Modern Methods of Clinical Investigation (1990) / Chapter Skim
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6. Perscription-Event Monitoring: An Example of Total Population Post-Marketing Drug Serveillance
6. Perscription-Event Monitoring: An Example of Total Population Post-Marketing Drug Serveillance
Pages 68-77
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From page 68... ...
. The need to supplement the yellow card scheme for voluntary reporting of suspected adverse reactions to drugs with a second scheme for recording events, irrespective of any recognized link with the use of new drugs, led to the establishment in 1980 of the United Kingdom's second national scheme, Prescription-Event Monitoring (PEM)
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From page 69... ...
On the other hand, to measure the acceptable level of risk of mortality for symptomatic treatment of a headache, which may be less than 1 in 1 million, would require huge numbers of patients and infinite resources. Unfortunately, nobody has ever been able to tell us precisely what is an acceptable level of risk for a particular treatment.
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From page 70... ...
Somewhere between these two extremes, between the clinical trial on the one hand and voluntary reporting on the other, are a number of schemes aimed at measuring middle-level risks, those in the region of 1 in 100 to 1 in 10,000. VOLUNTARY REPORTING SYSTEMS From 1964 to 1980, I was responsible for managing CSM's yellow card reporting scheme in the United Kingdom, which is very similar to the voluntary reporting scheme operated by the Food and Drug Administration in the United States.
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From page 71... ...
PO ST- MARKETING SURVEILLANCE In 1976 I proposed a scheme known as "recorded release," which would use our unique ability in the United Kingdom to assemble all prescriptions written under the National Health Service (1~. This scheme and a number of later variants, such as "retrospective assessment of drug safety," were all turned down on the grounds of impracticality by those who advised the ministers of the day.
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From page 72... ...
The prescriptions are then pulled out of the files by hand and photocopied for transmission to the DSRU; up to 1 million prescriptions are handled each year for the purpose of PEM. Let us briefly consider the word "event." Event monitoring was the idea of professor David Finney, who is currently a trustee of the DRSU and a founding member of the Adverse Reactions Subcommittee of the CSM.
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From page 73... ...
Many doctors were confused about what should be reported on the new yellow card. Although they were instructed to keep the card in the patient's notes and to use it only on the rare occasions when a serious or life-threatening adverse reaction occurred, large numbers of cards came back reporting that nothing had gone wrong or describing trivial events.
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From page 74... ...
It is quite likely that many minor adverse reactions are under-reported but when the side effect is serious the reports to the CSM may be more complete than has been thought. We analyzed indomethacin administered in the sophisticated delivery system known as "Osmosin," which releases the drug progressively as the capsule passes through the gut and thereby minimizes gastric intolerance.
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From page 75... ...
In the United Kingdom, Intercontinental Medical Statistics Limited (IMS) recently established a Post-marketing Surveillance Unit which is engaged in what seem to be post-marketing clinical trials rather than PMS.
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From page 76... ...
We have already seen several examples where promotional studies conducted by drug companies or market research organizations have seriously delayed the progress of PEM. Guidelines for post-marketing surveillance in the United Kingdom insist that it should not be promotional.
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From page 77... ...
Using the United Kingdom's unique ability to identify all patients who receive a particular drug, we can study its performance rapidly in large numbers of patients. The cost is quite modest; a one-year study of 10,000 patients, including follow-up of any who die or develop serious adverse reactions, costs on average $400,000.
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