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Liquid chromatography-tandem mass (LC MS/MS) was used for the determination of therapeutic drug monitoring (TDM) of the three antipsychotics (aripiprazole, quetiapine and olanzapine) and three antidepressants (paroxetine, Escitalopram and sertraline) drugs simultaneously. Both groups of drugs can be concurrently used to treat behavioral disorders. It appears that there is no test for the rapid detection of all six compounds simultaneously using LC MS/M, despite the fact that several analysis publications found these drugs individually. 50µl of taken from finger pricks as dried blood spots (DBS) spiked with sample solution containing the six understudied drugs was extracted. A C18-BEH column with a mobile phase made up of gradient elution ammonium acetate with acetonitrile in methanol. The total run time of this method is about 5.5 min. LC MS/MS showed an excellent linearity in the range of 5-100ng ml-1 with a correlation coefficient (r) >0.992. The values of the intra- and inter-day precision of the tested drugs satisfy the regulatory requirements' acceptance criteria. The test was approved in accordance with accepted standards for bioanalytical procedures and it can be successfully applied for therapeutic drug monitoring studies for the tested drugs if they administered concurrently or individually.
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Antipsicóticos , Espectrometría de Masas en Tándem , Antidepresivos , Aripiprazol , Fumarato de QuetiapinaRESUMEN
BACKGROUND: Direct oral anticoagulants (DOACs) are considered high-risk medications and used to prevent thromboembolic events and stroke. This study aimed to examine patients' views and experiences of DOACs use and factors that can promote safety associated with DOACs. METHODS: In-depth interviews were conducted with adult patients who had been prescribed DOACs, identified and invited by local collaborators in three different tertiary care hospitals in Saudi Arabia. A topic guide developed based on was used to inform the interview. Data were analysed thematically. RESULTS: Data saturation was achieved by the ninth participants. Three major themes were identified: (1) factors affecting DOAC's safety from the patients view; (2) barriers to adherence to DOACs and (3) strategies to promote the safety of DOACs. Lack of knowledge of DOACs, using inappropriate sources of information, lack of communication with HCPs, difficulty in having access to DOACs and lack of monitoring were the main factors affecting the safe use of DOACs. Unavailability of the drugs and difficulty in timely getting to hospitals affected adherence. Patients acknowledged difficulties communicating with healthcare professionals, timely access to anticoagulation clinics and in obtaining their DOACs on time. CONCLUSIONS: There is a need to develop and evaluate theory-based interventions to promote patient knowledge, understanding and shared decision-making to optimise DOACs use and improve their safety.
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Introduction: Studies have indicated that half of all patients with diabetes do not take their medication as prescribed. Patient social circles, including professionals (health care providers) and nonprofessionals (family and friends) might contribute to low medication adherence. Therefore, this study explored the point of view of healthcare providers and family members of patients with diabetes on patient medication adherence. Methods: Our study included health care providers and family members using in-depth, semi structured interviews. The theoretical domain framework (TDF) was used to explore their perspectives. TDF was used to build a topic guide and to frame the data analysis. The interviews were transcribed verbatim and thematically analyzed using the MAXQDA 2022 program. Results: The participants identified a variety of factors potentially associated with diabetes medication adherence. Most factors were related to the environmental context and resources such as the burden of polypharmacy, medication shortages, and long wait times for care. In addition, factors related to patient beliefs concerning diabetes complications and insulin injections were reported. Several factors were identified that related to knowledge and social influences. Discussion: Interventions that target the factors identified by the social circle of patients with diabetes might improve medication adherence and promote better disease management outcomes.
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BACKGROUND: Despite their effectiveness and ease of use, medication errors have been reported to be highly prevalent with direct-acting oral anticoagulants (DOAC). AIM: The aim of this study was to explore views and experiences of pharmacists on contributory factors and mitigation strategies around medication errors in relation to DOAC. METHOD: This study used a qualitative design. Semi-structured interviews were conducted with hospital pharmacists in Saudi Arabia. The interview topic guide was developed based on previous literature and Reason's Accident Causation Model. All interviews were transcribed verbatim and MAXQDA Analytics Pro 2020 was used to thematically analyse the data (VERBI Software). RESULTS: Twenty-three participants representing a range of experiences participated. The analysis recognised three major themes: (a) enablers and barriers faced by pharmacists in promoting safe utilisation of DOAC, such as opportunities to conduct risk assessments and offer patient counselling (b) factors related to other healthcare professionals and patients, such as opportunities for effective collaborations and patient health literacy; and (c) effective strategies to promote DOAC safety such as empowering the role of pharmacists, patient education, opportunities for risk assessments, multidisciplinary working and enforcement of clinical guidelines and enhanced roles of pharmacists. CONCLUSION: Pharmacists believed that enhanced education of healthcare professionals and patients, development and implementation of clinical guidelines, improvement of incident reporting systems, and multidisciplinary team working could be effective strategies to reduce DOAC-related errors. In addition, future research should utilise multifaceted interventions to reduce error prevalence.
