FDA wants to tighten access to painkillers
By Toni Clarke REUTERS
WASHINGTON — The Food and Drug Administration recommended tighter restrictions yesterday on products that contain hydrocodone, an opioid painkiller present in commonly prescribed, potentially addictive drugs such as Vicodin.
Currently, Vicodin and other products that contain less than 15 milligrams of hydrocodone are classified as Schedule III controlled substances. The FDA recommends reclassifying them more restrictively — potentially as Schedule II products, in line with opioid painkillers such as oxycodone and morphine.
- Reclassifying the products would make them harder to obtain, both by addicts and by legitimate pain patients. Physicians are not allowed to call in a prescription for a Schedule II product to a pharmacy. Instead, patients must present a written prescription.
- In addition, patients would not be allowed as many refills before returning to see their doctors, potentially representing a hardship for patients in chronic pain.
The proposed change was urged by the Drug Enforcement Administration, which is battling a rising tide of prescription-drug abuse. The change must be approved by the Department of Health and Human Services and the DEA, which will make a final decision on scheduling.
- Opponents of the rule change, including many physicians, have argued for years that restricting pain products further could cause hardship to pain patients, especially the elderly.
Proponents argue that the death toll from abuse is unacceptably high.
Nearly 3 in 4 prescription-drug overdoses are caused by opioid painkillers, according to data from the Centers for Disease Control and Prevention.
Regulators are tackling the problem from a variety of angles. In an attempt to restrict supply, the DEA has been putting pressure on wholesale suppliers of prescription drugs to police their customers better. (like that’ll do any good?)
Several companies, including Pfizer Inc. and Endo Health Solutions, have been working to develop tamper-resistant opioids that cannot be easily crushed or dissolved by addicts looking to get a full dose of the drug quickly.
- The misuse of prescription painkillers was responsible for more than 475,000 emergency department visits in 2009, a number that nearly doubled in just five years, according to the CDC.
In January, a panel of outside medical experts voted 19-10 to reclassify the products.
Dr. Janet Woodcock, director of the FDA’s pharmaceuticals division, said in a statement that the agency has, over the past few years, been “challenged with determining how to balance the need to ensure continued access to those patients who rely on continuous pain relief while addressing the ongoing concerns about abuse and misuse.”
In the end, she said, the level of opioid abuse and the “tremendous amount of public interest” in the matter led the agency to recommend a change.
This is something I feel deeply about and sincerely wish I could wave the magic wand and correct, but alas. . .simplistic answers are wasting everybody’s time. There is no question that this is a real problem and action of some kind should be taken. But this solution sounds to me as if it will injure the very people who need help the most. — Seriously ill people, the aged and frail. We should not be making the lives of these more difficult or costly. Therefore, this solution isn’t acceptable at all. Nor is the placing of additional responsibility on the wholesalers going to be the answer as they are neither using or selling their wares to the offenders — so why do it? Just to say you are doing ‘something’? How ineffectual!
Surely, it rests with the doctors who care for these ‘patients’ being referred to as abusers of narcotic meds. Who else would logically be in a position to make that judgement? And if not the physicians, then who? If not the physicians, then why do we even have a so-called medical system? They don’t know how to tell a person who is sick apart from one who is fakin’ symptoms? Guess we’re in worse trouble than I thought. From what I could tell over the past couple of years, most of the pill-pushing “Pain Clinics” have been run out of town with doctors cut off at the knees.
One could hope that those still practicing medicine are in fact taking care of people and seeing to their needs. If these ‘medical professionals’ are to do their work – ply their craft, they must be free to do that according to their best judgement. We don’t need government agencies telling doctors how to care for their patients — that would be the very epitome of idiocy! If doctors are not taking the time to know their patients well enough to treat them effectively, that’s a dereliction of duty and down-right malpractice. As to handing out dope to abusers, that should be seen as ‘bad-medicine’. Among other things, these professionals must learn discrimination, tact and the meaning of ethics. People with addictions need care too, but perhaps, specialized care in a confined environment — if they are of a mind to to correct their lifestyle. But many there are who will not take help, and one cannot help. Everyone still has the right to his/her own choice and action. An addiction clinic is not the same as a doctor’s office.
It is wise to remember that people are all different. None of us need judgement heaped upon us. We all know the meaning of pain which of course comes in in so many varieties, shades, strengths and forms. We each find our own way of coping and some of us do pretty well maintaining ‘balance’ while some slide off the deep end. It just is. While some say “ain’t it grand?” . .others find life sucks! This is not a question of who deserves to be helped, to received appropriate care, to be respected — we all do. It is probably not going to be the same for each of us, nor should it be, because we are all different. But our humanity binds us. Jan)