Bridging the Gap: Promoting Adverse Drug Reaction Reporting through Innovative Strategies in Zero-reporting Zones at Karaikal – An Educational Intervention Study at Adverse Drug Reaction Monitoring Center

Abstract

Objective:

Adverse drug reactions (ADRs) contribute to morbidity, mortality, compromised quality of life, and increased healthcare costs. Despite various efforts by the regulatory authorities, there remains a problem of underreporting. Our ADR monitoring center was established in JIPMER, Karaikal, and there were nil reports from the nearest hospitals in this geographical area before 2 years. The reasons are lack of knowledge, time constraints, etc., and to overcome the challenge of underreporting, we planned a study to identify the effect of an educational intervention program on ADR reporting by healthcare professionals.

Methods:

A total number of 200 participants were involved in the program, which included various components such as game activities, video, poster, meme contest, hands-on training, and lectures, followed by practice-based learning. The participants filled out a pretest questionnaire before attending the program. A posttest questionnaire was filled out after 1 month.

Findings:

There was a significant improvement in the knowledge before and after the intervention (P < 0.0001). More than 50% believed that there would be legal consequences of ADR reporting, and very few people (12%) had reported ADR to their seniors through telephone. The study also increased the spontaneous ADR reporting in a period of 1 year.

Conclusion:

The findings of the study suggest that the active educational intervention has a major impact on ADR reporting, yet it requires multiple reminders, through telephone, messages help in a consistent ADR reporting culture among the healthcare professionals.

INTRODUCTION

India is the second largest populated country with 1.2 billion and one of the largest drug-consuming countries worldwide. The country is also the fourth largest producer of pharmaceuticals. The integral part of drug treatment is adverse drug reactions (ADRs), and various observational studies and systematic reviews highlighted the importance of medication-related harm in causing mortality, morbidity, reduced quality of life, and increased healthcare cost among the patients.[1] The contribution of ADRs ranges between 1% and 10% in different countries.[2] The Pharmacovigilance Programme of India (PvPI), initiated by the Government of India, plays a major role in monitoring patient safety by detecting, assessing, and preventing ADR.[3,4] At present, the National Coordinating Center PvPI is coordinating with the World Health Organization Uppsala Monitoring Centre, Sweden, to form an ADR database globally.[5,6] It has been many years since the program actively started, yet the problem of underreporting of ADRs is present globally. The factors that led to underreporting were a lack of awareness, insecure feel, lack of time, laziness to report, feeling unnecessary to report mild reactions, and lack of adequate training among the healthcare professionals. It was identified that only 23%–75% of the health professionals were aware of the existence of the ADR reporting system.[7,8,9] Karaikal is a town with approximately 2 lakh population, a government hospital, community health centers, and primary healthcare centers. JIPMER, Karaikal, was established in 2016, and the ADR monitoring center (AMC) approval was obtained in August 2022. Previously, the nearest AMC to Karaikal functioned in JIPMER, Puducherry, and there was nil reporting from Karaikal before 2 years. Being a resource-limited setting at present with a secondary care hospital, this study is planned to identify the impact of educational intervention on ADR reporting. Hence, the aim of the present study is to evaluate the impact of innovative methods as active interventions on ADR reporting among a diverse population in a secondary care hospital in a resource-limited area.

METHODS

A prospective questionnaire-based study was planned to evaluate the impact of the intervention program on the knowledge, attitude, and practice of the healthcare professionals regarding the reporting of ADRs and on the ADR reporting rate in Karaikal. The study was conducted after the approval of the institute’s scientific committee and ethics committee (scientific committee number: JSAC/03/2023/019 and ethics committee number: JIP/IEC/2023/05/049). The study also has three phases: baseline data collection, introducing the intervention, follow-up period, calculating the month-wise reports.

The study is a single-group pre–post educational intervention, and we enrolled 200 health professionals. The sample size was identified to confirm the statistical power to identify a small yet meaningful increase in the proportion of those who participated reporting more than one ADR after intervention. Under standard statistical assumptions (α = 0.05, power = 80%, and minimal reverse change), a paired McNemar test was used to estimate the sample size. For a total sample of 200 participants, the smallest detectable absolute improvement was approximately 3.9%.

