[e-drug] WHO Pharmacovigilance Indicators: practical manual for assessment of PV systems

e-drug
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E-DRUG: WHO Pharmacovigilance Indicators: practical manual for assessment of PV systems
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Dear E-Drug Member,

I am pleased to announce a new publication from WHO, with the title:
WHO Pharmacovigilance Indicators: A practical manual for the assessment of pharmacovigilance systems.

You can access a soft copy of the Manual at: http://www.who.int/medicines/areas/quality_safety/safety_efficacy/EMP_PV_Indicators_web_ready_v2.pdf?ua=1

The main objective of the pharmacovigilance (PV) indicators is to provide measures that will enable the assessment of the status and progress of pharmacovigilance, the activities and their impact, at all levels of the health-care system.

The WHO Manual of PV indicators is designed to be simple and can be understood by any worker in pharmacovigilance without formal training in monitoring and evaluation.

The Manual is published as version 1 (v1.0), to underscore its evolving nature: feedback from user groups will be used in developing the subsequent versions.

The PV indicators proposed are based on the expected functions of pharmacovigilance centres as described in the WHO Minimum Requirements for a Functional Pharmacovigilance System http://www.who.int/medicines/areas/quality_safety/safety_efficacy/PV_Minimum_Requirements_2010_2.pdf?ua=1

The structural, process and outcome or impact indicators described in the Manual will reflect the existence of pharmacovigilance facilities, the dynamics in the set-up, and the eventual outcomes, respectively. The indicators are further classified as either core or complementary.

It is critical that all public health programmes include a good pharmacovigilance strategy to monitor the safety and safe use of their medicines. The WHO Manual proposes a set of nine pharmacovigilance indicators for public health programmes.

An assessment checklist is also included in the Manual as a ready-to-use tool for collecting and reporting the value of each indicator.

This Manual does not replace the WHO harmonized tool for assessing a national regulatory agency (NRA); however, a subset of indicators from this Manual has been included in the WHO NRA assessment tool to support the assessment of pharmacovigilance as an NRA deliverable.

We are grateful to Prof Ambrose Isah, University of Benin, Nigeria (Chairman, National Drug Safety Advisory Committee, Nigeria), for leading the work on this Manual; to national pharmacovigilance centres of countries participating in the WHO Programme for International Drug Monitoring for identifying the core and complementary indicators; to the WHO Advisory Committee on the Safety of Medicinal Products (ACSoMP) and other collaborators and experts for guiding the various stages of the Manual development. Thank you.

With kind regards,
Shanthi Pal

Dr Shanthi Pal
Group Lead, Medicines Safety
Safety & Vigilance
Department of Essential Medicines and Health Products
World Health Organization
Geneva, Switzerland
Tel: + 41 22 791 1318
E-mail: pals@who.int
Website: http://www.who.int/medicines

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E-DRUG: WHO Pharmacovigilance Indicators: practical manual for assessment of PV systems (2)
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These look like good indicators; but note how the model of 'lifecycle monitoring' has accompanied more and more new medicines being approved faster on weaker and even dubious evidence that they offer advantages to patients over existing medications. For evidence, see the BMJ editorial this spring, 'Why do cancer drugs get such an easy ride?' See the forthcoming pair of articles and editorial in the BMJ in a few weeks.

The risks of serious harm rises sharply with faster reviews, a trade-off between generating revenues faster for the companies that pay for the regulatory reviews and the number of patients hospitalized, dying, or put at serious risk. Postmarket vigilance tacitly supports this Faustian bargain.

No evidence supports the claims that modernized vigilance can or will work. For a deep worry, see Moore and Furberg's assessment:
http://link.springer.com/article/10.1007%2Fs40264-015-0305-9#page-1

About 90 percent of the medicines that the FDA and EMA approve, so that companies can start spending billions to turn doctors heads towards prescribing, are found to provide few or no advantages. At the same time, based on chart reviews of hospitalized patients, prescription drugs are a major cause of illness, hospitalizations, and deaths. See
http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2282014

A good manual for the assessment of pharmacovigilance systems is just what industry wants, after flooding markets with minor variations under-tested for safety that have new patents to protect high prices.

What patients and their doctors need is scientifically rigorous testing (not biased trial designs) before approval that new medicines are clinically advantageous for patients. Then pharmacovigilance can monitor for remaining rare or delayed problems. This is my opinion, at least.

Don Light

For a series of analyses in top journals, see pharmamyths.net
<http://pharmamyths.net>
"Donald W. Light Jr." <dlight@princeton.edu>