Drug intelligence and access to medicine

Abstract

Access to safe, effective and good quality medicines is an evolving, complex and multifactorial challenge which has significant impact on public health and may contribute to health inequalities. This research aimed to develop a rational and prompt medicines accessibility framework. The objectives related to enhancing access to medicines were to: 1 Analyse retrospective queries and 2 Propose a framework to deal with access issues. The methodology involved two stages: 1 Analysing retrospectively access queries recorded at the Medicines Intelligence and Access Unit within the Malta Medicines Authority. A focus group was set up to identify patient-related barriers to access medicines and to develop a risk-based approach to assess lack of access alongside patient medicines needs. 2 Devising an innovative framework to enhance access to medicines by acquiring medicines intelligence and analysing real case scenarios. Observations and corresponding results progressed across the two stages: 1 All the 480 retrospective queries recorded at the Medicines Intelligence and Access Unit over a 60-month period (June 2014 and June 2019) were analysed. The focus group classified the access queries into four categories which were identified as barriers to access medicines: (i) safety (n=201, 42%) (ii) availability (n=143, 30%), (iii) pharmacoeconomic (n=97, 23%) and (iv) shortages (n=39, 8%). A risk-based approach was adopted to assess the outcomes of the access issues on patient medicines needs. The focus group recommended to classify risk by drawing on the classification of findings of the Good Manufacturing Practice quality management system and categorise risk as critical, major and other. 2 A scientific framework based on risk identification, access implications and medicines intelligence was devised to address access issues. Medicines intelligence on access issues was acquired through participation in fora and communication with the patient. Two hundred and nineteen critical risk access queries were evaluated through case scenarios in line with the category of barriers to access which was identified. Critical risk related to safety was due to adverse effects related to the change of the medicinal product manufacturer such as a generic or biosimilar medicine (n=12, 5.5%) and contamination of active pharmaceutical ingredients with nitrosamine impurities (n=175, 79.9%). The latter was associated with a disruptive occurrence and was identified as an outlier. Availability issues were critical when the medicine was not marketed (n=8, 4%) or not listed on the Government Formulary List (n=3, 1.4%). Pharmacoeconomic issues, classified as critical (n=4, 1.8%), were associated with the high cost of medicines. Critical risk related to shortages occurred due to disruptions in the supply chain (n=15, 6.8%) and withdrawal of the marketing authorisation (n=2, 0.9%). For each case scenario, patient-centered medicines intelligence interventions were recommended such as the proposal of a standard operating procedure for the inpatient pharmacy to prepare extemporaneous preparations of adrenaline injections instead of commercially unavailable adrenaline autoinjectors. An innovative framework to detect, address and mitigate access issues based on medicines intelligence and risk identification was developed to proactively enhance access to medicines in a personalised care approach.