By Roger Chriss, Columnist
As the overdose crisis worsens, new strategies and policies are being considered, including a recent petition to remove so-called high-dose opioids from the market.
The petition asks the FDA to ban opioid pills that, when taken as directed, would add up to a daily dose equivalent to more than 90mg of morphine. It is signed by leaders of several anti-opioid activist groups, including Physicians for Responsible Opioid Prescribing (PROP).
"The existence of these products implies that they're safe. They're not,” says Andrew Kolodny, MD, Executive Director and founder of PROP. "These are not medicines. These are lethal weapons that should be removed from the market.”
Before we start removing access to pain medication, it’s incumbent upon us to analyze the question of prescription opioid doses and what role, if any, they have in the overdose crisis.
First, higher doses of opioids are more dangerous. That is obvious, since most substances become dangerous at a sufficiently high dose, or as the Swiss physician Paracelsus supposedly said, “The dose makes the poison.” It is reasonable to conclude that higher doses of an opioid would be riskier.
But there is no inherent implication about safety in the existence of any substance. There is nothing "safe" about chemotherapy drugs, anti-seizure medication or anti-anxiety drugs, just as there is nothing safe about tobacco or alcohol.
Moreover, the opposite of safe is not necessarily dangerous, since something that is "dangerous" can still be clinically beneficial. Open heart surgery is dangerous, but beneficial to someone dying from heart disease.
Conspicuously absent from the signatories of the PROP petition are any physician groups or doctors involved in pain management. Asked to comment on the petition, the President of the Society of Palliative Care Pharmacists told Pharmacy Times that while she agreed that opioid abuse is an urgent concern, she dose not believe that removing high-dose opioids from the market would be the best way to combat the overdose crisis.
“Let’s put our efforts together in an interdisciplinary approach and train providers to accurately assess their patients rather than pulling certain drugs from the market, because there may be cancer patients or others who are truly benefiting from these high-dose opioids,” said Rabia Atayee, PharmD.
The petition argues that people who currently take high-dose opioid medication can simply take two or more lower-dose pills. This would supposedly reduce the risk of overdose when high-dose pills are stolen or diverted.
“Removing UHDU (ultra-high dosage unit) orally-administered opioids from the market will result in patients having to swallow more tablets or capsules. But this is unlikely to result in a significant inconvenience or hardship for patients,” the petition states.
In other words, there would be a trade off. The risk of an overdose would be lower for a person who gets an opioid analgesic from a friend to deal with severe pain. But a person with a disorder like achalasia that impairs swallowing or a GI disorder that impairs absorption may be harmed by having to take more pills.
The strength of the arguments is only one factor here. The unintended consequences of this petition should also be considered. One obvious effect would be an increase in the total number of pills, which would exacerbate concerns about over-prescribing. There would be more pills to steal or divert, and more potential problems in securing the opioid supply chain from manufacturer to pharmacy, a major source of diverted pills that often goes unremarked and unpunished.
Another likely effect is increased activity on the black market. In 2010, when Purdue Pharma brought out its abuse deterring form of OxyContin, some abusers started switching to illegal drugs, including heroin. An uncomfortable outcome of this well-intentioned change is that a public health policy meant to prevent abuse and addiction may have made the overdose crisis worse.
A similar outcome could result from this petition: Drug abusers who are intent on having a high-dose opioid pill may shift to street drugs.
Another possible outcome is that opioid doses keep getting smaller and smaller. If a daily dose of pills containing 90mg of a morphine equivalent (MME) is considered “dangerous,” then what about 80 MME? Or 70 MME? If the changes recommended in this petition do not work, will we try more restrictions in doses and prescribing? Clear measures of the success or failure of the proposal should be defined in a petition like this one, but they are not.
We already have vast quantities of data about the opioid crisis. According to the CDC, opioid prescribing peaked in 2010 and has been in decline ever since, yet overdose rates keep rising.
The average daily dose of opioids started falling even earlier, in 2006. By 2015, it had declined to nearly 48 MME -- well below the dose sought in the petition.
AVERAGE DAILY PER CAPITA MORPHINE EQUIVALENT DOSE (MME)
In other words, reducing the amount and dose of prescription opioids is inversely correlated with the number of overdoses. Of course, correlation is not causation, but the negative correlation does not bode well for the effects of this petition. Based on this data, the best we can reasonably hope for is small benefits on the margins of the overdose crisis, at the expense of people who benefit from high-dose prescription opioids.
And this petition will do nothing to improve treatment for people suffering from opioid use disorder or to reduce the risks of people overdosing on heroin or illicit fentanyl. These are key features of the opioid crisis, and a policy that claims to beat addiction without addressing them should be greeted with skepticism.
Instead of new restrictions, perhaps the CDC and state guidelines can be updated to include recommendations that physicians and pharmacists discuss with patients the safe storage and disposal of opioid medications.
Before we ban a medication for having too much of a chemically active ingredient for people who abuse it, we should do whatever we can to ensure that the people who benefit from it are not harmed.
To make a comment on the PROP petition to the FDA, click here.
Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.
Roger is a technical consultant in Washington state, where he specializes in mathematics and research.
The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.