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Inhibidores del Factor Xa , Farmacéuticos , Humanos , Actitud del Personal de Salud , Errores de Medicación/prevención & control , Investigación CualitativaRESUMEN
Qualitative studies are a valuable approach to exploratory research. Frequently, researchers are required to collect data in languages other than English, which requires a translation process for the results to be communicated to a wider audience. However, language-embedded meaning can be lost in the translation process, and there is no consensus on the optimum timing of translation during the analysis process. Thus, the aim of this paper was to review how researchers conduct qualitative research with Arabic-speaking participants and the timing of data translation. Three databases were searched (PubMed, Scopus, and Web of Science) for the period January 2010 to January 2020. Studies were excluded if the data collection was not in Arabic or the study was not qualitative or healthcare related. Thirty-one studies were included, 26 of which translated all transcripts into English and then analyzed the data in English. Five studies transcribed the data in Arabic, analyzed it in Arabic, and then translated the results to English or conducted a parallel analysis. The reason provided for translating the data into English before the analysis was to enable non-Arabic authors to access the data and assist with the analysis. The search results suggest that researchers prefer translating data before analyzing it and are aware of the possibility of losing meaning during the translation process, which might affect the results. A more thoughtful approach to the timing of translation should be undertaken to ensure the subtleties of language are not lost during the analysis of qualitative data.
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BACKGROUND: Direct oral anticoagulants (DOACs) have become preferable for the management of thromboembolic events. Recent publications have however identified high volume of medication errors related to DOACs. There is limited literature on why and how such errors occur or happen in clinical practice. AIM: This study aimed to explore views, experiences, contributory factors related to DOACs medication errors from the perspectives of healthcare professionals. METHOD: Semi-structured interviews using online videoconferencing were conducted with physicians and nurses from tertiary care hospitals in three different regions in Saudi Arabia. Questions included views, experiences and perceived factors contributing to errors. Interviews were transcribed verbatim and were thematically analyzed using MAXQDA Analytics Pro 2020 (VERBI Software). RESULTS: The semi-structured interviews (n = 34) included physicians (n = 20) and nurses (n = 14) until data saturation was achieved. The analysis identified five themes: Factors related to healthcare professionals (e.g. knowledge, confidence and access to guidelines); Factors related to patients (e.g. comorbidity, polypharmacy, medication review, and communication barriers); Factors related to organization (e.g. guidelines, safety culture and incidents reporting system); Factors related to the DOACs medications (e.g. lack of availability of antidotes and dosing issues); and Strategies for error prevention/mitigation (e.g. the need for professional training and routine medication review). CONCLUSION: Healthcare professionals identified errors in relation to DOACs as multifactorial including their own and patient lack of knowledge, lack of clinical guidelines and organizational factors including safety culture. Medication review and reconciliation on discharge were key strategies suggested to reduce DOACs related errors. These strategies support the role of pharmacists as direct patients care providers to minimize DOACs errors.
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Errores de Medicación , Médicos , Anticoagulantes/efectos adversos , Humanos , Errores de Medicación/prevención & control , Farmacéuticos , Investigación CualitativaRESUMEN
OBJECTIVE: Metformin (MET), an oral biguanide agent, can improve insulin resistance and decrease hepatic glucose production, leading to a reduction in blood-sugar levels. The objective of the present study was to develop and validate simple and rapid LC-MS/MS method for analysis of MET in dried blood spot (DBS) sample for patient monitoring studies purposes (drug adherence). METHODS: The chromatographic separation was achieved with Waters HSS-T3 column using gradient elution of mobile phases of two solvents: 1) solvent A, consisted of 10mM ammonium formate, 0.2% formic acid 1%; and 2) acetonitrile solvent B, contained 0.2% formic acid in acetonitrile at a flow rate of 0.2 mL/min. The total run time was 3.0 min. The effectiveness of chromatographic conditions was optimized, and afatinib was used as the internal standard. The assay method was validated using USP 26 and the ICH guidelines. RESULTS: The method showed good linearity in the range 8-48 ng/mL for MET with correlation coefficient (r) >0.9907. The intra- and interday precision values for MET met the acceptance criteria as per regulatory guidelines. MET was stable during the stability studies at ambient temperature 25 °C, at refrigerator 4 °C, at 10 °C autosampler, freeze/thaw cycles and 30 days storage in a freezer at -30 ± 0.5 °C. CONCLUSION: This method has successfully fulfilled all validation requirements referring to EMA and FDA guidelines, and successfully can be applied for MET adherence study. All the six studied patients were approved to metformin adherence.
