Assessing Nontechnical Skills in Senior Pharmacy Students Using an Innovative Simulation Setting.

OBJECTIVES: To evaluate pharmacy students' nontechnical skills in a simulated session by assessing their teamwork skills and ability to identify patient safety priorities. METHODS: This study involved 2 phases. Phase I was a simulated case with a total of 23 errors. Students were divided into groups and instructed to identify errors in the setting. Teamwork skills were assessed using the Individual Teamwork Observation and Feedback Tool. Phase II was a debriefing and reflection session. Quantitative data were generated using the number of errors and Individual Teamwork Observation and Feedback Tool domain scores, while qualitative data were obtained using thematic analysis. RESULTS: The study participants were 78 female PharmD students who were divided into 26 groups. The average number of errors identified was 8 (range: 4-13), and the most identified error was using the wrong drug (96%). The teamwork skills displayed by most groups were shared decision-making, participating in discussions, and demonstrating respect and leadership in ways that were sensitive to the needs of the team. The students described the activity as fun and novel as it encouraged them to be more detail oriented. CONCLUSION: The designed simulation setting is an innovative tool to assess students' understanding of patient safety priorities and teamwork skills.

The cost-effectiveness of sequential versus standard triple therapy for Helicobacter pylori eradication in Saudi Arabia.

Background: The utilization rate of different treatment regimens for Helicobacter pylori infection is believed to be high; however, the cost-effectiveness of these regimens has not been examined before. Therefore, the aim of this study was to examine the cost-effectiveness of the two commonly prescribed treatments for H. pylori infection. Methods: The data of.an open-label, single-center, randomized trial that compared the efficacy of sequential therapy (SQT) (i.e., esomeprazole 20 mg twice daily for 10 days, amoxicillin 1000 mg twice daily for 5 days, then clarithromycin 500 mg and tinidazole 500 mg twice daily for 5 days) to standard triple therapy (STT) (i.e., esomeprazole 20 mg, amoxicillin 1000 mg, and clarithromycin 500 twice daily for 14 days) in the eradication of H. pylori, as confirmed by the negative urea breath test (UBT), were used. Propensity score matching bin bootstrapping, with 10,000 replications and bias correction was conducted to generate the 95% confidence limits. Moreover, probabilistic sensitivity analysis was conducted by varying both the eradication rates and the costs of treatment regimens. Results: There were 82 and 88 patients who were on SQT and STT, respectively. Patients' mean age was 47 years, and approximately 55% of them were females. The mean treatment costs were SAR 2,075.51 (USD 553.47) and SAR 2,629.26 (USD 701.14) for SQT and STT, respectively. The mean eradication rates for SQT and STT were 63.41% and 67.05%, respectively. The mean difference in costs and eradication rates for SQT versus STT were SAR - 550.75 (95% CI: -563.84- -537.69) and - 3.64% (95% CI: -6.98- 5.88). The use of SQT was more likely to be cost saving and more effective with 56.25% confidence level, in comparison to STT. Conclusion: The use of SQT in the treatment of H. pylori seems to be more cost-effective than STT.

Proxy-Reported Quality of Life and Access to Nusinersen Among Patients with Spinal Muscular Atrophy in Saudi Arabia.

BACKGROUND: The recent approval of innovative therapies for spinal muscular atrophy (SMA), such as nusinersen, has brought hope to patients and their families. OBJECTIVE: The aims of this study were to compare the characteristics and HRQoL of SMA patients treated with nusinersen and those treated with the standard of care. METHODS: This was a cross-sectional, interviewer-administered telephone questionnaire, which used a purposive sampling of SMA patients through a social support network. EuroQol five-dimensions-3-level (EQ-5D-3L) and the visual analog scale (VAS) have been used to assess the HRQoL. Different descriptive and inferential tests have been performed to compare the characteristics, EQ-5D responses, and mean scores of EQ-VAS between patients on nusinersen and the standard of care. RESULTS: Eleven out of 36 SMA patients (30.55%) have been treated with nusinersen. Patients with type I SMA represented 54% of those treated with nusinersen (P=0.012). Only 12.5% of SMA patients living in the Mecca region are treated with nusinersen in comparison to 50% of patients living in the Riyadh region (P=0.029). No difference was noticed in the proxy-responses for the five domains of the EQ-5D or the mean VAS scores for patients on nusinersen and the standard of care despite controlling for the SMA type and the ability to breathe independently (ß= 1.39, 95% CI= - 5.15-7.93, P=0.667). However, the mean VAS score for patients who are unable to breathe independently was significantly lower than their counterparts who are able to breathe independently even after controlling for the SMA type and nusinersen treatment (ß= -31.61, 95% CI= - 51.59 - -11.63, P=0.003). CONCLUSION: The results of this study highlight the uncertainty about the impact of nusinersen on SMA patients' HRQoL. Therefore, the impact of nusinersen on HRQoL should be examined using more robust study designs.

