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ANOTHER STEP TOWARDS BETTER POSTMARKETING DRUG SURVEILLANCE?

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Page 1: ANOTHER STEP TOWARDS BETTER POSTMARKETING DRUG SURVEILLANCE?

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ANOTHER STEP TOWAROS BETTER POSTMARKETING ORUG SURVEILLANCE?

Growing interest in postmarketing surveillance of new drugs ha~ given rise to several suggested monitoring schemes. A new method of prospective drug research in the community being studied at the Dcddington Health Centre could enhance these proposed systems. To start with, patient records are analysed and relevant information computerised. Problem lists are drawn up for each patient and updated at succeeding visits. Groups who regularly receive drugs from the dispensary or fresh groups may be

identified and placed on a recall register. The second phase is to identify groups whose cl inical picture qualifies them to recei ve particular drugs under study. So far , bronch itis. hypertension and allergy have been studied. In the over-60 hypertensive study, 1]00 patients werecxamined and BP was recorded. Artcr being catcgorised and investigated for suitabil ity they were then admitted to a double-blind randomiscd clinical trial. So far. about 400 have qualified and over 150 are receiving treatment. They wil l be followed long term. If other centres could be included in the scheme and about 30,000 problem lists created and maintained, this would be a useful adjunct to monilOred release. 'Our experie nce so far is that besides locating drug related problems this prospective surveillance has enabled us to detect disease problems earlv,' In phase 3 each clinical problem list will be linked loa !1rug problem list which will help in long term drug surveillance. It is unlikely that such a scheme could replace proposed monitoring systems because of the large numbers of patients and centres and the COSts involved. A linking of the 2 systems. however. could enhance proposed drug monitoring. Not aU drugs could eth ically be tried on patients already being treated and there would need to be a definite benefit in the new subsl3.nte. 'but if these criteria are satisfied then we feel our system has e part to play in post marketing drug surveillance ,' Fel t. P.J . e! al.: European Journat orClinicaJ PI\,.rmaeo!o&y I), )15 fNo 4. 1978)

INPHARMA 22nd JuIV. 1978 p.2