ADR Reporting Awareness and Practice Study at a Model Community Pharmacy with a PvPI-Aligned Reporting Desk

ADR Reporting Awareness and Practice Study is a pharmacy-practice mini-report built around the 500-hour practical training that the Pharmacy Council of India's Education Regulations 2020 require in the second year of D.Pharm. Instead of a routine pharmacy-tour report, the project turns the training placement into a small, ethically careful research study conducted at Sahyadri Medicals, a model community pharmacy, together with the neighbouring pharmacies of the same locality.

The study has two parts. The first measures what registered pharmacists and walk-in consumers actually know, feel and do about adverse drug reactions (ADRs) using a pilot-tested knowledge–attitude–practice (KAP) questionnaire, with all responses anonymised and analysed only in aggregate. The second part converts the model pharmacy into a working ADR reporting desk: a rack of Suspected ADR Reporting Forms in the PvPI format, signage in the local language, a referral card listing the nearest ADR Monitoring Centres (AMCs), and a role-play demonstration that walks a simulated patient through a report.

Everything is aligned to the Pharmacovigilance Programme of India (PvPI), whose National Coordination Centre (NCC-PvPI) functions at the Indian Pharmacopoeia Commission, Ghaziabad. The deliverables — preceptor-signed training diary, mini-report, poster and desk artefacts — are exactly the evidence an examiner expects from a D.Pharm student who has understood community pharmacy beyond dispensing.

India consumes an enormous volume of medicines, yet contributes a disproportionately small share of the individual case safety reports held in the WHO's global VigiBase database, and most Indian reports originate from a limited number of hospital-based ADR Monitoring Centres. The community pharmacy, where patients collect medicines every day, sits outside this loop: Suspected ADR Reporting Forms are usually not stocked, pharmacists are frequently unaware of the PvPI procedure and the nearest AMC, and consumers have no idea that a side effect is something one reports rather than merely tolerates.

Nobody measures this gap at the counter level, and nothing at the counter tells a patient that reporting is even possible. There is a need for (a) a simple, ethically sound measurement of ADR-reporting awareness among community pharmacists and consumers, and (b) a low-cost, visible, PvPI-aligned reporting desk that converts a pharmacy from a passive dispenser into an active drug-safety outpost — the role the Pharmacy Practice Regulations, 2015 already envision for the registered pharmacist.

Abstract

Adverse drug reactions are a quiet but heavy burden on Indian patients, yet the reports that reach the national pharmacovigilance system come mostly from a limited set of hospital-based ADR Monitoring Centres. This project studies the gap where it actually lives: the community pharmacy counter. Run across the final six weeks of the ER-2020 practical training, the study measures ADR-reporting awareness among 25 registered community pharmacists and 100 consumers using an anonymised, aggregate-only KAP questionnaire, audits the model pharmacy's reporting readiness before and after an intervention, and installs a working ADR reporting desk aligned to PvPI procedures.

Introduction

India runs one of the world's largest pharmacovigilance networks. The Pharmacovigilance Programme of India was launched in July 2010, and since April 2011 the Indian Pharmacopoeia Commission, Ghaziabad has functioned as its National Coordination Centre, with roughly 250 ADR Monitoring Centres — medical colleges, district and corporate hospitals — feeding individual case safety reports into the WHO's VigiBase through VigiFlow. Consumers can also call the toll-free helpline 1800-180-3024 or use the ADR PvPI mobile app.

But the network's entry points remain largely institutional. The community pharmacist — often the first and last health professional a patient speaks to — is rarely equipped to recognise a suspected reaction and pass it on, even though the Pharmacy Practice Regulations, 2015 frame patient counselling and the maintenance of medication records as professional duties of the registered pharmacist. The counter where lakhs of Indians collect medicines every day is, at present, a blind spot of the safety system.

Existing vs proposed

• Existing practice: ADR reporting is treated as a hospital activity; Suspected ADR forms are not stocked at most counters; patients mention side effects casually and are often told simply to stop the medicine; there is no record, no referral and no data.
• Proposed: measure the exact awareness gap with a structured KAP instrument for pharmacists and consumers; fix the counter with a visible desk (form rack, signage, AMC referral card); rehearse the correct flow through ten role-played, fully simulated cases; report findings and recommendations to the pharmacy owner so the desk survives after the training ends.

Feasibility

• Technical: the study needs printed forms, a clipboard, consent scripts and Excel — all within a D.Pharm student's reach during the placement.
• Economic: total cost stays under ₹500 for printing and signage; the desk occupies one shelf of the counselling corner.
• Operational: the preceptor supervises every step; respondents give informed consent; the desk adds about a minute to a counselling interaction once installed.
• Ethical: the design deliberately avoids identifiers — the report never names a respondent, a patient or a prescription, only counts and patterns. Every demonstration case is simulated, so the study never creates or submits a fabricated real-world ADR report.

