Generic Prescribing
This article was originally published in SRA
Executive Summary
Swedish MPA issues report on the pros and cons of generic prescribing
Swedish MPA issues report on the pros and cons of generic prescribing
The Swedish Medical Products Agency (MPA) has analysed the pros and cons of generic prescribing and concluded that patient safety cannot be used as an argument either for or against its use.
The MPA presented its results in a report which considers generic prescribing from the perspective of patient safety, medical care and cost. Unlike some other Nordic countries, Sweden does not allow generic prescribing, which refers to the right of a physician to prescribe according to a product's international nonproprietary name (INN) only. The government commissioned the report in order to find out whether generic prescribing should be introduced1. The results of the agency's investigation, however, were mixed.
The MPA said that generic prescribing would be simpler for healthcare practitioners because they would not need to choose between many products when prescribing. But this had to be weighed against the initial costs involved in developing IT systems and educating healthcare personnel on the practice. In addition, the agency considered that there were no community economic reasons for implementing generic prescribing. Furthermore, the agency noted that no follow-up studies have been carried out into how generic prescribing affects patient safety in countries where this practice is common.
The general director of the MPA, Gunnar Alvan, said that since Sweden had introduced a medicines' substitution system, there was less need now than before, for generic prescribing. The substitution system is a procedure whereby a pharmacy can exchange a prescribed product with the cheapest equivalent alternative. However, Mr Alvan said that if generic prescribing were introduced, the MPA would recommend a combined system in which the exchange system was maintained alongside generic prescribing. The MPA would then be responsible for listing the medicinal products which might be generically prescribed with the name of the active substance. The agency also pointed out that, in order to begin generic prescribing, a one-to-two-year period would be needed to implement the policy.
Classification of non-prescription products
In a separate study, the MPA evaluated the differences between the medicinal products classified as non-prescription products in Sweden and other European Union (EU) countries2. It found that only 9.9% of medicinal products are available over-the-counter (OTC) in Sweden. Only Norway, Portugal and Austria sell a smaller proportion of marketed products OTC than Sweden. France (22.1%) and UK (21.7%) are the countries in which the most medicinal products are available OTC.
The MPA's report, which was commissioned by the government, showed that Swedish patients do not have OTC access to many of the products which are available OTC in many EU countries because many non-prescription products in other EU countries have never been approved (with or without prescription) in Sweden; not because the MPA has a more restrictive view on allowing medicinal products to be administered without a prescription.
Non-prescription products have usually been on the market for a long time as prescription products before they are classified as non-prescription. Such products were therefore approved in the EU member countries long before EU central marketing authorisation applications began. The MPA found that now, as more products are approved and classified according to common guidelines across the EU, there is more harmonisation between the EU countries concerning which medicinal products are available with or without a prescription.
The MPA concluded that in Sweden, there are non-prescription alternatives within most treatment areas suitable for self-medication. Additionally, there is a reasonable balance between access to OTC products and the risks of less control over the use of medicinal products.
INGEGERD WENNERBECK
References
1. Generisk fÖrskrivning. Läkemedelsverket Januari 2006, www.mpa.se
2. Regeringsuppdrag om receptfria läkemedel 2005, Läkemedlesverket, published 22 December 2005, www.mpa.se