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BACKGROUND: Cardiovascular disease (CVD) is an emerging contributor to national morbidity and mortality in Saudi Arabia. CVD risk prevention services are limited, particularly with an over-utilised public health sector and an under-utilised and under-resourced primary care sector. Globally, there is evidence that community pharmacists can play a key role in CVD prevention within primary care. However, the perspectives of policymakers and opinion leaders are critical to successful translation of evidence into practice. Thus, the aim was to engage policymakers and professional leaders in discussions about implementing high-quality CVD risk prevention services in community pharmacy. METHODS: Qualitative semi-structured interviews were conducted, audio-recorded and transcribed verbatim. All transcripts were thematically analysed. RESULTS: A total of 23 participants (87% male) from government and non-government sectors were interviewed. Of these, almost 65% had pharmacy qualifications. Limited provision of CVD risks preventative services in primary care was acknowledged by most participants and building community pharmacists' capacity to assist in preventive health services was viewed favourably as one way of improving the status quo. The data yielded four key themes: (1) future pharmacy CVD health service models; (2) demonstrable outcomes; (3) professional engagement and advocacy; and (4) implementability. CVD health services roles (health screening, primary and secondary prevention services), pragmatic factors and tiered models of care (minimal, medium, and comprehensive pharmacist involvement) were discussed. The need for humanistic, clinical, and cost effectiveness outcomes to be demonstrated and active involvement of professional bodies were deemed important for such services to be sustainable. Professional pharmacy governance to develop pharmacy careers and workforce, pharmacy curricular reform and ongoing education were posed as key success factors for novel pharmacy roles. Practice policies, standards, and guidelines were seen as required to adhere to stringent quality control for future pharmacy services provision. Participant's implementation vision for such services included scalability, affordability, access, adoption and health system reform. Most discussions focused on the need for structural improvement with limited input regarding processes or outcomes required to establish such models. CONCLUSIONS: Most participants favoured pharmacy-based CVD risk prevention services, despite the variability in proposed service models. However, prior to developing such services, support structures at the health system and health professional level are needed as well as building public support and acceptability for pharmacy services.
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Objectives: Patients with schizophrenia are at high risk of developing diabetes. Our study aimed to determine the prevalence of diabetes in patients with schizophrenia and assess their quality of diabetes care. We further aimed to explore the factors affecting diabetes care in patients with schizophrenia. Research design and methods: We conducted a retrospective review of medical records for patients presenting with schizophrenia from October 2017 to October 2018. Thereafter, we conducted semi-structured interviews based on the Theoretical Domains Framework to explore healthcare providers' attitudes and perspectives toward diabetes care in patients with schizophrenia at a tertiary hospital for mental health services in Saudi Arabia. Results: The prevalence of diabetes in patients with schizophrenia was 3.7%. The rates of annual testing for quality indicators of diabetes were 8.6% for HgbA1c and 31.4% for low-density lipoprotein cholesterol (LDL-C). Screenings for albuminuria and examinations of the eyes and feet were not conducted. Documentation of smoking status was done infrequently (8.6%). The in-depth interviews uncovered issues with managing diabetes in patients with schizophrenia. We identified four themes: the consequences of poor quality diabetic care provided to patients with schizophrenia; problems with the identification of diabetes in patients with schizophrenia; challenges in the management of patients with both diabetes and schizophrenia; and opportunities to improve the quality of diabetes care provided to patients with schizophrenia. Conclusions: This study identified areas that need a considerable amount of work to be undertaken in Saudi Arabia to help patients with schizophrenia. There are numerous opportunities for improving the quality of Type 2 diabetes care such as the involvement of pharmacists to effectively manage diabetes and expanding community-based health services to include mental health, which could accelerate improved care services.
