In today’s healthcare landscape, understanding the dynamics behind drug shortages and their unavailability is crucial to ensuring continuous patient care. A drug shortage, defined as a patient’s difficulty or inability to obtain a necessary medication, can stem from various issues, such as the unavailability of active ingredients, production problems, regulatory actions, or a sudden surge in demand. This phenomenon can lead to treatment interruptions or the need to switch to an alternative therapy, which may be less effective or require an adjustment period.
On the other hand, unavailability refers to difficulties in obtaining a drug that are not related to production issues but rather to disruptions in the distribution chain. Unlike shortages, unavailability does not occur uniformly across the country and is often caused by market distortions, such as parallel trade. In these cases, the medication may be present in the marketing authorization holder’s (MAH) warehouses but not available in certain regional depots or pharmacies.
To address these issues, collaboration among healthcare professionals, regional structures, and regulatory bodies is essential. For example, the Italian Medicines Agency (AIFA) continuously monitors the situation and regularly updates the list of temporarily unavailable drugs. In cases of shortages, the importation of equivalent drugs authorized abroad may be permitted to ensure patients’ therapeutic continuity.
Differences Between Drug Shortages and Unavailability
Drug Shortages
A drug is considered in shortage when the marketing authorization holder (MAH) cannot ensure its supply across the national territory. This can happen due to several reasons, including:
- Unavailability of active ingredients: Difficulty in sourcing the necessary ingredients for drug production.
- Production problems: Disruptions in the production chain that prevent continuous drug manufacturing.
- Regulatory actions: Regulations or policies that affect drug distribution.
- Commercial decisions: Strategic decisions made by the manufacturing company.
- Unexpected demand increases: Health emergencies that cause a surge in drug demand.
MAHs must promptly report any shortage status to AIFA, which publishes this information in a regularly updated list of drug shortages.
Drug Unavailability
A drug is considered unavailable when the difficulty in obtaining it is due to disruptions in the distribution chain. Unlike shortages, unavailability is not uniform across the national territory and may be linked to:
- Market distortions: Distribution problems that prevent drugs from reaching all geographic areas.
- Distribution dynamics: Logistical issues that affect the availability of the drug in specific regions or pharmacies.
What to Do in Case of Drug Shortages or Unavailability
When faced with drug shortages or unavailability, it is essential to follow a series of steps to ensure patients’ therapeutic continuity.
First, it is crucial to verify whether the missing drug is listed in AIFA’s drug shortages list.
It is vital that all involved parties—pharmacists, doctors, regional structures, and regulatory bodies—collaborate effectively to address these situations, ensuring that patients receive the life-saving medications they need without interruption.
If the Drug is in Shortage
When a drug is in shortage, it is essential to follow several steps to ensure the patient’s therapeutic continuity. First, consult the drug shortages list on AIFA’s portal to confirm the drug’s status. This list is regularly updated and provides useful information on available alternatives and the procedures to follow.
If the drug is indeed in shortage, available equivalent drugs on the market can be considered as therapeutic alternatives. In more complex situations, it is possible to request the importation of equivalent drugs from abroad. This procedure must be initiated by the specialist or general practitioner (GP) through the appropriate healthcare facilities, such as hospital pharmacies.
If the Drug is Unavailable
When a drug is unavailable, it is essential to contact at least three wholesalers to ensure that the drug is not available from any of them.
When a drug is unavailable, it is essential to contact at least three wholesalers to ensure that the drug is not available from any of them. This thorough verification is crucial to avoid false alarms and ensure that all supply options have been explored.
If the unavailability of the drug is confirmed, the pharmacist must immediately report this situation to the regional or autonomous province authorities. Such a report allows further checks and interventions by the competent authorities, which may include direct contact with the MAH to request a direct supply of the drug. According to Article 105, paragraph 4 of Legislative Decree 24 April 2006, No. 219, the MAH is required to supply the drug within 48 hours of the request, including to hospital pharmacies.
Additionally, for many drugs, specific emergency contacts provided by the MAHs can be used to activate the direct supply procedure if a drug is unavailable in the distribution network. If the MAH does not respond to a direct order, it is crucial to send a documented report to AIFA at farmacicarenti@aifa.gov.it. This step allows AIFA to initiate the necessary verification and intervention actions.
The Importance of Compounding
In some cases, a physician may prescribe a compounded medication, a customized pharmaceutical preparation, to address a drug shortage. This solution is particularly useful when the active ingredient is available, but the commercial product is in shortage.
Compounding plays a crucial role in contexts where life-saving drugs or specific equivalent drugs are unavailable on the market. Hospital pharmacies and healthcare facilities, with their ability to prepare personalized medications, can ensure therapeutic continuity for patients, avoiding treatment 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 necessary medications.
Artificial Intelligence as a Solution to Drug Availability Challenges
The integration of artificial intelligence in pharmaceutical inventory management offers innovative solutions to address drug shortages and unavailability.
Here’s how AI can be used to improve warehouse efficiency:
- Demand forecasting: AI algorithms analyze historical data and market trends to accurately predict future demand, reducing the risk of shortages and optimizing stock levels.
- Logistics optimization: AI automates inventory processes, improving drug distribution and preventing unavailability caused by inefficiencies in the distribution chain.
- Alternative identification: In the event of a drug shortage, AI can suggest therapeutic alternatives, ensuring continuity of treatment for patients.
- Real-time monitoring: AI systems provide continuous stock monitoring, promptly signaling any anomalies and allowing timely interventions to resolve supply issues.
The adoption of AI solutions in pharmaceutical warehouse management (such as Profiter) can significantly improve drug availability, ensuring optimal therapeutic continuity and effectively responding to the challenges of the sector.
