International Journal of Clinical Pharmacy最新文献

Background: Although amivantamab has shown clinical benefits for non-small cell lung cancer (NSCLC) patients with epidermal growth factor receptor (EGFR) exon 20 insertions, its cost-effectiveness requires further investigation.

Aim: To evaluate the cost-effectiveness of amivantamab plus chemotherapy for the treatment of NSCLC patients with EGFR exon 20 insertions from the United States payer perspective.

Method: A partitioned survival model was developed based on the data from the PAPILLON trial. Costs were derived from the pricing files of Medicare and Medicaid Services and published literature, and utility values were derived from previous studies. A 3% annual discount rate was applied to both costs and outcomes. The primary outcome was the incremental cost-effectiveness ratio (ICER). One-way sensitivity analysis, probabilistic sensitivity analysis and scenario analysis, were conducted to test the model stability.

Results: Amivantamab plus chemotherapy yielded an additional 1.12 quality-adjusted life years (QALYs) while increasing costs by $483,769.50 relative to the chemotherapy regimen, leading to an ICER of $432,401.16/QALY. The combination of amivantamab with chemotherapy was not cost effective at a threshold of $150,000/QALY. In the scenario analysis, the results showed that the ICERs were $263,680.69/QALY and $418,416.35/QALY when different utility values and 10-year time horizons were adopted, respectively. For PSA, the probability that amivantamab plus chemotherapy would be cost-effective was 0% if the willingness-to-pay (WTP) threshold was $150,000/QALY.

Conclusion: Amivantamab plus chemotherapy is unlikely to be a cost-effective option for NSCLC patients with EGFR exon 20 insertions. Reducing the cost of amivantamab may produce favorable economic outcomes.

The national centralized drug procurement (NCDP) policy, known as the "4 + 7" policy in China, has transformed pharmaceutical procurement and access by leveraging healthcare institutions' collective buying power to reduce drug prices substantially. This policy has profoundly impacted drug pricing mechanisms, healthcare expenditures, market dynamics, and the quality of available drugs. This commentary evaluates the efficacy, challenges, and broader implications of the NCDP, summarizes the current state of post-marketing monitoring of selected generic drugs for centralized procurement, and presents relevant considerations.

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: Potentially inappropriate prescribing (PIP) is usually associated with a higher risk of adverse health outcomes. It is therefore important to identify PIP in older adults. However, there are no clear prioritisation strategies to select patients requiring prescription reviews.

Aim: The aim of this study was to assess the association between the identification of seniors at risk (ISAR) score and the number of PIPs.

Method: A 12-month retrospective hospital-based study was conducted. PIPs, including potentially inappropriate medications (PIMs) and potential prescribing omissions (PPOs), were detected using the STOPP/START tool. Multivariate linear regressions were conducted to identify factors associated with the number of PIPs. Sensitivity, specificity, Youden index, and ROC curve were calculated to determine the predictive power of ISAR score.

Results: This study included 266 records. The analysis led to the detection of 420 PIMs and 210 PPOs, with a prevalence of 80.1% and 54.9%, respectively. Multivariate linear regression revealed that the ISAR score (p = 0.041), and the number of medications (p < 0.001) were determinants of PIP. The number of medications remained the sole determinant of the number of PIMs (p < 0.001), while living in a nursing home was the only determinant of the number of PPOs (p = 0.036).

Conclusion: The study showed that the ISAR score and the number of medications were independently associated with the number of PIPs. Considering the use of the ISAR score and the number of medications may be useful strategies to prioritise patients for whom prescribing appropriateness should be assessed using explicit criteria.

Background: Endothelin receptor antagonists are commonly used in clinical practice, with concerns about their hepatotoxicity.

Aim: This study aimed to conduct a comprehensive pharmacovigilance study based on FDA adverse event reporting system data to evaluate the possible association between endothelin receptor antagonists and drug-induced liver injury.

Method: Adverse event reports from FDA adverse event reporting system between January 2004 and December 2022 were analyzed. Disproportionality algorithms, including reporting odds ratio and information component, were used to evaluate the association between endothelin receptor antagonists and liver injury. Sex- and age-stratified analyses of drug-induced liver injury events were also conducted in relation to endothelin receptor antagonists.

Results: Significant associations between bosentan, macitentan, and liver injury were identified. Bosentan showed a strong link with liver injury, with reporting odds ratios for cholestatic injury at 7.59 (95% confidence interval: 6.90-8.35), hepatocellular injury at 5.63 (5.29-6.00), and serious drug-related hepatic disorders events at 1.33 (1.24-1.43). Drug-induced liver injury signals associated with bosentan were detected in all age groups. Macitentan was associated with liver injury, with reporting odds ratios for hepatic failure at 1.64 (1.39-1.94), cholestatic injury at 1.62 (1.43-1.83), and serious drug-related hepatic disorders events at 1.40 (1.29-1.51). No drug-induced liver injury signal was detected for ambrisentan, and no significant sex differences were observed in drug-induced liver injury events.

Conclusion: Both bosentan and macitentan are associated with liver injury. Routine monitoring of serum aminotransferase levels is recommended, especially in patients at higher risk of liver injury. Further research into drug-drug interactions involving endothelin receptor antagonists is warranted.

