Need for constant vigilance

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An analysis on the progress of India’s pharmacovigilance programme

In 2010, Dr Surinder Singh, Former DCG(I), launched the Pharmacovigilance Programme of India (PvPI) with the objective of studying the adverse effects of drugs, to strengthen the number of drug inspectors and to maintain quality parameters in countries from where India imported drugs. In observance of Pharmacovigilance Day, let’s examine the progress of the PvPI programme so far.

Improved ADR reporting

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Dr Renuka Munshi

Commenting on the progress so far, Dr Renuka Munshi, Coordinator, AMC, TN Medical College & BYL Nair Hospital says, “In the last seven years, the programme has been progressing in leaps and bounds. Recently, PvPI has also taken the responsibility of reporting adverse events due to medical devices and has initiated the process of reporting adverse events due to drugs used for vector-borne diseases like Kala-azar. We have more than 250 ADR monitoring centres, which have been involved in the activity. Programmes like Revised National Tuberculosis Control Program (RNTCP) and ART and their respective centres have been roped in to report ADRs.”

Enhanced Data Collection

PvPI has contributed numerous data to the WHO-Uppsala Monitoring Centre (UMC) and Central Drugs Standard Control Organization (CDSCO). Quality checks of the submitted ADRs is done by National Coordinating Centre (NCC) and queries sent to respective ADR Monitoring Centre (AMC). There has been a positive impact on the quality of Indian Society for Clinical Research (ISCR) submitted to AMC at Uppsala. During 2014-2015, the completeness score of the ISCR reports submitted by India to Uppsala has been as high as 0.92 out of a total score of 1. The fact that the Medical Council of India (MCI) has also made it mandatory for medical colleges to incorporate ADR reporting to PvPI as a Minimum Standard Requirement (MSR) for those medical colleges seeking MCI recognition has given added impetus to the programme.

Private sector participation

Munshi informs, “Another feather in the cap of the PvPI programme is the involvement of private hospitals and physicians into the system. The NCC has signed an MoU with NABH to promote monitoring and reporting of ADRs by National Accreditation Board for Hospitals & Healthcare Providers (NABH) accredited hospitals to PvPI. Similarly, an MoU has been signed with the Indian Medical Association (IMA) to encourage private physicians to submit ADR reports. The programme also encourages patients/ consumers to report ADRs directly into the PvPI system using the PvPI toll free number.”

Introducing post-marketing PV

An entire foundation was set up by the regulators to introduce post marketing PV into PvPI, an endeavour which had failed in the previous two attempts. Most of the post marketing PVs such as assessing Periodic Safety Update Reports (PSUR), every adverse event report generated from the market, signal management and further increasing awareness of PV among the general public, are now being assigned to PvPI. This programme is centered in more than 170 medical colleges and hospitals of India to ensure that every report is captured in order to have better assessment of the benefit-risk ratio of the drugs that are present in the Indian market. They have toll free numbers to report any side effects as well as forms in many languages that can be filled up by patients/ healthcare professionals and submitted to the nearest centre.

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Dr Subhash C Mandal

Dr Subhash C Mandal, Chairman, Regulatory Affairs Division, Indian Pharmaceutical Association updates, “The pharma industry is already providing PSUR data to the CDSCO as per the requirement of the Drugs Act & Rules. As a result of the recent mandate, ones which do not have PV system for ADR reporting are in the process of setting up the same.”

Though PV is well practiced in developed countries, multinational pharma companies operating in India realised that they too need better understanding in this arena.

Educating the industry

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Indu Nambiar

Indu Nambiar, Senior Manager – Local Pharmacovigilance/ LPVM, Boehringer Ingelheim India shared, “Being a part of a multinational company with the headquarters being regulated by EMA, our association with this word came in much earlier though we were based out of India. Being associated with this function for the past 11+ years, I can confirm that a lot has been achieved. In the initial stages of my association with this function, I would admit, I hardly knew about this function. The start was to internalise the concept of PV; self understand the importance of this function, how it helps in protecting a company’s credibility and data and how it touches and safeguards the biggest customer pool of any pharma company – the patients followed by the healthcare professionals.”

