Allan Coukell, senior director of drugs and medical devices, testified before the U.S.-China Economic and Security Review Commission on the global pharmaceutical supply chain security and the importance of the newly passed Drug Quality and Security Act.More info
As Prescription Painkiller Overdoses Mount, Researchers Outline Effective Approaches to Curb Epidemic
WASHINGTON — Prescription painkillers are responsible for more fatal overdoses in the United States than heroin and cocaine combined. And while most states have programs to curb abuse and addiction, a new report from Brandeis University shows that many states do not fully analyze the data they collect.
Experts from the Prescription Drug Monitoring Program Center of Excellence at Brandeis University's Heller School for Social Policy and Management systematically assessed prescription drug monitoring programs and found a patchwork of strategies and standards. Their report also outlines best practices that all U.S. states and territories can use to improve their effectiveness.
"An epidemic of prescription drug abuse is devastating American families and draining state and federal time, money and manpower," said Rep. Hal Rogers (R-Ky.), chairman of the House Appropriations Committee. "Law enforcement and health officials are doing heroic work and, thankfully, this report provides a roadmap to help them further."
Among the study's primary conclusions: prescription drug monitoring programs should shift from a reactive to a proactive approach.
"Being proactive is the key to success in the fight against prescription painkiller abuse," said John L. Eadie, Director, PDMP Center of Excellence at the Heller School for Social Policy and Management, Brandeis University. "While doctors may routinely collect and report data to a state program that signals where and when prescription painkillers are likely being misused, the program might not share that information with others who can best use it."
"State programs should analyze the data they collect," Peter Kreiner, Principal Investigator of Brandeis' Center of Excellence, continued, "and reach out to prescribers, pharmacists, insurers, law enforcement agents and others who can prevent powerful narcotics from falling into the wrong hands. Where this is already taking place, it has proven to be very effective."
"Good things happen when state prescription drug monitoring programs shift to a proactive strategy," said Dr. Nathaniel Katz, assistant professor of anesthesia at Tufts University School of Medicine. "Not only can it prevent painkillers from being misused or distributed illegally in the first place, but it can also enable health professionals to identify patients who need help overcoming addiction."
By the end of 2001, the report found that 16 states had authorized the creation of prescription drug monitoring programs; within 11 years that number had grown to 49. Today, 41 states have programs in operation.
The paper identified several practices with demonstrated effectiveness. For example:
- States that collected prescribing data for all controlled substances (e.g., anti-anxiety medication as well as painkillers) reported lower rates of doctor-shopping (visiting multiple doctors to obtain prescriptions) than other states.
- The rates of fatal painkiller overdoses grew more slowly in three states using state-issued prescription forms with uniquely configured page numbers, a practice designed to curb fraud.
- Proactively sending alerts about possible abuse to physicians and pharmacists was associated with decreased prescription sales and lower rates of doctor-shopping.
- Analyzing trend data helped law enforcement agencies identify "pill mills" that were illicitly distributing prescription painkillers.
- Boosting doctors' participation in and utilization of prescription drug monitoring programs was associated with reduced fatal prescription painkiller overdoses.
"BJA has historically provided strong support for the promulgation and dissemination of best practices," said Denise O'Donnell, Director of the Bureau of Justice Assistance, U.S. Department of Justice, "and we are gratified by the publication of this paper, which provides much needed guidance and support for how states can most effectively utilize their prescription drug monitoring programs."
The Pew Health Group, a division of The Pew Charitable Trusts, provided funding for the research.
"Protecting patients from medical risks and ensuring their access to safe and effective therapies are significant goals for Pew," said Allan Coukell, director of medical programs for the Pew Health Group. "Prescription painkillers clearly play an important role in modern medicine, but their abuse is also responsible for mounting deaths, suffering and health care costs. These researchers' work will advance the vital actions already being taken to attack this problem."
The House Energy and Commerce Subcommittee on Oversight and Investigation held a hearing on Feb 16 entitled "Counterfeit Drugs: Fighting Illegal Supply Chains." Elizabeth Jungman, director of drug safety and innovation testified on counterfeit drugs the importance that newly passed Drug Quality and Security Act will have on the safety of the U.S. pharmaceutical supply chain.
The following case studies illustrate breaches to the pharmaceutical supply chain—the route a drug travels from its raw material origins to the delivery of a finished medicine. These examples, all of which are discussed in Pew Health Group’s report After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs, demonstrate the different ways in which contaminated, fake, or otherwise unsafe medicine can reach patients, and underscore the need for reform.More info