The landscape of biosimilars in Saudi Arabia: preparing for the next decade.

INTRODUCTION: The government of the Kingdom of Saudi Arabia (KSA) has developed a well-defined strategy to restructure the health sector and operate on value-based principles. Biosimilars are a viable option for increasing accessibility while lowering health-care costs. AREAS COVERED: We describe the current and future biosimilar landscape in KSA. We discuss the growth of the biosimilar market, the regulatory approval process, biosimilar adoption, and the potential impact on health-care systems and patient outcomes. EXPERT OPINION: The biosimilar market in KSA is expanding and expected to continue this trajectory in the coming decade. The growth of the market is influenced by the KSA health transformation initiative, the well-defined regulatory framework for biosimilars set by the Saudi Food and Drug Authority (SFDA), and the adoption of biosimilars by health-care providers. Overall, the biosimilar regulation is evolving and the future of biosimilars looks promising in KSA. Biosimilars offer a more cost-effective alternative, which can help to expand access to more treatment options for patients and contribute to cost saving for the health-care system.

Local causes of essential medicines shortages from the perspective of supply chain professionals in Saudi Arabia.

Background: The global supply chains of essential medicines faced frequent disruptions over the past five years, particularly during the COVID-19 pandemic. Different causes of prescription drug supply interruptions have been identified in Saudi Arabia. However, studies have yet to explore the views of pharmaceutical supply chain personnel regarding the causes of these interruptions. Therefore, this study aimed to survey individuals working in the pharmaceutical supply chains about their views on the observed interruptions in the supply of some essential drugs. Methods: This was a questionnaire-based cross-sectional study. The 10-item questionnaire was created based on the findings of previously published research that investigated the root causes of essential drug shortages and the impact of COVID-19 pandemic on the supply chains of essential drugs in Saudi Arabia. Purposive sampling was used to identify individuals with at least one year of experience in the area of the pharmaceutical supply chain, and the data collection occurred between April 19th, 2022 and October 23rd, 2022. In addition, descriptive statistics (e.g., frequencies and percentages) were conducted to present the views of the respondents. Results: Seventy-nine pharmaceutical supply chain specialists accepted the invitation and completed the questionnaire. About two-thirds (69.62%) of the respondents reported that centralized pharmaceutical procurement negatively affected the supply chain of essential drugs. Procurement of unregistered medications by the Saudi Food and Drug Authority (SFDA), as well as generic drugs with a history of recalls, and failure to supply requested quantities were the three most commonly reported reasons behind the observed interruptions in the supply of some essential drugs according to those respondents with a negative view of the centralized procurement. Furthermore, failure of pharmaceutical companies to inform SFDA of potential drug shortages, manufacturing issues, poor demand forecasting, unpredictable increase in demand, and low prices of essential drugs were also believed to be behind the observed interruptions in the supply of some essential medicines. Conclusion: The majority of surveyed pharmaceutical supply chain professionals held negative views about the role of centralized pharmaceutical procurement in exacerbating the issues with essential medicines supply chain. Future research should examine different strategies to improve purchasing and procurement practices in Saudi Arabia.

Perceived barriers and enablers of a personal health record from the healthcare provider perspective.

Personal health records (PHRs) have been implemented around the world as a means to increase the safety, quality, and efficiency of health care. The Ministry of National Guard Health Affairs in the Kingdom of Saudi Arabia launched their PHR in 2018. This study aimed to explore healthcare provider (HCP) perspectives of barriers to and enablers of PHR adoption in Saudi Arabia. The 291 participating HCPs (40.5% nurses, 23.0% pharmacists, 17.2% physicians, 15.5% technicians, and 3.8% other) selected the following as top-3 barriers to PHR adoption: 1) lack of patient awareness (19.4%), 2) patient low literacy (17.7%), and 3) patient resistance to new technologies (12.5%). Of these, 36 responded to the open-ended question gauging feedback on the PHR. Three main themes were identified from the comments: 1) general perceptions of the PHR (positive attitudes, negative attitudes, additional features); 2) patient engagement as a requirement for the successful implementation of the PHR; and 3) education/training of HCPs, patients, and caregivers. This analysis extends our understanding of HCP perspectives of barriers and enablers to PHR adoption. Further qualitative research with patients is required to confirm our findings.

