Managing Drug Shortages: Compounding Pediatric Pharmaceutical Suspensions

 

Managing Drug Shortages: Compounding Pediatric Pharmaceutical Suspensions

By Anna Vratsista

Drug shortages have become a serious problem affecting patients and healthcare providers worldwide. According to the American Society of Health-System Pharmacists (ASHP), drug shortages have increased rapidly in the past decade, with over 350 drugs currently in short supply in the U.S. alone.1

The etiology of the problem is complicated but there are a few main factors that contribute to drug shortages, including problems at manufacturing process, quality and regulatory problems, natural disasters, global pandemic, and economic factors. Many of the current drug shortages, are the result of the global pandemic COVID-19, where increased demand, supply chain disruptions and trade restrictions have caused shortages of many drugs.2

Drug shortages can have serious consequences for patients, healthcare providers and drug manufacturers. Patients may face delayed or interrupted treatments, increased healthcare costs, reduced quality of life, and even death in some cases. Healthcare providers may experience decreased patient satisfaction and increased risk of medical errors due to unfamiliar or alternative drugs. Drug manufacturers may also suffer financial loss, reduced market share and reputational damage due to the inability to meet demands.3

The availability of pharmaceutical drugs is crucial for both patients and healthcare providers in providing proper care and treatment. Drug shortages, however, have become a serious issue lately, affecting many areas of medicine, including pediatric pharmaceuticals. In the case of pediatric medicines, this shortage can create difficulties in dosage administration which may effect treatment outcomes. Access to drugs such as acetaminophen, amoxicillin, azithromycin, cefprozil, cefuroxime, clarithromycin, ibuprofen and many others, is becoming more and more difficult nowadays, hindering effective treatment of the pediatric population.

Drug shortages can significantly affect pediatric population in many ways. For example, children with infections may be unable to receive appropriate antibiotics. In this case, children may be forced to switch to alternative treatments, which may be less effective or have more side effects. This can lead to poor outcomes, lower efficacy of treatment, and increased healthcare costs. Children may also face longer hospital stays, increased emergency room visits, and readmissions, leading to higher healthcare expenditures.

Pharmacists can have a significant impact mitigating the effect of emerging drug shortages, especially those related to the pandemic.4 In particular, through compounding they can offer personalized formulas to cover the gap of drug shortages. Compounding provides pharmacists with a unique opportunity to practice their time-honored profession and to contribute to the positive therapeutic outcome for the patient.5

Compounded medications by pharmacists in the form of pharmaceutical suspensions could be a great solution to overcome some of the above challenges, especially in the case of pediatric population. Compounding pharmaceutical suspensions is the process of mixing solid and liquid ingredients to create a homogeneous mixture that is easy to administer.6 This method of compounding has been used effectively in managing drug shortages. When drug shortages arise, an effective solution is to switch to a compounded suspension that has a closely similar chemical composition to the original drug. For instance, pharmacists can use a powdered form of the drug, mix it with a suitable liquid, and administer the mixture as a suspension. This solution can provide effective management of drug shortages in many cases.

When compounding a suspension choosing the correct suspending vehicle is key. The ideal suspending vehicle should offer the right rheological characteristics to the final suspension, including being both simple to homogenize and stable at rest. This can be achieved through pseudoplasticity and thixotropy features of the vehicle. These behaviors are very important in order to provide high accuracy and dosage consistency throughout treatment.7 Moreover, the right suspending vehicle should be compatible with a wide range of APIs, supported by multiple scientific stability studies. Another characteristic that makes a suspending vehicle suitable, is the ingredient safety. All the ingredients should be chosen meticulously to minimize side effects and allergic reactions, especially for vulnerable patients such as children. Along with ingredient safety, patient comfort is also important. The suspending vehicle should offer to the final suspension pleasant taste with a light texture, no medicinal aftertaste and be easy to swallow especially in case of pediatric pharmaceutical suspensions.

