Drug, Healthcare And Patient Safety[JOURNAL]
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200 papers
Review of the Safety, Efficacy and Tolerability of Palivizumab in the Prevention of Severe Respiratory Syncytial Virus (RSV) Disease.
O'Hagan S, Galway N, Shields MD … +2 more , Mallett P, Groves HE
Drug Healthc Patient Saf · 2023 · PMID 37720805 · Full text
Respiratory Syncytial Virus (RSV) is a major global cause of childhood morbidity and mortality. Palivizumab, a monoclonal antibody that provides passive immunity against RSV, is currently licensed for prophylactic use in...
Respiratory Syncytial Virus (RSV) is a major global cause of childhood morbidity and mortality. Palivizumab, a monoclonal antibody that provides passive immunity against RSV, is currently licensed for prophylactic use in specific "high-risk" populations, including congenital heart disease, bronchopulmonary dysplasia and prematurity. Available research suggests palivizumab use in these high-risk populations can lead to a reduction in RSV-related hospitalization. However, palivizumab has not been demonstrated to reduce mortality, adverse events or length of hospital stay related to RSV. In this article, we review the management of RSV, indications for palivizumab prophylaxis, the safety, cost-effectiveness and efficacy of this preventative medication, and emerging therapeutics that could revolutionize future prevention of this significant pathogen.
Prevalence and Factors Associated with Dyslipidemia Among People Living with HIV/AIDS on Follow-Up Care at a Tertiary Care Hospital in Ethiopia: A Cross-Sectional Study.
Assefa A, Abiye AA, Tadesse TA … +1 more , Woldu M
Drug Healthc Patient Saf · 2023 · PMID 37546170 · Full text
BACKGROUND: Despite its importance as a major risk factor for cardiovascular disease, dyslipidemia remains poorly characterized in the African population. OBJECTIVE: To assess the prevalence and factors associated with d...
BACKGROUND: Despite its importance as a major risk factor for cardiovascular disease, dyslipidemia remains poorly characterized in the African population. OBJECTIVE: To assess the prevalence and factors associated with dyslipidemia in people with HIV/AIDS in follow-up at Zewditu Memorial Hospital, Addis Ababa, Ethiopia. MATERIALS AND METHODS: A hospital-based retrospective cross-sectional study evaluated the charts of 288 people living with HIV/AIDS who had received Highly Active Antiretroviral Treatment for at least six months at Zewditu Memorial Hospital from July to September 2021. Sociodemographic and clinical data were collected from the patient's charts. Statistical analysis was performed using the Statistical Package for Social Sciences software version 25. RESULTS: The overall prevalence of dyslipidemia was 55.2% in people living with HIV/AIDS. The prevalence of high-density lipoprotein cholesterol <40 mg/dl in men and <50 in women was 46.9%; total cholesterol ≥200 mg/dl was 22.6%; triglycerides ≥150 mg/dl was 18.8%, and low-density lipoprotein ≥130 mg/dl was 4.9%. Sex [Female adjusted odds ratio (AOR) = 0.595, 95% CI: 0.37-0.956], age greater than 40 years (AOR = 1.026, 95% CI: 1.005-1.048), body mass index >25 kg/m (AOR = 1.767, 95% CI: 1.099-2.84), viral load >50 (AOR = 0.477, 95% CI: 0.27-0.842), and CD4 <500 (AOR = 1.938, 95% CI: 1.18-3.183) were identified as determinants of dyslipidemia. CONCLUSION: There was a high prevalence of dyslipidemia among study participants compared to several studies published in a similar population. Being male, older age, higher BMI, low CD4 count, and viral load of < 50 copies/mL were associated with dyslipidemia in people living with HIV/AIDS. Therefore, lipid profile measurements at baseline must be part of routine care to prevent the devastating effects of dyslipidemia.
The Utility of Internet-Enabled Antibiotic Self-Medication and Its Associated Factors Among Patients Attending Private Clinics in Kawempe Division in Kampala Capital City, Uganda: Community-Based Cross-Sectional Study.
Nakakande J, Taremwa IM, Nanyingi M … +1 more , Mugambe S
Drug Healthc Patient Saf · 2023 · PMID 37035632 · Full text
INTRODUCTION: The expanding practice of internet-based antibiotic self-medication raises public health concerns as it increases antibiotic resistance and introduces avoidable risks. This study aims to examine the utility...