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Background: Cardiovascular diseases (CVD) are the leading cause of mortality worldwide. Early identification and management of modifiable CVD risk factors are highly effective in preventing disease onset and/or improving outcomes in CVD. As highly accessible primary health professionals, pharmacists can assume a role in screening and risk factor management in collaboration with physicians; however, such prevention services are not established practice in Saudi pharmacies. Therefore, the aim was to explore physicians' perceptions about the utility of a role in CVD risk screening and management for Saudi pharmacists. Methods: Qualitative semi-structured interviews were conducted, audio-recorded and transcribed verbatim in Arabic or English. All transcripts were thematically analyzed in an inductive approach after translation into English if required. Results: A total of 26 physicians recruited from public hospitals and primary healthcare centers were interviewed. Most were unaware of pharmacists' potential to undertake a role in CVD risk prevention. Although there was broad support for the concept, they recommended physician-pharmacist collaborative models, extensive provider pharmacist training, and strict oversight by the Saudi Ministry of Health (MoH)/other official authorities to ensure service quality and sustainability, should implementation occur. Healthcare system reform was considered key to expanding private sector (i.e., community pharmacy) involvement in healthcare, as was incentivizing providers and 'marketing' for patient acceptance. Conclusion: Physicians were positive about setting up a collaborative community pharmacist-physician CVD risk screening and management service model with the help of an authorized body within the Saudi Arabian healthcare system.
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OBJECTIVE: Despite the positive attitudes pharmacists have toward evidence-based practices (EBPs), its application in community pharmacies in Saudi Arabia is lacking. Therefore, this study aimed to explore and assess EBPs by community pharmacists in Saudi Arabia when they dispense over-the-counter (OTC) medications for three minor ailments: diarrhea, cough, and the common cold. RESEARCH DESIGN AND METHODS: We used a mixed-methods approach consisting of two study parts. The first was a quantitative investigation that used mystery shoppers. Four researchers, posing as mystery shoppers, visited 214 randomly selected pharmacies in the Riyadh region of Saudi Arabia. They used 14 questions from a standardized checklist to examine EBPs by community pharmacists. The qualitative part of the study entailed three focus-group discussions with 13 pharmacists from different community practice settings and explored factors that affected the application of EBPs when supplying OTC medications from the pharmacists' point of view. RESULTS: The analysis indicated that 40% of pharmacists dispensed OTC medications according to EBPs. Logistic regression analysis showed that one question, "Describe your symptoms", predicted the correct supply of OTC medications (p = 0.021). The qualitative section of the study identified nine factors that affected EBP. Some of these factors facilitated EBP, such as established patient-pharmacist relationships, some acted as barriers such as conflicts between available evidence, while other factors could either facilitate or hinder EBPs, such as the health literacy of the patient. CONCLUSION: Given that dispensing OTC medication is a core function of pharmacists, this study uncovered low adherence to EBPs by community pharmacists in Saudi Arabia when dispensing OTC medication for three minor ailments: diarrhea, cough, and the common cold. Furthermore, this study identified a number of explanatory factors for this low adherence. Targeting these factors could help change the behavior of pharmacists and decrease undesirable outcomes.
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Práctica Farmacéutica Basada en la Evidencia , Medicamentos sin Prescripción/provisión & distribución , Servicios Comunitarios de Farmacia , Grupos Focales , Humanos , Farmacias/organización & administración , Farmacéuticos , Rol Profesional , Relaciones Profesional-Paciente , Arabia Saudita , Encuestas y CuestionariosRESUMEN
INTRODUCTION: Cardiovascular diseases (CVD) are one of key leading causes of mortality worldwide. Both modifiable and non-modifiable risk factors contribute to the development of CVD. Modifiable risk factors such as smoking, unhealthy diets and lack of exercise are increasing in prevalence in Saudi Arabia but may be mitigated using pharmacological and non-pharmacological approaches. Thus, identifying, assessing and managing these modifiable risks at an early stage is essential. Pharmacists are highly accessible primary health professionals and can play a crucial role in screening and managing these risk factors in collaboration with primary care physicians. There is currently no research in Saudi Arabia exploring the views of health consumers with CVD risk factors regarding their preferences for or willingness to engage with community pharmacy CVD preventive health services. OBJECTIVES: To explore the perceptions of health consumers about current and feasible future services by pharmacists with a specific focus on CVD risk screening and management in Saudi Arabia. METHODS: Semi-structured interviews were conducted with consumers with at least one modifiable CVD risk factor. The interviews were audio-recorded, transcribed verbatim, translated into English and then thematically analysed. RESULTS: A total of 25 individuals, most of whom were Saudi (88%) and women (65%), participated in face to face interviews. Five main themes emerged from the analysis of consumers' responses. 1. Perception of pharmacists' role, the pharmacists' main role was perceived as medication supply. 2. Trust and satisfaction with current service, most participants appeared to have low trust in pharmacists. 3. Preferences for future pharmacy services, most participants were willing to engage in future pharmacy delivered CVD preventive health services, provided there was stringent regulation and oversight of the quality of such services. 4. Viability of new pharmacy services was raised with promotion of such services to the public, collaboration with other health professionals, financial incentivization and motivational rewards thought of as essential ingredient to ensure service feasibility. 5. Health beliefs and help seeking behaviours of consumers were diverse and low health literacy was evident; it was thought that pharmacists can help in these matters by educating and advocating for such consumers. Overall, the data suggested that clinical, communication and professional skills need to be enhanced among Saudi pharmacists to enable them to provide optimal patient cantered services. CONCLUSION: Health consumers participants were willing to participate and utilise CVD risk screening and management pharmacy-based services, when offered, provided their concerns are addressed. Therefore, in light of the burden of CVD disease in the country, development, implementation and evaluation of pharmacist provided CVD risk screening and management should be undertaken.
