In today's healthcare landscape, understanding the dynamics behind drug shortage and unavailability is crucial to guaranteeing continuity of treatment for patients. A drug shortage, meaning difficulty or impossibility for the patient in obtaining a medicine, can stem from several problems: the active ingredient being unobtainable, manufacturing issues, regulatory measures, or a sudden rise in demand. This can lead to treatment being interrupted, or to the need to switch to a therapeutic alternative that may be less effective or require a period of adjustment.

Unavailability, on the other hand, means difficulty in obtaining a medicine that is not linked to manufacturing problems but to malfunctions in the distribution chain. Unlike shortages, unavailability does not occur uniformly across the country and is often the result of market distortions such as parallel trade. In these cases the medicine may be present in the marketing authorisation holder's warehouses but not available at certain regional depots or pharmacies.

Addressing these problems requires collaboration between healthcare professionals, regional bodies and regulators. In Italy, AIFA continuously monitors the situation and periodically updates the list of temporarily unavailable medicines. Where a shortage occurs, it is possible to authorise the import of equivalents approved abroad in order to guarantee continuity of treatment.

The difference between drug shortage and unavailability

Shortage

A medicine is considered to be in shortage when the marketing authorisation holder is unable to guarantee its supply across the whole country. This can happen for a number of reasons, including:

• Active ingredient unobtainable: difficulty in sourcing the ingredients needed to manufacture the medicine.

• Manufacturing problems: interruptions in the production chain that prevent continuous manufacture.

• Regulatory measures: rules or regulations affecting the distribution of the medicine.

• Commercial decisions: strategic choices made by the manufacturer.

• Unforeseen increases in demand: health emergencies that cause a spike in demand for the medicine.

Marketing authorisation holders must report any shortage to AIFA promptly, and AIFA publishes this information in a regularly updated list of medicines in shortage.

Unavailability

A medicine is considered unavailable when the difficulty in obtaining it is caused by malfunctions in the distribution chain. Unlike a shortage, unavailability is not uniform at national level and may be linked to:

• Market distortions: distribution problems that prevent medicines from reaching every geographical area.

• Distribution dynamics: logistical issues affecting the availability of a medicine in specific regions or pharmacies.

What to do in the event of a shortage or unavailability

When faced with a drug shortage or unavailability, a series of steps is essential to guarantee continuity of treatment for patients.

First of all, it is fundamental to check whether the missing medicine appears on the list of medicines in shortage published by AIFA.

It is crucial that everyone involved — pharmacists, doctors, regional bodies and regulators — works together to address these situations effectively, ensuring that patients receive the life-saving medicines they need without interruption.

If the medicine is in shortage

When a medicine is in shortage, a series of steps is essential to guarantee continuity of treatment. The first is to consult the list of medicines in shortage on the AIFA portal to confirm the status of the medicine. This list is updated regularly and provides useful information on available alternatives and the procedures to follow.

If the medicine is genuinely in shortage, equivalent medicines available on the market can be considered as therapeutic alternatives. In more complex situations, it is possible to request the import of equivalent medicines from abroad. This procedure must be initiated by the specialist or the general practitioner through the relevant healthcare bodies, such as hospital pharmacies.

If the medicine is unavailable

Where a medicine is unavailable, which often stems from distortions in the distribution market, it is necessary to contact several authorised wholesalers to verify whether the medicine can genuinely not be obtained.

When a medicine appears to be unavailable, at least three wholesalers should be contacted to establish that it is not available from any of them. This thorough check is crucial to avoid false alarms and to ensure that every supply option has been explored.

If unavailability is confirmed, the pharmacist must report the situation immediately to the relevant regional or autonomous province contacts. This report allows the competent authorities to carry out further checks and take action, which may include contacting the marketing authorisation holder directly to request direct supply of the medicine. Under Article 105, paragraph 4 of Italian Legislative Decree 219 of 24 April 2006, the marketing authorisation holder is obliged to supply the medicine within 48 hours of the request, including to hospital pharmacies.

In addition, many medicines have specific contacts made available by marketing authorisation holders for emergency requests. These can be used to activate the direct supply procedure where a medicine is not available through the distribution network. If the marketing authorisation holder does not respond to a direct order, it is essential to send a documented report to AIFA, the Italian Medicines Agency, at farmacicarenti@aifa.gov.it. This allows AIFA to begin the necessary checks and interventions.

The importance of compounding

In some cases a doctor may prescribe a compounded medicine, a personalised pharmaceutical preparation, to make up for a shortage. This solution is particularly useful when the active ingredient is available but the industrial product is not.

Compounding takes on a crucial role in contexts where life-saving medicines or specific equivalents are not available on the market. Thanks to their ability to prepare personalised medicines, hospital pharmacies and healthcare facilities can guarantee continuity of treatment for patients, avoiding interruptions that could have serious consequences. The role of the hospital pharmacy is therefore fundamental in filling temporary gaps in the pharmaceutical market and ensuring immediate access to the medicines needed.

Artificial intelligence as a solution to availability challenges

Integrating artificial intelligence into pharmaceutical stock management offers innovative solutions for addressing drug shortage and unavailability.

Here is how AI can be used to improve warehouse efficiency:

• Demand forecasting: AI algorithms analyse historical data and market trends to predict future demand accurately, reducing the risk of shortages and optimising stock levels.

• Logistics optimisation: AI automates inventory processes, improving the distribution of medicines and preventing unavailability caused by inefficiencies in the distribution chain.

• Identifying alternatives: where a medicine is in shortage, AI can suggest therapeutic alternatives, guaranteeing continuity of treatment for patients.

• Real-time monitoring: AI systems provide continuous stock monitoring, flagging anomalies promptly and allowing timely intervention to resolve supply problems.

Adopting AI solutions in pharmaceutical warehouse management, such as Profiter, can significantly improve the availability of medicines, ensuring optimal continuity of treatment and responding effectively to the challenges of the sector.