A qualitative exploration of Bahrain and Kuwait herbal medicine registration systems: policy implementation and readiness to change

Azhar H Alostad 1, Douglas T Steinke 1, Ellen I Schafheutle 1

Affiliations

09 October 2019

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doi: 10.1186/s40545-019-0189-7

Abstract

Background: The Kuwaiti drug regulatory authority (DRA) lack a structured classification system for the assessment of imported herbal medicines (HMs), which leads to ambiguity in the registration process. This study aimed to examine the policy development and implementation process in an established HM registration system (Bahrain) and harness lessons to inform recommendations for a suitable HM classification system and explore implementation readiness in Kuwait.

Methods: A sequential study design was chosen, with data collected in Bahrain (case 1), recommendations formed and readiness for implementation explored subsequently in Kuwait (case 2). With ethics and DRA approval in place, data sources were documentary review of regulatory policies, direct observations of HMs registration processes, and semi-structured interviews with twenty three key officials involved in the HMs registration processes. Data from all three sources were analysed thematically and findings triangulated.

Results: The classification policy in Bahrain was found to be based on evidence and extensive stakeholder engagement, resulting in a clear and organised HM registration process. The availability of HMs classification policies in other DRAs, officials' dedication and teamwork, and support by higher authority, were identified as the main facilitators in policy development and successful implementation. Barriers were the diversity of HM classifications worldwide, a lack of staff and resultant workload, and lack of training. Proposed recommendations for Kuwait were to adopt a clear definition of what constituted HMs, and to introduce a Traditional Herbal Registration based on this definition and the product's characteristics. Interviews in Kuwait showed that almost all participants were in favour of the proposed recommendations and were in support of timely implementation. Interviewees anticipated that consistency in the HM registration process would be the main benefit, increasing reviewer's confidence in making regulatory decisions. Interviewees also identified potential challenges which may impede successful implementation, including staff shortages, resistance to change by internal and external stakeholders, and the impact of cultural and traditional ways of working.

Conclusions: Insights into the HM policy development and implementation process in Bahrain, and exploration of Kuwait's readiness to implement resultant recommendations informed an effective implementation process for a well-designed HMs policy for Kuwait and other Arab countries.

Keywords: Case study; Drug regulatory authority; Herbal medicine; Medicines regulation; Policy implementation; Readiness to change.

Conflict of interest statement

Competing interestsThis is an independent research undertaken as part of a PhD, and the authors were not asked nor commissioned to inform a herbal medicine registration system for the Kuwaiti drug regulatory authority (DRA). However, it is projected that the recommendations generated from this research will be proposed to the Kuwaiti DRA for consideration.

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