Competencies, skills, and personal characteristics needed for pharmacy leaders: An in-depth interview.

Objectives: This study aims to explore the essential competencies, leadership development strategies, skills, values, and personal characteristics required for pharmacists aspiring to leadership positions in Saudi Arabia. Methods: Semi-structured, in-depth interviews, conducted either in person or via video, were selected to confidentially explore the leadership traits and strategies of pharmacists. The study included twelve pharmacists, consisting of 7 males and 5 females, with varying levels of experience: 3 aspiring leaders, 5 current leaders, and 4 retired leaders. A fourteen-question interview guide was developed to investigate the key elements necessary for effective pharmacy leadership development. The guide was pilot tested with two pharmacists, whose responses were excluded from the final sample and subsequent analysis. Results: The study revealed significant disparities in the perceptions of leadership skills and personal characteristics among the different groups. The junior cohort, consisting of aspiring pharmacists, emphasized idealistic personal characteristics over practical skills. In contrast, current and retired leaders demonstrated a clear ability to differentiate between personal characteristics and essential skills. Furthermore, the study identified leadership development strategies grounded in the Saudi context, which were particularly resonant with both current and former leaders. Conclusions: The study examined the essential competencies and leadership development strategies for pharmacists aspiring to leadership roles, revealing notable disparities between early-career individuals and current or former leaders. Future research should focus on bridging these differences in perception and skills through targeted knowledge interventions.

Retrospective descriptive assessment of clinical decision support medication-related alerts in two Saudi Arabian hospitals.

OBJECTIVES: To determine the frequency of clinical decision support system (CDSS) medication-related alerts generated, accepted, or overridden, to assess appropriateness of alert display and overrides, and to characterise the documentation of clinician justification for these overrides in an academic medical centre in Saudi Arabia. MATERIALS AND METHODS: System-generated CDSS reports for the period June 2015 to December 2017 were retrospectively reviewed and analysed. Alerts were classified into different types, and rates of alert overrides calculated as percentages of all generated alerts. A subset of 307 overridden alerts was assessed for appropriateness of display and override by two clinical pharmacists. Physician documentation of reasons for overriding alerts were categorised. RESULTS: A total of 4,446,730 medication-related alerts were generated from both inpatient and outpatient settings, and 4,231,743 (95.2%) were overridden. The most common alert type was 'duplicate drug', accounting for 3,549,736 (79.8%) of alerts. Of 307 alerts assessed for appropriateness, 246 (80%) were judged to be appropriately displayed and 244 (79%) were overridden appropriately. New drug allergy and drug allergy alerts had the highest percentage of being judged as inappropriately overridden. For 1,594,313 alerts (37.7%), 'no overridden reason selected' was chosen from the drop-down menu. CONCLUSIONS: The alert generation and override rate were higher than reported previously in the literature. The small sample size of 307 alerts assessed for appropriateness of alert display and override is a potential limitation. Revision of the CDSS rules for alerts (focusing on specificity and relevance for the local context) is now recommended. Future research should prospectively assess providers' perspectives, and determine patient harm associated with overridden alerts.

Knowledge and Barriers Among Physicians Toward Adverse Drug Reaction Reporting at a Tertiary Care Hospital in Saudi Arabia.

BACKGROUND: Spontaneous reporting systems are essential as they help detect serious unknown adverse drug reaction (ADR). However, underreporting of ADR is a commonly associated problem. This research work aims to assess knowledge, barriers, and factors that encourage the reporting of ADR among physicians. METHODS: A total of 600 physicians working at a tertiary referral hospital in Riyadh, Saudi Arabia, were included in this cross-sectional study. A pretested questionnaire was used. RESULTS: Out of the 600 physicians, 240 (40%) completed the questionnaire. Most of the participants (85.4%) could correctly define ADR; nearly 75% physicians were unaware of the spontaneous reporting of ADR in Saudi Arabia. A total of 175 (72.9%) physicians had not reported any ADR among their patients in the last year; 40% of the physicians said that they did not report ADR because they were unaware of the online reporting of ADR. Providing guidelines and regular bulletins on the reporting of ADR is a critical aspect that encourages physicians to report ADR (51%). Education and training are the most recognized measures for improving the reporting of ADR. CONCLUSION: Physicians were adequately aware of ADR but inadequately aware of the reporting system and reporting authorities. Continuing medical education, training, and integration of the reporting of ADR into physicians' various clinical activities may improve ADR reporting.