The cost-effectiveness of biologic versus non-biologic treatments and the health-related quality of life among a sample of patients with inflammatory bowel disease in a tertiary care center in Saudi Arabia.

AIMS: This study's objectives were to examine and compare the cost-effectiveness of biologic and non-biologic therapies in the improvement of the health-related quality of life (HRQoL) of patients with inflammatory bowel disease (IBD) in Saudi Arabia. MATERIALS AND METHODS: This retrospective cohort study analyzed data from the medical records of patients with IBD treated at a tertiary-care hospital in Riyadh, Saudi Arabia. Drug utilization costs and HRQoL scores were evaluated at baseline and after six months of treatment. Patients' HRQoL was measured using the Arabic version of the standardized EuroQol 5 Dimensional 3 Level (EQ-5D-3L) questionnaire with a visual analog scale (VAS). RESULTS: Eighty-seven patients with Crohn's disease (CD) and 69 patients with ulcerative colitis (UC) were included in the study (N = 156), and 59 (37.82%) were treated with biologics. Similar effects of both types of medications were found on the HRQoL domains of mobility, usual activities, and pain and discomfort, while biologics outperformed non-biologics on the self-care domain. The mean utilization cost of a biologic-based treatment over a six-month period was SAR 25,690.46 (USD 6,850.79) higher than that of the non-biologic treatment (95% confidence interval (CI): 24,548.55-27,465.11), and the change in the ED-5D-3L VAS score from baseline to follow-up was 4.78 points (95% CI: 1.96-14.00). A probabilistic sensitivity analysis demonstrated that IBD therapy with biologic-based treatment is always more expensive, but also more effective in improving HRQoL 99.45% of the time. Adalimumab was found to be less cost effective than infliximab in the management of CD. LIMITATIONS: Information bias cannot be ruled out, as this investigation was a retrospective cohort study with a relatively small sample that was not randomized. CONCLUSIONS: The results of this analysis can serve as a foundation to introduce HRQoL-based recommendations for the use of biologics in the management of IBD in Saudi Arabia.

Efficacy of inpatient personalized multidisciplinary rehabilitation in multiple sclerosis: behavioural and functional imaging results.

BACKGROUND: Although multidisciplinary rehabilitation programs are commonly used in clinical practice for patients with multiple sclerosis (MS), they are currently underexamined. OBJECTIVE: This study aims to investigate the efficacy and underlying brain mechanisms of an inpatient multidisciplinary rehabilitation. METHODS: Twenty-four patients with relapse-onset MS underwent a 4-week personalized inpatient multidisciplinary rehabilitation and three assessment sessions including MRI, clinical, cognitive and motor function evaluation. Twenty-four healthy controls underwent two assessment sessions 4 weeks apart. Test performances were compared using repeated measures ANOVA, Tukey and t tests. A motor sequence learning (MSL) task was presented during fMRI and data were analysed using FSL. RESULTS: Patients had less perceived fatigue, improved walking speed and quality of life following the rehabilitation, which could be maintained at follow-up 4 weeks after rehabilitation. After rehabilitation, differences in accuracy of the MSL task between groups diminished, indicating an improved performance in patients. Improved accuracy went along with changes of brain activity in the left cerebellum and right frontal lobe post-rehabilitation, which could be maintained at follow-up. No changes between sessions were observed in controls. CONCLUSION: Multidisciplinary rehabilitation may improve highly impacting symptoms through more efficient recruitment of brain regions and therefore positively influence MS patients' quality of life.

The validation of a newly developed Arabic scale to assess patient-reported side-effects of antineoplastic agents.