Predicting Health Care Providers' Acceptance of a Personal Health Record Secure Messaging Feature.

BACKGROUND: Personal health records (PHRs) can facilitate patient-centered communication through the secure messaging feature. As health care organizations in the Kingdom of Saudi Arabia implement PHRs and begin to implement the secure messaging feature, studies are needed to evaluate health care providers' acceptance. OBJECTIVE: The aim of this study was to identify predictors of health care providers' behavioral intention to support the addition of a secure messaging feature in PHRs using an adapted model of the Unified Theory of Acceptance and Use of Technology as the theoretical framework. METHODS: Using a cross-sectional survey design, data on acceptance of secure messaging features in PHRs were collected from health care providers working at the Ministry of National Guard Health Affairs between April and May 2021. The proposed model was tested using partial least squares structural equation modeling in SmartPLS. RESULTS: There were 224 participants: female (66.5%), 40 to 49 years of age (39.9%), nurses (45.1%), and those working more than 10 years in the organization (68.8%). Behavioral intention to support the addition of a secure messaging feature was significantly influenced by performance expectancy (ß = 0.21, p = 0.01) and attitude (ß = 0.50, p < 0.01), while other predicting factors, such as effort expectancy, social influence, and facilitating condition, did not significantly affect the intention. Furthermore, age, years of experience, and professional role did not moderate the relationships. CONCLUSION: Health care professionals will support introducing a secure messaging feature in the PHRs if they serve the intended purpose. Considering attitude also plays a significant role in acceptance, it is necessary to arrange for training and support, so that caregivers, health care providers, and the patients become familiar with the benefits and expected outcomes of using the feature.

Health Care Providers' Acceptance of a Personal Health Record: Cross-sectional Study.

BACKGROUND: Personal health records (PHRs) are eHealth tools designed to support patient engagement, patient empowerment, and patient- and person-centered care. Endorsement of a PHR by health care providers (HCPs) facilitates patient acceptance. As health care organizations in the Kingdom of Saudi Arabia begin to adopt PHRs, understanding the perspectives of HCPs is important because it can influence patient adoption. However, no studies evaluated HCPs' acceptance of PHRs in the Kingdom of Saudi Arabia. OBJECTIVE: The aim of this study was to identify predictors of HCPs' acceptance of PHRs using behavioral intention to recommend as a proxy for adoption. METHODS: This cross-sectional study was conducted among HCPs (physicians, pharmacists, nurses, technicians, others) utilizing a survey based on the Unified Theory of Acceptance and Use of Technology. The main theory constructs of performance expectancy, effort expectancy, social influence, facilitating conditions, and positive attitude were considered independent variables. Behavioral intention was the dependent variable. Age, years of experience, and professional role were tested as moderators between the main theory constructs and behavioral intention using partial least squares structural equation modeling. RESULTS: Of the 291 participants, 246 were included in the final analysis. Behavioral intention to support PHR use among patients was significantly influenced by performance expectancy (ß=.17, P=.03) and attitude (ß=.61, P<.01). No moderating effects were present. CONCLUSIONS: This study identified performance expectancy and attitude as predictors of HCPs' behavioral intention to recommend PHR to patients. To encourage HCPs to endorse PHRs, health care organizations should involve HCPs in the implementation and provide training on the features available as well as expected benefits. Future studies should be conducted in other contexts and include other potential predictors.

Predicting Patients' Intention to Use a Personal Health Record Using an Adapted Unified Theory of Acceptance and Use of Technology Model: Secondary Data Analysis.

