To support the president’s plan, FDA is requiring a Risk Evaluation and Mitigation Strategy (REMS) for all extended-release and long-acting opioid medications. This program will require manufacturers of these products to provide educational programs to doctors who prescribe them. Firms also will have to provide materials to help prescribers advise patients about the risks and benefits of opioid use. FDA will review the educational materials that companies develop, and confirm that they are not promotional.

“This is the most far-reaching REMS program that FDA has instituted,” said Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research, in a press conference. “The action affects 16 companies, including branded and generic products,” she added.

The main goals of the agency’s new REMS plan are to teach doctors about proper pain management and patient selection, and to teach patients how to use opioid medications safely. As part of the plan, FDA is asking drugmakers to give patients educational materials, including a medication guide that uses consumer-friendly language to explain safe drug use and disposal. The agency is encouraging pharmaceutical manufacturers to collaboratively develop a single system for implementing the REMS strategies. FDA is notifying opioid makers that they must propose a REMS plan within 120 days.

“Long-acting and extended-release opioid drugs have benefit when used properly and are a necessary component of pain management for certain patients, but we know that they pose serious risks when used improperly, with serious negative consequences for individuals, families, and communities,” said FDA Commissioner Margaret A. Hamburg, in a White House press release. “The prescriber-education component of this opioid REMS balances the need for continued access to these medications with stronger measures to reduce their risks.”

The REMS plan does not make doctor training mandatory, but federal agencies are asking Congress to link mandatory physician training to the Drug Enforcement Administration registration number that doctors need to prescribe controlled substances. FDA also will require the risk-management plan to include a method to evaluate whether the education programs are helping to reduce problems associated with long-acting and extended-release opioids.

In addition, sponsors will have to determine whether the REMS adversely affects patient access to opioids. FDA will monitor the situation closely to make sure that access to the medications is not compromised and that the REMS does not unduly burden the healthcare system, said Woodcock.

Drug firms’ risk-reduction measures are expected to become effective in early 2012. The measures will be required for hydromorphone, oxycodone, morphine, oxymorphone, methadone, transdermal fentanyl, and transdermal buprenorphine.

FDA gained the authority to require manufacturers to develop and implement REMS with passage of the FDA Amendments Act of 2007. REMS are intended to ensure that a drug or biological product’s benefits outweigh its risks.

Opioids (e.g., morphine and oxycodone) are synthetic versions of opium used to treat moderate and severe pain. Extended-release and long-acting opioids are extensively misprescribed, misused, and abused, according to an FDA press release. These practices cause overdoses, addiction, and deaths.

By Erik Greb from EPT–THE ELECTRONIC NEWSLETTER OF PHARMACEUTICAL TECHNOLOGY

This program provides Utah households the opportunity to get rid of unused or unwanted over-the-counter and prescription drugs for safe disposal. Click here to find a collection site near you or see here for a list of Permanent Community Collection Sites.

Drug-related deaths now kill more people in Utah than auto accidents do.

This trend shift shows driving is becoming safer, and the abuse of powerful prescription painkillers is rising, according to the Associated Press.

“It’s not uncommon to see at least one overdose death per week in Utah Valley,” said Lt. Phil Murphy, director of the Utah County Division of Substance Abuse.

In 2008, 276 people died because of auto accidents on Utah public roads.

“That’s actually the lowest number of auto accident deaths that we’ve had in Utah since 1992,” said Gary Mower, research analyst for the Utah Department of Health.

In 2007, there were 467 drug-related deaths, with 317 attributed to prescription or over-the-counter legal drugs, according to a report by the Utah Department of Health.

“The alarming trend is that we’re seeing a lot of people getting hooked on opiate pain killers like Oxycontin, Oxycodone and Hydrocodone, along with heroin, causing accidental deaths,” Murphy said.

Prescription overdose rates have more than quadrupled over the past 10 years.

“The two main things that are contributing to prescription drug abuse are the lack of education about the consequences of prescription misuse by medical professionals and the fact that pills are very available in medicine cabinets across the county,” said Kye Nordfelt, research analyst for the Utah County Division of Substance Abuse.

The average age of those dying from prescription overdose deaths is between 39 and 41. according to useonlyasdirected.org.

“Drug abuse can occur with people in the community that you would least expect,” Murphy said. “For an ultra conservative state and county, you wouldn’t think that drug abuse would be a problem.”