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BACKGROUND: In common with many developed countries, Saudi Arabia is currently experiencing an increasing cardiovascular disease (CVD) burden. However, systematic screening programs for early identification and minimization of CVD risk within community or general clinical settings are limited. Globally, research suggests that pharmacists can play an effective role in identifying, assessing, managing and referring people at risk of CVD in the community as well as in the hospital setting. This role is not yet developed in Saudi Arabia. OBJECTIVES: This study aimed to explore the perspectives of hospital and community pharmacists in Saudi Arabia about potential roles in CVD risk screening. The purpose of the study was to propose potential interventions to facilitate the development of pharmacist delivered models for CVD risk prevention and management services in Saudi Arabia. METHODS: A qualitative study was conducted using semi-structured in-depth interviews and focus group discussions with a purposive convenience sample of hospital and community pharmacists in Saudi Arabia. Data collection continued until saturation was achieved. All interviews were audio recorded, transcribed verbatim and thematically analyzed. RESULTS: A total of 50 pharmacists (26 hospital and 24 community pharmacists) participated in this study. Twenty hospital and eight community pharmacists were interviewed individually, while the remaining participants contributed to three focus groups discussions. Currently, it appears that CVD risk prevention services are rarely provided, and when offered involved provision of discrete elements only such as blood pressure measurement, rather than a consolidated evidence based approach to risk assessment. Participating pharmacists did not appear to have a clear understanding of how to assess CVD risk. Four key themes were identified: pharmacists' perception about their current roles in CVD, proposed future clinical and service roles, impeding factors and enabling factors. Subthemes were mainly related to determinants likely to influence future CVD services. These subthemes included public perception of pharmacists' roles, pharmacist-physician collaboration, legislative restrictions, systemic issues, sociocultural barriers, organizational pharmacy issues, lack of professional motivation, government and organizational support and professional pharmacy support frameworks. These influencing factors need to be addressed at micro, meso and macro systems level in order to facilitate development of new pharmacist delivered cognitive services in Saudi Arabia. CONCLUSIONS: Pharmacists in Saudi Arabia are willing to expand their role and offer pharmacy-based services, but influencing determinants have to be addressed at the individual, professional and health system levels. Further work is needed to clarify and develop practical and appropriate protocols for pharmacist CVD prevention and management services within the Saudi public and health care system. Such work should be guided by implementation science frameworks rather than embarking on conventional research trial pipelines where public benefit of generated evidence is delayed or limited.
