scholarly journals A qualitative exploration of pharmacovigilance policy implementation in Jordan, Oman, and Kuwait using Matland's ambiguity-conflict model

Author(s):  
Hamza Y. Garashi ◽  
Douglas T. Steinke ◽  
Ellen I. Schafheutle

Abstract Background As Arab countries seek to implement the 'Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries', understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). Results Matland's ambiguity-conflict model served to frame data analysis from 55 face-to-face interviews which showed that policy ambiguity and conflict were low in Jordan and Oman suggesting an "administrative implementation" pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied suggesting a mixture between "experimental implementation" and “political implementation”. Factors reducing policy ambiguity in Jordan and Oman included: decision-makers' guidance to implementors, stakeholder involvement in the policy's development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy's compliance with internationally recognised standards and the policy's fit with local capabilities (all three countries), decision-makers' cooperation with and support of the national centre as well as stakeholders' agreement on policy goals and means (Jordan and Oman), and adopting a stepwise approach to implementation (Jordan). Conclusion Using Matland’s model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.

2021 ◽  
Vol 17 (1) ◽  
Author(s):  
Hamza Y. Garashi ◽  
Douglas T. Steinke ◽  
Ellen I. Schafheutle

Abstract Background As Arab countries seek to implement the ‘Guideline on Good Pharmacovigilance Practice (GVP) for Arab countries’, understanding policy implementation mechanisms and the factors impacting it can inform best implementation practice. This study aimed to explore the mechanisms of and factors influencing pharmacovigilance policy implementation in Arab countries with more established pharmacovigilance systems (Jordan, Oman), to inform policy implementation in a country with a nascent pharmacovigilance system (Kuwait). Results Matland’s ambiguity-conflict model served to frame data analysis from 56 face-to-face interviews, which showed that policy ambiguity and conflict were low in Jordan and Oman, suggesting an “administrative implementation” pathway. In Kuwait, policy ambiguity was high while sentiments about policy conflict were varied, suggesting a mixture between “experimental implementation” and “symbolic implementation”. Factors reducing policy ambiguity in Jordan and Oman included: decision-makers’ guidance to implementors, stakeholder involvement in the policy’s development and implementation, training of policy implementors throughout the implementation process, clearly outlined policy goals and means, and presence of a strategic implementation plan with appropriate timelines as well as a monitoring mechanism. In contrast, policy ambiguity in Kuwait stemmed from the absence or lack of attention to these factors. Factors reducing policy conflict included: the policy’s compliance with internationally recognised standards and the policy’s fit with local capabilities (all three countries), decision-makers’ cooperation with and support of the national centre as well as stakeholders’ agreement on policy goals and means (Jordan and Oman) and adopting a stepwise approach to implementation (Jordan). Conclusions Using Matland’s model, both the mechanism of and factors impacting successful pharmacovigilance policy implementation were identified. This informed recommendations for best implementation practice in Arab as well as other countries with nascent pharmacovigilance systems, including increased managerial engagement and support, greater stakeholder involvement in policy development and implementation, and undertaking more detailed implementation planning.


2019 ◽  
Vol 3 (1) ◽  
pp. 13
Author(s):  
Pasakorn Sakolsatayatorn

Renewable energy has become the buzzword in the 21st century especially during the United Nations declarations of the Submit 21 in which world leaders renewed their efforts in achieving the seventeen sustainable development goals. One of the challenges of the developing world is achieving a reliable energy supply for industrialization and energy security. Thailand is one of the countries with the highest energy consumption within the ASEAN region and hence, several policies have been implemented to deploy a clean source of energy for both domestic and manufacturing purposes. However, there are many institutional factors that seem to impede this drive for a greener energy supply in the country. This study sought to investigate the institutional factors that support sustainable renewable energy policy development in the Thai context. The study selected 400 respondents from renewable energy producing companies in Bangkok and Ayutthaya using a survey instrument. The results were analyze using SPSS version 22.0 with multiple regression technique. The results showed that institutional variables such as stakeholder involvement, government R&D framework, regulatory procedures, and government subsidies had an influence on sustainable renewable policy development. The study recommends that future government policies should engage key stakeholders in the policy dialogue and implementation process.


Author(s):  
Azhar H. Alostad ◽  
Douglas T. Steinke ◽  
Ellen I. Schafheutle

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.


