Allow me to point out problems I see with the Risk Evaluation and Mitigation Strategy (REMS) for extended release/long acting opioid analgesic drug products. I am in favor of mandatory training for all doctors who prescribe these substances.
I strongly believe the FDA supports weak, ineffective instruction that is biased in the interests of Big Pharma. I urge you to help change the present REMS strategy you will read below. At the end of this blog entry, I provide you with a petition to sign.
All information concerning the petition will be collected and sent to the office of the commissioner of the FDA. Please sign and get your friends to sign. It will take only a minute of your time. There is also a place on the petition to include your comments.
In italic blue print is the present FDA Required REMS Program. I have noted areas of concern with a red asterisk (*). Then, I address each asterisk and explain the reasons for my concern in black print.
- * FDA Required REMS Program for Serious Drug Risks
This program is not mandatory training for prescribers; instead, it is voluntary. REMS is just encouraging prescribers to cooperative. So, REMS is “required” merely in the sense of its own creation. The FDA “required” REMS to be conducted – their goal does not even due justice to their purpose. The projected goal of 60% voluntary compliance in three years is totally unacceptable in that death and serious injury due to prescribing opioids will continue at record levels during this time.
- Subject: Announcement of a Risk Evaluation and Mitigation Strategy (REMS) for all extended release/long acting opioid analgesic drug products due to their risks of misuse, abuse, addiction, and overdose.
Dear DEA‐Registered Prescriber:
Extended‐release and long‐acting (ER/LA) opioid analgesics are approved for the management of chronic * moderate-to-severe pain in the U.S., and * can be safe and effective in appropriately selected patients when used as directed. However, opioid analgesics are also associated with serious risks and are at the center of a major public health crisis of increased misuse, abuse, addiction, overdose, and death.
Several widely used instruments let patients rate pain on a scale of one to 10. The one-to-three range is described as mild, nagging pain that does not greatly interfere with a patient’s daily life. The four-to-six range is “moderate pain” that significantly interferes with a patient’s ability to perform activities of daily living such as working, cooking and doing chores. The seven-to-10 range is “severe pain” that is disabling and renders a patient unable to perform daily-life activities.
* First, the FDA should not approve these opioids for management of moderate pain. Evidence of long-term efficacy for chronic non-cancer pain (≥16 weeks) is limited and of low quality. For many patients with chronic pain, analgesic efficacy is not maintained over long time periods. These opioids can be dangerous. With daily opioid use, physical dependence and tolerance can develop in days or weeks.
Critics of REMS warn that there's no mention of the drugs' risk of addiction or dependence in the REMS patient counseling document although about 25% of patients on long-term opioid therapy exhibit DSM criteria for addiction, according to Joseph Boscarino, PhD, MPH, of the Geisinger Clinic in Danville, Pa., who has published several studies on rates of addiction and dependence among these patients.
"People who are exposed to daily opioids for years have a great deal of [difficulty] getting off these drugs," Mark Sullivan, MD, PhD, professor of psychiatry at the University of Washington in Seattle, told MedPage Today. "Few successfully get off them."
Sullivan also noted that while the document warns about the risks of drinking alcohol while taking opioids, it fails to mention the risk of concomitant sedatives -- noting that benzodiazepines like Valium are especially deadly in combination with opiates. Both increase the risk of respiratory depression.
The REMS medication guide, distributed by pharmacists, offers advice similar to that of the patient counseling document -- don't share your pills, flush the excess down the toilet, don't tamper with your tablets, and get emergency help if you take too much -- without mention of risks of addiction or concomitant use of sedatives.
In 2012, a group led by 37 physicians, the Physicians for Responsible Opioid Prescribing, petitioned the Food and Drug Administration to no longer approve the use of opioid analgesics in patients with moderate noncancer pain.
The petition asked the FDA to change the label for instant-release and extended-release opioids by:
- Striking the term “moderate” from the indication for noncancer pain.
- Limiting the maximum daily dose to the morphine equivalent of 100 mg for noncancer pain.
- Limiting daily use for noncancer pain to 90 days.
