Select Committee on Health Minutes of Evidence

APPENDIX A

  The relationship between pharmacovigilance and drug safety

  1.  To equate drug safety with pharmacovigilance in its present form is a dangerous delusion: Pharmacovigilance makes only a modest and partial contribution to drug safety.

  2.  Accidental and avoidable harm is nowhere near revealed by pharmacovigilance. Mishaps involving medicines are a leading cause of death in hospitals in the UK. To assure the public about drug safety on the grounds that we have a well developed pharmacovigilance system is misleading.

  3.  The gross underreporting of ADRs in all countries means that we cannot conclude that a lack of reports even about a widely used drug means that it does no harm.

  4.  Neither in the UK nor as far as I know in any other European country has there ever been any public enquiry into any mishap with drugs (unless TV programmes count).

Table—Professional tasks relating to adverse drug effects

  Work on adverse effects of drugs is considered under headings linking signal generation, ADRs, pharmacoepidemiology, regulatory decisions & clinical practice.

Task		Is it done?	With what results?
A.	Preclinical animal toxicology	Always done	Results secret
B.	Preclinical human toxicology, including adverse effect monitoring during clinical trials	Always done	Results often secret
C.	Gather and analyse spontaneous reports of suspected ADRs	Done	Crude summaries accessible details usually secret
D.	Assess causality: is a particular kind of adverse event caused by the drug? Can it be distinguished from similar events not caused by it, and if so, how?	Done, but often by people not medically trained nor experienced	Some results, published with delay
E.	Describe the characteristics and natural history of the effect	Rarely done	It seems to be no-one's responsibility
F.	Investigate and discover the pharmacological/ biological mechanisms involved	Rarely discussed; rarely done?	Regulators not equipped companies not interested?
G.	Investigate the epidemiology of the effect: frequency, seriousness, risk factors	Sometimes done	Selectively published in summary with delay
H.	Work out possible ways of preventing or attenuating the effect, and testing them	Rarely done properly	Mostly attempted by desk/ armchair work
I.	Develop treatments for people who have suffered damage	Rarely done systematically	No-one's official job
J.	Review the balance of benefits and harmful effects of the drug in different clinical situations	Done by regulators	Process and methods secret, results published
K.	Communicate the knowledge gained to health professionals and the public	Poorly done	Not considered a priority by regulators; distortion by marketing efforts
L.	Revise the official Summary of Product Characteristics, leaflet for patients and licensing status	Done by regulators	Usually not linked to the underlying data, nor properly explained
M.	Check that the new knowledge is used in practice	Not done	Seems to be no-one's job

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Prepared 26 April 2005