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Gap analysis of some key stakeholders of Indian pharmacovigilance

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On World Pharmacovigilance Day, Dr J Vijay Venkatraman, Managing Director & CEO, Oviya MedSafe, takes stock of the country’s pharmacovigilance programme and suggests ways to plug the gaps

Ever since the Pharmacovigilance Programme of India (PvPI) was launched on July 14, 2010, Indian pharmacovigilance has been making continuous and commendable progress. This strong and sustained growth resulted in the Ghaziabad-based Indian Pharmacopoeia Commission (IPC), the National Coordination Centre (NCC) of PvPI, becoming a WHO Collaborating Centre for Pharmacovigilance in Public Health Programmes and Regulatory Services in 2017, among several other achievements. With the success of India’s pharmacovigilance story being now well-accepted in the global arena, this may be the right time for us to exercise prudence and perform a gap analysis to comprehend what more we should do in order for India to be even more productive in pharmacovigilance in the future. It is obvious that such an analysis should focus on the same key stakeholders whose contributions led to the building of the success story in the first place. This article aims to provide a brief overview of the gaps seen in some of the key stakeholders of Indian pharmacovigilance, in the view of the author.

Dr J Vijay Venkatraman

PvPI structure
The basic unit of PvPI is an Adverse Drug Reaction Monitoring Centre (AMC), which refers to medical colleges, hospitals and centres of public health programmes in India, which are authorised to collect suspected ADR reports from healthcare professionals and/or consumers and forward them to the NCC at IPC, Ghaziabad. At the moment, India has more than 250 AMCs directly connected to the NCC. The NCC analyses the received reports and provides recommendations, if any, to the Central Drugs Standard Control Organization (CDSCO) which is India’s National Regulatory Authority. All the reports received by the NCC are submitted to the Uppsala Monitoring Centre in Sweden which is the WHO Collaborating Centre for International Drug Monitoring. In addition, the NCC is well-networked with several national health programmes and government institutions which share ADR information with the NCC. Apart from the above, the NCC also receives reports from the industry since 2015. The process flow of PvPI is illustrated in Figure 1 below.

Healthcare professionals (HCPs) and consumers
HCPs and consumers in India may report suspected ADRs to the PvPI or to the concerned pharmaceutical company. Both the PvPI and the pharma industry have adopted traditional as well as electronic modes for accepting ADR reports. While the report may be processed in a similar manner at both ends, the report sent to the industry would also eventually reach the PvPI via industry reporting. On the other hand, there is no mechanism at present for reports sent to the PvPI directly to be classified and forwarded to the concerned pharma companies.
Although the term HCP may refer to any member of a healthcare delivery team, the reality in India is that most of the healthcare environments are clinician-centric. Therefore, the comfort level a particular clinician has with ADR reporting is the most important determinant of the ‘pharmacovigilance activeness’ of the respective healthcare facility itself. Clinicians enthusiastic about reporting ADRs would implicitly inspire their entire team of HCPs to be ‘pharmacovigilant’ and thereby motivate them to bring any ADR information they receive to the knowledge of the clinicians. A clinician validating an ADR report collected by another member of the HCP team also provides the much critically needed ‘medically confirmed’ status to the case. But, such scenarios are still rare in India which is proven by the fact that the number of ADRs reported in India is still negligible compared to the population of the country. So, why do clinicians not report the ADRs they encounter?

Apart from the usually stated primary reason of lack of time which is obviously a stark reality in India, there are so many other factors that impede doctors from reporting ADRs. First and foremost: a doctor is not able to see the purpose of ADR reporting as they are not made aware of the life cycle an ADR report would go through after it has been received from the doctor. In several one-on-one interactions the author had with renowned clinicians, it transpired that even scientifically inclined doctors were of the opinion that a drug once approved was to be considered always safe and also safe for all patients all the time. The dynamic nature of the benefit-risk profile of a drug is unfortunately not attached due significance in the typical doctor’s cabin where the focus is more on the disease rather than the drug. Whenever the safety profile of a particular drug is discussed, doctors tend to refer to results of clinical trials for the data rather than looking for the more relevant safety information reported in the post-authorisation phase. This could partly be because the former is easily made available to doctors by pharma companies through their medical representatives. Hence, unless a doctor understands the benefit the patient community at large could possibly beget from the ADRs they report, it is unreasonable on the part of other stakeholders to expect doctors to report ADRs especially when they are struggling to find time to provide treatment to all their patients in the first place.

