Bush Signs Law: More Patients May Be Treated for Opioid Dependence/ Addiction With Buprenorphine
To: HEALTH/MEDICAL EDITORS
Contact: Harriet Ullman of Feinstein Kean Healthcare, +1-617-577- 8110, hullman@fkhealth.com, for Reckitt Benckiser Pharmaceuticals Inc.
RICHMOND, Va., Dec. 29 /PRNewswire-USNewswire/ — President Bush hassigned into law an amendment to the Controlled Substances Act that willincrease the availability of buprenorphine for the treatment of opioiddependence/addiction. The new law raises from 30 to 100 the number of patientsa physician may treat with buprenorphine, the only FDA-approved, controlledmedication indicated for treatment of opioid dependence that doctors mayprescribe in private medical offices, as permitted under special legislation.The new law will ease restrictions on Suboxone(R) (buprenorphine HCl/ naloxoneHCl dihydrate) C-III Sublingual Tablets and Subutex(R) (buprenorphine HCl)C-III Sublingual Tablets.
“The President’s signature now makes it the law of the land — medicaltreatment can now be available to more Americans across the country who areaddicted to opioids,” said Edwin A. Salsitz, MD, of Beth Israel Medical Centerin New York City. “Many of the estimated six million people in the UnitedStates who are dependent on opioids have been forced to wait for the medicaltreatment they so desperately need simply because of a mandated 30-patient’cap’ on how many people a doctor may treat. By increasing the number ofpatients each physician can treat with buprenorphine, this new law begins toaddress this inequity.”
Addiction to opioids is defined as a long-term brain disease by the WorldHealth Organization (WHO) and the National Institute on Drug Abuse (NIDA). Itis a treatable medical condition that is caused by changes in the chemistry ofthe brain. Opioid dependence can start with use of pain medication that adoctor appropriately prescribes for pain but that a person continues to useafter the medical need for pain relief has passed. Or it may begin asrecreational drug use that spins out of control.
“Millions of everyday Americans from all walks of life are burdened withdependence on such prescription painkillers as oxycodone, hydrocodone,fentanyl, morphine, or are battling heroin addiction,” continued Dr. Salsitz.”This chronic brain disease often has devastating consequences forindividuals, their families, and their communities. Opioid dependence andaddiction is a national public health crisis, and giving more patients accessto an FDA- approved medical treatment that can be prescribed in the privacy ofa doctor’s office, just as treatment for other serious diseases is offered, isa tremendously positive step forward.
“Whether patients suffer from drug dependence or any other disease, theyare entitled to FDA-approved medicines that can treat their conditions.Physicians should be armed with as many medical options as possible as theytailor treatment plans to the needs of individual patients. Office-basedtreatment with Suboxone is one option in the physician’s arsenal, and removingrestrictions around its use surely will be beneficial to patients across thecountry. And, of course, the corollary to removing unnecessary restrictionson prescribing is that more doctors need to become active in treating thisundertreated and often unrecognized but life-threatening disease.”
Physician Training to Prescribe Buprenorphine
Any doctor may take the training to become certified to prescribe Suboxoneand Subutex in his or her private office as a treatment for opioid dependence.Physicians interested in becoming certified may obtain more information fromdocoptin.com. Additionally, information about online and CD-ROM training maybe obtained from 1-877-782- 6966.
About the New Law
The 30-patient prescribing limit on individual doctors was part of theoriginal Drug Addiction Treatment Act of 2000 (DATA 2000) that allowed office-based treatment with Scheduled III-V drugs indicated for treatment of opioiddependence. To qualify for the higher prescribing limit now allowed by law,doctors must have been certified to treat opioid dependence with buprenorphinefor at least a year. The legislation that underlies the new law was part ofSenate Bill 2560, the Reauthorization of the Office of National Drug ControlPolicy, introduced by Sen. Arlen Specter (PA) and co- sponsored by Sens. Biden(DE), Dayton (MN), Grassley (IA), Hatch (IT) and Levin (MI). Thecorresponding Bill in the House of Representatives, HR 2829, was introduced byRep. Mark Souder (IN) and co-sponsored by Rep. Tom Davis (VA). The bill thePresident has now signed raising the patient limit to 100 is HR 6344.
