Pharmacovigilance Outsourcing » pharmacovigilance

Why do pharmaceutical companies want to outsource their pharmacovigilance operation?

admin — Thu, 17 Sep 2009 00:00:00 +0000

Some pharmaceutical companies treat their drug safety surveillance activities as an exercise in compliance rather than as an integral part in ensuring the well-being of the patients taking their products. Pharmacovigilance can seem like a burden and a chore rather than a necessary part in running a pharmaceutical company. Yet the benefits of an effective pharmacovigilance department can often mean the difference between having a drug withdrawn from the market and having it stay. Companies that relegate pharmacovigilance to a distant second in terms of priority will often experience expensive crisis after expensive crisis that cost the company far more than effective pharmacovigilance – crises that would have been avoided if the pharmaceutical company took their responsibilities seriously.

However pharmacovigilance IS expensive. And pharmaceutical companies ARE companies and do have to make a profit, even the most responsible pharma company knows that it is answerable to its shareholders and stakeholders as well as the regulatory authorities.

So what to do?

Well one solution is to outsource some or all of the drug safety surveillance activities or to bring in consultants. Is this wise? Well it might be but it depends where the work goes and why the work is being outsourced in the first place.

Reasons for outsourcing

admin — Wed, 16 Sep 2009 23:30:58 +0000

1.) SAVING MONEY

It costs money to recruit staff and keep them permanently. It costs a LOT of money to set up a pharmacovigilance system. For example a full working drug safety database on its own can cost in excess of £200,000 before the staff to run it are even notified of vacancies.

2.) PROVIDING FLEXIBILITY

A lot of companies strike a balance between permanent staff and hired hands by bringing in consultants to provide flexibility during periods of higher workloads. This enables them to meet their regulatory requirements while at the same time ensuring that there isn’t an excess of staff during quieter times.

3.) COVERING FOR OTHERS

Sickness, maternity leave and all sorts of other factors can leave temporary gaps in the workforce. Just because employees are not present doesn’t mean the work goes away and inevitably it may be necessary to bring in temporary cover for absent colleagues.

4.) PROVIDING EXPERTISE

From time to time specific, highly specialized, expensive skills are required to carry out pharmacovigilance effectively. Those who can do the work may then not be needed for a period of time before they are next required, if they are required at all. Rather than having pharmacovigilance experts sitting around twiddling their thumbs and drawing a wage, it can make a lot more sense to temporarily draft in help when needed in order to gain their support and expertise that is not currently available in-house.

Almost all of the functions and work of a pharmacovigilance department can be outsourced effectively. This includes both the work for clinical trials and post-marketing spontaneous adverse event reporting.

implications of outsourcing

admin — Wed, 16 Sep 2009 22:50:54 +0000

When people mention outsourcing the implication is often that the work is being outsourced overseas where labour is cheaper, but that quality of work may be lower too. For many companies the cost factors are the prime driving force but in pharmacovigilance where the suspension of a drug can cost a pharmaceutical company billions, quality control must be paramount. PrimeVigilance are leaders in this field as they have found possibly the ideal solution, taking advantage of lower overheads and teaming it with exceptional quality management, by carrying out routine pharmacovigilance activities in Eastern and Southern Europe where the overheads are lower than in Western Europe and North America but where the emphasis on quality management is very strong. They have then teamed this competitive advantage up with a specialist consulting arm that is second to none and a specialist phase 4 CRO to bring to the market a complete range of services. Now small and medium-sized pharmaceutical companies can afford the kind of pharmacovigilance cover they could previously only dream about, ensuring full compliance whilst driving down their drug safety overheads.

One problem with smaller, dedicated pharmacovigilance consultancies is that they won’t have the facilities to provide safety databases and expedited reporting but there are a few who can offer it, mainly through arrangements with third parties who will perform these functions on the consultant’s behalf. Amongst these consultancies the depth and range of expertise will vary widely. Some consultancies, for example the UK-based Elliot Brown Consulting, will have medically trained staff and will involve a global network of pharmacovigilance associates including former senior regulators and industry specialists. Pietrek Associates operate in a similar way. Companies such as these can often provide high end consulting, helping to deal with serious safety issues that can affect pharmaceutical products, in addition to the more run-of-the-mill pharmacovigilance activities which would include writing and review of PSURs and auditing. With such companies the costs of these consultants can seem high but it must be borne in mind that they can often turn work around faster. More experienced contractors may be able to complete a project faster than their less experienced counterparts thanks to their greater experience and knowledge.

conclusions – what to do next

admin — Wed, 16 Sep 2009 22:45:54 +0000

There are also issues regarding the clients themselves. A lot of companies still feel that pharmacovigilance is a drain on resources, a cost with no benefit and essentially a set of routine actions which have to be taken to comply with regulations. They certainly don’t seem to feel they have an ethical duty to try to keep their customers and the wider community safe. There may also be the underlying knowledge that where safety issues do occur and are not spotted early enough and managed well enough, they could permanently cripple the company. However increasingly companies are realising that effective pharmacovigilance seem to act effectively like life insurance for the company. It protects the products and the patients and therefore the company. In all of these cases companies wanting to outsource pharmacovigilance face a dilemma. Should they go for the lowest possible cost saving in the short term or should they go for a solution that will be more likely to protect the company itself.

In the end it must be remembered that the responsibility for product safety lies with the pharmaceutical company. It doesn’t matter whether you use a pharmacovigilance service provider or bring in contractors or consultants. The company that holdes the marketing authorisation (EU) – or manufacturer (US) is free to delegate some or even most of its pharmacovigilance responsibilities but overall control and responsibility lies with the pharmaceutical company itself. Therefore, all outsourcing of pharmacovigilance must have clear and proper accountability with transparent organisational strucutre and a decision making process for the client company that is robust. There also needs to be contract documentation that is both comprehensive and detailed in terms of dictating which party is to carry out which of the many pharmacovigilance activities. This is the only way that patients’ interests can be protected and that all of the company’s legal obligations may be met. satisfied and the patients’ interests protected.