Stakeholder-led proactive risk assessment of medication safety in the pharmaceutical supply chain

Abstract

Abstract Introduction In 2022/23, 1.08 billion medications were dispensed to patients using NHS England, at a cost of £19.04 billion1 . However, Elliot et al (2019)2 estimate every year there are 237 million medication errors at some point of the medication process, with a high associated cost. Increasingly, media is reporting medication shortages of critical medicines3 that can contribute to errors of omission. Medication errors suggests system, tasks and processes should be explored to understand if they have been poorly designed. This paper is a pre-Brexit study that examines the pharmaceutical supply chain with stakeholders. Aim To explore risk to medication safety in the pharmaceutical supply chain using qualitative interviews of stakeholders across the supply chain and proactive risk assessment method SHERPA (Systematic Human Error Reduction and Prediction Approach). Method 1. Qualitative interviews with process models System process models were developed (by literature, field observations and interviewees) and employed to elicit stakeholder perceptions about risk to medication safety in 31 qualitative interviews. Participants included pharmacists, wholesalers, pharmaceutical industry representatives, regulators and policymakers. Ethical approval was granted by Cambridge LREC to include healthcare professionals and 6 patients. Interviews were audio-recorded, transcribed and thematically analysed using N-Vivo. 2. Focus group for SHERPA Six stakeholders participated in the SHERPA focus group4 , including pharmacists and representatives from pharmaceutical manufacturing and wholesale industries. Interview participants were invited and those that agreed, attended. The SHERPA template was completed by the group. The session was audio-recorded, transcribed and thematically analysed using N-Vivo. Results The system models led to a greater understanding of the current system ‘as-is’ and created an overview of the supply chain. SHERPA is a validated method and provided the rigour to risk assess the supply chain process and identify sources of risk. However, the error mode terminology required adjustment to healthcare. Across all supply routes, the main source of risk was failure to supply medicines that caused errors of omission and the risk of counterfeit medicines. Failure to supply resulted from shortages that take place from trading activities that result in stockpiling or exporting of medicines. A lack of robust regulation and parallel imports increased the risk of counterfeit medicines. Stakeholders highlighted deficiencies in the supply chain and poor performance of stakeholders, as medication safety concerns. In order of frequency, the deficiencies include fragmented supply chain; complacency by stakeholders; poor communication and integration across supply chain; and end-user often regarded as the pharmacist, rather than the patient. Discussion and conclusion From the findings, strategies emerged as possible solutions. These included communication of shortages in each component of supply chain; robust counterfeit strategies; use of technology (automation/digital tools); and re-design tasks and processes in dispensaries and wards. Staff training, education, and revalidation of stakeholders is vital. Key limitations in this study include biases that can occur from recruitment strategy and small sample size. The SHERPA method posed terminology problems. In conclusion, this multi-method approach reveals risk and possible solutions to improve safety and reduce cost in the NHS. It is clear this study needs to be repeated to understand the impact of Brexit and current reconfiguration of NHS.