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Background: Understanding antibiotic consumption patterns over time is essential to optimize prescribing practices and minimizing antimicrobial resistance. This study aimed to determine whether the antibiotics restriction policy launched by the Saudi Ministry of Health in April has impacted antibiotic use by assessing changes and seasonal variations following policy enforcement. Antibiotics consumption was measured in defined daily doses per 1, inhabitant per day- in a quarter DDDdq. A comparative analysis of antibiotic consumption pre- and post-policy periods introduction was conducted by computing the average consumption values for each period. Statistical comparison of the mean differences between the two periods were then made using independent samples t-test, Mann-Whitney U Test where needed. Time series analysis was employed to estimate the projected antibiotic consumption in the post-policy period if the restriction policy had not been implemented, which was then compared to actual consumption values to evaluate the effectiveness of the restriction policy. Results: During the pre-policy, there were seasonal trends of the total and oral antibiotic consumption through quarters, with higher consumption observed in the first and fourth quarters. In contrast, parenteral antibiotic consumption did not appear to follow a clear seasonal pattern. Conclusion: Overall, our analysis of antibiotics consumption from to displays great success for the policy implemented by the Saudi Ministry of Health in significantly reducing the total and oral use of antibiotics. However, future studies are needed to explore the increased consumption of the parenteral antibiotics as well as the persistent high consumption patterns during the fall and winter months even after the implementation of the restriction policy. The current global increase in antimicrobial resistance AMR coupled with the shortage in developing new antibiotics poses serious public health and economic challenges Ventola, Projections indicate that AMR could become the leading cause of death globally by , unless it is adequately addressed de Kraker et al. Several investigations conducted in Saudi Arabia highlighted the significant burden of AMR and its growing prevalence among Gram-negative and Gram-positive bacteria Al Johani et al. Increased levels of AMR could be arise from various factors, such as inadequate therapy duration, inappropriate dosages, and irrational fixed-dose drug combinations, but the most significant factor is the misuse of antibiotics WHO, During previous years, the prohibition of over-the-counter antibiotics sales in private pharmacies was not enforced in Saudi Arabia, and non-prescribed use of antibiotics was common practice for unnecessary self-limiting conditions such as common cold Nafisah et al. A study conducted by AlKhamees et al. Several studies from various regions in Saudi Arabia have indicated a lack of public knowledge and widespread misuse of antibiotics Al-Rukban and Khalil, ; Alharbi et al. Similarly, inadequate knowledge and poor practices among healthcare professionals have been reported Alzahrani et al. In , it was reported that the pharmaceutical expenditure in Saudi Arabia reached 7 billion US dollars, with nearly 2 billion US dollars spent on antibiotics Almeleebia et al. Global stewardship programs were implemented in many countries to reduce overall antibiotic prescribing and reduce the burden of AMR resistance. In April , the Saudi Ministry of Health MOH initiated a nationwide antibiotics restriction policy, in which pharmacies are strictly prohibited from dispensing antibiotics without a prescription. Failure to adhere to the regulations could lead to severe penalties, including license revocation, fines up to thousand riyals, and imprisonment for up to 6 months MOH, Despite the large volume of antibiotic consumption, only little is known about usage patterns. Detailed surveillance of antibiotic use in the community is one of the strategies that could be used to guide and control antibiotic overuse and misuse. Unfortunately, the effectiveness of governmental interventions to enhance antibiotic use in Saudi Arabia has not been thoroughly investigated in Saudi Arabia. One recent study conducted by Al-Jedai et al. Moreover, the analyses used in this study have not fully addressed the potential seasonality effect of antibiotic consumption. Therefore, this study aims to assess the impact of the Saudi MOH restriction policy over a more extended period 5 years period; — It also seeks to describe trends and seasonal variations in antibiotic use to determine opportunities for public health intervention where seasonal peaks may represent increases in inappropriate use. We finally attempted to assess the potential effect of the COVID pandemic on antibiotic use patterns during the last three-quarters of The finding from this study can be utilized by policymakers to continue monitoring antibiotic misuse, developing rational-use policies, and establishing a baseline for future assessment. The IQVIA database provides estimates of antibiotic use based on the volume sold in retail and hospital pharmacies through national surveys conducted along pharmaceutical sales distribution channels from manufacturer to wholesaler to retailer. However, topical, ophthalmic, otic, and local intravaginal and pessaries antimicrobial data were excluded. Information for amphenicols J01B and combinations of antibacterials J01R are unavailable. The distribution of antibiotics into classes is listed in Table 1. Antibiotic consumption was estimated based on sales volume reported in standard units SUs. The annual antibiotic consumption rate in Saudi Arabia, expressed in DDDdq, was calculated using population estimates from the World Bank — Prior to