Factors affecting the patient journey and patient care when receiving an unlicensed medicine: A systematic review.

BACKGROUND: Unlicensed medicines are used across the UK to treat an individual's clinical needs when there are no appropriate licensed alternatives. Patients, carers and parents have reported facing challenges with unlicensed medicines at the points of transfer of care between settings, a key time when medication errors may occur. There is little known about the patient journey as a whole, or the factors affecting patient care when receiving an unlicensed medicine. OBJECTIVE: A systematic review of UK literature to better understand factors that affect the entire patient journey from the decision to initiate treatment with an unlicensed medicine to the point at which treatment is supplied through a community pharmacy or ends. METHODS: Scopus, OVID EMCARE, EMBASE, OVID Medline ALL, CINAHL, Web of Science and Joanna Briggs Institute were searched from 1968 (introduction of the Medicines Act) until November 2020, using the PRISMA guidelines. Narrative synthesis of UK studies was employed to analyse descriptive and qualitative data on any reported findings that would impact the patient journey or care related to the use of unlicensed medicines, and any described barriers or enablers. RESULTS: Forty-five studies met criteria for final inclusion, with high levels of heterogeneity in terms of designs and methods. Specific challenges that were seen to impact the continuity of care across care settings, patient safety and provision of patient-centred care included diversity of clinical needs and impact of patient population age; healthcare professional awareness and acceptability of the use of unlicensed medicines; the hierarchical structure of the NHS; inconsistent doses and formulations with varying bioequivalence; patient/parent/carer/public awareness of unlicensed medicines use and perceived acceptability. CONCLUSIONS: This review identified a clear need for consistent information to be provided to healthcare professional and patients alike to support the safe and effective use of unlicensed medicines across care settings.

Unprevented or prevented dispensing incidents: which outcome to use in dispensing error research?

OBJECTIVES: To compare the rate, error type, causes and clinical significance of unprevented and prevented dispensing incidents reported by Welsh National Health Service (NHS) hospital pharmacies. METHODS: Details of all unprevented and prevented dispensing incidents occurring over 3 months (September-December 2005) at five district general hospitals across Wales were reported and analysed using a validated method. Rates of unprevented and prevented dispensing incidents were compared using Mann-Whitney U test. Reported error types, contributory factors and clinical significance of unprevented and prevented incidents were compared using Fisher's exact test. KEY FINDINGS: Thirty-five unprevented and 291 prevented dispensing incidents were reported amongst 221,670 items. The rate of unprevented (16/100,000 items) and prevented dispensing incidents (131/100,000 items; P = 0.04) was significantly different. There was a significant difference in the proportions of prevented and unprevented dispensing incidents involving the wrong directions/warnings on the label (prevented, n = 100, 29%; unprevented, n = 4, 10%; P = 0.02) and the wrong drug details on the label (prevented, n = 15, 4%; unprevented, n = 6, 14%; P = 0.01). There was a significant difference in the proportions of prevented and unprevented dispensing incidents involving supply of the wrong strength (prevented, n = 46, 14%; unprevented, n = 2, 5%; P = 0.02) and issue of expired medicines (prevented, n = 3, 1%; unprevented, n = 5, 12%; P = 0.002). CONCLUSION: The use of prevented dispensing incidents as a surrogate marker for unprevented incidents is questionable. There were significant differences between unprevented and prevented dispensing incidents in terms of rate and error types. This is consistent with the medication error iceberg. Care must be exercised when extrapolating prevented dispensing incident data on error types to unprevented dispensing incidents.

Unlicensed "Special" Medicines: Understanding the Community Pharmacist Perspective.

OBJECTIVE: Community pharmacy staff are responsible for obtaining and supplying unlicensed "special" medicines to patients in primary care. Less well-defined parameters for safe and effective use of unlicensed compared to licensed medicines, along with issues around maintaining consistency between care settings or among manufacturers, have been associated with increased risks. This study aimed to explore the views and experiences of community pharmacy staff on accessing and supplying unlicensed "special" medicines to patients in Wales and the perceived impact of challenges faced on patient care. METHODS: A qualitative, phenomenological approach was employed, involving semi-structured interviews with pharmacists and pharmacy technicians working at one small chain of community pharmacies in Wales. The interview schedule focused on the personal experiences and perceptions of the participants on the processes involved in accessing and supplying unlicensed "special" medicines from a community pharmacy. Interviews were audio-recorded and transcribed verbatim. RESULTS: A total of six participants completed the interview. Three main themes were constructed from inductive thematic analysis of the transcribed interviews: requirement for additional patient responsibilities; influences on the confidence felt by pharmacy staff when accessing and supplying unlicensed "special" medicines; and continuity of supply. CONCLUSION: This study gives a preliminary insight into the views and experiences of community pharmacy staff in Wales when accessing and supplying unlicensed "special" medicines. Further research is required to see if these views and experiences are representative of community pharmacy staff across the country.

Incidence, type and causes of dispensing errors: a review of the literature.

