This document discusses the role of community pharmacists in adverse drug reaction (ADR) monitoring. It outlines how community pharmacists can identify ADRs, assess causality, document reactions, and report serious reactions. It also describes India's Pharmacovigilance Program of India and how it coordinates ADR monitoring and reporting nationally. The document advocates for continuous pharmacy education programs to train pharmacists in proper ADR monitoring and reporting.

1. ADR MONITORING IN
COMMUNITY PHARMACY
ASSIGNMENT
Submitted To,
Mr. Dawn V J
Associate Professor
Dept. of Pharmacy Practice
Sanjo College of Pharmaceutical Studies
Submitted By,
Ameena Kadar K A
First Sem M Pharm
Dept. of Pharmacy Practice
Sanjo College of Pharmaceutical Studies

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INTRODUCTION
 ADVERSDE DRUG REACTIONS (ADR): “A response to a drug which is
noxious and unintended, and which occurs at doses normally used in man for
prophylaxis, diagnosis, or therapy of disease, or for the modification of
physiological function”.
PREDISPOSING FACTORS
 Race and Genetics
 Gender
 Age
 Allergic disorders
 Renal & hepatic disease
 Plasma protein binding
 Formulation of drugs
 Poly pharmacy.
CLASSIFICATION OF ADR
1. BASED ON MECHANISM AND CHEMISTRY
 Type A (Augmented) Eg: Bleeding with warfarin, Bronchospasm with beta
blocker.
 Type B (Bizarre) Eg: Anaphylaxis with penicillin , Aplastic anaemia
with Chloramphenicol
 Type C (Chemical) Eg: Adrenal suppression with corticosteroid.
 Type D (Delayed) Eg :Tardive dyskinesia with neuroleptics

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 Type E (Exit) Eg: Withdrawal reaction with benzodiazepine
 Type F (Unexpected Failure of therapy) Eg: Resistance to antimicrobial.
 Type G (Genotoxicity) Eg: Thalidomide causing genetic damage to foetus
 Type H (Hypersensitivity) Eg: Allergy skin reaction with antimicrobial
 Type U (Unclassified) Eg: Taste disturbance with Simvastatin.
2. BASED ON SEVERITY/ INTENSITY
 Mild (minor)
 Moderate
 Severe (major)
 Lethal (life threatening)
3. BASED ON PREVENTABILITY
 Predictable
 Unpredictable
 Preventable
 Unpreventable
4. BASED ON THE INCIDENCE
 Very common
 Common
 Uncommon

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 Rare
 Very rare
 PHARMACOVIGILANCE: It is defined as “the science and activities
relating to the detection, assessment, understanding and prevention of
adverse effects or any other possible drug related problems in humans”.
ROLE OF COMMUNITY PHARMACIST IN ADR MONITORING
 Adverse drug reactions (ADRs) are the most common causes of morbidity,
mortality and poor economical outcomes. Therefore post marketing surveillance
is very important for monitoring the risks and benefits of pharmaceutical
products after they have been marketed.
 The roles of pharmacists have expanded to other aspects of patients' care, which
include reporting ADR, improving patients' health and economic outcomes.
 The pharmacists traditionally have been playing the role of preparing and
dispensing medications, with no or minimal emphasis on providing services to
the patients.
 Community Pharmacists (CPs) as part of their pharmaceutical care functions
have roles and professional responsibilities to monitor the safety of medicines
for which they are sole custodians.
 CPs are an important source of adverse drug reaction reporting because they are
the first to be contacted by patients in most adverse drug reaction cases.
 CPs can play an important role in adverse drug reactions reporting by
increasing the number and the quality of submitted report.

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STEPS INVOLVED IN ADR MONITORING:
1. Identifying adverse drug reaction (ADR).
2. Assessing causality between drug and suspected reaction by using various
algorithms.
3. Documentation of ADR in patient's medical records.
4. Reporting serious ADRs to pharmacovigilance centres /ADR regulating
authorities.
What happens to Submitted Information?
1. The causality assessment is carried out at Adverse Drug Reaction Monitoring
Centers (AMCs) by using WHO-UMC scale.
2. The analyzed forms are forwarded to the National Coordinating Centre
through the ADR database.
3. Finally the data is analyzed and forwarded to the Global Pharmacovigilance
Database managed by WHO Uppsala Monitoring Center in Sweden.
4. The reports are periodically reviewed by the National Coordinating Centre
(PvPI).
5. The information generated on the basis of these reports helps in continuous
assessment of the benefit-risk ratio of medicines.
 Continuous Pharmacy Education Program (CPE)
CPE program was designed for community pharmacists to educate and train them
in ADR monitoring and reporting services. The contents of the educational
material were customized to include the issues on pharmacovigilance and need for
ADR reporting in the community setting. The materials were delivered through