BACKGROUND: With the rise in the use of information and communication technologies in health care, patients have been encouraged to use eHealth tools such as personal health records (PHRs) for better health and well-being services. PHRs support patient-centered care and patient engagement. To support the achievement of the Kingdom of Saudi Arabia's Vision 2030 ambitions, the National Transformation program provides a framework to use PHRs in meeting the 3-fold aim for health care-increased access, reduced cost, and improved quality of care-and to provide patient- and person-centered care. However, there has been limited research on PHR uptake within the country. OBJECTIVE: Using the Unified Theory of Acceptance and Use of Technology (UTAUT) as the theoretical framework, this study aims at identifying predictors of patient intention to utilize the Ministry of National Guard-Health Affairs PHR (MNGHA Care) app. METHODS: Using secondary data from a cross-sectional survey, data measuring the intention to use the MNGHA Care app, along with its predictors, were collected from among adults (n=324) visiting Ministry of National Guard-Health Affairs facilities in Riyadh, Jeddah, Dammam, Madinah, Al Ahsa, and Qassim. The relationship of predictors (main theory constructs) and moderators (age, gender, and experience with health apps) with the dependent variable (intention to use MNGHA Care) was tested using hierarchical multiple regression. RESULTS: Of the eligible population, a total of 261 adult patients were included in the analysis. They had a mean age of 35.07 (SD 9.61) years, 50.6 % were male (n=132), 45.2% had university-level education (n=118), and 53.3% had at least 1 chronic medical condition (n=139). The model explained 48.9% of the variance in behavioral intention to use the PHR (P=.38). Performance expectancy, effort expectancy, and positive attitude were significantly associated with behavioral intention to use the PHR (P<.05). Prior experience with health apps moderated the relationship between social influence and behavioral intention to use the PHR (P=.04). CONCLUSIONS: This study contributes to the existing literature on PHR adoption broadly as well as in the context of the Kingdom of Saudi Arabia. Understanding which factors are associated with patient adoption of PHRs can guide future development and support the country's aim of transforming the health care system. Similar to previous studies on PHR adoption, performance expectancy, effort expectancy, and positive attitude are important factors, and practical consideration should be given to support these areas.

Response to COVID-19 Pandemic: Managing Inpatient Pharmacy Services at King Abdulaziz Medical City - Jeddah.

Since early December 2019, the coronavirus disease 2019 (COVID-19) has been relentlessly spread worldwide and has hit the healthcare systems with terrible force. Pharmacists play a vital role in the healthcare system in providing medicines, therapeutics, vaccines, clinical services, and other pharmaceutical care services to patients. Therefore, to ensure all these services continued at King Abdulaziz Medical City - Jeddah during the COVID-19 pandemic, the Department of Pharmaceutical Care initiated a departmental crisis preparedness plan, as a part of general hospital preparedness plan. It started with adjusting medication dosing time, instituting a daily medication refill process, working remotely, expanding the use of automation, and modifying employee schedules. Other actions included the following: handling drug shortages, placing restrictions on some medications, using personal protective equipment, changing routine practices of pharmacy aides, revising the medication delivery process, starting a contingency training program, and restricting pneumatic tube operation. We took guidance from the Ministry of Health, our own institute's experience, World Health Organization recommendations, updated scientific research, and the American Society of Health-System Pharmacists regulatory updates. This article aims to describe how health services, policies, and systems were applied and adapted to address a specific problem while maintaining all pharmacy employees' safety. This article reviews the inpatient pharmacy's particular needs and responses to these needs to meet the COVID-19 pandemic challenges.

Adoption of a Personal Health Record in the Digital Age: Cross-Sectional Study.

BACKGROUND: As health care organizations strive to improve health care access, quality, and costs, they have implemented patient-facing eHealth technologies such as personal health records to better engage patients in the management of their health. In the Kingdom of Saudi Arabia, eHealth is also growing in accordance with Vision 2030 and its National Transformation Program framework, creating a roadmap for increased quality and efficiency of the health care system and supporting the goal of patient-centered care. OBJECTIVE: The aim of this study was to investigate the adoption of the personal health record of the Ministry of National Guard Health Affairs (MNGHA Care). METHODS: A cross-sectional survey was conducted in adults visiting outpatient clinics in hospitals at the Ministry of National Guard Health Affairs hospitals in Riyadh, Jeddah, Dammam, Madinah, and Al Ahsa, and primary health care clinics in Riyadh and Qassim. The main outcome measure was self-reported use of MNGHA Care. RESULTS: In the sample of 546 adult patients, 383 (70.1%) reported being users of MNGHA Care. MNGHA Care users were more likely to be younger (P<.001), high school or university educated (P<.001), employed (P<.001), have a chronic condition (P=.046), use the internet to search for health-related information (P<.001), and use health apps on their mobile phones (P<.001). CONCLUSIONS: The results of this study show that there is substantial interest for the use of MNGHA Care personal health record with 70% of participants self-reporting use. To confirm these findings, objective data from the portal usage logs are needed. Maximizing the potential of MNGHA Care supports patient engagement and is aligned with the national eHealth initiative to encourage the use of technology for high-quality, accessible patient-centered care. Future research should include health care provider perspectives, incorporate objective data, employ a mixed-methods approach, and use a theoretical framework.