This new law is the second amendment to the Controlled Substances Act toincrease patient access to buprenorphine treatment. Last July, Congresslifted a provision of DATA 2000 that had limited to 30 the number of opioid-dependent patients able to be treated at any one time in a group medicalpractice, even if multiple doctors within the practice were certified to treatwith buprenorphine. As an example of the impact this restriction had imposed,all group medical practices, including large institutions such as hospitalsand entire health maintenance organizations, could only treat 30 patients at atime.
Resources for Opioid Dependence and Its Treatment
Individuals who need more information about opioid dependence and itstreatment, either for themselves or for someone they are concerned about, haveseveral options. Educational materials on opioid dependence are available toanswer questions about this often- misunderstood disease and the treatmentsthat are available for it. Free educational Resource Kits on this topic canbe obtained from turntohelp.com or by calling 1-866-455-TURN, both provided byReckitt Benckiser Pharmaceuticals. Turntohelp.com also offers a physicianlocator designed to help individuals find an area doctor available toprescribe buprenorphine.
Additionally, the non-profit patient advocacy group NAABT – NationalAlliance of Advocates for Buprenorphine Treatment – is dedicated to helpingeducate the public on opioid dependence and treatment in a private doctor’soffice. NAABT now offers a nationwide confidential matching service to pairindividuals seeking buprenorphine treatment with available doctors. Thismatching service is an important corollary to the new law, in that it providesa mechanism for the additional patients to find treatment that the law nowallows. For information on physicians who can prescribe buprenorphine totreat opioid dependence in a private medical office, visit naabt.org.SAMHSA’s Web site also provides a physician locator and other valuableinformation at buprenorphine.samhsa.gov.
About Reckitt Benckiser Pharmaceuticals Inc.
Reckitt Benckiser Pharmaceuticals Inc. is a specialty pharmaceuticalcompany that markets Suboxone(R) (buprenorphine HCl/ naloxone HCl dihydrate [2mg/0.5 mg and 8 mg/2 mg]) C-III Sublingual Tablets and Subutex(R)(buprenorphine HCl [2 mg and 8 mg]) C-III Sublingual Tablets, formulations ofbuprenorphine used to treat opioid dependence in a medical office-basedsetting. Suboxone and Subutex, manufactured by Reckitt Benckiser HealthcareLtd., are the only controlled medications under the Drug Addiction TreatmentAct of 2000 approved by the FDA for office-based treatment of opioiddependence. Reckitt Benckiser Pharmaceuticals Inc. is committed to expandingaccess to medical therapies for patients suffering from the chronic, relapsingbrain disease of opioid dependence. For more information, visit suboxone.comor opioiddependence.com. Reckitt Benckiser Pharmaceuticals Inc. is a whollyowned subsidiary of Reckitt Benckiser PLC, a publicly traded UK firm.
Important Safety Information
Intravenous use of buprenorphine, usually in combination withbenzodiazepines or other CNS depressants has been associated with significantrespiratory depression and death. Suboxone(R) and Subutex(R) have potentialfor abuse and produces dependence of the opioid type with a milder withdrawalsyndrome than full agonists. Cytolytic hepatitis and hepatitis with jaundicehave been observed in the addicted population receiving buprenorphine. Thereare no adequate and well-controlled studies of Suboxone or Subutex (apregnancy category C medication) in pregnancy. Due caution should beexercised when driving cars or operating machinery. The most commonlyreported adverse events with Suboxone have included headache (36%, placebo22%), withdrawal syndrome (25%, placebo 37%), pain (22%, placebo 19%), nausea(15%, placebo 11%), insomnia (14%, placebo 16%), sweating (14%, placebo 10%).See full prescribing information for complete information at suboxone.com..Suboxone and Subutex are registered trademarks of Reckitt Benckiser HealthcareLtd.
Feinstein Kean Healthcare Harriet Ullman (617) 577-8110 hullman@fkhealth.com
SOURCE Reckitt Benckiser Pharmaceuticals Inc.
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