Signals of bleeding among direct-acting oral anticoagulant users compared to those among warfarin users: analyses of the post-marketing FDA Adverse Event Reporting System (FAERS) database, 2010-2015.

PURPOSE: To analyze and compare the signals of bleeding from the use of direct-acting oral anticoagulants (DOACs) in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database over 5 years. METHODS: Reports of bleeding and of events with related terms submitted to the FAERS between October 2010 and September 2015 were retrieved and then analyzed using the reporting odds ratio (ROR). The signals of bleeding associated with DOAC use were compared with the signals of bleeding associated with warfarin use utilizing the FAERS databases. RESULTS: A total of 1,518 reports linked dabigatran to bleeding, accounting for 2.7% of all dabigatran-related reports, whereas 93 reports linked rivaroxaban to bleeding, which accounted for 4.4% of all rivaroxaban-related reports. The concurrent proportion of bleeding-related reports for warfarin was 3.6%, with a total of 654 reports. The association of bleeding and of related terms with the use of all three medications was significant, albeit with different degrees of association. The ROR was 12.30 (95% confidence interval [CI] 11.65-12.97) for dabigatran, 15.61 (95% CI 14.42-16.90) for warfarin, and 18.86 (95% CI 15.31-23.23) for rivaroxaban. CONCLUSIONS: The signals of bleeding varied among the DOACs, and the bleeding signal was higher for rivaroxaban and lower for dabigatran compared to that for warfarin.

Medication adherence among patients with Type 2 diabetes: A mixed methods study.

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.

Patients' understanding of prescription drug label instructions in developing nations: The case of Saudi Arabia.

BACKGROUND: Processing health-related data is challenging for patients. It is believed that low education level and low socioeconomic status are associated with prescription label misunderstanding, which may lead to poor clinical outcomes, increased adverse drug reactions, and increased health costs. OBJECTIVES: The aim of this study was to gain a better insight into the current understanding of prescription drug labels, and to determine the main factors affecting patients' understanding of prescription labels. METHOD: A total of 511 adult participants in 4 major hospitals in Riyadh were interviewed. The primary outcome was patient understanding of prescription labels for 5 commonly prescribed medications. Prescription label understanding was assessed using a prespecified structured interview protocol. Participants with less than a 6th-grade education level and monthly income less than 10,000 Saudi Riyal were considered to have a low education level and low monthly income, respectively. Logistic regression analysis was used to examine the cross-sectional association of socioeconomic factors with the participants' understanding of the medication label. RESULTS: The prevalence of poor understanding of the medication labels was 38.6% among the participants. Out of those participants with poor understanding, 27.9% incorrectly understood at least 4 of the 5 labels. The degree of misunderstanding significantly worsened for older participants (P-value = 0.004), male (P-value < 0.001), with low education level (P-value = 0.002), and low monthly income (P-value = 0.012). The most common features misunderstood were duration of treatment (38.9%) and storage instructions (29.5%). CONCLUSIONS: Prescription label misunderstanding is common among participants. More efforts should be made to improve patients' understanding by reducing the ambiguity of the prescription labels.

Completeness of adverse drug reactions reports of the Saudi adverse event reporting system.

OBJECTIVES: To assess completeness of reports in the Saudi Adverse Event Reporting System (SAERS), which is a part of the Saudi Food and Drug Authority pharmacovigilance system for monitoring the safety of medications. METHODS: A cross-sectional study was conducted in Riyadh, Saudi Arabia using the reports that were received between December 2009 and June 2012 in the SAERS. The completeness was assessed by reviewing the components of the adverse drug reactions (ADRs) form, and how many fields were completed. Descriptive statistics are reported. RESULT: There were 14,783 reports during the study period. Eighty percent of these reports were spontaneous reports. Information related to the drug (99%) and adverse events (98%) of the reports were completed. While the patient's demographic data were completed only in 38% of all reports, the least completed item in the ADRs form was the reporter information (15%). The most reported drug class was tumor necrosis factor inhibitors (7%), whereas events involving the respiratory organ system were the most frequently reported (4.5%). CONCLUSION: Although the SAERS is considered new, it has a high number of reports. More efforts are needed to improve the completeness of the SAERS to be a good source to assess the signals between events and suspected drugs, especially when there is a high number of reports.

Knowledge and attitude of health-care professionals in hospitals towards pharmacovigilance in Saudi Arabia.