April , antibiotics were accessible over the counter in Saudi Arabia, despite Ministry of Health MOH advisories against such practices, with limited pharmacy adherence. To address this, the MOH launched a nationwide restriction policy in April prohibiting pharmacies from dispensing antibiotics without a prescription. Complementing this policy, the MOH also launched extensive campaigns to educate both the public and healthcare providers about rationalizing antibiotics use, utilizing various platforms including malls, healthcare institutions, and social media MOH, Descriptive statistics were used to evaluate antibiotic consumption in the form of the DDDdq across the defined pre- and post-policy periods to capture the seasonal variations and assess the effectiveness of the restriction policy. To compare the consumption between pre-policy and post-policy periods, we computed the average consumption within each period; then, we used independent samples t-test, Mann Whitney U Test where needed, to compare the mean difference between the two periods. We also calculated the percentage of change in consumption from pre-policy to post-policy periods. Furthermore, we assessed the effectiveness of the restriction policy using time series analysis to forecast antibiotic consumption in the post-policy period if the restriction policy had not been implemented. The forecasted consumption was then compared with the actual consumption during the corresponding period to assess potential differences. Stationary R-squared was used to assessed the seasonal variation and the forecast model reliability. The model was proved reliable and able to detect seasonality for total and oral antibiotic consumption but not for parenteral antibiotic consumption. The potential effect of the COVID pandemic on antibiotic consumption during the post-policy period was evaluated by comparing antibiotic consumption from Q3 to Q1 with the remaining quarters of Q2—Q4, The average DDDdq of the total, oral, and parenteral antibiotic consumptions in Saudi Arabia during the pre-policy period were Pre-policy data indicated seasonal consumption trends for total and oral antibiotics through quarters, with peaks observed in Q1 and Q4. In contrast, parenteral antibiotic consumption did not exhibit a clear seasonal pattern. During the post-policy period, noticeable declines in total and oral antibiotic consumption were observed, while an increase in parenteral antibiotic consumption was noted Figure 1. In addition, the percentage change in actual antibiotic consumption reflected substantial decreases in total and oral consumptions post-policy, while parenteral consumption notably increased Figure 2. Percentage of change in the antibiotic actual consumption from the pre-policy period to the post-policy period. Error bars were derived from relative standard deviation RSD. Analyzing consumption by antibiotic class, similar seasonal trends of total and oral antibiotic consumption were observed during pre- and post-policy periods, with J01C exhibiting the highest DDDdq among all classes. The percentage of change in the antibiotic actual consumption from the pre-policy period to the post-policy period demonstrated significant decreases in the consumption of J01C, J01D, and J01M classes. In contrast, a significant increase in the percentage of change was observed for the consumption of the J01X class. The antibiotic consumption in Saudi Arabia by quarters and class from to The model was, however, unreliable in detecting the seasonality for parenteral antibiotic consumption due to poor stationary R-squared, which indicates an absence of seasonality Figure 4. Forecasting model of antibiotic consumption during the post-restriction policy period if the policy was not implemented. These results suggest that the restriction policy markedly reduced total and oral antibiotic consumption, which would have otherwise continued to rise. Forecasted vs. The findings indicated no significant pandemic-related impacts on total, oral, or parenteral antibiotic consumption. However, a significant decrease in J01D class consumption and an increase in J01E class consumption during the pandemic period were noted Figure 6. This study aimed to measure the changes in antibiotic consumption—considering the seasonal variations of consumption—before and after the implementation of the MOH restriction policy in Saudi Arabia in mid- It also assessed the effect of the COVID pandemic on antibiotic consumption during the post-policy period. We noted a substantial decrease in the consumption of antibiotics for systemic use ATC J01 , from Seasonal fluctuations were observed over the study period—including both pre- and post-policy periods, where the highest dip in antibiotic use was in Q2 and Q3, and the highest peaks were during Q1 and Q4. Such convenience, while innovative, could inadvertently contribute to the misuse of antibiotics during the post-policy period. Penicillin is the most commonly used antibiotic in Saudi Arabia and many parts of the world such as European Union countries Bruyndonckx et al. A sudden increase in the ATC group J01A; Tetracyclines consumption was observed in the last quarter of during the pre-policy phase. Despite our thorough analysis, the specific factors contributing to this sudden increase remain indeterminate and challenging. It is important to acknowledge that in complex healthcare systems and pharmaceutical landscapes, not all variations in consumption patterns can be definitively explained. However, several non-exclusive factors such as epidemiological trends, policy changes, prescribing behaviors, availability, or even the marketing practices of pharmaceutical companies giving the fact that J01A is one of the cheapest drugs, all these reasons could influence these pattern sudden changes. Unfortunately, we are