In scope

• One model community pharmacy (Sahyadri Medicals, a fictional stand-in for your training site) plus five neighbouring pharmacies for the pharmacist survey.
• 25 registered pharmacists and 100 adult consumers, surveyed only after informed consent.
• Awareness, attitude and self-reported practice regarding ADR reporting; a desk-readiness audit; simulated role-play cases.
• Descriptive statistics (frequencies, percentages, means, cross-tabs) computed in Excel.
• Awareness poster and handbill in the local language, plus the mini-report and training diary.

Out of scope (and out of ethics)

• No real patient identifiers, prescriptions or case records are collected, and no government ID numbers are ever stored.
• No causality assessment beyond what the Suspected ADR form itself asks — the study does not practise medicine.
• No actual submission of real ADRs: every demonstration case is simulated. If a genuine reaction appears during training, the standing rule is to refer the patient to the pharmacist or physician and use the pharmacy's normal referral channel.
• No clinical trials, no paediatric respondents, no laboratory or clinical measurements.
• No inferential claims: a six-week, single-locality sample cannot prove why reporting rates differ, and the report says so plainly.

Research design. A cross-sectional, descriptive KAP study with an embedded pre-test/post-test audit of the model pharmacy's reporting desk. The design is deliberately simple: the training window is short, respondents include lay people, and the ethical bar — anonymised, aggregate-only data — must be easy to maintain in a busy shop.

Sampling. Pharmacists: purposive sampling of one registered pharmacist per pharmacy across six outlets in the locality, extended to a second pharmacist where staffing allows, up to 25. Consumers: systematic convenience sampling — every fifth consenting adult customer during assigned counter hours, until 100 responses. Both questionnaire versions share one structure: 10 knowledge items (true/false/unsure), 5 attitude items on a five-point Likert scale, and 5 practice items (ever reported, ever seen the form, knows the helpline 1800-180-3024, knows the nearest AMC).

Instruments. (1) The two KAP questionnaires, content-validated by the preceptor and one pharmacy-practice faculty member and pilot-tested on five respondents each. (2) A ten-point desk-readiness checklist: form rack stocked, signage visible, AMC referral card current, counselling corner marked, counter staff briefed. (3) A five-criterion role-play rubric — recognition, empathy, form accuracy, referral guidance, documentation habit — applied to ten simulated cases written by the student and cross-checked by the preceptor.

Analysis plan. All data goes into one Excel workbook with a written code book. Analysis is descriptive: frequencies and percentages per item, mean attitude scores, cross-tabs of pharmacist awareness against qualification and years in practice, and a pre/post comparison of the desk audit.

Ethics. Verbal informed consent precedes every questionnaire; participation is voluntary and refusal changes nothing about service. No names, phone numbers or ID numbers are recorded — sheets carry codes only, and the preceptor keeps the master code list, which is destroyed after the report is graded.

Because this is a field study rather than a software build, the architecture is the study's information flow: who gives what to whom, how it is anonymised, where it is analysed, and how a simulated ADR report would travel through the real PvPI machinery.

Study data flow

flowchart TD
  P1(["Registered community pharmacist"]) -->|"informed consent + coded KAP form"| S["D.Pharm trainee (study coordinator)"]
  P2(["Adult pharmacy consumer"]) -->|"verbal consent + coded KAP form"| S
  S --> D1[("Anonymised response sheets (codes A01, A02 ...)")]
  D1 --> E["Excel workbook: frequencies, percentages, cross-tabs"]
  E --> R["Mini-report + poster + recommendations"]
  S --> P["Preceptor weekly review and diary signing"]
  P --> R

Simulated ADR reporting pathway (the desk)

flowchart TD
  C(["Consumer mentions a simulated side effect"]) --> PH["Community pharmacist at the ADR desk"]
  PH --> F["Suspected ADR Reporting Form (PvPI format)"]
  F --> AMC(["Nearest ADR Monitoring Centre"])
  AMC --> NCC["NCC-PvPI at IPC Ghaziabad (VigiFlow)"]
  NCC --> UMC(["Uppsala Monitoring Centre - VigiBase (WHO)"])
  NCC --> SIG["Feedback and signal detection"]
  PH -.->|"helpline 1800-180-3024 / ADR PvPI app as alternates"| NCC

Read the second diagram as the desk's promise: the pharmacy does not judge the reaction, it documents and routes it. In the study, every step after the pharmacist is rehearsed with simulated cases, because a student project must never submit a fabricated real-world report. The first diagram is the study's own hygiene: identifiers never enter the pipeline, so the analysis can only ever see counts and patterns. This separation — respondents, anonymised store, analysis, report — is what the examiner probes when asking how personal data was protected, and the two diagrams let you answer in one breath.

• Extend the KAP survey to the catchment hospitals and to nursing and pharmacy students, building a locality-level baseline.
• Re-audit the desk at three and six months to check that the form rack stays stocked and that real reports begin to flow to the nearest AMC.
• Add a demonstration of the ADR PvPI mobile app and the helpline to everyday consumer counselling, with a quarterly wall chart of medicine-safety tips.
• Partner with the nearest AMC so the pharmacy can serve as a recognised collection point for consumer reports.
• Introduce simple inferential tests (chi-square) once the sample grows beyond one locality, and compare localities.