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ISSUE 5 OCTOBER
Article

Managing medicine shortages

  • Tom Simpson, Jerry Yik

SUMMARY

Medicine shortages are increasingly common and disruptive to the optimal delivery of health care.

They are caused by a variety of factors, including manufacturing and supply-chain issues, regulatory and trade issues, and fluctuations in demand.

Prescribers and pharmacists in Australia can manage a shortage by switching to another brand, strength or dosage form of the same medicine, switching to a different registered medicine, or accessing an unregistered medicine that has been made available via section 19A of the Therapeutic Goods Act 1989 or through the Special Access Scheme.

There are a range of resources and tools that can assist clinicians with identifying and managing medicine shortages in Australia.

Shortages are managed most effectively when prescribers, pharmacists and nurses work together, in collaboration with patients, to develop, implement and monitor strategies to manage the shortage.

 

Introduction

Medicine shortages disrupt the optimal delivery of health care. They reduce patients’ access to medicines and may lead to the use of less effective or less safe medicines.1 They also increase the risk of dispensing, prescribing and administration errors.2 Managing shortages, and implementing risk mitigation strategies, creates significant additional workload for prescribers and pharmacists, reducing time available for patient care.3

Medicine shortages have always occurred, and they were increasing in prevalence, both locally and internationally, even well before the COVID-19 pandemic.4 However, they have become increasingly common since the pandemic.5 At the time of writing, the Therapeutic Goods Administration (TGA) lists almost 400 medicine product shortages in Australia.6

The Therapeutic Goods Act 1989 provides a definition for medicine shortages that can be paraphrased as the current or imminent unavailability or short supply of a registered medicine product in Australia.7

This article provides an overview of resources and processes that Australian healthcare professionals can use to manage medicine shortages.

 

Causes of medicine shortages

Medicine shortages are caused by a variety of factors, including manufacturing and supply-chain issues, regulatory and trade issues, demand fluctuations and economic factors (Box 1).8-11 According to the TGA, over 90% of prescription medicines used in Australia are imported, which creates risk of shortages when there are disruptions to global supply chains.12

Box 1 Causes of medicine shortages8-12

Manufacturing and supply-chain issues

  • Quality problems
  • Production delays caused by equipment malfunction or shortages of raw materials
  • Just-in-time procurement practices leaving minimal margin for error or capacity to absorb shocks to the system
  • Limited manufacturing capacity or transportation issues caused or exacerbated by natural disasters
  • Dependence on limited number of countries for raw materials
  • Political instability in the limited number of countries that undertake most of the world’s pharmaceutical manufacturing

Regulatory and trade challenges

  • Slow approval processes for new medicines or changes to manufacturing processes
  • Stricter regulatory requirements delaying production timelines
  • Trade restrictions in the form of tariffs, export bans and other trade barriers

Fluctuations in market demand

  • Sudden increases in demand caused by health events, mainstream or social media promotion, fear of shortages leading to stockpiling, responses to other shortages causing a cascading effect
  • Seasonal variations such as cold and flu seasons causing increased demand for certain medicines

Economic factors

  • Discontinuations of medicines when it becomes no longer economically viable for manufacturers, or when subsidy or funding is withdrawn
  • Increased competition due to emergence of generics rendering some manufacturers with smaller market share unviable
 

How clinicians find out about medicine shortages

There are several active and passive ways that clinicians may learn that a medicine is in short supply.

Pharmacists most commonly become aware of a possible or likely medicine shortage via wholesaler ordering systems.3,13 Prescribers and nurses often become aware of a shortage when a pharmacist or patient informs them that they are unable to obtain the medicine.14

Other sources that may alert clinicians to medicine shortages include:

  • professional associations, wholesalers and manufacturers, and pharmacy-groups’ head offices
  • healthcare, social and mainstream media
  • the TGA.

Medicine Shortage Reports Database

The TGA maintains the Medicine Shortage Reports Database, which is the most comprehensive list of medicine shortages in Australia. It is a searchable database of current and anticipated shortages; it also includes planned discontinuations of medicines.15

Medicines are reported at the individual product level; if multiple brands, strengths or dosage forms of the same medicine are in short supply, each is listed as an individual entry.

Since 1 January 2019, sponsors (usually pharmaceutical companies) have been required to report shortages and permanent discontinuations to the TGA, including the duration or expected end date of the shortage, and to confirm the resolution of a previously notified shortage. Reportable medicines are Schedule 4 (prescription-only medicines), Schedule 8 (controlled drugs) and certain non-prescription medicines.

Mandatory reporting has led to greatly improved accuracy of the Medicine Shortage Reports Database; however, a 2022 survey found that 29% of shortages experienced by community and hospital pharmacists were not in the database.13

Other limitations of the Medicine Shortage Reports Database include:

  • there may be delays in updating the database following sponsor notifications
  • shortages are not always uniformly experienced in all parts of the country
  • a medicine in short supply may be removed from the database prior to consistent availability of the medicine.

