
reporting because the most serious adverse drug events occur
in hospitals.

12. Pharmacist under NCC-PvPI, IPC
• Doctors are well aware of disease, and diagnosis in Indian
Perspective.
• Pharmacist knows better about the medicine because of the
knowledge of Pharmacology.
• Because of the lack of knowledge of medicine and proper
identification of an ADR, our country is probably running a
status of under reporting.
• under reporting can be significantly reduced by actively
involving pharmacists in the surveillance of drug safety.

13. Contd..
• The participation of pharmacists especially in a country
like ours, where the unawareness is accounted for the
decline in reporting.
• Negligence of reporting is also considered to be a factor
for the steady dearth in reporting and seen as a major
setback among Indian HCPs.
• PvPI now has a dedicated website with a PvPI toolkit for
the stakeholders. PvPI has launched toll free number
1800-180-3024 to facilitate reporting of Adverse
Reactions.

14. Number of ADRs reported by Pharmacist since 2014

15. Conclusion
• A pharmacist can perhaps be entrusted as an
effective tool in collection and reporting of ADRs
for they are present at all levels of medical care,
right from community pharmacy to primary
healthcare centers, government hospitals to
corporate hospitals.
• Stay tuned, re-invent yourselves and be prepared.
A budding pharmacist should realize clinical
pharmacy is not just drug-drug, drug-food
interaction, but it is also tracking adverse drug
effects, reducing medication errors, monitoring
patients’ compliance, counseling patients

16. Acknowledgement
• Prof (Dr.) Nina Das, Professor & Head, AMC Coordinator,
Dept of Pharmacology, NRS Medical College & Hospital,
Kolkata.
• Dr. Tania Sur (Kundu), Associate Professor, Causality
Assessment Committee Member, Dept of Pharmacology, NRS
Medical College & Hospital, Kolkata.
• Dr. V. Kalaiselvan, Principal Scientific Officer, NCC-PvPI,
IPC, Ministry of Health & Family Welfare, Govt of India,
Ghaziabad

17. Anindya BanerjeeAnindya Banerjee
Patient Safety- Pharmacovigilance AssociatePatient Safety- Pharmacovigilance Associate
Dept of PharmacologyDept of Pharmacology
NRS Medical College & HospitalNRS Medical College & Hospital
andand
NCC-PvPI, IPCNCC-PvPI, IPC
Ministry of Health & Family WelfareMinistry of Health & Family Welfare
Govt of IndiaGovt of India
email:email: anindyabanerjee1988@gmail.comanindyabanerjee1988@gmail.com