Patient safety is an indisputably good thing, and the reporting of adverse events¹ by health professionals, carers, and patients themselves plays a vital role in improving it. Hardly controversial.

In the UK, the Yellow Card Scheme allows anyone to report an adverse event to the authorities, and many countries have similar systems. However, over and above this, market research studies conducted on behalf of a pharmaceutical company about its medicinal products, are obligated to check for adverse events and report any identified to the company’s pharmacovigilance (PV) department, within one working day of discovery.

If that process improves patient safety then fine, I’m happy to drop the arguments below and persevere – but I have struggled to find evidence that adverse events reported via market research make a difference beyond what is already achieved by the Yellow Card Scheme. If any reader knows otherwise, I’m be happy to be pointed in the right direction. On the other hand, if the evidence is indeed lacking we should lobby to opt-out, because adverse event reporting is killing healthcare market research.

I’m not alone in being concerned about this, Thomas Hein, President of EPhMRA says:

I believe there are better channels through which to carry out the vital task of adverse event reporting, approaches that do not destroy the neutrality of market research. As President, I will be speaking to the authorities about this and other issues.

However for me it is about more than preserving our neutrality …

It saps our resources

The professional body for healthcare market research in the UK, the BHBIA, produces an ABPI-approved set of adverse event reporting guidelines, supported by compulsory training and certification. On top of that, most companies have their own version of the guidelines supported by their own compulsory training and certification. The detailed reporting and paperwork requirements also vary by pharmacovigilance (PV) department. If it sounds like an orgy of red tape, it is. The BHBIA guidance has 27 pages on how to identify and report an adverse event, but nothing convincing on why we should report, other than to confirm that we are supporting Pharma’s obligation to comply:

Attention to company values, legal and policy requirements are necessary for successful participation in market research. This is especially important because of the potential generation of safety (or quality) information which Marketing Authorisation Holders (MAHs) have an obligation to monitor, collect and manage.

Our projects and operations manager (one of four full-time employees here) who leads on adverse event reporting, now spends at least 20% of her working hours on related tasks, just to accomplish the necessary. The rest of us need to sit through training programmes and pass tests, and as a company we must ensure that any sub-contractors are fully educated and signed-up too. Adherence to the regulations is fastidiously enforced. None of this contributes to our project deliverables, and of course none of it is financially recompensed. Adverse event reporting is a service that as a research supplier we are effectively forced to provide, free of charge, to our pharmaceutical clients and – in turn – their regulatory masters.

It discourages respondents

At the start of our questionnaires and discussion guides we must include a long-winded paragraph about our obligations, and ask health professionals if they are happy to waive their usual right to anonymity if they happen to mention an adverse event that a PV department later decides it wants to follow-up. In which case, we must pass on their identity and contact details so that someone can call them to find out more. We have enough problems with response rates as it is, and this kind of extra hassle is yet another reason for health professionals to think twice before participating.

It undermines good research design

I am certain that many an excellent research idea has been abandoned early for fear of probable adverse event reporting implications. It is a brave researcher who proposes a technique that will smash the business objectives, but risk a glut of incoming adverse events.

We are in danger of defeating the purpose

Worse, some company PV departments are now pre-screening research materials, on the look-out for questions that may lead to adverse events. Any spotted are unceremoniously culled. When this happens, researchers and marketers have to fight determinedly and at length to protect them. My impression is that more pharmaceutical companies are granting PV and Medical teams the casting vote on which questions enter the field. Presumably, the volume of adverse events received by PV departments via market research studies is sapping Pharma’s resources too – but is the answer simply to stem the flow? What is the point in market research being included in the wider adverse event reporting initiative if we then actively avoid capturing them?

Is the information we submit helpful?

When health professionals complete market research studies, what they contribute is mostly a product of memory and perception². Whether or not an adverse event is reportable is contingent on recall (which may be months out-of-date) and turn of phrase (i.e. open to interpretation). Add to that the massive breadth of the qualifying criteria. If a GP tells us that some of their less fit patients taking the client’s psoriatic arthritis treatment complain of joint pain, we have to report that. When a Urologist tells us that our client’s hormone therapy for advanced prostate cancer failed to prevent disease progression in their most recent patient, we have to report that too because lack of clinical efficacy – in any setting – is also a reportable adverse event.

Ultimately, there is a legal requirement to comply³ and so we continue to wade diligently through the paperwork, despite the occasional whinge…

But I wonder how many readers feel as I do? I do not criticise the BHBIA – they do a great job of supporting us through the process and keeping us up to date. However, as a supply side business owner “investing” many hours in this endeavour I feel like we at least deserve to know whether or not our efforts make a difference. I suspect those working in Pharma are just as frustrated? Above all, as a market researcher I simply want to be free to design for my client’s objectives!

 


¹ Adverse events approximate to ‘side effects’. Also included in the reporting requirements are ‘special situations’ and ‘product complaints’ (click here for more)

² The most notable exception is longitudinal (tracked over-time) patient-record studies, which are often conducted on a large scale. They have been given special exemption from adverse event reporting, which I guess makes sense if we assume that doctors will in theory already have reported any adverse events via the Yellow Card Scheme…

³ Here is an extract from the BHBIA’s ‘Guidance notes on the collection of adverse events and product complaints from market research programmes’: In Europe, the two pieces of legislation that underpin PV expectations are: Regulation 726/2004 (as amended by Regulation 1235/2010) and Directive 2001/83/EC (as amended by Directive 2010/84/EU). Companies must ensure that all their activities comply with the appropriate legislative requirements for PV and with the ABPI Code of practice for the pharmaceutical industry. The BHBIA requires all members to adhere to the BHBIA Legal and ethical guidelines for healthcare market research as a condition of membership and this includes the responsibility to collect and report adverse events and product complaints.