Sterile injectable products shortage in Saudi Arabia: a survey-based cross-sectional study

Abstract

Sterile Injectable Products (SIPs) represent a critical class of pharmaceuticals that frequently face shortages and ultimately compromise patient care. Disruptions within the pharmaceutical supply chain are significant factors contributing to these shortages. This study aimed to investigate the causes and impacts of SIPs shortages in Saudi Arabia, with the central hypothesis that pharmaceutical supply chain disruptions are the primary drivers of these shortages and that they negatively affect patient outcomes. A cross-sectional questionnaire was administered to two key stakeholder groups: supply chain management (SCM) personnel and healthcare professionals (HCPs). A total of 350 responses were collected and statistically analyzed. Our findings demonstrate a strong consensus among SCM respondents, with 73% agreeing that supply chain disruptions significantly affect SIPs availability. Poor demand forecasting and limited sourcing capabilities were identified as the primary contributing factors. From the perspective of HCPs, over 65% indicated that SIP shortages adversely impacted patient care, resulting in treatment delays, extended hospital stays, and increased healthcare costs. Additionally, many respondents reported that staff time is often wasted in the search for alternative therapies, which may also be of short supply. Interestingly, more than 70% of respondents from both groups expressed robust support for the adoption of advanced technologies such as artificial intelligence (AI) and machine learning (ML) to enhance forecasting and inventory management. Taken together, these findings underscore the urgent need for integrated strategies including proactive forecasting, sustainable inventory management, expanded local manufacturing, and AI-driven tools to strengthen the resilience of the SIP supply chain in Saudi Arabia and beyond.

Supplementary Information

The online version contains supplementary material available at 10.1007/s44446-025-00053-z

Introduction

The pharmaceutical supply chain presents ongoing challenges globally, and disruptions can negatively affect healthcare delivery. These challenges also impose significant financial burdens, accounting for more than 35% of the total healthcare expenditure, compared to only 5% in the retail industry (Jaberidoost et al. 2013; Kwon et al. 2016). This disparity arises primarily from the fragmented nature of the supply chain, which involves multiple stakeholders, including pharmaceutical manufacturers, regulatory authorities, group purchasing organizations (GPOs), and healthcare professionals (HCPs). Additionally, the complexity of product movement, inventory management, and distribution further amplifies supply chain vulnerabilities. (Kwon et al. 2016; Singh et al. 2016).

Numerous studies have demonstrated a strong relationship between supply chain efficiency and healthcare system performance, underscoring the costly consequences of frequent and prolonged disruptions. A tangible result of these disruptions is drug shortages, which became especially apparent during the COVID-19 pandemic (Chen et al. 2013, Brianne Bowen and Weinstein 2022). This crisis exposed weaknesses in the global pharmaceutical supply chain, leading to widespread drug shortages (Vogler 2024). Approximately 14% of drugs experienced shortages from 2017 to 2021, with the most significant number of shortages occurring during the pandemic (AlRuthia et al. 2017, 2018). Moreover, many pharmaceutical products that were already in short supply before the pandemic continued to face shortages today (Denigan-Macauley 2025).

Sterile injectable products (SIPs) are particularly affected by supply shortages, which have profound implications for patient health, particularly given their frequent use in emergency interventions and acute critical care situations. Commonly used SIPs, such as antibiotics, pain management medications, electrolytes, and oncology drugs, frequently experience shortages (Goldsack et al. 2014; Holcombe et al. 2018; Denigan-Macauley 2025). Several factors contribute to the vulnerability of SIPs, including manufacturing complexity, stringent regulatory compliance, quality issues, and logistical challenges (Fox et al. 2014; O'Brien et al. 2021). Additionally, a lack of marketing incentives for certain generic SIPs intensifies the risk of supply disruptions in several countries, including Saudi Arabia (Woodcock and Wosinska 2013; O'Brien et al. 2021). In a recent position paper, SIPs have been highlighted as a critical concern owing to major shortages. Their complex and highly regulated production requirements combined with market pressures for low pricing make them especially vulnerable to manufacturing and economic instabilities, resulting in prolonged and clinically challenging supply shortages in healthcare (Serchen et al. 2025).

