An investigation into the competency framework required for the responsible pharmacist in the pharmaceutical manufacturing sector in South Africa

>Magister Scientiae - MScThe pharmaceutical manufacturing sector operates within a highly regulated environment, with companies accountable to South African statutory bodies. The responsible pharmacist (RP) is responsible for their company’s adherence to the legislation requirements. Whilst the Pharmacy and the Medicines Acts outline the RP’s, there is no mandatory training requirement prior to registration as an RP, nor thereafter. This study investigated the role and competencies required of newly registered RPs in meeting their professional responsibilities in the pharmaceutical manufacturing sector. An online survey questionnaire elicited responses from RPs (n=102) about views and perceptions pertaining to their role and responsibilities. In addition, semi-structured interviews were conducted with statutory (n=3) and non-statutory representatives (n=5). Survey findings indicated that the majority (89,5%) of RPs felt competent and that they possessed the necessary skills and training. Almost two-thirds of respondents (63,2%) were experienced RPs who shared some reservations, that RPs may be excluded from far-reaching decisions with potential consequences for the company and patients. They added that RP performance monitoring was not regular, which may indicate that some companies view the RP as an appointment of convenience. The majority of respondents (89,5 %) were in favour of the development of training guidelines Findings from the semi-structured interviews indicated that RPs were not fully aware of their scope of duties and the implications thereof. The interviewees were also concerned that some companies, by not giving the RP role the level of importance and authority it required, were practicing tokenism. Further, that not all RPs had the necessary in-depth knowledge of the applicable laws, regulations, guidelines and codes. A competency framework for newly appointed RPs is needed to streamline their roles and responsibilities in the pharmaceutical manufacturing secto