Marketed medicines that have passed bioequivalence testing should in general be substitutable. The Royal Dutch Pharmacists Association (KNMP) has published professional guidelines for community pharmacies concerning generics substitution. The generics substitution guidelines are based on scientific principles and provide a strong impetus for maintaining uniform professional standards.
The Dutch generics substitution guidelines were first published in 1988 and updated in May 2004, with the aim of providing pharmacists with an instrument to weigh out the risks and benefits of substitution based on patient safety.
This first edition of the guidelines was published due to the introduction, in 1988, of a financial rule for pharmacists that offered them a fee of one-third of the price difference between a generic and a brand-name drug per substitution. Thereafter, the reimbursement rules that affect substitution were changed many times, but in year 2000 the interest in substitution increased, partly for financial reasons and partly because prescribing using the generics name was introduced some years before. In 2008, a chapter on biosimilars was added.
The procedure to establish the guidelines was as follows:
– A literature search was done, and pharmacists were consulted on which problems should be addressed in the guidelines.
– Based on this information (including EMA guidelines and initially also FDA guidelines) a draft was composed.
– The draft version was sent to the Dutch Medicines Evaluation Board, the Board of the KNMP (Royal Dutch Pharmacists Association) and a pharmaceutical lawyer for comments.
– The final document was published in May 2004.
– Thereafter, it was updated several times based on new literature or new issues that should be addressed.
– The chapter about biosimilars was added in 2008. For this purpose a search in literature was done, and the draft version was sent to the Laboratory of Dutch Pharmacists, to Professor Arnold G Vulto and to several others for comments.
The impact of these guidelines is rather high. If there is any new reimbursement rule that affects generics substitution, pharmacists and the Royal Dutch Pharmacists Association use the guidelines to check whether this rule is not conflicting with the guidelines.
In a GaBI Journal article Leonora Grandia et al. present the main features of these guidelines. Click here to view the article abstract.
Conflict of interest
Dr Leonora Grandia declared that there is no competing interest in substitution besides being the author of the Guideline for Generic Substitution of KNMP. Professor Arnold G Vulto was involved in commenting on the draft guidelines.
Editor’s comment
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Source: www.gabionline.net