Thus, the study is powered to identify even the modest increase in reporting, allows subgroup and adjusted analyses, and provides a robust buffer for attrition and clustering effects. The sample size calculated is 200.

Inclusion criteria

1. Registered medical practitioners in healthcare facilities in Karaikal

2. Pharmacists

3. Nurses and nursing students

4. MBBS students

5. All the healthcare professionals who are willing to attend the intervention and attend the follow-up programs.

Exclusion criteria

Nonclinical staff with no role in prescribing, dispensing practices.

We conducted a study in the government hospital and medical college in which a questionnaire was used to assess the knowledge, attitude, and practice of pharmacovigilance among medical students, nurses, and pharmacists. Written informed consent was obtained from all the participants. The target group answered a pretest questionnaire followed by active educational intervention in the form of game activities, lectures, and hands-on training in filling ADR forms [Flow chart 1].

Flowchart 1.

Flowchart of the methodology

The active interventions include the following, as shown in Table 1.

Table 1.

List of innovative educational interventions

Teaching material	Learner group
Role play	Pharmacists, nurses
Game activities like connexions and Chinese whiper	Students
Student-generated videos	Student
Practice-based/experiential learning	Involving MBBS students to identify ADRs and write reports
Posters/memes created by students	Students

MBBS=Bachelor of Medicine and Bachelor of Surgery, ADRs=Adverse drug reactions, [Figures 2 and 3]

The Google Forms link and QR code were created for the ease of reporting. The baseline knowledge, attitude, and practice of ADR monitoring will be assessed in both groups using the pretest questionnaire, followed by intervention, and then the posttest questionnaire after a month. The reporting rate of ADRs was calculated before and after intervention [Figure 1].

Figure 1.

Impact of educational interventions on the reporting of adverse drug reactions from September 2022 to May 2025. ADR = Adverse drug reaction, Footnote: Approval – August 2022, Minimal programs were conducted in September 2022, but reports were not received, Research initiated in ADR reporting was less in the initial 1 year, followed by a sensitization program from September 2023, and baseline ADR reporting was recorded for 1 year. Active intervention focusing diverse group was initiated in September 2023 and 2024 Current ADR reporting rate – 2–10/month

Figure 2.

Examples of memes. Credit: Mr. Ankit Jaiswal, MBBS student, JIPMER, Karaikal (Image sent for publication in newsletter Rx factor)

Figure 3.

Meme-2 created by an MBBS student

Parameters measured

The parameters were measured before and after intervention.

• Knowledge, attitude, and practice among healthcare professionals before and after intervention

• % of population who were aware of pharmacovigilance and its scope

• % of population who were aware of ADR reporting (who, why, and how)

• % of people who were aware of the importance of ADR reporting

• % of population who had already reported ADR.

Adverse drug reaction reporting rate

• Increase in adverse drug reaction reporting rate before and after educational intervention.

Data analysis

The responses were collected in either hard copy or Google Forms. The data were entered into Microsoft Excel and analyzed using SPSS software (Version 27.0, IBM Corp., Armonk, NY, USA). P <0.05 is considered statistically significant.

RESULTS

A total of 200 participants were included in the study. The participants were doctors, nurses, pharmacists, and MBBS students. After the active intervention given to the healthcare professionals (HCP), there is an increase in the ADR reporting, which is evident from the number of ADRs reported to IPC by AMC.

The basic demographic details are listed in Table 2.

Table 2.

Basic demographic details of participants

Characteristics of participants	n
Age
20–40	175
40–60	25
Sex
Male	122
Female	78
Education
MBBS	120
Nursing	55
Pharmacy	15
Doctors	10
Designation
Student	175
Working	25

MBBS=Bachelor of Medicine and Bachelor of Surgery

DISCUSSION

The primary aim of pharmacovigilance is to monitor drug safety through reporting ADRs, and there are many reasons for underreporting.[10] However, with specific interventions such as educational strategies, monitoring by health professionals such as doctors and clinical pharmacists, the incidence of ADRs can be reduced.[11,12] In the newly approved AMCs, the reports are lesser because the awareness is completely lacking. The present study identified the impact of educational intervention on the reporting of ADR among pharmacists, nurses, medical students, and doctors in our AMC. It is identified that the knowledge and attitude component significantly improved after the educational intervention in our study.

