The use of confidential medical data and postmarketing surveillance: a survey of the opinion of patients.
OBJECTIVE
To study the perceptions of patients regarding privacy in relation to the performance of postmarketing surveillance studies.


METHODS
A population-based cross-sectional study (survey).


METHODS
Out of a source population of 1030 pharmacists a random sample of 30 (2.9%) was taken. Twenty-eight (93.3%) of them co-operated with the investigation. Pharmacists were visited for 1 day each in their pharmacy during which visit their patients were questioned with a closed questionnaire.


METHODS
On the day of the visit a random sample of patients was taken and asked whether they had filled prescriptions for their own use. 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 and viewpoints of privacy in relation to the reporting of adverse drug reactions (ADR) and postmarketing surveillance studies.


RESULTS
Of the respondents 94% had no objection to the reporting of ADR to the Inspectorate for Health Care by their medical practitioner or pharmacist. Among the respondents 77% did not object to the use of their medical data, even if these data 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 did not have objections to the 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.
de Wit
M E
ME
Drug Safety Unit, Inspectorate for Health Care, PO Box 5850, 2280 HW Rijswijk, The Netherlands.
Porsius
A J
AJ
Stricker
B H
BH