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

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.

Exploration of facilitators and barriers to the regulatory frameworks of dietary and herbal supplements: a scoping review

“…It is also important to note that certain gaps within this regulatory work have not been completely resolved. Molin et al 2019 [ 18 ] Regulatory framework for dietary supplements and the public health challenge Brazil Brazil To further assess the proposition of new regulatory frameworks being developed for DHSs in Brazil. Their existing representation and obstacles posed by new legislation were also examined.…”

“…For example, the Therapeutic Goods Association of the Australian government established a pharmacovigilance program to assess adverse events reported by complementary medicine consumers, healthcare professionals, and international medical and scientific experts on advisory boards [ 16 ]. When compared to countries such as France, Brazil, and Austria, that have established laws regarding DHS registration, Kuwait and Bahrain lack a well-defined regulatory system as they primarily import DHSs from other countries [ 18 ]. Moreover, in the United Kingdom, many unlicensed herbal remedies reached consumers without meeting safety or quality standards until 2010 [ 19 ].…”

Herbal Medicine Classification: Policy Recommendations

“…1. Adoption of a legally binding HM definition and classification guideline, with an additional route of evaluation and registration for HMs which are not classified as complete medicines [e.g., the Bahraini Pharmaceutical Classification Guideline (12)]. Furthermore, to avoid inconsistency in the review process, HMs matching the proposed definition must be assessed in one department (the Herbal Department).…”

“…The second study consisted of a review of relevant implementation literature (Alostad et al, under review). The third and fourth studies consisted of a qualitative exploration of an established system (Bahrain), which similarly to Kuwait, relies on registering HMs manufactured elsewhere, followed by an investigation of Kuwait's system and readiness for implementation (12). Using the findings from the above studies, the aim of this article is to provide a description and justification of the proposed definition, classification policy, and the plan to implement it, generated from the four studies.…”

Evaluation of Policy Governing Herbal Medicines Regulation and Its Implementation in Ethiopia

“…1 It is estimated that around 80% of the world’s population uses herbal medicines, either for maintaining general wellbeing or as part of their primary source of health care. 2 As such, herbal medicines can save many lives, particularly in the developing countries. 3 Despite herbal medicines with an extended history of popular use being normally safe when used appropriately at common therapeutic doses, the absence of evidence of toxicity or adverse drug events can not be taken as confirmation of the lack of toxicity or safety of herbal medicines.…”