Drug Supply Chain Security: OIG Finds Pharmacies Received Most Tracing Information
Regulatory News | 29 March 2018 |
A new report from the Department of Health and Human Services’ Office of Inspector General (OIG) found that among a sample of 40 pharmacies, all received at least some of the required drug product tracing information from their supply chain partners, though many said they are not reviewing the information.
Under the Drug Supply Chain Security Act (DSCSA), dispensers, including independent, chain and hospital pharmacies, are required to receive complete tracing information before accepting ownership of a drug shipped from a manufacturer or wholesaler.
“Although dispensers are generally implementing the requirements for drug product tracing, missing information and a lack of awareness of DSCSA requirements raise concerns that a complete tracing record for a drug product may not always be available to support investigations of suspect and illegitimate drug products in the supply chain,” OIG said.
For example, OIG’s review found that of the 40 selected dispensers, 26 received all required elements, including transaction information, transaction history and transaction statements, but 14 did not. Two of these dispensers were unaware of the DSCSA requirements.
In addition, of the 40 dispensers, 25 reported that they never review the drug product tracing information they receive.
“Dosage form was the most common element of the transaction information that was missing. Dispensers gave some explanations for missing dosage form, noting that the dosage form may be included in the drug product name (e.g., Spiriva HandiHaler, which is an inhaler) or that they can determine the dosage form by looking up information associated with the NDC. Although the NDC is one way to determine the dosage form, the DSCSA requires that the transaction information include both the NDC and dosage form,” OIG said.
The report also discusses how dispensers are receiving tracing information in a variety of ways and formats.
“This variety is a result of dispensers and their trading partners using different systems rather than adopting a standardized way to exchange this information. Neither the DSCSA nor FDA guidance require the exchange of drug product tracing information in the same way,” the report said.
OIG recommends (and FDA concurred) that FDA offer educational outreach to dispensers of drugs to ensure they understand their responsibilities in receiving complete tracing information from supply chain partners before accepting ownership of such pharmaceuticals.
OIG Report
Under the Drug Supply Chain Security Act (DSCSA), dispensers, including independent, chain and hospital pharmacies, are required to receive complete tracing information before accepting ownership of a drug shipped from a manufacturer or wholesaler.
“Although dispensers are generally implementing the requirements for drug product tracing, missing information and a lack of awareness of DSCSA requirements raise concerns that a complete tracing record for a drug product may not always be available to support investigations of suspect and illegitimate drug products in the supply chain,” OIG said.
For example, OIG’s review found that of the 40 selected dispensers, 26 received all required elements, including transaction information, transaction history and transaction statements, but 14 did not. Two of these dispensers were unaware of the DSCSA requirements.
In addition, of the 40 dispensers, 25 reported that they never review the drug product tracing information they receive.
“Dosage form was the most common element of the transaction information that was missing. Dispensers gave some explanations for missing dosage form, noting that the dosage form may be included in the drug product name (e.g., Spiriva HandiHaler, which is an inhaler) or that they can determine the dosage form by looking up information associated with the NDC. Although the NDC is one way to determine the dosage form, the DSCSA requires that the transaction information include both the NDC and dosage form,” OIG said.
The report also discusses how dispensers are receiving tracing information in a variety of ways and formats.
“This variety is a result of dispensers and their trading partners using different systems rather than adopting a standardized way to exchange this information. Neither the DSCSA nor FDA guidance require the exchange of drug product tracing information in the same way,” the report said.
OIG recommends (and FDA concurred) that FDA offer educational outreach to dispensers of drugs to ensure they understand their responsibilities in receiving complete tracing information from supply chain partners before accepting ownership of such pharmaceuticals.
OIG Report
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