The next key factor could be the fear of potential legal implications which may arise following the reporting of an ADR. While this fear may appear irrational to other stakeholders, a closer look at why doctors feel so reveals that many of them have the apprehension that the mere occurrence of an ADR in a patient under their treatment may get tagged as their ‘medical negligence’ and result in medico-legal suits. It may be too premature and unrealistic to ignore this apprehension in India where consumer courts have penalised doctors in such instances even in the absence of any medication error. Medication errors occur due to medical negligence and may result in adverse outcomes. But, to assume every ADR to be an outcome of a medication error is unscientific. In addition, the risk of physical assault on doctors by the relatives of patients, which has become more pronounced in the recent times, may significantly discourage doctors from opting to report ADRs. Doctors are also wary of being harassed by government authorities if an ADR report they sent in good faith may be turned against them during enquiries in future. More than all these, doctors feel that they may lose their reputation just by being alleged of negligence even if it did not get proved eventually, as it is perceived to increase the risk of inability to continue their practice in the same locality in the long-term. Last but not the least, doctors practising in medical institutions governed by a hierarchical structure may face roadblocks from senior members of their own fraternity and/or from the administrative heads of the concerned institutions that may be averse to reporting ADRs due to a multitude of reasons.

While we still have to go a long way to resolve the above-mentioned issues, it is high time we started addressing them. Promoting healthy interactions between medical societies and the pertinent government authorities would help in quelling the undue fears and apprehensions of the medical community. The distinction between a spontaneously occurring ADR and a medication error should be made clear to all stakeholders. The fact that “even a good drug can do harm” should be understood by doctors, patients, regulators, media and judiciary alike. In a conversation, the author had with a past National President of the Indian Medical Association (IMA), it transpired that the IMA could insist to the government that a doctor should be considered to have done his/her duty if they have reported a spontaneously occurring ADR to the PvPI and should be protected by the government from harassment by authorities or by relatives of patients. Moreover, the report made by the doctor to PvPI should be considered as a legal evidence of the doctor’s proper handling of the situation unless a medication error is proven to have happened. On another note, the inclusion of clinical pharmacists in the healthcare team could drastically improve the reporting rate of ADRs, as they possess the relevant expertise and would have sufficient time to interact with the patients and prepare the reports which could finally be signed off by the doctor.

Coming to consumers, we have two distinct types in India: (i) the patient who consumes medicines prescribed by their doctor and (ii) the self-medicator who consumes medicines at their own discretion. Those patients who properly comply with the prescription usually trust their doctor and therefore we can anticipate that they would also share any suspected adverse drug experience only with their doctor. While such faith in the doctor is good for doctor-patient relationship, this also transitions the responsibility of reporting the ADR to the doctor. Some patients may withhold the suspected ADR information assuming that it may not be related to the doctor’s prescription. Only an intuitive proactive question from the doctor may bring out that information. Nevertheless, it must be remembered that only expected ADRs can be specifically sought for by the doctors. It is therefore advisable to ask open-ended questions in order to diagnose unexpected ADRs. Hence, it is quite premature to expect patients to report ADRs directly to PvPI/industry and in fact, it poses the inherent risk of leading to inadequate or inaccurate reporting, especially given the scenario that patients in India may also be taking traditional/alternative medicines with or without the knowledge of their doctor and the same may not get revealed in their directly reported ADRs which are not medically confirmed. Self-medicators have different problems and erroneously think they do not need a doctor’s advice. This often leads to a wide range of ADRs, some of which may be life-threatening. This gap is unfortunately rampant in India as enforcement of laws prohibiting sale of prescription drugs over the counter is not always uniform and stringent.

