Reporting of adverse drug reactions in India: A review of the current scenario,obstacles and possible solutions

Abstract

Pharmacovigilance is a practice aimed to monitor drug safety in real life conditions and capture adverse drug events during the post marketing phase of drug’s life cycle. But under reporting of adverse reactions is a major cause of concern and a threat to the pharmacovigilance systems. The present article looks into the major obstacles affecting the spontaneous reporting of adverse drug reactions (ADRs) in India and the possible solutions. As per available scientific literature, the major impediments to ADR reporting are inadequate knowledge and awareness among health professionals, clinicians’ perceptions towards reporting, problems with establishing reporting systems in hospitals and insufficient training to recognize ADRs. Measures to improve the situation include greater involvement of nurses, pharmacists as well as consumers in the reporting of ADRs, making the process simpler and faster through electronic means, introducing educational interventions and training programs for health care providers and spreading awareness about the reporting system amongst caregivers and receivers alike. Providing a momentum to the pharmacovigilance system and ensuring a robust reporting process is a challenge but proper planning, feasible solutions and focussed efforts can help bring about the change ensuring patient safety - the ultimate goal of pharmacovigilance.

Keywords

Adverse drug reactions spontaneous reporting underreporting

1 Introduction

Every pharmaceutical drug that enters the market is expected to have some adverse reactions when used by patients outside clinical trial settings. An Adverse Drug Reaction (ADR), as defined by the World Health Organization (WHO), is a “response to a drug that is noxious and unintended and that occurs at doses used in humans for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function” [1]. It is quintessential for both the consumers as well as health care professionals to detect these adverse effects that can further be used to generate “warnings” regarding unexpected drug associated events and establish its safety. As a rule, drugs are often made available to the public before relatively rare but potentially important ADRs have been captured and quantified [2]. Due to the inherent limitations of drug development framework, it is essential to monitor and report ADRs consistently throughout the duration of use of a medicine in a population, to evaluate if the benefits continue to outweigh the risks, detect ADRs early, predict their frequency and ensure safe and efficacious use of medicines.

Post authorization, a significant amount of the information on drug safety is acquired through ‘pharmacovigilance’. According to the World Health Organization, pharmacovigilance is defined as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.” The scope of pharmacovigilance includes herbals, traditional medicines, blood products, biologicals, vaccines and medical devices as well. The International Drug Monitoring programme was launched by WHO after the thalidomide incident that occurred in the early 60 s. Pharmacovigilance is promoted by the WHO through its Collaborating centre at Uppsala and aims to enhance patient safety, and provide relevant and reliable information for the continued risk-benefit assessment of marketed drugs [3].

As per findings from the Centre for Health Policy Research, the proportion of approved drugs in the U.S. associated with adverse reactions that go undetected during clinical trials is about 50% [4]. Studies have shown that ADRs occur in about 10–20% of hospitalized patients, with their overall incidence being around 6.7% and that of fatal ADRs around 0.32%. They are the 4th to 6th largest cause of mortality in the U.S. [5]. According to Centre for Disease Control, about 40% of costs related to ambulatory ADRs are preventable and this is a significant concern worldwide [6]. A recent study that assessed the prevalence of ADRs internationally showed that the proportion of inpatient hospitalizations due to an adverse reaction was 2.3%, 4.8% and 7.3% for England, Germany and the U.S. respectively [7]. Based on data from US - National Electronic Injury Surveillance System–Cooperative Adverse Drug Event Surveillance project, it was estimated that more than 700 000 patients per year were treated for adverse drug events in emergency departments, and 1 out of every 6 patients, required hospital admission, transfer to alternative healthcare facility, or observation admission [8]. Depending upon the size of healthcare facility, annual costs for all ADEs have been estimated to be up to $5.6 million per hospital [9].

