By Pete Jackson, Guest Columnist
Recently, several columns have appeared in American News Report expressing negative views toward a petition submitted to the FDA by doctors, researchers and public health officials, many of them associated with an organization called Physicians for Responsible Opioid Prescribing (PROP), which recommends certain labeling changes for prescription opioid analgesics. This proposal, which is intended to reduce harm to chronic pain patients caused by overprescribing of opioids, has met with strong praise and also strong criticism.
It is apparent from reading these columns and the follow-up comments of readers that there are many incorrect assumptions being made about this proposal. As a supporter of the PROP petition, I would like to explain why these changes are needed and why the changes will not restrict doctors from prescribing opioids. I also hope to clear up some misconceptions to promote a better understanding of PROP’s proposal.
First, why am I involved in advocating for the PROP labeling proposal?
In 2006, I lost my wonderful 18-year-old daughter Emily, who was a cancer patient, to a one-time encounter with OxyContin. In my grief, I began to study the issue and found that Emily’s tragedy was part of a dramatic increase in overdose deaths and addictions stemming from the liberalized use of prescription opioids, which began in the late 1990’s.
I made a commitment to try and prevent other vital young people from losing their lives like my Emily did. I got involved with some other families from around the country and wound up co-founding the organization of which I am president, Advocates for the Reform of Prescription Opioids, or ARPO. Many of ARPO’s members have lost a son, daughter, or other family member to opioids, and in a majority of these cases the lost loved one was on a doctor’s opioid prescription for pain. Other members are fighting a terrible opioid addiction in their family. Most of those cases also began as pain patients.
Before I continue, I would like to say something to the pain patients. I have the utmost compassion for the pain which you experience in your daily lives. ARPO does not want to see any individual suffer from pain, and we want to see safer care and better treatment outcomes for those patients who may experience adverse effects from chronic opioid therapy.
We are not attempting to “criminalize” pain patients on opioid medications. The PROP proposal would not place any restriction on a doctor’s prescribing of opioid medications. This is the most common misperception regarding the PROP proposal. Claims that the PROP labeling changes would take opioid medications away from pain patients are incorrect.
Why is a change in labeling needed?
Under the Fderal Food, Drug and Cosmetic Act, before a drug can be labeled for a given use the drug maker must prove that the drug is safe and effective for that use. Unfortunately, when approved by the FDA, most opioids were labeled for very broad indications, meaning that they were effectively approved for many different types and levels of pain, including moderate and severe non-cancer pain, for which the long-term safety and effectiveness of opioid medications have not been established. This allowed the drug companies to conduct an aggressive campaign to promote the use of these drugs for virtually all types of pain.
The result has been a four-fold increase in prescribing of opioid analgesics over the past decade, along with a four-fold increase in opioid-related overdose deaths and a six-fold increase in addiction treatment over the same time period. The Centers for Disease Control now estimates that we are losing about 15,000 Americans per year from prescription opioid overdose deaths.
These trends in prescribing and adverse outcomes have been rising in parallel since the late 1990’s, when doctors were urged by the drug companies to more aggressively treat pain by prescribing opioids. This included, by the way, false claims made by at least one prominent opioid manufacturer that opioids were safe for long-term use. Purdue Pharma was convicted in 2007 after admitting that they lied to doctors about the safety of OxyContin.
Contrary to the claims of some defenders of the status quo, many of the victims of opioid-induced overdoses, addiction or other disorders are pain patients. One study found that 35 percent of outpatients undergoing long-term opioid therapy at a large health care system in Pennsylvania had developed a lifetime opioid use disorder.
Another study reviewed data for over three thousand individuals who died from an opioid in Ontario, Canada between 1991 and 2004. Two-thirds of these patients were seen by a physician within four weeks of their death and 82% had received an opioid prescription from a doctor the year before they died.
The notion that an addict is limited to those who use an opioid recreationally is incorrect. The addictive qualities of opioids are not reduced by simply writing a prescription. Pain and addiction are not mutually exclusive.
Additionally, many prominent physicians have noticed a gradual decline in function and pain relief in patients on opioid therapy and have come to the conclusion that opioids are not generally effective for long-term use in treating chronic non-cancer pain. Which is not to say that long-term use of opioids is not helpful to some patients; only that doctors are increasingly concerned that opioids pose high risks and uncertain outcomes when used long-term.
What would the PROP labeling changes do?