In the context of Saudi Arabia’s ongoing healthcare transformation, drug shortages have emerged as a pressing issue, drawing significant attention from key governmental bodies, such as the National Unified Procurement Company (NUPCO) and the Saudi Food and Drug Authority (SFDA), which have intensified efforts to facilitate local pharmaceutical manufacturing. Despite these initiatives, domestic production capacity remains limited, particularly for sterile injectable products, resulting in continued reliance on imported pharmaceuticals. This dependency highlights the structural vulnerability within the national healthcare supply chain and underscores the importance of strengthening local manufacturing capabilities. Consequently, addressing drug shortages and promoting local production have become integral components of Saudi Vision 2030, which emphasizes self-sufficiency and resilience in the supply of essential medicines (Rahman and Al-Borie 2021). Recently, drug shortages in Saudi Arabia have attracted significant attention, as evidenced by a growing number of reports examining the extent, underlying causes, and practical strategies for mitigation (AlRuthia et al. 2017, 2018; Alshaya and Aljedai 2023; Alyami et al. 2023; Alshibli et al. 2024). However, existing studies have predominantly focused on overall drug shortages, with limited attention paid to specific pharmaceutical classes.

This study aimed to investigate the causes and impacts of SIPs shortages in Saudi Arabia, focusing on disruptions in the pharmaceutical supply chain. Data were collected from SCM experts in local hospitals as well as critical stakeholders from the SFDA and NUPCO. Furthermore, this study evaluated the impact of SIP shortages on patient outcomes by analyzing feedback from HCPs who worked closely with patients. The findings are intended to support the development of multilevel policy recommendations to enhance the resilience of the SIP supply chain and mitigate its adverse effects on patient care. To the best of our knowledge, this is the first study to investigate SIP shortages caused primarily by supply chain disruptions in healthcare facilities in Saudi Arabia.

Methodology

Study design, setting, targeted populations and ethical approval

This study utilized a cross-sectional, quantitative research design to collect insights into procurement processes within the healthcare sector. Data were gathered remotely through a self-administered online questionnaire distributed using Google Forms. The survey specifically targeted individuals with expertise in SCM and HCPs working in both public and private health care facilities throughout Saudi Arabia.

To ensure the relevance of the data, clearly defined selection criteria were established for eligible participants. Individuals actively engaged in critical activities related to procurement, inventory management, contracting, and distribution of pharmaceutical products were included. Additionally, HCPs currently employed in healthcare institutions were invited to participate in this study. Conversely, individuals who no longer held relevant positions, those who had relocated outside the healthcare sector, or those who were not presently employed within Saudi Arabia were excluded from the study to maintain focused and applicable results.

This study was approved by the Standing Committee for Scientific Research Ethics at King Saud University (reference number E-24–9052). Participation was voluntary and informed consent was obtained from all participants before they could access the survey questions. Respondents were informed about the study’s objectives, the confidentiality of their responses, and their right to withdraw at any stage without penalties. Furthermore, to safeguard the privacy and confidentiality of all participants, measures were implemented to ensure that all responses remained anonymous throughout the research process, thereby creating a secure environment in which participants could share their insights. The study was conducted in accordance with the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) guidelines for cross-sectional studies.

Questionnaires, distribution and collection

The survey questionnaire was divided into two sections based on responses to an initial screening question. The first section gathered demographic information, including age, sex, type of healthcare facility, educational level, years of experience, and hospital bed capacity. The second section was tailored to participants' responsibilities in SCM. For those involved in SCM, this section included two subsections. The first evaluated their agreement with key factors influencing the distribution of SIPs through six questions using a 5-point Likert scale. The second subsection assessed the frequency of shortages with four additional questions using a 5-point Likert scale.

