Identifying and managing adverse drug reactions: Qualitative analysis of patient reports to the UK yellow card scheme.

INTRODUCTION: Adverse drug reactions (ADRs) can have significant negative impact on peoples' daily lives, with physical, economic, social and/or psychological effects. Patient reporting of ADRs has been facilitated by pharmacovigilance systems across Europe. However, capturing data on patients' experiences of ADRs has proved challenging. Existing patient reports to the UK Yellow Card Scheme contain free-text comments which could be useful sources of information. OBJECTIVES: To investigate patients' experiences of ADRs and their impact on patients as described in free-text data within patient Yellow Card (YC) reports submitted to the Medicines and Healthcare products Regulatory Agency. METHODS: A qualitative review of narrative texts was conducted on free-text data from 2255 patient YC reports from July to December 2015. RESULTS: Three key narrative themes emerged from analysis of the free-text data in 2255 reports: (1) identification of ADRs, (2) severity and impact of ADRs, and (3) management of ADRs. Temporal associations were the most common method of identification followed by differential diagnoses and confirmation with information sources such as healthcare professionals (HCPs). A combination of explicit and implicit impacts were described: physical, psychological, economic and social effects often persisted and caused serious disruption to many patients' lives. A range of strategies were used to manage ADRs, including consultation with HCPs, stopping/reducing the medicine or taking medicines to alleviate symptoms. CONCLUSION: Free-text data from YC reports has been an underutilised resource to date, but this research has confirmed its potential value to pharmacovigilance and medication safety research.

Use of information sources regarding medicine side effects among the general population: a cross-sectional survey.

AIM: To determine the use and perceived value of different information sources that patients may use to support identification of medicine side effects; to explore associations between coping styles and use of information sources. BACKGROUND: Side effects from medicines can have considerable negative impact on peoples' daily lives. As a result of an ageing UK population and attendant multi-morbidity, an increasing number of medicines are being prescribed for patients, leading to increased risk of unintended side effects. METHODS: A cross-sectional survey of patients who use medicine, recruited from community pharmacies. The survey sought views on attributes of various information sources, their predicted and actual use, incorporating a shortened Side Effects Coping Questionnaire (SECope) scale and the abbreviated Miller Behavioural Style Scale (MBSS). FINDINGS: Of 935 questionnaires distributed, 230 (25.0%) were returned, 61.3% from females; 44.7% were retired and 84.6% used at least one medicine regularly. 69.6% had experienced a side effect, resulting in 57.5% of these stopping the medicine. Patient information leaflets (PILs) and GPs were both predicted and actually most widely used sources, despite GPs being judged as relatively less accessible and PILs less trustworthy, particularly by regular medicine users. Pharmacists, considered both easy to access and trustworthy, were used by few in practice, while the internet was considered easy to access, but less trustworthy and was also little used. SECope sub-scales for non-adherence and information seeking showed positive associations with stopping a medicine and seeking information from a health professional. More high monitors than low monitors stopped a medicine themselves, but there were no differences in use of information sources. Information seeking following a side effect is a common strategy, potentially predicted by the SECope, but not the MBSS. Limited GP accessibility could contribute to high internet use. Further research could determine how the trustworthiness of PILs can be improved.

Making medicines safer: analysis of patient reports to the UK's Yellow Card Scheme.

Objectives: No studies describing UK patient Yellow Card reports have been published since the evaluation of the first two years of direct patient reporting (2005-7), when 5,180 reports were analyzed.Methods: Patient Yellow Card reports submitted July-December 2015 for vaccines and other drugs were analyzed. Comparisons to the initial evaluation were made of: reporting method, number of suspect drugs, proportion classed as serious. Factors affecting seriousness of reports were examined.Results: There were 3,060 patient Yellow Card reports analyzed. Vaccine reports have increased from very few in 2005-7 to 25% of reports. The proportion of reports citing one drug (94.3%) and the proportion considered serious (70.3%) increased from the 84% and 58% respectively found in 2005-7. The main method of reporting had changed from paper (61%) to internet (88.5%). Serious reports were more common in females, for vaccines in young persons, but in adults for other drugs, and included more reaction terms than non-serious reports.Conclusion: Patient reporting, in particular to vaccines, has increased dramatically since 2005-7. Increases in the proportion of reports concerning one drug and the proportion considered serious could indicate that the usability of patient reports may have improved in comparison to early reporting.

