ObjectivesTo evaluate the readiness to implement the Falsified Medicines Directive (FMD) by community pharmacies in England. Eight secondary objectives were assessed.SettingCommunity/retail pharmacies.ParticipantsWe invited pharmacists from 501 pharmacies to complete a survey. Non-contractors, non-pharmacists or pharmacists practising abroad were excluded. We randomly selected addresses, ensuring that they were nationally representative.InterventionsWe mailed the survey in October 2018 with a single follow-up in January 2019. Respondents were invited to provide self-reported answers. A prepaid self-addressed envelope was provided. We received favourable ethical approval.Results102 responses (20.44% response rate) were received. Readiness to implement was poor: 4 (3.9%) said very much, while 40 (39.2%) said not at all and 29 (28.4%) said not really. Increased workload and reduced profitability were anticipated, accompanied with improved patient safety. Prevalence of ‘substandard and falsified (SF) medical products’ was estimated at 1%–5%, with erectile dysfunction at greatest risk of falsification. Different packaging would raise suspicions. Five (4.9%) had identified SFs (p<0.001 one-sample binomial test). Of these, three (2.9%) informed the medicines agency. None had been involved in any public health campaigns. Confidence and self-efficacy was low. Strategies to reduce SFs reaching the public are described. Pharmacist’s role in combating SFs was elucidated. SFs were identified in deprived areas 4 (9%) more often than in affluent areas 1 (2%).ConclusionsMany pharmacies are not ready to implement FMD, potentially not capturing anticipated benefits of the directive, with greatest risk of harm in deprived area. We further validated a confidence scale. Limited public health campaigns may result in a lack of awareness among pharmacy professionals and patients. Limited awareness of technologies to identify falsified medicines exist, though further training is welcome. A worrying trend of under-reporting maybe prevalent. A larger sample study using this survey would be valuable.
Objective To examine the effect of the COVID‐19 pandemic on gonadorelin analogue prescription for community patients in England. Materials and methods We included data from all primary‐care patients who had relevant prescriptions dispensed in the community in England. Descriptive statistics and interrupted time series analysis over 22 months (15 months before and 7 months after lockdown) was evaluated. Results A total of 22 months’ worth of data were analyzed (or 1 041 638 total items, monthly average 47 347 items). Goserelin; leuprorelin, and triptorelin are the medicines most used by total quantity in the study period. Simple descriptive statistics show that mean values have declined during the pandemic. The Interrupted Time Series (ARIMA Modeling) shows declining trends. After the pandemic's onset, we observe a statistically significant downward trend for goserelin ( P = .017) and leuprorelin ( P = .014). As these are the major constituents of the model, we interpret this overall data as showing a significant downward category trend. Aside from linearity, a significant step change was noted for leuprorelin ( P = .029) showing an increase in prescription items with a similar effect that is close to being statistically significant for goserelin ( P = .051). The actual cost of medicines shows minimal variation suggesting that prices of individual medicines have remained stable. The regional data showed variation but this was not statistically significant. In all cases, the Oct‐20 figures are lower “year on year.” This novel work reports the impact of a global pandemic on prescription volumes of prostate cancer (PCa) medicines. Conclusions A worrying decrease in prescription medicines raises concerns for the care of PCa patients. We encourage diagnosed patients to discuss their planned care with their doctor.
Background: Disease-modifying anti-rheumatic drugs (DMARDs), including methotrexate and azathioprine, are commonly used for rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). Blood test safety monitoring is mainly undertaken in primary care. Normal blood results are common. Aim: To determine the frequency and associations of persistently normal blood tests in RA patients prescribed methotrexate and IBD patients prescribed azathioprine. Design and setting: Two-year retrospective cohort study using pseudonymised primary care/laboratory data in Hampshire. Method: RA and IBD patients were identified with associated methotrexate (RA) and azathioprine (IBD) prescriptions. NICE-recommended tests and thresholds were applied and persistent normality defined as a) no abnormalities of any tests, and b) individually for alanine aminotransferase (ALT), estimated glomerular filtration rate (eGFR), white blood count (WBC), and neutrophils. Logistic regression was used to identify associations with test normality. Results: Of 702,265 adults, 7102 had RA and 8597 had IBD. 3001 (42.2%) RA patients were prescribed methotrexate and 1162 (13.5%) IBD patients prescribed azathioprine. Persistently normal tests occurred in 1585 (52.8%) of the RA/methotrexate and 657 (56.5%) of the IBD/azathioprine populations. In RA/methotrexate patients 585 (19.5%) had eGFR, 219 (7.3%) ALT, 217 (7.2%) WBC, and 202 (6.7%) neutrophil abnormalities. In IBD/azathioprine patients 138 (4.6%) had WBC, 88 (2.9%) eGFR, 72 (2.4%) ALT and 65 (2.2%) neutrophil abnormalities. Those least likely to have persistent test normality were older and/or had comorbidities. Conclusions: Persistent test normality is common in monitoring these DMARDs in primary care, with few hepatic or haematological abnormalities. More stratified monitoring approaches should be explored.
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