For HCPs, two distinct subsections were included. The first gauged the perceived impact of SIP shortages on patient care through six questions on a 5-point Likert scale. In contrast, the second study examined the frequency of shortage-related clinical scenarios and their relevant experiences using four questions on the same scale. Both groups received a shared third subsection, consisting of a multiple-choice question related to strategies for mitigating the risk of shortages, with similar responses noted across the targeted populations. The questionnaire was adapted from a previously published survey on drug shortages in large hospitals in Riyadh (AlRuthia et al. 2017). Minor modifications have been introduced to address sterile injectable products and the perspectives of both supply chain personnel and healthcare providers. Content validity was confirmed by three faculty experts in pharmacy and supply chain management. The instrument was piloted with ten participants to ensure clarity and comprehension, and no substantial revisions were needed before distribution.

The survey was designed for clarity and ease of completion, featuring a large font and straightforward layout to ensure that it could be completed in approximately five minutes. An a priori sample size calculation was conducted using G*Power 3.1 (Exact test, two independent proportions; two-tailed; α = 0.05; power = 0.95). Assuming a baseline proportion of p = 0.50, and an odds ratio (OR) of 2.2 (approximately 19% difference), the analysis indicated a required total of approximately 352 participants. The final sample (n = 350) closely matched this target, demonstrating adequate statistical power for the planned analyses. A convenience sampling strategy was employed to distribute the survey through professional networks,institutional email lists, and social media platforms during the data collection period from November 1, 2024, to February 28, 2025. The responses were anonymous and confidential. Data were automatically recorded in a secure Google Sheets database linked to the survey form for streamlined data management and analysis.

Data analysis

Survey responses were exported from Google Forms to Microsoft Excel and analyzed using R statistical software, version 4.2.2. Descriptive statistics (frequencies and percentages) were used to summarize the participant demographics and survey responses. Associations between categorical variables were examined using the chi-square test (or Fisher’s exact test when the expected cell count was < 5). Logistic regression analysis was conducted to identify predictors of SIP shortages, with ORs and 95% confidence intervals (CIs) reported. All statistical analyses were performed using R (version 4.2.2), and a two-sided p-value < 0.05 was considered statistically significant.

Results

Demographic characteristics

A total of 350 responses were collected from the participants. The majority of the respondents were pharmacists (77.7%), followed by technicians (10.0%), others (4.9%), physicians (4.6%), and nurses (2.9%). More than half (52%) of the participants reported being involved in supply chain management responsibilities. In terms of age distribution, the largest group consisted of participants aged 30–39 years (43.4%), followed by those aged 20–29 years (41.4%), and 40–49 years (12.0%). Male respondents comprised 63.4% of the sample, while female respondents comprised 36.6%.

Regarding the type of healthcare facility, 47.4% of the respondents were employed in government facilities, 40.6% in private institutions, and 12.0% in semi-government healthcare institutions. In terms of educational attainment, 65.7% held a Bachelor of Science (BSc) or equivalent degree, 25.7% held a Master of Science (MSc) or equivalent degree, 6.9% held a Doctor of Philosophy (PhD) or equivalent degree, and 1.7% held a diploma.

Regarding years of experience, 26.6% had 1–3 years of experience, 24.3% had more than 10 years, 20.6% had 4–6 years, 14.9% had 7–10 years, and 13.7% had less than 1 year of experience. With respect to hospital volume, 28.9% of participants were from hospitals with more than 500 beds, 24.0% from hospitals with 100–300 beds, 20.9% reported 'Not Applicable', 17.7% from hospitals with 301–500 beds, and 8.6% from hospitals with fewer than 100 beds. Table 1 presents the demographic characteristics.

Table 1.

Demographic characteristics of participants surveyed (n = 350)

Variable	No	%
Age
20–29	145	41.4
30–39	152	43.4
40–49	40	11.4
50 or above	13	3.7
Gender
Male	222	63.4
Female	128	36.6
Role
Pharmacist	272	77.7
Technician	35	10.0
Others	17	4.9
Physician	16	4.6
Nurse	10	2.9
SCM Responsibility
Yes	178	52.0
No	172	48.0
Facility Type
Government	166	47.4
Private	142	40.6
Semi-Government	42	12.0
Education
Bachelor of Science (BSc.) or equivalent	230	65.7
Master of Science (MSc.) or equivalent	90	25.7
Doctor of Philosophy (PhD.) or equivalent	24	6.9
Diploma	6	1.7
Experience
Less than 1 year	48	13.7
1–3 years	93	26.6
4–6 years	72	20.6
7–10 years	52	14.9
More than 10 years	85	24.3
Hospital Volume
More than 500 beds	101	28.9
100–300 beds	84	24.0
301–500 beds	62	17.7
Less than 100 beds	30	8.6
Not Applicable	73	20.9