The participants had moderate knowledge, with 50% choosing the right option in the pretest questions on definition, scope of ADR, form for ADR, etc., [Table 3]. The results of the present study show a significant improvement in knowledge on the definition of pharmacovigilance (60%–95%), ADR (54%–92%), and all other knowledge-based questions (P < 0.0001). Our study differs from another reported study conducted in a tertiary care center in Kanchipuram, in which postgraduate students participated. The knowledge component was 100% in the reported study due to the fact that the postgraduate students are well aware of ADR reporting, whereas our study had a diverse population of health professionals.[13] The results of our study are similar to another study conducted in Nepal in which the intervention had a major impact on preintervention and postintervention scores.[14] It is mandatory for healthcare professionals to know where and how to report ADRs, and hence, sensitizing them is a priority in healthcare needs.

Table 3.

Effect of educational intervention on the knowledge component of pharmacovigilance among the target population

Question to test knowledge	Correct response	Pretest correct response (%)	Posttest correct response after a month (%)
Definition of pharmacovigilance	The study of detection, understanding, and prevention of adverse drug reactions	160 (80)	190 (95)*
Scope of pharmacovigilance	Allopathy medicine, herbal products, vaccines	90 (45)	191 (96)*
Definition of adverse drug reaction	Unintended noxious response to a drug in normal doses	108 (54)	184 (92)*
Type of ADRS to be reported	All types of suspected adverse reactions of a drug	136 (68)	187 (93.5)*
Need for reporting ADRs	To ensure patient’s safety by monitoring ADRs	191 (96)	197 (98.5)
Who should report ADRs?	Doctors, nurses, pharmacists, general population	139 (70)	198 (99)
Regulatory authority responsible for monitoring ADRs	Indian Pharmacopoeia Commission through PvPI	128 (64)	198 (99)*
Form necessary for reporting ADRs among health professionals	Red form	106 (53)	199 (99.5)*
Possibility of general population to report ADRs	Yes	111 (56)	193 (96.5)*
Where to report ADRs?	Nearest ADR monitoring center	146 (73)	200 (100)
Whether the reactions to blood and blood products can reported through pharmacovigilance?	No (reported to haemovigilance)	38 (19)	198 (99)*
Availability of ADR from in all languages	Yes	167 (83.5)	200 (100)

*P<0.0001. Statistical test: McNemar test. ADRs=Adverse drug reactions, PvPI=Pharmacovigilance Programme of India

In our study, almost 50% of the people believe that drugs are completely safe, and reporting ADRs may lead to legal punishment of the people involved in treating patients [Table 4]. The barriers for ADR reporting mentioned by the participants include a lack of knowledge about ADR reporting, fear of legal repercussions, less serious ADRs, and time constraints due to patient load [Table 5]. The hindering factors for ADR reporting reported from various studies include lack of motivation, crowded work places, knowledge, time, fear of legal liability, lack of coherence with guidelines, lack of awareness about medication errors, and doubt of reporting mild drug reactions.[15,16,17,18,19] A drug utilization study of amphotericin B for the neutropenic patients in Iran identified that out of 35 patients, 10 received inappropriate doses, and the hypokalemia is the major ADR. The study suggested that the intervention of clinical pharmacists would improve the outcome.[20]

Table 4.

