Drug, Healthcare and Patient Safety最新文献

Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone of lifelong treatment for patients who have undergone a solid organ transplant. Tacrolimus has a narrow therapeutic index (NTI), giving rise to questions about the potential for clinically relevant altered drug exposure. Its use in transplant patients also gives rise to questions about the most discriminative subject population for bioequivalence studies. The recognised need for stringent criteria to support approval of generic drugs with an NTI led the European Medicines Association and Health Canada to provide detailed information on requirements for bioequivalence studies and introduce tighter bioequivalence limits for these drugs, including tacrolimus. The aim of this article is to illustrate how regulatory guidance is implemented during the clinical development of generic immunosuppressants, using a generic, once-daily prolonged-release formulation of tacrolimus as an example.

Background: Penicillins have never been associated with any form of hearing disorders. The Eritrean Pharmacovigilance Centre recently received two cases of hearing disorder (including one case of deafness) following the intake of amoxicillin capsules. This study was conducted to assess the causal link between amoxicillin and deafness.

Methods: Data mining was carried out in the WHO global database of individual case safety reports, VigiBase, and the Austin Bradford-Hill criteria were used to assess causality.

Results: A total of 94 cases of 'hearing disorders' related to amoxicillin were retrieved from VigiBase. Of these, 49 (52.1%) were reported as "deafness," and amoxicillin was marked as the sole suspected drug in 18 and the only drug administered in 13 cases. In the rest of the deafness cases (n=31), amoxicillin was concurrently administered with other drugs and reported as co-suspected. The median time to onset was three days and the outcome was marked as recovered (14), recovering (2), not recovered (16) and unknown (17). In five cases, deafness resolved following the withdrawal of amoxicillin.

Conclusion: There appears a causal association between amoxicillin and hearing loss that requires further substantiation with better epidemiologic studies.

Background: Antibiotic resistance has become one of the major global health threats. The lack of knowledge on antibiotics contributes to the indiscriminate use of these medications and subsequent antibiotic resistance.

Objective: To evaluate the knowledge and attitude of university students regarding antibiotics.

Methods: A cross-sectional study was conducted on university students at a private university in Malaysia in 2018, using a self-administered validated questionnaire.

Results: Of the 424 respondents included in this study, 25.7% had taken antibiotics in the previous month while 22.6% had good knowledge about antibiotics. The faculty to which the respondents were attached was the only determinant associated with the respondents' knowledge level on antibiotics. The odds of respondents from other faculties having poor knowledge level on antibiotics were significantly higher than those from the Faculty of Health and Medical Sciences (P<0.001). The study found that 77.8% of the respondents knew the roles of antibiotics in treating bacterial infections, but only 27.4% knew that antibiotics were not for viral infections. However, 46.5% of the respondents recognized that penicillin is an antibiotic, but only 35.4% and 9.2% knew that aspirin and diphenhydramine, respectively, are not antibiotics. More than 70% of the respondents were aware that antibiotics have side effects and that overuse of antibiotics could lead to resistance. However, 35.6% expected antibiotics to be prescribed for common colds and 33% would not complete their course of antibiotics.

Conclusion: The study shows that university students do not have adequate knowledge and about one-third have misconceptions about antibiotics. This calls for health education interventions at university level as this target population will be the future leaders of the country.

Background: The widespread dissemination of unhealthy dietary habits, childhood-teenage obesity, and sedentary lifestyle in young adults has paved the way for public health burden metabolic syndrome and early onset of type 2 diabetes mellitus. The aim of this study was to assess the prevalence and risk factors for metabolic syndrome and diabetes among young adult students.

Methods: This cross-sectional study was conducted among students of age group (18 to 25 years) studying at Manmohan Memorial Institute of Health Sciences and Central Institute of Science and Technology. The diabetes risk score of each individual was calculated by the Finnish Diabetes Risk Score (FINDRISC tool). Independent risk factors for diabetes and metabolic syndrome were measured by multivariable logistic regression analysis. The p-value of <0.05 was considered statistically significant in this study.

Results: A total of 825 students were recruited and 739 (89.6%) students completed the study with all the fulfilled criteria. The metabolic syndrome (Harmonized Joint Scientific Statement (HJSS) criteria) was present in 7.1%, and the most prevalent defining component was low HDL-C (78%); 74.8% of students were under low risk, 22.18% were at slightly elevated risk, 2.02% were at moderate risk, and 1.01% were at high risk of diabetes. The cardiometabolic risk factors like BMI, TC, and LDL-C were higher at a significant level (p<0.001) with an increased diabetes risk score. Independent lifestyle risk factor for metabolic syndrome was current smoking (AOR, 4.49, 95% CI 1.38-14.62) whereas, an independent lifestyle risk factor for diabetes was low adherence to physical exercise (AOR, 4.81, 95% CI, 2.90-7.99).

