Does safety sell medicines?

As an EU Qualified Person for Pharmacovigilance (EU QPPV), I am often asked what my role is and how it adds value to the company. I see my job as being responsible for ensuring the establishment and maintenance of the company's pharmacovigilance system, and ensuring we meet our regulatory commitments - and thereby keep our patients safe. I would even be so bold as to suggest that by protecting the patients, the pharmacovigilance function protects the products and therefore contributes significantly to the success of an organisation.

In the past it may have been perceived that the safety function is merely there to tell the commercial arms of an organisation what it cannot do, or to tie it in knots with strict rules regarding adverse event reporting. New legislation in Europe introduced in 2012 has also led companies to expand what they collect from just side effects to reports of occupational exposure, off-label use and medication errors. Is this just a case of bureaucracy gone mad? No - the modern application of pharmacovigilance revolves around proactive signal detection of all available data - hence the collection of a wide range of events that reflect how the product is actually being used in the marketplace. Safety professionals ensure that information on possible side effects, both from clinical studies and real-world use, is constantly assessed to determine the impact on patients. New information is utilised to update the product label - the Summary of Product Characteristics (SmPC) and Patient Information Leafet (PIL) here in Europe - to enable physicians and patients to make informed decisions about the products they use. In addition, to maintain a product on the market in Europe, regular reports on the safety information received by the company must be submitted to the European Medicines Agency and other national authorities. This Periodic Benefit Risk Evaluation Report seeks to put the risks of the product in context of the number of patients treated and the benefit the product brings. This regular review by the authorities acts as a continued licence to operate.

Risk management plans identify measures that ensure the product is used safely

Clear labelling with well-thought-out warnings and precautions are combined, where necessary, with risk minimisation measures, such as educational materials for patients and doctors, to help to promote safe and effective use of the products. Risk management plans, which became compulsory for all products in 2012, identify measures that the company will put in place to ensure the product is used appropriately and safely. Such measures have enabled products that may otherwise would have been considered 'too risky' to be on the market and available for patients who will benefit from them. Who would have thought 50 years ago that thalidomide would be back on the UK market helping patients with life-threatening multiple myeloma - possible due to a risk management programme centered around preventing pregnancy. Statins - the most widely prescribed medicines on the planet - might not have been the success story they are without high quality pharmacovigilance detecting the risk of rhabdomyolysis and linking it to high starting doses - particularly in Asian patients - and putting in place appropriate warnings.

Through the collection and review of adverse event reports and information on other safety findings (such as misuse, abuse, off-label use and medication errors), pharmacovigilance teams get a unique insight into how products are being used and any concerns that physicians and patients may have. Good cross-functional working can act as a conduit to bring this insight into the marketing mix and lead to innovation in product or packaging design or additional education or services that are required.

Patient support programmes have rapidly increased in number in recent years as marketeers try to add value to the product offering and ensure patients keep taking the product. These programmes provide valuable support to patients such as financial co-payments, access to education or help lines or even allowing patients to receive injectable medicines in their own home. However this contact with patients and carers can result in high numbers of adverse event reports which are challenging for companies to handle effectively.

Just recently introduced, the web portal is proving popular for its ease of use

An example of best practice that I have been involved in setting up is when a pharmacovigilance function partners with commercial colleagues to provide oversight and governance of such programmes to allow them to continue while still being compliant with safety reporting legislation. This can be thought of as implementing a four-part compliance 'matrix'. The first element is a comprehensive set-up phase. Anyone wanting to start a patient support programme must first engage with staff on the safety function to discuss the design and determine which level of safety reporting is necessary - a process facilitated by a simple web-based workflow. Key to the safety assessment is the philosophy of how best to modify the proposed programme design or add elements that will facilitate safety reporting, rather than dampen innovation and external patient engagement. Programmes cannot be initiated without contracts being in place that set out the company's expectations for collecting adverse events and other safety findings, and anyone involved in the programme - whether company staff or those working for a third party vendor - being appropriately trained. This is linked to the purchase order system meaning that finances are not released until these elements are in place. Secondly, vendors undergo regular monitoring visits complemented by more formal audits to ensure that they understand the importance of safety reporting and remain compliant.

Commercial staff understand that they have a responsibility towards patients and that anything raised by patients who are part of these programmes must be reported to the pharmacovigilance team promptly. To facilitate ease of safety reporting in all patient support programme settings, commercial staff have asked for tools to assist with ready capture of information. The third part of the matrix is therefore a web-based portal which provides simple access to reporting forms on a tablet computer, mobile phone or desktop. This allows nurses visiting patients at home to enter adverse event information directly into a mobile application, and call centre staff to collect adverse event information alongside other desktop programmes. The adverse event information collected in the web portal is in turn sent to the company immediately. Just recently introduced, the web portal is proving popular for its ease of use.

The final part of the compliance matrix is an oversight committee of senior safety, commercial and compliance staff to provide governance over commercial programmes, who receive regular updates on the 'health' of these initiatives and have the authority to recommend terminating programmes where there are compliance concerns.

So is the safety function just a cost centre or does it really contribute as a strategic partner to the more commercial areas of a pharmaceutical company? I would argue that through thorough safety assessment and reporting we ensure that products remain on the market and available to patients, our labelling and risk minimisation measures ensure the safe and effective use of the product, and collaborative partnerships with commercial provide a compliant culture in which to operate. Does safety sell medicines - it sure does!

Acknowledgement

I'd like to thank Cheryl Finch, executive director PV operations, Amgen for her insightful comments and contribution to this article.

Article by
Sue Rees

is EU QPPV and executive director of global patient safety at Amgen

26th April 2016