Health Authorities Call on Compounders to Support Global Shortages in Amoxicillin Suspension

If you work in the pharmacy or have been there lately, you've definitely noticed plenty of shortages, particularly in essential pain and fever medication (check out our blog Partnering with Compounders to Address the Pediatric Acetaminophen Shortage), cold and flu medication, and antibiotics. A drug shortage in itself is not a new phenomenon; it can occur as a result of manufacturing delays, lack of raw ingredients, or a sudden increase in the demand of a medication. What is new, is the recent unavailability of an essential antibiotic used to treat pediatric infectious diseases – amoxicillin suspension.

Key amoxicillin manufacturers, across the globe, are reporting drug shortages that are anticipated to last several months 1,2. Being one of the most commonly prescribed antibiotics for children, the consequences of the unavailability of amoxicillin suspension are huge and can be life threatening. It means that one less first-line therapeutic is available when a child gets sick with respiratory tract infections, which peak in the winter months. The US Food and Drug Administration (FDA) and the Australian Therapeutic Goods Administration (TGA) – two markets significantly impacted by the current amoxicillin suspension shortage – continue to work with drug manufacturers to secure product, but when supply does come in, pharmacies are often being limited to a small amount per day or per week.

With more and more parents calling their pediatrician or general practitioner to tell them that they can’t find amoxicillin suspension anywhere, healthcare professionals are left scrambling for solutions. In the US, the American Academy of Pediatrics (AAP) recommend turning to other commercial formulations of amoxicillin, such as tablets, capsules or chewable tablets when possible, and suggest rounding to the nearest dose (±10%)4. Tablets can be split or crushed and mixed with a liquid or semisolid, like applesauce4. However, alternatives that require caregiver manipulation such as this leaves room for error, increases risk for cross-contamination, impacts child compliance, and burdens parents and caregivers. Addressing the shortage with options that are appropriate and safe to administer a patient are needed. Compounding pharmacists are uniquely positioned to address this need and healthcare authorities are supporting compounders with guidances to reduce risk and facilitate dispensing.

Compounded Amoxicillin Suspension

Defined as the practice of preparing customized medications in accordance with a licensed practitioner’s prescription, pharmaceutical compounding exists to allow providers the opportunity to explore customized therapies that are otherwise not commercially available. This includes personalizing dosage strengths, using alternative dosage forms, eliminating unwanted ingredients, combining therapeutics, or filling demands during drug shortages like the one we are currently facing. In this particular instance, where amoxicillin suspension is unavailable, a compounding pharmacist can prepare the suspension in their lab, supporting the demand for this product while on shortage and avoiding challenges with using other commercial forms, notably parents cutting and crushing tablets. Take home – compounders can prepare the specific formulation on shortage.

Recently, the FDA has issued an immediately in effect guidance on the preparation of amoxicillin suspension due to the urgent need of beta-lactam oral suspension preparations 5,6. Before the shortage, amoxicillin suspension was not to be compounded due to the availability of the commercial product. However, due to the critical nature of the shortage, this guidance has been set forth to outline steps to reduce the risk of cross-contamination when compounding amoxicillin suspension. It serves as a resource for compounders looking to address the amoxicillin shortage. Similarly, in Australia, the TGA has released the Serious Scarcity Substitution Instrument (SSSI) for amoxicillin to allow pharmacists to dispense a substitute product containing the same active ingredient without prior approval from the prescriber7– facilitating patient access. Under this act, compounding should not occur when commercial substitutions are available.

Medisca – Partnering to Support Compounders with the Amoxicillin Shortage

As a supplier of pharmaceutical compounding products and services, one of the primary roles of Medisca is to support compounding pharmacies and hospitals during times of shortages. With drug shortages being sky high across the globe, Medisca has been working around the clock to leverage their relationships with qualified manufacturers and suppliers to meet product demand. Medisca compounding services – led by a team of highly skilled formulation chemists, pharmacists, and technical support service representatives – continue to support compounders with formulation design, calculations, preparatory questions, ingredient selection, and much more. Compounding pharmacists can learn more about Medisca Compounding Services here.

• Suspending agents: Oral Suspend or ORA Plus®
• Flavoring agents: Oral Syrup,Oral Syrup SF,ORA Sweet®,ORA Sweet SF
• Suspending and flavoring: Oral Mix,Oral Mix SF,ORA Blend®,ORA Blend SF

Aside from the ingredients themselves, compounding formulas are the most essential element to compounding. Like a recipe, they detail all the pertinent information and instructions needed for the pharmacists to prepare compounded preparations. With over 10,000 compounding formulas in our library, Medisca is well-recognized in the industry as the go-to resource for formulation support.

Amoxicillin Formulas – A Complimentary Resource to Support Shortages

Given the critical nature of drug shortages, all shortage-related Medisca formulas are shared with the healthcare community free of charge. Shortage formulas are consolidated on the Medisca Shortage Formulas webpage, formatted in an easy-to-filter-through table. Shortages are continuously monitored across the globe and the Medisca compounding service team proactively develops formulas when possible, to support the need. With pediatric patients in mind, the below compounding formula was developed in response to the unavailability of amoxicillin suspension. This formula uses 250 mg commercial capsules. F 009 743 Amoxicillin 250mg/5ml Oral Liquid In addition to the formulas themselves, we are currently offering free compounding services to support the current amoxicillin suspension shortage – including support with formula searches, preparatory questions, pharmaceutical calculations, and more – to compounding pharmacies and hospitals across the globe. Inquiries can be sent to compoundingservices@medisca.com or phoned in directly to 1-800-665-6334 ext. 1203.

If you are a provider, caregiver, or patient in need of this care, we encourage you to reach out to your local compounding pharmacy.

References:

Tripplaar, K. 2022. Pharmacies are reporting shortages of the widely used antibiotic amoxicillin. NBC News. Retrieved from:https://www.nbcnews.com/science/science-news/pharmacies-are-reporting-shortages-widely-used-antibiotic-amoxicillin-rcna53476

Amoxicillin shortage: antibiotic options for common pediatric conditions. 2022. American Academy of Pediatrics. Retrieved from:https://www.aap.org/en/pages/amoxicillin-shortage-antibiotic-options-for-common-pediatric-conditions/

Lee, B.Y. 2022. FDA: Amoxicillin shortage hits U.S., how this antibiotic is misused for respiratory illnesses. Forbes. Retrieved from:https://www.forbes.com/sites/brucelee/2022/11/19/fda-amoxicillin-shortage-hits-us-how-this-antibiotic-is-misused-for-respiratory-illnesses/?sh=3a219c1b746d

Jenco, M. 2022. New resource provides alternatives to amoxicillin suspension during shortage. American Academy of Pediatrics. Retrieved from:https://publications.aap.org/aapnews/news/22760?_ga=2.189046891.1942171177.1673492294-300085736.1673492294?autologincheck=redirected

FDA issues immediately in effect guidance for compounding of amoxicillin to alleviate shortages.2022. State of Ohio Board of Pharmacy. Retrieved from:https://www.fda.gov/regulatory-information/search-fda-guidance-documents/compounding-certain-beta-lactam-products-shortage-under-section-503a-federal-food-drug-and-cosmetic

Guidance document: compounding certain beta-lactam products in shortage under section 503A of the Federal Food Drug and Cosmetic Act. 2022. FDA. Retrieved from:https://www.fda.gov/media/163367/download

Therapeutic Goods Administration (TGA). Antibiotics shortages. 2022. Australian Government. Retrieved from:https://www.tga.gov.au/safety/shortages/medicine-shortage-alerts/antibiotics-shortage