The Pains of Pain Management Today

It’s amazing hearing the stories coming out regarding a celebrity’s ability to gain access to a seemingly limitless supply of pain medications while all-too-many seniors suffer needlessly in pain because of barriers to access. This is a significant problem. Approximately 25-50%¹ of community-dwelling older adults experience persistent pain. In nursing homes the problem is even larger, with prevalence ranging from 49% to 83%.^2,3

Unfortunately, there are many barriers that stand in the way of proper treatment for older adults with pain. The barriers start with clinical issues such as diagnostic and treatment planning, and continue with medication access issues. However, there are opportunities available to improve pain management, which begins with an understanding of these barriers. Much has already been written with regard to the clinical issues of pain management in this Journal and in others. The American Geriatrics Society (AGS) and the American Medical Directors Association (AMDA) have created guidelines for the treatment of pain in the elderly that incorporate both nonpharmacologic and pharmacologic methods (www.americangeriatrics.org/education/final_recommendations.pdf; www.amda.com/tools/cpg/chronicpain.cfm). Because the clinical issues have been extensively covered elsewhere, this article will instead focus on medication access issues, which, unfortunately, are growing.

Right Pain Medication for the Right Patient

There has always been pressure from the Food and Drug Administration (FDA) to limit adverse events from medications. This includes medications that may be appropriate for some patients but not for others. Pain medications are especially prone to these programs, given their wide use and potential for significant adverse events.

The case of rofecoxib can be viewed as an example of a valued pain medication felt by some to have too many risks when left to broad prescribing and use rather than being used more sparingly. Of course, as with all medications, there are patients who benefit from access and those who experience adverse reactions. Rofecoxib was no exception, as some patients saw significant reductions in their pain while others experienced cardiac complications.

As a result of this issue and similar ones, the FDA has focused on regulations to assure that the right medication gets to the right patient and no one else. In the case of rofecoxib, this resulted in its removal from the market. Some may argue that this was appropriate given the risks, yet there are others who have argued that when used properly the risks were outweighed by its benefits.

The take-home message from this is that prescribers need to constantly be evaluating the risks and benefits of every medication for each individual patient. Without this level of care to ensure that the right patient is getting the right medication, the FDA or others may be forced to take action. In some cases, this may mean the inconvenience of Risk Maps (see www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ucm119346.pdf); in others, it may mean the removal of a medication from the market, causing patients to lose access to a potentially needed medication to control their pain. This debate is currently being argued regarding the most widely utilized pain medication, acetaminophen, which as with any medication has benefits and risks associated with its use.

Acetaminophen Headache

Hopefully, the results of the FDA expert panel looking into acetaminophen overdoses will not result in access restrictions. The concerns about acetaminophen arise from patients being harmed by a medication that is safe when utilized by the appropriate person and taken correctly. These medication management issues have resulted in acetaminophen overdoses that have led to 56,000 Emergency Room visits annually and approximately 100 accidental overdose deaths per year. As a result, the FDA recently chose to examine this issue, although this problem has been recognized for many years. In June, the FDA convened 37 healthcare professionals who serve on one of three advisory committees (drug safety and risk management, nonprescription drugs, or anesthetic and life-support drugs) for the purpose of reducing acetaminophen overdosages.

While there were many recommendations, the most significant on which to focus attention are the following:

• Reduction of the maximum daily dosage of acetaminophen from the current level of 4000 mg per day
• Reduction of the single adult dose from 1000 mg to 650 mg for over-the-counter use, with the 1000 mg being limited to prescription access only
• Elimination of acetaminophen prescription combination products such as oxycodone + acetaminophen and hydrocodone + acetaminophen, while not recommending a similar restriction on nonprescription combinations

The critical point to be made in the case of acetaminophen is that prescribers need to take care to educate patients on the appropriate use of this medication (which admittedly can be difficult since patients may be taking it also as a nonprescription drug). Taking steps to assure that patients realize that some of their pain medications may contain acetaminophen should decrease unintended overdoses. If physicians and pharmacists do not starting taking steps to assure that this occurs, then the FDA may follow through with many of the committee recommendations, which would result in restricted access to an important pain medication for millions of patients.

Class II Drugs

Yet another recent change that has made it more difficult for hospice and nursing home residents to receive controlled medications is the enforcement by the Drug Enforcement Administration (DEA) of the need for a signed prescription for pharmacy release of Class II drugs unless extraordinary circumstances are present. If extraordinary circumstances are present, only then may a prescriber provide a verbal order. These extraordinary circumstances only happen in emergency situations, which the DEA defines as one in which the prescribing practitioner determines:

• that immediate administration of the controlled substance is necessary, for proper treatment of the intended ultimate user; and
• that no appropriate alternative treatment is available, including administration of a drug that is not a controlled substance under Schedule II of the Controlled Substances Act; and
• that it is not reasonably possible for the prescribing practi- tioner to provide a written prescription to be presented to the person dispensing the substance, prior to dispensing

The DEA has stated that an emergency situation should only happen rarely. As a result, the association is levying heavy fines against pharmacies that dispense Class II drugs without first receiving a written prescription. Physicians need to have a process in place to assure that written prescriptions can be provided in a timely manner for patients to receive Class II drugs without delay.

The Power of a Little Pressure

Earlier this year, the FDA pulled from the market 14 pain medications that contained liquid morphine because they had never been approved by the FDA. This was because these medications were available before the FDA approval system; as a result, they were grandfathered in needing to submit research data. This grandfathering had ended, resulting in the inability to continue to market these medications, including this critical (liquid morphine) pain medication.

Because of concerns raised by hospice organizations and others over the hardship for terminally ill patients, the FDA decided to extend the usage until an approved substitution is available. This points out the power of a little pressure—physicians from the AGS and others contacted the FDA to ask for reconsideration so that patients could continue to receive these important pain medications. As a result, the FDA changed its earlier decision, allowing patients to continue to receive these medications.

Ensuring Appropriate Pain Management

So again, to ensure that older adults have access to their needed pain medications, the starting point remains a careful clinical process of making the correct diagnosis and ordering the right treatment plan. Of course, once the treatment plan is developed there is more to assuring that patients will have access. Access begins with physicians knowing the rules, and from these rules, developing an efficient and effective process utilizing the entire interdisciplinary care team. In addition, work on the part of physicians is needed to make certain that patients manage these medications correctly so that restrictions are not placed, making it difficult to gain access in the future.

Beyond these practice points, physicians need to be proactive politically through the AGS and other groups to assure access to critical pain medications. While all of these steps may seem laborsome, this is of course nothing in comparison to the pain that would be felt by our patients if they are unable to access needed medications.

The author reports no relevant financial relationships.

Dr. Stefanacci served as a CMS Health Policy Scholar for 2003-2004. He is Director of the Institute for Geriatric Studies at the Mayes College of Healthcare Business & Policy, University of the Sciences, Philadelphia, PA.