Studies conducted in several parts of India have estimated the incidence of suspected ADRs to be nearly 2% to 3% among hospitalized patients [10–12]. A recent systematic review estimated the median incidence of ADRs that led to hospitalization and those that developed during hospitalization as 2.85% and 6.34% respectively [13]. A study conducted by Rajakannan et al. valued the total cost of ADRs to the hospital as INR 1567397. The average cost of management of a patient hospitalized with an ADR was around INR 5000 (USD 115). The costs were found to be significantly burdensome for a country where the per capita annual expenditure on health is nearly USD 109 [14]. ADRs increase the length of hospital stay, add to treatment costs and are a burden on the healthcare system of a country.

Spontaneous reporting is the most commonly used form of reporting ADRs by health professionals, and in many countries, by patients themselves. Spontaneous reporting is voluntary and involves an alert health professional or patient linking an adverse reaction to the use of a particular drug and reporting it to an ADR Monitoring Centre (AMC) [15]. Individual Case Safety Reports (ICSRs)are ultimately sent to the WHO centre in Uppsala, for processing, identification and analysis of new signals for adverse reactions associated with the particular drugs [16]. A very critical issue identified with this form of safety monitoring is under reporting. A systematic review done in the UK to estimate the extent of under reporting of ADRs from available literature showed the median rate of under reporting as high as 94%, with not much difference between reporting rates from hospitals and general practice [17].

Focussing specifically on India, the government launched a national pharmacovigilance program, called the Pharmacovigilance Program of India (PvPI) in 2010, to safeguard the health of the people of the country and ensure that the benefits of the medications consumed, outweigh their risks. As compared to India’s previous attempts at setting up a formal ADR monitoring system in healthcare facilities, the current programme is making steady progress. India has currently more than 200 ADR monitoring centres (AMCs) in various medical colleges and governmental and non-governmental institutes across the country and the number is gradually increasing [18]. AMCs play a pivotal role in collection of ADR information from the patients and send completed reports to the NCC. NCC further sends the data to the Uppsala Monitoring Centre, Sweden. Recent studies have reported AMC functioning rate as 56.45% thus highlighting under reporting of ADRs as a significant barrier to upscaling the programme and limiting its usefulness in making evidence based regulatory decisions [19]. Although, India’s contribution to the global database of WHO-UMC is about 2%, reporting of ADRs needs to improve in order to achieve optimum number of reports per million inhabitants in the country [20].

In this review, we aimed to assess the knowledge, attitudes, and practices of healthcare professionals regarding pharmacovigilance in India, investigate the obstacles associated with spontaneous reporting of suspected adverse drug reactions, and the possible solutions as suggested by the published literature, to fill the lacunae and thus improve this kind of safety monitoring.

2 Literature search

An open search for relevant articles was undertaken in MEDLINE (the Pubmed database) and google search using key words like “pharmacovigilance”, “spontaneous reporting”, “ADR reporting”, “adverse drug reaction reporting”, “under reporting of ADRs”, “spontaneous ADR reporting system” and “India”; with their corresponding MeSH terms if any, joined by OR or AND operators where applicable. Also, the articles obtained from the reference list of the preliminary search were used to further gather relevant articles using what is referred to as the snow ball technique. No search filters were used but the articles were limited to the ones published in English Language. Themes emerging from the literature search for both obstacles as well as possible solutions were characterized into distinct categories. We did not use any predetermined categories for analysis and allowed incorporation of relevant themes and issues emerging from the search to provide a more comprehensive understanding of the context and processes linked to the problem.

3 Knowledge attitudes and practices (KAP) regarding ADR reporting

According to global statistics, the ADR reporting rates are the highest for the high-income countries and lowest for the low-income countries. Also, there is considerable variation in these statistics among countries in each income group [21]. Several studies conducted in various healthcare institutions across the country have revealed the significant unmet need for ADR reporting. A recent meta-analysis highlighted the significant gap in KAP towards PV reporting by finding more than 50% healthcare professionals were not aware of the national programme of pharmacovigilance, 32% considered all marketed drugs to be safe, nearly three quarters had never reported an ADR and further nearly 30% were not interested in reporting them [22].