INTRODUCTION: The expanding practice of internet-based antibiotic self-medication raises public health concerns as it increases antibiotic resistance and introduces avoidable risks. This study aims to examine the utility of internet-enabled antibiotic self-medication and its associated factors among patients attending private clinics in Kawempe division in Kampala Capital City, Uganda. METHODS: This was an analytical cross-sectional study that enrolled participants attending private clinics in Kawempe Division's randomly selected zones. These were interviewed using a structured questionnaire, and the data were analyzed using STATA version 12 software. Logistic regression analysis was used, and variables with p ≤ 0.05 were considered as significantly associated with internet-enabled antibiotic self-medication. RESULTS: Out of the 313 respondents, 246 (79%) reportedly had ever used internet sources to self-medicate with antibiotics. Factors such as being male; single; had knowledge of antibiotics; believed that Internet should be used for antibiotic self-medication; Distance to the nearest medical center/hospital from your residence/workplace of about 5 km and residing near a drug shop/pharmacy that gives antibiotics without a prescription increased internet-enabled antibiotic self-medication. Furthermore, the variables of more than three household members; common practice of antibiotic self-medication in a household; did not agree that one can recover from the illness without a doctor's prescription and medical workers who did not explain adequately the antibiotics medication given for the illness decreased internet-enabled antibiotic self-medication. CONCLUSION: This study found that internet-enabled antibiotic self-medication practice is highly utilized and is associated with a variety of individual, household, and healthcare system factors. This necessitates strict adherence to national drug policy regulations governing antibiotic use. Furthermore, community health education is critical in combating such medication practices.
Safety Aspects and Rational Use of Testosterone Undecanoate in the Treatment of Testosterone Deficiency: Clinical Insights.
Campbell K, Muthigi A, Ghomeshi A … +3 more , Schuppe K, Sandler MD, Ramasamy R
Drug Healthc Patient Saf · 2023 · PMID 37025099 · Full text
Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone...
Testosterone deficiency is diagnosed by a serum total testosterone level below 300 ng/dL in combination with symptoms such as decreased energy and libido. These symptoms can be ameliorated by restoring serum testosterone to the physiologic range with testosterone therapy (TT). There are numerous forms of testosterone therapy, such as injectable, transdermal, nasal, and subcutaneous applications. There are also multiple formulations of injection, such as testosterone cypionate, testosterone enanthate, and testosterone undecanoate. Testosterone undecanoate (TU) is a long-acting ester formulation of testosterone that can be provided in an injectable or oral form. Oral testosterone undecanoate is marketed as Andriol, Jatenzo, Tlando, and Kyzatrex. Oral TU provides a convenient option for many patients, which may increase compliance with TT. Injectable testosterone undecanoate is marketed as Aveed and Nebido. Injectable TT remains the most cost-effective therapeutic option and is appropriate for most patients as an initial therapy. This review describes the pharmacokinetics of these testosterone undecanoate products and provides a guide for prescribers using these medications. While many forms of testosterone are appropriate for TT, a patient-centered discussion focused on goals of care should best guide physician prescription of these medications.
The Clinical Efficacy, Safety, and Tolerability of Vancomycin for the Treatment of Recurrent Infection - A Systematic Review.
Knudsen MJS, Rubin IMC, Petersen AM
Drug Healthc Patient Saf · 2023 · PMID 36974197 · Full text
INTRODUCTION: The aim of this systematic review of randomized clinical trials (RCTs) was to examine the efficacy, safety, and tolerability of vancomycin for treatment of recurrent infection (rCDI). METHODS: The PubMed d...
INTRODUCTION: The aim of this systematic review of randomized clinical trials (RCTs) was to examine the efficacy, safety, and tolerability of vancomycin for treatment of recurrent infection (rCDI). METHODS: The PubMed database was searched from inception to August 23, 2022. An initial screening was performed followed by a full-text evaluation of the papers. Inclusion criteria were RCTs investigating vancomycin for treatment of rCDI. RESULTS: A total of six studies and 269 patients were included in the review. Three studies used a fixed dose regimen of vancomycin, one study used pulse regimen, one study used a taper-and-pulse regimen, and one study used a taper-and-pulse regimen for the participants with two or more recurrences. The resolution of infection varied from 19% to 58.3% in five of six studies reporting this as an outcome. Four out of six studies reported new episodes of rCDI as an intervention outcome, in those studies 50-63% of participants experienced rCDI. Regarding the safety and tolerability of vancomycin treatment for rCDI, one study described several adverse events regarding gastrointestinal discomfort along with fatigue and skin rash. There were no records of serious adverse events in the included studies. CONCLUSION: While oral vancomycin is mostly safe and well tolerated in the RCTs reviewed here, the efficacy for treating rCDI varies greatly from 19-58.3%, and 50-63% of participants experienced new episodes of rCDI.
Updated Evaluation of the Safety, Efficacy and Tolerability of Tafamidis in the Treatment of Hereditary Transthyretin Amyloid Polyneuropathy.
