Browsing by Author "Falck, Jenni"

Biological medicines are gaining ground in drug therapy. However, biological medicines are considerably expensive. Top ten drugs that caused the most drug reimbursement expenses included six biological drugs in Finland in 2017. A biosimilar is a biological medicine which is highly similar to another biological medicine (the reference medicine) that has already approved. Biosimilar prices are cheaper than the original medicines because their clinical development program does not have to be as extensive. A wide use of biosimilars save costs for both the patient and society without changing the effectiveness of drug therapy. The aim of this study is to investigate the automatic substitution of biological drugs containing the same active ingredient, especially from the point of view of medication safety. The study was conducted as a systematic literature review. Literature search was carried out by using Pubmed and Scopus databases. The literature was also searched manually from references of the articles and from the industry experts. The literature search produced a total of 454 articles after the deletion of duplicates. A title, abstract and full text screening was conducted by two independent researchers. All in all, 65 articles met the inclusion criteria of the study. As no studies were found on the automatic substitution of biological medicines from the point of view of medication safety, it was decided to include in the study original studies investigating the substitution of biological drugs from the point of view of doctors (n=8), pharmacists (n=3), patients (n=1) and various stakeholders (n=2). The original studies were all surveys except one study. In addition, the review included statements of various medical associations and organizations (n=23), descriptive reviews (n=27), and expert views (n=2) on the automatic substitution of biological drugs. According to the results of the original studies (n=13), it can be stated that automatic substitution is not considered generally acceptable. Doctors consider it is very important that the pharmacist informs them if substitution occurs. They also think it’s critical that doctors should be able to prevent substitution. Patients are also sceptical about the substitution of biological drugs. The quality of the original studies was assessed by the generalizability of the research results. The generalizability of the results of the original studies is weak due to the methodological shortcomings of the studies. Although the automatic substitution of biological drugs is legal in some countries, such as in France and in Australia, it has not been studied from the point of view of medication safety. In order to be safe to implement automatic substitution of biological medicines, more should be investigated on the subject. From the point of view of medication safety, healthcare professionals and patients will need further target group education on biosimilars. In addition, it should be clarified what kind of education the healthcare professionals and patients would need if the automatic substitution of biological medicines was to be realized.