New draft guidelines by the Centers for Disease Control and Prevention (CDC) would – if adopted — sharply reduce the prescribing of opioids for both chronic and acute pain in the U.S. The proposed guidelines may also trigger a turf battle between the CDC and the Food and Drug Administration over which agency has primary responsibility for the safe prescribing of medication.
In an unusual online “webinar” held by the CDC, the agency today unveiled a dozen draft guidelines for physicians to follow when prescribing opioids. The first recommends “non-pharmacological therapy” as the “preferred” treatment for chronic non-cancer pain, and states that opioids should only be prescribed if the benefits of reducing pain outweigh the risk of addiction and overdose.
Other guidelines recommend urine drug testing of patients both before and during opioid use, and that smaller doses and quantities be prescribed. Only “three or fewer days” supply of opioids is recommended for most types of acute pain. The guidelines also recommend that benzodiazepines not be prescribed concurrently with opioids.
Pain patients listening to the webinar expressed alarm over some of the recommendations.
“I would caution the CDC that putting these dosage limits in here would cause problems for patients,” said Marjorie. “These recommendations have severe ramifications.”
“I have been on and off opiates for a few years. I do not have cravings for opiates. I am not addicted to opiates. I do think there has been a demonization of opiates among the medical community, as well as the CDC possibly and definitely the DEA,” said Chardonnay. “How do you decide which patients to continue, that really get benefits from this, and how do you decide which patients take them to get high?”
The CDC took comments about the guidelines during the webinar, but refused to answer any questions about them. The agency said it would finalize its guidelines in early November to submit to the Department of Health and Human Services, with the goal of publishing them in January, 2016.
The CDC’s guidelines were not publicly available before the webinar, there was little advance notice about it, and there were numerous technical problems for some people who tried to participate online. There were so many complaints about lack of access to the webinar, the CDC said it would hold a second one tomorrow.
While the CDC recorded the webinar, it is not making it available for people to watch or listen to afterwards. The draft guidelines, outlined below, will also not be available on the CDC’s website.
CDC Draft Guidelines for Opioid Prescribing
1. Non-pharmacological therapy and non-opioid pharmacological therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.
2. Before starting long term opioid therapy, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function that outweighs risks to patient safety.
3. Before starting and periodically during opioid therapy, providers should discuss with patients risks and realistic benefits of opioid therapy and patient and provider responsibilities for managing therapy.
4. When starting opioid therapy, providers should prescribe short-acting opioids instead of extended-release/long acting opioids.
5. When opioids are started, providers should prescribe the lowest possible effective dosage. Providers should implement additional precautions when increasing dosage to 50 or greater milligrams per day in morphine equivalents and should avoid increasing dosages to 90 or greater milligrams per day in morphine equivalents.
6. Long-term opioid use often begins with treatment of acute pain. When opioids are used for acute pain, providers should prescribe the lowest effective dose of short-acting opioids and should prescribe no greater quantity than needed for the expected duration of pain severe enough to require opioids. Three or fewer days will usually be sufficient for non-traumatic pain not related to major surgery.
7. Providers should evaluate patients within 1 to 4 weeks of starting long-term opioid therapy or of dose escalation to assess benefits and harms of continued opioid therapy. Providers should evaluate patients receiving long-term opioid therapy every 3 months or more frequently for benefits and harms of continued opioid therapy. If benefits do not outweigh harms of continued opioid therapy, providers should work with patients to reduce opioid dosage and to discontinue opioids when possible.
8. Before starting and periodically during continuation of opioid therapy, providers should evaluate risk factors for opioid-related harms. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid-related harms are present.
9. Providers should review the patient’s history of controlled substance prescriptions using state Prescription Drug Monitoring Program data to determine whether the patient is receiving excessive opioid dosages or dangerous combinations that put him/her at high risk for overdose. Providers should review Prescription Monitoring Program data when starting opioid therapy and periodically during long-term opioid therapy (ranging from every prescription to every 3 months).
10. Providers should use urine drug testing before starting opioids for chronic pain and consider urine drug testing at least annually for all patients on long-term opioid therapy to assess for prescribed medications as well as other controlled substances and illicit drugs.
11. Providers should avoid prescribing of opioid pain medication and benzodiazepines concurrently whenever possible.
12. Providers should offer or arrange evidence-based treatment (usually opioid agonist treatment in combination with behavioral therapies) for patients with opioid use disorder.
The CDC said the guidelines were developed after a series of meetings with a “core expert group” and “independent peer reviewers” that the agency did not identify by name.
CDC officials have long been critical of opioid prescribing practices and have repeatedly cited a study that claims over 16,000 Americans are killed annual by overdoses linked to pain medications.
“If the evidence of their guidelines are of the quality of their research on opioid overdoses, then we are in big trouble. They claim they will be using evidenced based material in forming these guidelines, however they have never shown any desire to correctly evaluate evidence for its strength and value,” said Janice Reynolds, a retired nurse and longtime activist in the pain community.
“I am sure their information came from addiction disease doctors who have an arrogance based model of practice and many don’t care about pain management. Much of their information comes from PROP.”
PROP (Physicians for Responsible Opioid Prescribing) is a controversial organization that has lobbied Congress and criticized the FDA for not doing more to limit access to opioids. A link to PROP literature recommending “cautious, evidence-based opioid prescribing” can be found — unedited — on the CDC’s website.
“The CDC knows nothing about pain management and possibly less about pharmacology, so why should anyone listen to them?” asked Reynolds. “Their complaints against opioids only increases the misery of people with pain and does little to prevent deaths as most people with an addiction to prescription medications obtain their meds not by legitimate prescriptions.”
According to the National Institutes of Health, only about 5% of patients taking opioids as directed for a year end up with an addiction problem.
The CDC does not normally get involved in setting guidelines for prescription drugs, a responsibility that falls on the FDA – which regulates drugs and determines which ones can be used to treat medical conditions. A spokesman for the FDA who handles opioid issues told Pain New Network he was unaware the CDC was drafting its own opioid guidelines