3.1 Awareness about pharmacovigilance and ADRs

Healthcare professionals across various studies felt that ADR reporting was crucial [23, 24] but only 23–75% of them were aware that such systems were already in place [23, 25–30]. In few studies, majority of health care practitioners were not aware as to where and how should an ADR be reported [26, 31, 32]. The awareness among resident doctors, that even nurses, physiotherapists and pharmacists could report ADRs, according to a study, was 70%, 33% and 37% respectively [27].

In studies conducted among the pharmacists, the proportion aware of the term ADR was found to be nearly 95% but only 57% were aware of the pharmacovigilance system and its inception in India. Only 30% respondents knew about the nearest pharmacovigilance centre to their area. Almost all pharmacists knew that they were obliged to report ADRs but only 50% of them knew what type of ADRs should be reported [33].

In a study focussing specifically on the future healthcare practitioners, the proportion of medical post graduate students correctly aware of pharmacovigilance and ADRs was only around 35% [34].

One study revealed that only two-thirds of the clinicians could define an ADR correctly, only one one-third of them could correctly define pharmacovigilance and all of them felt the need of a pharmacovigilance programme in India, with 27% lacking knowledge about the existence of one [25]. In another study, only about 40% of healthcare professionals were aware of the Uppsala Monitoring Centre of the WHO. Only about 23% of them had ever reported an ADR. Less than half of them were aware that rare ADRs could be identified during the Phase 4 clinical trials (45%) and that spontaneous reporting was a tool to monitor adverse reactions of newly introduced drugs (33%) [23].

3.2 Attitudes, beliefs and practices

Findings from a few studies showed that a majority of clinicians believed only ADRs to new drugs should be reported, and about two-thirds believed that ADR reporting is a professional duty they are obliged to fulfil [23]. Most of them had witnessed ADRs in their patients [23, 35] and had seen the reporting form [23] and yet only less than a third had ever reported an ADR themselves to the ADR monitoring centres [23–26, 30, 32, 36]. Almost half of the medical practitioners in a survey, felt that more monitoring centres were required [36].

One study showed that the proportion of resident doctors reporting adverse reactions to the ADR monitoring centres was as low as 3% [27]. Also, more than 50% of the prescribers in a survey were of the perception that only serious ADRs were expected to be reported [24]. A significant percentage of respondents in two surveys believed that reporting adverse drug reactions to herbals, traditional medicines, blood products, medical devices and biologicals was not as important as that for allopathic medicines [26, 27].

About 5% of pharmacists also believed that all drugs are supposedly safe and around 16% of them felt that herbal drugs do not cause any ADRs [33].

Data from a study conducted on medical interns showed that less than 50% reported the adverse reactions they observed. Out of them, about 30% reported the ADRs to their heads of departments, about 10% to the ADR monitoring committee and only 4% actually reported them to the pharmacovigilance centre [34]. Another study conducted in Madhya Pradesh demonstrated that the gap between the number of ADRs experienced and the frequency of reporting them, was huge, especially among dentists and nursing professionals who had hardly reported an ADR in their career [30]. It has been reported that about 50% of the clinicians had never received any training on ADR surveillance methods [23, 35].

Thus, the awareness, attitudes and practices among Indian healthcare professionals with respect to spontaneous reporting of ADRs and pharmacovigilance as a whole is suboptimal and the seven deadly sins originally reported by Inman significantly impede voluntary reporting of ADRs in India [37].

4 Obstacles to reporting of adverse reactions: Factors associated with under reporting

The review of available data highlighted some critical barriers that hinder the spontaneous reporting of adverse drug reactions. Potential issues as highlighted by available data can be classified into several categories summarized in Table 1.

