Session Speaker

Generic Substitution – A Challenge for Adherence in Primary Care and a Reason for Mistakes in Hospitals
Else-Lydia Toverud, H. Håkonsen, M. Eilertsen, H. Borge, H. Hopen, L. Abelsen* and A.K. Røise
Norway

Background and Objective: Generic substitution was introduced in Norway in 2001. The sale of these drugs had by 2008 reached 40% of the market shares in defined daily doses. For patients on chronic medication adherence can easily be less than 50%. Little is known, however, whether the intervention causes an even poorer adherence among chronic patients or to what extent it can be a reason for medication errors for nurses who often are responsible for the substitution. The objectives for three different studies in our department have therefore been to look into this problem by interviewing patients on antihypertensives in primary care and also to interview nurses in one of the country’s biggest hospitals.

Material and Methods: Study 1: Focus group studies were performed with 22 patients (51-76 yrs) from five pharmacies in Oslo regarding adherence after their brand-name antihypertensive drug had been substituted to a non-brand alternative.- Study 2 (1): In Norway’s two biggest cities (Oslo, Bergen), 174 patients (50-80 yrs) who had been through the same sort of substitution as in Study 1, were personally interviewed in their homes with a semi-structured questionnaire.They also had to show the interviewer what drug(s) they were taking. Study 3: Personal interviews with 100 nurses employed in a regional hospital (360 beds), using a semi-structured questionnaire. All participants in the studies gave their written consent .The studies were approved by the Regional Ethics’ Committee and the Norwegian Social Science Data Services.

Results and Discussion: In the focus group study the patients said that their adherence wasas good or as bad after generic substitution as it had been before. Nevertheless they felt insecure about the information they had got in the pharmacy about the effect being equally good as that of the brand product they used earlier. Three patients had in fact changed back to that product. Some also meant they had got new side effects. They relied on the doctor and felt things had been easier if he had told them about generic substitution. When the 174 personal interviews were performed one in three patients felt that generic substitution made keeping track of their medications more demanding. It was easier to recognise the brand-name drug since the different non-branded products often looked alike both when it came to packaging and the tablets themselves. A frightening result was that one out of twenty patients used one brand-name and one non-branded product, or two or three non-branded products, at the same time. In a few cases the patient had therefore been hospitalised because of too high doses. In the hospital study half of the nurses claimed that they had to substitute prescribed drugs daily even if they lacked knowledge about generic substitution. This was the case even if it is the physicians’ responsibility to prescribe the hospital’s preferred drugs. About 60% reported that they also changed to products that did not contain the same active compound. Forty-two percent said that they had experienced that medical errors had occurred, and nine in ten wished the circumstances to be so that they did not have to substitute drugs.

Conclusion: Norway is a country where increased use of generic prescription drugs as alternatives to more expensive brand-name products has led to substantial savings in the health care sector. However, it is important to be aware of the facts that the present three studies show since generic substitution is obviously an additional challenge both to the patients and their drug adherence and to the nurses who too often have to substitute drugs. The doctors should definitely have a more active role both to patients and nurses.

Reference:
1. Håkonsen H, Eilertsen M, Borge H, Toverud EL.Generic substitution: an additional challenge for adherence in hypertensive patients ? Curr.Med.Res.& Opin.2009;25 (10); 2515-21.