He said addiction to pills usually begins with a medical pretense or legitimate pain issue. As people become more addicted, they often make the switch to using heroin because of its significant price difference.

“The important thing to consider is what impact that six percent of drug abusers has on the community,” said Nordfelt. “Not only to consider the death rates, but the economic and work losses as well as problems in the home that result from abuse.”

by Erika Potter for The Daily Universe

When addiction exists, if a person tries to go off the medication, withdrawal symptoms of a wide range of intensity create great discomfort. He or she may then resume medication, seeking relief, and find all the discomfort temporarily eliminated. Then he/she concludes the drug is good for him/her, and very much needed. Some withdrawal symptoms can be dangerous and need medical supervision. Some symptoms may not start for several days after medication is discontinued, they may not seem directly connected if a woman does not have a person educated in drug withdrawal to advise her.

Jan suggests that if you have any suspicion at all that you may have a problem, call one of the excellent facilities available for help, tell them what you are taking and how much and ask if they would advise a consultation. Many drug dependency programs give free consultations to help you determine the extent of your problem and whether treatment is needed.

You may not be concerned for yourself but may notice symptoms in a relative or friend who may need your involvement in order to get the help they need.

The link to Mary and Jan’s stories can be found here.

Utah’s other drug problem — prescription drug abuse — has caught the attention of state lawmakers who are nationally known for their crackdown on street drugs and drunken driving but run a state regularly deemed the country’s prescription drug abuse capital.

“This is a No. 1 ranking we don’t want, we’ve got a problem in this state and we need to address it,” state Attorney General Mark Shurtleff told a group of physicians and care center providers recently.

It is well-known to Shurtleff, to public and private health care providers, pharmacists, drug treatment counselors and police officers who encounter firsthand what they say is a growing problem that has taken a back seat to other state-sanctioned prevention efforts such as stiffening criminal penalties for drunken driving and cracking down on street drugs, particularly methamphetamine.

Lawmakers have wanted to get a handle on prescription drug abuse long before now. Rep. Brad Daw, R-Orem, has been raising the topic since he was elected in 2004. He has introduced four bills so far for the upcoming legislative session. Rep. Trisha Beck, D-Sandy, is also preparing legislation aimed at clarifying language in the state’s four main prescription medication laws.

Recent prescription overdose deaths and a spate of pharmacy holdups in which robbers took painkillers but left the cash are signs of how powerful addiction is and are clear indication that lawmakers can no longer ignore a public safety problem that is not about to go away, the legislators said.

Physicians and law enforcement officers say they’re on board.

Daryl Bingham, a Lindon police officer who has become known for his capacity to detect someone driving under the influence, said many people using prescription drugs don’t know they can be as impaired on doctor-prescribed medication as someone using alcohol.

An older driver who Bingham found passed out in her car became incensed when he suggested that she might have a pill problem and that she might want to talk to her doctor about it. The state Division of Occupational and Professional Licensing database showed that in the past year three different doctors had prescribed 15,000 pills for various medical conditions.

“She had no alcohol or illegal substances on board, but she angrily said that (the pills) came from her doctor, they’re safe and therefore it’s all right,” Bingham said, adding that people need to keep in mind that substances — controlled or illegal — can put someone under the influence without them knowing it.

“Driving under the influence of prescription drugs is still driving under the influence,” he said.

Daw’s legislation focuses on the state’s licensing database. Under one bill, if a person is admitted to an emergency room for an overdose, the hospital will be obligated to report to DOPL the person’s name and inform the doctor or caregiver that one of their patients has overdosed.

Rep. Eric Hutchings, R-Kearns, supports the idea in general but is wary of its implications of criminal behavior and the likelihood that the person involved likely has no intention to commit a crime or even knowledge one is being committed.

Huthchings said two people at his work are facing that issue right now. One not only had no idea she was under the influence while in her car, “she didn’t even know she was driving and didn’t realize that until she woke up in her car on top of a fire hydrant. She was in a complete stupor.”

She was using a popular sleeping pill, Hutchings said. “I don’t know how in the world we prescribe this stuff then not make sure they’re handcuffed to their bed,” he said.

Dr. Don Fairbanks, an urgent-care physician and BYU professor, said he endorses the legislation because it amounts to a wake-up call to average medical care providers “who are sitting behind a prescription pad not realizing they are contributing to someone’s substance use or abuse problem.”

