After quite a few false starts (See article Pharmacovigilance: The way forward for India; Express Pharma, September 1-15, 2013; http://bit.ly/15UnKEM) the Pharmacovigilance Programme of India (PvPI) seems to be finally picking up some momentum. A recent workshop saw some interesting interactions between various stakeholders – policy makers, doctors, pharmacologists, pharmaceutical companies, anti-counterfeiting device manufacturers, and patients (currently represented by consumer/patient activist groups). India has a long way to go but these are important steps towards getting all stakeholders on the same page.
The workshop was the second national training workshop on “Secured Medicines & Robust Pharmacovigilance hosted by the Partnership for Safe Medicines (PSM) India Initiative and followed a similar session in Bengaluru.
An interesting query posed was whether doctors should be paid to report if their patients suffer from adverse reactions to the drugs they prescribe. The question was raised by Dr VG Somani, Joint Drugs Controller India, in response to a slide in Dr Urmila Thatte’s presentation, where she mentioned that a research study done among resident doctors in KEM Hospital revealed that 16 per cent of them expected payment for reporting adverse drug reactions (ADRs).
As professor and head of the department of clinical pharmacology of KEM Hospital, she was quite adamant that ADR reporting was part of a doctor’s duty and no extra payment was required. Others in the audience, some of them heads of ADR monitoring centres (AMCs), seconded her stance saying that studies conducted at their hospitals threw up similar percentages of RMOs expecting payment. So, clearly it’s not an isolated phenomenon.
Dr Thatte brushed away the finding saying that it was still a minor percentage compared to other challenges to spontaneous reporting of ADRs across countries: 95 per cent of healthcare professionals claimed ignorance, while lethargy (77 per cent), diffidence (72 per cent), indifference and insecurity (67 per cent) and complacency (47 per cent) were the other challenges listed. Her point was that an alert healthcare professional is really the key to spontaneous reporting of ADR and we therefore needed to educate doctors/prescribers, which she believes will be dependent on pressure from patients.
It is very clear that without an attitudinal and cultural change among practising clinicians, nurses and all healthcare professionals involved in patient care, there is no way PvPI can achieve any degree of success.
Therefore such workshops serve as an opportunity to brainstorm for ways to strengthen PvPI. For instance, rather than remuneration, it was very clear that recognition of their efforts will convince doctors to report ADRs. Today, most of them shy away from playing their part in PvPI. For instance, Dr Ketan Parikh, a paediatric surgery consultant who also runs his own nursing home in Mumbai, related how his one attempt at reporting an ADR got no result, and he felt that it was an exercise in futility. His recommendation therefore was doctors must be convinced that reporting ADRs had a purpose.
If naming the top ADR reporters- and shaming the laggards – would do the trick then we need look no further than the monthly ‘report card’ of AMCs posted on the website of the Indian Pharmacopoeia Commission. IPGIMER, Chandigarh tops the July report, with the highest number of ADR reports in VigiFlow (301) followed by 203 reports from JSS, Mysore; 169 reports from MMC Chennai; 129 reports from TNMC, Mumbai (Dr Thatte’s hospital); and at fifth place, 125 reports from JIPMER, Puducherry.
Rather than the prosaic line: ‘We appreciate the progress of all the AMCs’, the National Coordination Centre should play up the efforts of these centres, especially when you consider that 33 out of 90 AMCs did not provide any ADR’s reports via VigiFlow in June.
It is interesting to note that the top performers in June were more or less the same institutions, with some change in rankings. This makes at least three things very clear. Firstly, once ADR reporting starts, it becomes easier to build and sustain the ADR reporting culture and this is a sign of hope for those AMCs still struggling to get started.
Two, the ‘toppers’ need to ‘mentor’ the laggards and three, the naming and shaming has to be louder and more stringent. Maybe organisations like PSM India and the like can start building awareness among patients about the need to report ADRs and more importantly, reporting on their doctors who try to brush their complaints under the carpet. For once, doctors and hospital managements will be forced to listen to their patients. This is one prescription they cannot afford to ignore.
Viveka Roychowdhury
Editor