FDA to place new limits on prescription narcotics

by • March 1, 2009 • UncategorizedComments Off on FDA to place new limits on prescription narcotics1606

© 2009 The Medical-Legal News


By Margaret S. Wacker, RN, PhD

Federal drug officials announced recently that many doctors may lose their ability to prescribe 24 popular narcotics as part of a new effort to reduce deaths and injuries that result from these medicines’ inappropriate use.
The story was reported in The New York Times, Feb. 10.
According to the article, officials additionally plan to create a massive new control program that they believe will result in further restrictions on the prescribing, dispensing and distribution of extended-release opioids like Oxycontin, fentanyl patches and methadone tablets.
These schedule II narcotics are already restricted, according to the Food and Drug Administration and the Drug Enforcement Agency. However, Dr. John Jenkins, director of the FDA’s new drug center, reports that the current restrictions do not “fully meet the goals we want to achieve,” according to the story.
He expressed concern that hundreds of patients die and thousands are injured each year in the U.S. because they are inappropriately prescribed drugs like Oxycontin or Duragesic (fentanyl) patches or that the patients took these drugs in ways that were dangerous.

No one would deny that hundreds of deaths and thousands of injuries are unacceptable. What is far more unacceptable, though, is removing these agents from the estimated 75 million cancer and non-malignant chronic pain patients who would be in moderate to severe pain on a daily basis without them.
Unrelieved pain causes needless suffering and diminished quality of life. Patients with chronic unrelieved pain have weakened immune systems, cardiovascular, respiratory, musculoskeletal, cognitive and endocrine compromise. They are frequently depressed and often in relationships strained by their irritability and dependency.

It has taken more than three decades to bring attention to physicians and nurses regarding the need for pain management.
Federal regulations for prescribing controlled substances such as opioids were established in the 197os. Intractable Pain Treatment Acts (IPTAs) were then adopted by many states in an effort to protect physicians from inappropriate disciplinary action.
In 1986 the Wisconsin Cancer Pain Initiative organized professionals and volunteers to improve cancer pain management. Now, all 50 states have pain initiatives or are in the process of forming them.
The Agency for Health Care Policy and Research (AHCPR) in 1992 published guidelines for Acute Pain Management. Cancer Pain Management guidelines followed in 1994.
As recently as 2001 the Joint Commission on Accreditation of Health Care Organizations (JCAHO) set new pain standards and made pain control a quality indicator. Pain assessment and management is now added to the Patient’s Bill of Rights.
Specialty organizations in medicine and nursing began to focus on pain in their particular specialty organizations. Pharmacy programs included pain management PharmD degrees. Curricula in nursing and medical schools included theory and clinical experience in pain management.
The number of pain facilities has increased, as has the number of acute pain services within hospital systems.
All of this progress has underscored that effective pharmacologic pain management requires maintaining a stable analgesic blood level whenever pain is expected to be present for more than 12 out of 24 hours. Extended release agents help maintain that stable level.

The effect of the restrictions
Removing these agents from the market or restricting physician prescriptive practice will harm 75 million patients in the service of preventing hundreds of deaths or thousands of injuries.
The FDA will hold meetings this year with manufacturers, patient and consumer advocates, and the public, to ask for advice on how to carry out the new control program. Hopefully, physicians and other healthcare providers with prescriptive authority will be included in these meetings.
Attorneys and LNCs should be aware of the clinical consequences if this proposal goes into effect.
We should expect to see an increase in inappropriate use of medications such as propoxyphene (Darvon ) and Tylenol with codeine. Codeine is a very weak analgesic often overprescribed by physicians who are uncomfortable with prescribing stronger opioids. Darvon has a toxic metabolite with a half life of 30-36 hours. It produces confusion in the elderly, and many chronic pain patients are elderly. Elderly patients have decreased liver and renal function, which limits their ability to metabolize drugs, and impairs their ability to clear drugs from their systems. Prescribing inappropriate agents such as Darvon may well contribute to the misdiagnosis of dementia and the increased risk of falls.
Also, patients in pain may take toxic doses of NSAIDS or acetaminophen in an effort to relieve their pain. Intake above ceiling limits of NSAIDS will increase the risk of gastrointestinal bleeding. Exceeding maximum doses of acetaminophen will cause liver damage or failure.
This action by the FDA, while motivated by good reasons, may have the unwanted side-effect of creating desperation in pain patients and related clinical fallout. This action also may cause decision-making difficulty for both those prescribing (the providers) and the recipients of the prescriptions (the patients) and eventual legal fallout. •

Margaret S. Wacker, RN, PhD, is a pain expert witness and is based in Florida; chakdoc@aol.com.

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