Home » Drug shortages. Aifa publishes distribution methods applicable in the case of medicines that are referenced in the transparency lists

Drug shortages. Aifa publishes distribution methods applicable in the case of medicines that are referenced in the transparency lists

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Drug shortages.  Aifa publishes distribution methods applicable in the case of medicines that are referenced in the transparency lists

AIFA Provides Guidelines on Pharmaceutical Assistance in Case of Drug Shortages

The Italian Medicines Agency (AIFA) recently reiterated the need for clear communication and guidelines to ensure pharmaceutical assistance at a regional level, particularly in cases of drug shortages. In a note distributed to Regions and Autonomous Provinces, AIFA summarized the distribution methods applicable in the event of a shortage of drugs listed in the transparency lists.

The measures outlined by AIFA aim to guarantee pharmaceutical assistance while avoiding financial burdens on patients and optimizing economic resources. Regions and Autonomous Provinces have the flexibility to choose the most suitable methods to ensure pharmaceutical assistance, taking into account their regulatory framework, organizational choices, and healthcare strategies.

Some of the methods usually adopted by Regions and Autonomous Provinces in case of drug shortages include the application of the “safeguard clause” to cover the price difference between the medicine supplied and the AIFA reference price, removal of the drug from the transparency list at the regional level, and the use of Distribution on account (DPC) or Direct Distribution (DD) agreements.

AIFA also emphasized the importance of monitoring the production capacity of new drugs to ensure supply availability and conduct monitoring activities to meet the needs of the population. In cases where supply difficulties are encountered, Regions and Autonomous Provinces have the option to intervene using the methods mentioned above.

The guidelines provided by AIFA serve to enhance transparency, ensure access to essential medicines, and optimize healthcare resources at a regional level. By collaborating with regional authorities and healthcare providers, AIFA aims to strengthen pharmaceutical assistance and reduce the impact of drug shortages on patients.

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