Drug, Healthcare and Patient Safety最新文献

Hereditary angioedema (HAE) is a rare genetic disorder characterized by recurrent episodes of skin/mucosal swelling, and/or attacks of severe abdominal pain when it affects the gastrointestinal tract. The disease might be unexpectedly fatal when the upper airways are compromised. HAE clinical presentation, disease course and prognosis are associated with significant disease burden and severely impaired quality of life. Lanadelumab is a breakthrough therapy for the prevention of attacks in HAE type 1 and 2 patients. This revolutionary approach to administer a single subcutaneous injection (once every two to four weeks) and achieve complete disease control has dramatically improved patient care resulting in significant change in the life of affected families. Current data support the drug's tolerability in adult and adolescent patients without notable safety concerns in both clinical research and real-world settings. Rational use of prophylactic treatments of HAE searches for a socio-economic balance, taking into account the life-long course of the disease, the public health funds who pay the monetary price, and the patients who might need to receive the therapy for a period longer than investigated during the development program. In this review, we address the current evidence on lanadelumab's tolerability, highlighting aspects of the drug's rationale use in clinical practice. Further studies need to investigate whether this therapy might be appropriate in other forms of angioedema, such as idiopathic primary angioedema and HAE with normal C1 inhibitor. Future efforts must focus to improve modern drugs' accessibility in more countries. Although modern prophylactic options lessen the risk of fatal laryngeal attacks, patients must be equipped with reliable on-demand therapies and be trained how to use them as such a risk cannot be fully diminished with potentially life-threatening attacks occurring even in subjects with successful and stable long-term prophylaxis. Notwithstanding, further studies are needed to identify early responders from non-responders and develop therapies for the latter.

Purpose: The purpose of the study was to develop and implement an institution-specific trigger tool based on the Institute for Healthcare Improvement medication module trigger tool (IHI MMTT) in order to detect and monitor ADEs.

Methods: We performed an investigator-driven, single-center study using retrospective and prospective patient data to develop ("development phase") and implement ("implementation phase") an efficient, institution-specific trigger tool based on the IHI MMTT. Complete medical data from 1008 patients hospitalized in 2018 were used in the development phase. ADEs were identified by chart review. The performance of two versions of the tool was assessed by comparing their sensitivities and specificities. Tool A employed only digitally extracted triggers ("e-trigger-tool") while Tool B employed an additional manually extracted trigger. The superior tool - taking efficiency into account - was applied prospectively to 19-22 randomly chosen charts per month for 26 months during the implementation phase.

Results: In the development phase, 189 (19%) patients had ≥1 ADE (total 277 ADEs). The time needed to identify these ADEs was 15 minutes/chart. A total of 203 patients had ≥1 trigger (total 273 triggers - Tool B). The sensitivities and specificities of Tools A and B were 0.41 and 0.86, and 0.43 and 0.86, respectively. Tool A was more time-efficient than Tool B (4 vs 9 minutes/chart) and was therefore used in the implementation phase. During the 26-month implementation phase, 22 patients experienced trigger-identified ADEs and 529 did not. The median number of ADEs per 1000 patient days was 6 (range 0-13). Patients with at least one ADE had a mean hospital stay of 22.3 ± 19.7 days, compared to 8.0 ± 7.6 days for those without an ADE (p = 2.7×10^-14).

Conclusion: We developed and implemented an e-trigger tool that was specific and moderately sensitive, gave consistent results and required minimal resources.

Background: While the research findings confirm the existence of private drug retail outlets that do not comply with regulatory standards in many low-income countries, there are a lack of reports that evaluate the quality of medicines obtained from these firms. Therefore, the aim of this study was to evaluate the regulatory compliance of the retails and associated quality of amoxicillin in Southwestern Ethiopia.

Methodology: Forty-two drug retail outlets in Jimma town were evaluated using an inspection checklist developed by the Ethiopian regulatory authority, and dispensers from these retail outlets were interviewed using the pretested structured questionnaire. The drug outlets were coded and categorized into noncompliant and compliant drug retail outlets. The physicochemical quality of amoxicillin capsules obtained from these retail outlets were evaluated following methods described in the US Pharmacopoeia.

Results: The present study revealed that about 54.76% drug retail outlets were compliant with the regulatory standard. Factors like income of retail outlet, experience of dispenser, and training regarding good storage practice were associated with status of regulatory compliance (p-value <0.05). The identification, dissolution, and assay results indicated that all amoxicillin samples obtained from both noncompliant and compliant drug retail outlets complied with pharmacopoeial specification limit. Besides, the independent unequal variance t-test revealed that there is no significant difference between mean dissolution and assay of API of the amoxicillin samples obtained these drug retail outlets (p-value >0.05).

