Managing critical drug shortages in clinical practice

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Introduction

Drug shortages are a complex medical, social, and political problem with significant negative impacts on clinical practice in Canada. On March 17, 2017, amendments to the Food and Drug Regulations came into force mandating that market authorization holders must publicly report both drug shortages and discontinuations to a third-party website ^[1]. Since the enactment of this legislation, over 18,000 shortages and discontinuations have been documented ^[2]. In late summer 2022, critical shortages of liquid formulations of over-the-counter pain relievers and antipyretics were reported, garnering significant media attention, alarming families, and challenging health care systems. Weeks later, shortages of liquid formulations of antibiotics commonly used in paediatric practice were classified as Tier 3 drug shortages. Tier 3 drug shortages have the greatest potential impact on Canada’s drug supply and health care system. 

There are multiple reasons for these drug shortages, including complex supply chain issues, labour-related challenges, and a lack of both manufacturing capacity and emergency stock in the face of increased demand.  

Current critical drug shortages are anticipated to last several months, and new supply challenges may emerge as prescribers pivot to second- and third-line drugs. These serious drug shortages highlight both short-and long-term priorities for Canada’s health care providers and policy-makers, which include: 1. the need to ensure that prescribing practices align with the best available evidence; and 2. the need to proactively establish a safe, stable, and secure supply of the medications most necessary to treat children in Canada.

Prescribing according to best evidence

Resource-sensitive prescribing can optimize care and, simultaneously, conserve vital supply. Current best evidence supports the following prescribing principles:

1. Most acute respiratory illnesses are viral and do not require antibiotics. Patients presenting with viral syndromes should not be prescribed antibiotics. Choosing Wisely Canada has developed provider and patient education materials to support appropriate prescribing. Their resources include viral prescription pads (including one designed for treating children aged 6 months and over), family-centred advice in multiple languages on delayed prescribing (to encourage supportive care before filling an antibiotics prescription), and educational posters suitable for waiting rooms.

2. While modest evidence exists to support the use of macrolide antibiotics for an anti-inflammatory effect in very specific clinical circumstances ^[3][4], there is no evidence that macrolides play a significant role in moderating inflammation in uncomplicated paediatric respiratory illnesses. Young patients presenting with uncomplicated upper or lower respiratory illnesses (including asthma exacerbations) should not be prescribed macrolides for their anti-inflammatory properties. Macrolides are indicated when treating an infection caused by an atypical organism (e.g., Mycoplasma pneumoniae, Chlamydia pneumoniae, Chlamydia trachomatis) or when treating children with common bacterial infections and a life-threatening beta-lactam allergy.

3. Virtual care increased significantly during the pandemic ^[5][6]. While considered safe and effective in many clinical circumstances, scenarios remain where virtual care is inappropriate. Acute otitis media, pneumonia, Group A streptococcal (GAS) pharyngitis, and most urinary tract infections cannot be reliably diagnosed without a physical exam and, in some cases, a confirmatory laboratory test. With rare exception, patients should not be prescribed antibiotics for these clinical conditions based solely on a virtual encounter. As much as possible, providers should ensure that patients have access to in-person, ambulatory care when presenting with symptoms concerning for a bacterial infection.

4. When prescribing antibiotics, the shortest possible evidence-based effective course should be selected. Resource-sensitive prescribing will optimize patient outcomes by avoiding unnecessary (or unnecessarily long) antibiotic exposure, mitigate the surge of resistant bacterial strains, and conserve vital supply. See Table 1 ^[7]-[11] for an overview of antibiotic choices, doses, and durations for common paediatric infections. Local resistance patterns should be considered when prescribing.

Table 1. Recommended antibiotic doses and durations for common paediatric infections is also available as a supplementary file.

5. Providers should prescribe an antibiotic rounded to a dose that can be dispensed in tablet or capsule form whenever possible and appropriate. 

Certain tablets can be split or crushed to ensure the appropriate dose is administered. Pharmacists may instruct families to mix a crushed tablet with milk, juice, other cold liquid or with pudding or ice cream (depending on the medication) to mask the taste.  

To aid pharmacists with resource-sensitive dispensing, prescriptions must call for dosing that aligns with standard tablet sizes. For greater clarity, consider writing specifically on each prescription to “provide as quarter, half, or full tablets if oral liquids are not available”. 

Certain capsules can be opened, and the medication dissolved in a liquid or mixed with a particular food, before administration. The guidance to parents regarding the manipulation of capsules should be provided by pharmacists.    

6. Children and youth should be encouraged to learn how to swallow pills when they are old enough and readily able to do so. Several effective online resources are available to help patients learn this valuable skill. By directing parents to administer tablets or capsules when appropriate, prescribers and pharmacists help reserve the limited supply of liquid formulations for the patients who most need them.

7.  While rolling shortages are expected to continue, it is important for physicians to be aware of the availability of commonly prescribed medications in their community. It is challenging for pharmacists to contact physicians when a prescribed medication is not available. This additional step delays care and demands extra time from all care providers. 

Acknowledgements

This practice point was reviewed by the CPS Infectious Disease and Immunization Committee.

CANADIAN PAEDIATRIC SOCIETY DRUG THERAPY AND HAZARDOUS SUBSTANCES COMMITTEE (2022-2023)

Members: Yaron Finkelstein MD, Shinya Ito MD, Geert ‘t Jong MD (Chair), Derek McCreath BScPharm, Tom McLaughlin MD, Charlotte Moore Hepburn MD (Board Representative), Eva Slight-Simcoe MD (Resident Member)

Liaison: Michael J. Rieder MD PhD (Canadian Society of Pharmacology and Therapeutics)

Principal authors: Derek McCreath BScPharm, Geert ‘t Jong MD PhD, Yaron Finkelstein MD, Charlotte Moore Hepburn MD

References

Disclaimer: The recommendations in this position statement do not indicate an exclusive course of treatment or procedure to be followed. Variations, taking into account individual circumstances, may be appropriate. Internet addresses are current at time of publication.