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Enfermedades Cardiovasculares/diagnóstico , Conductas Relacionadas con la Salud , Tamizaje Masivo/normas , Farmacéuticos/normas , Rol Profesional , Investigación Cualitativa , Adulto , Actitud del Personal de Salud , Enfermedades Cardiovasculares/etnología , Enfermedades Cardiovasculares/psicología , Servicios Comunitarios de Farmacia/tendencias , Femenino , Conductas Relacionadas con la Salud/etnología , Humanos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Farmacéuticos/psicología , Servicio de Farmacia en Hospital/normas , Rol Profesional/psicología , Medición de Riesgo/métodos , Medición de Riesgo/normas , Arabia Saudita/etnología , Adulto JovenRESUMEN
OBJECTIVE: Oral hypoglycemic agents (OHAs) are highly effective in managing Type 2 diabetes if taken appropriately. This study assessed adherence to OHAs among patients with Type 2 diabetes and explored factors associated with adherence behaviour. RESEARCH DESIGN AND METHODS: Mixed methods were used comprising a cross-sectional study using the Arabic version of the Morisky Medication Adherence Scale followed by semi-structured interviews using the Theoretical Domain Framework to explore key determinants of adherence. RESULTS: The cross-sectional study included 395 patients of whom 40% achieved a high level of OHA adherence. Lower adherence was associated with younger age (Odds Ratio (OR) 1.084; 95% CI 1.056 to 1.112), higher numbers of non-OHAs (OR 0.848; 95% CI 0.728 to 0.986) and higher HbA1c levels (OR 0.808; 95% CI 0.691 to 0.943). Semi structured interviews based on the Theoretical Domain Framework were completed with 20 patients and identified a wide range of factors potentially associated with OHA adherence, particularly behavioural related factors (e.g. scheduling medication intake, ability to develop a habitual behaviour), social influences (e.g. acting as a role model, the effect of family support), and gaps in knowledge about diabetes and its management with OHAs. CONCLUSIONS: This unique mixed-methods study has highlighted possible reasons for the low levels of OHA adherence in this patient population. Whilst the theoretically-derived determinants of behaviour illustrate the complexities associated with OHA adherence, they also provide a robust underpinning for future intervention(s) development to improve adherence and maximise patient health outcomes.
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Diabetes Mellitus Tipo 2/tratamiento farmacológico , Cumplimiento de la Medicación/estadística & datos numéricos , Estadística como Asunto/métodos , Anciano , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana EdadRESUMEN
PURPOSE: This study aimed to explore the physician's knowledge and identify the perceived barriers that prevent family medicine physicians from engaging in deprescribing among older patients. METHODS: This qualitative study was designed and conducted using an interpretive theoretical approach. Purposive sampling was undertaken, whereby family medicine physicians of King Saud University Medical City (KSUMC), Riyadh, Saudi Arabia, were invited to participate in the study. The topic guidelines were designed to give the physicians the freedom to express their views on exploring their knowledge about deprescribing and to identify the perceived barriers and enablers that prevent them from engaging in the practice in older patients. The focus group discussions were conducted in English, audio-taped with permission, and transcribed verbatim. Each transcript was independently reviewed and coded separately to explore the themes and sub-themes. RESULTS: A total of 15 physicians participated in three focus group discussions. Their thematic content analysis identified 24 factors that facilitated or hindered deprescribing. The facilitators included cost-effectiveness and time effectiveness, side effects avoidance, clinical pharmacist's role, need for system(s) to help in applying deprescribing, and patient counseling/education. Similarly, barriers included lack of knowing the deprescribing term and process, patient comorbidities, risk/fear of conflict between physicians and clinical pharmacists, lack of documentation and communication, lack of time or crowded clinics, and patient resistance/acceptance. CONCLUSION: The study identified several factors affecting family medicine physician's deprescribing behavior. The use of theoretical underpinning design helped to provide a comprehensive range of factors that can be directed when defining targets for intervention(s).
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Actitud del Personal de Salud , Deprescripciones , Médicos Generales/psicología , Prescripción Inadecuada/prevención & control , Pautas de la Práctica en Medicina , Anciano , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos , Femenino , Grupos Focales , Humanos , Masculino , Investigación Cualitativa , Arabia SauditaRESUMEN
OBJECTIVE: To investigate the epidemiology of medication errors and error-related adverse events in adults in primary care, ambulatory care and patients' homes. DESIGN: Systematic review. DATA SOURCE: Six international databases were searched for publications between 1 January 2006 and 31 December 2015. DATA EXTRACTION AND ANALYSIS: Two researchers independently extracted data from eligible studies and assessed the quality of these using established instruments. Synthesis of data was informed by an appreciation of the medicines' management process and the conceptual framework from the International Classification for Patient Safety. RESULTS: 60 studies met the inclusion criteria, of which 53 studies focused on medication errors, 3 on error-related adverse events and 4 on risk factors only. The prevalence of prescribing errors was reported in 46 studies: prevalence estimates ranged widely from 2% to 94%. Inappropriate prescribing was the most common type of error reported. Only one study reported the prevalence of monitoring errors, finding that incomplete therapeutic/safety laboratory-test monitoring occurred in 73% of patients. The incidence of preventable adverse drug events (ADEs) was estimated as 15/1000 person-years, the prevalence of drug-drug interaction-related adverse drug reactions as 7% and the prevalence of preventable ADE as 0.4%. A number of patient, healthcare professional and medication-related risk factors were identified, including the number of medications used by the patient, increased patient age, the number of comorbidities, use of anticoagulants, cases where more than one physician was involved in patients' care and care being provided by family physicians/general practitioners. CONCLUSION: A very wide variation in the medication error and error-related adverse events rates is reported in the studies, this reflecting heterogeneity in the populations studied, study designs employed and outcomes evaluated. This review has identified important limitations and discrepancies in the methodologies used and gaps in the literature on the epidemiology and outcomes of medication errors in community settings.
