International Journal of Clinical Pharmacy最新文献

Background: The process of identifying drug-related hospitalisations is subjective and time-consuming. Assessment tool for identifying hospital admissions related to medications (AT-HARM10) was developed to simplify and objectify this process. AT-HARM10 has not previously been externally validated, thus the predictive precision of the tool is uncertain.

Aim: To externally validate AT-HARM10 in adult patients admitted to the emergency department (ED).

Method: This retrospective cross-sectional study investigated 402 patients admitted to the ED, Diakonhjemmet Hospital, Oslo, Norway. A trained 5th-year pharmacy student used AT-HARM10 to assess all patients and to classify their ED visits as possibly or unlikely drug-related. Assessment of the same patients by an interdisciplinary expert panel acted as the gold standard. The external validation was conducted by comparing AT-HARM10 classifications with the gold standard.

Results: According to AT-HARM10 assessments, 169 (42%) patients had a possible drug-related ED visit. Calculated sensitivity and specificity values were 95% and 71%, respectively. Further, positive and negative predictive values were 46% and 98%, respectively. Adverse effects/over-treatment and suboptimal treatment were the issues most frequently overestimated by AT-HARM10 compared with the gold standard.

Conclusion: AT-HARM10 identifies drug-related ED visits with high sensitivity. However, the low positive predictive value indicates that further review of ED visits classified as possible drug-related by AT-HARM10 is necessary. AT-HARM10 can serve as a useful first-step screening that efficiently identifies unlikely drug-related ED visits, thus only a smaller proportion of the patients need to be reviewed by an interdisciplinary expert panel.

Background: Pharmacist prescribing legislation aims to enhance healthcare quality and accessibility. However, in many countries, like the Netherlands, it has not yet been legally established.

Aim: To investigate pharmacists' perspectives on potential pharmacist prescribing in the Netherlands.

Method: An online survey using a questionnaire that was distributed via e-mail and electronic newsletters to most practicing pharmacists in the Netherlands during October and November 2023. The questionnaire was based on previous literature, further developed during an international conference with pharmacists and piloted with Dutch pharmacists. Agreement with statements about potential prescribing models, settings, preconditions, and perceived benefits and risks was measured using a 4-point Likert scale. Data were analysed descriptively.

Results: In total, 625 participants from community pharmacy (n = 432; 69.1%), hospital pharmacy (n = 149; 23.8%), or other/combined settings (n = 44; 7.0%) completed the questionnaire. Most pharmacists (somewhat) agreed with the introduction of an independent prescribing model with limitations (n = 538; 86.1%) or a model dependent on collaborative agreements with physicians (n = 471; 75.4%). A minority (n = 245; 39.2%) supported independent prescribing with diagnostic authority. The precondition that participants most frequently (somewhat) agreed with was access to health records (n = 607; 97.1%). The most (somewhat) agreed-upon benefits were enhanced professional position of pharmacists (n = 574; 91.8%) and reduced workload for other prescribers (n = 573; 91.7%). Increased workload for pharmacists (n = 495; 79.2%) was the most (somewhat) agreed-upon identified risk.

Conclusion: Pharmacists in the Netherlands are generally supportive of an independent but limited or collaborative pharmacist prescribing model. These findings support further investigations into the potential introduction of pharmacist prescribing legislation.

Medicine shortages are an increasing issue, with broad public health implications for patients, health professionals and institutions. Despite national notification mechanisms involving sponsors and national regulators (e.g. Australian Therapeutic Goods Administration), shortages continue to be a significant workload in hospitals, particularly for pharmacy staff. In this article, we describe the implications of medicine shortages and a team approach to their management in an Australian public hospital. The medicine shortages team comprises senior pharmacists, a pharmacy technician, and a purchasing officer, in consultation with medical staff. A 10 week audit recorded 34 medicine shortages and/or discontinuations, comprising 49 usually stocked products. Shortages were more quickly identified by the purchasing officer using established relationships with suppliers, rather than relying on sponsor or government communication. Having a team systematically dealing with these shortages enables expertise in supply chains, finances, therapeutics, and medicine safety to be shared, to identify optimal interventions to mitigate patient risk.

