BPJ special edition - Generics

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Key Points
  • The quality, safety and effectiveness of generic medicines in New Zealand is evaluated by Medsafe following processes that are at least as stringent as those in Australia, Europe and the USA.
  • Medicines that are evaluated as being bioequivalent are very unlikely to have altered clinical effects or adverse effect profiles.
  • Generic medicines have been used effectively and safely for many years in many countries, including New Zealand.
  • Negative perceptions about generic medicines can influence patient acceptability. Explanation and counseling by prescribers and pharmacists can help to allay concerns
  • Simple strategies such as the doctor prescribing generically and the pharmacist labeling the container with the name of the active ingredient (generic name) can help to avoid patient confusion when brand changes occur.
  • Healthcare professionals have an important role in helping patients understand that generic medicines are safe and effective.
  • Generic prescribing and dispensing would enable patients to be educated about the names of the active ingredient of their medicine to avoid confusion between different brands of the same medicine.
  • Reporting mechanisms are in place (e.g. CARM) to monitor the safety and effectiveness of generic medicines.

Introduction

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. With this potential for savings the use of quality generic medicines is becoming increasingly part of national medicines management strategies. For example, the UK will introduce generic substitution from 2010 and there are similar initiatives in Australia.

We can expect the use of generic medicines to increase in New Zealand. This publication is intended to inform health professionals about the processes by which generic medicines are tested, approved and monitored, to provide reassurance of their quality, safety and effectiveness. As our patients are often misinformed or have concerns about the use of generic medicines we also provide advice on how to increase acceptance of generics amongst patients. Finally, we discuss the monitoring processes in place in New Zealand to ensure that if problems do occur they are identified and resolved in a timely manner.

A few words about the terminology used in this publication. When we mention brand switching it will usually mean a switch from an innovator brand such as the Aropax brand of paroxetine to Loxamine, which is the generic brand. Occasionally, the generic medicine does not have a brand name and may be simply known by the approved chemical name. When bioequivalence studies are described, we refer to the generic compared to the innovator medicine.

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Comments recieved about this article

23 July 2009
Comment from:
Patrick Crisp		An issue: Ranbaxy was recently investigated by the FDA and its manufacturing process was found to be deficient. Medsafe chose to continue to allow Ranbaxy's products to be prescribed in NZ. I read the FDA report, which was available online, and I was very surprised that Medsafe did not take action. What this means to me is that I cannot be confident that the generic drug manufacturer will continue to produce a safe, bioequivalent product and I cannot be confident that Medsafe will take action when the drug manufacturer fails.
24 July 2009
Comment from:
Dave Woods		Dear Patrick,

Here is the response from Medsafe re. Your question.

Medsafe and medicines regulators in Europe and Australia were made aware of the FDA inspection findings in October last year. Ranbaxy's manufacturing process was not found to be deficient, the FDA called into question the final testing of manufactured product made at two Ranbaxy sites, their subsequent action related to product that was manufactured at a single site in Paonta Sahib. As a result of the information provided by the FDA the two manufacturing sites in question underwent a number of independent inspections. The inspections were both announced and unannounced and were undertaken by an International inspection team over three months at the end of last year. The inspection team included inspectors from Australia, Europe and the World Health Organisation. The results of these inspections revealed no evidence of fraud or any reason to suspect that the quality of the medicines that are manufactured by Ranbaxy did not meet the high standards required. Based on the inspections the TGA in Australia, and European Medicines Agency representing the 28 European member states did not find any reason to follow the action taken by the FDA. In addition, pending the results of the inspections Medsafe contacted the New Zealand sponsor for the relevant medicines who voluntarily impounded the product. The medicines in question also underwent independent testing, commissioned by Medsafe which revealed no issues relating to the quality of the medicines produced by Ranbaxy. It is also important to note that the FDA action did not result in a recall of any Ranbaxy product from the US market and indeed the FDA are still allowing the import of one product that is produced at the site in question. having examined all the evidence Medsafe had no reason to believe that regulatory action was necessary. The bioequivalence testing of products produced by Ranabaxy has not been questioned by the FDA and product manufactured by Ranbaxy at sites other than the Paonta Sahib plant are still allowed to be imported and used in the US. Medsafe is committed to ensuring the quality, safety and efficacy of all medicines in New Zealand.

For more information see;
http://apps.who.int/prequal/info_press/Ranbaxy_samples.pdf

Thanks

Kind regards

Enver Yousuf
Manager, Product Regulation Branch
Legislation Review
Medsafe