In a recently issued policy statement, the Drug Enforcement Administration proposed a new rule that would ease current restrictions
on prescribing Schedule II controlled substances. Under the new rule, doctors will be able to prescribe 90-day supplies of
Schedule II medications such as OxyContin (oxycodone, Purdue Pharma), methylphenidate HCl, and codeine. The public can submit
comments about the new rules through Nov. 6.
"We listened to the comments of more than 600 physicians, pharmacists, nurses, patients, and advocates for pain treatment
and studied their concerns carefully," explained DEA administrator Karen P. Tandy in a written statement. "The policy statement
reiterates DEA's commitment to striking the proper balance to ensure that people who need pain relief get it, and those who
abuse it, don't."
The proposed change is designed to make it easier for patients with chronic pain to avoid multiple doctor visits. Physicians
will be permitted to prescribe up to a 90-day supply of Schedule II drugs during a single office visit, when medically appropriate.
Doctors can write a single prescription or multiple Rxs, as long as the total does not exceed a 90-day supply. The Controlled
Substances Act (CSA) does not permit refills.
The changes came about as a result of a concerted effort by pharmacists and doctors to clarify the DEA position. "We are extremely
pleased with the turn of events," said Kevin Nicholson, R.Ph., J.D., VP of pharmacy regulatory affairs at the National Association
of Chain Drug Stores. "We're glad DEA recognizes that the earlier rules were an unnecessary inconvenience. In some ways, these
rule changes will provide more oversight over patients."
The American Medical Association was also pleased with the new rule. "Relieving suffering while doing everything we can to
prevent the abuse of controlled substances reflects appropriate patient care, a standard that's easier to achieve when a strong
patient-physician relationship exists," explained Rebecca J. Patchin, M.D., an AMA board member, in a written response to
the new rule.
The new rule is the result of a long, slow process to update the existing rules governing Schedule II drugs. In September
2001, the agency committed itself to a "balanced policy," which aimed to give equal measure to both the enforcement of abuses
and the legal use of controlled substances. In February 2004, DEA issued an interim statement and invited feedback.
The challenge has been to control nonmedical uses of controlled substances without adversely impacting patients with true
medical need. Abuse of Rx drugs appears to be a growing trend. According to the recent National Survey on Drug Use and Health
by the Department of Health & Human Services, prescription drugs are now the second-most commonly abused drugs, behind only
marijuana. In 2004, the survey noted, 2.4 million people used Rx drugs for nonmedical reasons. In another study, by the University
of Michigan, in 2005 9.5% of 12th graders reported using Vicodin (acetaminophen; hydrocodone bitartrate, Abbott) during the
previous year and 5.5% reported using oxycodone during the same period.
One of the side effects of the increased misuse of Rx drugs has been a tendency to underprescribe controlled substances. In
2004, the Federation of State Medical Boards of the United States noted that a significant body of evidence suggests that
"both acute and chronic pain continue to be undertreated." The group attributed the problem to a lack of knowledge of medical
standards, current research, and clinical guidelines for appropriate pain treatment; fear of undue scrutiny by regulatory
authorities; misunderstanding of addiction and dependence; and a lack of understanding of regulatory policies and processes.
In its statement, DEA noted that it would not indicate when prescribing controlled substances was and was not medically appropriate.
The agency noted that its authority under the CSA is "equivalent to that of a state medical board" and that the agency "does
regulate the general practice of medicine."
this is in response to "steve" from roland, OK. i will be a pharmacist in a year and unless i want to leave my chosen field (which has already taken 6 years to acheive) and go to JAIL... i will continue to refuse filling expired c-II prescriptions (including yours if you ever come to my pharmacy). we aren't playing cops; we're watching out for ourselves, our careers, our reputations, and the children who do fall into the temptation of drugs from those who do abuse, whether you do or not.
Steve / roland, OK
Posted Jan 08 2007 11:33AM
I have to drive 160 miles every month to see my doctor, I don't abuse or misuse my medication it would be great to only make the trip once every 3 months. As for all the pharmacist and tech that have a problem with it you need to go into law inforcement and leave your chosen field, I have been made to feel like a second class citizen more that once by someone playing cop. Do your job which is to dispense the right medicine and amount, let the DEA catch the drug addicts.
T Kenneth Lawson CPhT / FRESNO, CA, UNITED STATES
Posted Nov 28 2006 02:32PM
THE PROPOSAL HAS MERIT, IT HAS A LONG HELD TRADITION OF ISSUING MULTIPLE Rx'S for CII'S ,THE PROPOSAL HAS A REQUIREMENT AS TO WHEN THE 2ND OR 3RD CAN BE DISPENSED,METHYELPHENADATE PROBABLY SHOULD BE RECLASSIFIED AS A CIII, THIS PROPOSAL IS LONG OVERDUE AND STATE LAWS CAN REDEFINE PARTICULARS. PROGRESS ON INTRACTABLE PAIN IS NEEDED IMMENSELY.