Falcão de Campos C, Conceição I
Drug Healthc Patient Saf · 2023 · PMID 36824481 · Full text
Hereditary amyloid transthyretin (ATTRv) amyloidosis is a devastating hereditary multisystemic disease affecting predominantly the peripheral and autonomic nervous systems and the heart. ATTRv is caused by mutations in t...
Hereditary amyloid transthyretin (ATTRv) amyloidosis is a devastating hereditary multisystemic disease affecting predominantly the peripheral and autonomic nervous systems and the heart. ATTRv is caused by mutations in the () gene, leading to extracellular deposition of amyloid fibrils in multiple organs including the peripheral nervous system. If untreated, it is associated with a fatal outcome 10-12 years after disease onset. Different treatments are available for patients with ATTRv polyneuropathy. Tafamidis 20 mg is approved in Europe since 2011 for early stages of ATTRv polyneuropathy (stage I - able to walk without support) and it is recommended as first-line therapy in these patients. Tafamidis is a TTR stabilizer that selectively binds to TTR and kinetically stabilizes both wild-type native TTR and mutant TTR. Consequently, it has the potential to prevent the amyloidogenic cascade initiated by TTR tetramer dissociation into its monomers and subsequent misfolding and aggregation. Tafamidis is an oral drug, taken once per day, with proved efficacy, safety and tolerability in ATTRv-PN patients as demonstrated in different clinical trials and open-label extension studies as well in clinical practice setting with around 10 years of experience. Tafamidis treatment started in the earliest stages of the disease is associated with better neurological outcomes. A multidisciplinary approach in referral centres is also fundamental for monitoring patients to assess individual response to treatment.
Self-Medication and Associated Factors Among Pregnant Women in Rural Ethiopia: The Importance of Husband Education in Ensuring a Safe Pregnancy.
Tujuba TD, Chilo D, Abebe E … +1 more , Zenu S
Drug Healthc Patient Saf · 2023 · PMID 36814849 · Full text
BACKGROUND: Self-medication is the use of drugs without a medical prescription to treat self-identified illnesses; it is also the continued use of drugs without a physician's order for recurring symptoms, either by shari...
BACKGROUND: Self-medication is the use of drugs without a medical prescription to treat self-identified illnesses; it is also the continued use of drugs without a physician's order for recurring symptoms, either by sharing or purchasing them from unlicensed vendors. It entails substantial risk to pregnant women and fetuses. Magnitude of the problem and its factors among rural pregnant women is not studied in Ethiopia. OBJECTIVE: This study aimed to assess the prevalence of self-medication practice and identify its associated factors among pregnant women in rural Southwest Shewa, Ethiopia. METHODS: A cross-sectional study was conducted on 585 randomly selected pregnant women in selected rural public health institutions from May to July 2021. Data was collected by using an interviewer-administered pretested structured questionnaire. Multivariable logistic regression was used to identify factors associated with self-medication. Variables with value <0.05 for the 95% confidence interval of the adjusted odds ratio were considered statistically significant. RESULTS: A total of 585 pregnant women participated in the study with a response rate of 92.3%. The prevalence of self-medication among pregnant women was 19.8%. Primigravidity (AOR = 2.7, 95% CI: 1.2-6.1), lower educational status of husbands (AOR = 3.6, 95% CI: 1.02-12.9), living close to health facilities (AOR = 0.23, 95% CI: 0.09-0.6) and knowing one's own gestational age (AOR = 0.5,95% CI: 0.30-0.9) were significantly associated with self-medication practice. CONCLUSION AND RECOMMENDATION: One in five of the pregnant women practiced self-medication during the current pregnancy. Primigravidity and lower educational status of husbands were associated with a higher probability of self-medication. Knowing gestational age and living close to health facilities were associated with a lower likelihood of practicing self-medication. Rational drug use has to be promoted among pregnant women. Maternal and child health interventions should also target husbands. Health education has to be strengthened to help pregnant women have a safe pregnancy.
Delta-8, a Cannabis-Derived Tetrahydrocannabinol Isomer: Evaluating Case Report Data in the Food and Drug Administration Adverse Event Reporting System (FAERS) Database.
Simon TA, Simon JH, Heaning EG … +2 more , Gomez-Caminero A, Marcu JP
Drug Healthc Patient Saf · 2023 · PMID 36742440 · Full text
PURPOSE: The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS)...
