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[Privacy and drug surveillance: a study of the viewpoints of medication users]
M E de Wit1, B H Stricker, A J Porsius
1Inspectie voor de Gezondheidszorg, sectie Geneesmiddelenbewaking, Rijswijk.
Objective:
To study the views of patients regarding privacy in relation to the procedures of postmarketing surveillance studies.
Design:
A population-based cross-sectional study (survey).
Setting:
Dutch community pharmacies.
Methods:
From a source population of 1030 pharmacists 30 (2.9%) were selected at random; 28 (93.3%) of them co-operated with the investigation. Pharmacists were visited for one day each in their pharmacies during which visit their patients were asked to fill in a questionnaire. On the day of the visit, a random number of patients were asked whether the prescriptions were for themselves. Out of a total of 1277 patients in the 28 pharmacies, 849 (66.5%) used the filled prescriptions themselves. Of these 849, 669 patients (78.8%) co-operated and completed a questionnaire pertaining to their perceptions of privacy in relation to reporting of adverse drug reactions (ADR) and postmarketing surveillance studies.
Results:
Of the 669 respondents 628 (94%) had no objection against the reporting of ADR to the Inspectorate for Health Care by their medical practitioner or pharmacist. 505 (77%) respondents did not object to the use of their medical data, even if these were not anonymous, as long as the data were kept strictly confidential. Most patients were of the opinion that such data could be used without asking permission. Males would more readily give their permission than females.
Conclusions:
Most respondents had no objections to use of their medical data for postmarketing surveillance studies. The large majority of patients did not object to the reporting of ADR to the Inspectorate for Health Care.