Growing regulatory role

PV remains a dynamic clinical and scientific discipline. It continues to play a crucial role in meeting the challenges posed by ever increasing range and potency of medicines. Robust regulatory arrangements are undertaken to strengthen PV activities. PvPI encourages reporting of all drug-related adverse events, even if they seem to be insignificant, keeping in mind that it may be important since it may highlight a widespread prescribing problem. In addition to regular medicines, the safety of complementary and traditional medicines, vaccines and biological medicines is carried out.

New developments

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Dr Raman Mohan Singh

Dr Raman Mohan Singh, Director, Central Drugs Testing Laboratory (CDTL), Mumbai, shares information about new developments
initiated under the programme and says, “Under the umbrella of PvPI, two more programmes, Haemovigilance Programme of India and Biovigilance Programme of India are taken care by NIB-Noida.”

He further informs, “PvPI system in India has been declared functional with a maturity level of four by WHO-NRA team which is the highest level as per the currently evolved definitions. Standard guidelines for PV in India will truly serve the purpose of ensuring safety of our patients. It is important that medicines developed for treatment, actually do not do more harm than good, and that is the pre-requisite for the progress of the medicine. PV organisations should evolve in future by embracing the conservative approach of precluding direct patient contact and taking inputs from all platforms, right till the nursing staff, paramedical staff and end users.”

Ushering a new era for PV

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Deepa Arora

Both the industry as well as regulatory bodies are working towards instrumenting a system which will work effectively. Deepa Arora, Vice President-Pharmacovigilance and Global Head- Drug Safety and Risk Management, Lupin states, “CDSCO’s release of draft revised PV guidelines for industry signals the start of a new era for PV in India. PvPI has relentlessly worked with the industry for preparing these guidelines.”

She elaborates with an example that PvPI is regularly sharing signals detected by them with industry through newsletters as well as text messages. Intensive monitoring is especially important with new drugs like Bedaquiline. It is a new anti-tubercular drug and as India is the biggest market for this drug, collaboration of PvPI and Central TB Division is useful in particular for fully understanding the safety of Bedaquiline.

The above moves are sign of actions that have been taken at the right time, however, a country like India where health and medicine literacy is not well developed, self-medication and incorrect use of non-prescription as well prescription medicines is common. In such a scenario, pharmacists play a significant role in early detection, reporting and most importantly prevention of ADRs.

Pivotal role of community pharmacists

According to a research study titled, ‘Improving pharmacovigilance and the role of the pharmacists’ research studies, the highest percentage of pharmacists’ reports received via spontaneous
reporting systems were recorded among community pharmacists in Canada (89 per cent), Australia (41 per cent), The Netherlands (40.2 per cent), Spain (26 per cent) and Portugal (24 per cent). Presently, India has more than 250 ADR monitoring centres (AMCs) across the country, which are functioning under the PvPI monitored by NCC at IPC Ghaziabad. Since the objective of the programme is to deliver safe medicines to consumers, pharmacists have an important responsibility in monitoring the ongoing safety of medicines.

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Manjiree Gharat

Manjiree Gharat, Vice-President, Indian Pharmaceutical Association, Chairperson-Community Pharmacy Division, and Vice-Principal, Prin KM Kundnani Pharmacy Polytechnic, Ulhasnagar, Maharashtra, says, “Community pharmacists are the first point of contact for people with symptoms and the last point of contact for those who buy medicines having prescriptions. Since the incidence of ADRs is more than 50 per cent in community settings, community pharmacists overseas are playing a vital role in monitoring and reporting ADRs to their respective national PV programme.”

Research evidence suggests that on a global scale, major improvements can be made and the extent of ADR and other drug-related problems under reporting can be considerably reduced by actively involving pharmacists in surveillance of drug safety. She adds, “Sensitisation of consumers by the pharmacists to talk about the side effects if any, experienced by them can help in increasing ADR reporting and for further prevention of such ADRs. Pharmacists can actively counsel patients on responsible use of medicines, which will improve safety profile of the drugs and will in turn reduce ADRs.”