Addressing Cancer Treatment Shortages in Saudi Arabia: Results of a National Survey and Expert Panel Recommendations.

PURPOSE: Cancer treatment shortages are complex and a persistent problem worldwide. Patients with cancer are most vulnerable to drug shortages, which provides opportunities to examine the extent of the challenge(s) facing Saudi Arabia and to provide recommendations toward mitigating the impact of cancer treatment shortages on patient outcomes. MATERIALS AND METHODS: A qualitative methodologic approach was conducted in April 2019 using a validated questionnaire and structured panel discussion for data generation. RESULTS: Overall, 55 responses were received from practicing oncology health care professionals (26 pharmacists and 29 physicians). The annual average number of treated patients with cancer per institution was 640 (adults [n = 400] and pediatric [n = 240]). All respondents (100%) reported that cancer treatment shortages constitute a current problem in their center, with an average of 5 (range, 1-9) per month. The panelists recognized 2 fundamental points. First, the definition of cancer drug shortages should be standardized and recognized at the national level. Second, the current system must be improved to ensure proper and efficient use of the current resources. On that basis, the panelists developed 9 recommendations for action. CONCLUSION: Cancer drug shortage is a significant problem in all health centers in Saudi Arabia. This study presents challenges that should be addressed at the national level and essential consensus recommendations for a coordinated action developed by a panel of experts to tackle the current national problem of cancer treatment shortages. Implementing these recommendations will provide a blueprint for management of national drug shortages in general and cancer treatment shortages in particular.

Emerging Role of Biosimilars in Oncology-Hematology in Saudi Arabia: A Practical Perspective.

Biologics are significant drivers of globally escalating healthcare costs. Biosimilars have potential to offer cost savings with comparable efficacy and safety to innovator products and increase the access of treatment to more patients. This study aimed to increase understanding and perception of biosimilars concept. It also described the pharmacoeconomic impact of biosimilar in oncology and formulary consideration of oncology biosimilars substituting with their originators in major oncology centers in the Saudi Arabia. A biosimilar is a biological product that is similar to a reference biopharmaceutical product. As the manufacturing process hinders the ability to identically replicate the structure of the original product, biosimilar cannot be described as an absolute equivalent of the original medication. Different regulatory agencies such as United States Food and Drug Administration, European Medicines Agency, and Saudi Food and Drug Authority have approved several biosimilars of oncology biologics. The experience of biosimilar use in Europe and USA provides valuable insights into the use of biosimilars. The widespread use of biosimilars has the potential to reduce healthcare expenditure, as well as improving access without compromising patient outcomes. There is a need for increasing awareness about biosimilars to improve acceptance rates. The use of biosimilar filgrastim in Ministry of National Guard Health Affairs, Saudi Arabia, has resulted in a significant cost saving annually. It was proposed that further substitution and switching to biosimilars in oncology would lead to major savings in resources.

Epidemiology of Preventable Drug-Related Problems (DRPs) Among Hospitalized Children at KAMC-Jeddah: a Single-Institution Observation Study.

AIM: Drug-related problems (DRPs) "are the unwanted effects of drugs that potentially lead to a harmful outcome" thereby requiring considerable attention. Hospitalized pediatric patients, in particular, represent a population at risk of DRPs. The epidemiology of preventable DRPs among children in Saudi Arabia remains scarce, which thus poses distinct challenges to all healthcare professionals. We aim to characterize preventable DRPs among hospitalized children at KAMC-Jeddah. METHODS: A prospective observational study of children (≤15 years) admitted to pediatric units (excluding cancer units) at KAMC-Jeddah over a 3-month period (May 29 to August 30, 2016) is carried out to determine the incidence of preventable DRPs and investigate the possible associated factors (gender, age, admission location, type of admission, and number of medications). RESULTS: A total of 319 DRPs were identified among 235 patients, of which 280 DRPs (87.8%, 280/319) were deemed preventable. The majority of preventable DRPs were related to dose selection (78%, 219/280). None of the preventable DRPs were life threatening or fatal, and the majority were assessed as moderate in severity (94.3%, 264/280). There was no significant difference between DRP incidences with age mean 3.5 (P=0.389), gender mean (P=0.436), and weight mean 13.47 (P=0.323). Younger children (age ≤2years) admitted to PICU were more likely to have DRP (OR 4.44, 95% CI, 1.87 to 10.52, P=0.00001). Scheduled admissions were 2.89 times more likely to be exposed to DRP compared to transferred admissions (OR 2.8, 95% CI, 1.83 to 4.70, P=0.005). Additionally, DRP incidences increased proportionally to the number of medications. CONCLUSION: Our data suggest that establishing appropriate prevention strategies towards improvement and safety in medicine use among this vulnerable patient population is a high priority.