Development and preliminary validation of an instrument to enable laypersons to assess suspected side effects from medicines.

PURPOSE: Research into causality assessment tools enabling patients to assess suspected adverse drug reactions (ADRs) is limited. Supporting patients with tools could improve their confidence in discussions with health professionals and encourage reporting of suspected ADRs to regulators. This study describes development and preliminary validation of an instrument: Side Effect Patient ASsessment Tool (SE-PAST). METHODS: SE-PAST was developed from survey and interview data involving patients experiencing suspected ADRs. It included 10 statements enabling causality assessment, covering timing, additional information sources, and experiences, with four options: yes/no/don't know/not applicable. Scoring and weighting resulted in four categories of causal association: highly probable, probable, possible, unlikely. Validation involved obtaining feedback from 31 individuals experiencing an ADR. Further validation involved online distribution through patient support groups and comparison of reported symptoms to known ADRs. RESULTS: Validators found SE-PAST easy to read (31), to understand (27), and to complete (29). A total of 294 respondents completed SE-PAST online, with 98% completing eight or more causality assessment statements. Symptoms were categorised as highly probable (46; 16%), probable (80; 62%), possible (44; 15%), and unlikely (21; 7%). A total of 221 respondents identified one suspected medicine, with 95% of these reporting at least one symptom known to be an ADR. Of 227 providing feedback, 139 (61%) found SE-PAST useful, 160 (71%) felt motivated to discuss their experience with a health professional, and 136 (60%) were encouraged to report to the regulator. CONCLUSION: SE-PAST was easily completed and understood by people experiencing suspected ADRs and could be useful in encouraging patient reporting to health professionals and agencies.

Cross-sectional survey of patients' need for information and support with medicines after discharge from hospital.

BACKGROUND: Most patients experience changes to prescribed medicines during a hospital stay. Ensuring they understand such changes is important for preventing adverse events post-discharge and optimising patient understanding. However, little work has explored the information that patients receive about medicines or their perceived needs for information and support after discharge. OBJECTIVES: To determine information that hospital inpatients who experience medicine changes receive about their medicines during admission and their needs and preferences for, and use of, post-discharge support. METHODS: Cross-sectional survey with adult medical inpatients experiencing medicine changes in six English hospitals, with telephone follow-up 2-3 weeks post-discharge. KEY FINDINGS: A total of 444 inpatients completed surveys, and 99 of these were followed up post-discharge. Of the 444, 44 (10%) were unaware of changes to medicines and 65 (16%) did not recall discussing them with a health professional, but 305 (77%) reported understanding the changes. Type of information provided and patients' perceived need for post-discharge support differed between hospitals. Information about changes was most frequently provided by consultant medical staff (157; 39%) with pharmacists providing information least often (71; 17%). One third of patients surveyed considered community pharmacists as potential sources of information about medicines and associated support post-discharge. Post-discharge, just 5% had spoken to a pharmacist, although 35% reported medicine-related problems. CONCLUSION: In north-west England, patient inclusion in treatment decisions could be improved, but provision of information prior to discharge is reasonable. There is scope to develop hospital and community pharmacists' role in medicine optimisation to maximise safety and effectiveness of care.

Medicine-related services in community pharmacy: public preferences for pharmacy attributes and promotional methods and comparison with pharmacists' perceptions.

BACKGROUND: Public awareness of pharmacy services designed to support the use of medicines is low, yet little is known about how the public view promotion of these services, or their preferences for the attributes of pharmacies from which they would like to receive them. OBJECTIVE: To compare the public's preferred attributes of pharmacies and methods for promoting medicine-related services with community pharmacists' perceptions of their customers' views. METHODS: Parallel surveys were conducted in South East England, using a street survey for the general public and a postal survey for community pharmacists. RESULTS: Response rates were as follows: public 47.2% (1,000/2,012) and pharmacists 40.8% (341/836). Pharmacists' perceptions of customer preferences for using the same pharmacy, independent ownership, and personal knowledge of the pharmacist were higher than actual public preferences. More pharmacists than public respondents also believed that approachability and previous good service would be important. The public's desires for long opening hours and for a pharmacy with a good relationship with their doctor's surgery were higher than pharmacists believed. The majority of the public prefer not to interrupt a pharmacist who is busy in the dispensary, which was not perceived by pharmacists as a factor. Pharmacists' perceptions aligned more with the preferences of regular medicine users and frequent pharmacy users. Both groups viewed direct recommendation as the most effective approach for promoting pharmacy services, particularly by doctors and pharmacy staff. Pharmacists' expectations of the effectiveness of posters and mass media methods were much higher than those of the public. CONCLUSION: Pharmacists and pharmacy owners must ensure good relationships with local medical practices to enable them to maximize opportunities for using the promotional methods judged most effective in encouraging the use of medicine-related services. Staff must be approachable and enable access to pharmacists, ensuring that perceptions of pharmacist busyness are not a deterrent.