PURPOSE: The aim of this study was to characterize the frequency of adverse effects where delta-8 tetrahydrocannabinol (D8-THC) was identified as a possible suspect drug in the FDA Adverse Event Reporting System (FAERS) database. METHODS: A case-series design was used. RESULTS: A total of 183 cases listed D8-THC as a suspect drug in FAERS as of June 30, 2021. The most common events included dyspnea, respiratory disorder, and seizure. The reporting odds ratios were consistently and significantly greater than 2, a 2-fold increase from 2019 to 2021, indicating a potential safety signal. CONCLUSION: The first report of D8-THC, in the FAERS database, as a suspect drug appears to be in 2011. Overall, there are 183 total cases listing D8-THC as a suspect drug in the FAERS database as of June 30, 2021. Of the 183 cases, most were respiratory in nature.
Validation of the Safety Attitudes Questionnaire for Assessing Patient Safety Culture in Critical Care Settings of Three Selected Ugandan Hospitals.
Atukwatse J, Niyonzima V, Asher Aliga C … +5 more , Nakandi Serwadda J, Nankunda R, Nakiganda C, Komugabe P, Nantongo H
Drug Healthc Patient Saf · 2023 · PMID 36727107 · Full text
BACKGROUND: The safety attitudes questionnaire (SAQ) short form (2006) is important for assessing patient safety culture in clinical environments. However, little is known about its validity and applicability in Uganda....
BACKGROUND: The safety attitudes questionnaire (SAQ) short form (2006) is important for assessing patient safety culture in clinical environments. However, little is known about its validity and applicability in Uganda. This study validated the SAQ short form (2006) for use in assessing patient safety culture in critical care settings of hospitals in the Ugandan context. METHODS: Using a sequential exploratory mixed-methods research design, the face, content and construct validity for the SAQ short form (2006) was assessed in a multi-phased approach. A panel of eight (8) purposively selected experts assessed the face and content validity in rounds 1 and 2, respectively, while construct validity was assessed in round 3 using data from a cross-sectional survey of 256 frontline health workers in critical care settings of the selected hospitals. Analysis of survey data followed confirmatory factor analysis. Cronbach's alpha examined internal reliability. RESULTS: Of the 36 items in the tool's original version, 33 were rated clear, with a score of 100% on face validity. The use of contextual vocabulary and formatting issues arose as concerns. The S-CVI/ was 100%, and S-CVI/ was 86.1%. Four new items added on effective communication as another dimension of patient safety culture. The survey had KMO=0.8605, the a priori-based model had a scale Cronbach's alpha=0.8881, with unsatisfactory goodness of fit (RMSEA=0.051, 90% CI: 0.044-0.057, close=0.427; chi-square=694.28, <0.001; CFI=0.884, TLI=0.871). The modified final model had a scale Cronbach's alpha =0.8967 and satisfactory goodness of fit (RMSEA=0.030, 90% CI: 0.019-0.039, close=1.000; chi-square=424.98, =0.002; CFI=0.966, TLI=0.960). CONCLUSION: In the tool's original form, the face validity was lacking despite satisfactory scores on item clarity. Content validity was adequate, while construct validity required modifications in construct specifications. Reliability was adequate before and after specification modifications. The modified version has adequate psychometric properties for Uganda.
Prevalence and Determinants of Household Medication Storage During the COVID-19 Outbreak in Southwest Ethiopia.
Kahssay SW, Hammeso WW, Getachew D … +1 more , Woldeselassie BD
Drug Healthc Patient Saf · 2023 · PMID 36699285 · Full text
BACKGROUND: Most households worldwide keep medicines on hand for various reasons, including emergency use, treatment of acute and chronic diseases, and anticipated future use. Being infected or fear of getting COVID-19 i...
BACKGROUND: Most households worldwide keep medicines on hand for various reasons, including emergency use, treatment of acute and chronic diseases, and anticipated future use. Being infected or fear of getting COVID-19 in the current pandemic could increase the storage of drugs at home. Thus, this study aimed to assess the prevalence of household storage of medicines and associated factors in southwest Ethiopia during the COVID-19 outbreak. METHODS: A cross-sectional household survey was conducted from February 1 to May 30, 2022. Data on the extent of storage, storage conditions, their current status, disposal methods, among others, were collected through structured interviews and observations. The data were entered into EPI info, exported, and analyzed using Statistical Packages for Social Sciences (SPSS). Bivariate followed by multivariate logistic regression was used to identify associated factors. P-value <0.05 was used as a cut-off point to decide statistical significance. RESULTS: The magnitude of household medication storage was 48% (95% CI). Analgesics (28.7%) and antibacterial (21.1%) agents were the most predominant class of drugs stored in the households. The most significant proportion of the home-stored medications (34.7%) was reserved for future use, and 31.8% were for treating current medical conditions. The majority of the respondents (84.1%) had never heard/learned about the safe disposal ways of drugs. The presence of children aged less than 5 years in a household [AOR = 1.90 (1.19, 3.05)] and the existence of chronically sick patients in a household [AOR = 4.3 (2.25, 8.45)] were factors significantly associated with household medication storage. CONCLUSION: The current study revealed a high prevalence of home medication storage; thus, to lessen or eliminate the negative consequences of storing medications at home, it is necessary to review the medication utilization chain and offer community-based training on proper medication storage and disposal techniques, including establishing take-back programs.