BACKGROUND: Drug safety has major implications for patients' lives. However, this concept is still considered new to some healthcare professionals. OBJECTIVE: This study aims to investigate the knowledge and awareness of Saudi healthcare professionals to pharmacovigilance (PV). Setting Governmental and private hospitals at three main cities in Saudi Arabia (Riyadh, Jeddah, and Dammam). METHODS: A cross-sectional survey among healthcare professionals (pharmacists, physicians, and nurses) within 12 Saudi hospitals was conducted between November and December 2012. The questionnaire consisted of 18 questions assessing the knowledge, awareness, and attitude of healthcare professionals (HCPs) towards science and the concept of PV. Descriptive statistics were used to analyze the data. The data were analyzed using Statistical Analysis Software (SAS 9.3). Main outcome measure Knowledge, attitude and practice of HCPs toward pharmacovigilance. RESULTS: Three-hundred and thirty-two healthcare professionals completed the survey (response rate 72 %), 110 (34 %) physicians, 106 (33 %) pharmacists, and 104 (32 %) nurses. More than half of the participants (55 %) did not know the correct definition of PV. Two-thirds of the respondents, 207 (65.5 %), had knowledge of the aim of post-marketing surveillance, yet only 113 (36.9 %) were aware that the National Pharmacovigilance and Drug Safety Center is the official body for monitoring adverse drug reaction in Saudi Arabia. In addition, 34.7 % agreed that lack of time could be a major barrier for reporting. The majority of the respondents (78.4 %) believed that reporting was a professional obligation and hospitals should have a drug safety department. CONCLUSIONS: There was a limited knowledge of pharmacovigilance that could have affected reporting incidence. Educational intervention and a practical training program need to be applied by the drug regulatory body as well as health authorities to enhance the pharmacovigilance and drug safety culture in Saudi Arabia.

Community pharmacists' knowledge of isotretinoin safety.

OBJECTIVE: To explore the practice and knowledge of community pharmacists in Saudi Arabia regarding dispensing isotretinoin-containing products. METHODS: This was a cross-sectional study conducted in 2012 that included community pharmacists from 3 cities in Saudi Arabia. A validated and piloted self-administered survey collected demographics and information on the pharmacist's knowledge regarding isotretinoin precautions, as well as his dispensing, and counseling practices. RESULTS: One hundred and sixteen questionnaires were returned with a 72.5% response rate. Only around half of the participants (56%) knew the correct pregnancy risk classification category for oral isotretinoin. Most participants (78%) correctly identified teratogenicity as the most serious risk associated with the use of oral isotretinoin. However, only 6.2% of the pharmacists recommended using 2 methods of contraception. Almost one-fifth of the pharmacists dispensed isotretinoin without a prescription. Finally, 11% of the pharmacists did not ask whether the patient performed a pregnancy test prior to dispensing oral isotretinoin. CONCLUSION: Pharmacists at community pharmacies are not adequately aware of the risks for female patients using isotretinoin. Additionally, an alarming proportion of pharmacists dispense isotretinoin without a prescription. It is essential to implement risk minimization plans for certain medications to limit and prevent adverse drug reactions.

Health care professionals' awareness of, knowledge about and attitude to influenza vaccination.

OBJECTIVES: Influenza vaccination is recommended to all health care professionals (HCPs). However, vaccination rate among HCPs is low and may be due to uncertainty about the effectiveness of the vaccine and fear of its adverse effects. Therefore, this study aimed to investigate the awareness, knowledge, and attitude of HCPs towards influenza vaccination and we ascertain reasons for not getting vaccinated. METHOD: A cross-sectional conducted in 6 major hospitals in Saudi Arabia. 245 anonymous questionnaires were distributed to a convenient sample of staff during the 2012-2013 influenza season. The validated questionnaire consists of five sections that collect information about: demographics, attitude towards influenza vaccination, knowledge about influenza virus and vaccination, current practice and awareness of published guidelines. RESULTS: 242 completed questionnaires were received, a response rate of 98%. 38% of HCPs reported getting vaccinated. The most common reasons given by HCPs for not getting vaccinated were: fear of contracting illness (16%), belief that they are not at risk from influenza because they are young and healthy (13%) and being unaware of vaccine availability (13%). Non-availability of vaccine (43%) was the highest barrier for not providing vaccine for patients and HCPs followed by safety concerns for the patients (35%) and the respondents (33%). Almost 75% of HCPs were not aware of the influenza immunization guidelines published by the Advisory Committee on Immunization Practices and Centre for Disease Control. CONCLUSION: Despite the recommendations, only low percentage of HCPs in Saudi Arabian hospitals is vaccinated against influenza. The attention of health policy makers is needed to improve compliance of HCPs with guidelines on influenza vaccination.

