pv outsourcing
Comments (1)
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 Yet the benefits of an effective pharmacovigilance department can often mean the difference between having a drug withdrawn from the market and having it stay.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.
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What can be outsourced
Comments (5)
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.
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What can be outsourced, pv outsourcing
Comments (3)
ROUTINE DATA PROCESSING:
This includes receiving the safety data from the public and from health professionals, triage of routine cases to determine seriousness, entry of the data into a validated pharmacovigilance database, coding the narrative and providing medical review and surveillance of cases.
EXPEDITED REPORTING:
All reports of serious adverse events have to be reported to regulatory authorities within strict timescales. This expedited reporting includes electronic reporting such as Eudravigilance and usually include both expected as well as unexpected serious events.
ROUTINE REPORTING:
All reports of adverse events, serious and non-serious, expected and unexpected, must be submitted periodically to the regulatory authorities. These reports include periodic safety update reports, US periodic reports and annual safety reports. The preparation of these reports can be outsourced.
DETECTING SIGNALS:
As well as reporting events, pharmacovigilance staff must carry out exercises in signal detection to see if there are any underlying trends or issues that need to be reported.
LITERATURE SCREENING:
Likewise pharmacovigilance professionals need to carry out regular searches of the peer-reviewed literature to ensure that any mentions of their product are duly noted and reported to the competent authorities. This includes searching for potential safety issues as well as individual case reports.
QUALIFIED PERSON:
In the EU, each marketing authorisation requires there to be a single point of contact, with a deputy, that is available 24-7 to act as the Qualified Person for Pharmacovigilance for Europe. Elsewhere a local Qualified Person is often required. The QP’s job is to co-ordinate the pharmacovigilance response to any safety issues that occur. QPs are required due to the complicated and convoluted structures of many pharmaceutical companies which may mean that it can be difficult to ascertain which subsidiary of which company is responsible for which product. Requiring appointment of a QP bypasses these complications.
RISK – BENEFIT:
All pharmaceutical products are supposed to bring benefits. All pharmaceutical products are associated with risks. Balancing the one against the other is the job of the pharmacovigilance professional and of course as products stay on the market and their safety profile becomes better known, so the risk profile of a product will change.
RMP, RiskMAP, REMS
Risk management planning has become an essential part of pharmacovigilance with the requirements of submission of a Risk Management Plan in the EU and, in the US, establishment of a Risk Minimizarion Action Plan as part of a Risk Evaluation and Mitigation Strategy. Setting up and maintaining these strategies can be outsourced to pharmacovigilance specialists.
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