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.

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 (β= 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 (β= –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

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BackgroundMultiple 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.ObjectivesTo develop and validate a new scale in Arabic to assess patient-reported antineoplastics’ side-effects among Arabic-speaking patients undergoing chemotherapy.MethodsA 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.ResultsThe 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.ConclusionThe newly developed ASES demonstrated good validity and reliability. This tool will hopefully help healthcare providers and patients to identify commonly reported antineoplastic side effects.