Limits Urged On Painkillers By FDA Advisory Panel

Editor's Choice
Main Category: Pain / Anesthetics
Also Included In: Alcohol / Addiction / Illegal Drugs;  Regulatory Affairs / Drug Approvals
Article Date: 28 Jan 2013 - 11:00 PST


New restrictions should be applied to widely used narcotic painkillers, because of an alarming increase in addiction and overdose deaths, an FDA Drug Safety and Risk Management Advisory Committee (The Panel) recommended.

The Drug Safety Advisory Panel voted 19 to 10, recommending that drugs containing hydrocodone should be reclassified as Schedule II controlled substances, together with other narcotic painkillers, including oxycodone.

Products containing hydrocodone are currently in Schedule III. The painkiller Vicodin contains hydrocodone.

Tens of millions of people in the USA receive prescriptions for painkillers containing hydrocodone. If the Panel's recommendation becomes law, doctors' prescribing patterns will change considerably, experts say. Hydrocodone-containing drugs will be subject to more rigorous storage and handling rules.

Even though the FDA does not have to go along with what the Panel members recommended, it nearly always does. In this case, with a 19 to 10 majority in favor of limits, it is highly unlikely that the Agency will go against it.

U.S. Senator Joe Manchin Thanks the FDA Panel

U.S. Senator Joe Manchin (D-W.Va.), a proponent of changing the scheduling for hydrocodone-containing drugs, announced that he is grateful for the FDA Drug Safety and Risk Management Advisory Committee's vote to reschedule such medications. The Panel listened to his testimony at a public meeting last Thursday.

Senator Manchin said that the recommendation will help guide the regulatory Agency in its final decision to reschedule the addictive drug.

Senator Manchin said:

"Today was a huge step forward in fighting to help curb the prescription drug abuse epidemic that has ravaged our state and our country. Rescheduling hydrocodone from a Schedule III to a Schedule II drug will help prevent these highly addictive drugs from getting into the wrong hands. I want to sincerely thank the committee for listening to West Virginians' heart-wrenching stories that I shared today.

Every city, town and home I've visited across West Virginia is affected by this critical problem in some way, shape and form. It seems that any 18 to 25 year old can go to any doctor, claim they have chronic pain, and get a recurring prescription for 120+ of these pills per month. The high price people are willing to pay for these drugs on the street inevitably gives our young, drug dealing citizens more incentive to continue in their illegal behavior than to earn an honest living.

With that being said, it is now in the FDA's hands to help stop this epidemic. It is my hope that the FDA implements the committee's recommendations and reschedules these addictive drugs immediately."

Several experts say that the problem of narcotic painkiller abuse will need much more than a change in its schedule status in order to address it. The Generic Pharmaceutical Association, which says it will abide with whatever the FDA dictates, reiterated this viewpoint during the weekend.

New York City took steps to control opioid painkiller abuse

New York Mayor, Michael Bloomberg, announced new emergency room guidelines earlier this month to prevent prescription painkiller abuse.

He said the guidelines will be used in all the city's public hospitals. Emergency departments at New York City's public hospitals will not be allowed to prescribe long-acting opioid painkillers. Emergency department doctors will only be authorized to prescribe three-days' worth of such drugs. Anybody whose medication supply has been destroyed, lost or stolen will not be able to get repeat/new prescription from emergency departments.

In 2004, there were 55 painkiller-related emergency department visits per 100,000 people in New York City, compared to 143 per 100,000 in 2010 - a nearly threefold increase in six years.

Painkiller abuse and associated deaths, a public health issue

The majority of people who abuse painkillers obtain them from leftover medications.

The CDC (Centers for Disease Control and Prevention) says that over 16,500 people died from opioid-based painkiller overdoses in 2010 in the USA. No other type of drugs, including illegal drugs, kills so many people.