Charles L. / Hampton, VA, UNITED STATES
Posted Nov 05 2006 07:15PM
Initially the concept of easing the restrictions on CII substances is alarming. However, after researching the topic, I strongly feel that this amendment to the policy should have been made long ago. An argument can be made regarding the potential for abuse. Abusers will go to any length to get the drugs regardless of the legislations placed on it. Considering the regulations currently placed on schedule II substances, has this stopped the abuse? Easing the regulations helps those who have legitimate reasons for being on chronic pain management therapy.
MKA / NEWARK, NJ, UNITED STATES
Posted Oct 29 2006 10:29PM
It is a good idea. If an rx is written for a legitimate purpose, then it is equally legitimate for 90 days as it is for 30. Why cause people in chronic pain to run to their doctor every month when they are the ones most inconvenienced by having to go to the doctor in the first place. I have many patients who are sometimes in too much pain to leave their house to go to the doctor to get the new rx when it's the same rx every single month. 90 days is smart and shows caring for the patients who would most benefit from this change. It is a good move by the DEA.
Steven R.Ph. / Bellingham, MA, UNITED STATES
Posted Oct 27 2006 07:24AM
A 90 day supply would be beneficial for the patients who need it. bUT, we, as Pharmacists will be put in a tighter position for gatekeping. Doctors and other prescribers do not follow Federal law chapter 21 section 1306.05 as it is, and the DEA wants Pharmacists to increase their inventory three fold. No way. I work for a chain and they will do what they have to do. All I would ask is that the DEA arm Pharmacists better than they do. I am extremely tired of patients who show up at 12:01 AM with a prescription dated for the new day. Knowing there is no way on earth that the doctor dated the prescription in that last minute. No one cares about this but me. There are too many drug seekers out there and once again the DEA is punishing Pharmacists. Thanks again.
Thomas RPh / GA, UNITED STATES
Posted Oct 26 2006 06:51PM
If the prescription is for a legitimate medical purpose for a legitimate patient then a law to allow physicians to prescribe up to a 90 day supply on one visit would be good. According to current DEA law now, a C-II does not expire by Federal Law, a C-II can already be written in any quantity the physician fills is appropriate. The reason most physicians that I have delt with in the past only prescribe a 30 day supply is that they fear reprocushions from DEA and other legal entities if they prescribe in large quantities, they also realize that most insurance companies will only pay for a 30 day supply at a time. Hospice is not an issue, because by law it is legal to partially fill a hospice prescription. Unfortunately we have a long way to go in educating both the medical community and the lay people about the issues surrounding the safe and effective use of C-II narcotics in chronic non-malignant pain. Palliative care is a much needed niche that needs to be addressed. Addiction can not be equated to use of need alone. If you have a patient on insulin and their need increases do we say they are addicted to insulin? No, but we don't use a very educated analogy when it comes to a chronic pain patient.
Pharmacist for 35yrs / Huntsville, AL, UNITED STATES
Posted Oct 25 2006 10:07AM
I do NOT favor 90-day supplies because of the severe diversion problem. This will just open flood gates for the user/abuser. I DO believe a Physician could write multiple RXs for the CONFIRMED pain-controlled patient (only the one drug with correct instruction, DEA, etc on the RX) and the Pharmacist could continue their role of "gatekeeper" in monitoring this program. I do NOT think these proposed changes should be made to merely make it more convenient for the MD at the expense of the RPh. but rather a re-inforcement of each's role in meeting the ultimate goal: Timely, consistent, "proper" patient care! I also see this as an economic issue in regard to the mail order issues and the positive impact for insurance companies at the expense of patient care aa well as retail viability.
Been pharmacist for almost 31 years,i say better 3 refills per prescrptions for a 90 days supply than 90 days supply,this will regulate abuse or missuse of them,imagine 4 rxs for 90 days supply on a drug abuser....will sell 3 rxs pills to get 3 months supply, not a bad idea or is it?
JACK HODGE,RPH,AADE / EDGEFIELD, SC, UNITED STATES
Posted Oct 24 2006 08:10PM
A 90 DAY SUPPLY OF OXYCONTIN FOR ELDERLY PATIENTS IS NOT A GOOD IDEA.MANY SENIORS FORGET TO TAKE THEIR MEDICATIONS AND ACCUMULATE 100'S OF EXTRA TABLETS. THIS WILL ENABLES CAREGIVERS AND FRIENDS TO HAVE EASIER ACCESS.
Posted Apr 22 2007 11:09PM