Agreement on the role of supply chain disruption in the shortage of SIPs

The survey responses highlighted varying levels of agreement regarding several key factors influencing the supply chain of SIPs and underscored their impact on continuous supply. Notable factors include high demand, delays stemming from stringent regulatory requirements, and the slow adoption of new technologies designed to alleviate shortages. For instance, when participants were asked whether supply chain disruptions significantly impacted the availability of SIPs, a notable 73.0% expressed agreement or strong agreement with this statement (see Fig. 1). Regarding whether demand frequently exceeds supply, approximately half of the respondents (47.2%) agreed or strongly agreed. In comparison, 28.1% remained neutral and 24.8% disagreed or strongly disagreed.

Fig. 1.

SCM experts’ perceived contribution percentages of various supply chain contributing factors to the shortage of SIPs

Regarding communication from suppliers during shortages, 39.9% reported an agreement or strong agreement, 27.5% remained neutral, and 32.6% disagreed or strongly disagreed. Although the rate of agreement may not be excessively high, nearly 40% represents a significant proportion. Enhancing communication and maintaining transparency with suppliers could be beneficial in mitigating the risk of shortages in pharmaceutical products, particularly SIPs. When asked about the importance of inventory management systems in preventing SIP shortages, 42.7% agreed or strongly agreed, 27.0% were neutral, and 30.3% disagreed or strongly disagreed.

Regarding the impact of regulatory and compliance requirements on the supply chain efficiency of SIPs, 60.1% expressed an agreement or strong agreement. Meanwhile, 24.7% were neutral and 7.9% disagreed or strongly disagreed. This sentiment may stem from the stringent quality and safety standards imposed by regulatory authorities for SIPs, which results in longer lead times and increased product unavailability. Surprisingly, there was a high level of consensus, with 73.3% agreeing or strongly agreeing with the potential role of technology and automation in reducing shortages. This was the highest level of agreement recorded among all the questions. Only 13.6% responded neutrally, while 13.0% expressed disagreement or strong disagreement, reflecting a robust sense of optimism regarding the impact of digital solutions on alleviating SIP shortages (see Fig. 1).

Frequency of challenges related to SIPs shortage

The survey revealed that supply chain disruptions and sourcing difficulties are the most frequently reported challenges impacting SIPs’shortcomings. Over half of the respondents (54.5%) indicated that they occasionally faced supply chain disruptions, while 18.0% reported experiencing them often, and 11.2% stated that they always encountered such issues. Collectively, this accounted for approximately 80% of the participants, underscoring the significant influence of supply chain disruptions on SIP shortages. Conversely, only a small percentage indicated that they rarely (8.4%) or never (7.9%) experienced such challenges.

Similarly, sourcing difficulties were noted as occurring sometimes by 51.7% of respondents, with 17.4% stating they occur often, and 10.7% claiming they always encounter these struggles. Fewer respondents reported these issues as being rare (11.8%) or never (8.4%). This suggests challenges in establishing reliable relationships with suppliers, which is crucial for maintaining consistent product supply and minimizing shortages.

Although not as prevalent, shortages resulting from poor forecasting and inventory management were still significant. They were reported to occur sometimes by 38.8% of the respondents and often by 23.0%, indicating that deficiencies in demand planning and inventory control may contribute to overall supply disruptions (Fig. 2).

Fig. 2.