Apart from educating consumers of risks pertaining to intake of medicines and on how to report ADRs, consumer associations and forums must also take upon themselves the mission of discouraging self-medication practices. The consumer society needs to be vigilant of traditional medicines and alternative medicinal products which are incorrectly claimed to be free of adverse effects. It is pertinent to recall that the Ministry of AYUSH introduced a new Central Sector scheme for promoting pharmacovigilance of AYUSH Drugs in 2018. Care must be taken by the governmental authorities as well as the consumer community to actively disregard and rebuff unscientific messages spread on social media about the adverse effects of drugs and instead promote validated health information from authorised sources. All other stakeholders of Indian pharmacovigilance should come together to augment the consumer’s understanding of the subject on an ongoing basis.

ADR Monitoring Centres (AMCs) and NCC-PvPI
As explained above, an AMC is the basic unit of PvPI. Typically, an AMC is situated in a medical college and the co-ordinator of the AMC is usually the head of the department of pharmacology in the college. Every AMC has a pharmacovigilance technical associate appointed by the NCC who works in tandem with the co-ordinator. The spectacular performance of some very active AMCs in terms of numbers of ADR reports collected was a key reason for India to achieve the recognition of being the first country to contribute more than 100000 reports to UMC’s Vigibase database as early as 2014. Further, the completeness score of the reports from India was 0.94 out of 1, which again points to the diligence exercised by the concerned AMCs.

However, the AMCs have their own share of challenges. While most of these AMCs try to make clinicians in their medical college aware of ADR reporting and also offer their support in paperwork, clinicians do not seem to have warmed up to the idea even in the case of AMCs located within government institutions. The active AMCs have achieved numbers by proactively going for rounds in the hospital wards with requests for ADR reports, thereby jeopardising the spontaneous nature of the ADR report itself. However, until clinicians move into a mindset to report the ADRs they encounter in their practice seeing it as a professional duty rather than a favour they do to the pharmacology department, we are unlikely to get all ADRs occurring even in an institution that has an in-house AMC. Some AMCs have been successful in roping in clinical professors by inviting them as speakers for the pharmacovigilance seminars they organise. On the other hand, it is also true that quite a number of AMCs in different parts of the country are entirely or mostly inactive, due to a variety of reasons. Some private hospitals enrolled themselves as AMCs for fulfilling their accreditation obligations but have since then been found to hesitate to forward the ADRs received. Optimal functioning of all AMCs with the unconditional support of the respective medical college/hospital administration would be the ideal solution for all the above-mentioned challenges. However, the NCC does not seem to have the wherewithal for ensuring this homogeneity across 250+ AMCs across the length and breadth of our country. Hence, the state health authorities throughout India should be formally and actively involved in PvPI activities in order to ensure appropriate checks and balances in the system.

At the NCC, the advantage is that it is centralised and well-connected with each AMC which in turn has access to UMC’s Vigiflow software. Therefore, the data received by the NCC is already as validated as possible. The centralised team of pharmacovigilance technical associates at the NCC streamline the flow of information. Nevertheless, the NCC is unable to provide permanent government job positions for the associates and suffers from attrition as no attractive career progression is visible for the associates. Naturally, this gap results in a manpower crunch which at times impacts the turnaround time. Further, the lack of a centralised pharmacovigilance database even after nine years of the new PvPI being implemented is a major pitfall that has to be urgently rectified. Last but not the least, the NCC should devise an objective method for analysing the effectiveness of the AMCs in a periodic manner and subject themselves also to external audits to pursue excellence.

Conclusion
Although Indian pharmacovigilance still has numerous challenges ahead, it must be remembered what PvPI has achieved is extraordinary, considering the fact that all these have become a reality within a short span of nine years and that this has been India’s first successful pharmacovigilance programme after a few failed attempts in the last few decades. It obviously means that we have learnt a lot from our past mistakes and have strategised PvPI accordingly. Similarly, there is quite a lot of room to be optimistic about the betterment of Indian pharmacovigilance in the years to come, with each stakeholder complementing the other with mutual strengths.

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