|Year : 2023 | Volume
| Issue : 1 | Page : 1-3
Clinical guidance on managing drug shortages in Saudi Arabia
Abdulrahman I Alshaya1, Ahmed Aljedai2
1 College of Pharmacy, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center, Pharmaceutical Care Department, King Abdulaziz Medical City, Riyadh, Saudi Arabia
2 Deputyship of Therapeutic Affairs, Ministry of Health, Riyadh, Saudi Arabia
|Date of Submission||01-Mar-2023|
|Date of Acceptance||02-Mar-2023|
|Date of Web Publication||30-Mar-2023|
Dr. Abdulrahman I Alshaya
Consultant Critical Care Clinical Pharmacist at KAMC-NGHA, Riyadh, SA, Pharmacy Practice Department, COP, KSAU-HS. Riyadh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Alshaya AI, Aljedai A. Clinical guidance on managing drug shortages in Saudi Arabia. Saudi J Clin Pharm 2023;2:1-3
|How to cite this URL:|
Alshaya AI, Aljedai A. Clinical guidance on managing drug shortages in Saudi Arabia. Saudi J Clin Pharm [serial online] 2023 [cited 2023 Jun 10];2:1-3. Available from: http://www.sjcp.org/text.asp?2023/2/1/1/372928
Drug product shortages affect healthcare systems directly and might lead to unsafe healthcare practices and potentially harmful clinical and economic consequences. Drug product shortages caused by drug manufacturing issues, supply chain mismanagement, natural disasters, or business decisions from pharmaceutical companies., The main reasons behind drug product shortages in Saudi Arabia were improper supply chain management, lack of clear national regulations and policies regarding drug procurement, ineffective law-violation penalties, and overdependence on drug imports, based on a root-cause analysis study published in 2018.
The Health Sector Transformation Program, Saudi Arabia took serious actions to ensure proper management of drug product shortages. The Saudi Food and Drug Administration, the Local Content and Government Procurement Authority, and the national unified procurement company (NUPCO) in collaboration with other governmental and non-governmental entities are leading drug product shortages management from a national level through stockpiling, importing medications from multiple resources and enhancing local pharmaceutical manufacturer in Saudi Arabia. Nonetheless, clinicians should have a key role at the bedside in minimizing the risk of potential harm that may arise from drug product shortages in patient care.
Tailoring potential clinical solutions to manage drug shortages toward the type of medication affected by drug product shortages is essential. The following list displays some suggested strategies which can be summarized in [Figure 1]:
- Temporary formulary strategy: the ASHP defines a formulary as “a continually updated list of available medications and related information, representing the clinical judgment, resulting from a review of the clinical evidence, of physicians, pharmacists, and other clinicians in the diagnosis, prophylaxis, or treatment of disease and promotion of health.” This part of the formulary system that ensures proper resources are available to provide optimal patient care. Introducing a “temporary” formulary may relieve the pressure when making decisions to add to remove particular medications to the hospital formulary. The “temporary formulary” is supposed to undergo an expert review in a fast and dynamic fashion. This process should utilize evidence-based evaluation to add an alternative medication such as adding another drug from the same pharmacological class that exists in the current formulary. The pharmacy and therapeutics committee chairperson, committee coordinator, and the director of the pharmacy are the key decision-makers in the temporary formulary process
- Temporary stewardship strategy: prioritizing disease severity and indication in certain medications can aid in better management of drug utilization and minimize adverse outcomes. An example of this category may include Intravenous Immune Globulin (IVIG). This medication is used for multiple indications, however, it can be replaced with plasmapheresis in certain cases. Therefore, a proper institutional stewardship program can mitigate the risk of IVIG shortage by stratifying indications and medication utilization.
- De-prescribing strategy: this strategy is dependent on the clinical value of medication continuation. Examples of these medications are antibiotics, proton-pump inhibitors, opioids, fluids, multivitamins, and others. Prolonged exposure to some of these medications may not carry any additional benefits only but have potentially harmful consequences such as antimicrobial resistance, increased risk of acute kidney injury, drug dependence, and overall mortality. Appropriate assessment of goals of care for each patient can impact medication utilization heavily and offers better resource management in futile care scenarios.,,,,
- Clinical alternative strategy: switching IV to PO and vice versa, optimizing IV push administration, and switching drugs within the same class or having similar clinical effects are commonly used strategies to manage drug shortages. This strategy can be implemented by forcing institutional guidelines on clinicians through guided computerized provider order entry (CPOE) options or through pharmacy-driven protocols. These protocols allow pharmacists to switch routes and agents without prior approval from the prescribing physician. An example of this case includes but is not limited to anticoagulation, antiepileptic medications, and antihypertensive medications shortages. During heparin shortage, multiple institutions developed internal guidelines to switch between anticoagulants and encouraged a faster transition from parentral anticoagulants to oral anticoagulants. Similarly, during fluid shortages, there was a shift towards adopting IV push strategies for antiepileptic medications such as fosphenytoin, lacosamide, levetiracetam, and valproic acid in addition to other classes.,,,,
- Medication extended expiration strategy: expiration dates stated by the manufacturers determine medication stability and not necessarily their efficacy. The U.S. Department of Defense is overseeing the “Shelf-Life Extension Program” (SLEP) that aims to assist in national stockpiling efforts as part of their public health emergency preparedness. According to stability information, 88% of the lots had their expiration dates extended, on average by 66 months. About 12% of these lots continued to be stable for at least 4 years after the expiration date. Only 18% of these 2652 batches were canceled because of failure. Biologics are not included in the SLEP program. Examples of these medications included amoxicillin sodium tablets (extended 23 months), Acetaminophen/pseudoephedrine capsules (extended 24 months), and calcium chloride injection solution (extended 81 months)., The Saudi FDA also adopted the same policy during the COVID-19 era. Drug shortage and availability, the Executive Directorate of Evaluation, and the Executive Directorate of Regulatory Affairs collaboratively decided on the extended duration for shelf-life for each drug based on the provided stability data from drug companies. The average extended duration was 12 months and it ranges between 6 months – 12 months. Similarly, this published guidance excluded biological agents.
- Medication Recycling strategy: unused prescribed medications impose a missed opportunity to reallocate them to the right patient if they are deemed to be stable. The US Drug Enforcement Administration sponsors National Prescription Drug Take Back Day intending to prevent medication misuse. Initiatives like this can also be implemented at healthcare institutions to optimize medication use with strict policies on storage history for these medications.,
An initiative to establish a central Medication Exchange and Sharing Network Program (MESNP) to serve all hospitals in Saudi Arabia received 500 requests, of which 63% were related to drug shortages. A central hub for medication re-allocation within the same healthcare facility or outside can help to optimize medication utilization nationally. This initiative is currently led by the Saudi FDA with their Drug Track and Trace System for pharmaceutical products (RSD) program which aims to ensure national drug security, drug availability, and prevents counterfeit drugs. Collaborative work to alleviate the burden of drug product shortages should be implemented starting from early notification of production issues from a pharmaceutical company and ending with providing clinically appropriate options to provide optimal patient care. We are all part of solving this problem and the key aspect here is proper communication.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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