A framework for the use of biological medicines in the free state province, South Africa.

PURPOSE The use of biological medicines (BM) has increased worldwide owing to their effectiveness in the treatment of many chronic diseases. However, in South Africa, access to BM remains limited, hence, there is a need to develop strategies that will enable timely access to BM by all patients who need them. OBJECTIVE To develop a framework for the use of BM in South Africa. METHODS Using a Delphi questionnaire that was developed by integration of the opinions of newly qualified doctors (<2 years practice), prescribing specialists, and patients using BM, a Delphi method was used to guide an experts' panel into consensus on the different opinions in the questionnaire, and from this, a framework for the use of BM was constructed. RESULTS From the surveys, 76.2% of the newly qualified doctors and 91.7% of the prescribing specialists indicated that they had limited knowledge on the pharmacology of BM, and, respectively, 64.5% and 77.8% admitted that their knowledge on BM was not adequate for prescribing and taking care of patients on BM. Also, 58.3% and 75% of the prescribers indicated that the high cost and the tedious procurement process, respectively, were barriers of access to BM. The Delphi panel reached consensus after two rounds, and the resultant framework recommends that, appropriate use of BM requires establishing guidelines for the use of BM, increasing BM content in the medical training programs and information resources used by healthcare professionals, enacting drug regulations and drug policies that will increase availability of BM, offering appropriate patient information and public engagement. CONCLUSION The lack of knowledge on BM by health professionals, together with the high cost and a complex procurement processes are the major impediment to access to BM. A framework for the use of BM in South Africa was successfully developed to address these and other challenges.