Addiction Expert Dr. Indra Cidambi Highlights Hurdles to Overcome for Wide Adoption
New York – December 1, 2017 – The Food & Drug Administration (FDA) announced yesterday its approval of an injectable form of buprenorphine (brand name: Sublocade), a medication used to treat opiate addiction. Sublocade releases a steady dose of buprenorphine for one month. Buprenorphine works by reducing cravings and withdrawal symptoms and Sublocade is recommended for patients stabilized on a steady, maintenance dose of buprenorphine for seven days.
“Sublocade offers important benefits not currently provided by the sublingual form of buprenorphine. Medication is steadily released into the blood stream, which helps patients to be compliant with the regimen, and diversion is a non-issue. It could truly help individuals seeking longer-term maintenance treatment for Opiate Use Disorder,” says Dr. Indra Cidambi, leading Addiction Expert and Medical Director at Center for Network Therapy, New Jersey’s first licensed outpatient detox facility. “However, prescribers should be careful to introduce Sublocade after patients have completed the early stage of treatment (3 phases) where therapy, to effect life style changes needed to maintain long-term sobriety, is a major component. Co-abuse of other drugs while on this medication and DEA regulations are also issues,” she adds.
Introducing Sublocade in the early stage of treatment may backfire: The early stage of treatment consists of detoxification (the most acute phase), followed by partial care and intensive outpatient programs – lasting a total of 3-4 months. During these phases, group and individual therapy, focused on relapse prevention and coping skills, is a major component of treatment coupled with medication. For opioid use disorder, buprenorphine is introduced in higher doses during the detoxification stage and later tapered to settle at a maintenance dose. “Introducing Sublocade in the early stage of treatment could jeopardize the recovery process. The patient may need frequent dose adjustment that Sublocade cannot deliver and the patient may turn to licit or illicit drugs to satiate unaddressed cravings and/or withdrawal symptoms. Or, it could demotivate the patient from engaging in therapy, as there is a month’s worth of supply in the system, relative to receiving a week’s worth of prescription at a time,” says Dr. Cidambi.
Abuse of other drugs while on Sublocade not unlikely: “When a patient is switched to Sublocade (injectable buprenorphine) the prescriber should be mandated to perform a drug screen on the patient before administering the next dose,” says Dr. Cidambi. Co-abuse of other classes of drugs, such as benzodiazepines, along with buprenorphine has the same effect as using opiates and benzodiazepines together – i.e. increased risk of respiratory depression. As per NCBI, co-abuse of benzodiazepines and opiates increased by 570% from 2000 to 2010. Use of alcohol along with buprenorphine is also contraindicated. “Also, many of my patients have reported that they are less concerned with abusing Fentanyl while on Suboxone (sublingual form of buprenorphine), as the naloxone in the medication reduces the chances of overdose,” she adds. “Consequently, a dirty urine is a serious issue and should not be ignored. The patient should be asked to engage in a higher level of treatment for increased support, as it is evidence that the patient is still struggling.”
Logistics and DEA regulations may deter prescribers: Sublocade will likely be distributed under a ‘closed distribution system.’ This means that the manufacturer/specialty pharmacy will ship the product directly to buprenorphine prescribers and they will inject it in their office. “The providers will have to store the injectable buprenorphine (a controlled substance under the purview of the DEA) in their offices and implement an inventory accounting system to satisfy DEA regulations. Unless there is a special waiver, the DEA requires practitioners to utilize a ‘TL-15’ rated safe to store controlled substances (costs a few thousand dollars) and install alarms and cameras for security. Additionally, prescribers will now be subject to unannounced visits by the DEA to ensure compliance. “The cumbersome responsibility of storing the medication and additional paperwork could be a strong deterrent to providing the injection,” observes Dr. Cidambi.
About Dr. Indra Cidambi
Indra Cidambi, M.D., Medical Director, Center for Network Therapy, is recognized as a leading expert and pioneer in the field of Addiction Medicine. Under her leadership, the Center for Network Therapy started New Jersey’s first state-licensed Ambulatory (Outpatient) Detoxification program for all substances nearly three years ago. Dr. Cidambi is Board Certified in General Psychiatry and double Board Certified in Addiction Medicine (ABAM, ABPN). She is the Vice President of the New Jersey Society of Addiction Medicine. She is fluent in five languages, including Russian.
About the Center for Network Therapy
Center for Network Therapy (CNT) was the first facility in New Jersey to be licensed to provide Ambulatory (Outpatient) Detoxification Services for all substances of abuse – alcohol, anesthetics, benzodiazepines, opiates and other substances of abuse. Led by a Board Certified Addiction Psychiatrist, Indra Cidambi, M.D., experienced physicians and nurses closely monitor each patient’s progress. With CNT’s superior client care and high-quality treatment, Dr. Cidambi and her clinical team have successfully detoxed roughly 1500 patients in five years. CNT also offers Partial Care and IOP programs.Share