Knowledge and attitude of healthcare professionals toward medication pregnancy category systems in Saudi hospitals.

OBJECTIVE: To assess the knowledge and attitudes of healthcare professionals (HCPs) toward systems used in describing the safety of medications use during pregnancy. METHODS: A cross-sectional self-administered survey was conducted in 4 tertiary hospitals in Riyadh, Saudi Arabia between March and May 2012. The targeted HCPs were physicians and pharmacists. The survey was validated and contained 4 main sections. Descriptive statistics were used to report responses to the survey's questions. RESULTS: A total of 393 HCPs responded to the survey, with a response rate of 97%. Half of the respondents were physicians. Of the participants, 60% were males. Most respondents (66%) stated that they have prescribed/dispensed a drug that may cause teratogenicity. Moreover, 87% of the respondents (48% pharmacists and 39% physicians) were aware of the Food and Drug Administration (FDA) pregnancy category, and most (72%) found it helpful. Only 11% of the participants strongly agree to use the European Medicine Agency (EMA) system for pregnancy category system as their main reference. CONCLUSION: In general, HCPs in Saudi Arabian hospitals have good knowledge of and attitudes toward pregnancy category systems, with more familiarity with the FDA system. The FDA system is preferred over the EMA system.

Supplement Use Among Pregnant Women in Ethiopia: Prevalence and Predictors.

Purpose The purpose of this article was to assess the pattern of supplement use and associated factors among pregnant women in Ethiopia. Methods A facility-based cross-sectional study was conducted. A total of 339 pregnant women were included in the study, 63 (18.3%) and 23 (6.8%) of whom used at least 1 supplement during pregnancy and 2 to 4 weeks prior to pregnancy, respectively. Only 3 women were prescribed folic acid during pregnancy. The pregnant women were interviewed to collect supplements use and pregnancy-related information through a pretested semistructured questionnaire. Subsequent charts of prescribed supplements were reviewed using a pretested data collection format. Results The majority (76.4%) of the women claimed no awareness about the benefits of early supplementation. Supplement use was about 8 times higher among women with > 3 children (adjusted odds ratio, 7.85; 95% confidence interval, 1.69-36.28; P = .008) than among nulliparous women, and about 6 times higher among women in their second trimester (adjusted odds ratio, 6.26; 95% confidence interval, 1.91-20.55; P = .03) of pregnancy compared to those women in their first trimester. Conclusion Overall supplement use, particularly folic acid intake, was found to be negligible during the prenatal as well as antenatal periods. The majority of the women in the study lacked awareness about the benefits of supplementation and potential risks associated with the absence of folic acid during pregnancy. Information by the media and health care personnel given to childbearing women about the need to take folic acid to prevent neural tube defects seems to improve the intake of folic acid during the protective period.

Knowledge on adherence and safety of the oral contraceptive pill in Saudi women.

OBJECTIVE: To assess knowledge regarding adherence and safety of oral contraceptive pills (OCP) in Saudi women. METHODS: We conducted a cross-sectional prospective study in an outpatient pharmacy at King Khalid University Hospital, Riyadh, Kingdom of Saudi Arabia from April to September 2011. Participants were healthy women aged greater than or equal to 18 years with an OCP prescription for contraception. We used a validated questionnaire to assess their knowledge regarding adherence and safety of OCPs. RESULTS: Four hundred and sixty women participated. Most (79%) knew to take an extra pill if they missed one in less than 12 hours, but only 6.5% knew they also had to use extra protection for the next 7 days if it was more than 12 hours. Multiple logistic regression analyses indicated that years of contraceptive use and educational level are predictive factors of better knowledge regarding adherence. Few were aware of the action if they experienced diarrhea for more than 12 hours (10%) or vomiting within 2 hours (13.5%) of taking an OCP. Only 30% knew of the adverse effects of smoking while on OCPs. Weight gain (51%) was the most commonly reported side effect. CONCLUSION: Most Saudi women taking OCPs have limited knowledge of its correct use regarding missing pills, vomiting and diarrhea, and poor awareness of the effects of smoking while using OCPs.