OBJECTIVES: To identify, review and evaluate the published literature on the incidence, type and causes of dispensing errors in community and hospital pharmacy. METHOD: Electronic databases were searched from 1966 to February 2008. This was supplemented by hand-searching the bibliographies of retrieved articles. Analysis of the findings explored the research methods, operational definitions, incidence, type and causes of dispensing errors. KEY FINDINGS: Sixty papers were identified investigating dispensing errors in the UK, US, Australia, Spain and Brazil. In general, the incidence of dispensing errors varied depending on the study setting, dispensing system, research method and operational definitions. The most common dispensing errors identified by community and hospital pharmacies were dispensing the wrong drug, strength, form or quantity, or labelling medication with the incorrect directions. Factors subjectively reported as contributing to dispensing errors were look-alike, sound-alike drugs, low staffing and computer software. High workload, interruptions, distractions and inadequate lighting were objectively shown to increase the occurrence of dispensing errors. CONCLUSIONS: Comparison of the reviewed studies was confounded by differences in study setting, research method and operational definitions for dispensing errors, error rate and classification of error types. The World Health Organization is currently developing global patient safety taxonomy. Such a standardized taxonomy for dispensing errors would facilitate consistent data collection and assist the development of error-reduction strategies.

Development and Evaluation of Topical Gabapentin Formulations.

Topical delivery of gabapentin is desirable to treat peripheral neuropathic pain conditions whilst avoiding systemic side effects. To date, reports of topical gabapentin delivery in vitro have been variable and dependent on the skin model employed, primarily involving rodent and porcine models. In this study a variety of topical gabapentin formulations were investigated, including Carbopol® hydrogels containing various permeation enhancers, and a range of proprietary bases including a compounded Lipoderm® formulation; furthermore microneedle facilitated delivery was used as a positive control. Critically, permeation of gabapentin across a human epidermal membrane in vitro was assessed using Franz-type diffusion cells. Subsequently this data was contextualised within the wider scope of the literature. Although reports of topical gabapentin delivery have been shown to vary, largely dependent upon the skin model used, this study demonstrated that 6% (w/w) gabapentin 0.75% (w/w) Carbopol® hydrogels containing 5% (w/w) DMSO or 70% (w/w) ethanol and a compounded 10% (w/w) gabapentin Lipoderm® formulation were able to facilitate permeation of the molecule across human skin. Further pre-clinical and clinical studies are required to investigate the topical delivery performance and pharmacodynamic actions of prospective formulations.

A preliminary investigation into the ability of three rapid microbiological methods to detect microorganisms in hospital intravenous pharmaceuticals.

This study investigated the capability of three rapid microbiological methods to detect microorganisms in aseptically prepared pharmacy preparations at National Health Service hospitals in the United Kingdom. BacT/ALERT 3D (bioMerieux), AKuScreen (Celsis), and BactiFlow ALS (AES Chemunex) technologies were used to detect levels of microorganisms in pharmaceutical products. Four products selected to represent the range of pharmaceuticals prepared in National Health Service hospital pharmacy departments were spiked with known levels of microorganisms. The presence of microorganisms in these products was then determined using each of the rapid microbiological methods and compared to the number determined by traditional total aerobic microbial count methodology. An evaluation of the performance parameters associated with each of the methods, including cost analysis, was also undertaken. There was good correlation between rapid microbiological methods and total aerobic microbial count for heparin and parenteral nutrition products. The rapid microbiological methods had difficulty recovering Gram-positive organisms from vancomycin and methotrexate products; however, protocol developments demonstrated that this was surmountable. The main differences between the rapid microbiological method systems were time-to-result, the initial equipment cost, and the skill required to operate the instruments. The main finding from this work is that rapid microbiological methods can detect microbial contamination of hospital pharmaceutical products in a reduced time when compared to traditional microbiological techniques. The instrument comparison showed that Celsis AKuScreen provided the most rapid result for detecting bacteria; BacT/ALERT was the least expensive instrument and the simplest system to use; and BactiFlow ALS was the most expensive and more complex to use and gave intermediate time to results. LAY ABSTRACT: Traditional methods to assure quality and detect any microbial contaminants in intravenous products takes at least 2 weeks to complete. Hospital-prepared intravenous products are often high risk and have short shelf lives. This sometimes means that the traditional quality microbiological results are only available after the product has been administered to the patient. There have been some fatal incidents in which contaminated intravenous products have been used. Rapid microbiological methods have been used in the food, cosmetic, and pharmaceutical industries; however, they have not as yet been used in United Kingdom National Health Service pharmacy manufacturing. Rapid microbiological methods are able to detect contaminants in shortened periods of time. This study investigates the ability of three rapid microbiological methods to detect artificially contaminated, National Health Service-prepared intravenous products and compares the results to those obtained from traditional total aerobic microbial count methodology. The results show that there are differences between the methods; however, generally rapid microbiological methods are able to detect contaminants from pharmacy-prepared intravenous products quicker than current traditional methods.

The impact of automation on pharmacy staff experience of workplace stressors.