Table 1
Obstacles to spontaneous reporting of adverse drug reactions in India

S.No Obstacles Individual characteristics References

1. Perceptions regarding adverse drug reaction (ADR) reporting •Reports should be backed by evidence of causality. [27, 38, 39]

•One case cannot contribute much [19, 23, 27, 28, 39]

•Only safe drugs are approved for marketing [19, 39]

•Inadequate risk perception of herbal/OTC products [23, 27, 30, 38]

2. Gaps in knowledge and training •Unaware of existence and purpose of national pharmacovigilance systems [24, 28–33, 38]

•Unaware of what to report and how to report adverse drug reactions [24–26, 31, 32, 34]

•Lack of formal training on ADR reporting during graduation/ post-graduation courses [23, 27, 28, 30, 33, 38]

•Unable to decide whether ADR has occurred [27, 32]

3. Issues with potential conflicts •Fear of being stuck in legal issues [24, 28, 32, 33]

•Problems of confidential patient data [24, 31]

4. Issues related to local/ regional pharmacovigilance systems •Ignorance of local PV systems and reporting forms [23, 30]

•Inadequate availability of reporting forms [24, 26]

•Issues with access to PV systems when required. [33]

5. Attitudes towards ADR reporting •Lack of interest/ enthusiasm in reporting ADRs [24, 28, 30, 39]

•Lack of time from routine clinical activities [32]

•Procrastination in reporting ADRs [19, 24, 38, 39]

•Managing ADRs is more important than reporting them [24, 31, 34]

•Lack of incentives for reporting ADRs [23, 33, 35]

S.No	Obstacles	Individual characteristics	References
1.	Perceptions regarding adverse drug reaction (ADR) reporting	•Reports should be backed by evidence of causality.	[27, 38, 39]
		•One case cannot contribute much	[19, 23, 27, 28, 39]
		•Only safe drugs are approved for marketing	[19, 39]
		•Inadequate risk perception of herbal/OTC products	[23, 27, 30, 38]
2.	Gaps in knowledge and training	•Unaware of existence and purpose of national pharmacovigilance systems	[24, 28–33, 38]
		•Unaware of what to report and how to report adverse drug reactions	[24–26, 31, 32, 34]
		•Lack of formal training on ADR reporting during graduation/ post-graduation courses	[23, 27, 28, 30, 33, 38]
		•Unable to decide whether ADR has occurred	[27, 32]
3.	Issues with potential conflicts	•Fear of being stuck in legal issues	[24, 28, 32, 33]
		•Problems of confidential patient data	[24, 31]
4.	Issues related to local/ regional pharmacovigilance systems	•Ignorance of local PV systems and reporting forms	[23, 30]
		•Inadequate availability of reporting forms	[24, 26]
		•Issues with access to PV systems when required.	[33]
5.	Attitudes towards ADR reporting	•Lack of interest/ enthusiasm in reporting ADRs	[24, 28, 30, 39]
		•Lack of time from routine clinical activities	[32]
		•Procrastination in reporting ADRs	[19, 24, 38, 39]
		•Managing ADRs is more important than reporting them	[24, 31, 34]
		•Lack of incentives for reporting ADRs	[23, 33, 35]

4.1 Healthcare professionals’ perceptions regarding ADR reporting

A common barrier seen across several studies is lack of suspicion regarding occurrence of ADRs. There is a common belief that reporting should be backed by evidence suggesting a causal relationship between the drug and the ADR and unless confirmed, ADRs need not be reported [27, 38, 39]. Indifference towards spontaneous reporting is an issue. Healthcare professionals often perceive that one case cannot possibly contribute to the pool of knowledge [19, 23, 27, 28, 39]. It is a general perception that since a medicine has been allowed to be marketed, it must be safe and only safe drugs get approved [19, 39]. Often, potential reporters find it difficult to take a call and decide if an ADR actually occurred [23, 27, 30, 38].

