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Prescription drug abuse is on the rise in the general public and especially among teens. Alcohol and drug treatment facilities have watched this trend for some time, and now the US Food and Drug Administration is taking action. The article below is not only informative for AOD professionals, but also for anyone who is using opioids or knows someone who is.

Opioids like hydrocodone (Vicodin), oxycodone (Oxycontin), and methadone can bring much-needed pain relief to severe pain sufferers. But when the pain has subsided, proper practice is to return any unused medication to the pharmacy where it was obtained. The reason is to prevent a patient from using prescription drugs as they would any over-the-counter drugs. It will also ensure that medications stay out of the hands of those who would abuse them.

Opioid addiction, involving pain killers, harms the user physically and emotionally, and causes stress in relationships. When use becomes abuse and then addiction, it is important to begin the process of recovery with an opiate detox program. In many cases during aftercare treatment, acute pain sufferers can find alternatives to opiate medications for pain management.

FDA moves some opioids into risk evaluation program

Alcohol and Drug Abuse Weekly
March 16, 2009 – Volume 21, Number 11

Due to a rise in overdoses associated with prescription opioids, the Food and Drug Administration (FDA) has selected 16 of the medications for compliance with a new program called Risk Evaluation and Mitigation Strategy (REMS). Opioid manufacturers will now have to prove that their Risk Minimization Action Plans (RiskMAPs) are working. The FDA is seeking to balance the need for pain relief with the need to prevent overdoses.

The FDA alerted manufacturers of the 16 drugs by letter in February that their products would need a REMS, and on March 3 met with them in a closed meeting to discuss how the agency plans to proceed. There will be a public meeting on the subject later this spring.

The FDA can require a REMS under the Food and Drug Administration Amendments Act of 2007 (FDAAA) “to ensure that the benefits of a drug outweigh the risks,” according to the agency.

Opioid drugs are “a necessary component of pain management for certain patients,” the FDA said in announcing its plan to require REMS for certain opioids. Despite the RiskMAPs, “the rates of misuse and
abuse, and of accidental overdose of opioids, have risen over the past decade,” the FDA said.

Opioid manufacturers will now be asked to assess the effectiveness of their own RiskMAPs — probably
retroactively, said Kevin L. Zacharoff, M.D., director of medical affairs at Inflexxion, a technology
company with several efforts in the prescription drug area. The manufacturers will need to monitor and
assess risk, and then “retool their strategies,” he said.

Inflexxion, based in Newton, Mass., focuses on risk management assistance to opioid manufacturers, as well as tracking of prescription drug abuse for addiction treatment programs.

Abuse vs. misuse

There are risks involved in the risk evaluation process, because physicians may respond by under-prescribing, said Zacharoff. “In primary care, where most non-cancer pain is treated, this is definitely an
issue, because people don’t understand the difference between abuse and misuse.”

Abuse is “knowingly taking the medication for a reason other than that for what it was prescribed,” he
said. “Misuse is just misusing it.” For example, if a patient gets an opioid prescription for a toothache, and saves the pills in their medicine cabinet, and later takes one because they hurt their knee, that is misuse, he said. But if someone figures out that the pills also make them sleepy, and they start taking them in order to go to sleep, and then require more and more, that is abuse, he said.

Extended-release formulations of opioids were developed in order to minimize the incidence of breakthrough
pain, because they provide steady relief without the hills and valleys of short-term medications. There are now three kinds of opioids: intermediate or short-acting release, extended release, and abuse-deterrent. OxyContin is an example of an extended-release formulation — but by chewing the pill instead of swallowing it whole, people obtained short-acting effects.

Zacharoff also noted that there is a difference between tolerance and addiction. “If you’re in your late 40s, and you have rheumatoid arthritis, you’ll probably be on opioids for the rest of your life,” he said. “If you stop taking them, if you’ve been on them for at least three months, you’ll go into withdrawal.” But that doesn’t mean the person is addicted, he said. “That’s why people who are on chronic opioid therapy can operate heavymachinery — theirbodies are dependent.’

The patient with an addiction history — including current addiction — who has chronic pain “has the right to compassionate pain medication,” said Zacharoff. “But they have to understand what their responsibility is, and why the clinician is taking a certain approach to their pain management.” For example, the patient may need to come in more frequently for monitoring.

New guidelines

There are long-established guidelines for the use of opioids for patients with cancer pain. But for patients with non-cancer pain, there were no official guidelines until a document was published last month
in the Journal of Pain.

Most notable is the recommendation that physicians who prescribe methadone for pain be familiar with it. If they are “not familiar with methadone and its side effects,” they should refer the patient to a doctor who is, said Zacharoff. “If you don’t have a high comfort level with using methadone, it’s probably not a good drug to keep in your roulette wheel,” he said.

Drugs that may be required to have REMS:

• Fentanyl (Duragesic Extended Release Transdermal System)
• Fentanyl (Fentanyl Extended Release Transdermal System) (5 different manufacturers)
• Hydromorphine (Palladone Extended Release Capsules)
• Methadone (Methadose Tablets)
• Methadone (Methadone HCl Tablets) (2 different manufacturers)
• Methadone (Dolophine Tablets)
• Morphine (Avinza Extended Release Capsules)
• Morphine (Kadian Extended Release Capsules)
• Morphine (MS Contin Extended Release Tablets)
• Morphine (Oramorph Extended Release Tablets)
• Oxycodone (OxyContin Extended Release Tablets)
• Oxycodone (Oxycodone Extended Release Tablets) (3 different manufacturers)
Source: FDA

Tarzana Treatment Centers in Los Angeles makes a daily effort to find treatment news articles that we can share with our readers in the alcohol and drug treatment community. The article above was found in Alcoholism and Drug Abuse Weekly among others of equal informational and educational quality.