Dr. Lewis Nelson, an emergency physician and medical toxicologist at NYU Langone Medical Center, explained that “It’s time to close the loophole on opioid labels,” which he says amounts to “a mechanism that allows drug companies to promote opioids for unproven uses.” Physicians are wrong to assume that “on-label” indications are evidence-based with regard to safety and efficacy.
Yet, he FDA chose not to take action on the petition, change the labeling as requested or appoint an advisory committee to examine the matter. The agency did not even respond to a request for comment by this article’s deadline.
* Second, the claim of “safe and effective in appropriately selected patients” cannot stand scrutiny. Despite the fact that prescription opioid overdose is now the second leading cause of accidental death in the United States, killing more people than heroin and cocaine combined, doctor prescriptions for opioids flow freely across America.
Recently, researchers from the National Institute on Drug Abuse (NIDA), a component of the National Institutes of Health, found that more than half of patients who received an opioid prescription in 2009 had filled another opioid prescription within the previous 30 days. This finding was based on an extensive research sample which included 79.5 million prescriptions dispensed in the United States during 2009 (almost 40 percent of all the opioid prescriptions filled nationwide).
Most prescriptions for opioids come from primary care providers (doctors, dentists, etc.). Instead of adhering to safety, many of these medical professionals routinely over-prescribe these drugs. From 1991 to 2009, prescriptions for opioid analgesics increased almost threefold, to over 200 million. And, according to the Drug Abuse Warning Network system, which monitors drug-related emergency department visits and drug-related deaths, emergency room visits related to the nonmedical use of pharmaceutical opioids has doubled between 2005 and 2009.
The U.S. Food and Drug Administration (FDA) has determined that a Risk Evaluation and Mitigation Strategy (REMS) is necessary for ER/LA opioid analgesics to ensure that * the benefits continue to outweigh the risks of adverse outcomes (addiction, unintentional overdose, and death) resulting from inappropriate prescribing, abuse, and misuse. A REMS is a strategy to manage a known or potential serious risk associated with a drug product.
* The truth is that opioids are responsible for a national painkiller epidemic. Benefits of prescribing opioids do not outweigh the risks of adverse outcomes. The problem of prescription drug abuse has become so severe that drug overdose deaths attributed to opioid pain medicines such as Vicodin or Oxycontin exceed overdose deaths from heroin and cocaine combined.
The Center for Disease Control reports that in 2008, 36,450 people died from drug overdoses in the United States, and 20,044 of those were due to prescription drug overdose. Opioid pain relievers were involved in 14,800 of those 20,044 deaths.
Drug Czar Gil Kerlikowske, director of the Office of National Drug Control Policy, admitted the prescription painkiller epidemic is responsible for about 15,600 deaths in 2009, the latest year for which there are data.
In the interest of public health and to minimize the burden on the healthcare delivery system from having multiple unique REMS programs, * pharmaceutical companies subject to this REMS have joined together to implement this REMS for all ER/LA opioid analgesic drug products.
* Industry-sponsored medical education cannot be trusted. The very pharmaceutical companies that manufacture opioids are in charge of funding and administering REMS programs. Pharmaceutical companies are actually using REMS for a marketing tool to convince consumers of their utmost concern for public safety as they continue to push for higher profits and higher distribution. Lobby groups boast of their ability to “craft” legislation with the FDA. Along with the financial lobbies, the pharmaceutical and health products industries have historically been one of the biggest and most powerful lobbies in Washington. Drug companies enjoy more power and influence in America than with any other government in the world.
Please understand that the FDA does no testing on new pharmaceutical products itself, but relies on the reports produced from the testing carried out by the drug manufacturers. In too many cases the drug manufacturers ignore or down play possible side effects in these reports in order to get permission to put their drug on the market
According to one observant source:
“Trying to select the most dishonest and disreputable United States government agency would be a daunting task indeed. But the Food and Drug Administration would have to be considered a strong contender for that dubious distinction. Allegedly created to make sure the foods we eat and the drugs we take are safe, the FDA long ago abandoned its mission in order to more effectively promote the interests of agribusiness and the pharmaceutical companies. While some – but not all – of the scientists who work for the organization are honest, the bureaucrats who make the final decisions at the FDA are mostly concerned with protecting the profit margins of the industries they are allegedly regulating.