Based on all the above, SyrSpend® SF is an innovative vehicle range for the compounding of oral liquid dosage forms with all the criteria of the ideal suspending vehicle. SyrSpend® SF contains in its composition food starch that gives superior active suspending properties and provides consistent, individual dosing throughout treatment. SyrSpend® SF vehicle range can be used for the compounding of pharmaceutical suspensions to cover drug shortages in the market. Below, there are some examples of formulas with APIs in shortage:

·         Amoxicillin in SyrSpend® SF

·         Azithromycin in SyrSpend® SF

·         Cefuroxime in SyrSpend® SF

·         Cephalexin in SyrSpend® SF

·         Furosemide in SyrSpend® SF

·         Ibuprofen in SyrSpend® SF

  •          Acetaminophen in SyrSpend® SF

 

Check out the Fagron Academy website at www.fagronacademy.us for more information and formulation alternatives.

Compounded pediatric pharmaceutical suspensions can provide various benefits, including accurate and precise dosage administration, flexibility in drug formulations and the ability to customize drug formulations to suit different patient needs. Moreover, the flexibility of drug formulation ensures that the suspension can be adapted to meet the specific needs of individual patients, which enhances treatment outcomes. 8

In conclusion, drug shortages can be managed by using compounded pediatric pharmaceutical suspensions.9 The process of compounding provides a viable solution for ensuring that patients receive the correct dosage of medication, even when there is a shortage of the required drug. By mixing solid and liquid ingredients to create a homogeneous mixture, pharmacists can ensure that patients receive effective treatment. Maximum attention though should be paid to the compounding procedure and the choice of the ideal suspending vehicle, because this is reflected in slow sedimentation combined with good resuspendability and pourability.10 Though drug shortages are a significant problem facing healthcare providers, by implementing effective strategies such as compounding pediatric pharmaceutical suspensions, we can mitigate the challenges and provide adequate and quality care to all patients.

 

1.        Gu, A., Wertheimer, A. I., Brown, B., & Shaya, F. T. (2011). Drug shortages in the US–causes, impact, and strategies.

2.       Mazer‐Amirshahi, M., Pourmand, A., Singer, S., Pines, J. M., & van den Anker, J. (2014). Critical drug shortages: implications for emergency medicine. Academic Emergency Medicine, 21(6), 704-711.

3.      Phuong, J. M., Penm, J., Chaar, B., Oldfield, L. D., & Moles, R. (2019). The impacts of medication shortages on patient outcomes: a scoping review. PloS one, 14(5), e0215837.

4.      Badreldin, H. A., & Atallah, B. (2021). Global drug shortages due to COVID-19: impact on patient care and mitigation strategies. Research in Social and Administrative Pharmacy, 17(1), 1946-1949.

5.      Mohiuddin, A. K. (2019). Extemporaneous compounding: selective pharmacists with separate skill. Innovations in Pharmacy, 10(4).

6.      Kristina, S. A., Wiedyaningsih, C., Widyakusuma, N. N., & Aditama, H. (2017). Extemporaneous compounding practice by pharmacists: a systematic review. Int J Pharm Pharm Sci, 9(2), 42.

7.       Visser, J. C., Ten Seldam, I. E., van der Linden, I. J., Hinrichs, W. L., Veenendaal, R. F., Dijkers, E. C., & Woerdenbag, H. J. (2018). Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations. International journal of pharmaceutical compounding, 22(3), 247-251.

8.      Carvalho, M., & Almeida, I. F. (2022). The Role of Pharmaceutical Compounding in Promoting Medication Adherence. Pharmaceuticals, 15(9), 1091.

9.      McBane, S. E., Coon, S. A., Anderson, K. C., Bertch, K. E., Cox, M., Kain, C., ... & Philbrick, A. M. (2019). Rational and irrational use of nonsterile compounded medications. Journal of the American College of Clinical Pharmacy, 2(2), 189-197.

10.   Visser, J. C., Ten Seldam, I. E., van der Linden, I. J., Hinrichs, W. L., Veenendaal, R. F., Dijkers, E. C., & Woerdenbag, H. J. (2018). Comparison of Rheological and Sedimentation Behavior of Commercially Available Suspending Vehicles for Oral Pharmaceutical Preparations. International journal of pharmaceutical compounding, 22(3), 247-251.

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