4.2 Gaps in knowledge and inadequate training

Although the clinicians and other healthcare workers are gradually becoming aware, there is still a significant lack of awareness and knowledge regarding the existence, purpose and functioning of national pharmacovigilance programmes and ADR monitoring systems [24, 28–33, 38]. Health care providers are uncertain and not aware about what exactly is to be reported and how to do the same [24–26, 31, 32, 34]. Another barrier is lack of formal training of health care professionals regarding ADR identification, reporting and the procedures that should be followed [23, 27, 28, 30, 33, 38]. There is a perception of inadequate promotion of the spontaneous reporting of ADRs among both the consumers as well as the medical fraternity [33]. The knowledge and expertise required to correctly identify ADRs is inadequate [27, 32] and so is the risk perception of medicines available over the counter, herbal medicines and relatively older drugs [38, 40].

4.3 Issues with potential conflicts

Obstacles related to potential conflicts have also been stated to impact reporting by healthcare professionals. Several responders are concerned about being stuck in legal issues that may arise due to reporting of ADRs [24, 28, 32, 33]. There are problems with managing patients and addressing their confidentiality issues while reporting since they are often apprehensive about giving their details [24, 31].

4.4 Problems with organizing the pharmacovigilance system at hospitals and among consumers

Familiarity with the objectives and potential utility of ADR monitoring is has been reported to be suboptimal. The knowledge with respect to the available ADR reporting forms is inadequate [23, 30]. There are logistic issues like unavailability of ADR forms in hospitals and pharmacies or lack of access to them when required [24, 26]. Pharmacists feel that information needed to report the ADR is inadequate due to failure on part of the patient to furnish the required data [33].

4.5 Attitudes of health care professionals towards ADR reporting

Healthcare professionals often complain of lack of time and in addition, there is also a lack of interest and/or time to get the appropriate reporting form [24, 28, 30, 39]. It has been reported that clinicians may lack the enthusiasm to report an adverse reaction they encounter [32]. This is compounded by the fact that they are expected to fill additional forms for reporting ADRs. This results in lethargy and procrastination in reporting [19, 24, 38, 39]. Some studies have also highlighted the perception that managing individual ADRs is more important than reporting them [24, 31, 34]. Another possible obstacle felt is lack of any incentives to healthcare professionals, for performing this task which is an added burden given their excessive work load [23, 33, 35]. There is a perception that encountering ADRs are routine part of patient care and hence need not be reported [31, 40].

5 Solutions to under reporting: Filling the lacunae

Inadequacy in reporting of ADRs ultimately leads to many critical signals being missed or unduly delayed in being captured, thus allowing potentially unsafe drugs to remain in market, posing a threat to patient safety. Based on available evidence including the surveys conducted among health care professionals, several measures that can be undertaken to improve the spontaneous system of adverse event reporting in India are identified.

5.1 Greater involvement of all the stakeholders in reporting of ADRs

5.1.1 Nurses and pharmacists

While available evidence highlights that nurses are often unsure of their role in spontaneous reporting of adverse drug reactions [41, 42] studies have suggested greater involvement of nurses in not just collecting and managing ADRs but reporting and documenting them as well contributes to the improvement of system [43, 44]. A study conducted in Sweden to analyse ADR reports submitted by nurses quantitatively as well as qualitatively showed an increase from 2–3% in the mid-90 s to 12% in 2004 [45]. Nurses serve as an excellent complementary resource for detecting and reporting adverse drug reactions.A few other studies have also demonstrated a substantial increase in the ADR reporting rates and increase in proportion of serious and unlabelled ADRs after involving nurses who were well instructed to report them [46, 47]. Involving pharmacists in ADR reporting along with clinicians is also necessary since consumers are in frequent contact with pharmacists who can provide useful and reliable information, complimentary to the reports by the clinicians [48, 49]. The reports also reflect possible concerns of the patients with respect to the ADRs they experience [50, 51]. Although, it is believed that India’s drug distribution system does not leave much scope for pharmacists [52], availability of consumer reporting forms through pharmacies can provide a significant boost to direct patient reporting of ADRs.

