Privacy and Ethical Considerations

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Chapter: Pharmacovigilance: PEM in New Zealand

The processes and practices of the IMMP have been set up to comply with the NZ Health Information Privacy Code, and the Privacy Commissioner has been advised of the purpose and methodology of the programme.


PRIVACY AND ETHICAL CONSIDERATIONS

The processes and practices of the IMMP have been set up to comply with the NZ Health Information Privacy Code, and the Privacy Commissioner has been advised of the purpose and methodology of the programme (Coulter, 2001). In line with the Privacy Code, there are processes in place within the IMMP to protect patient privacy and maintain confidentiality. These include appointment of a privacy officer and training of all staff in all aspects of confidentiality.

Regarding patient consent for involvement in the programme, the IMMP operates on the ‘opt-out’ principle, like other national epidemiological studies. Patients should be informed by their doctor that they have been prescribed a monitored medicine, the reasons why their medicine is monitored and the type of information collected. The IMMP also provides information leaflets that doctors may give to patients. The patient then has the right to opt out of the monitoring study by requesting that the IMMP does not store their personal data. In practice, this happens very rarely and – although the reasons for this have not been evaluated formally – it is possible that patients view the monitoring of their medicine as a ‘safety net’ in place to protect them rather than as an invasion of their privacy.

Ethics Committee approval is not sought for routine monitoring of medicines in the IMMP as the programme is longstanding and has regularly been scrutinized without objection. However, for particular studies that are not part of the routine monitoring, ethics approval is sought in the usual way and approval has invariably been given.

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