Evaluation of medication package inserts in Saudi Arabia

Sinaa A Al-aqeelClinical Pharmacy Department, King Saud University, Riyadh, Kingdom of Saudi ArabiaPurpose: The aim of this study was to examine if package inserts (PIs) supplied with prescribed and over-the-counter medications in Saudi Arabia contain information relevant for the safe and appropriate use of these medications.Methods: Sixty PIs for prescription-only medications (n = 37) and over-the-counter medications (n = 23) were evaluated against a set of safety criteria compiled from the literature.Results: Analyzed PIs were defective in many aspects. Particularly of concern were unclear dosage instructions, lack of measures to be taken when an administrative error was made, inappropriate presentation of side effects, and lack of measures to be taken if serious side effects occurred.Conclusion: This study indicated that information relevant to the safe and appropriate use of medications was not uniformly mentioned in the PIs analyzed. To avoid medication errors due to deficits in the current PIs, we recommend improvement in the existing PIs based on best practice for information content and design.Keywords: drug information, patient education, patient information leaflets, package insert

The use of pharmacoeconomic evidence to support formulary decision making in Saudi Arabia: Methodological recommendations

AbstractIn pharmacoeconomics the costs and consequences of alternative medications are compared. Many countries have begun to use pharmacoeconomic evidence to support decisions on licensing, pricing, reimbursement, or addition to the formulary. In Saudi Arabia, it is not mandatory to submit cost effectiveness evidence to support licensing or addition to the formulary decisions however, data will be considered if submitted. Previous evidence suggests that the use of pharmacoeconomic evidence by Saudi Pharmacy and Therapeutic (P&T) committee members in formulary decisions making process is limited mainly because of lack of expertise and lack of resources. This paper intended to provide Saudi P&T decision makers with a clear set of best practice methodological recommendations to help in increasing the utilisation of pharmacoeconomic evidence in the formulary decisions making process

Analysis of written advertising material distributed through community pharmacies in Riyadh, Saudi Arabia

Background: Advertising is a crucial component of pharmaceutical industry promotion. Research indicates that information on advertisement materials might be inadequate, inaccurate, biased, and misleading.Objective: To analyse and critically assess the information presented in print pharmaceutical advertisements in Saudi Arabia.Methods: Pharmaceutical advertisements were collected from 280 community pharmacies in Riyadh city, Saudi Arabia. The advertisements were evaluated using criteria derived from the Saudi Food and Drug Authority (SFDA) regulation, the World Health Organization (WHO) ethical medicinal drug promotion criteria, and other principles reported in similar studies. The data were extracted independently by two of the researchers using a standardized assessment form.Results: One hundred eighty five printed advertisements were included in the final sample. Approximately half of the advertisements (n = 94, 51%) were for over-the-counter (OTC) medications, and 71 (38%) were for prescription-only medication. Information such as the name of active ingredients was available in 168 (90.8%) advertisements, therapeutic uses were mentioned in 156 (98.7%) of analysed advertisements. Safety information related to side effects, precautions, and major interactions were stated in 53 (28.5%), 58 (31%), and 33 (16.5%) advertisements, respectively. Only 119 advertisements (64%) provided references for information presented.Conclusions: Our findings suggest that print advertisements do not convey all the information necessary for safe prescribing. These results have implications for the regulation of drug advertising and the continuing education of pharmacists

Improving medication dispensing and counselling for patients with vision impairment: a qualitative study of pharmacist-reported barriers and facilitators