In a Position Statement, the American Academy of Pain Medicine (AAPM) explained that Schedule II substances face more stringent manufacturing and distribution regulations, as well as stricter prescribing rules, including a new written prescription for each refill, no call-in refills, and limits on who can prescribe.

Changing these painkillers to Schedule II status would probably result in the following changes:

• There would be more frequent patient visits
• Doctors who prescribe improperly would face greater penalties
• Pharmacists, and possibly doctors too, would face additional paperwork
• There would be a requirement to secure pills
• Medicare and insurance companies would incur higher costs
• Access to pain medications would be reduced
• Probably, there would be less non-medical use of narcotic painkilling medications, fewer deaths from overdoses, and some related cost savings

More stringent regulations on narcotic painkillers would result in fewer prescriptions. This would be good for some people and bad for others.

Medical populations: Who is being prescribed hydrocodone medications?

Non-specialists commonly prescribe drug combinations which include hydrocodone for acute, trauma-related and post-surgical pain, including dental procedures. Any change in scheduling status will impact on much more than just the specialty of pain medicine.

Hydrocodone-combination medications are also commonly prescribed for patients with chronic pain, either on their own or together with other opioids, or in combination with non-opioid adjuvants, such as:

• For conditions where intermittent pain is common. Examples include sickle cell disease, interstitial cystitis, and endometriosis


• For long-term continuous pain when long-acting opioids are not advisable, not indicated, or simply not available


• For sudden flares of pain that occur in patients who suffer with chronic pain

Nonmedical populations at risk for harm

As hydrocodone products are widely prescribed, they become more widely available for unintentional misuse, recreational abuse and diversion. This leads to higher rates of death from overdose and addiction.

If a patient experiences acute pain and needs painkillers just for one or two days but receives a prescription for a 10-to-30 day supply of hydrocodone, the risk of abuse, overdosing and addiction is much greater, the AAPM explained.

Lynn Webster, president-elect of the AAPM, said "I hope people in pain won't suffer as a result (if narcotic painkillers are rescheduled)."

The benefits of changing hydrocodone-containing drugs to Schedule II

Some doctors and other providers may rethink their current prescribing practices. They may lean towards prescribing fewer pills for shorter periods.

If people who had been treated with short-acting hydrocodone products were switched to long-acting opioids, there will be stricter monitoring guidelines, which is good for the patients.

If the new schedule results in a drop in exposures, fewer people who are vulnerable to addiction will come into contact with the substance through legal prescriptions.

There will be fewer leftover hydrocodone pills, resulting in fewer opportunities from accidental overdose or illicit use.

The risks of changing hydrocodone-containing drugs to Schedule II

Patients who currently have a legitimate clinical need for hydrocodone-containing medications may find it harder to get their drugs, especially if they live out in the country or other underserved areas. They may have to face more co-pays, more frequent clinic visits, and a higher price for their newly-scheduled medication.

There will be no more telephone refills. The AAPM wrote "Even under FDA rules that allow three consecutive 30-day Schedule II prescriptions to be written, clinic visits are likely to increase with the stricter medical monitoring accorded Schedule II opioids. Costs to private and government payers, including Medicare, may also increase. Some physicians, particularly in primary care, would decrease prescribing rather than face increased regulatory scrutiny that accompanies Schedule II controlled substances. This could have grave consequences in pain left untreated."

If hydrocodone-containing drugs are replaced with less regulated ones, there could be further consequences. Examples include:

• Codeine - there is a risk of overdose, lack of efficacy
• Tramadol - a higher risk of seizures and serotonin syndrome
• Non-steroidal anti-inflammatory drugs - a higher risk of myocardial infarction, bleeding, and gastrointestinal effects
• Benzodiazepines - non-medical use leads to a higher risk of overdosing and addiction

If a patient is switched from a short-acting hydrocodone medication to a long-acting opioid, the risk of harm may increase. Most deaths related to opioids involve long-acting formulations. Some may even be switched to methadone, another Schedule II drug, because it is cheaper.

Written by Christian Nordqvist


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