Safety Aspects and Rational Use of Lanadelumab Injections in the Treatment of Hereditary Angioedema (HAE): Clinical Insights.
Petkova E, Yordanova V, Staevska M … +1 more , Valerieva A
Drug Healthc Patient Saf · 2022 · PMID 36578774 · Full text
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 b...
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.
Reduction of In-Hospital Preoperative Waiting Time of Elective Surgeries in the Amidst of COVID-19 Pandemic: Experience from Ethiopia.
Teklewold B, Abebe E, Anteneh D … +1 more , Haileselassie E
Drug Healthc Patient Saf · 2022 · PMID 36274904 · Full text
BACKGROUND: The higher demand for surgical services during the advancement of the COVID-19 pandemic has resulted from the need for a pre-admission negative result, the need for extra resources, and a shortage of skilled...
BACKGROUND: The higher demand for surgical services during the advancement of the COVID-19 pandemic has resulted from the need for a pre-admission negative result, the need for extra resources, and a shortage of skilled expertise. This quality improvement project aimed to reduce the in-hospital preoperative waiting time of elective cases to less than 24 hours. METHODS: The study was conducted in a tertiary care center. Following the collection of baseline data, we formed a multidisciplinary team to analyze the root causes and intervention ideas of delay using fishbone and driver diagrams, respectively. We prioritize key drivers and implemented several low-cost interventions using Plan-Do-Study-Act (PDSA) model. We monitored the average in-hospital preoperative waiting time of patients. RESULTS: Overall, in-hospital preoperative waiting time for elective cases has been reduced from a baseline of 4.89 days to 1.32 days on average by the end of 10 months of initiating the project. Similarly, monthly elective case cancellation rate due to COVID-19-related reason has been reduced from baseline 62.5% of the total cancellation to 0%. Due to this, the average monthly inpatient bed utilization has increased from 2.21 patients per month during pre-COVID-19 period to 5.9 patients per month in each bed of the surgical ward by the end of the project. CONCLUSION: The implementation of a quality improvement project can optimize operation theatre efficiency, inpatient bed utilization, and reduce the surgical backlog. Meticulous and rigorous effort has to be laid down to do root cause analysis, generate feasible change ideas, and continuous follow-up, and testing of multiple PDSA cycles is required to impact an improvement and sustain it in the long run. The emergence of COVID-19 pandemic could be used as an opportunity to reduce the length of stay in the hospital.
Epidemiology of Snake Bites Linked with the Antivenoms Production in Colombia 2008-2020: Produced Vials Do Not Meet the Needs.
Estrada-Gómez S, Vargas-Muñoz LJ, Higuita-Gutiérrez LF
Drug Healthc Patient Saf · 2022 · PMID 36199542 · Full text
INTRODUCTION: Snakebite envenomation is a public health event of mandatory reporting in Colombia. It is considered a medical emergency in which the government must guarantee antivenom availability. We describe snakebite...
INTRODUCTION: Snakebite envenomation is a public health event of mandatory reporting in Colombia. It is considered a medical emergency in which the government must guarantee antivenom availability. We describe snakebite epidemiological figures in Colombia between 2008 and 2020 and correlate them with antivenom manufacturing figures to determine rate coverage and the need for antivenom. METHODS: We performed an ecological study based on secondary official figures from the National Health Institute, the National Institute for Surveillance of Medicines and Foods, the National Administrative Department of Statistics and the Ministry of Health and Social Protection. Absolute and relative frequencies were calculated with 95% confidence intervals, position measurements, dispersion and central tendency. RESULTS: Through our research, we revealed that in the last 13 years (2008-2020), there were an average of 4467 annual snakebite envenomation cases affecting all the departments in Colombia. Antioquia reported the highest number of snakebites with 647 (95% CI 588-706) cases per year. The population incidence per 100,000 inhabitants was 9.5; the highest rates were found in Vaupés at 116.1 and Guaviare at 79.24. During the last seven years (2014-2020) Colombia produced an average of 21,104 antivenom vials per year, while the annual demand for antivenom is estimated at 54,440 units needed to guarantee access. DISCUSSION: Colombia does not produce sufficient vials to cover their needs, and this is why only 74.4% of accidents (out of the 92% not classified as dry bites) were treated, and even 9.7% of the severe accidents did not receive the specific treatment (8% of the victims were classified as dry bites). Figures support the regular antivenom shortages declared by the Ministry of Health and Social Protection in the last 13 years (11 health emergency declarations). New efforts are needed to: 1) boost the production of GMP-based high-quality antivenom, that covers the national needs and is made availability, 2) a better estimation method to calculate the need for antivenom in Colombia, and 3) implementation of production-distribution chains guaranteeing access in remote communities.