Comparison of pharmacist and public views and experiences of community pharmacy medicines-related services in England.

BACKGROUND: Services provided by community pharmacists designed to support people using medicines are increasing. In England, two national services exist: Medicine Use Reviews (MUR) and New Medicines Service (NMS). Very few studies have been conducted seeking views of the public, rather than service users, on willingness to use these services or expectations of these services, or determined whether views align with pharmacist perceptions. OBJECTIVE: To compare the perceptions of pharmacists and the general public on medicines-related services, particularly MUR and NMS services. METHODS: Two parallel surveys were conducted in one area of England: one involved the general public and was administered using a street survey, and the other was a postal survey of community pharmacists. Similar questionnaires were used, seeking views of services, awareness, reasons for using services, and perceived benefits. RESULTS: Response rates were 47.2% (1,000/2,012 approached) for the public and 40.8% (341/836) for pharmacists. Few people had experienced a discussion in a private consultation room or were aware of the two formal services, although their willingness to use them was high. Pharmacists estimated time spent on service provision as 10 minutes for MUR and 12 minutes for NMS, which aligned with acceptability to both pharmacists and the public. Pharmacists underestimated the willingness of the public to wait for an informal discussion or to make appointments for formal services. Both pharmacists and the public had high expectations that services would be beneficial in terms of increasing knowledge and understanding, but public expectations and experiences of services helping to sort out problems fell well below pharmacists' perceptions. People who had experienced a pharmacy service had different perceptions of pharmacists. CONCLUSION: Views differed regarding why people use services and key aspects of service delivery. For services to improve, the pharmacy profession needs a better awareness of what the public, especially those with potential to benefit from services, view as acceptable and desirable.

Delegation: a solution to the workload problem? Observations and interviews with community pharmacists in England.

OBJECTIVE: This study aims to describe how pharmacists utilise and perceive delegation in the community setting. METHOD: Non-participant observations and semi-structured interviews with a convenience sample of community pharmacists working in Kent between July and October 2011. Content analysis was undertaken to determine key themes and the point of theme saturation informed sample size. Findings from observations were also compared against those from interviews. KEY FINDINGS: Observations and interviews were undertaken with 11 pharmacists. Observations showed that delegation occurred in four different forms: assumed, active, partial and reverse. It was also employed to varying extents within the different pharmacies. Interviews revealed mixed views on delegation. Some pharmacists presented positive attitudes towards delegation while others were concerned about maintaining accountability for delegated tasks, particularly in terms of accuracy checking of dispensed medication. Other pharmacists noted the ability to delegate was not a skill they found inherently easy. Comparison of observation and interview data highlighted discrepancies between tasks pharmacists perceived they delegated and what they actually delegated. CONCLUSIONS: Effective delegation can potentially promote better management of workload to provide pharmacists with additional time to spend on cognitive pharmaceutical services. To do this, pharmacists' reluctance to delegate must be addressed. Lack of insight into own practice might be helped by self-reflection and feedback from staff. Also, a greater understanding of legal accountability in the context of delegation needs to be achieved. Finally, delegation is not just dependent on pharmacists, but also on support staff; ensuring staff are empowered and equipped to take on delegated roles is essential.

Describing interruptions, multi-tasking and task-switching in community pharmacy: a qualitative study in England.

