The Senate has sent a bill to electronically track drugs and boost oversight of compounding pharmacies to President Obama, who is expected to sign it, reports Politico. The House passed the measure in September.
The legislation calls on the U.S. Food and Drug Administration to develop an electronic system for tracking pharmaceuticals "from manufacturing to distribution." The bill--known as the Drug Quality and Security Act--was designed to replace a patchwork of state laws governing drug tracking.
It was introduced in part as a response to a 2012 meningitis outbreak that killed 64 people and sickened more than 700. The outbreak occurred after a Massachusetts compounding pharmacy produced tainted steroids.
The bill encourages compounding pharmacies like the Massachusetts facility to register for FDA regulation. Though not mandatory, the agency's stamp of approval is expected to carry weight in the market, providing assurance for hospitals and other providers that they are buying quality compounded drugs. Registration is expected to begin next year.
The tracking process is to be phased in over 10 years. Eventually, each packet of drugs will be traceable throughout the entire system.
Hospital use of compounding pharmacies has come under increased scrutiny and Harvard Pilgrim, the second-largest health insurer in Massachusetts, announced in June that it would no longer cover the specialty medications due to safety concerns.
Forty-nine states have at least passed legislation to create databases to track prescriptions--attempts to stem doctor shopping for painkillers and to track questionable prescribing habits. Only Missouri has not. California lawmakers have introduced legislation to upgrade its system, though state officials say they don't have the resources to use the system effectively.
To learn more:
- read the Politico article