Opioid Utilization and Management in the Setting of Stewardship During Inpatient Rehab Care.
Murphy L, Leblanc K, Badr S … +7 more , Ching E, Mao L, Steenhof N, Hamandi B, Rubin B, Seto A, Furlan AD
Drug Healthc Patient Saf · 2022 · PMID 36118374 · Full text
BACKGROUND: Opioid utilization and management in an inpatient rehabilitation setting have not been widely described, despite the unique opportunities that exist in this setting to support opioid stewardship across transi...
BACKGROUND: Opioid utilization and management in an inpatient rehabilitation setting have not been widely described, despite the unique opportunities that exist in this setting to support opioid stewardship across transitions in care. We aimed to characterize opioid utilization and management by interprofessional teams across a large, inpatient rehabilitation setting after incorporation of opioid stewardship principles by pharmacists as part of their daily practice. PATIENTS AND METHODS: This was a retrospective chart review at Toronto Rehab, University Health Network, Toronto, Canada. Patients with admission orders for any opioid from November 2017 to February 2018 were included. Complex continuing care and palliative care patients were excluded. Descriptive statistics were primarily used to describe the data as well as univariate linear regression to compare associations with milligram morphine equivalent (MME) reduction. RESULTS: A total of 448 patients were included. A reduction in total daily MME was seen in 49% (n=219) of the patients during their inpatient stay, with 73% (n=159) of these patients having a reduction of ≥50%. Sixty-nine percent (n=311) of the patients received an opioid prescription at discharge, with most scheduled (90%, n=98) with a supply of less than 30 days. Rehabilitation length of stay was correlated with a MME decrease during rehab (p<0.01), suggesting that longer lengths of stay contributed to a greater reduction in MME. Patients with chronic opioid use prior to acute care admission (p=0.01), and those who started extended-release opioids during acute care (p=0.02) were significantly less likely to discontinue opioids during rehab stay. CONCLUSION: Opioid utilization and management in the setting of opioid stewardship across inpatient rehab and transitions of care were characterized. Opportunities exist for further quality improvement initiatives within inpatient rehabilitation and acute care settings to identify and support patients with complex pain management needs.
Clinical Utility and Tolerability of Tolvaptan in the Treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).
Raina R, Houry A, Rath P … +6 more , Mangat G, Pandher D, Islam M, Khattab AG, Kalout JK, Bagga S
Drug Healthc Patient Saf · 2022 · PMID 36105663 · Full text
Autosomal dominant polycystic kidney disease, also known as ADPKD, is the most common hereditary kidney disease, affecting different age groups. ADPKD can eventually lead to end-stage renal disease. The etiology of ADPKD...
Autosomal dominant polycystic kidney disease, also known as ADPKD, is the most common hereditary kidney disease, affecting different age groups. ADPKD can eventually lead to end-stage renal disease. The etiology of ADPKD is genetic, resulting in the formation of cysts containing fluids on the kidneys. Patients with ADPKD present a range of symptoms following a decline in kidney function. Pain, stones, proteinuria and osteoporosis are few of the many symptoms, resulting from decreased kidney function. Tolvaptan, a selective V2 receptor antagonist, is the etiological treatment used for ADPKD. In this paper, we conducted a systematic review of the literature between 2011 and 2021 to gather data regarding the tolerability and efficacy of tolvaptan use in ADPKD. A total of 22 trials were reviewed. Tolvaptan efficacy in the trials was measured using changes in eGFR or changes in total kidney volume. Results showed that tolvaptan use in ADPKD was associated with a slower decline in kidney function and a decrease in total kidney volume. Side effects of this drug include polyuria, nocturia and polydipsia along with hepatotoxicity. The two biggest trials, TEMPO and REPRISE, change in eGFR from pre-treatment baseline to post-treatment was 1.3 mL/min/1.73 for REPRISE and 1 mL/min/1.73 for TEMPO 3:4. A mean decrease of 49% in total kidney volume from baseline to post-treatment was found in the TEMPO 3:4 study.
Describing and Quantifying Wrong-Patient Medication Errors Through a Study of Incident Reports.