Frequency percentage of challenges related to SIPs

SIPs shortages are driven by high demand, regulatory impact and supply chain disturbance

Logistic regression analysis (R² = 0.538) indicated that several factors were significantly associated with the availability of SIPs. The independent variables included age, sex, facility type, education, experience, hospital bed capacity, demand exceeding supply, effective communication from suppliers, inventory system preventing stockouts, regulatory and compliance impact efficiency, investment in tech/automation reducing shortage, supply chain disturbance affecting availability, sourcing issues, quality issues, and poor forecasting impact. As illustrated in Table 2, these factors include imbalances between supply and demand, the efficiency of regulatory compliance, investments in technology, and disruptions in the supply chain. Notably, respondents who believed that demand frequently surpassed supply were more likely to report limited availability (β = 0.349, 95% CI: 1.22–1.65, p < 0.01). Similarly, perceived regulatory and compliance burdens were associated with a decrease in availability (β = 0.276, 95% CI: 1.10–1.58, p < 0.01). Interestingly, respondents who recognized the potential of technological investments to alleviate shortages demonstrated a significant positive association with availability (β = 0.353, 95% CI: 1.20–1.68, p < 0.01). Finally, those who reported experiencing supply chain disturbances were also significantly more likely to perceive these disruptions as affecting availability. These findings highlight the multifaceted issues that significantly contribute to the shortage of SIPs, as noted by supply chain management experts.

Table 2.

Logistic regression analysis of factors affecting SIPs Availability. OR: Odds Ratio

Variable	β	Std. Error	OR	95% CI	p-value
Age	0.189	0.142	1.21	(0.91–1.60)	0.185
Sex	−0.286	0.174	0.75	(0.53–1.06)	0.103
Facility Type	0.182	0.093	1.2	(1.00–1.44)	0.052
Education	−0.001	0.133	1.0	(0.77–1.30)	0.998
Experience	−0.077	0.083	0.93	(0.78–1.09)	0.352
Hospital Bed Capacity	0.004	0.052	1.0	(0.90–1.11)	0.939
The demand exceeds supply	0.349	0.077	1.42	(1.22–1.65)	< 0.01*
Effective communication from Supplier	0.055	0.073	1.06	(0.92–1.22)	0.446
Inventory system prevents stockouts	0.027	0.075	1.03	(0.89–1.19)	0.719
Regulatory and compliance impact efficiency	0.276	0.090	1.32	(1.10–1.58)	< 0.01*
Investment in tech/automation reduces shortage	0.353	0.084	1.42	(1.20–1.68)	< 0.01*
Supply chain disturbance affects availability	0.279	0.101	1.32	(1.08–1.61)	< 0.01*
Sourcing issues	−0.174	0.107	0.84	(0.68–1.04)	0.105
Quality issues	−0.044	0.084	0.96	(0.81–1.13)	0.600
Poor forecasting impact	0.008	0.081	1.01	(0.86–1.18)	0.914

HCPs perception on the impact of SIP shortages

The survey conducted among HCPs provided valuable insights into the clinical implications of SIP shortages. When asked whether these shortages impacted patient care in their hospitals, a majority of respondents (65.7%) agreed or strongly agreed, while 19.2% remained neutral. A small proportion disagreed (8.7%) or strongly disagreed (6.4%). Regarding the duration of shortages, 36.1% of respondents agreed or strongly agreed that they typically lasted only a few days, while 29.1% were neutral and 34.9% disagreed or strongly disagreed. This indicates that nearly one-third of HCPs have persistent shortages that may pose risks to patients when alternatives are unavailable.

In response to the presence of an effective communication system within hospitals to share information about SIP shortages, 50.0% of the respondents agreed or strongly agreed, while 30.2% were neutral. When asked whether SIP shortages resulted in a loss of staff time during an average week, 45.3% agreed or strongly agreed, 27.9% were neutral, and 26.7% disagreed or strongly disagreed. Concerning trust in the hospital’s supply chain management system, 50.0% of the respondents expressed agreement or strong agreement, 29.7% were neutral, and 20.4% disagreed or strongly disagreed. Similar to SCM respondents, a significant majority (72.7%) agreed or strongly agreed that investing in technology and automation could potentially alleviate SIP shortages. Only 19.2% were neutral, whereas a small percentage disagreed (2.3%) or strongly disagreed (4.1%) (Fig. 3).

Fig. 3.

