Vibhu Paudyal

Are pharmacy-based minor ailment schemes a substitute for other service providers?: A systematic review

BACKGROUND Pharmacy-based minor ailment schemes (PMASs) have been introduced throughout the UK to reduce the burden of minor ailments on high-cost settings, including general practice and emergency departments. AIM This study aimed to explore the effect of PMASs on patient health- and cost-related outcomes; and their impact on general practices. DESIGN AND SETTING Community pharmacy-based systematic review. METHOD Standard systematic review methods were used, including searches of electronic databases, and grey literature from 2001 to 2011, imposing no restrictions on language or study design. Reporting was conducted in the form recommended in the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement and checklist. RESULTS Thirty-one evaluations were included from 3308 titles identified. Reconsultation rates in general practice, following an index consultation with a PMAS, ranged from 2.4% to 23.4%. The proportion of patients reporting complete resolution of symptoms after an index PMAS consultation ranged from 68% to 94%. No study included a full economic evaluation. The mean cost per PMAS consultation ranged from £1.44 to £15.90. The total number of consultations and prescribing for minor ailments at general practices often declined following the introduction of PMAS. CONCLUSION Low reconsultation and high symptom-resolution rates suggest that minor ailments are being dealt with appropriately by PMASs. PMAS consultations are less expensive than consultations with GPs. The extent to which these schemes shift demand for management of minor ailments away from high-cost settings has not been fully determined. This evidence suggests that PMASs provide a suitable alternative to general practice consultations. Evidence from economic evaluations is needed to inform the future delivery of PMASs.

A cohort study of influences, health outcomes and costs of patients’ health-seeking behaviour for minor ailments from primary and emergency care settings

Objectives To compare health-related and cost-related outcomes of consultations for symptoms suggestive of minor ailments in emergency departments (EDs), general practices and community pharmacies. Design Observational study; prospective cohort design. Setting EDs (n=2), general practices (n=6) and community pharmacies (n=10) in a mix of rural/urban and deprived/affluent areas across North East Scotland and East Anglia. Participants Adults (≥18 years) presenting between 09:00 and 18:00 (Monday–Friday) in general practices and 09:00–18:00 (Monday–Saturday) in pharmacies and EDs with ≥1 of the following: musculoskeletal pain; eye discomfort; gastrointestinal disturbance; or upper respiratory tract-related symptoms. Interventions Participants completed three questionnaires: baseline (prior to index consultation); satisfaction with index consultation and follow-up (2 weeks after index consultation). Main outcome measures Symptom resolution, quality of life, costs, satisfaction and influences on care-seeking behaviour. Results 377 patients participated, recruited from EDs (81), general practices (162) and community pharmacies (134). The 2-week response rate was 70% (264/377). Symptom resolution was similar across all three settings: ED (37.3%), general practice (35.7%) and pharmacy (44.3%). Mean overall costs per consultation were significantly lower for pharmacy (£29.30 (95% CI £21.60 to £37.00)) compared with general practice (£82.34 (95% CI £63.10 to £101.58)) and ED (£147.09 (95% CI £125.32 to £168.85)). Satisfaction varied across settings and by measure used. Compared with pharmacy and general practice use, ED use was significantly (p<0.001) associated with first episode and short duration of symptom(s), as well as higher levels of perceived seriousness and urgency for seeking care. Convenience of location was the most common reason for choice of consultation setting. Conclusions These results suggest similar health-related outcomes and substantially lower costs with pharmacy consultations for minor ailments. Effective strategies are now needed to shift demand for minor ailment management away from EDs and general practices to the community pharmacy setting.

Estimating the burden of minor ailment consultations in general practices and emergency departments through retrospective review of routine data in North East Scotland

Background. Minor ailment attendances in general practices and emergency departments (EDs) place significant burden on health care resources. Objectives. To estimate the prevalence and type of minor ailment consultations for adults in general practice and ED that could be managed in a community pharmacy. Methods. Retrospective review of routine data from general practices (n = 2) and one ED in North East Scotland. Two independent consensus panels assessed each consultation summary to determine whether it represented a minor ailment. Outcomes included prevalence of consultations for minor ailments in general practice and ED and frequency of different minor ailment type that could be managed in community pharmacies. Results. In total, of the 494 general practice and 550 ED consultations assessed, 13.2% [95% confidence interval (CI): 18.6–25.9%] and 5.3% (95% CI: 4.0–8.0%), respectively, were categorized as minor ailments suitable for management in community pharmacies. Consensus among panel members was moderate for general practice consultations, but fair to poor for ED consultations. Agreement between uni- and multi-disciplinary panels was good. Applied to national data, these estimates would equate to ~18 million general practice and 6500000 ED consultations that could be redirected to community pharmacy, equating to ~£1.1 billion in resources. Conclusion. Minor ailment consultations still present a major burden on higher cost settings. Effective strategies are needed to raise awareness among patients and health professionals regarding conditions that can be managed effectively in pharmacies and to change patient health-seeking behaviour for such conditions.