Takahashi M, Okudera H, Wakasugi M … +5 more , Sakamoto M, Shimizu H, Wakabayashi T, Yamanouchi T, Nagashima H
Drug Healthc Patient Saf · 2022 · PMID 36039072 · Full text
PURPOSE: Our aim was to inform a new definition of wrong-patient errors, obtained through an analysis of incident reports related to medication errors. METHODS: We investigated wrong-patient medication errors in incident...
PURPOSE: Our aim was to inform a new definition of wrong-patient errors, obtained through an analysis of incident reports related to medication errors. METHODS: We investigated wrong-patient medication errors in incident reports voluntarily reported by medical staff using a web-based incident reporting system from 2015 to 2016 at a university hospital in Japan. Incident report content was separately evaluated by four evaluators using investigational methods for clinical incidents from the Clinical Risk Unit and the Association of Litigation and Risk Management. They investigated whether it was the patient or drug that was incorrectly chosen during wrong-patient errors in drug administration in incident reports and assessed contributory factors which affected the error occurrence. The evaluators integrated the results and interpreted them together. RESULTS: Out of a total 4337 IRs, only 30 cases (2%) contained wrong-patient errors in medication administration. The cases where the intended drugs were administered to incorrect patients occurred less frequently than cases where the wrong drugs were administered to the intended patients through the investigation of wrong targets. After a discussion, the evaluators concluded that the patient - drug/CPOE screen mismatch, caused by choosing the wrong patient, drug, or CPOE screen (mix-ups), occurred in the wrong-patient medication errors. These errors were caused by three conditions: (1) where two patients/drugs were listed next to one another, (2) where two patients' last names/drugs' names were the same, and (3) where the patient/drug/CPOE screen in front of the staff involved was believed to be the correct one. Additionally, these errors also involved insufficient confirmation, which led to failure to detect and correct the mismatch occurrences. CONCLUSION: Based on our study, we propose a new definition of wrong-patient medication errors: they consisted of choosing a wrong target and insufficient confirmation. We will investigate other types of wrong-patient errors to apply this definition.
Knowledge and Perceptions of Nurse Practitioners on Adverse Events Following Immunization and Barriers to Reporting in the Central Region, Eritrea: A Cross-Sectional Study.
Abdu N, Mosazghi A, Yehdego T … +2 more , Tesfamariam EH, Russom M
Drug Healthc Patient Saf · 2022 · PMID 35915655 · Full text
BACKGROUND: Though vaccines are generally considered extremely safe and effective, they have been associated with some serious adverse events following immunization (AEFIs). AEFIs might be related to either the vaccine,...
BACKGROUND: Though vaccines are generally considered extremely safe and effective, they have been associated with some serious adverse events following immunization (AEFIs). AEFIs might be related to either the vaccine, immunization error, anxiety related to immunization, and/or coincidental events. If they are not reported and investigated in timely fashion, they can create rumors and confidence gaps. In the last few years, reporting AEFIs in the Central Region of Eritrea, compared to other regions, has been found to be very low, with the root cause for this variation unknown, making intervention strategies challenging. This study was conducted to assess nurse practitioners' knowledge and perceptions on AEFI surveillance and barriers to reporting in the region. METHODS: An analytical cross-sectional study was conducted among all nurse practitioners who were directly or indirectly involved in immunization services working in all health facilities of the region. Data were collected between October 2019 and February 2020 using an interview-based questionnaire. Percentages and medians (IQR) were used as descriptive statistics, and Mann-Whitney and Kruskal-Wallis tests were used as inferential tools. RESULTS: A total of 130 respondents with a median age of 40 (IQR 23) years were included in the study. The overall median (IQR) knowledge score of the respondents on AEFI surveillance was 87.50 (19) out of 100. Furthermore, median (IQR) comprehensive perception score was 70 (20) out of 100 (range 40-95). Shortage of motivation and not knowing how to report were identified as the main barriers to reporting AEFIs. CONCLUSION: Knowledge and perceptions of nurse practitioners in the Central Region on AEFI surveillance were generally encouraging. They should however need to be further trained on the basics of AEFI surveillance to bridge the identified barriers to reporting.
Clinical Manifestations and Genetic Influences in Sulfonamide-Induced Hypersensitivity.
Asyraf PA, Kusnadi IF, Stefanus J … +2 more , Khairinisa MA, Abdulah R
Drug Healthc Patient Saf · 2022 · PMID 35903308 · Full text
Drug hypersensitivity is an inflammatory or immune reaction induced by drugs. It can be fatal if not appropriately treated and cause the risk of long-term complications. Sulfonamides are classified as antimicrobial drugs...
