Drug supply chain security: wholesalers exchange most tracing information
- Collection:
- Health Policy and Services Research
- Series Title(s):
- Report in brief
- Contributor(s):
- United States. Department of Health and Human Services. Office of Inspector General. Office of Evaluation and Inspections, issuing body.
- Publication:
- [Washington, D.C.] : U.S. Department of Health and Human Services, Office of Inspector General, September 2017
- Language(s):
- English
- Format:
- Text
- Subject(s):
- Pharmaceutical Preparations -- supply & distribution Prescription Drug Diversion Information Dissemination Security Measures Humans United States United States. Department of Health and Human Services. United States. Food and Drug Administration.
- Genre(s):
- Technical Report
- Abstract:
- Why OIG Did This Review. Drug diversion, counterfeiting, and the importation of unapproved drugs may result in potentially dangerous drugs entering the drug supply chain, posing a threat to public health and safety. To enhance drug supply chain security, the Drug Supply Chain Security Act (DSCSA) requires trading partners in the drug supply chain to create a record of each drug product transaction. The Food and Drug Administration (FDA) can then use such tracing records to investigate suspect and illegitimate drug products and potential diversion. This study is the first in a series of Office of Inspector General (OIG) examinations of drug supply chain security that will follow the implementation of various DSCSA provisions. Future OIG work will examine dispensers' exchange of drug product tracing information as well as test whether drug product tracing information can be used to trace drug products through the entire drug supply chain. How OIG Did This Review. In December 2015 and January 2016, we interviewed 31 of 353 wholesalers identified in FDA's database. These wholesalers from across the country were of varying sizes and included the three largest wholesalers. We also reviewed examples of drug product tracing information provided by each of the 31 wholesalers. What OIG Found. We found that all 31 selected wholesalers exchange drug product tracing information. Of these, 17 wholesalers--including the 3 largest wholesalers that account for more than 80 percent of drug distribution revenue--exchange all required drug product tracing information. The remaining 14 exchange most elements of drug product tracing information but are missing a few of the required elements. Missing information among these wholesalers raises concerns that complete drug product tracing information may not always be available to support investigations into suspect and illegitimate drug products and potential diversion. The 31 wholesalers in this study exchange drug product tracing information using a wide variety of transmission modes and formats, taking advantage of the latitude provided by DSCSA and FDA guidance. Wholesalers may eventually coalesce around one means of exchange as DSCSA requirements are implemented. However, at this time, a standardized way to exchange this information has not emerged. What OIG Recommends and How the Agency Responded. To ensure that all wholesalers comply with the DSCSA, we recommend that FDA offer technical assistance where appropriate. Specifically, we recommend that FDA provide technical assistance to wholesalers regarding direct purchase statements, exempt drugs, and exchanging drug product tracing information for transactions involving 340B-covered entities and 340B contract pharmacies. FDA concurred with all of our recommendations.
- Copyright:
- The National Library of Medicine believes this item to be in the public domain. (More information)
- Extent:
- 1 online resource (1 PDF file (34 pages))
- Illustrations:
- Illustrations
- NLM Unique ID:
- 101737921 (See catalog record)
- Permanent Link:
- http://resource.nlm.nih.gov/101737921