A case study investigation into the use of multi-compartment compliance aids in older people resident in very sheltered housing.

BackgroundMulti-compartment compliance aids (MCAs) are repackaging systems for solid dosage form medicines, heralded by some as a solution to non-adherence but with little evidence of benefit.ObjectiveThe aim was to use a theoretical approach to describe the behavioural determinants impacting the use of MCAs in older people from the perspectives of the individual and health and social care providers.DesignA case study investigation was conducted.SettingThe study took place in three very sheltered housing sites in North East Scotland.SubjectsTwenty residents (≥65 years) using an MCA for at least 6 months and 34 members of their care team [17 formal carers, eight general practitioners (GPs), eight pharmacists, one family member].MethodsSemi-structured, face-to-face interviews with items based on the Theoretical Domains Framework were conducted. Interviews were audio-recorded, transcribed and analysed thematically.ResultsSeveral behavioural determinants impacted the use of MCAs from the perspectives of the stakeholders involved. Goals of use related to promoting adherence and safety, with less emphasis on independence. Beliefs of consequences related to these goals and were considered of value, with additional consequences of concern around reduced awareness of medicines and complexities of changing medicines. There was a lack of clearly defined roles of professionals for all processes of MCA use, with evidence of blurring and gaps in roles. There were additional issues relating to capabilities of older people in using MCAs and capacity issues for pharmacy-supplied MCAs.ConclusionsSeveral behavioural determinants impacted the use of MCAs, and while MCAs were valued, there is a need to more clearly define, develop, implement and evaluate a model of care encompassing resident and medicines assessment, supply and ongoing review of MCAs.

Relocating patients from a specialist homeless healthcare centre to general practices: a multi-perspective study

BACKGROUND The relocation of formerly homeless patients eligible to transfer from a specialist homeless healthcare centre (SHHC) to mainstream general practices is key to patient integration in the local community. Failure to transition patients conferring eligibility for relocation may also negatively impact on SHHC service delivery. AIM To explore barriers and facilitators of relocation from the perspectives of formerly homeless patients and healthcare staff involved in their care. DESIGN AND SETTING Qualitative semi-structured face-to-face and telephone interviews conducted in the north east of Scotland. METHOD Participants were patients and healthcare staff including GPs, nurses, substance misuse workers, administrative, and local community pharmacy staff recruited from one SHHC, two mainstream general practices, and four community pharmacies. Interview schedules based on the 14 domains of the Theoretical Domains Framework (TDF) were drafted. Transcripts of the interviews were analysed by two independent researchers using a framework approach. RESULTS Seventeen patients and 19 staff participated. Key barriers and facilitators aligned to TDF domains included: beliefs about consequences regarding relocation; patient intention to relocate; environmental context and resources in relation to the care of the patients and assessing patient eligibility; patient skills in relation to integration; social and professional role and identity of staff and patients; and emotional attachment to the SHHC. CONCLUSION Implementation of services, which promote relocation and integration, may optimise patient relocation from SHHCs to mainstream general practices. These include peer support networks for patients, better information provision on the relocation process, and supporting patients in the journey of identifying and adjusting to mainstream practices.

Methodological considerations in clinical outcomes assessment of pharmacy-based minor ailments management: A systematic review

Background The accessibility of services within community pharmacies provides an ideal opportunity to manage minor ailments, yet over £1.1 billion is spent by the National Health Service (NHS) in the United Kingdom (UK) in managing minor ailments in high cost settings. There is a need to review the evidence base around clinical effectiveness of pharmacy-based management of minor ailments since the absence of such may lead to under-utilisation of pharmacy services and non-implementation of available pharmacy service models. This study aimed to systematically review the methodological approaches used to assess clinical outcomes of pharmacy-based management of minor ailments in the research literature. Methods A systematic review was conducted to identify relevant literature using the following databases: Medline, EMBASE, CINAHL, IPA, CRD, CDSR, and Google Scholar from publication year 2000 onwards. Studies were included if they evaluated clinical outcomes of pharmacy-based management of any minor ailments, with or without a comparator setting such as Emergency Departments (EDs) or general practices. Screening and selection of titles, abstracts and full texts followed by data extraction and quality assessment (QA) was conducted. Paired researchers, from the team, reviewed papers using a protocol based on the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). QA was undertaken using the Critical Appraisal Skills Programme (CASP). Reporting was conducted in accordance with PRISMA checklist and statements. Results A total of 19 studies were included. The majority of studies were observational, conducted in community pharmacies, and did not use a comparator participant group nor a comparator setting. Interventions included counselling, medicines supply and provision of advice on the management of minor ailments. One study used the randomised controlled trial (RCT) design with majority of the study utilising observational design. A range of clinical outcomes including symptom severity, pattern, resolution, and quality of life were reported. Methods used for the assessment of clinical outcomes were, overall, poorly reported. This included a lack of information on the development and validation of the data collection tools and the timing of baseline and follow-up data collection. Adverse clinical outcomes data were collected by only seven studies. Conclusions Currently, there are methodological limitations in the studies that have sought to assess clinical outcomes of pharmacy-based management of minor ailments. Such lack of high quality evidence may contribute to failings to shift care from high cost settings, such as EDs and general practices. Generation of high quality evidence is likely to influence public choices when seeking care for minor ailments. There is scope for development of a core outcomes set specific to minor ailments management and development of a validated methodology for measuring such outcomes in a research study.