“But remember, this is a quid pro quo relationship we are talking about here, and in return for their cooperation the FDA requires the drug companies, along with the manufacturers of medical devices, to pay what are referred to as “user fees.” Ostensibly, these fees are paid to cover the costs of the testing and review process that the FDA must undertake before allowing any new drug to enter the marketplace, but critics charge these payments are little more than a form of legalized bribery that all but guarantees a favorable response every time a pharmaceutical company submits a new product for review. Given how frequently pharmaceuticals granted FDA approval end up being recalled because of the high number of deaths and permanent injuries they cause, this view would appear to have some basis in fact.”
Neither should individuals with financial ties to the drug industry be approving drugs for public use nor should they be conducting REMS training. It should be important to all of us that the FDA find honest, independent scientists and researchers who work for the public, not the pharmaceutical industry.
RISK EVALUATION AND MITIGATION STRATEGY (REMS)
A Risk Evaluation and Mitigation Strategy (REMS) is a strategy to manage known or potential serious risks associated with a drug product and is required by the Food and Drug Administration (FDA) to ensure that the benefits of a drug outweigh its risks.
The FDA has required a REMS for extended-release and long-acting (ER/LA) opioid analgesics.
Under the conditions specified in this REMS, prescribers of ER/LA opioid analgesics are strongly encouraged to do all of the following:
* Train (Educate Yourself) - Complete a REMS-compliant education program offered by an accredited provider of continuing education (CE) for your discipline.
* Counsel Your Patients - Discuss the safe use, serious risks, storage, and disposal of ER/LA opioid analgesics with patients and/or their caregivers every time you prescribe these medicines.
* Emphasize Patient and Caregiver Understanding of the Medication Guide - Stress to patients and their caregivers the importance of reading the Medication Guide that they will receive from their pharmacist every time an ER/LA opioid is dispensed to them.
* Consider Using Other Tools - In addition to the PCD, there are other publicly available tools to improve patient, household and community safety, as well as compliance with conditions of treatment, including Patient-Prescriber Agreement (PPA) and risk assessment instruments.
* What do you believe the likelihood of prescribers of ER/LA opioid analgesics doing these things voluntarily would be? How often have you had these experiences with your doctors concerning prescriptions? Just take a minute to consider your past experiences.
- Your doctors take time in their busy schedules to educate themselves through intensive voluntary training
- Your doctors counsel you about the use, risks, storage, and disposal of the drugs “every time” they prescribe your medication
- Your doctors “emphasize” the importance of reading the medication guides for the medicines they prescribe
- Your doctors advise you about other “tools” of safety, compliance, and risk
The FDA has developed core messages to be communicated to prescribers in the FDA Blueprint for Prescriber Education for Extended-Release and Long-Acting Opioid Analgesics ("FDA Blueprint"), which will be used by Continuing Education (CE) providers to develop the REMS-compliant training programs.
These core messages include:
* Understand how to assess patients for treatment with ER/LA opioid analgesics.
* Be familiar with how to initiate therapy, modify dose, and discontinue use of ER/LA opioid analgesics.
* Be knowledgeable about how to manage ongoing therapy with ER/LA opioid analgesics.
* Know how to counsel patients and caregivers about the safe use of ER/LA opioid analgesics, including proper storage and disposal.* Be familiar with general and product-specific drug information concerning ER/LA opioid analgesics.
"These educational programs are likely going to do more harm than good," Kolodny said. "Nowhere does it say that prescribers should tell patients these drugs are addictive. And these programs give the implied message that there's evidence for using opioids in long-term, noncancer chronic pain."
What top dogs supported mandatory training? The panel of experts including Dr. Margaret A. Hamburg, the F.D.A. commissioner, and R. Gil Kerlikowske, President Obama’s top drug policy adviser, said that mandatory training was essential
- To reduce the abuse of strong painkillers, or opioids, and
- To make sure that pain patients were treated appropriately with them.
Go figure. I am outraged by the present FDA Required REMS Program for Serious Drug Risks. Please, I beg you. Go to the following site and sign the petition to change this program. It is a duty of our citizenship and a commitment to better health for generations to come.
PLEASE SIGN THE PETITION ON CHANGE.ORG. Click here to sign and feel free to include your comments. Thank you so much.
CLICK HERE TO SIGN: