Study find some pharmacies still not DSCSA-compliant

Several pharmacies in the US are not receiving all the required drug product tracing information required under the Drug Supply Chain Security Act, and some dispensers are even unaware of the legislation’s track and trace requirements, a new study reveals.

According to the US Office of Inspector General (OIG), 14 out of 40 pharmacies sampled for the study were found to be missing several of the required drug tracing elements received from trading partners that are now required by law. Twenty-six dispensers received all required elements of this information.

The OIG report also found that two of the pharmacies sampled were unaware of the Drug Supply Chain Security Act (DSCSA) and requirements for drug product tracing.

The DSCSA, which comes fully into force in 2023, requires an electronic, interoperable track and trace system to be introduced to monitor the distribution of drugs in the US to prevent counterfeit, contaminated and diverted drugs.

As part of the system, trading partners – from manufacturers through to pharmacies – are required to exchange certain transaction and product tracing information when pharmaceutical products change hands along the supply chain to create a record of ownership. Dispensers are not supposed to accept ownership of a drug product without the complete tracing information, which includes transaction information, a transaction history, and a transaction statement.

Missing information may indicate the drug product is suspect.

The US Food and Drug Administration published recommendations last month for the standardisation of transferring transaction information along the pharma supply chain.

The OIG noted its concern over the study’s findings, suggesting the DSCSA may not be entirely effective in preventing the distribution of counterfeit drugs.

“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,” the OIG said. “Ultimately, dispensers’ receipt and review of complete drug product tracing information can help ensure the security of the drug supply chain and protect patients from harmful drugs that have entered.”

The study involved interviews with 40 dispensers including independent retail pharmacies, chain retail pharmacies, and small and large hospital pharmacies.

These dispensers submitted examples of drug product tracing information provided by their trading partners. This information was in a variety of transmission modes and formats – from paper invoices to emails – based on the use of different systems rather than adopting a standardised way to exchange this information, OIG said.

Among the pharmacies that only received some of the required information, three did not receive information on the strength of the drug product, five did not receive information on dosage form and two were not given transaction dates.

Meanwhile, there was one instance of a missing transaction history, and six pharmacies were not given transaction statements, which confirms that the entities that have transferred ownership of the drugs are authorised under the DSCSA, that the legislative requirements have been met, and that all transaction information is true and unaltered and there has been no knowledge of suspect products.

From the 40 interviews, the OIG also found that 25 pharmacies never review the drug product tracing information they receive, meaning they may not be aware of missing information and may not realise they are non-compliant with the DSCSA. Of these 25 pharmacies, 13 were found to have missing information.

Although the findings from 40 selected pharmacies cannot be extrapolated to the whole pharmacy industry, the OIG said it recommended that the FDA offer educational outreach programmes to dispensers to improve compliance with the DSCSA.

The OIG study is the second that has examined the drug supply chain under DSCSA provisions. The previous study found that selected wholesale distributors exchanged drug product tracing information with other trading partners and about one-half of wholesalers exchanged all required information.

Future OIG work will test whether drug product tracing information can be used to trace drug products through the entire drug supply chain.