Behavioral Aspects of Pharmacovigilance: Research Methods Considerations

Abstract Low-income countries share 90% of the global disease burden and are major consumers of prescription medicines. Establishing safety profiles of medicines in the developing world has been challenging historically due to lack of effective and efficient pharmacovigilance systems or due to nonuse of currently available systems. This is particularly challenging in the context of disease areas endemic to the developing world. Influencing behaviors of patients, healthcare professionals, policy makers, and wider stakeholders is key to establishing and promoting effective and efficient pharmacovigilance. Exploratory and evaluative research requires health services research grounding with consideration of rigor at every phase of the research. Behavioral pharmacovigilance research can inform the development, implementation, and evaluation of successful interventions to positively impact on pharmacovigilance practices in developing countries. This chapter will outline key research methods that are relevant to exploring behavioral aspects of pharmacovigilance. Issues, challenges, and opportunities for undertaking research in developing countries are discussed.

F. ALves da Costa, J. W. F. van Mil and A. Alvarez-Risco (eds): The pharmacist guide to implementing pharmaceutical care: Springer International Publishing, 2019. ISBN 978-3-319-92575-2 and ISBN 978-3-319-92576-9 [eBook]

The book ‘Pharmacists’ guide to implementing pharmaceutical care’ seeks to provide answers to ‘what’, ‘why’ and ‘how’ questions in relation to pharmaceutical care services provision. There are six sections comprising a total of forty chapters. The book commences with the basics of pharmaceutical care leading to critical reflection of—current and future service models, evidence based implementation strategies, theoretical frameworks and implementation outcomes. The chapters have been authored by many leading international experts from diverse geographical, clinical and research expertise lending the text both rigour and wide scope. The book is able to communicate the need to adapt the conventional definition of pharmaceutical care in light of how the pharmacy profession has been evolving recently in provision of novel services. Services described in depth include medication review and reconciliation services, general practice and care home based pharmacy service and pharmacist independent prescribing models. In addition, there is also a focus on provision of prevention and anticipatory care. The book includes specific chapters on pharmaceutical care services provision for special patient population such as the elderly, children; and clinical areas including diabetes, cardiovascular health and infectious diseases. As people are living longer, pharmacists are also increasingly managing co-morbidities. Co-morbid patients are likely to experience fragmentation of care when using health services. The book provides a guide for delivering advanced services and thereby reducing such barriers and promoting collaborative working across healthcare professionals. A common theme across chapters is the emphasis on pharmacists’ patient counselling and communications skills. By considering patients’ cultural, emotional and societal beliefs and perspectives, pharmacists can provide person centred care when delivering services. A key aspect we have often seen being missed in implementation textbooks is the discussion about sustainability. Transient impact is often easy to achieve, however sustainability requires multi-factorial considerations. A key factor in ensuring sustainability of services offered is the need for appropriate remuneration for services provided. If pharmacists are to be relieved of traditional activities in substitution of novel pharmaceutical care programmes, finding appropriate remuneration models are imperative. The book provides a dedicated section, comparing and contrasting various remuneration models that can be adapted to suit local and political contexts in order to ensure sustainability. Sustainability has also been discussed in the context of sustaining quality and clinical outcomes of the service, patient and multiple stakeholder engagement, and sustaining behaviour changes. The book is successful in linking successful implementation and sustainability to strong evidence base on which to develop services, including pilot and feasibility studies, definitive randomised controlled trials and service improvement methodology. Evaluation should be an integral part of an implementation strategy. The book provides a framework and importance of identifying the right sets of core outcomes relevant to a particular service evaluation. The importance of considering adverse clinical outcomes when designing implementation strategies has been considered in depth. Drug related problems (DRPs) and medication errors contribute * Vibhu Paudyal v.paudyal@bham.ac.uk

Overview of this issue: pharmacovigilance, what is new?