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Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Prescripción Inadecuada/estadística & datos numéricos , Errores de Medicación/estadística & datos numéricos , Seguridad del Paciente , Atención Ambulatoria , Humanos , Incidencia , Atención Primaria de Salud , Factores de RiesgoRESUMEN
Introduction The Middle East respiratory syndrome coronavirus (MERS-CoV) infection can cause transmission clusters and high mortality in hemodialysis facilities. We attempted to develop a risk-prediction model to assess the early risk of MERS-CoV infection in dialysis patients. Methods This two-center retrospective cohort study included 104 dialysis patients who were suspected of MERS-CoV infection and diagnosed with rRT-PCR between September 2012 and June 2016 at King Fahd General Hospital in Jeddah and King Abdulaziz Medical City in Riyadh. We retrieved data on demographic, clinical, and radiological findings, and laboratory indices of each patient. Findings A risk-prediction model to assess early risk for MERS-CoV in dialysis patients has been developed. Independent predictors of MERS-CoV infection were identified, including chest pain (OR = 24.194; P = 0.011), leukopenia (OR = 6.080; P = 0.049), and elevated aspartate aminotransferase (AST) (OR = 11.179; P = 0.013). The adequacy of this prediction model was good (P = 0.728), with a high predictive utility (area under curve [AUC] = 76.99%; 95% CI: 67.05% to 86.38%). The prediction of the model had optimism-corrected bootstrap resampling AUC of 71.79%. The Youden index yielded a value of 0.439 or greater as the best cut-off for high risk of MERS infection. Discussion This risk-prediction model in dialysis patients appears to depend markedly on chest pain, leukopenia, and elevated AST. The model accurately predicts the high risk of MERS-CoV infection in dialysis patients. This could be clinically useful in applying timely intervention and control measures to prevent clusters of infections in dialysis facilities or other health care settings. The predictive utility of the model warrants further validation in external samples and prospective studies.
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Infecciones por Coronavirus/etiología , Coronavirus del Síndrome Respiratorio de Oriente Medio/patogenicidad , Diálisis Renal/efectos adversos , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Infecciones por Coronavirus/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Diálisis Renal/métodos , Estudios Retrospectivos , Arabia Saudita , Adulto JovenRESUMEN
BACKGROUND: Research evidence exists that poor prognosis is common in Middle East respiratory syndrome coronavirus (MERS-CoV) patients. OBJECTIVES: This study estimates recovery delay intervals and identifies associated factors in a sample of Saudi Arabian patients admitted for suspected MERS-CoV and diagnosed by rRT-PCR assay. METHODS: A multicenter retrospective study was conducted on 829 patients admitted between September 2012 and June 2016 and diagnosed by rRT-PCR procedures to have MERS-CoV and non-MERS-CoV infection in which 396 achieved recovery. Detailed medical charts were reviewed for each patient who achieved recovery. Time intervals in days were calculated from presentation to the initial rRT-PCR diagnosis (diagnosis delay) and from the initial rRT-PCR diagnosis to recovery (recovery delay). RESULTS: The median recovery delay in our sample was 5 days. According to the multivariate negative binomial model, elderly (age ≥ 65), MERS-CoV infection, ICU admission, and abnormal radiology findings were associated with longer recovery delay (adjusted relative risk (aRR): 1.741, 2.138, 2.048, and 1.473, respectively). Camel contact and the presence of respiratory symptoms at presentation were associated with a shorter recovery delay (expedited recovery) (aRR: 0.267 and 0.537, respectively). Diagnosis delay is a positive predictor for recovery delay (r = .421; P = .001). CONCLUSIONS: The study evidence supports that longer recovery delay was seen in patients of older age, MERS-CoV infection, ICU admission, and abnormal radiology findings. Shorter recovery delay was found in patients who had camel contact and respiratory symptoms at presentation. These findings may help us understand clinical decision making on directing hospital resources toward prompt screening, monitoring, and implementing clinical recovery and treatment strategies.
