A systematic review of pharmacovigilance systems in developing countries using the WHO pharmacovigilance indicators

BACKGROUND: In the context of the growth of pharmacovigilance (PV) among developing countries, this systematic review aims to synthesise current research evaluating developing countries’ PV systems’ performance. METHODS: EMBASE, MEDLINE, CINAHL Plus and Web of Science were searched for peer-reviewed studies published in English between 2012 and 2021. Reference lists of included studies were screened. Included studies were quality assessed using Hawker et al.'s nine-item checklist; data were extracted using the WHO PV indicators checklist. Scores were assigned to each group of indicators and used to compare countries’ PV performance. RESULTS: Twenty-one unique studies from 51 countries were included. Of a total possible quality score of 36, most studies were rated medium (n = 7 studies) or high (n = 14 studies). Studies obtained an average score of 17.2 out of a possible 63 of the WHO PV indicators. PV system performance in all 51 countries was low (14.86/63; range: 0–26). Higher average scores were obtained in the ‘Core’ (9.27/27) compared to ‘Complementary’ (5.59/36) indicators. Overall performance for ‘Process’ and ‘Outcome’ indicators was lower than that of ‘Structural’. CONCLUSION: This first systematic review of studies evaluating PV performance in developing countries provides an in-depth understanding of factors affecting PV system performance. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s43441-022-00415-y

Clinical Inertia in Type 2 Diabetes: A Retrospective Analysis of Pharmacist-Managed Diabetes Care vs. Usual Medical Care

Background: Evidence suggests that patients with type 2 diabetes (T2DM) suffer from a high rate of “clinical inertia” or “recognition of the problem but failure to act.” Objective: The aim of this study is to quantify the rate of clinical inertia between two models of care: Pharmacist-Managed Diabetes Clinic (PMDC) vs. Usual Medical Care (UMC). Methods: Patients in a university based medical clinic with type 2 diabetes (T2DM) were analyzed in this retrospective cohort study. Patients were exposed to either PMDC or UMC. The difference in days to intervention in response to suboptimal laboratory values and time to achieve goal hemoglobin A1c (A1c), systolic blood pressure (SBP) and low-density lipoprotein (LDL) was compared in the two models of care. Results: A total of 113 patients were included in the analysis of this study, 54 patients were in the PMDC and 59 patients were in the UMC group. Median time (days) to intervention for A1c values \u3e7% was 8 days and 9 days in the PMDC and UMC groups, respectively (p\u3e0.05). In patients with baseline A1c values \u3e8%, median time to achieving A1c Conclusions: Rates of clinical inertia, defined as time to intervention of suboptimal clinical values, did not differ significantly between patients enrolled in a PMDC compared to patients with UMC with respect to A1c, SBP and LDL. Participation in PMDC, however, was associated with achieving goal A1c, SBP, and LDL levels sooner compared to UMC

Patient prioritisation for hospital pharmacy services: current approaches in the UK

Objectives To survey and explore current approaches to deployment of pharmaceutical care prioritisation tools in acute hospitals in the UK.Methods A national online survey was circulated electronically to chief pharmacists of hospitals to determine if they use a prioritisation tool or process. Where such mechanisms exist, respondents were invited to participate in a semistructured telephone interview to explore the development, evaluation and application of their tool and share relevant documentation. Interviews were transcribed and thematically analysed.Results Seventy hospitals (70/130) used a tool or process to prioritise clinical pharmacy services. Thirty-six interviews were conducted, and two were excluded. The majority of tools had been developed in-house. Few hospitals had undertaken formal evaluations of their prioritisation tool. Pharmacy prioritisation tools ranged in complexity and often included a combination of pharmacy service prioritisation, such as medicines reconciliation, and a section to assign an individual patient prioritisation level. Determining the priority of a patient based on the identification of set indicators instilled confidence in pharmacists by ensuring they were not missing high-risk patients. Electronic prioritisation tools were especially useful at retrieving real-time data to prioritise workload, improving workflow and ensuring continuity in patient care. Drawbacks of using prioritisation tools included lack of tool sensitivity across certain specialties and time spent using the tool if not all information was accessible.Conclusions Prioritisation tools were seen to be useful for prioritising workload and ensuring the right patients are seen at the right time. As few hospitals had formally evaluated their tools, it is important to rigorously and systematically develop an evidence-based prioritisation tool that is both useable and acceptable. Further research to evaluate such tools would be needed to ensure it improves patient health outcomes and efficiency in pharmacy services

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

From Springer Nature via Jisc Publications RouterHistory: received 2021-04-06, accepted 2021-08-10, registration 2021-08-12, pub-electronic 2021-08-30, online 2021-08-30, collection 2021-12Publication status: PublishedFunder: Kuwait Ministry of Health; Grant(s): Kuwait Ministry of HealthAbstract: 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

Development of the manchester framework for the evaluation of emergency department pharmacy services

Background- Many countries, including the United Kingdom, have established Emergency Department (ED) pharmacy services where some ED pharmacists now work as practitioners. They provide both traditional pharmaceutical care and novel practitioner care i.e. clinical examination, yet their impact on quality of care is unknown. Aim- To develop a framework of structures, processes and potential outcome indicators to support evaluation of the quality of ED pharmacy services in future studies. Method- Framework components (structures, processes and potential outcome indicators) were identified in three ways: from a narrative review of relevant international literature, and separate panel meetings with ED pharmacists and then other ED healthcare professionals. Structures and processes were collated into categories developed iteratively throughout data collection, with outcome indicators collated into six domains of quality as proposed by the Institute of Medicine. These raw data were then processed e.g. outcome indicators screened for clarity i.e. those which explicitly stated what would be measured were included in the framework. Results- A total of 190 structures, 533 processes, and 503 outcome indicators were identified. Through data processing a total of 153 outcome indicators were included in the final framework divided into the domains safe (32), effective (50), patient centred (18), timely (24), efficient (20) and equitable (9). Conclusions- The first framework specific to the quality evaluation ED pharmacy services, service evaluators should validate potential outcome indicators prior to their use. The minimum expected of a high-quality service should also be defined to enable interpretation of relevant measurements

2008 FORUM Questions

What qualities of the helping person are needed for care in the context of fear?Are the strategies of care different when fear is all around us