Pharmacovigilance, usually defined with the World Health Organization (WHO) definition of “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problems,” [1] is a mandate for the pharmaceutical industry, including Medication Authorisation Holders (MAHs), in most developed countries, but this is not the case for all countries. The International Federation Pharmaceutical Manufacturers & Associations (IFPMA) has a statement on their website regarding the importance of pharmacovigilance [2]. It should also be considered the responsibility of all governments and health care providers (HCPs) in the interest of the public’s health; a clearer role for the public is being established. This special issue of the International Journal of Clinical Pharmacy looks at the current state of pharmacovigilance from different countries and provides some insight into the future. It also explores some special patient populations. Fornasier et al. [3] presents an overview of the history of pharmacovigilance, while Baldo et al. [4] offers a guide to the terminology. The definitions of pharmacovigilance used by the authors are broad or narrow interpretations of the WHO definitions for adverse drug reactions (ADRs) and adverse drug events (ADEs). These definitions can limit pharmacovigilance programs to ADRs or broaden them to include medication errors, inappropriate use, counterfeiting, quality issues and lack of effectiveness. Causality is always an issue; Behera et al. [5] compare different methods of assessment. The European Medicines Agency (EMA) [6], working closely with WHO and the United States’ Food and Drug Administration (FDA), has established good pharmacovigilance practices.1 The range of compliance with these guidelines is very good in many developed countries but may be non-existent in the developing nations, representing a large percentage of the world’s population. Eight working groups identified and discussed this and numerous other issues at a 2016 Oman meeting of the WHO Programme for International Drug Monitoring [7]. Olsson comments on the role of the International Society of Pharmacovigilance [8]. Francescon et al. and Baldo et al. [9, 10] comment on pharmacovigilance in oncology and regulations relative to oncology drugs. Al Hail et al. [11] present the progress of a pharmacovigilance system in Qatar while Zhao et al. [12] present on the status in China. No country has a perfect pharmacovigilance system. This is even more true as the system applies to over-the-counter and veterinary drugs as well as the aspects included in the broader interpretation. Elshafie et al. [13] presents the concern related to the common practice of self-medication in developing nations. This phenomenon is not restricted to low income population, with the Internet and medical tourism/ travel being used extensively [14]. Li et al. [15] investigated anaphylaxis related to traditional Chinese medicine, compounds usually not included in most databases. The pharmacovigilance of rare diseases is even more complicated, since the number of reports will be extremely low. Chaumais et al. [16] describe a solution for this challenge. Clinical preand post-authorization studies are the primary source of ADRs reports early in the product life cycle. Spontaneous reports become more important in the later stages of the cycle. Concerns about the ability and responsibility to collect data on generic versions have been raised [17]. Historically, most information outside of studies has come from spontaneous reports from HCPs; although pharmacists have been reporting for years, expanding this role in many countries is critical. Coulter [18] reports on the role * Linda Gore Martin linda.martin@uwyo.edu

Incidence, nature and causes of medication errors in hospitalised patients in Middle Eastern countries: A systematic review

Background and aim: Medication errors (MEs) are a major global issue, adversely impacting patient safety and health outcomes. Promoting patient safety through minimising MEs is therefore a key global healthcare objective. This study aims to systematically review the incidence, nature and causes of MEs in hospitalised patients in Middle Eastern countries. Method: A systematic search of studies related to MEs originated from Middle Eastern countries was performed using the following databases: MEDLINE, EMBASE, International Pharmaceutical Abstracts, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Cochrane Database of Systematic Reviews (CDSR), Centre for Review and Dissemination (CRD) database, Joanna Briggs Institute Library. A systematic review protocol was developed and registered with the Centre for Reviews and Dissemination (CRD). The title, abstract and full article were screened for inclusion. Each paper was assessed by two reviewers for methodological quality prior to inclusion in the review. Studies were critically appraised prior to data extraction and findings synthesised using a narrative approach. Results: Database searching identified 2611 studies; 51 met the inclusion criteria and originated from nine of fifteen Middle Eastern countries, largely Iran, Saudi Arabia and Israel. Preliminary review results indicate error incidence rates of between 11 and 90% of patients (depending on the method of data collection), with the categories of errors reported being mostly prescribing errors followed by administration, dispensing and transcribing. Deficiencies in staff knowledge, lack of experience, insufficient training, poor adherence with protocols and policies, miscommunication and excessive workload were identified as major causative factors. Conclusion: MEs occur at high rates of incidence in the Middle East. Causes of errors are multifactorial and should be targeted in future interventions, which are likely to be complex interventions at varying levels within the healthcare systems. This project is funded by QNRF (NPRP project NPRP–388-3-095).