unable to distinguish between these factors since the IQVIA data did not include information on prescription indications or microbiological data. This highlights the necessity for ongoing research where further investigations, could provide additional insights into these consumption dynamics especially for J01A group. Surprisingly, antibiotic consumption of ATC group J01X significantly increased after implementing the restriction policy. This is possibly because the J01X antibiotic class is categorized as a reserve group according to the AWaRe access, watch, reserve classification system e,g. Similarly, we believe that the increase in J01X prescriptions, especially vancomycin and colistin in Saudi Arabia, may be related to an increase in similar cases Zowawi, Other potential causes for the rise in J01X consumption in recent years include the emergence and spread of multidrug-resistant bacteria, poor prescribing habits, and the shortage of effective alternative treatments Banawas et al. Future direction in Saudi Arabia should include long-term surveillance and extensive research to elucidate the reasons behind the increase in reserve antibiotic use and to develop targeted interventions. Although the MOH restriction policy was solely intended to limit the use of over-the-counter antibiotics, a substantial increase in the use of parenteral antibiotics following the implementation of the policy was observed. The overuse of parenteral antibiotics in this study cannot be ignored and poses concerns. Several potential factors could explain the reported rise in the usage of parenteral antibiotics. Another reason is the tendency of patients to delay seeking medical attention for infections when accessibility to oral antibiotics is constrained. This may cause the infection to worsen to the point where parenteral antibiotics are a better alternative for treatment. Other patients may have difficulty adhering to oral antibiotic regimens, leading to treatment failure, the development of AMR, and the need for more potent parenteral antibiotics. Another factor contributing to the increase in parenteral antibiotic use after the implementation of a restriction policy is the inappropriate prescribing practice by healthcare providers. Healthcare workers may be more likely to prescribe parenteral antibiotics as a precautionary measure, especially if they do not have time to diagnose bacterial infections or are faced with uncertainty in difficult cases Pulcini et al. Usually, the antibiotic prescription is a difficult procedure influenced by multiple factors such as physician attitudes, patient symptoms, and time constraints Rodrigues et al. Another reason could be the lack of proper education and training programs among healthcare providers on antibiotic prescribing guidelines. Therefore, more in-depth studies are needed to explore indications of parenteral use to understand why these antibiotics are so popular among patients and physicians. It is crucial for healthcare providers and policymakers to carefully consider the potential impacts of restriction policies on antibiotic use and to implement strategies to mitigate any negative effects or unintended consequences. However, we sought to use data from the final three-quarters of to investigate any potential influence of COVID on antibiotic usage during these three-quarters compared to previous quarters since the restriction policy was implemented. Overall, we found no statistically significant changes in total, oral, or parenteral antibiotic usage. Our findings agree to previous research, which indicated that the global trend of antibiotic consumption remained steady over the study period Guisado-Gil et al. These observations could be attributed to Saudi governmental population-forced measures mask usage, social distance, hand sanitizer to minimize respiratory illnesses, which correlate to restricted antibiotic use. Interestingly, however, we found that ATC group J01E consumption has significantly increased during the pandemic. The increased use of this group, which possess immunomodulatory and anti-inflammatory properties, could be due to their perceived benefits for treating severe COVID cases, especially given the early recommendations against the use of non-steroidal anti-inflammatory drugs NSAIDs for COVID patients Micallef et al. One study has suggested the importance of using Trimethoprim therapy ATC J01E to reduce acute lung injury in patients with severe COVID, thereby reducing the need for ventilatory support and improving outcomes Varney et al. However, it is important to acknowledge that this approach was part of an evolving therapeutic strategy in response to an emergent unknown and new viral pandemic, rather than a reflection of established clinical efficacy. In Saudi Arabia, the early stage of the COVID pandemic presented unprecedented challenges to healthcare providers like the situation worldwide. There was significant uncertainty regarding effective treatment standard protocols for COVID, leading to varied therapeutic approaches based on emerging evidence and clinical trials. Nevertheless, future research is needed to assess patterns of antimicrobial use before, during, and after the COVID pandemic in Saudi Arabia. To the best of our knowledge, the current study is the first study by far that investigated the changes in antibiotic consumption—considering the seasonal variations of consumption—before and after the implementation of the MOH restriction policy in Saudi Arabia, yet several limitations need to be addressed. Firstly, the IQVIA database used in the study does not differentiate between sales of prescription and non-prescription antibiotics. This means that the sales data may not accurately reflect the real consumption status in Saudi Arabia, especially in the pre-policy phase. Finally, the IQVIA