Drug, Healthcare and Patient Safety最新文献

Background: Self-medication with antibiotics is being practiced worldwide with high prevalence, mostly in developing countries. Several factors induce the practice of self-medication, such as irrational and uncontrolled dispensing of medicinal substances, difficulty accessing health-care systems, and cost of diagnosis. Thus, this study assessed the prevalence of self-medication with antibiotics, and its associated factors among the community of Bule-Hora town, South West Ethiopia.

Methods: A community-based cross-sectional study design was used. All households residing in Bule Hora town were used as source population and households in the selected kebeles were included by using a systematic random sampling method. Eight hundred twenty-six study participants were selected for the study. Pre-tested structured questionnaires had been used to collect the required data. Then the collected data were checked for completeness and analyzed by using SPSS version 20. Odds ratios with 95% C.I. were used to measure the association between independent variables and outcome and variables with p-value <0.05 had been considered statistically significant.

Results: Prevalence of self-medication with antibiotics in the past 12 months prior to the data collection was found to be 38.9% [95% CI (1.56, 1.64)]. Being male (AOR = 1.53; 95% CI: 0.489, 0.869) with p value of 0.004, no health insurance scheme (AOR = 2.16; 95% CI: 0.274, 0.779) and availability of some drugs in shop (AOR = 12.98; 95% CI: 0.017, 0.353) with p value of 0.001 were found to be significantly associated with self-medication of antibiotics.

Conclusion: The study revealed that more than one-third of the respondents practiced self-medication. Availability and irrational dispensing of some drugs in the shops were significantly associated with self-medication practice. Therefore, it is important to educate society on the appropriate use of drugs and discourage the use of prescription drugs without medication order.

Purpose: Perioperative cardiac arrests (CAs) are a rare but catastrophic perioperative complication. Much about incidence, risk factors, and outcomes of such events are still unknown. This study investigated anesthesia-related CAs at a tertiary teaching hospital.

Methods: CA incidence within 24 hours of anesthesia administration was prospectively identified from May 1, 2016 to April 31, 2019. Each CA was matched by four other cases without CA receiving anesthesia on the same date and under similar operating conditions. The CA cases were reviewed and assigned to one of three groups: anesthesia-related, anesthesia-contributing, and anesthesia not related.

Results: A total of 58,303 patients underwent 73,557 procedures under anesthesia during the study period. In sum, 27 CAs were reported for incidence of 3.7 per 10,000 anesthesia administrations (95% CI 2.3-5.1). Eleven CA were anesthesia-related for incidence of 1.5 per 10,000 anesthesia administrations. Four CA cases were anesthesia-contributing for incidence of 0.5 per 10,000 anesthesia administrations, while 53% of the anesthesia-related and -contributing CAs were due to respiratory problems. American Society of Anesthesiologists (ASA) physical status score, cardiovascular surgery, emergency surgery, and increased duration of surgery were significantly correlated with CA incidents when compared to the control group. ASA physical status score is an independent risk factor of the occurrence of perioperative CA (OR 7.6, 95% CI 2.6-22.4; P<0.001).

Conclusion: Identifying factors associated with increased risk for anesthesia-related CA is of great importance in risk stratification for surgical patients. ASA physical status score was found to be a major factor in predicting perioperative CA, since patients with higher ASA scores had a statistically significant increased risk of CA. Therefore, extra precautions must be taken when dealing with unprepared patients who have uncontrolled medical illnesses, especially those who will be undergoing emergency surgery.

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.