PROP’s proposal would make it illegal for drug companies to promote opioids for uses other than those listed on the label. For non-cancer pain, this would mean drug companies cannot promote the use of a drug for moderate pain, for a maximum daily dose equivalent to 100 mg of morphine, or for longer than 90 days of continuous use. Any other use of a drug would be considered “off-label.”
The PROP labeling changes would also promote awareness of the lack of scientific evidence to support the long-term use of opioids for managing pain. Doctors and their patients should be aware of the risks of chronic opioid therapy as well as the benefits. After all, these are very dangerous narcotics that are chemically almost identical to heroin.
What would the PROP labeling changes not do?
The PROP labeling changes would NOT restrict the ability of a prescriber to prescribe a drug for off-label uses. Off-label prescribing is actually a legal and common practice in the United States. Thus, if a pain patient is currently on a prescription for an opioid for long-term use or a dose equivalent of greater than 100 mg of morphine, the PROP labeling changes would not in any way restrict a doctor from continuing with chronic opioid therapy for that patient. If a doctor wishes to initiate opioid therapy for a new patient, that would also not be restricted by the PROP proposal.
Much of the misunderstanding of the PROP proposal stems from a misperception that the restrictions in the proposal are directed at prescribers, whereas they are actually directed at the drug companies.
What scientific evidence is there to support the proposed labeling changes?
The proposed labeling changes are based on the limits of the available data from clinical trials of opioid use in treating chronic pain. For example, a maximum duration of 90 days of continuous use is based on an average trial duration of 12 weeks. Effectiveness, functional improvement, and safety for a longer duration have not been adequately studied. Similarly, a dosage of 100 mg morphine equivalent is based on the much lower doses that are typically used in clinical trials. Recent observational studies indicate that doses above the 100 mg morphine equivalent level result in a marked increase in overdose risk.
How will the PROP labeling changes affect prescribing of opioids for CNCP?
The PROP labeling proposal comes at a time when there is a great deal of interest in better educating prescribers about the use of opioids in treating pain. The collective result of these initiatives should lead to much greater caution in prescribing for moderate pain indications, something that the vast majority of medical experts agree would be a good thing.
The PROP proposal will not place any restrictions on the ability of doctors to prescribe opioids for their patients. Patients on chronic opioid therapy who suffer from intractable chronic pain will not be “cut off” from opioid treatment.
We recognize that opioid medications will continue to be a necessary element in the treatment of chronic pain. But even the medical professionals opposed to the PROP proposal acknowledge that they have “serious concerns about the safety of chronic opioid use.”
The PROP labeling changes, combined with prescriber education, will provide much needed balance in our opioid marketing and prescribing policies, which are seriously flawed in promoting the use of opioids for all types and degrees of pain.
You can submit a comment to the PROP petition on the FDA’s website.
Ballantyne JC, Shin NS. Efficacy of opioids for chronic pain: a review of the evidence. Clin J Pain 2008; 24:469-78.
Boscarino JA, Rukstalis MR, Hoffman SN, Han JJ, Erlich PM, Ross S, Gerhard GS, Stewart WF. Prevalence of prescription opioid-use disorder among chronic pain patients: comparison of the DSM-5 vs. DSM-4 diagnostic criteria. Journal of Addictive Diseases 2011; 30: 185-194.
Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine Clinical Practice Guideline. The Journal of Pain, Vol 10 No 2 (February) 2009: pp. 147-159
Dhalla IA, Mamdani MM, Sivilotti MLA, Kopp A, Qureshi O, Juurlink DN. Prescribing of opioid analgesics and related mortality before and after the introduction of long-acting oxycodone. CMAJ 2009; 181(12): 891-896.
Centers for Disease Control. Vital Signs: Overdoses of Prescription Opioid Pain Relievers—United States, 1999-2008. MMWR 2011; 60: 1-6 http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6043a4.htm
Centers for Disease Control. Policy impact: prescription painkiller overdoses. 2012. http://www.cdc.gov/homeandrecreationalsafety/rxbrief/
Food and Drug Administration. FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics. http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM311290.pdf July 1, 2012.
Kalso E, Edwards JE, Moore RA, McQuay HJ. Opioids in chronic non-cancer pain: systematic review of efficacy and safety. Pain2004;112:372-80.
Martell BA, O’Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, et al. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med2007; 146:116-27.
Papaleontiou M, Henderson CR, Turner BJ, Moore AA, Olkhovskaya Y, Amanfo L, Reid MC. Outcomes associated with opioid use in the treatment of chronic non-cancer pain in older adults: A systematic review and meta-analysis. JAGS 2010; 58:1353-1369.
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