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Infecciones por Coronavirus/patología , Coronavirus del Síndrome Respiratorio de Oriente Medio/aislamiento & purificación , Remisión Espontánea , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Animales , Niño , Preescolar , Infecciones por Coronavirus/epidemiología , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Coronavirus del Síndrome Respiratorio de Oriente Medio/genética , Reacción en Cadena en Tiempo Real de la Polimerasa , Estudios Retrospectivos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Arabia Saudita/epidemiología , Factores de Tiempo , Adulto JovenRESUMEN
BACKGROUND: The rapid and accurate identification of individuals who are at high risk of Middle East respiratory syndrome coronavirus (MERS-CoV) infection remains a major challenge for the medical and scientific communities. The aim of this study was to develop and validate a risk prediction model for the screening of suspected cases of MERS-CoV infection in patients who have developed pneumonia. METHODS: A two-center, retrospective case-control study was performed. A total of 360 patients with confirmed pneumonia who were evaluated for MERS-CoV infection by real-time reverse transcription polymerase chain reaction (rRT-PCR) between September 1, 2012 and June 1, 2016 at King Abdulaziz Medical City in Riyadh and King Fahad General Hospital in Jeddah, were included. According to the rRT-PCR results, 135 patients were positive for MERS-CoV and 225 were negative. Demographic characteristics, clinical presentations, and radiological and laboratory findings were collected for each subject. RESULTS: A risk prediction model to identify pneumonia patients at increased risk of MERS-CoV was developed. The model included male sex, contact with a sick patient or camel, diabetes, severe illness, low white blood cell (WBC) count, low alanine aminotransferase (ALT), and high aspartate aminotransferase (AST). The model performed well in predicting MERS-CoV infection (area under the receiver operating characteristics curves (AUC) 0.8162), on internal validation (AUC 0.8037), and on a goodness-of-fit test (p=0.592). The risk prediction model, which produced an optimal probability cut-off of 0.33, had a sensitivity of 0.716 and specificity of 0.783. CONCLUSIONS: This study provides a simple, practical, and valid algorithm to identify pneumonia patients at increased risk of MERS-CoV infection. This risk prediction model could be useful for the early identification of patients at the highest risk of MERS-CoV infection. Further validation of the prediction model on a large prospective cohort of representative patients with pneumonia is necessary.
Asunto(s)
Infecciones por Coronavirus/complicaciones , Infecciones por Coronavirus/epidemiología , Neumonía/complicaciones , Neumonía/diagnóstico , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Alanina Transaminasa/metabolismo , Animales , Camelus , Estudios de Casos y Controles , Infecciones por Coronavirus/tratamiento farmacológico , Infecciones por Coronavirus/virología , Diagnóstico Precoz , Femenino , Humanos , Masculino , Persona de Mediana Edad , Coronavirus del Síndrome Respiratorio de Oriente Medio/genética , Coronavirus del Síndrome Respiratorio de Oriente Medio/aislamiento & purificación , Neumonía/epidemiología , Neumonía/inmunología , Valor Predictivo de las Pruebas , Desarrollo de Programa , Reacción en Cadena en Tiempo Real de la Polimerasa , Estudios Retrospectivos , Riesgo , Arabia Saudita/epidemiología , Adulto JovenRESUMEN
Warfarin is routinely monitored by assessing its pharmacologic effects on the international normalized ratio. However, having a patient with INR not responding to increasing warfarin dose mandates a direct measurement of warfarin concentrations (total and free) for better patient clinical management of warfarin therapy. Therefore, a new fully validated specific, precise and accurate ultra-performance liquid chromatography tandem mass spectrometry was developed for the determination of free and total warfarin in human plasma. Free warfarin was measured in plasma filtrate, prepared by ultrafiltration, and sample pretreatment involved protein precipitation with acetonitrile. Linear response (r(2) ≥0.99) was observed over the studied range of free and total warfarin, with the lower limit of detection of 0.25 ng/mL. The intra- and inter-day precision (relative standard deviation) values were <10% and the accuracy (relative error) was ≤6.6 for free and total warfarin. There was no significant difference (p>0.05) between inter- and intra-day studies for the free and total warfarin, which confirmed the reproducibility of the assay method. The mean extraction efficiency was 88.6-107.2% of free and total warfarin. The assay was sensitive to follow warfarin pharmacokinetics (free and total) in a patient with resistance to warfarin up to 24 h after a daily dose of warfarin.