White House Implements Plan to Fight Abuse of Prescription Opioids and Other Medications

August 3, 2011 3:29 pm Topics: Prescription drug abuse

Originally published in the August 2011 NABP Newsletter

Unintentional drug overdose is now the leading cause of injury death in 17 states, reports Centers for Disease Control and Prevention Director Thomas Frieden, MD, in a press release on the White House action plan to fight prescription drug abuse. As stressed in the plan, Epidemic: Responding to America’s Prescription Drug Abuse Crisis, opiate overdoses are occurring more often, in large part due to prescription painkiller abuse; whereas, in the past opiate overdoses were most often due to heroin use. Acknowledging that many classes of prescription drugs are currently abused, the White House plan focuses primarily on prescription opioid abuse, a growing problem with a growing number of fatalities.

Recognizing that these pain medications “have great potential for relieving suffering, as well as great potential for abuse,” the plan seeks to strike a balance between minimizing abuse and ensuring access for legitimate use. The prescription drug abuse prevention plan focuses on four major areas:

1. Educating patients and health care providers
2. Increasing use of prescription monitoring programs (PMPs)
3. Implementing and promoting use of prescription drug disposal programs
4. Supporting law enforcement efforts against illegal prescribing

Many of the objectives for addressing these areas include working with stakeholders, such as boards of pharmacy, Drug Enforcement Administration (DEA), law enforcement, and nonprofit educational organizations. Further, the plan includes timelines for developing new legislation, establishing regulations for new laws, and implementing educational campaigns that will likely impact boards of pharmacy and their licensees. The plan also reinforces NABP actions and board of pharmacy efforts to fight prescription drug abuse and protect the public health.

Public Awareness

The White House plan recognizes that many people are still not aware of the dangers of misusing or abusing prescription medications, and stresses the need for educating the public, including parents, youth, and patients, on this issue. The plan calls upon stakeholders, including boards of pharmacy, to support and to implement public education campaigns. Further, the Office of National Drug Control Policy (ONDCP) and the Office of the National Coordinator will work with private entities to develop media campaigns to support educational efforts.

NABP, through the NABP Foundation’s AWARxE™ consumer protection program, is working to educate consumers about the dangers of prescription drug abuse and also provides information on safely obtaining and administering medications. Recognizing that the majority of people who misuse prescription drugs get them from friends or family for free, the AWARxE Web site, www.AWARErx.org, promotes DEA take-back events and local efforts to prevent prescription drug abuse.

The AWARxE Web site and the NABP Web site also help to raise public awareness about the risks of ordering prescription drugs online. According to a recent study published in Health Affairs, the growth in Internet use may be associated with the growth of prescription drug abuse. Specifically, the study determined that for every 10% increase in high-speed Internet access, by state, there was a 1% increase in rates of treatment facility admission for prescription drug abuse. Through the NABP Not Recommended list of Web sites selling prescription drugs, the list of VIPPS^® (Verified Internet Pharmacy Practice Sites^CM)-accredited Internet pharmacies, and through numerous publications and AWARxE events, NABP continues to educate the public about Internet drug outlets, including raising awareness about how rogue Internet drug outlets fuel prescription drug abuse.

REMS and Education for Health Care Providers

As noted in a Drug Information Update, Food and Drug Administration experts say “extended-release and long-acting opioids. . . are extensively misprescribed, misused, and abused,” leading to overdoses, addiction, and even deaths. The White House plan includes detailed objectives for involving drug manufacturers and health care providers in efforts to protect patients from such dangers. According to the plan, prescribers and dispensers currently do not receive enough training on appropriate prescribing of opioids to prevent adverse effects, diversion, and addiction. Thus, the plan includes several initiatives for improving training and providing specialized training to prescribers and dispensers to assist in patient care decisions. As explained in a frequently asked questions section on the FDA Web site, “The new REMS [Risk Evaluation and Mitigation Strategy] plan focuses primarily on: educating doctors on proper pain management, patient selection, and other requirements and improving patient awareness about how to use drugs safely.” Prescribers will also be educated on how to recognize evidence of and potential for opioid misuse, abuse, and addiction. Additional training and materials are also aimed to support health care provider efforts to educate patients.

As part of the plan’s objectives, federal agencies are called upon to work with Congress to amend the law so that prescribers must complete training on opioid prescribing in order to obtain their DEA number. This revision would prevent the need to establish a new, separate system for tracking whether health care providers have completed such training.

The plan also calls for health care provider training to be addressed in the health care systems of federal agencies, such as the Department of Veterans Affairs (VA), where continuing education on prescribing and proper drug disposal is to be provided.

Manufacturers are required to implement opioid REMS, that call for the development of effective educational materials for providers and patients, and initiatives to train practitioners on the appropriate use of opioid pain relievers. FDA also encourages companies to give patients educational materials, such as consumer friendly medication guides, for certain medications.