BACKGROUND: Multiple scales in different languages were developed to measure patient-reported side effects of antineoplastics. However, these scales vary in their coverage of antineoplastics' side effects, and none of them address both the severity and impact of antineoplastics' side effects on patient quality of life. Hence, there is a need to develop a comprehensive, concise, and general scale to assess patients' perceptions of both severity and impact of the commonly reported side effects of antineoplastics on patients' activities of daily living and make it available in Arabic. OBJECTIVES: To develop and validate a new scale in Arabic to assess patient-reported antineoplastics' side-effects among Arabic-speaking patients undergoing chemotherapy. METHODS: A new scale was developed in Arabic that addresses 40 different emotional, cognitive, and physical side-effects of antineoplastics. The Antineoplastic Side effects Scale (ASES) contained three subscales focused on the side effects frequency, severity, and interference with patients' activities of daily living. Seventy-eight patients with different cancer types were recruited from the oncology clinics of a university-affiliated tertiary care hospital in Riyadh, Saudi Arabia. The reliability of the questionnaire was examined using Cronbach's alpha method. The construct validity was examined using principal component analysis with varimax rotation. The association between the scores of ASES subscales and various patient medical and sociodemographic characteristics were also examined. RESULTS: The mean age of participants was 53.8 (12.5) years and most of them were female (65.3%) and married (84.6%). The ASES demonstrated good internal consistency (Cronbach's alpha = 0.91). The severity of the perceived side effects and their impact on activities of daily living were positively associated with female gender. CONCLUSION: The newly developed ASES demonstrated good validity and reliability. This tool will hopefully help healthcare providers and patients to identify commonly reported antineoplastic side effects.

Drug shortages in Saudi Arabia: Root causes and recommendations.

Drug shortages are a multifaceted problem that has been recurring in Saudi Arabia over the past decade with its significant negative impact on patient care. However, there is a dearth of evidence about possible domestic reasons, if any, behind this recurring problem. Recently, the Pharmacy Education Unit at King Saud University College of Pharmacy has called for a meeting with multiple stakeholders from academia, pharmaceutical care, pharmaceutical industry, purchasing and planning, and regulatory bodies to unveil the root domestic causes of the drug shortages in the Kingdom. Four major topics were used to guide the discussion in this meeting, including: current situation of drug shortages in Saudi Arabia, major factors contributing to drug shortages, challenges and obstacles to improve drug supply, and stakeholders' recommendations to manage drug shortages. The meeting was audio-recorded and transcribed into verbatim by five authors. The text was then reviewed and analyzed to identify different themes by the first and third authors. Multiple causes were identified and several recommendations were proposed. The main domestic causes of drug shortages that were explored in this study included poor medication supply chain management, lack of government regulation that mandates early notification of drug shortages, a government procurement policy that does not keep pace with the changes in the pharmaceutical market, low profit margins of some essential drugs, weak and ineffective law-violation penalties against pharmaceutical companies and licensed drug importers and distributors, and overdependence on drug imports. The participants have also proposed multiple recommendations to address drug shortages. Policy makers should consider these factors that contribute to drug shortages in Saudi Arabia as well as the recommendations when designing future initiatives and interventions to prevent drug shortages.

Vitamin D Supplementation for Premenstrual Syndrome-Related Mood Disorders in Adolescents with Severe Hypovitaminosis D.

STUDY OBJECTIVE: Premenstrual syndrome (PMS) might become severe enough to interfere with normal interpersonal relationships. This study was planned to assess whether administration of vitamin D (200,000 IU at first, followed by 25,000 IU every 2 weeks) for a 4-month period might lessen the appearance and the intensity of mood disorders associated with PMS in young girls with severe hypovitaminosis D. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: One hundred fifty-eight young girls (15-21 years old) with PMS-related severe symptoms of the emotional and cognitive domains and low serum 25-hydroxycholecalciferol (25-OH-D) levels (≤10 ng/mL) were randomly assigned to two treatment groups and treated for 4 months with vitamin D (group 1; n = 80) or placebo (group 2; n = 78). Clinical and hormonal effects were compared between the two groups. RESULTS: In patients from group 1, levels of vitamin D reached the normal range (35-60 ng/mL) after the first month and remained stable throughout the whole study. At the end of treatment, anxiety score decreased from 51 to 20 (P < .001 vs baseline); irritability score declined from 130 to 70 (P < .001 vs baseline). Crying easily and sadness decreased by a score of 41 and 51 to a score of 30 and 31, respectively (P < .001). For disturbed relationships, the score decreased from 150 to 70 (P < .001). Conversely, no appreciable changes were noted in symptom intensity from patients of group 2. The frequency of adverse events (nausea and constipation) was not different between participants of group 1 and group 2. CONCLUSION: On the basis of the present findings, vitamin D therapy can be proposed as a safe, effective, and convenient method for improving the quality of life in young women with severe hypovitaminosis D and concomitant mood disorders associated with PMS.

Males with low serum levels of vitamin D have lower pregnancy rates when ovulation induction and timed intercourse are used as a treatment for infertile couples: results from a pilot study.

BACKGROUND: Vitamin D (Vit D) is important for the regulation of reproductive physiology. In humans, maternal Vit D deficiency has been implicated in several reproductive- and pregnancy-related disorders. Very few data are available regarding the Vit D status in male partners of couples attempting pregnancy. This observational study (IRB Prot. N. 078/13) aimed to evaluate whether low Vit D serum levels in males might decrease the rate of successful conception in couples attempting pregnancy. METHODS: Male and female partners of infertile couples (n = 102) were classified into 2 GROUPS according to normal (≥30 ng/ml) or low (below 30 ng/ml) serum Vit D levels in male partners. Semen analysis was performed in each male participant based on the WHO reference criteria. The female partners of both groups were subjected to 3 consecutive cycles of gonadotropin-induced mono-ovulation. The main outcome measures included the clinical pregnancy rate, delivery per patient and per cycle, and miscarriage rate between the 2 groups evaluated at the end of the three-month period of the study. RESULTS: In male partners of both groups, standard semen analysis did not highlight substantial differences in sperm concentration, sperm progressive motility, or typical form. The pregnancy rates per patient and per cycle and delivery rates per patient and per cycle were all significantly higher (p< 0.05) in couples with normal Vit D levels. CONCLUSIONS: These results suggest the existence of a relationship between male Vit D serum levels and semen ability to begin a pregnancy during cycles of timed vaginal intercourse.

Dehydroepiandrosterone decreases the age-related decline of the in vitro fertilization outcome in women younger than 40 years old.

BACKGROUND: With infertility populations rapidly aging, treatments improving pregnancy chances assume increasing clinical importance. Dehydroepiandrosterone (DHEA) has been reported to improve pregnancy rates and lower miscarriage rates in women with diminished ovarian function. This study was planned to evaluate whether pretreatment with DHEA may improve in vitro fertilization (IVF) parameters and pregnancy outcomes in infertile women with advanced reproductive age and normal ovarian reserve. METHODS: In this double-blind, randomized, placebo-controlled study, 109 infertile patients aging 36-40 years old were selected to undergo the long protocol IVF. Eight weeks before starting the IVF cycle and during treatment, patients in Group 1 received 75 mg of DHEA once a day; patients in control group (Group 2) received placebo. The primary endpoint of the study was number of clinical pregnancy, live birth and miscarriage rates; secondary endpoint was modification of standard IVF parameters, including stimulation duration (days of rhFSH administration), E2 on HCG-day, endometrial thickness, number of retrieved oocytes, metaphase II oocytes, number of transferred embryos and score of leading embryos transferred. RESULTS: Patients in the DHEA group had a significantly higher live birth rate compared with controls (P<0.05). Conversely, miscarriage rate was higher for patients in the control group (P<0.05). CONCLUSIONS: DHEA supplementation may significantly improve IVF outcomes in infertile women with advanced reproductive age and normal ovarian reserve.

Intermittent low-dose finasteride administration is effective for treatment of hirsutism in adolescent girls: a pilot study.

STUDY OBJECTIVE: Hirsutism has negative impact on adolescent psychosocial development for both cosmetic and endocrine reasons. This study evaluated the effectiveness of a new intermittent, low-dose finasteride regimen consisting of 2.5 mg of drug given every 3 days (1 day of treatment, 2 days of drug withdrawal) for 6 months in girls with hirsutism by polycystic ovarian syndrome (PCOS) or idiopathic hirsutism (IH). DESIGN AND PARTICIPANTS: Twenty-eight girls (15-19 y old) with hirsutism were randomly assigned to 2 treatment groups and treated for 6 months. Fourteen patients (7 with IH, 7 with PCOS) received finasteride; fourteen patients (7 with IH, 7 with PCOS) received placebo. Hirsutism score (HS), clinical, and hormonal effects were compared between the 2 groups. RESULTS: In patients treated with finasteride, the HS value at 6 months was 52.9% lower than that observed at baseline in girls with IH, and 52.8% lower in girls with PCOS (P < .0001 for both). Similarly, the 3α-17 ß-androstenediol glucuronide serum levels were decreased by 34.8% in patients with IH, and by 47.5% in patients with PCOS (P < .0001, respectively). Finasteride treatment was well tolerated and did not alter values of BMI, serum levels of sexual hormones, metabolic parameters related to liver and kidney function as well as glycemic and lipidic asset. CONCLUSIONS: A low-dose of finasteride, given every 3 days, reduces the HS in young patients affected by PCOS or IH. Compared with conventional continuous finasteride administration, the intermittent low-dose regimen has similar efficacy with the advantage to be safer and less expensive.