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didactic lectures, demonstrations, and interactive discussions conducted
periodically to the community pharmacists both in the study center and respective
pharmacies so as to provide the participants, the knowledge about
pharmacovigilance concepts and the necessary skills to monitor and report ADRs.
The key learning objectives of the CPE program included:
 Understanding the epidemiology of ADRs and drug safety
 Highlighting the concepts of pharmacovigilance
 Pharmacists roles in ADR monitoring and reporting
 Current scenario in India and importance of reporting ADRs by community
Pharmacists.
 In the CPE program, ADR reporting form and ADR documentation form were
distributed to the pharmacists and demonstrations were given for filling the
same. Earlier, the theoretical concepts of ADR monitoring included:
▪ WHO definition of the ADR, how to report the ADRs, where to report the ADRs,
causes of the ADRs, risks factors of ADRs,
 How to assess the causality of the ADRs and the role of pharmacists in
preventing and reporting of ADRs were delivered through appropriate audio
visual aided lectures.
 ADR awareness posters were also prepared and distributed for displaying in
prominent places at community pharmacies, which most of the customers could
visualize and become aware of this service.
 ADR MONITORING BY COMMUNITY PHARMACIST
1. Pharmacist should Report ADR because he/she have complete data collection of
patient.

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2. High-risk patients (receiving multiple doses) should be identified and monitored.
3. After confirming ADR evaluated on the bases of patients history, circumstances
of AE, etiology and literature review.
4. After evaluation ADR categorized into definite, likely, possible and unlikely.
5. On categorization, the description of ADR and outcomes from the event should
be documented in patients’ medical record.
6. Report to PTC Committee then to regulatory authority.
Benefits of ADR monitoring
✓ Safety of Drug Therapy
✓ Prevent ADR related to pharmaceutical products
✓Introduction about ADR to pharmacist, nurses, doctor, health care provider.
PHARMACOVIGILANCE PROGRAM OF INDIA
 The Central Drugs Standard Control Organization (CDSCO) under the aegis of
Ministry of health and family welfare, Government of India has developed a
nationwide pharmacovigilance program with the Indian Pharmacopeia
Commission (IPC) named as the National Coordination Centre for
Pharmacovigilance Program of India (NCC PVPI).
 Its main responsibility is to monitor ADRs of medicines observed in Indian
population and maintain its own pharmacovigilance database.
 https://www.ipc.gov.in/images/ADR_Reporting_Form_1.4.pdf
 pvpi@ipcindia.net or pvpi.ipcindia@gmail.com.
 Android Application ADR Reporting App. can be downloaded from Google
play store Indian Pharmacopoeia Commission; Pharmacovigilance Program of

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India ADR- PVPI is the indigenously developed Mobile App for all healthcare
professionals and consumers to report adverse drug reactions.
 REFRENCES
1. Impact of continuing pharmacy education on the knowledge attitude and
practice of community pharmacists about ADR monitoring and reporting, M.
Deepalakshmi, Preethi Kumar, K. P. Arun and S. Ponnu Sankar Department of
Pharmacy Practice, JSS College of Pharmacy, A Constituent College of JSS
Academy of Higher Education and Research, Ooty- 643 001, India
2. Lihite, Ratan J.; Lahkar, Mangala (2015). An update on the Pharmacovigilance
Programme of India. Frontiers in Pharmacology,doi:10.3389/fphar.2015.00194
3. https://who-ume.org/
4. https://www.ipc.gov.in/PvPI/adr.html
5. https://cdsco.gov.in/opencms/opencms/en/PvPI/
6. https://www.slideshare.net/PCRGUSM/opportunities-for-pharmacy-practice
research-in-community-setting.
7. A Text Book of Clinical Pharmacy Practice by G Parthasarathy.Page no: 85-91.