2020 ◽  
Author(s):  
Micha Werner ◽  
Nora van Cauwenbergh ◽  
Tibor Stigter ◽  
Leonardo Alfonso Segura ◽  
Teresita Betancur Vargas ◽  
...  

<p>Despite a significant increase in attention for uptake of scientific results, the integration of emerging science in policy development and implementation remains challenging. The persistent gap between science and policy may frustrate the parties involved. For the scientists, the intended impacts of what are typically very much applied research efforts remain unattained. Those involved in policy implementation and development may perceive a lack of scientific support. This may particularly be the case in transitional countries, where the development of science may struggle to keep up with rapid societal and policy development; with several factors either impeding or facilitating the uptake of emergent scientific knowledge.</p><p>We implemented a series of participatory and action research activities to support the development and implementation of groundwater management policies in Colombia and explore barriers and enabling conditions to a functional science-policy interface. The factors that either impede or facilitate the process are examined through three case studies in different regions of the country. Although the national policies that govern groundwater resources management in these three areas are the same; the degree to which scientific knowledge is used to support policy implementation varies. Several factors are identified that influence the effectivity of the linkage, including among others; the availability of scientific knowledge; the establishing of trust relationships and positioning of institutions and stakeholders; as well as institutional readiness in supporting the policy implementation process. This comparison provides useful insight into how addressing some of the impeding factors may enrich the science-policy process.</p>


2020 ◽  
pp. 1-20
Author(s):  
ANNA COLEMAN ◽  
JENNY BILLINGS ◽  
PAULINE ALLEN ◽  
RASA MIKELYTE ◽  
SARAH CROKE ◽  
...  

Abstract Policy driven change is challenging, with a significant gap between theory and practice. A key tension in enacting such change is achieving a balance between bottom-up development of local, context-specific approaches, and top-down, centrally determined policy solutions and their mutual sequencing. Ideal type models of the policy-making process envisage a rational ordered approach, driven by evidence and accompanied by ongoing evaluation of outcomes (Parsons, 1995, p77); however, the reality is far more complex. We examine the implementation and early operation of the New Care Models (NCM) Vanguard programme in England, using Matland’s (1995) ambiguity-conflict model, to explore the aims and expectations of the programme. We consider the relationship between top-down and bottom-up approaches to policy development and draw attention to the pressures coming from what was initially perceived as a permissive policy approach of encouraging experimentation, whilst also requiring rapid learning, scale and spread. We suggest that future programmes for large-scale policy implementation initiatives could be crafted differently to take account of the environment of implementation and render ambitions more realistic. Rather than aiming to create a set of definite products and templates, it may be that a set of principles for design and implementation should be developed and spread.


2018 ◽  
Vol 18 (1) ◽  
pp. 45-63
Author(s):  
Carolyn Page ◽  
Russell Ayres

Cultural barriers can impede evaluative discourse in government agencies and can pose challenges to good public policy and program implementation. These barriers can be raised—and ameliorated—by applying the “Policy Logic” framework. Policy Logic incorporates elements of the standard “Program Logic” approach, but it goes more deeply into government’s purpose, focusing on the government policy problem to be addressed by the proposed policy or program. The manner in which the framework is used in workshops and discussions with evaluation clients is critical to its success as an evaluation tool. Since its initial development in the Department of Agriculture, Fisheries and Forestry in 2001, Policy Logic has become increasingly popular as an analytic tool in policy development and program evaluation. The lively, interactive nature of Policy Logic workshops also makes them useful in bridging the divide between policy and program expertise, helping build a confident, speculative conversation in organisations about “what’s needed” and “what works” and improving the way the purpose of policy and programs is communicated to government and to stakeholders. This can deepen the role of evaluation as integral to policy development and program management, rather than as a “bolt on” or an “afterthought” in the policy-implementation process. This article is based on a café-style interactive workshop at the 2017 Australasian Evaluation Society Conference in Canberra, Australia. The workshop was aimed at stimulating discussion and debate about how evaluation practice—assisted by the Policy Logic tool—can help bridge the policy-implementation divide.