HCPs perception percentage of the impact of SIP shortages on healthcare delivery

Frequency of SIPs shortages from HCPs perspective

The responses from HCPs indicated that shortages of SIPs, particularly those lasting more than a month, can result in delays in patient treatment, even when therapeutic alternatives are available (Fig. 4). A significant proportion of respondents (39.5%) reported encountering prolonged shortages at times, with an additional 9.3% stating that such shortages occur often and 7.6% indicating that they happen consistently. These findings underscore the inconsistency between suppliers and the frequency of shortages. In contrast, 26.7% of the respondents reported experiencing these shortages rarely, while 16.9% reported that they never occurred.

Fig. 4.

Frequency percentage of scenarios related to SIPs shortages

Regarding the impact on patient outcomes, 43.0% of HCPs indicated that SIP shortages sometimes delay treatment, with 13.4% noting that these delays occur often and 4.7% stating that they happen regularly. Only 9.3% asserted that delays never occurred, highlighting the potential risks of timely patient management. Furthermore, our analysis reveals that 43.0% of respondents are sometimes able to find therapeutic or near-equivalent alternatives, 23.3% do so often, and 11.6% always manage to find alternatives. This highlights the established treatment protocols among HCPs for addressing SIP shortages. Conversely, only 22% of the respondents reported that such shortages rarely or not at all.

In summary, regarding overall experiences with SIP shortages, 44.8% of HCPs reported that they sometimes encountered shortages, 16.9% indicated that they often did, and 8.7% noted that they always experienced them. Although the majority of HCPs reported “sometimes,” the combined 25.6% who noted frequent (often or always) shortages raised significant concerns about the supply of SIPs and their potential impact on patient care (Fig. 4).

Proposed strategies to mitigate the risk of SIPs shortages

Various strategies have been proposed as action plans to enhance the resilience of supply chains for SIPs. While most respondents reached a consensus on the suggested strategies, some notable differences emerged. Among the SCM respondents, approximately 60% expressed support for encouraging local manufacturing and optimizing medication usage guidelines for SIPs. This indicates that relying on international partners for SIP sourcing may present significant risk. Additionally, the strategy of conducting regular supply chain risk assessments has garnered considerable attention, likely because of its potential to forecast shortages and identify alternative sources.

For HCPs, around 60% favored strategies, such as empowering suppliers to manage hospital inventory and implementing robust inventory management systems. Interestingly, 55% of the HCPs recommended increasing communication with the SCM team to manage shortages more effectively. All the other strategies received comparable levels of support, with no significant differences observed between the two groups (Fig. 5).

Fig. 5.

Response percentage on strategies to mitigate the risk of SIPs shortages. HCP: Healthcare professionals. SCM: Supply Chain Management

Discussion

These findings reinforce that disruptions within the pharmaceutical supply chain constitute the primary determinant of SIP shortages, with deficiencies in demand forecasting and constrained sourcing capacity emerging as the most influential contributors. Such shortages exert multifaceted adverse effects on healthcare delivery, including delayed initiation of therapy, escalation of overall healthcare costs, and redirection of healthcare professionals’ time and resources toward identifying and securing alternative therapies, which may also be subject to limited availability. Mitigating these challenges necessitates a comprehensive, multilevel strategy encompassing advanced demand forecasting, risk-based inventory management, promotion of local manufacturing capacity, and integration of emerging technologies such as AI to strengthen supply chain resilience. In this context, the reference to low manufacturing capacity primarily pertains to local pharmaceutical production within Saudi Arabia, where domestic manufacturing of sterile injectable products remains limited, leading to dependence on international suppliers. Therefore, strengthening national manufacturing capacity is essential to improving supply chain resilience and reducing reliance on imports.