Effect of educational intervention on the attitude component of pharmacovigilance among the target population

Question to test attitude	Expected outcome	Pretest (%)	Posttest (%)
Do you believe all the drugs available in the market are safe?	No	54.5	95*
Do you think reporting ADR will result in legal punishment?	No	52	100*
Do you think reporting of adverse drug reaction is necessary?	Yes	60	100*
Do you think every hospital should have ADR monitoring center?	Yes	52	98*
Do you think Pharmacovigilance should be taught in detail to healthcare professionals?	Yes	76	90
Are you aware of any drug that banned due to serious ADR?	Yes	63	79*

*P<0.05. Statistical test: McNemar test. ADR=Adverse drug reaction

Table 5.

Effect of educational intervention on practice component of pharmacovigilance among target population: (Only pretest)

Question to test practice	Common response	n (%)
Have you ever encountered ADR in clinical practice/among family members?	Yes	23 (11.5)
Have you ever reported ADR?	Yes (through telephone to doctors) but not actually reported to PvPI	24 (12)
If yes, how did/will you report?	Through ADR form to AMC	10 (5)
If no, why you did not report?		Lack of time - 35% Unawareness - 43% Fear - 18% Other reasons - 4%
Have you ever counseled any patient regarding any ADR?	Yes

PvPI=Pharmacovigilance Programme of India, ADR=Adverse drug reaction, AMC=ADR monitoring centre

Karaikal is a less populated town with one government hospital and two other medical colleges. There were nil reporting of ADRs in this geographical area until August 2022. During the sensitization program, the participants had various queries such as lack of awareness on ADR reporting, legal consequences of ADR reporting, and simplified methods of reporting.

The ADR reporting was increased after September 2024 when a series of active educational intervention was targeted among clinicians, pharmacists, nurses, and students. Our study results mimic some similar studies of educational intervention targeting ADR reporting. A cluster randomized clinical trial conducted in various health centers in Spain reported that the active intervention increased the reporting by 65.4%. The ADR reporting rate (per 1000 physicians/year) also increased from 29.1 to 39.6 in the intervention group.[21] Another cluster-randomized trial was conducted in Portugal in which 1034 physicians were subjected to a telephonic interview, and 438 physicians underwent workshop intervention. The workshop intervention significantly improved the spontaneous reporting in terms of quantity and relevance compared to the telephonic intervention.[22] The ADR reporting was doubled after an educational intervention among 235 healthcare professionals in a tertiary care hospital, JIPMER, Puducherry.[23]

The major interventions for improving the spontaneous reporting of ADRs are educational interventions, engineering strategies, economic and enforcement. The educational interventions are lectures, workshops, group discussions, and engineering strategies including clear reporting systems and electronic reporting of ADRs. The economic method includes incentives/monetary benefits, and enforcement includes the rule for ADR reporting.[24] The educational intervention involving face-to-face interactions improved the quantity and quality of ADR reporting.[25] It also requires multiple interventions compared to a single intervention.[26] Though ADR reporting being part of MBBS curriculum the practice of reporting is hugely lacking among doctors. Most of the studies on pharmacovigilance are focused on either educational or engineering strategies. The sustainable impact of the educational intervention is less in our study [Figure 1]. The ADR reporting increases few days after the educational intervention and then decreases. It requires a consistent educational approach through active methods (workshop and lecture) and passive methods (telephone reminders) to enhance the quality of ADR reporting rate. The strength of the study is that a diverse population, who are the major stakeholders involved in health care, participated in the study. The duration of the study is longer, and hence, the pattern of increase or decrease in reporting can be observed over time. The limitation of the study is that it requires frequent reminders/workforce for active surveillance to increase the ADR reporting rate.

CONCLUSION

The health professionals are more driven toward treating patients with drugs, and in the process monitoring of ADRs or focus toward drugs is highly compromised. The study concludes that to improve the monitoring of drug safety, the barriers should be addressed through education, and the reporting process needs to be simplified. A fostering and supportive environment is highly crucial to improve drug safety monitoring.

Authors’ contributions

Dr. R. P. Priyadharsini conceptualized the study, designed the methodology, collected and analyzed the data, and drafted and revised the manuscript. The other authors, Dr. S. Kiruthika and Dr. Dhivya, also participated and contributed in all the stages of the study.

Conflicts of interest

There are no conflicts of interest.

Funding Statement

Nil.