BACKGROUND: There is growing evidence around interruptions, multi-tasking and task-switching in the community pharmacy setting. There is also evidence to suggest some of these practices may be associated with dispensing errors. Up to date, qualitative research on this subject is limited. OBJECTIVE: To explore interruptions, multi-tasking and task-switching in the community setting; utilising an ethnographic approach to provide a detailed description of the circumstances surrounding such practices.Setting Community pharmacies in England, July-October 2011. METHOD: An ethnographic approach was taken. Non participant, unstructured observations were utilised to make records of pharmacists' every activity. Case studies were formed by combining field notes with detailed information on pharmacists and their respective pharmacy businesses. Content analysis was undertaken both manually and electronically, using NVivo 10. Main outcome measure To determine the factors influencing interruptions, multitasking and task-switching in the community pharmacy setting. RESULTS: Response rate was 12 % (n = 11). Over fifteen days, a total of 123 h and 58 min of observations were recorded in 11 separate pharmacies of 11 individual pharmacists. The sample was evenly split by gender (female n = 6; male n = 5) and pharmacy ownership (independent n = 5; multiple n = 6). Employment statuses included employee pharmacists (n = 6), owners (n = 4) and a locum (n = 1). Average period of registration as a pharmacist was 19 years (range 5-39 years). Average prescription busyness of pharmacies ranged from 2600 to 24,000 items dispensed per month. All observed pharmacists' work was dominated by interruptions, task-switches, distractions and multi-tasking, often to manage a barrage of conflicting demands. These practices were observed to be part of a deep-rooted culture in the community setting. In particular, support staff regularly contributed to interruptions and distractions for pharmacists; pharmacists in turn continued to permit these. Novel directional work maps illustrated the extent and direction of task-switching and multi-tasking employed by pharmacists. CONCLUSIONS: In this study pharmacists' working practices were permeated by interruptions, distractions and multi-tasking. Task-switching was also frequently employed by pharmacists. Changes to working practices by both pharmacists and support staff would help to minimise these which in turn has the potential to lead to safer and more efficient methods of working.

Views of English Pharmacists on Providing Public Health Services.

Locally-commissioned pharmacy public health services have developed in England over the last 20 years. Few studies have sought pharmacist views on commissioning and provision of public health services in general. This study sought views of community pharmacists (n = 778) in 16 areas of England on services provided, decisions about services, support, promotion and future developments, using a postal questionnaire with two reminders. Response rate was 26.5% (206). Funded public health services provided most frequently were: emergency contraception (71%), smoking cessation (62%), and supervised drug consumption (58%). Blood pressure monitoring was provided by 61% and was considered to be one of the services pharmacists perceived as being most valued by customers, but was not National Health Services (NHS)-funded. Motivation for providing public health services was professional not financial, particularly from those working in independent pharmacies. Only 35% were personally involved in deciding which services to deliver, and fewer than 20% based decisions on local public health reports. Pharmacists had positive attitudes towards providing public health services, but mixed views on support for services and their promotion. Most thought services would increase in future, but were concerned about commissioning. Both national and local support is needed to ensure future commissioning of pharmacy public health services.

Workload and its impact on community pharmacists' job satisfaction and stress: a review of the literature.

OBJECTIVE: The objective was to identify, review and evaluate published literature on workloads of pharmacists in community pharmacy. It included identification of research involving the measurement of pharmacist workload and its impact on stress levels and job satisfaction. The review focused on literature relating to practice in the UK. METHODS: Electronic databases were searched from 1995 to May 2011. In addition, manual searches were completed for documents not available electronically. The findings were analysed with specific focus on research methodology, workload and its impact on pharmacist job satisfaction and stress levels. KEY FINDINGS: Thirteen relevant studies relating to workload in community pharmacy alone or in conjunction with job satisfaction and stress were identified. One utilised both qualitative and quantitative methods to identify differences in pharmacist workload in retail pharmacy businesses before and after the implementation of the 2005 English and Welsh community pharmacy contractual framework. This indicated that pharmacists spend most of their working day dispensing. The majority of studies suggested community pharmacists generally perceived that workload levels were increasing. Several also stated that increased workload contributed to increasing job-related stress and decreasing job satisfaction. No studies reporting dispensing rates for community pharmacies in the UK were identified and there was limited evidence concerning time devoted to non-dispensing services. One study investigated the differences between self-estimated and actual workload. CONCLUSIONS: Whilst there is a clear perception that the type and amount of work output expected from individual community pharmacists has been changing and increasing over the last few decades, pharmacists are viewed as continuing to remain based in the dispensary. The impact of such changes to the practice of community pharmacy in the UK is poorly defined, although links have been made to increasing levels of pharmacist job dissatisfaction and stress.