Drug, Healthcare and Patient Safety最新文献

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.

Purpose: The second-generation antipsychotic quetiapine has been associated with misuse and dependency. We aimed to review questions to the Norwegian network of drug information centers concerning this potential drug safety problem.

Methods: We conducted a Boolean search in the database of the Regional Medicines Information and Pharmacovigilance Centres in Norway (RELIS) combining the indexed categories "quetiapine" and "adverse drug reaction" with the text words "misuse" or "dependency". Question-answer pairs (Q/As) in the full-text, searchable RELIS database were defined as cases. Cases were analyzed for drug safety issues linked to use of quetiapine, including off-label use, polypharmacy and other patient risk factors.

Results: The search resulted in 54 cases. Forty-six cases (85%) were patient-related, and a majority came from physicians working in hospitals. Twenty-nine cases (54%) concerned patients with a history of addiction, 14 cases (26%) had polypharmacy, and off-label use of quetiapine for insomnia was identified in 14 of the cases (26%). Only three of the cases included a specific question about patient dependency of quetiapine, and these cases were all associated with insomnia.

Conclusion: We conclude that our case series from the Norwegian network of drug information centres reflects that quetiapine frequently involves clinical narratives of a history of addiction, polypharmacy or insomnia (off-label use). However, the case series did not reveal new information about the drug's addictive potential.

Introduction: Patient safety is an issue of global concern; however, health-care organizations have lately observed to pay more attention to the importance of establishing a culture of safety. The study aimed to assess the level of patient safety culture and associated factors among health-care providers at the University of Gondar comprehensive specialized hospital, Northwest Ethiopia, 2020.

Methods: A cross-sectional study design supported by the qualitative approach was conducted from March 15 to May 15/2020. A stratified simple sampling technique was used to select 575 study participants. The standardized tool, which measures 12 safety culture dimensions, was used for data collection. Bivariate and multivariable linear regression analyses performed using SPSS version 23. The significance level was obtained at 95% CI and p-value <0.05. For the qualitative part, a semi-structured interview guide with probing was used. Data were analyzed thematically using open code software version 4.02.

Results: The overall level of positive patient safety culture was 45.3% (95% CI: 44.7, 45.9) with a response rate of 92.2%. Factor analysis indicated that female, masters, participation in patient safety program, adverse event report, hospital management encourage reporting event and resource were positively associated with the patient safety culture. Whereas divorced/widowed, midwives, anesthetist, medicine, pediatrics, emergency, outpatient, pharmacy, direct contact with patients, and hospital management blame when medical errors happened were negatively associated. The in-depth interview revealed that teamwork, health-care professionals' attitude toward patient safety and patient involvement as important factors that influence patient safety culture.

Conclusions and recommendations: The overall level of positive patient safety culture was low. All variables except age, training, working hour, and working experience were factors significantly associated with the patient safety culture. Health-care policy-makers and managers should consider patient safety culture a top priority, and also create a blame-free environment that promotes event reporting.

Background: Usage of traditional-herbal medicines (THM) for various illnesses has been increased around the world, so does the adulteration of these products with hazardous compounds. There are limited Malaysian data that have been published on the characteristics trend and adverse events associated with adulterated THM products.

Aim: This study described characteristics of adulterated THM products in Malaysia and aimed to quantify THM products' safety signals of adverse reactions (ARs).

Methods: THM products that were seized by Pharmacy Enforcement Division between 2008 and 2014 were extracted and analysed for 59,440 THM products. Of these, only 6452 THM products with complete information were included in the final analyses. Safety signalling tools were used to measure AR signals from AR reports obtained from the National Pharmaceutical Regulatory Agency Adverse Drug Reaction Database.

Results: More than half of adulterated THM products originated from countries outside of Malaysia, with the majority were from Indonesia. The most common claimed indication of adulterated THM products was for pain and fever relief, while steroids were the most common adulterant. AR signals were generated for cough and cold products for respiratory and thoracic disorders, weight-loss products for cardiac disorders, and women's health products for reproductive and breast disorders.

Conclusion: Health authorities from various fields can work collaboratively by implementing strategic actions that include the use of safety signalling tools to curb the increasing number of adulterated THM products in the Malaysian market.

