Article Text
Abstract
Background and Importance Drug shortages are a global problem; all types of drugs are liable for shortages with multifactorial causes such as supply, demand, and sometimes regulatory issues. Regulatory agencies, associations, and governments have developed various policies, programmes, research studies, and guidelines to address the issue. However, the phenomenon is growing, representing a problem for access to therapies. Our team was the first in Europe to develop a web platform called DruGhost for monitoring unavailable drugs, distinguished for the first time from shortages, proving to be a valid tool for monitoring the phenomenon and related management.
Aim and Objectives The web-based platform, integrated into a national portal for Italian pharmacists (SIFO), collects all reports of unavailable medicines to map their progress and take actions.
Materials and Methods All hospital pharmacists have access to the platform to submit reports, which are published if the necessary conditions are met. These conditions include that the medicine cannot be on the list of shortages, the order date cannot be older than 15 days, and the company must have received one prompt. Concurrently with the validation and publication of the report, the company receives an alert. The data is shared with the national regulatory agency, Agenzia italiana del farmaco (AIFA), with the aim of providing timely information for the possible adoption of rapid measures, especially for orphan, innovative, and life-saving drugs.
Results In the first year following the platform’s introduction in Italy in 2022, 17,563 reports were received. Out of the total number of reports, 1,214 were effective reports of unavailable drugs, the remaining, in fact, referred to shortage of drugs already published by AIFA, duplicate reports and, some, were considered non-compliant. 90 reports of unavailability referred to orphan drugs, and 92 others to drugs we have witnessed the transition from unavailable to shortage. Analysing the data for first-level of ATC, it appears as follows: 25% nervous system (N), 15% antineoplastic and immunomodulators (L), and 4% blood drugs and haematopoietic organs (L), followed by lower percentages for the other classes.
The reports are growing exponentially. Our team’s aims, among others, is to identify early alerts and adopt preventive measures to guarantee constant access to treatment.
Reference
Shukar S, et al. Drug shortage: causes, impact, and mitigation strategies. Front Pharmacol. 2021.