Study reveals multiple root causes for drug shortages

Published: 14-Jun-2013

Quality system issues identified as the leading cause of drug shortages by new ISPE report


Issues within the quality systems of manufacturing were identified as the leading cause of drug shortages by ISPE, the International Society for Pharmaceutical Engineering, in the findings of its 2013 Drug Shortages Survey. Aimed at identifying the technical, engineering, quality and regulatory issues affecting drug shortages, the study confirmed that drug shortages are multi-factorial, often resulting from issues within the quality systems, which can be affected by key aspects of organisational governance and the quality of interactions with regulatory authorities.

Earlier this year, ISPE issued a comprehensive survey to industry professionals and companies about the technical, engineering, quality, governance and regulatory issues believed to affect drug shortages. ISPE envisions using the results to support industry and regulators in the development of risk-based approaches to mitigating these occurrences.

‘This survey reveals many new opportunities for ISPE to lead and support the industry in further dialogue around process improvements that may support drug shortage mitigation while also advancing our collective understanding of the causes of drug shortages,’ said Nancy S. Berg, ISPE president and CEO. ‘We look forward to working with our members and regulatory and industry partners to build global solutions for ensuring a reliable supply of medicines.’

While no single technical or manufacturing cause for drug shortages was identified, the key findings include:

  • Issues within the quality systems of manufacturing can lead to drug shortages. Respondents weighted quality issues as the single most important factor leading to drug shortages. Within the quality systems, the data suggested that issues with aseptic processing equipment are a significant factor in sterile drug shortages. In addition, quality issues leading to drug shortages or near misses were present during technology transfer in a small but significant number of cases.
  • Companies that have successfully avoided drug shortages focus on strong quality systems, and the involvement of company leadership is notable in those companies that avoid shortages. The top-ranked success factor cited by companies that were successful in preventing shortages was an organisational focus on strong quality systems aimed at ensuring compliance with manufacturing regulations. Support from senior management to drive the drug shortage prevention programmes, as well as well-defined metrics tailored to identify proactively the potential risk of a shortage, adequate resources for the prevention programme and specific organisational goals to prevent shortages differentiated the companies who successfully avoided a shortage from those that did not.
  • Improved regulatory interaction can mitigate the likelihood of a shortage. A significant number of respondents indicated that issues related to health authority inspections and approval processes also played an important role in drug shortages. Respondents identified a number of areas where they believed the level and quality of interaction with regulators could be improved. Interestingly, an additional differentiator of companies that successfully avoided shortages was their emphasis on building strong relationships with regulatory authorities. Respondents from companies that avoided shortages also cited the importance of fostering communication links between the companies and the regulators as an important success factor.

ISPE plans to further analyse the survey findings, and present and publish additional reports in the future. ISPE is also concurrently conducting a study on clinical trial packaging to help industry better understand how packaging and labeling of clinical trial medicines is viewed from the perspective of patients. This study is expected to be released in November 2013 during the ISPE Annual Meeting.

To download the Report on the ISPE Drug Shortages Survey please visit www.ISPE.org/DrugShortages/2013JuneReport.

You may also like