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BPJ SE Generics May 2009

Best Practice Journal

Introduction: BPJ Generics special edition

Generic drugs are reproductions of the original innovator medicine which are made widely available when a drug’s patent expires. They have been widely used in many countries for over 40 years, including New Zealand. The use of generic medicines is an important part of health care, providing economical alternatives to more expensive branded products and allowing considerable savings for the overall health care budget View Article

What is Bioavailability and Bioequivalence

Bioequivalence is established by undertaking a single or in certain circumstances a number of bioequivalence studies. Most bioequivalence studies employ a randomised crossover design in healthy volunteers, in which each individual acts as his/her own control. View Article

The regulation and oversight of generic medicines in NZ

In New Zealand, Medsafe is responsible for the regulation of generic medicines. This involves evaluating the manufacturing processes, assessing product quality and evaluation of bioequivalence study reports. In the wake of recent high profile medicine brand changes, pharmacists, general practitioners and patients have raised a number of questions about the regulation and oversight of generic medicines. We put these questions to Dr Stewart Jessamine and Dr Enver Yousuf from Medsafe View Article

Medicine Brand Changes

A short article on the perceptions of generics and brand changes. View Article

Counseling patients through a brand change

Health care professionals have an important role in helping patients understand that generic medicines are as safe and effective as the innovator medicine. Patients should be educated about the names of the active ingredient of their medicine to avoid confusion between different brands of the same medicine. View Article

Monitoring of generic medicines and brand changes

Dr Michael Tatley of CARM advises on how brand changes are monitored. View Article

How does PHARMAC assess if a brand change is appropriate

PHARMAC carefully considers whether brand changes for specific medicines are appropriate, taking into account clinical risks. Clinical risks are particularly important where there are limited treatment options within the therapeutic group, where the medicine has a narrow therapeutic index, or where patient adherence is considered critical and could be compromised by the brand change. Dr Dilky Rasiah of PHARMAC discusses how decisions on brand change appropriateness are made. View Article

Appendix: How is Bioequivalence Established

Bioequivalence is established by undertaking a single or in certain circumstances a number of bioequivalence studies. Most bioequivalence studies employ a randomised crossover design in healthy volunteers, in which each individual acts as his/her own control. View Article

Video interviews: Generics

We interviewed experts, regulators and clinicians about generic medicines and medication brand change. You can view extracts from these interviews here. View Article