Reporting incidents to DOPL isn’t about catching people or doctors, and the proposal specifically states the purpose is not to add liability on care providers, Daw said, noting it wouldn’t change current restrictions on access to the database.

* Schedule I and II drugs have a high potential for abuse. They require greater storage security and have a quota on manufacturing, among other restrictions. Schedule I drugs are available for research only and have no approved medical use; Schedule II drugs are available only by prescription (unrefillable) and require a form for ordering. Schedule III and IV drugs are available by prescription, may have five refills in 6 months, and may be ordered orally. Most Schedule V drugs are available over the counter.

** Taking drugs by injection can increase the risk of infection through needle contamination with staphylococci, HIV, hepatitis, and other organisms.

*** Associated with sexual assaults.

⁺ Not available by prescription in U.S.



Recent news stories have highlighted the increasing number of teens and adults abusing prescription drugs, particularly painkillers.

For example, the National Institute on Drug Abuse‘s 2003 Monitoring the Future survey of 8th, 10th, and 12th graders found that 10.5 percent of 12th graders reported using Vicodin for non-medical reasons and 4.5 percent of 12th graders reported using OxyContin without a prescription.

Painkillers such as Vicodin and OxyContin are opiates and are very powerful medications against pain, but they need to be taken under close supervision of a doctor. These same medications when taken inappropriately can cause addiction for they act on the same places in the brain as does heroin.

These painkillers can be very effective in treating individuals with the medical need for these medications; however, using these drugs without the supervision of a physician or for purposes different from their intended use can lead to serious adverse consequences, including death from overdose.

As a physician, I want to raise awareness among other doctors about the potential for abuse of these drugs; however, I don’t want to alarm them and their patients who have a legitimate medical need for painkillers and other prescription drugs.

I also want to remind young people, their parents and others that even though prescription drugs are medications, their improper use can have serious consequences. I’d encourage parents, grandparents, and other adults to check their medicine cabinets and to discard any prescription drugs that are no longer required to treat a medical condition so that these medications are not available to be misused.

Sincerely,

Nora D. Volkow, M.D.
Director

Like tranquilizers, sedative use had shown a decade-long rise among high school seniors before leveling at 9.5% in 2002 and 8.8 percent in 2003.

Only 12th grade data are reported for abuse of narcotics other than heroin in the MTF. The annual prevalence of this class of drugs had risen considerably from 3.3% in 1992 to 7% in 2000 and 6.7% in 2001. In 2002, the survey item was changed to incorporate two new specific pain relievers, OxyContin (a controlled-release form of oxycodone that can cause severe health consequences if crushed and ingested) and Vicodin (hydrocodone), and separate items asking about use of these drugs also were introduced. Following the change in the other narcotics item, past year use was reported by 9.4% of seniors in 2002 and 9.3% in 2003.

Although not significantly higher than in 2002, annual OxyContin use was reported in 2003 by 4.5% of 12th-graders, 3.6% of 10th-graders, and 1.7% of 8th-graders. The annual prevalence rate for Vicodin was considerably higher than for OxyContin, at 10.5% in 12th-graders, 7.2% in 10th-graders, and 2.8% in 8th-graders in 2003. Considering the addictive potential of oxycodone and hydrocodone, these are disturbingly high rates of use—contrasting with an annual prevalence of less than 1% in all three grades for heroin, for instance.

The latest data are online at www.drugabuse.gov.

Patients, healthcare professionals, and pharmacists all have roles in preventing misuse and addiction to prescription medications. For example, when a doctor prescribes a pain relief medication, CNS depressant, or stimulant, the patient should follow the directions for use carefully, learn what effects the medication could have, and determine any potential interactions with other medications. The patient should read all information provided by the pharmacist. Physicians and other healthcare providers should screen for any type of substance abuse during routine history-taking, with questions about which prescriptions and over-the-counter medicines the patient is taking and why. Over time, providers should note any rapid increases in the amount of a medication needed-which may indicate the development of tolerance-or frequent requests for refills before the quantity prescribed should have been used.

Commonly Abused Prescription Drugs

While many prescription drugs can be abused or misused, these three classes are most commonly abused (click on each class of drug to learn more):

• Opioids – often prescribed to treat pain.
• CNS Depressants – used to treat anxiety and sleep disorders.
• Stimulants – prescribed to treat narcolepsy and attention deficit/hyperactivity disorder.

*This text came from NIDA (National Institute on Drug Abuse)