Conclusion: Metabolic syndrome is present, although in low numbers in young adults putting them at risk to develop diabetes in the near future. Early assessment of metabolic syndrome and diabetes risk in young may provide insights for preventive and control plans for risk population.

Background: Patient-safety culture is an important component of health-care quality and currentlyan issue of high concern globally. In Ethiopia, little is known about patient-safety culture in hospitals. We assessed the patient-safety culture and associated factors among health-care workers in public hospitals of East Wollega Zone, western Ethiopia.

Methods: This institution-based cross-sectional study was conducted among 421 health-care workers selected using simple random sampling from March 4 to March 29, 2019. A standardized measuring 12 patient safety-culture components was used for data collection. Data were cleaned and entered into EpiData version 3.1 and analysis done using SPSS version 25 (IBM). Bivariate and multivariate linear regression analyses were performed. Significance was set at 95% CI and p<0.05, and unstandardized β-coefficients were used to measure extent of association.

Results: This study revealed that the level of patient-safety culture was 49.2% and patient safety culture-component scores ranged from 29.2% for nonpunitive responses to error to 77.9% for teamwork within a hospital unit. Age ≥45 years (β=13.642, CI: 5.324-21.959; p=0.001), 1-5 years' experience at the current hospital (β=5.559, 95% CI 2.075-9.042; p=0.002), and working in general hospitals (β=11.988, 95% CI 7.233-16.743; p<0.001) and primary hospitals (β=6.408, 95% CI 2.192-10.624; p=0.003) were factors associated with better scores on patient-safety culture.

Conclusion: Overall scores for patient-safety culture were low. Improving the current state of patient safety in public hospitals would require tailored interventions to address low-scoring components, such as nonpunitive responses to error.

Background: Pharmaceutical products need to be of good quality and it is even more critical when it comes to life saving medicaments like infusions.

Objective: This research surveyed the quality fitness of some ciprofloxacin and metronidazole infusion samples marketed in South-eastern of Nigeria.

Methods: Using Official Compendial methods, microbiological quality, active pharmaceutical ingredients quantitation, pH and particle count tests were evaluated on eighty infusion bottles (from eight pharmaceutical companies) of each of the two drugs.

Results: Out of the sixteen brands tested, 2 metronidazole brands and 1 ciprofloxacin brand (representing 18.75% of the total 16 brands/makes) were contaminated while the remaining 13 brands (81.25%) were found sterile. The active pharmaceutical ingredients quantitative assay showed that all the brands of ciprofloxacin infusion were between the 95% and 105% limit of label claim while one metronidazole brand has <95-110% limit label claim. Six brands each of the two drugs evaluated fall below the acceptable pH range [ciprofloxacin (3.5-4.6) and metronidazole (4.8-5.2)], while the other two brands of both drugs passed the test. In the antibacterial study, Pseudomonas aeruginosa and Escherichia coli were susceptible to the ciprofloxacin (5 µg). However, Salmonella typhi recorded inhibition zone diameters within resistant and intermediate range. Peptostrepococcus spp was susceptible (at minimum inhibitory concentrations of 100 µg/mL) to all the brands of metronidazole, while none of the brands were effective on Lactobacillus spp. All the brands passed the test for particulate contamination. The particles size range was <10µm.

Conclusion: About eighty-one percent (81.25%) of the infusions have acceptable good microbiological quality. However, 18.75% that failed the tests is a concern knowing that these are lifesaving products.

Purpose: Assessment of medication errors (ME) is crucial to improving the quality of health care. A questionnaire that can be used to explore pharmacists' perspectives regarding ME would be very useful as part of an ongoing process of quality improvement in patient care. The aim of this study was to develop and validate a questionnaire to measure perceived causes of ME and attitude towards ME reporting among pharmacists.

Methods: The questionnaire was developed from the literature together with outcomes from focus group discussions. It was divided into two domains which are knowledge on ME and attitude towards ME reporting. Content validity index (I-CVI), exploratory factor analysis (EFA), Cronbach alpha and intraclass correlation coefficient (ICC) to assess test-retest reliability were obtained during the validation process.

Results: Overall Cronbach alpha for internal consistency was good (0.742), where subscale of the questionnaire demonstrated adequate internal consistency, with Cronbach alpha value 0.83 for knowledge and 0.70 for reporting behaviour attitude. The I-CVI showed good scores (knowledge=0.88) and (attitude=0.81), while ICC was moderately accepted with a value of 0.77. Two factors were extracted from the 16 items in EFA.

Conclusion: The questionnaire to assess knowledge on ME and attitude towards ME reporting among pharmacists is valid and reliable. It demonstrates good psychometric properties.