Background: Provision of take-home naloxone (THN) and overdose education reduces opioid-related mortality. In Australia, from July 2022, all Australian community pharmacies were eligible to supply naloxone for free through the national THN Program.

Aim: This study aimed to identify naloxone stocking rates and correlates of stocking naloxone across Australian pharmacies.

Method: Data were collected from a representative sample of Australian pharmacists in Victoria, New South Wales, Queensland and Western Australia via an online survey. Data collected included pharmacy and pharmacist characteristics and services offered within the pharmacy, including needle and syringe programs, opioid agonist treatment (OAT) and stocking naloxone. Binary probit regression analysis was used to identify correlates of stocking naloxone after controlling for key covariates.

Results: Data from 530 pharmacists were analysed. In total, 321 pharmacies (60.6%) reported stocking naloxone. Chain pharmacies and pharmacies that provided OAT had a greater probability of stocking naloxone (B = 0.307, 95%CI: [0.057, 0.556], and B = 0.543, 95%CI: [0.308, 0.777] respectively). Most (61.7%) pharmacists felt comfortable discussing overdose prevention with patients who use prescription opioids, and this comfort was associated with a higher probability of stocking naloxone (B = 0.392, 95%CI: 0.128, 0.655). Comfort discussing overdose prevention with people who use illicit opioids was lower (49.4%) and was not associated with stocking naloxone.

Conclusion: There is scope to increase stocking of naloxone and comfort with overdose prevention, particularly through addressing comfort working with higher risk groups such as people who use illicit opioids.

Background: Remimazolam tosilate is a new type of benzodiazepine currently used for gastrointestinal endoscopy and can be combined with alfentanil.

Aim: This trial compared the effectiveness and safety of remimazolam with alfentanil to propofol with alfentanil in patients undergoing gastrointestinal endoscopy.

Method: One hundred and sixty-six patients were randomly divided into propofol-alfentanil anaesthesia (Group P) and remimazolam-alfentanil anaesthesia (Group R). The primary outcomes were perioperative haemodynamic variables, including systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR) and oxygen saturation (SpO₂) preoperatively (T0); after anaesthesia induction (T1); when the gastroscope passed through the oropharynx (T2); 3 min (T3), 5 min (T4) and 7 min (T5) after T2; at the end of surgery (T6); and when patients successfully awakened (T7). The secondary outcomes included induction and awakening time, patient satisfaction, operator satisfaction, and adverse event occurrences.

Results: Compared with those in Group P, the SBP in Group R was significantly higher at T1, T2, T3, and T6 (P < 0.05); the DBP and MAP were significantly higher at T1, T2, T3, T5, and T6 (P < 0.05); the HR was significantly faster at T1 to T6 (P < 0.05); the SpO₂ was significantly higher at T1 to T4 (P < 0.05); the incidences of hypoxemia, hypotension, and drug injection pain were significantly lower in Group R (P < 0.05); the incidence of hiccups was higher (P < 0.05); the awakening time was shorter in Group R (P < 0.05); and the operator satisfaction score was high (P < 0.05).

Conclusion: Compared to propofol with alfentanil, remimazolam with alfentanil can be used safely and effectively for sedation in patients undergoing gastrointestinal endoscopy, with less impact on the patient's circulatory and respiratory systems and a lower incidence of adverse events.

Trial registration: This trial protocol was registered in the Chinese Clinical Trial Registry (ChiCR2300077252, date: 2023-11-02).

Background: Community pharmacy practice is rarely considered in ethical research, although various ethical conflicts are known for this setting. Data on the actual frequency and perceived burden of ethical conflicts occurring in the community pharmacy setting are required.

Aim: The survey aimed at investigating the frequency and perceived burden of ethical conflicts, reasons for the perceived burden and influences on decision-making in ethical conflicts in German community pharmacists.