Drug hypersensitivity is an inflammatory or immune reaction induced by drugs. It can be fatal if not appropriately treated and cause the risk of long-term complications. Sulfonamides are classified as antimicrobial drugs with a broad spectrum effective for gram-positive and gram-negative bacteria. This antibacterial agent works by competitively inhibiting folic acid synthesis, which prevents the growth and proliferation of microorganisms. In its use as antibiotics, sulfonamides can also cause adverse reactions in specific individuals. It has been widely reported that sulfonamide antimicrobials cause hypersensitivity reactions mediated by IgE or T cells. This review identifies symptoms or signs that can appear, as well as genes associated with sulfonamide hypersensitivity reactions, as sulfonamide may cause hypersensitivity in the form of uveitis, skin rash, Stevens-Johnson syndrome (SJS)/toxic epidermal necrolysis (TEN), parotitis, angioedema, drug reaction with eosinophilia and systemic symptoms (DRESS), and pruritus. In addition, several genes were found to be associated with sulfonamide hypersensitivity, including HLA-A29, HLA-B12, HLA-DR7, HLA-B44, and HLA A*11:01.
Psychiatric Disorders and Genotoxicity Following Primary Metal on Polyethylene Total Hip Arthroplasty and Their Correlation to Cobalt/Chromium Levels.
Abdel Hamid OI, Attia ME, Hirshon JM … +3 more , El-Shinawi M, El-Hussaini M, El-Setouhy M
Drug Healthc Patient Saf · 2022 · PMID 35880007 · Full text
INTRODUCTION: Hip arthroplasty (HA) using implantable metal components is among the commonest orthopedic interventions. However, it can be followed by several complications following corrosion and the release of metal io...
INTRODUCTION: Hip arthroplasty (HA) using implantable metal components is among the commonest orthopedic interventions. However, it can be followed by several complications following corrosion and the release of metal ions. Several studies proved that damaged genomic DNA may contribute to the pathophysiology of mental disorders. AIM: The current work aims to evaluate the psychiatric disorders in metal on polyethylene hip arthroplasty (MOP-HA) patients and its correlation to cobalt/chromium (Co/Cr) levels and genotoxicity. METHODS: The work was a longitudinal follow-up study including 34 adults with unilateral primary MOP-HA meeting the inclusion and exclusion criteria. Preoperatively, 6, 12-months-postoperatively, patients were examined for cognitive impairment using mini-mental-state-examination (MMSE), depression using major-depressive-inventory (MDI), and blood samples were collected for estimation of Co/Cr, detection of genotoxicity by single-cell-gel-electrophoresis (comet assay) and serum 8-hydroxy-2'-deoxyguanosine (8-OHdG). RESULTS: Cognitive impairment was reported in 18.5% and 14.8% at 6-months, and 12-months postoperative, respectively. Depressive disorder was recorded in 22.2% at 6-months and 14.8% at 12-months postoperative. The marginal homogeneity tests proved a non-significant difference. There was a non-significant difference in preoperative, 6-months, 12-months postoperative MMSE, and MDI scores. There were significantly increased Co/Cr levels at 6-months postoperative. The levels decreased at 12-months postoperative, however, still significantly higher than preoperative values. There was a significant increase in serum 8-OHdG and the levels were positively correlated to cobalt levels at both 6 and 12-months-postoperative. There was a non-significant difference among preoperative, 6-months, and 12-months postoperative comet assay measurements. CONCLUSION: From previous findings, we can conclude that will-functioning MOP hip arthroplasty can induce increased ion levels and positively correlated increase in biochemical markers of genotoxicity (8-OHdG).
Clinical Efficacy, Safety, Tolerability, and Real-World Data of Patiromer for the Treatment of Hyperkalemia.
Colbert G, Sannapaneni S, Lerma EV
Drug Healthc Patient Saf · 2022 · PMID 35860695 · Full text
Hyperkalemia remains one of the most difficult consequences of disease state and treatment for patients with chronic kidney disease, heart failure, and diabetes. Controlling hyperkalemia can be difficult, but has become...
Hyperkalemia remains one of the most difficult consequences of disease state and treatment for patients with chronic kidney disease, heart failure, and diabetes. Controlling hyperkalemia can be difficult, but has become easier with the introduction of novel oral potassium binders. Patiromer was approved in 2015 for the treatment of hyperkalemia by the FDA in the United States. Several pivotal trials proved its efficacy, safety, and improved tolerability compared with previous hyperkalemia treatments. Additionally, many real-world publications and trials have given deeper insights into the capabilities of patiromer. We discuss improved disease state outcomes with combining patiromer with RAASi. This paper will also highlight new trials forthcoming that are highly anticipated to expand the possibilities in using patiromer to improve outcomes and populations.
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