Idiopathic Pulmonary Fibrosis (IPF) is a chronic fibrotic disease characterized by a progressive decline in lung function with a median survival of 3-5 years after diagnosis. The course of disease is highly variable and unpredictable, often punctuated by episodes of acute respiratory failure, known as acute exacerbations. The incidence of IPF is on the rise due to the aging population, as age is the most important risk factor for this disease. Pirfenidone and nintedanib are the two anti-fibrotic drugs approved for IPF which have shown reduction in lung function decline. This review will discuss the efficacy, safety and tolerability profile of pirfenidone from clinical trials and the real-world clinical experience. Pirfenidone reduces the decline in lung function and improves progression-free survival in patients with IPF. It is generally well tolerated with the most common side effects being gastrointestinal and phototoxicity.

Background: Drug therapy problems (DTPs) are of major concern in health care because of the associated increased cost of treatment, morbidity, and mortality. Thus, clinical practice should constitute the mainstream practice of clinical pharmacy in every ward. However, nothing is known about DTPs and the role of clinical pharmacist in the surgical ward of Ethiopia (the neglected ward).

Objective: To assess the prevalence of DTP among patients hospitalized at the surgical ward and the role of clinical pharmacists in their identification and resolution.

Methods: Hospital-based prospective observational and interventional study design was used with daily patients' chart review using a semi-structured questionnaire among hospitalized adult patients at the surgical ward. After identification of DTP, verbal communication was used as a means of intervention with the treating physician. Acceptance of clinical pharmacist's intervention was considered only if a change was made to the patients' medication order. To identify determinants of DTPs, multiple stepwise forward logistic regression analysis was done by SPSS version 20.0. Statistical significance was considered at p-value < 0.05. Written informed consent was sought and the data were secured.

Results: The response rate was 97.1% (300) for the final analysis. The mean (±SD = standard deviation) age of the participants was 42.62 ±18.29 with male (67%) predominance. DTP was identified in 76% of study participants. A total of 449 DTPs were identified, which equates with an average of 1.97 per patient. Dose too low 124/449 (27.6%) and dose too high 81/449 (18.0%) were found to be the most common types of DTPs. The intervention rate was 86.0% (196/228 per patients) and 86.2% (387/449 DTPs), with the acceptance rate of 85.2% (167/196 per patients) and 78% (302/387 per DTP) which mean (67.3%) 302/449 of the problems were fully resolved by the clinical pharmacist. Poly-pharmacy [AOR, 7.23; 95% CI, 2.29-22.13: P-value < 0.001] and hospital stay > 20 days [AOR, 5.42; 95% CI, 2.74-10.70; p < 0.001] were the only independent predictors for DTPs.

Conclusion and recommendation: This study identified a high prevalence of DTP which was independently predicted by the presence of poly-pharmacy and >20 days of hospital stay. The rate of intervention provided and acceptance from the physician was high, which is one indicator that the role of clinical pharmacists in the identification and resolution of DTP was paramount in the surgery ward and should be implemented as a must not as optional.

Background: South African medical insurance schemes (known as medical schemes) cover about 17% of the population. Within these schemes, access to medicines for a defined set of chronic diseases is mandated by legislation. However, much of the responsibility for treatment of minor conditions with non-prescription over-the-counter (OTC) medicines has been transferred to the individuals within the medical schemes. The overall expenditure on pharmacist-assisted therapy (PAT)/OTC medicines in South Africa is considerable and medical schemes endeavor to limit amounts paid out by devising strategies that will limit their financial exposure.

Aim: To investigate how benefit design and other factors within two medical schemes influenced access to and payment for OTC medicines and to explore whether access to OTC medicines by individuals impacted on utilization of other health-care services.

Methods: Medical scheme data were obtained from a leading administrator for two health plans: one with comprehensive benefits covering 4593 beneficiaries (designated HI) and the other with lower benefits covering 54,374 beneficiaries (LO). Extracted data included beneficiary demographics, OTC medicines prescribed by doctors and/or dispensed by pharmacists, and monetary amounts claimed by individuals and paid by the medical schemes. Doctor consultations, costs and payments were also extracted, as were beneficiaries' records of their chronic disease(s) and any episode(s) requiring hospitalization.

Results: Some 60-70% of beneficiaries submitted claims for OTC medicines accessed directly or recommended by a pharmacist, and 80-90% claimed OTC medicines that were prescribed by a doctor during a consultation. Amounts claimed and percentages of original products prescribed were substantially higher when accessed directly by beneficiaries or recommended by pharmacists than when doctors prescribed the medicines. In multivariate analysis, there was no clear advantage of offering access to OTC medicines in order to reduce visits to general practitioners, although in the LO plan it appeared that beneficiaries with chronic diseases made less use of the OTC benefit and more use of medical specialists.

Conclusion: Within these two plans, there were higher costs and greater use of original products when beneficiaries or pharmacies accessed OTC medicines than when these medicines were prescribed by doctors. A key question is whether access to these medicines and the costs thereof would be managed better if paid for directly by individuals and not as insured benefits through the medical scheme.