FDA Shift May Signal Trouble for Patients Battling Pain

As published in the National Law Journal

B. Douglas Hoey, RPh, MBA
CEO of the National Community Pharmacists Association

America is in the midst of a prescription drug abuse epidemic that requires a balanced approach to prevent misuse by addicts while preserving access to painkillers for patients suffering from pain. A reversal in prior policy, recently announced by the Food and Drug Administration (FDA), fails this test by making some of the most commonly prescribed pain relief medications harder for patients to obtain with no assurance of a reduction in diversion and abuse of these medicines.

FDA is recommending the re-classification of Vicodin® and other hydrocodone-containing products from the Drug Enforcement Administration’s (DEA) Schedule III list of controlled substances to the more restrictive Schedule II list. This will likely pose significant hardships and delay relief for many patients, especially those in nursing home and long-term care settings as well as rural areas. Moreover, there are alternative solutions to combat abuse without harming patients.

Hydrocodone-containing products account for almost 3,000 different available combinations of strength, formulation and manufacturer. If these drugs are moved to Schedule II, patients suffering from legitimate, chronic pain will face new hurdles to obtaining relief. Pain medication prescribing options have been substantially reduced by the removal of other non-Schedule II pain medications from the marketplace. Rescheduling hydrocodone would mean there would be no other comparable, non-Schedule II medication used for moderate chronic pain. This could affect quality of care if patients are prescribed less effective agents to manage their pain.

In addition, refills would no longer be allowed. Patients would need more time off work or away from other pursuits in order to see their doctor once a month, in some instances, for a new prescription. That means additional co-pays and likely higher premiums to account for the additional costs incurred by their insurance plan.

Patients in rural areas may have to travel many miles for those additional physician consultations. Those with limited mobility, who may be homebound or in nursing homes or long term care, will face similar challenges. In sum, there is a greater chance that patients with a legitimate clinical need would be unnecessarily forced to endure symptoms of pain for a longer period of time.

Patients in nursing homes and assisted living facilities already face unacceptable delays in accessing controlled substances to relieve intense pain, under existing regulations. A 2010 Senate Aging Committee hearing entitled “The War on Drugs Meets the War on Pain: Nursing Home Patients Caught in the Crossfire” documented heart-wrenching instances of patient suffering due to DEA policies and enforcement practices. The new FDA policy will likely exacerbate this problem.

For doctors, their hectic days are about to get busier still. Physician assistants and nurse practitioners would be prohibited from writing these prescriptions in many states. For those who can still write these prescriptions, the prescribing process could become more complicated. E-prescribing would no longer be allowed in some states, nor would faxing a prescription. Already overbooked physicians particularly in rural areas could be harshly affected as well as those physicians who service nursing home patients and are not on-site at the facility.

For pharmacists, the change presents challenges as well. Because no refills are allowed on Schedule-II medications, in many cases pharmacy staff contact with individual prescribers would increase from once every six months to monthly. Restrictions on efficiencies like e-prescribing and faxes could make the prescription-filling process slower for patients. Schedule-II medications take two to three business days to order, due to federal regulations, potentially delaying patient access to their medication.

Most importantly, there is no evidence that rescheduling hydrocodone will make a dent in our country’s prescription drug abuse crisis. There are better ways to combat prescription drug abuse without imposing such burdens on vulnerable patients and independent community pharmacists.

First, we support more effective prescriber education because fewer large quantities of pain medications should be prescribed and dispensed in the first place. For example, policymakers could require prescribers to obtain additional education or certification on understanding addiction to and abuse of controlled substances and their appropriate and safe use by tying such education to the prescribers DEA registration number.

Second, make more effective use of state-based prescription drug monitoring programs (PDMPs) and electronic prescribing. This can help alleviate some of the problems with doctor shopping, pharmacy shopping and drug diversion. These systems can be more effective as they move toward real-time reporting and integration into pharmacy workflow processes.

Third, shut down prescription writing enabling pill mills, which are encouraging addiction, creating a thriving black market for narcotic drugs and fueling desperate criminals to rob pharmacies.

Fourth, update federal regulations to establish a practical means by which pharmacies can voluntarily dispose of unused or expired controlled substances. Approximately 1,600 independent community pharmacies participate in the medication take-back program Dispose My Meds, but are legally prohibited from accepting controlled substances.

Independent community pharmacists support these reforms as part of an aggressive effort to reducing prescription drug abuse, while protecting patient access for legitimate needs. They also align with the Office of National Drug Control Policy’s Prescription Drug Abuse Prevention Plan, which focuses on education, monitoring, proper disposal and enforcement.

By contrast, moving hydrocodone-containing products to Schedule II could result in significant barriers for patients and adding to the nation’s health care costs, with no guarantee of reducing abuse of the drugs.

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Kevin Schweers
Senior Vice President, Public Affairs
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