Towards a bright future

Success of the programme has already begun and all stakeholders have started noticing it. Munshi informs, “The biggest benefit to AMCs is access to Vigiflow, which is a WHO software where entries can be made on adverse drug reaction reports. In previous programmes, hard copies of reports were submitted to the NCC, which were hand written and resulted in errors. Now with the centres doing it directly, the responsibility and ownership lies with individual AMCs. The programme has also appointed PV/Technical Associate/s (PvA0) to various AMCs to help them in the task of collecting ADR reports and submitting the same to NCC. NCC also organises training programmes for newly recruited AMC co-ordinators and PvAs at regular intervals. It also provides funds for selected regional AMCs to organise training workshops in PV in that region.”

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Nambiar mentions, “The concept of PV is still an area of fear for a majority of the stakeholders, which is self-created. Every possible opportunity and forum will be utilised to clear this misconception. In an effort towards this, the Indian Society for Clinical Research (ISCR) forum was convinced to form a PV Council that was established in early 2015. Many other bodies have been formed in order to strengthen this function and bring about a revolution in this field. The PvPI team is also involved in developing guidelines on good PV practices which will soon see the light of the day. The team also offers courses for professionals in order to make them enlightened on this subject and understand their responsibilities. PvPI has now teamed up with industry bodies as well and this collaboration would definitely be beneficial for India.”

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Gharat highlights, “Recently, PvPI has constituted a national level advisory committee consisting of various experts to engage community pharmacists in PvPI. Training module will be finalised and conducted for pharmacists. Posters to create awareness about the ADR reporting, helpline numbers will be displayed in pharmacies. This is a welcome step and was most needed for initiating involvement of community pharmacists in PV. Pharmacy Practice Regulations 2015 (PPR 2015) released by Pharmacy Council of India also include ADR reporting as one of the professional responsibilities of the pharmacists. Indian Pharmaceutical Association (IPA) has been running a Campaign on Awareness on Responsible Use of Medicines (CARUM) and role of pharmacist. Thus, efforts from various stakeholders have begun to develop the new role of the pharmacist.”

Way forward

In the last seven years, many activities have been undertaken to improve PV in India and build it into a robust system. Yet, there is a long way to go for PvPI. Arora suggests, “Information about adverse reactions of alternate therapy, as India is one of the largest user of alternate medicines, would be particularly useful if PvPI and AYUSH can collaborate to identify adverse reactions associated with use of various alternate therapies commonly used in India like Ayurveda, Unani and Homeopathy.”

Munshi point outs, “The downside is that in spite of all these efforts, it is still difficult to change the mindset of the clinicians and get them to submit ADR reports, especially those in the private sector. The ground reality is that physicians are reluctant to complete the ADR forms and sign the same for various reasons – fear of litigation and medico-legal repercussions being the main issues. Often the reply received when requested for ADR reports is that they see only the common, known adverse reactions and so don’t feel the need to report the same again. Another area that needs focus is the end user i.e the patient.”


A survey conducted by TN Medical College & BYL Nair Hospital, AMC among patients/ consumers from different age groups and educational level regarding the PV programme and the importance of reporting ADRs made us realise that the impact has not yet reached the end user i.e. the patient. Although most of the consumers/ patients interviewed were aware that drugs can cause adverse reactions, most of them, irrespective of the age group or education level, had very little information (max 20 per cent had some knowledge) regarding the PV system and the need to report ADRs. Although 70 per cent of the responders felt that patients too should report ADRs; however, majority (95 per cent) said that they were more comfortable reporting the ADRs to their family physicians. Most of the responders, in the younger age group (18-35 years), were willing to report ADRs in the future; however, they wanted access to more information regarding how, what and where to report ADRs. The mobile app for reporting ADRs prepared by PvP would be a useful alternative to this generation to encourage reporting.


She further says, “PV programme is definitely moving in the right direction and has taken giant steps to live up to its motto of ‘Let’s join hands to promote patient safety’ wherein it has taken efforts to bring together all stakeholders, both public and private, regulators, industry, academicians, physicians, pharmacists, nurses and other paramedical staff and most of all the patient on one common platform to promote safe use of drugs.”

Nambiar points out, “There are many loopholes that need to be addressed, which will take time. However, with the kind of start that has been witnessed, it can be ensured that success is not very far.”

u.sharma@expressindia.com

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