Our study examines the impact of pharmaceutical supply chain disruptions on the shortage of SIPs. Two complementary perspectives emerged from the analysis: SCM personnel highlighted upstream factors affecting product availability, whereas HCPs concentrated on downstream implications within hospitals. Our findings indicate that supply chain disruptions contribute significantly to SIP shortages, as evidenced by the strong consensus among SCM respondents (see Fig. 1). Notably, 47.2% of SCM respondents "agreed or strongly agreed" with the statement “demand exceeds supply,” underscoring a significant issue of high demand coupled with poor forecasting (see Fig. 2). These challenges align with the findings of a recent study that analyzed and identified the causes of essential medicine shortages in hospitals managed by the Saudi Arabian Ministry of Health (MOH). Inadequate planning and ineffective forecasting appear to be universal factors disrupting the supply of various classes of pharmaceutical products (Alyami et al. 2023; Alshibli et al. 2024).

SIPs represent a complex category of pharmaceutical products that demand significant attention across the entire supply chain, from manufacturing and regulatory approval to patient administration (O'Brien et al. 2021; Panchal et al. 2023). Several classes of SIPs have faced ongoing shortages, even before the disruptions caused by the COVID-19 pandemic that have affected various pharmaceutical products (Holcombe et al. 2018; Denigan-Macauley 2025). Factors contributing to supply chain challenges include shortage of raw materials, manufacturing delays, and increased operational risks (Fox et al. 2014; O'Brien et al. 2021). For example, heparin SIPs are among the most frequently reported shortages, mainly because of the limited number of manufacturers and the fact that many operate at full capacity, restricting their ability to respond to unforeseen disruptions (Woodcock and Wosinska 2013; Oduah et al. 2016). Additionally, stringent regulatory and compliance requirements appear to be significant factors affecting the availability of SIPs, as indicated by 60% of SCM respondents, as illustrated in Fig. 1. This situation can be attributed to numerous concerns related to strict manufacturing conditions, sterility requirements, and the tightly controlled logistical challenges involved in the delivery of SIPs (Woodcock and Wosinska 2013; Fox et al. 2014). Consequently, even minor alterations in manufacturing conditions or product composition (such as excipients, preservatives, or cryoprotectants) necessitate a thorough regulatory review before products can be distributed, which may clarify SCM experts' consensus on the delays linked to regulatory compliance.

Although the strategy of building high inventory levels of critical products has been proposed as a means to mitigate future supply chain disruptions for SIPs, fewer than 50% of SCM respondents agreed or strongly agreed with this approach. This hesitancy may stem from challenges such as limited storage capacity, complexities of inventory management, and significant capital required to maintain larger stock levels. In a survey conducted among pharmacists regarding shortage of injectable oncology drugs, many respondents indicated that the high costs associated with increasing inventory could make this strategy impractical (Goldsack et al. 2014).

These issues were highlighted by the findings from our survey of HCPs, which gathered responses from a diverse array of professionals directly involved in patient care. Our analysis revealed that over 65% of HCPs "agreed" or "strongly agreed" with the statement, “Shortage of SIPs affects patient care,” with a notable number of respondents identifying treatment delays as a primary consequence of these shortages (Fig. 3 and 4) (Nonzee and Luu 2019). This aligns with data from a recent online survey conducted among group purchasing organizations, where 70% of participants reported that drug shortages resulted in therapy delays (McLaughlin et al. 2013). More importantly, shortages of SIPs are particularly critical because delays often persist for more than one month, amplifying risks to patient health. Numerous studies have confirmed that prolonged shortages pose serious threats to clinical outcomes (Fox et al. 2014; Alshibli et al. 2024; Wosińska 2024; Serchen et al. 2025). Our findings also indicate that these shortages significantly strain hospital resources, with 46% of respondents "agreeing" or "strongly agreeing" that substantial staff time and effort is spent identifying suitable alternatives (Fig. 3). Furthermore, shortages frequently result in extended hospital stays and increased treatment costs, particularly when alternative medications are expensive. For instance, a research analysis by the Premier Healthcare Alliance estimated that procuring substitute therapies for drugs in short supply costs approximately $200 million annually (Barlas 2011; Ventola 2011).

