Navigation Links
Study Reveals Multiple Root Causes for Drug Shortages

TAMPA, Fla., June 12, 2013 /PRNewswire-USNewswire/ -- Issues within the quality systems of manufacturing were identified as the leading cause of drug shortages by ISPE, the International Society for Pharmaceutical Engineering. Today, this leading organization for technical and regulatory advancements throughout the global pharmaceutical lifecycle released the findings of its 2013 Drug Shortages Survey, which was aimed at identifying the technical, engineering, quality and regulatory issues impacting 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 organizational governance and the quality of interactions with regulatory authorities.


Earlier this year, ISPE announced its Drug Shortages Initiative and issued a comprehensive survey to industry professionals and companies. The highly complex instrument asked about the technical, engineering, quality, governance and regulatory issues believed to impact 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 this study and its findings are significant for the industry and regulatory authorities, it is equally important for each of us individually; after all, as patients, we count on having the medicine we need."

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 organizational focus on strong quality systems aimed at ensuring compliance with manufacturing regulations. Support from senior management to drive the drug shortage prevention programs, as well as well-defined metrics tailored to proactively identify the potential risk of a shortage, adequate resources for the prevention program and specific organizational 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 analyze 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

About the ISPE Drug Shortages Survey Report
ISPE deployed the Drug Shortages Survey to its global database of members and non-members for five weeks beginning February 20, 2013. The organization also worked with several reporters and publications covering the pharmaceutical industry to ensure maximum outreach and participation by industry participants with direct knowledge of actual drug shortages and shortages that had been narrowly avoided. In addition to seeking respondents to answer the survey items based on their individual experiences and opinions, ISPE also encouraged companies to compile an enterprise-level response and to designate a member of their staff to enter the information into the electronic survey system. In this way, duplication of data was minimized while still allowing individuals in the industry to share their personal (i.e. non-company) views. Complete anonymity was assured for all respondents.

The survey generated participation by individuals and companies from around the world who provided data concerning an actual drug shortage, a near miss, or an effective shortage prevention program.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world's largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA and offices in Brussels, Belgium, Singapore and Shanghai, China. Visit for more information.

For more information contact:
Danielle Hould
ISPE Communications Manager
Tel: +1-813-960-2105, ext. 277

Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. HemaQuest Pharmaceuticals Completes Patient Enrollment in Phase 2b Clinical Study of HQK-1001 in Patients with Sickle Cell Disease
2. Study Shows Medical Devices Complicate Complex Conditions in Kids
3. RXi Pharmaceuticals Announces Positive Results in its First Double Blind Study in Healthy Volunteers with RXI-109
4. CSL Behring Doses First Patient in Part 3 of Global Phase I/III Pivotal Study of rVIII-SingleChain (Recombinant Single-Chain Factor VIII) for Treatment of Hemophilia A
5. Boston Scientific Announces Collaboration with Pelvic Floor Disorders Network to Study Treatment Strategies for Uterine Prolapse
6. DelMar Pharmaceuticals Presents Additional Clinical Data from Ongoing Brain Cancer Study at ASCO
7. Nektar Presents Target-Specific Biomarkers Being Assessed in Ongoing Phase 3 BEACON Study of Etirinotecan Pegol for the Treatment of Metastatic Breast Cancer at the 2013 American Society of Clinical Oncology Annual Meeting
8. Amgen Presents Positive Results From Talimogene Laherparepvec Phase 3 Study In Patients With Metastatic Melanoma
9. Survey of Participants from Landmark GRACE Trial Provides Patients Perspectives from an HIV Clinical Study
10. Novan Announces Promising Results of SB204 Clinical Study
11. Antibiotic Resistance 2013: A Global Market Study
Post Your Comments:
(Date:11/27/2015)... , November 27, 2015 ... set to go online. The potential to save costs, ... vast and far from fully exploited as yet. Here, ... health records, either via mobile tablet or directly at ... --> ) -->      ...
(Date:11/27/2015)... -- Research and Markets ( ) has announced ... 2015-2019" report to their offering. ... the author the present scenario and growth prospects of ... the market size, the report considers revenue generated from ... and copper IUDs. The report forecasts the global intrauterine ...
(Date:11/26/2015)... , Países Bajos, November 26, 2015 ... la terapia fotodinámica de Bremachlorin para el cáncer avanzado. ... la inmunoterapia con la terapia fotodinámica de Bremachlorin para ... Un nuevo enfoque combina la inmunoterapia con la terapia ... Clinical Cancer Research . --> ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... Healthjump, Inc. announced ... a Healthcare IT consulting, development and support company. The purchase will expand the ... within DataTrade to extend the services currently provided by Healthjump. , ...
(Date:11/30/2015)... BAR, CALIF. (PRWEB) , ... ... ... Inc. ( ), a leading provider of enterprise Time and Attendance/Workforce ... Partner status in the Microsoft Partner Program with competencies in the Application ...
(Date:11/30/2015)... (PRWEB) , ... November 30, 2015 , ... ... in 2016. In 2016, expected coding changes are likely to include new codes ... codes. It’s not easy to understand the effects of code changes in musculoskeletal, ...
(Date:11/29/2015)... Orion, Clarkston, Metamora, Michigan (PRWEB) , ... ... ... Women's Excellence is once again accredited by the American Institute of Ultrasound ... process that allows practices to demonstrate that they meet or exceed nationally ...
(Date:11/29/2015)... ... November 29, 2015 , ... While conventional walkers afford considerable help with mobility, ... exercise weights. Fortunately, an inventor from Uniontown, Pa., has found a way to address ... benefits of a standard walker to improve the user’s quality of life. To begin ...
Breaking Medicine News(10 mins):