5.1.2 Patients/Consumers

A very crucial step that can contribute significantly to resolve the problem of under reporting of ADRs is wider inclusion of patients or consumers as reporters. An 11-country survey conducted by Hunzel et al. stressed the importance of giving the general public the opportunity to report the adverse reactions and enhance the scientific value of the collected data on pharmacovigilance [53].

Findings from another review done on patient reporting suggested that patients are more likely to identify and thus report the adverse reactions they experience, compared to health professionals. Also, reporting by patients adds value and meaning to professional’s reports of ADRs by throwing light on possible new reactions. Countries that have incorporated patients/consumers as reporters have had positive experiences so far [54]. Inclusion of patients can broaden the general outlook towards ADR reporting and facilitate a better understanding of the patient perspectives. This inclusion is a recent one, as far as India is concerned, and is expected to strengthen and add value to the existing programme. As per current estimates, less than 12% of ICSRs reported to PvPI come directly from consumers [55].

5.2 Making the reporting process easier, more convenient and less time consuming

5.2.1 Promoting eHealth tools for reporting

Several surveys conducted among health care professionals on ways to improve spontaneous ADR reporting have suggested devising techniques to make the reporting process faster and more convenient [24, 36]. To simplify ADR reporting and to better enable consumers to directly report adverse events, regulatory bodies are increasingly turning to data collected through mobile apps and social media [56]. Such efforts have already been initiated in India but adoption rates are still low since less than 1% individual case safety reports (ICSRs) received in 2015-16 were via mobile platforms [55]. Reporting of ADRs online, through a website that facilitates online filling and submission of forms can help in speeding up the reporting process making it more efficient. This technique increased the number of reports by about 50% and also decreased the reporting period considerably, as shown in a French study [57]. Automatic filling of certain sections of the reporting form (if online) has also been suggested to improve the reporting status [43]. For hospitals with a provision for electronic patient records especially in the significantly untapped private sector, a hyperlink for an online ADR reporting form can be included in the electronic record. A study done in Portugal demonstrated that inclusion of a hyperlink increased the number of ADR reports from an average of 1 earlier to 4 after the hyperlink was included [58].

5.2.2 Improving the availability and design of forms for spontaneous reporting of ADRs

Design and contents of spontaneous reporting forms is a critical feature of the pharmacovigilance programme that can influence the process positively. Wider access to ADR forms is also considered critical [24]. Reporting forms can be revised to contain all the mandatory information in addition to being less complex and more user-friendly. An unduly complex form can often dissuade the healthcare professionals from voluntarily reporting the adverse event. A study assessing the quality of ADR reporting forms of various countries showed that Malaysia had the best form in terms of completeness and capturing of necessary information. The others had discrepancies in data collected because of different designs. It’s important to harmonize the forms and come up with a comprehensive form to improve the reporting process and lessen the confusion [59].

5.3 Tools to enhance the pharmacovigilance system and encourage reporting among clinicians

In a study in India, an education programme for increasing knowledge and awareness about PV as well as ADR notification drop boxes were introduced [60]. These boxes were installed in all OPDs and wards of the hospital and had simplified reporting forms alongside. Physicians on encountering an ADR had to fill up the form and put it in the drop box. Many such forms were then collectively sent to the national pharmacovigilance centre. This almost doubled the frequency of ADR reporting in the 3-month period. Such innovative techniques can be tested and applied in hospital settings to achieve better reporting results. A survey conducted among resident doctors and nurses reported the respondents’ preference for telephones and drop boxes as modes of communication [40]. Periodic e-mail and/or text alerts have also been suggested as inexpensive and effective ways to encourage clinicians to regularly report the ADRs they encounter in their patients, both in the OPD as well as among indoor patients [19]. Some people might consider economic inducement as an incentive to encourage ADR reporting among healthcare professionals. But a study showed that around 80% respondents didn’t think that financial incentives could help boost the process [61]. Also, the use of economic incentives is not widely accepted to avoid biased and over reporting. Developing a harmonious relationship among stakeholders [26] such as clinicians and pharmacovigilance centres, bringing about a change in the way ADR reporting is perceived is of immense importance to long term success of the program. It is imperative that reporting of adverse reactions is made a crucial component of routine activities of clinicians and considered a responsibility by all healthcare professionals. Regular feedback for reported ADRs to individuals or groups of HCPs can also strengthen the culture of voluntary reporting [40].