Shortage alerts

The TGA also issues alerts and email notifications that provide information on medicine shortages and suggested measures to mitigate and manage them.16 Pharmacists and prescribers are encouraged to subscribe to TGA medicine safety email notifications to receive shortage alerts.

 

How clinicians can respond to and manage medicine shortages

Shortage of a medicine can be a trigger to consider whether ongoing use of the medicine is necessary. In some cases, deprescribing may be an option.17

If continued treatment is required, actions to respond to the medicine shortages should follow a stepwise cascade that is focused on minimising disruption and changes for the patient, to reduce the potential for confusion and medication errors.18

1.  Switch to a different brand of the same medicine

The simplest method to resolve a medicine shortage is for the pharmacist to dispense an alternative brand of the same medicine in the same dosage form and strength, after discussion with the patient and with their consent. This does not require contacting the prescriber or a change to the prescription, unless the prescriber has marked the ‘brand substitution not permitted’ box on the prescription.

2.  Substitute an alternative dosage form or strength of the same medicine

If the pharmacist cannot supply an alternative brand of the medicine in the same form and strength, they may be able to supply a product with the same active ingredient in a different form or strength. There are 2 ways this can be done.

If the TGA has issued a Serious Scarcity Substitution Instrument (SSSI) for the medicine in short supply, it can be done without prior approval or a new prescription from the prescriber.19 The pharmacist is required to notify the prescriber that a substitution was made. For example, in December 2023 an SSSI was issued for fluoxetine 20 mg dispersible tablets that were in short supply; the SSSI allowed the pharmacist to instead dispense fluoxetine 20 mg and 10 mg capsules without prior approval from the prescriber. A medicine substituted under an SSSI is eligible for Pharmaceutical Benefits Scheme (PBS) subsidy only if the Minister for Health and Aged Care (or their delegate) has made a determination to enable this;20 there may be a delay before this occurs, leading to increased cost to patients.

If the medicine in short supply is not subject to an SSSI, the pharmacist needs to contact the prescriber to obtain a new prescription before they can supply the same medicine in a different form or strength.

3.  Switch to a different medicine

If switching to a different brand, form or strength of the same medicine is not possible, which often occurs due to downstream impacts of shortages causing increased and unexpected demand for these alternatives, then prescribers can consider switching to:

  • a different medicine with the same efficacy as the originally prescribed medicine (e.g. another medicine from the same drug class)
  • a second- or third-line medicine according to guidelines.

4.  Access an unregistered medicine product

If the above options are not suitable, it may be appropriate to prescribe a product that is not on the Australian Register of Therapeutic Goods. The Therapeutic Goods Act provides for both the section 19A pathway and the Special Access Scheme (SAS) to support access to unregistered therapeutic goods from overseas markets.7

Section 19A

Section 19A of the Therapeutic Goods Act allows the TGA to approve the importation and supply of an overseas-registered medicine by a sponsor, to reduce the impact of a supply disruption in Australia.7 These substitute medicines are referred to as section 19A medicines.

Section 19A medicines that are imported to address a shortage of a PBS-listed medicine, and meet certain criteria, are automatically listed on the PBS. For other section 19A medicines, the sponsor may apply for PBS listing. Some section 19A medicines are significantly more costly than locally registered products and, if not PBS listed, these increased costs are absorbed by health services or consumers.

Examples of recent section 19A approvals include amoxicillin+clavulanate oral suspension, estradiol patches, timolol eye drops, semaglutide injections and various intravenous fluids. Box 2 provides a case study of a medicine shortage (oral morphine liquid) that required the use of section 19A products.21,22

Box 2 A case study of morphine oral liquid shortage21,22

In mid-2023, the only sponsor for morphine oral liquid announced they were discontinuing supply into the Australian market for all morphine oral liquid products. The start date of the shortage was anticipated to be around March 2024.

The Therapeutic Goods Administration (TGA) issued an alert on 29 June 2023, and convened a Medicines Shortage Action Group with representatives from the government, medical, pharmacy and consumer sectors, which developed advice for doctors, pharmacists, patients and carers.

On 1 December 2023, 3 unregistered morphine oral liquid products from the UK, USA and Switzerland received section 19A approval, allowing the prescription and supply of these products to patients in Australia during the shortage.

The UK and US products (2 mg/mL strength) received Pharmaceutical Benefits Scheme (PBS) approval from the same date. The Swiss product (10 mg/mL strength) did not receive PBS approval until 1 March 2024.

Communications to health professionals and consumers were distributed by the TGA, peak bodies, professional societies and the medical and pharmacy media. Risks associated with substitution of oral morphine liquid products, with different strengths and excipients, were highlighted.22

In February 2024, 3 additional oral morphine liquid products from New Zealand (1 mg/mL, 5 mg/mL and 10 mg/mL) received section 19A approval; these are not PBS approved at the time of writing.