BackgroundPeople with vision impairment encounter many difficulties when it comes to medicines use. However, evidence indicates that there are major gaps in pharmaceutical care service provision worldwide and limited research on interventions to optimise medication use for this patient population. The Theoretical Domains Framework (TDF) provides a method for theoretically understanding individuals’ behaviour and informing development of interventions. The aim of this research was to (a) identify the barriers and facilitators to the provision of medication dispensing and counselling services by pharmacists to patients with vision impairment, and (b) identify key TDF domains to be targeted in a future intervention.MethodsSemi-structured interviews were conducted with pharmacists from different pharmacy practice settings/areas in Saudi Arabia. The 14-domain TDF was utilised as the theoretical lens through which pharmacists’ behaviours were examined. Interviews were conducted in Arabic or English, either face-to-face or over the telephone based on the participant’s preference. Following transcription, interviews conducted in Arabic were translated into English before analysis. Data analysis involved using the framework method and content analysis to identify important barriers and facilitators to the provision of dispensing and counselling services to those with vision impairment. Key TDF domains that could be targeted in a future intervention were then identified using a consensus-based approach.ResultsTwenty-six pharmacists were interviewed. Pharmacists’ experience in pharmacy practice ranged from two to 28 years. A range of barriers and facilitators were highlighted as important in providing services to those with vision impairment. Eight domains were identified as ‘key domains’ including: ‘Knowledge’, ‘Skills’, ‘Beliefs about capabilities’, ‘Goals’, ‘Memory, attention, and decision processes’, ‘Environmental context and resources’, ‘Social influences’, and ‘Behavioural regulation’.ConclusionsBarriers and facilitators identified by pharmacists will inform the development of an intervention to ensure its applicability to everyday practice. Future research will focus on the process of developing the proposed intervention through targeting key TDF domains to improve medication dispensing and counselling by pharmacists to patients with vision impairment

Appropriateness of anemia management in hemodialysis patients

AbstractThe anemia of end stage renal disease (ESRD) is common and often severe complication that can be managed successfully by erythropoiesis-stimulating agents (ESA) administration.AimsTo investigate current practice of anemia management in hemodialysis patients and to assess the appropriateness of anemia management by comparing observed practice to the Kidney Disease Outcomes Quality Initiative (KDOQI) guideline recommendations.Settings and designThe study was conducted at two hemodialysis centers in Riyadh, Saudi Arabia. Data on anemia parameters, comorbidities, ESA dosing and iron supplementation were collected. The data were collected for 7 months retrospectively from April to the end of May 2008 and prospectively from June to October 2008. Patients who were over 18 years of age with ESRD undergoing hemodialysis were included. Patients were excluded if they have cancer or receiving chemotherapy or radiotherapy.ResultsData were collected from 87 patients. Mean Hgb value for those patients was 11.16±0.97g/dL. Thirty-nine patients (45%) had mean Hgb values between 11.0 and 12.0g/dL the target range recommended by KDOQI guideline. The mean weekly prescribed dose of erythropoietin was 8099±5946IU/Week (135±99IU/kg/Week). Information on ferritin concentrations was available for 48 (55%) patients. The mean serum ferritin concentration for those patients was 693±420.5ng/mL. Fifty-two patients had transferrin saturation (TSAT) values recorded. The mean TSAT value was 38.5±19.7%. Conclusions: There is an opportunity to improve anemia management in hemodialysis patients particularly thorough evaluation of causes of inadequate response rate and better monitoring and management of iron status

Barriers to and Facilitators of Adherence to Clinical Practice Guidelines in the Middle East and North Africa Region: A Systematic Review

The current review aims to investigate the barriers to and facilitators of the adherence to clinical practice guidelines (CPGs) in the Middle East and North Africa (MENA) region. English language studies published between January 2010 and May 2019 were searched on PubMed, Embase, and EBSCO. The barriers were categorized as clinician-related factors, such as lack of awareness of familiarity with the CPGs, and external factors, such as patients, guidelines, and environmental factors. The search identified 295 titles, out of which 15 were included. Environmental factors, specifically lack of time, resources, incentives, availability, and costs of treatment or diagnostic tests, training, and dissemination plans were the most commonly identified barriers. The familiarity with or awareness of healthcare professionals about the guideline, guideline characteristics, lack of agreement with the guidelines and preference in clinical judgment, physician self-efficacy, and motivation were reported to a lesser extent. Few studies reported on the compliance of facilitators with the guidelines including disseminating and advertising guideline materials, education and training on the guidelines, regulatory and financial incentives, and support from institutions. The review highlights that the studies on barriers to and facilitators of compliance with CPGs in the MENA region are limited in number and quality