I just read this article, [URL=http://updates.pain-topics.org/2009/12/rems-when-elephants-prance-ants-take.html] When Elephants Prance, Ants Take A Pounding.

The article discusses the outcome of a meeting held in December between the FDA who is proposing REMS(Risk Evaluation and Mitigation Strategy) for extended-release or long-acting opioid analgesic products containing oxycodone, morphine, methadone, and other agents and the manufacturers that produce these narcotics.

The companies joined together in an Industry Working Group (IWG) to deal with problems of reducing abuse of the drugs while still providing access of these narcotics to people who need them to live day by day such as chronic pain patients.

The FDA had provided little guidance on required solutions, and IWG members many hours in meetings to arrive at a preliminary plan.The article provides more details and problems with the proposed phased in plan.

I have read in various articles that some FDA representatives have admitted that their plan is to eventually keep physicians from prescribing these narcotics at all and future proposals include the creation of a register for everyone who legitimately takes these narcotics and then rationing the amount of narcotics we receive.  Whether or not this will happen I do not know.

The FDA have already banned two new medications. The current proposals involve REMS for each individual narcotic prescribed that will require each doctor who write prescriptions, medical staff in offices where these narcotics are prescribed, pharmacies who fill the prescriptions and manufacturers who distribute the narcotic to participate in training as required by the FDA before the narcotic can be given to the patient.

I have read in October FDA proposed regulations that patients will also be involved in the process of education and will have to provide documentation of education before their prescription can be filled.

I know that most of you are aware what has happened due in part to previous actions by the DEA. Many doctors will no longer prescribe narcotics. Obviously, if these proposals are enacted even more doctors will refuse to prescribe narcotics.

There are some physician practices that have formed alliances with companies. They have political influence and hopefully will be able to stop these proposals or at least delay the action until more can be done to assure that we receive the medication we need to survive.

Speaking for myself, even though I have a terminal illness, I don't plan to just roll over. I will go on telling everyone I can about information regarding the proposed REMS. I intend to write to my congressmen and women to let them know what is going on. I believe that the more people that know what is going on the more people there will be to help assure that we continue to receive the medication that we really need.

Eppie