At the time of writing, of the 6 section 19A approved substitute oral morphine liquid products, 3 were in short supply or not available, including the 2 lowest-strength products (1 mg/mL and 2 mg/mL).21 Prescribers and pharmacists have had to ration the use of these products, switch patients to a higher-strength product, or switch patients to an alternative dosage form (e.g. tablets) or medicine.

Another Australian pharmaceutical company has taken over sponsorship of the Australian-registered oral morphine liquid products and a return to normal supply is anticipated in late 2024.


A list of section 19A approved medicines can be found on the TGA website; section 19A medicines subsidised by the PBS are listed on the PBS website.

Special Access Scheme

The SAS pathway allows the importation and supply of an unregistered therapeutic good for a single patient, on a case-by-case basis. To access unapproved goods via the SAS, prescribers can submit an application to the TGA. Accessing SAS medicines can be administratively burdensome, and requires close liaison between the prescriber and pharmacist.

 

Collaboration between prescribers and pharmacists

Shortages are managed most effectively when prescribers and pharmacists work together. Prescribers who believe a medicine is in short supply can consider calling ahead to the patient’s nominated pharmacy at the time of prescribing to ascertain availability.17

Prescribers and pharmacists can also work together to reserve or ration stock for certain indications or patient groups based on the anticipated need for that medicine, anticipated stock availability, and appropriate alternatives that exist.3,13 For example, during recent shortages of various antimicrobials in both solid oral dosage forms and oral suspensions, doctors and pharmacists worked together to ration and reserve stock of oral liquid suspensions for patient cohorts that were most vulnerable, such as infants and young children, and those with swallowing difficulties. These practices may be informed by advice from regulatory and clinical authorities.6,23

 

Resources to support clinicians

When a medicine shortage is likely to have a critical impact on patients, the TGA may convene a Medicines Shortage Action Group (MSAG). An MSAG comprises relevant stakeholders (prescribers, pharmacy organisations, pharmaceutical wholesalers and sponsors). It helps the TGA formulate strategies to support continuity of patient treatment that can include rationing stocks of medicines or suggesting the use of alternative dosage forms or medicines. Typically, specific messages are developed for prescribers, pharmacists and consumers and are published on the TGA website.6

Sometimes the solution to address a medicine shortage for an individual requires modification of an oral dosage form (e.g. crushing a tablet). The Don’t Rush to Crush reference text provides advice on the safety of, and best methods for, modifying medicines.

Other resources and agencies that may provide specific advice about how to manage a shortage are:

 

Communicating with patients about shortages

Effective communication between clinicians and patients is crucial during shortages. Patients may feel a lack of trust in the healthcare system if they are not able to receive the medicine that is prescribed for them, and this is not communicated in a transparent and prompt manner. Inadequate communication may also cause confusion, impact negatively on medicines adherence and increase medication safety risks.

Prescribers and pharmacists should provide consistent information to patients about shortages and the alternative dosage forms or medicines prescribed to resolve a shortage for that patient.

When a patient’s regular medicine requires a change in context of a shortage, the counselling messages provided by the prescriber at the time of prescribing, and subsequently reinforced by the pharmacist, can help build trust and reduce confusion.

 

The future

In early 2024, the TGA commenced consultations to better understand the nature, extent and urgency of problems with the supply of medicines in Australia, including shortages and discontinuations. The feedback from the public consultation and market research will be used by the TGA to develop a workplan for potential future reform to address medicine shortages.26

 

Conclusion

Medicine shortages are a growing challenge. They disrupt patient care and increase the workload for prescribers and pharmacists in already-constrained environments.

Regulators, the pharmaceutical industry, health departments, health services, and clinicians, in partnership with consumers, need to work together to ensure medicine shortages are managed well and communicated clearly to patients, to uphold safe and quality use of medicines.

This article was finalised on 9 September 2024.

Conflicts of interest: Tom Simpson has received funding from Advanced Pharmacy Australia (formerly the Society of Hospital Pharmacists of Australia) for attendance at meetings and educational events. Jerry Yik has represented Advanced Pharmacy Australia on Medicine Shortage Action Groups convened by the Therapeutic Goods Administration, and in advocacy activities and stakeholder consultations in relation to medicine shortages.

This article is peer reviewed.

 

Australian Prescriber welcomes Feedback.

 

References

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Creative Commons License

Tom Simpson

Executive Director, Statewide Hospital Pharmacy, Tasmania

President, Advanced Pharmacy Australia (formerly the Society of Hospital Pharmacists of Australia)

https://orcid.org/0000-0001-6725-7546

Jerry Yik

Head of Policy and Advocacy, Advanced Pharmacy Australia (formerly the Society of Hospital Pharmacists of Australia)

https://orcid.org/0000-0002-1048-9116