Dr. Henry Paul, MD

Psychiatrist, Author and Educator

BLACK BOX WARNING ON PAINKILLERS

March 25th, 2016

“They’re the most powerful painkillers ever invented, and their creating the worst addiction crisis America has ever seen.” TIME Magazine Cover June 2015

6422127_sThe US Food and Drug Administration this week announced that painkillers, such as OxyContin and Fentanyl, will now have to carry a “black box” warning stating the dangers of abuse, addiction, overdose and death.

It is called a black box warning because that is how it appears – in a black box. According to the FDA website, “it appears on a prescription drug’s label and is designed to call attention to serious or life-threatening risks.”

The FDA hopes that this warning will help to slow a growing epidemic in this country of opioid addiction that is leading to heroin addiction, overdose and death. In 2015, TIME magazine reported in their cover story that “9.4 million Americans take opioids for long-term pain and 2.1 million are estimated by the NIH (National Institutes of Health) to be hooked.”

The article went on to say that the crisis is a “tragic combination of good intentions, criminal deception and feckless oversight to turn America’s desire to relieve its pain into such widespread suffering.”

Here’s what the FDA told CNN about how this warning will work. “When a patient gets his or her prescription filled, the bottle should have a notification indicating there is a black-box warning for the drug. The consumer would need to go to the manufacturer’s website for details. In addition, pharmacists are encouraged to provide patients with a medication guide — consumer-friendly language explaining the risks of the drug. Under this new effort from the FDA, all instant-release drugs will need to have such a guide. It is up to the pharmacist to dispense this information, something the FDA encourages.”

The FDA ruling is a long-overdue step toward fighting America’s drug epidemic. I’m not sure it is realistic to assume that consumers will go to the manufacturers website for details, but I do think that pharmacists taking the time to go over the risks of painkillers will help. I have to agree with Senator Markey in what he told CNN, “It’s too little, too late.” We have a long way to go to turn this epidemic around and educating the public and doctors is key.

LINKS
Time Magazine Releases Cover Story on Pain Killers
Physicians for Responsible Opioid Prescribing
FDA now requires ‘black box’ warning on painkillers

DISCLAIMER
Information contained in this blog is intended for educational purposes only. It is not intended as medical or psychiatric advice for individual conditions or treatment and does not substitute for a medical or psychiatric examination. A psychiatrist must make a determination about any treatment or prescription.

STOP THE DELAY! RELEASE NEW PAINKILLER PRESCRIPTION GUIDELINES

January 1st, 2016

“In 2013, health care providers wrote 207 million prescriptions for opioid painkillers, almost quadruple the number written in 1999.” Senator Joe Manchin, Beckley (WV)Register-Herald

Yesterday in my blog I talked about the need for the Affordable Care Act, also known as Obamacare, to include medication-assisted drugs to help those in treatment for opioid addiction. There is a movement afoot to make this happen, and I support it. Today, I want to talk about the letter that Senator Joe Manchin (D-WV) sent this month to HHS Secretary Sylvia Burwell urging her to support the release of the CDC’s guidelines for prescribing opioids.

24026286_sAccording to Manchin, this report has been delayed due to pressure from outside groups and objections from the Food and Drug Administration (FDA). Manchin told the Beckley (WV) Register-Herald, “At a recent meeting, the FDA’s Director of the Division of Anesthesia, Analgesia and Addiction Products, Sharon Hertz, was one of the strongest voices against the guidelines,” Manchin wrote, adding, “While the President of the United States, the Department of Health and Human Services, and every other agency of the federal government has been actively working to save lives and stop this epidemic, the FDA is working against these efforts and further endangering the public.”

Opioids are prescribed for pain management, but they are dangerous. Opioid addiction is a medical condition characterized by the overuse and abuse of opioids (i.e. morphine, heroin, codeine, oxycodone, hydrocodone, etc.). When abused, all of these classes of drugs directly or indirectly cause a pleasurable increase of dopamine in the brain’s reward pathway. Addiction happens when a person seeks to experience repeatedly that rewarding or “high” feeling.

34841088_sThe over-prescribing of opioids is the main problem. Many of these drugs are given for longer than 30 days – the time it takes to become addicted. Also, these drugs are often prescribed to teenagers recovering from sports injuries. Painkillers are the beginning of the addiction that leads to heroin. Why? Because heroin is cheaper. According to the CDC, in 2013, 207 million prescriptions were written for prescription opioid pain medications. Those are a lot of prescriptions. With the misleading information presented early on to doctors, there has been a lot of confusion and second-guessing about the use of these drugs and the potential risks.

I join Senator Manchin in urging Burwell “to stand behind the CDC in pushing for the strongest possible set of recommendations to help end prescription opioid abuse and overdose deaths.” It’s true that the horse is already out of the gate and that the epidemic is in full swing, but we can turn this around, and we have to start somewhere. These new guidelines regulating opioid prescribing, along with the medication-assisted drugs are good first steps.

LINKS
The Neurobiology of Opioid Dependence: Implications for Treatment
DrugFacts: Prescription and Over-the-Counter Medications
Manchin decries delay of CDC guidelines for prescribing opioids
The Monster of Accidental Opioid Addiction

DISCLAIMER
Information contained in this blog is intended for educational purposes only. It is not intended as medical or psychiatric advice for individual conditions or treatment and does not substitute for a medical or psychiatric examination. A psychiatrist must make a determination about any treatment or prescription. Dr. Paul does not assume any responsibility or risk for the use of any information contained within this blog.