10.33117/512 ◽  
2017 ◽  
Vol 13 (1) ◽  
pp. 47-69

Purpose: This paper presents aspects of a Corporate Social Responsibility (CSR) Implementation Success Model to guide CSR engagements. Design/methodology/approach: A qualitative case methodology is used to investigate two CSR companies in Uganda. Semi-structured interviews with managers and stakeholders are conducted. Data triangulation includes reviewing CSR reports and documents, and visiting communities and CSR activities/projects mentioned in the case companies’ reports. Grounded theory guides the data analysis and aggregation. Findings: The findings culminate into a “CSR Implementation Success Model. ” Key aspects of CSR implementation success are identified as: (i) involvement of stakeholders and management (i.e., co-production) at the start and during every stage of CSR implementation; (ii) management of challenges and conflicts arising within/outside of the company itself; and (iii) feedback management or performance assessment—i.e., accountability via CSR communications and reporting. Stakeholder involvement and feedback management (accountability) are pivotal, though all three must be considered equally. Research limitations: The studied companies were large and well-established mature companies, so it is unclear whether newer companies and small and medium-sized enterprises would produce similar findings. Practical implications: Successful CSR implementation starts with a common but strategic understanding of what CSR means to the company. However, CSR implementation should (i) yield benefits that are tangible, and (ii) have a sustainable development impact because these two aspects form implementation benchmarks. Additionally, top management should be involved in CSR implementation, but with clear reasons and means. Originality/value: This paper unearths a CSR Implementation Success Model that amplifies views of “creating shared value” for sustainable development. It guides organizations towards strategic CSR, as opposed to the responsive CSR (returning profits to society) that largely dominates in developing countries. Additionally, it explains how to add value to the resource envelope lubricating the entire CSR implementation process


2019 ◽  
Vol 37 (1) ◽  
pp. 83-111
Author(s):  
Ji Sun Kim ◽  
◽  
Do Ki Kim ◽  
Je Hyun Kim ◽  
Song Hwa Chai ◽  
...  

2021 ◽  
Vol 13 (14) ◽  
pp. 7621
Author(s):  
Daniella Troje

Procurement has long been used to fulfil policy goals, and social procurement policies can mitigate issues connected to social exclusion, unemployment and segregation. The target groups for such policies are disadvantaged people such as immigrants, young people and people with disabilities. Due to its close connection to exclusion and segregation issues, the construction and real estate sector has often been seen by policymakers as an appropriate sector for social procurement. However, practices to implement such policies are underdeveloped, which creates uncertainty and hinders the transition towards sustainability in the construction sector. This paper investigates how construction clients and contractors perceive the implementation of social procurement policies in practice. Drawing on policy-in-practice literature and interviewing 28 actors in the Swedish construction sector, the findings show a misalignment between: (1) social procurement policies, (2) the sector and its existing practices, and (3) the target group and their skills and needs. Although this misalignment adversely impacts policy implementation and practice formation, it can likely be mitigated if actors co-create policy goals and practices that mesh with existing practices, and provide more resources to enable policy implementation. This paper shows how procurement can help fulfil social policies and the difficulties of achieving that in practice.


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
H Vilaça

Abstract The Regulation responds to legislation failures in the European regulatory framework on medical devices (MD), which in turn led to public health issues. Two media scandals triggered the final actions on the elaboration of this EU Regulation, which was already being thought off in a context of fast MD development, and on the commitment of member-states to harmonize legislation in order to better manage resources. This Regulation is expected to address detected gaps, and contribute to the protection of European citizens' health by ensuring high quality and safety of MD, through advocating for more transparency, vigilance, and traceability. A technique to evaluate policies is the implementation analysis, as it links theory and practice. By understanding it, it is possible to ascertain if, in fact, the Regulation will contribute, as proposed, to improve public health. The implementation analysis framework I developed can be used in other countries affected by this Regulation, and may even be extrapolated to other scenarios. Entry into force 25/05/17.Full application 05/20. This qualitative study uses document analysis and semi-structured interviews to collect data, and literature review to frame the situation and to study implementation analysis. The questions are: identify the facilitators and resistance points of the implementation; explore perceptions of the Portuguese MD distributors; understand the policy implementation pathway; and have a picture of the implementation status in Portugal. The results can be summarized as: implementers are interested in complying with the Regulation; there is stakeholder involvement in policy making and throughout the implementation process; the main points of resistance, difficulties and the facilitators are identified; and the Regulation is being implemented according to the timelines. The public health action brought by the policy is that each economic operator is an active actor on vigilance and patient safety across MD lifecycle. Key messages If we are interested in the extent to which a particular polity is able to solve the problems with which it is confronted, we need to study the way in which the law is executed in practice. Focus on the effective implementation of the new regulatory framework on medical devices to protect patients and ensure it addresses new and emerging challenges.


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