Boards of pharmacy and other medical boards are called upon to encourage faculty of health professional schools to include instruction on the safe and appropriate use of opioids to treat pain.

In addition, the plan aims to support and advance research into developing abuse-deterrent formulations of certain prescription drugs, especially opioid painkillers.

White House Notes Impact of PMPs

The White House plan acknowledges the impact of PMPs on combating pill mills and the prescribing of prescription drugs outside the usual course of medical practice. The plan also acknowledges that PMPs can help identify patients in need of assistance due to misuse or abuse problems.

The plan cites three recent studies that show the impact of PMPs in fighting prescription drug abuse. The first study demonstrated that state PMPs were associated with reduced rates of substance abuse treatment admissions, and the second that PMPs slowed rates of abuse and misuse as shown through poison center information. The third study concluded that when PMP data was used in an emergency department, clinical management was changed in 41% of cases, with some patients receiving less opioid medication and others receiving more opioid medications.

The White House plan details several objectives for supporting PMPs, some of which include:

• Working with every state to establish PMPs
• Supporting the National All Schedules Prescription Electronic Reporting Act, which provides federal funding for state PMPs
• Exploring the feasibility of reimbursing prescribers who use PMPs
• Issuing the final rule on DEA electronic prescribing of controlled substances
• Encouraging continued research on the impact of PMPs

With the implementation of the NABP PMP InterConnect™, NABP and participating PMPs are helping to enhance the impact of PMPs by facilitating the sharing of PMP data across state lines. At press time, nine states had executed MOUs to participate in the NABP InterConnect, with an implementation beginning in the summer and continuing throughout the fall. In addition, four states have MOUs in process and at least 15 states also intend to sign on to participate in the NABP InterConnect in late 2011 or early 2012.

Drug Disposal to Prevent Abuse

Until regulations are established to implement the Secure and Responsible Drug Disposal Act of 2010, DEA will continue to provide consumers with a safe means for disposal of unwanted medications through nationally coordinated prescription drug take-back events to reduce diversion of addictive drugs. As 2009 Substance Abuse and Mental Health Services Administration data from the National Survey on Drug Use and Health shows, over 70% of people who abuse pain relievers got them from friends or family for free. Thus, holding take-back events to rid homes of unwanted, unused, and unneeded medications can have a significant impact on preventing misuse and abuse.

Once the DEA regulations for controlled substance drug disposal are established, ONDCP, Environmental Protection Agency, DEA, and other federal agencies will partner to “develop and execute a robust public education initiative to increase public awareness and provide education on new methods of safe and effective drug return and disposal.”

Increased Enforcement

A small number of practitioners prescribe medications, including opioid medications, outside the usual course of professional practice or for illegitimate purposes, as noted in the plan. To address these issues, ONDCP’s National Methamphetamine and Pharmaceutical Initiative, a law enforcement training initiative, “will contribute to the curriculum for the pharmaceutical crime investigation and prosecution training program sponsored by BJA [Bureau of Justice Assistance] in 2011.” Training will be targeted to states with the highest need. Other objectives to train law enforcement and prosecutors are included in the plan. In addition, the Department of Justice, DEA, and other agencies will continue aggressive enforcement actions against prescribers who are breaking the law as described above.

Other objectives to support law enforcement include developing a Model Pain Clinic Regulation Law, increasing multi-agency joint intelligence gathering, and using PMP data to identify criminal prescribers and pill mill clinics.

Planned Goals to Involve Pharmacists and Boards

The overall five-year goal for the plan is to see among people age 12 and older at least a 15% “reduction in non-medical use of prescription-type psychotherapeutic drugs” compared with statistics from the past year. Boards of pharmacy and their licensees may wish to take particular note of the following objective time frames:

• REMS for certain opioids are to be implemented within 12 months
• A Model Pain Clinic Regulation Law is to be developed and released within 12 months
• Indian Health Services (IHS) will increase the number of collaborative practice agreements that involve pharmacists prescribing privileges and monitoring of pain medication prescribing within 18 months
• Implementation of regulations and rules to implement the new medication disposal law is to be completed within 24 months
• FDA intends to issue a guidance document on developing abuse deterrent drug formulations and on post-market assessment of their performance within 24 months

Further, for boards that administer their state’s PMP, the objectives detail that within 24 months, Department of Defense, VA, and IHS will submit controlled substance prescription information to PMPs located in the states where these health systems operate health care facilities and pharmacies. Within 36 months, it is planned that all 50 states will have legislation to establish PMPs.

Finally, ONDCP calls upon all relevant agencies and stakeholders to take their part in implementing this national plan to prevent drug abuse. As a next step, ONDCP will convene a Federal Council on Prescription Drug Abuse, composed of federal agencies, and will engage private parties as necessary.