Impact of the e-prescribing system on the incidence and nature of drug-related problems in children in a Saudi hospital.

OBJECTIVES: To determine the impact of a computerised physician order entry (CPOE) system on the drug-related problems' (DRPs) incidence and characteristics in hospitalised children in a Saudi hospital, and to compare DRPs incidence pre-/post-CPOE implementation. METHODS: An observational study. DRPs were identified by pharmacists, reviewing children's (0-14 years) medical records on CPOE system, in paediatric wards and/or attending emergency department. DRPs preventability and severity were assessed. RESULTS: A total of 657 paediatric patients were included, with 235 (35.8%) experienced 328 DRPs, majority were preventable (99.7%, 327). Difference in DRP incidence pre- and post-CPOE implementation (44.8% versus 35.8%, P < 0.01) was significant. CONCLUSION: The CPOE system has significantly reduced DRPs incidence in children in the study hospital.

Pharmacists as Interprofessional Collaborators and Leaders through Clinical Pathways.

Pharmacists possess pivotal competencies and expertise in developing clinical pathways (CPs). We present a tertiary care facility experience of pharmacists vis-a-vis interprofessional collaboration for designing and implementing CPs. We participated in the development of CPs as leading members of a collaborative team of healthcare professionals. We reviewed literature, aligning it with hospital formulary and institutional standards, and participated in weekly team meetings for six months. Several tools and services were adapted to guide prescribing and standardization of care through time-bound order sets. Fifteen CPs leading to admissions in medical wards were developed and integrated into Computerized Prescriber Order Entry (CPOE) sets. Tools and services included (1) reporting of creatinine clearance to guide optimum dosing; (2) advisory flags for dosing and infusion rates; (3) piloting of medication reconciliation and counseling services before discharge were initiated; (4) Arabic drug leaflets were designed to educate patients; and (5) five CPs were included in pragmatic randomized control trials with a clinical pharmacist as co-investigator. Clinical pharmacists conducted continuous orientation to various healthcare professionals throughout the process. CPs provide unique opportunities for establishing and evaluating patient-centered pharmaceutical services and allow clinical pharmacists to demonstrate interprofessional leadership in collaboration with multidisciplinary teams.

Patients' Knowledge and Attitude toward the Disposal of Medications.

BACKGROUND: Safe disposal of medications is of high concern as malpractice may lead to harmful consequences such as undesirable effects, prescription drug abuse, overstocking, self-medication, accidental overdose, and even death. There is a lack of uniform and nationwide guidance on how patients should safely dispose their leftover medications. This study aims to assess patients' knowledge and attitude regarding the disposal of medications. METHOD: This research is a cross-sectional study. A self-administered questionnaire was used to collect data from various outpatient pharmaceutical services in King Abdulaziz Medical City (KAMC), Jeddah. RESULTS: The study revealed that 73% of the respondents throw the medications in the trash, 14% return the medications to a pharmacy, 5% never dispose them, and 3% donate the medications to a friend or charity centers. More than 80% of the respondents never received any information or advice from healthcare providers about safe and proper disposal of medications. CONCLUSION: Our findings suggest that there is an immediate requirement for the establishment of collaborative and uniform guidelines for the safe disposal of leftover medications. A policy for drug donation needs to be included in routine patient education as well as educational and collective programs for the public.

From Learning to Decision-Making: A Cross-Sectional Survey of a Clinical Pharmacist-Steered Journal Club.