Conclusion: The regulatory compliance of private drug retail outlets in Jimma town is not satisfactory. Moreover, the laboratory findings revealed that all samples of amoxicillin capsules compiled with pharmacopoeial specifications acceptance for packaging and labeling information, identification, assay, and dissolution. However, despite the fact that assays of the amoxicillin from retail outlets are within the required specification, the assays of amoxicillin obtained from noncompliant retail outlets appears to be slightly degraded, which may potentially demonstrate the impact of noncompliance of the drug retail outlets on the quality of medicines.

The treatment of migraine is often complicated by insufficient headache relief, a miscellany of side effects and the risk of developing Medication Overuse Headache (MOH). Novel acute therapies have been recently developed and are now in the early post-marketing phase. Lasmiditan is a highly selective serotonin receptor agonist that binds to the 5-HT_1F receptor, while ubrogepant and rimegepant antagonize the calcitonin gene-related peptide receptor. All three medications are now prescribed in a real-world setting, and an adequate level of knowledge is the starting point for rational use. In this rapid systematic review, we have established what is known about lasmiditan, ubrogepant and rimegepant, highlighting the most relevant safety aspects available from published studies and speculating about their risk of MOH.

Prescribing patterns by primary care physicians concerning ophthalmic problems were studied using the iCAREdata, a database containing information from the out-of-hours care setting in the Flanders region of Belgium. A very high percentage of prescribed ophthalmic medication was topical antibiotics (89.4%) with tobramycin as the most prevalent substance and in clear conflict with the prevailing guidelines. In addition, a very substantial fraction of prescribed medication contained corticosteroids (30.4%). This is a potentially unsafe option within the technical infrastructure of this setting, which limits the diagnostic possibilities concerning viral infections or preexisting glaucoma risk. We conclude that more efforts are required to limit unnecessary and inappropriate prescribing behavior to further promote patient safety.

Purpose: A high prevalence of medication errors in older adults are due to a combination of different factors such as polypharmacy, polymorbidity, enrolment in several disease-management programs, and fragmentation of care that causes medication errors in all age groups. This study aims to assess the incidence and determinants of medication errors among hospitalized adults in medical wards of Nekemte Specialized Hospital (NSH), West Ethiopia.

Patients and methods: A prospective observational study design was conducted at Nekemte Specialized Hospital among hospitalized adults from October 30, 2018 to January 30, 2019. Data were collected by using checklist-guided observation and review of medication order sheets, medication administration records, and patient charts. To identify the independent predictors of medication errors, logistic regression analysis was used. Statistical significance was considered at a p-value <0.05.

Results: A total of 351 patients were included in the present study. The mean age of the patients was 40.67+15.78 years. A total of 813 medication errors were recorded. The most common stage for medication errors was physician ordering 263 (32.4%). In the multivariable analysis, age ≥65 years (AOR: 2.54, 95%CI: 1.12-5.75, p=0.025), hospital stay ≥7 days (AOR: 2.16, 95%CI: 1.17-3.98, p=0.014), number of medication taken (AOR: 1.75, 95%CI: 1.13-2.73, p=0.013) and presence of comorbidity (AOR: 1.57, 95%CI: 1.01-2.46, p=0.049) had shown statistical significance in predicting medication errors.

Conclusion: Medication errors are common at Nekemte Specialized Hospital with an incidence of 48.3 per 100 orders, 231.6 per 100 admissions, and 433.4 per 1000 patient days. In particular, adults with older age, increased hospital stay, a greater number of medications, and presence of comorbidities were at greater risk for medication errors.

Although statins are effective for treating hypercholesterolemia, they can have various side effects, including rhabdomyolysis, a potentially fatal condition. This review evaluated the incidence and underlying molecular mechanism of statin-induced rhabdomyolysis and analyzed its risk factors, prevention, and management. We focused on the clinical and randomized clinical trials of statin monotherapies and combinations with other drugs. The primary mechanism of statin therapy-induced rhabdomyolysis is believed to be a decrease in ubiquinone (coenzyme Q) produced by the HMG-CoA pathway. Additionally, different types of lipophilic and hydrophilic statins play a role in causing rhabdomyolysis. Although statin-induced rhabdomyolysis has a low incidence, there is no guarantee that patients will be free of this side effect. Rhabdomyolysis can be prevented by reducing the risk factors, such as using CYP3A4 inhibitors, using high-dose statins, and strenuous physical activities.