Method: An online survey was conducted among community pharmacists. It contained 15 ethical conflicts in which the ethically required action conflicts with another principle (e.g. law). Basing on these conflicting principles, 12 considerations relevant for decision-making were defined (e.g. solidarity principle). Participants were asked to rate the ethical conflicts in terms of frequency and perceived burden and to rate the influence on decision-making for the considerations. Results were analysed descriptively.

Results: Five hundred and thirty-five questionnaires were evaluated. The participant's median age was 39 (min-max: 20-78) years, 378 (71%) were female. Seven of the 15 predefined ethical conflicts were rated as occurring predominantly at least once a week. "Generic drug is not most suitable" was rated as the most frequent. Three ethical conflicts were rated mainly with a (very) strong burden. "Concerns for an unborn child" was rated as the most burdensome. Three of the 12 predefined decision-making considerations: pharmaceutical knowledge, legal requirements and personal values were rated primarily as having a very strong influence on decision-making.

Conclusion: Pharmacists in community pharmacies are frequently affected by burdensome ethical conflicts in patient care situations.

Background: Despite developing a polypharmacy core outcome set (COS) in primary care, it is not clear how these outcomes should be measured.

Aim: To select outcome measurement instruments (OMIs) for a COS targeting appropriate polypharmacy in older patients in primary care.

Method: Following the Consensus-based Standards for the selection of health Measurement Instruments (COSMIN) guideline, OMIs were identified from a Cochrane review focusing on appropriate polypharmacy. The quality of OMIs was assessed using a published checklist. Subsequently, two rounds of Delphi questionnaires were conducted via the SoGoSurvey^® platform, engaging stakeholders (researchers, clinicians and journal editors specialising in geriatric primary care) to achieve consensus on OMIs using a scale encompassing "agree", "disagree", or "unsure". Consensus was achieved if 70% or more participants chose "agree" and 15% or fewer chose "disagree."

Results: The quality of 20 OMIs identified from the Cochrane review was evaluated. Seven OMIs were selected based on meeting the COSMIN guideline's minimum requirements. Out of 188 potential participants, 57 (30.3%) consented to participate. Rounds 1 and 2 of Delphi exercises were completed by 50 respondents, achieving agreement on three OMIs: 'number of serious adverse drug reactions (ADRs)' (98%), 'number of deaths' (76%), and 'number of patients who fell' (70%) for measuring 'serious ADRs,' 'mortality,' and 'falls,' respectively. No agreement was reached for 'medication appropriateness,' 'medication side-effects,' 'quality of life,' and 'medication regimen complexity.'

Conclusion: OMIs were selected for a limited number of outcomes in the polypharmacy COS. Future research should identify suitable OMIs for the remaining four outcomes.

Background: Monoclonal antibodies targeting calcitonin gene-related peptide (anti-CGRP mAbs) have shown clinical effectiveness and safety in randomized clinical studies. However, long-term studies in clinical practice remain limited.

Aim: To assess the long-term effectiveness, clinical predictors and safety of three anti-CGRP mAbs (erenumab, galcanezumab, fremanezumab) in resistant migraine patients.

Method: A single-center retrospective study was conducted from December 2019 to June 2023 involving 120 resistant migraine patients who received at least a month of anti-CGRP mAbs treatment. Patients completed a headache diary that included monthly acute medication intake (MAM), monthly migraine days (MMD), adverse events as well as completed Patient-Reported Outcome questionnaires (MIDAS [Migraine Disability Assessment] and Headache Impact Test 6 [HIT-6]). The number of patients achieving a ≥ 50% reduction in monthly migraine days was determined and classified as ≥ 50% responders, and baseline parameters and logistic regression between responders and non-responders were analyzed to identify potential predictors of response. Adverse events were registered in every follow-up.

Results: Treatment with anti-CGRP mAbs led to reductions in MIDAS, HIT-6, MMD and MAM from baseline to 6-24 months. At 6-12 months, responders (61% and 57%, respectively) exhibited lower baseline MMD and MAM. Medication overuse  was associated with non-responders from 6 to 24 months and it was identified as a negative predictor of treatment effectiveness (OR 0.23, 95% CI 0.07-0.74; p = 0.014).