antibiotics purchasing units do not provide information on consumption by specific groups, such as age or gender, which could have been useful for better planning antibiotics stewardship activities. In general, the IQVIA database gives information mainly on antibiotics used across the nation, where most of the antibiotic usage occurs. Future research must, therefore, take hospital data into account to obtain a fuller picture of antibiotic utilization in Saudi Arabia. We revealed a positive impact of the MOH restriction policy that aimed to reduce the misuse and overuse of antibiotics utilizing a sophisticated analysis approach such as seasonal variations. A more pronounced impact was observed on oral antibiotic consumption. Concerns remain regarding the increased consumption of parenteral antibiotics during the post-policy period. Requests to access these datasets should be directed to smotibi sfda. KA and SuA conceived and designed the study. KA and SaA analyzed the data. KA and SaA wrote the original draft. All authors contributed to the article and approved the submitted version. The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. The views expressed in this paper are those of the author s and do not necessarily reflect those of the SFDA or its stakeholders. Guaranteeing the accuracy and validity of the data is the sole responsibility of the research team. Alharbi, M. The dangerous effects of excessive use of antibiotics among community in Saudi Arabia. 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Inappropriate dental antibiotic prescriptions: potential driver of the antimicrobial resistance in albaha region, Saudi Arabia. Risk Manag. Policy 13, — Awadh, A. Assessment of knowledge, attitudes and practices regarding pulmonary tuberculosis among community in Riyadh city, Balkhy, H. Ten-year resistance trends in pathogens causing healthcare-associated infections; reflection of infection control interventions at a multi-hospital healthcare system in Saudi Arabia, Control 9, Ballal, R. Attitude and knowledge of self-medication with antibiotics among the public in Riyadh, Saudi Arabia. Asian J. AJP 13, Banawas, S. Multidrug-resistant bacteria associated with cell phones of healthcare professionals in selected hospitals in Saudi Arabia. Baraka, M. Perspectives of healthcare professionals regarding factors associated with antimicrobial resistance AMR and their consequences: a cross sectional study in Eastern Province of Saudi Arabia. Antibiotics 10, Bruyndonckx, R. Cara, A. Cost-effectiveness analysis of low versus high dose colistin in the treatment of multi-drug resistant pneumonia in Saudi Arabia. De Kraker, M. Will 10 million people die a year due to antimicrobial resistance by ? PLoS Med. Donkor, E. Methicillin resistant Staphylococcus aureus and extended spectrum beta-lactamase producing enterobacteriaceae: a therapeutic challenge in the 21st century. Open Microbiol. Guisado-Gil, A. Impact of the COVID pandemic on antimicrobial consumption and hospital-acquired candidemia and multidrug-resistant bloodstream infections. Basel 9, Decrease in penicillin sales in Brazil after over-the-counter restrictions. Agents Chemother. Micallef, J. Therapie 75, — MOH Ministry of health warns against selling antibiotics without prescription. Google Scholar. Nafisah, S. Over-the-counter antibiotics in Saudi Arabia, an urgent call for policy makers. Pulcini, C. Developing core elements and checklist items for global hospital antimicrobial stewardship programmes: a consensus approach. Qu, X. Consumption of antibiotics in Chinese public general tertiary hospitals : trends, pattern changes and regional differences. PLoS One 13, e Rodrigues, A. Understanding physician antibiotic prescribing behaviour: a systematic review of qualitative studies. Truter, I. The defined daily dose as a measure of drug consumption in South Africa. A preliminary study. South Afr. Van Boeckel, T. Global antibiotic consumption to an analysis of national pharmaceutical sales data. Lancet Infect. Varney, V. Int Jr Infect Dis Epidemlgy 23 4 , 1. Ventola, C. The antibiotic resistance crisis: part 1: causes and threats. P T 40, — WHO Antimicrobial resistance and primary health care. World Health Organization Yagoub, U. Antibiotic resistance: a hospital-based multicenter study in Tabuk city, Kingdom of Saudi Arabia. Drug Resist 12, — Yezli, S. Prevalence and antimicrobial resistance among Gram-negative pathogens in Saudi Arabia. Yoon, Y. Trends of antibiotic consumption in Korea according to national reimbursement data — : a population-based epidemiologic study. Medicine 94, e Zaidi, S. Cross-sectional survey among general population regarding knowledge and attitude toward antibiotic usage in Western Saudi Arabia. Pharmacy 9, Zowawi, H. Antimicrobial resistance in Saudi Arabia: an urgent call for an immediate action. The use, distribution or reproduction in other forums is permitted, provided the original author s and the copyright owner s are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. Alajel, smotibi sfda. Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher. Top bar navigation. About us About us. Sections Sections. About journal About journal. Article types Author guidelines Editor guidelines Publishing fees Submission checklist Contact editorial office. Drugs Outcomes Research and Policies. Evaluating the effectiveness of the Ministry of Health restriction policy on seasonal antibiotic consumption trends in Saudi Arabia, — Khaloud O. Introduction The current global increase in antimicrobial resistance AMR coupled with the shortage in developing new antibiotics poses serious public health and economic challenges Ventola, TABLE 1. J01 systemic antibacterials list. The antibiotic consumption in Saudi Arabia by quarters from to

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