5.4 Educational interventions and training for health care professionals and medical students

Several studies conducted across India have enquired on ways to improve spontaneous reporting of adverse events and an overwhelming majority of participants have suggested introducing training programs and continued medical education (CME) series [26, 29, 31, 36, 40]. A randomized controlled trial done among physicians to assess if educational interventions for pharmacovigilance could improve spontaneous reporting of adverse events demonstrated that the reporting rate increased by about 65% in the intervention group, suggesting the significant implication of the intervention [62]. Another RCT that developed a multi-faceted educational intervention for physicians (comprising of a regular outreach visit every week, a reminder card and an ADR report form) showed that the intervention group was almost 10% more likely to report ADRs compared to controls (adjusted RR 10.23%) Reporting of ADRs drastically increased in the first 4 months and the effect remained significant for the first 1 year. It is evident that such targeted outreach programs can improve ADR reporting rates among physicians [63].

Educational workshops aimed at sensitizing healthcare professionals have consistently demonstrated an improvement in the quantity and quality of spontaneous reporting. Workshops comprising of brief presentations focussing on principle PV terminology and need for ADR monitoring followed by presentation of a clinical case and hands on filling up of forms have yielded significant and durable improvements [64–66].

6 Conclusions and way forward

In an attempt to facilitate ADR reporting by patients/consumers as well as healthcare professionals, the PvPI launched a toll-free helpline facility in 2014, to encourage reporting of any suspected adverse reaction that could possibly be associated with the consumed drug [67] Also in May 2015, a mobile application was launched, to provide a platform for private and government healthcare professionals to promptly report ADRs. In addition, a medicines side effect reporting form for consumers has been introduced and made available in ten vernacular languages. While opening of further avenues of ADR reporting by healthcare professionals as well as consumers is commendable, continued efforts are warranted to ensure these channels are adopted well by respective groups to facilitate improved reporting of ADRs by all major stakeholders. Notably, the PvPI has maintained consistently high individual case safety report completeness scores and efforts to establish effective integrations with national programs on tuberculosis, HIV and immunization are underway [68].

In conclusion, a significant gap pertaining to knowledge, attitudes and practices related to pharmacovigilance activities exists. The review identifies inadequate knowledge and training of healthcare professionals, their attitudes and perceptions and problems with organizing reporting systems at the facility level as the major hurdles. Taking effective steps to involve all the stakeholders, ensuring a better, easier and more convenient system of reporting along with dedicated capacity building measures can make a significant difference and facilitate greater realization of the potential of pharmacovigilance. Establishing a robust system of reporting of ADRs and providing a momentum to the pharmacovigilance systems to grow is a challenge especially in developing countries like India. It is an uphill task that can only be completed through paying close attention to the limitations, planning meticulously to overcome them, and coming up with solutions that are meaningful, cost effective and feasible in the Indian scenario where the patient inflow is huge and the health care professionals are overburdened. Attempts to change the mindset first, by imparting knowledge & increasing awareness, followed by slow yet significant changes in practice and the general attitude, can make way for a more successful pharmacovigilance system that is well equipped to not just capture ADRs but capable of informed and evidence-based decision making for ensuring the safety of patients as well as the community at large.

Conflict of interest

None to report.

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