Ravina Barrett, University of Brighton
This national, patient-safety study investigates community pharmacists’ compliance with the Falsified Medicines Directive (FMD 2011/62/EC) by deprivation and prescription-volume. My pilot, found poor FMD implementation. This is important in detecting fake, expired and recalled medicines.
The study investigates FMD implementation and level of employer support to pharmacists in meeting compliance. Support includes provision of additional resources (e.g. computers, employee time), in workload and time allowance, team-preparedness and ongoing provision of training, and managing unexpected, unintended, after-effects of such change. This workforce study investigates pharmacists’ skills and how they fit in the multidisciplinary team to safeguard patients. In time, we hope to describe the impact of FMD on pharmacy services and its effectiveness at improving patient safety.
This study will also quantify the prevalence of substandard and falsified (SF) medicines, which is difficult because of its subversive nature, nondisclosure on governmental seizures as well as Brexit-related supply-chain disruptions. Covid-19 adds complexity to medicines consumption, that further needs to be investigated especially in the context of spurious suppliers praying on vulnerable people online.
Medicines are increasingly being purchased online and used appropriately (& inappropriately) by citizens, who present with adverse drug reactions for onward remedial care, which can include cancer-sufferers.7–10 How SF medicines are managed, including if they are reported as suspected fakes to The Medicines and Healthcare Products Regulatory Agency (MHRA) will be studied.
A basic health economic impact assessment of SF medicines (e.g. hospitalisation, GP appointments) will be conducted. Steps to improve practice and investigate if specific patient groups are more at risk (deprivation analysis) will be done.
The primary objective of this study is to evaluate the extent of FMD implementation.
Secondary objectives are:
a)Assess the impact of change on current operations (esp. Covid-19 & panic buying).
b)Investigate what visual checks are done to identify SF medicines.
c)Investigate reporting practice and levels of harm or resource utilisation by patients.
d)Investigate pharmacist’s awareness and training on SF medicines.
e)Explore pharmacist’s confidence in handling SF medicines.
f)Seek opinions on policy and understand the pharmacist’s role in combating SF medicines.
g)Examine association with geospatial location, dispensing data and Index of Multiple Deprivation (IMD) scores.
Proposed questions are fact based and can be easily answered. This survey was previously validated but needs a larger-dataset for statistical validation (& Covid-19 data). Funding will cover statistical training and a large survey cost. Surveys are cost-effective in establishing prevalence in representative samples (approx. 11,600 pharmacies in England). Follow-on work will quantitatively and qualitatively evaluate how community pharmacists deal with such patient-reported incidences and the potential impact on the National Health Service (NHS)
The final report is available to view here and the abstract can be viewed here.