Potentially inappropriate medication (PIM) is a primary health concern affecting the quality of life of patients over 65. PIM is associated with adverse drug reactions including falls, increased healthcare costs, health services utilization and hospital admissions. Various strategies, clinical guidelines and tools (explicit and implicit) have been developed to tackle this health concern. Despite these efforts, evidence still indicates a high prevalence of PIM in the older adult population. This systematic review explored the practice of using explicit tools to review PIM in hospitalized patients and examined the outcomes of PIM reduction. A literature search was conducted in several databases from their inception to 2019. Original studies that had an interventional element using explicit criteria detecting PIM in hospitalized patients over 65 were included. Descriptive narrative synthesis was used to analyze the included studies. The literature search yielded 6116 articles; 25 quantitative studies were included in this systematic literature review. Twenty were prospective studies and five were retrospective. Approximately, 15,500 patients were included in the review. Various healthcare professionals were involved in reviewing PIM including physicians and hospital pharmacists. Several tools were used to review PIM for hospitalized patients over 65, most frequently Beer's criteria and the STOPP/START tool. The reduction of PIM ranged from 3.5% up to 87%. The most common PIM were benzodiazepines and antipsychotics. This systematic review showed promising outcomes in terms of improving patient outcomes. However, the reduction of PIM varied in the studies, raising the question of the variance between hospitals in the explicit tools used for review. Additional studies need to be conducted to further investigate the outcomes of reviewing PIM at different levels, as well as assessing the cost-effectiveness of using explicit tools in reducing PIM.

Background: Self-medication with antibiotics (SMA) is an important public health issue, which can result in the facilitated development of antibiotic resistance, and may increase the risk of inappropriate utilization of antibiotics. So, the objective of the present study was to estimate the prevalence rate of SMA and to also explore SMA practices among the lay population of Kuala Lumpur (Malaysia).

Methods: The current study was cross-sectional population-based and used a convenient sampling technique. Moreover, Lorenz's formula was used to calculate the sample size and the required sample size was 480. Data were collected through face-to-face interviews with a pre-validated questionnaire and the study was conducted in Kuala Lumpur (Malaysia). Descriptive statistics, cross-tabulation, and logistic regression were executed by using SPSS version 24.

Results: Out of 480 participants, 45.8% were polled male and the prevalence of SMA in this study was found to be 15.1%. The majority of participants 23.1% indicated that they practiced antibiotics at least once in the last six months. The commonly self-medicated antibiotics were amoxicillin-clavulanate 20.6%, ampicillin/cloxacillin 14.2%, and levofloxacin 8.3%. Moreover, 64.8% of participants indicated that they bought their antibiotics from pharmacies. Whereas, most of the participants practice antibiotics to save money 19.2% and time 23.1%. Findings from multivariate logistic regressions showed that predictors of SMA were male gender, (95% CI: 0.300-0.877) occupation (95% CI: 0.122-10.797), health insurance (95% CI: 0.025-0.472), and education (95% CI: 0.084-0.800).

Conclusion: The results of this study indicate that SMA persists among the community and education level has a significant impact on this behavior. Thus, concerning health management authorities should step in with developing legislation to stop this practice, and by implementing such interventions and policies to educate and to raise awareness about the risk of SMA for the future.

Background: Rational use of medicines plays a vital role in avoiding preventable adverse drug effects, maximizing therapeutic outcomes with promoting patient adherence, and minimizing the cost of drug therapy. Irrational use of drugs is often observed in countries with weak health care systems. No review has been done that systematically expresses rational drug use practice based on the three WHO core drug use indicators in Ethiopia. Thus, this study was aimed to review systematically the prescribing, health-facility, and patient-care indicators based on WHO core drug use indicators in Ethiopia.

Methods: A systematic article search was conducted in different electronic databases including PubMed/ MEDLINE, the Cochrane Library, EMBASE, Web of Science, POPLINE, the Global Health, and Google scholar. Quality assessment was conducted using Newcastle-Ottawa quality assessment scale. Studies were synthesized and grouped in to prescribing, patient care and health facility indicators.

Results: From a total of 6239 articles, 21 studies were found suitable for the review. The highest average number of drugs per encounter was 2.5 while the lowest was 0.98. The percentage of generic drug use was ranged from 70.5% to 100%. The highest percentage of encounters with an antibiotic was 85%. The lowest percentage of drugs prescribed from essential drugs list was 81.4%. The highest percentage of drugs actually dispensed and adequately labeled was 96.16% and 96.25%, respectively.

Conclusion: This study showed that the practice of rational drug use varied across region of the country. The average number of drugs per prescription, percentage of drugs encounter with antibiotics, drugs prescribed by their generic name, average consultation time, average dispensing time, percentage of drugs adequately labeled, and availability of essential drugs showed deviation from the standard recommended by WHO. Thus, provision of regular training for prescribers and pharmacists, and ensuring the availability of essential drugs should be encouraged.