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.

Background: Many countries are experiencing an increased demand for health care and a shortage of health professionals in rural areas, impacting an individual's ability to receive timely treatment. The management of uncomplicated urinary tract infections by community pharmacists is usual practice in some regions of the United Kingdom and Canada, and Queensland, Australia.

Aim: To systematically gather, assess, and synthesize the available peer-reviewed published literature on the management of uncomplicated UTIs by community pharmacists in women aged 16-65 years, provide an understanding of the clinical and economic evidence, while also identifying the essential components of interventions employed.

Method: A systematic review was conducted to identify primary studies detailing interventions for the management of uncomplicated UTIs by community pharmacists. PubMed, PsycINFO, Scopus, Cochrane, CINAHL, EMBASE, and Web of Science were searched to February 2023. Non-primary and qualitative studies were excluded. Study details were recorded in a tailored data extraction form. The quality of studies was assessed using the Joanna Briggs Institute tools.

Results: Ten publications were included following review of 2129 records. High self-reported cure rates between 84 and 89% and referral rates of about 7% were reported. A single study found pharmacist management was cost effective compared to general practitioner management. No randomized controlled trials were found and papers were of variable quality.

Conclusion: Preliminary evidence suggests pharmacist-led management of uncomplicated UTIs is safe and effective, however no firm conclusion can be provided since the methodologies reported in included studies have significant limitations.

Background: Pharmaceutical decision support systems (PDSSs) use reasoning software to match patient data to modelled situations likely to cause drug-related problems (DRPs) or adverse drug events. To aid decision-making, modelled situations must be linked to well-defined systemic clinical risks.

Aim: To obtain expert consensus on the level of clinical risk for patients associated with each modelled situation that could be addressed using a PDSS.

Method: A two-round e-Delphi survey was conducted from February to April 2022, involving 20 experts from four French-speaking countries. Participants had to rate modelled situations on two five-point Likert scales, assessing the likelihood of clinical consequences and their severity. The degree of consensus was determined as the proportion of participants providing risk scores in line with the median. The combined median scores for likelihood and severity provided the level of risk according to the Clinical Risk Situation for Patients (CRiSP) scale, formalized via validated tools.

Results: The expert panel achieved consensus (≥ 75% agreement) on 48 out of 52 modelled clinical situations. Among these, 45 were categorized as high or extreme risk. The most common DRP identified was overdosing, accounting for 22% of cases. Furthermore, DRPs involving cardiovascular, psychiatric, and endocrinological drug classes were prevalent, constituting 45, 13, and 9% of cases, respectively.

Conclusion: Through consensus, our study identified 45 modelled clinical situations associated with high or extreme risks. This study highlights the interest of using PDSSs to prevent harm in patients and, on a large scale, document the impact of the pharmacist in preventing, intercepting and managing iatrogenic drug risk.

The current academic debate on the use of artificial intelligence (AI) in research and teaching has been ongoing since the launch of ChatGPT in November 2022. It mainly focuses on ethical considerations, academic integrity, authorship and the need for new legal frameworks. Time efficiencies may allow for more critical thinking, while ease of pattern recognition across large amounts of data may promote drug discovery, better clinical decision making and guideline development with resultant consequences for patient safety. AI is also prompting a re-evaluation of the nature of learning and the purpose of education worldwide. It challenges traditional pedagogies, forcing a shift from rote learning to more critical, analytical, and creative thinking skills. Despite this opportunity to re-think education concepts for pharmacy curricula several universities around the world have banned its use. This commentary summarizes the existing debate and identifies the consequences and opportunities for clinical pharmacy research and education.

Background: The global prevalence of hepatitis B virus (HBV) has presented a persistent challenge for public health prevention and treatment. However, studies that assess the public's access to anti-HBV drugs are absent.

Aim: To examine the availability, pricing, and affordability of anti-HBV drugs in Jiangsu province, China and provide recommendations for improvement.

Method: An enhanced methodology developed by the World Health Organization (WHO) and Health Action International was applied in a cross-sectional study that included 1026 healthcare facilities distributed in 13 prefectural-level cities in Jiangsu province.

Results: Since almost all drugs had an availability of less than 30%, the accessibility of anti-HBV drugs was notably low. Primary healthcare facilities had the lowest availability, reporting 1.4% for Original Brands (OBs) and 1.7% for lowest-priced generics (LPGs). Furthermore, the northern Jiangsu region recorded the lowest availability at 0.7%. LPGs demonstrated higher availability than OBs, with median availability probabilities of 2.6% and 1.4%, respectively. The drugs listed on the WHO Essential Medicines List exhibited higher availability than those on other lists. The median price ratios for OBs, LPGs, and volume-based purchasing drugs were 0.83, 0.50, and 0.27, respectively, less than 1.5 times the international reference price. Despite favorable pricing, affordability rate was 23% for urban residents and 0% for rural residents, which was discouraging.

Conclusion: Low availability and affordability of anti-HBV drugs were observed. Policy recommendations should emphasize the improvement of LPG availability by incentivizing priority prescribing. Healthcare subsidies should be provided more effectively and equitably.