Background: Post-anesthesia recovery is a continuous process which is considered to be complete after the patient returns to their preoperative physiological state. Although all patients who have had an operation under anesthesia are in a potentially unstable physiological state, most patients recover safely without significant problems due to better and immediate post-anesthesia care. Therefore, this study aimed to assess the staffing and service provision in the post-anesthesia care unit.

Methods: A multicenter, institution-based cross-sectional study was conducted in post-anesthesia care units from November 28 to December 31, 2020. The data were collected using a questionnaire prepared from standards and guidelines of the American Society of Anesthesiologists, the American Association of Nurse Anesthetists, and the Royal College of Anesthetists by direct observation.

Results: Ten hospitals found in Amhara regional state were examined for their staffing of and service provision in their post-anesthesia care units. The total ratio of nurses assigned in post-anesthesia care units to post-anesthesia care unit beds was around 1:3, with a minimum and a maximum ratio of 1:8 and 1:2, respectively. The average number of patients admitted in post-anesthesia care units per week was 98. Eighty percent of the hospitals' post-anesthesia care units had no policy or caregivers for cardiac arrest management.

Conclusions and recommendations: Standards, policies, and guidelines are not well prepared and posted so as to be visible to every caregiver. The majority of the hospitals have staff without special training for the management of possible complications in the post-anesthesia care unit. Generally, hospitals need to ensure standardized patient care in the post-anesthesia care unit for better and safer patient outcomes.

Background: Sodium hyaluronate/chondroitin sulfate fixed combination plays an essential role in the treatment of keratoconjunctivitis sicca, a multifactorial disease accompanied by ocular symptoms like alteration of the tear film. Despite low or no absorption of such drugs, these can cause secondary effects. An essential tool in the study of medication behavior is active pharmacovigilance. Unlike spontaneous reporting pharmacovigilance, this tool allows an appraisal of adverse drug reactions (ADRs)' real incidence, a higher capacity to identify safety signals, the relationship with concomitant drugs and pathologies prevalent in the study population. This study aimed to evaluate the safety profile and identify and/or assess adverse reactions in an uncontrolled population.

Methods: Active pharmacovigilance by Drug Event Monitoring was performed. A total of 3 follow-up calls were made for 30 days for the identification of the ADRs, tolerability (ADR severity, seriousness, long term sequelae, and duration) and the possible risks (safety signals, medical interactions) of sodium hyaluronate and chondroitin sulfate (HUM).

Results: Thirty-five ADRs were identified in the 212 patients included in the study (0.17 ADR/patient). The 35 ADRs were classified into 3 System Organ Class (SOC) groups: general disorders and administration site conditions (74.2%), eye disorders (22.9%), and nervous system disorders (2.9%); and 4 Preferred Term (PT) groups: burning sensation (74.2%), followed by blurred vision (20%), ocular pain (2.9%) and headache (2.9%). All the ADRs were categorized as mild and not serious. No statistically significant differences were found in concomitantly medications, posology and age groups.

Conclusion: Good tolerability to the solution was identified, with a low incidence of ADRs. Just the same, all the associated ADRs were consistent with the information found in HUM's physicochemical profile and the physiopathology of DED. No unknown risks were identified, reinforcing HUM's safety profile.

The care of older patients with cancer is becoming increasingly complex. Common challenges for this population include management of comorbidities, safe transitions of care, and appropriate medication use. In particular, polypharmacy-generally defined as the regular use of five or more medications-and inappropriate medication use can lead to adverse effects and poor outcomes in older adults with cancer, including falls, hospital readmissions, cognitive impairment, poor adherence to essential medications, chemotherapy toxicity, and increased mortality. Managing polypharmacy across different cancer care settings is often challenging. Providers face barriers to safe and successful medication management that may include lack of time, absence of reimbursement, underappreciation of the scale of polypharmacy-related harm, lack of ownership of deprescribing efforts, and poor communication across care settings. Existing literature on managing inappropriate medication use and polypharmacy in older adults with cancer has often focused on ideal state settings in which resources are plentiful and time is purposefully allocated for medication interventions. This paper presents a narrative, rather than a systematic review, of studies published in the past decade that provided detailed information on medication management and polypharmacy across cancer care settings. This review aims to also summarize different healthcare provider roles in taking action against inappropriate medication use and polypharmacy in older adults with cancer.