It might shock many patients that this doesn't already exist, but four U.S. senators are pushing a bill that would eventually require every pill bottle be to traceable through each step of the pharmaceutical supply chain.
"Over the past few years, we’ve had a record number of recalls and reports of tainted or ineffective drugs reaching our hospitals and drug store shelves,” Colorado Sen. Michael Bennet (D) said in a statement. “In fact, right now, we know more from a barcode on a gallon of milk than from a barcode on a bottle of pills, which could mean the difference between life and death. This draft bill would put steps in place to prevent and reduce those problems and help ensure our drug supply is safe.”
A key phrase in Bennet's statement is "draft bill," meaning its chances of passing in current form is uncertain at best.
The senators, two from each party - Bennet, Lamar Alexander (R. - Tenn.), Richard Burr (R. - N.C.) and Tom Harkin (D. - Iowa) - are encouraging discussion, and they will surely get some from several points in the supply chain.
They hope to replace a "patchwork" quilt of state regulations with a federal standard that is "strong, uniform" and would "ultimately result in electronic, interoperable unit level product tracing for the entire country."
Right now, the tracking only goes to the lot-level, not the individual bottle level where patients get medicine.
"It would require the entire drug supply chain, including manufacturers, repackagers, wholesale distributors, third-party logistics providers, and dispensers to pass transaction information, transaction history, and transaction statements, as applicable, when there is a change of ownership," the four senators said in a statement. "Additionally, no one in the supply chain would be allowed to accept drugs if this information is not provided as part of a transaction."
The number of types of people or companies mentioned there might surprise some patients, too.
But all along that chain, there will be attempts at minimizing the cost or shifting it to others.
AmerisourceBergen chief executive officer Steve Collis said last year in an interview with the Inquirer that he favors one system. But AmerisourceBergen, Cardinal Health and McKesson are the three biggest wholesale distributors, controlling about 90 percent of the market. The many smaller re-packagers will object because they say they don't always know who had the drug two steps before them and they can't afford all the fancy information technology. Others will want somebody else to pay.
This bill, the senators note, will not include prohibitions on compounding pharmacies.
Groups representing large drug companies (branded and generic) and the bigger distributors are aligned, at least in a general sense.
John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America; John Gray, president and CEO of the Healthcare Distribution Management Association, and Ralph Neas, president and CEO of the Generic Pharmaceutical Association, recently joined in a op-ed piece that appeared on Politico.
"The Pharmaceutical Distribution Security Alliance — a coalition of more than 25 stakeholders spanning the supply chain spectrum and including biopharmaceutical manufacturers, distributors, pharmacies, logistics providers and others — exemplifies this united commitment to a national solution for finished product tracing," the story said. "A national supply chain solution would:
- Require that prescription drug products contain sophisticated technology able to determine the product’s source and distribution history;
- Provide immediate protection and develop a building block approach to allow for ongoing enhancements;
- Provide the FDA with the nationwide authority to keep the system safe from bad actors; and,
- Ensure an efficient, cost-effective system applicable in all 50 states.