The impact of regulatory change on pharmacy practice: the implementation of the European Union falsified medicines directive in the United Kingdom

Thesis

The use of technological solutions within the healthcare environment is becoming widespread. The implementation of the Falsified Medicines Directive (FMD) is a large-scale regulatory mandated example of this innovation to impact pharmacy practice in modern times. At the core of the innovation lies the practice of visual and digital authentication and verification by clinicians supported by the digital systems. Few implementation studies for policy-driven digital health system changes of this magnitude have taken place previously in the area of pharmacy practice.

A preliminary literature review found that existing digital solutions focusing on prevention and detection of falsified medicines were limited, with little evidence of integrated national and international policy supported initiatives. In the empirical component of this study, I sought to i) explore the implementation process within community pharmacy; ii) understand the challenges and opportunities pertaining to adoption, scale-up and sustainability of FMD technologies at the local level; iii) place findings within a wider national and international policy context; and vi) inform clinicians’ and policy makers’ practice for future policy-driven driven innovations.

Fieldwork consisted of a three phased approach including 10 elite and expert participant semi-structured interviews, semi-structured interviews with 17 clinicians at each study site, and 112 hours of ethnographic observations in participating community pharmacies. Analysis was informed by a multi-level theoretical lens known as the Non-adoption or Abandonment of technology by individuals and difficulties achieving Scale-up, Spread and Sustainability (NASSS) framework alongside Shiffman’s Political Priority Framework (PPF). My approach has generated a rich qualitative dataset comprising of interviews, ethnographic fieldnotes, video and digital imagery, and extracts from documents.

My findings support a number of provisional conclusions. Primarily that my chosen framework, NASSS, is a suitable model in explaining the complexities with large-scale system implementation within pharmacy, becoming the first ever study to utilise this framework within this context. Secondly, for a digital solution of high complexity to be adopted, embedded, maintained, and interacted with by clinicians, the digital infrastructure must have capabilities to provide added value for clinical work. Thirdly, policy-driven reform is only an instigator for change, which also requires expert and clinician input to shape and develop policy at the front line of implementation.

Authors: Koshkouei, MJ

• DOI: 10.5287/ora-6gnjgqgqb
• Type of award: DPhil
• Level of award: Doctoral
• Awarding institution: University of Oxford
• Language: English
• Keywords: pharmacy practice; digital system implementation; NASSS; health policy; clinician's working practices; falsified medicines
• Subjects: Digital Systems Implementation; Health Policy; Primary health care; Pharmacy