Journal clubs have been traditionally incorporated into academic training programs to enhance competency in the interpretation of literature. We designed a structured journal club (JC) to improve skills in the interpretation of literature; however, we were not aware of how learners (interns, residents, clinical pharmacists, etc.) would perceive it. We aimed to assess the perception of learners at different levels of pharmacy training. A cross-sectional design was used. A self-administered online survey was emailed to JC attendees from 2010-2014 at King Abdulaziz Medical City, Jeddah, Saudi Arabia. The survey questions included: introduction sessions, topic selection, JC layout, interaction with the moderator, and decision-making skills by clinical pharmacists. The response rate was 58/89 (65%); 52/54 (96%) respondents believed that JC adds to their knowledge in interpreting literature. Topic selection met the core curriculum requirements for credentials exams for 16/36 (44.4%), while 16/22 (73%) presenters had good to excellent interaction with the moderator. JC facilitated decision-making for 10/12 (83%) of clinical pharmacists. The results suggest that clinical pharmacist-steered JC may serve as an effective tool to empower learners at different levels of pharmacy practice, with evidence-based principles for interpretation of literature and guide informed decision-making.

Drug-related problems found in children attending an emergency department in Saudi Arabia and in the United Kingdom.

BACKGROUND: No published studies investigating drug-related problems (DRPs) in children visiting emergency department (ED) in either the Kingdom of Saudi Arabia (KSA) or the United Kingdom (UK) were identified. OBJECTIVE: To determine the frequency and characteristics of DRPs in paediatric patients attending ED in the KSA and the UK. METHOD: An observational study. DRPs were identified by a researcher, reviewing the medical records of children attending the ED during a three-month period in KSA and a 1 month period in UK; severity and preventability of the DRPs were assessed. Incidence of DRPs overall and in each country was calculated. RESULTS: A total of 253 patients (KSA n = 143, UK n = 110) were included. Fifty-five patients (22%; 55/253), experienced 69 DRPs. 2% (5/253) of the patients attended the ED due to DRPs. Overall incidence was 21.7% (95% CI, 16.8-27.3). 78% (54/69) of the DRPs were assessed as preventable; 33% (23/69) as of moderate severity. CONCLUSION: DRPs were common in paediatric patients attending EDs; the majority were preventable. Further study is needed to investigate the impact of mild and moderate DRPs on paediatric patients' health and also to improve the care provided to minimise the occurrence of preventable DRPs.

Epidemiology and potential associated risk factors of drug-related problems in hospitalised children in the United Kingdom and Saudi Arabia.

AIM: Drug-related problems (DRP) are "an event or circumstance involving drug therapy that actually or potentially interferes with the desired health outcome". The extent and characteristics of DRPs in children in the UK and the Kingdom of Saudi Arabia (KSA) are unknown. Our aim was to determine the epidemiology of and identify risk factors for DRPs in hospitalised children. METHODS: A prospective cohort study was carried out in children aged 0-18 years, admitted to the medical ward, paediatric intensive care unit (PICU) and neonatal intensive care unit (NICU) during a 3-month period in two hospitals. Patients' charts, medical records and laboratory data were reviewed daily to identify DRPs; their preventability and severity were assessed. Logistic regression was used to analyse the potential risk factors associated with DRP incidence. RESULTS: Seven hundred and thirty-seven children (median age 2.3 years, interquartile range 6 months to 8 years, 58.1% male) were included. Three hundred and thirty-three patients suffered from 478 DRPs. Overall DRP incidence was 45.2% (95% CI, 41.5-48.8); KSA (51.1%; 95% CI, 45.8-56.3), UK (39.4%; 95% CI, 34.4-44.6). Incidence was highest in the PICU (59.7%; 95% CI, 47.0-71.5). Dosing problems were the most frequently reported DRPs (n = 258, 54%). 80.3% of DRP (n = 384) cases were preventable; 72.2% (n = 345) of DRPs were assessed as minor; 27% (n = 129) as moderate. Number of prescriptions and type of admission (transferred) were potential risk factors for DRP occurrence in children. CONCLUSIONS: Drug-related problems were common in the hospitalised children in this study; the most frequent were dosing problems and drug choice problems; the majority of them were preventable. Polypharmacy and transferred admission (another hospital or ward) were potential risk factors. To improve prescribing practices and minimise the risk of DRPs in hospitalised children, paediatric pharmacology and pharmacotherapy are important in medical education.