Conclusion: Anti-CGRP mAbs prove effectiveness and safety over a 24-month period in a RM population. Patients with no medication overuse and lower basal MMDs and MAM may respond better to anti-CGRP mAbs.

Background: Proton pump inhibitors (PPIs) are commonly prescribed for treating upper gastrointestinal hemorrhage, eradicating Helicobacter pylori, and stress ulcer prophylaxis, among other digestive system diseases. Recent case reports provided limited evidence of a correlation between PPIs and drug reactions with eosinophilia and systemic symptoms (DRESS). However, there is currently no established association between PPIs and DRESS.

Aim: This research aimed to identify the associations between PPIs and DRESS using the US Food and Drug Administration Adverse Events Reporting System (FAERS) database.

Method: A retrospective investigation of DRESS associated with six PPIs used FAERS data from Q1 2004 to Q3 2023. Data mining algorithms were used to identify adverse events in the FAERS database that met the following criteria: (1) proportional reporting ratio (PRR) ≥ 2; (2) reporting odds ratio (ROR) > 1; (3) 95% confidence interval (CI) of ROR > 1; (4) Chi-square (χ²) ≥ 4 and case count ≥ 3.

Results: There were 495 reports of PPI-related DRESS, including pantoprazole (174, 35.2%), omeprazole (103, 20.8%), lansoprazole (103, 20.8%), esomeprazole (101, 20.4%), rabeprazole (8, 1.6%), and dexlansoprazole (6, 1.2%). The results indicated a significant association of three PPIs (pantoprazole, omeprazole, and lansoprazole) with DRESS. The sensitivity analysis demonstrated that only pantoprazole remained significantly associated with DRESS after 10 concomitant drugs had been removed (ROR: 3.00, PRR: 2.99, and information component [IC]: 1.57).

Conclusion: This study identified the signals suggesting a potential association between DRESS and six PPIs. However, more investigation of epidemiological data is required to validate of these conclusions.

Background: Arylpropionic acid derivatives (APs) are the main triggers of nonsteroidal anti-inflammatory drug (NSAID) hypersensitivity. Data on clinical patterns and risk factors for AP hypersensitivity in children are quite limited.

Aim: To assess the clinical characteristics and potential risk factors for proven AP hypersensitivity in children.

Method: Patients with a history of AP hypersensitivity were retrospectively assessed using a standardized diagnostic algorithm. Children with confirmed hypersensitivity were defined as selective responders or cross-intolerants based on the result of drug provocation tests and further categorized according to the EAACI/ENDA classification. A multivariable logistic regression analysis was performed to analyze the potential risk factors for proven AP hypersensitivity.

Results: A total of 166 patients (51.2% male, median age of six years) with a history of AP hypersensitivity were included. Ibuprofen (89.2%) was the most frequently reported AP in the patients' histories. The reported hypersensitivity of 40 (22.4%) patients was confirmed by diagnostic testing: eight (13.6%) patients with a history of reaction only to APs and 32 (29.9%) patients with a history of reactions to multiple NSAIDs, including chemically unrelated NSAIDs in addition to APs. Five (12.5%) patients were classified as selective responders and 35 (87.5%) were cross-intolerants. Overall, five (12.5%) of the confirmed cases could not be categorized according to the EAACI/ENDA classification. Older age (aOR: 1.11, 95% CI 1.02-1.21, p = 0.015), chronic urticaria as an underlying disease (aOR: 2.87, 95% CI 1.09-7.54, p = 0.033) and a history of anaphylaxis (aOR: 7.84, 95% CI 1.86-33.04, p = 0.005) were related to confirmed AP hypersensitivity.

Conclusion: Almost a quarter of children and adolescents were confirmed to have AP hypersensitivity. Older age, the presence of chronic urticaria and a history of anaphylaxis were potential risk factors for proven AP hypersensitivity.