Both the targeted populations surveyed expressed strong support for investments in technology and advanced tools to mitigate the risk of shortages in SIPs. Notably, over 70% of the respondents "strongly agreed or agreed" to the adoption of advanced technological solutions. AI and ML have emerged as valuable tools for enhancing forecasting accuracy, improving inventory management, and streamlining logistical operations. Previous studies have highlighted their potential for predicting supply chain disruptions, optimizing inventory levels, and addressing numerous logistical challenges (Alicke 2022, Wong et al. 2023). Therefore, the integration of these technologies may significantly contribute to mitigating the risk of supply chain shortages of SIPs both globally and within healthcare facilities in Saudi Arabia.

Limitation

The main strength of this study lies in its integration of perspectives from both supply chain professionals and health care providers, which fosters a more nuanced understanding of the issue from both operational and clinical viewpoints. Including participants from various healthcare settings enhances the applicability of the findings across different institutional contexts. Additionally, multivariate analysis provided valuable insights into the key factors associated with shortages, thereby supporting the development of evidence-based recommendations.

However, the cross-sectional design presents inherent limitations in establishing causal relationships as it captures perceptions at a single point in time. In addition, this study employed a convenience sampling strategy, which introduced the potential for selection bias. Because the survey was distributed through professional networks, institutional mailing lists, and social media platforms, pharmacists were disproportionately represented, whereas other groups, such as nurses and physicians, were relatively underrepresented. Furthermore, participants with stronger opinions or experiences regarding shortages might have been more motivated to participate. These factors may limit the representativeness of the sample, and should be considered when interpreting the generalizability of the results. Finally, our investigation did not assess the shortages of SIPs at a regional level; instead, it treated Saudi Arabia as a centralized region. We believe that the shortage of SIPs, along with their contributing factors and implications for patient care, can differ significantly from one region to another due to variations in procurement processes and mitigation. It should also be noted that the findings may not be generalizable beyond Saudi Arabia and other healthcare settings. Additionally, this study did not explore the influence of budgeting and financial allocation on procurement and tendering processes, which are known to play a key role in determining the availability of sterile injectable products. Future studies should address these limitations by employing stratified or random sampling to obtain more representative samples, using longitudinal designs to better establish causal inferences, and conducting regional-level analyses to capture potential variations across healthcare settings.

Conclusion

This study demonstrates that disruptions within the pharmaceutical supply chain remain the primary determinants of SIPs shortages, with inadequate demand forecasting, limited manufacturing capacity, and supply demand mismatches identified as the most critical contributors. These shortages lead to treatment delays, higher healthcare costs, and diversion of HCPs’ time to identify alternative therapies, thereby compromising optimal patient care.

Our results emphasize the need for a coordinated multilevel response. Proactive demand forecasting must be prioritized, as nearly half of the SCM respondents agreed that demand consistently exceeds supply. Regularly updated guidelines for alternative therapies are also warranted, reflecting the concerns of more than 65% of HCPs who reported adverse effects of shortages on patient care. Risk-based inventory management is recommended, although fewer than 50% of SCM personnel strongly support large stockpiles owing to the financial and logistical challenges involved, highlighting the need for more sustainable inventory strategies. Expanding local manufacturing capacity is essential to reduce reliance on vulnerable global supply networks, while the adoption of advanced technological tools is strongly supported by over 70% of respondents, who favored the use of AI-driven forecasting and real-time tracking systems to mitigate future shortages. For future research, it will be important to investigate shortages within specific therapeutic subclasses of SIPs to identify those most vulnerable to disruption, and to critically evaluate the most effective national and international initiatives aimed at mitigating the risks of such shortages. Overall, these measures can strengthen the resilience of the SIP supply chain and ensure consistent delivery of critical therapies in Saudi Arabia and globally.

Supplementary Information

Below is the link to the electronic supplementary material.

Author contribution

Alzammam I: Writing-review and editing, data curation and analysis; Alrasheed M: Methodology, Data curation and analysis, writing–review and editing; Alruthia Y: Questionnaire validation, Methodology, Writing–review and editing; Alzhrani R: Conceptualization. Writing-original draft, supervision.

Data availability

Access to the datasets used in this study is not readily available. To request access, please contact the corresponding author at malrasheed1@ksu.edu.sa.

Declarations

Conflicts of interest

The authors declare that there are no conflicts of interest.