OBJECTIVE: Determine the effect of installing an original pack automated dispensing system (ADS) on staff experience of occupational stressors. METHODS: Pharmacy staff in a National Health Service hospital in Wales, UK, were administered an anonymous occupational stressor questionnaire pre- (n = 45) and post-automation (n = 32). Survey responses pre- and post-automation were compared using Mann-Whitney U test. Statistical significance was P ≤ 0.05. Four focus groups were conducted (two groups of accredited checking technicians (ACTs) (group 1: n = 4; group 2: n = 6), one group of pharmacists (n = 17), and one group of technicians (n = 4) post-automation to explore staff experiences of occupational stressors. Focus group transcripts were analysed according to framework analysis. KEY FINDINGS: Survey response rate pre-automation was 78% (n = 35) and 49% (n = 16) post-automation. Automation had a positive impact on staff experience of stress (P = 0.023), illogical workload allocation (P = 0.004) and work-life balance (P = 0.05). All focus-group participants reported that automation had created a spacious working environment. Pharmacists and ACTs reported that automation had enabled the expansion of their roles. Technicians felt like 'production-line workers.' Robot malfunction was a source of stress. CONCLUSION: The findings suggest that automation had a positive impact on staff experience of stressors, improving working conditions and workload. Technicians reported that ADS devalued their skills. When installing ADS, pharmacy managers must consider the impact of automation on staff. Strategies to reduce stressors associated with automation include rotating staff activities and role expansions.

The impact of automation on workload and dispensing errors in a hospital pharmacy.

OBJECTIVES: To determine the effect of installing an original-pack automated dispensing system (ADS) on dispensary workload and prevented dispensing incidents in a hospital pharmacy. METHODS: Data on dispensary workload and prevented dispensing incidents, defined as dispensing errors detected and reported before medication had left the pharmacy, were collected over 6 weeks at a National Health Service hospital in Wales before and after the installation of an ADS. Workload was measured by non-participant observation using the event recording technique. Prevented dispensing incidents were self-reported by pharmacy staff on standardised forms. Median workloads (measured as items dispensed/person/hour) were compared using Mann-Whitney U tests and rate of prevented dispensing incidents were compared using Chi-square test. Spearman's rank correlation was used to examine the association between workload and prevented dispensing incidents. A P value of ≤0.05 was considered statistically significant. KEY FINDINGS: Median dispensary workload was significantly lower pre-automation (9.20 items/person/h) compared to post-automation (13.17 items/person/h, P < 0.001). Rate of prevented dispensing incidents was significantly lower post-automation (0.28%) than pre-automation (0.64%, P < 0.0001) but there was no difference (P = 0.277) between the types of dispensing incidents. A positive association existed between workload and prevented dispensing incidents both pre- (ρ = 0.13, P = 0.015) and post-automation (ρ = 0.23, P < 0.001). Dispensing incidents were found to occur during prolonged periods of moderate workload or after a busy period. CONCLUSION: Study findings suggest that automation improves dispensing efficiency and reduces the rate of prevented dispensing incidents. It is proposed that prevented dispensing incidents frequently occurred during periods of high workload due to involuntary automaticity. Prevented dispensing incidents occurring after a busy period were attributed to staff experiencing fatigue after-effects.

Measuring dispensary workload: a comparison of the event recording and direct time techniques.

OBJECTIVES: To compare dispensary workload, determined using the Welsh benchmarking event recording technique and the direct time technique, at two district general UK National Health Service hospitals within different university local health Boards (hospital A--manual dispensing system; hospital B--automated dispensing system). METHODS: Data on dispensary workload were collected, over a period of 6 weeks (hospital A: 8 May-18 June 2007; hospital B: 1 October-11 November 2007), by a non-participant observer using two simultaneous methods of workload measurement: direct time and event recording. Direct time technique involved timing each task involved in dispensing a sample of prescriptions from receipt to issue of dispensed medicines to patients. Welsh benchmarking event recording involved continuously logging staff activities that deviated from the dispensary rota on a data collection form to enable calculation of total staff time involved in dispensing activities. Data on number of items dispensed were obtained from the pharmacy computer system and also by manual counting of prescription items. The mean dispensary workloads were calculated as the number of items dispensed per person per hour. Two-sample t-tests were used to compare dispensary workload measurements determined using direct time and event recording technique reported by each individual hospital. Mean workloads for hospitals A and B were compared using a two-sample t-test. Statistical significance was taken as P≤0.05. KEY FINDINGS: Hospital A was associated with a lower workload (direct time: 7.27±7.16 items per person per hour; event recording: 9.57±10.6 items per person per hour). In contrast, hospital B gave a higher workload (direct time: 11.93±8.3 items per person per hour; event recording: 12.6±8.80 items per person per hour). There was a significant difference between workload (direct time: P<0.01; event recording: P<0.01) reported for both hospitals. The direct time and event recording techniques produced consistent results at each hospital (hospital A: t=0.02, P=0.99; hospital B: t=0.004, P=0.1). CONCLUSION: The direct time and Welsh benchmarking event recording techniques produced consistent results at both hospitals. Thus the Welsh benchmarking event recording technique is a valid and reproducible method of measuring dispensary workload. Hospital B (automated) had a higher workload than hospital A (manual). Further work is required to investigate the impact of automation on dispensary workload.