The U.S. House Energy and Commerce Committee recently approved "track and trace" legislation, which would move pharmaceutical manufacturers under FDA oversight and require unit-level tracking for all products.
The legislation aims to improve patient safety by helping to ensure pharmaceuticals have not been adulterated, counterfeited or otherwise compromised before they reach the patient.
"The pharmaceutical supply chain touches every part of the healthcare system and it is imperative that we get the structure and segments of it connected in a safe, secure and effective manner that provides the best protection for patients," says Congressman Bob Latta (R-Ohio), one of the architects of the bill.
Rep. Latta says the pending legislation "will make improvements to the current supply chain, and help ensure that patients receiving care in hospitals are given prescription drugs that have been tracked and traced from the manufacturer to the pharmacy thereby ensuring that no counterfeit or adulterated drugs have entered the system."
The Senate Health, Education, Labor and Pensions Committee recently passed a similar bill as well.
The legislation will be soon be considered by Congress for passage into law, and carries importance for hospital administrators. "This is important legislation for hospitals" says Curtis Rooney, president of the Healthcare Supply Chain Association. "It's sad but true that it's easier to track a head of lettuce than the drugs given to patients…[this legislation] will definitely create a path to increased patient safety," he says.
While the focus of the legislation is on supply chain wholesalers, "hospitals should be ready to receive products that have been shipped that have been subject to the legislation," says Mr. Rooney. Hospitals' systems will need to be compatible with national standards on reporting shipments of pharmaceuticals.
To prepare for the bill's passage, Mr. Rooney recommends an internal audit of current capabilities to see if the current system can handle both lot and unit-level tracking of received drugs. "Hospitals have been so focused on IT changes recently," he says, "and this will be one more thing they need to do, but it will be tremendous benefit to patient safety."
"It might not be easy, but it will be beneficial" to both hospital compliance with federal regulations and patient safety, says Mr. Rooney.
Hospitals should begin evaluating their IT systems now, recommends Mr. Rooney, as he is confident the legislation will pass: "It has bipartisan, bicameral, and industry support," he says. "It will pass."
House Committee Approves Drug "Track and Trace" Bill
The legislation aims to improve patient safety by helping to ensure pharmaceuticals have not been adulterated, counterfeited or otherwise compromised before they reach the patient.
"The pharmaceutical supply chain touches every part of the healthcare system and it is imperative that we get the structure and segments of it connected in a safe, secure and effective manner that provides the best protection for patients," says Congressman Bob Latta (R-Ohio), one of the architects of the bill.
Rep. Latta says the pending legislation "will make improvements to the current supply chain, and help ensure that patients receiving care in hospitals are given prescription drugs that have been tracked and traced from the manufacturer to the pharmacy thereby ensuring that no counterfeit or adulterated drugs have entered the system."
The Senate Health, Education, Labor and Pensions Committee recently passed a similar bill as well.
The legislation will be soon be considered by Congress for passage into law, and carries importance for hospital administrators. "This is important legislation for hospitals" says Curtis Rooney, president of the Healthcare Supply Chain Association. "It's sad but true that it's easier to track a head of lettuce than the drugs given to patients…[this legislation] will definitely create a path to increased patient safety," he says.
While the focus of the legislation is on supply chain wholesalers, "hospitals should be ready to receive products that have been shipped that have been subject to the legislation," says Mr. Rooney. Hospitals' systems will need to be compatible with national standards on reporting shipments of pharmaceuticals.
To prepare for the bill's passage, Mr. Rooney recommends an internal audit of current capabilities to see if the current system can handle both lot and unit-level tracking of received drugs. "Hospitals have been so focused on IT changes recently," he says, "and this will be one more thing they need to do, but it will be tremendous benefit to patient safety."
"It might not be easy, but it will be beneficial" to both hospital compliance with federal regulations and patient safety, says Mr. Rooney.
Hospitals should begin evaluating their IT systems now, recommends Mr. Rooney, as he is confident the legislation will pass: "It has bipartisan, bicameral, and industry support," he says. "It will pass."
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