User:HALPRIN - CPRX

Opioid Crisis:

The history of the "opioid crisis" is traced to the advent of synthetic opioids by the major pharmaceutical companies in order to treat acute and chronic pain conditions. It has become significantly newsworthy in the past year, as state and federal government agencies have indicted and brought criminal charges against the companies that distribute medications such as Fentynyl, Oxycodone and Oxycontin. The common element in all of these wholesale and retail medications is the opioid poppy seed.

Purdue, Reckett and Benkiser, as well as Jansen and Johnson and Johnson are currently facing criminal charges, and defending these charges with high profile attorneys. Many of the drug companies are pleading guilty to negligence and other charges and paying hefty fines resulting in more treatment programs resulting from the fines collected by the United States Government.

The Drug Abuse Treatment Act (DATA) passed by Congress in 2000, allows more treatment options, including Outpatient Treatment Programs utilizing medication assisted treatment. The primary medication in this treatment modality is Buprenorphine HCL.

Many physicians and mid-level practitioners have now qualified to treat opioid dependency with Buprenorphine HCL, commonly referred to as Subutex and Suboxone. With over 150 dealths per month resulting from recreational overdoses, the understanding that the United States and other countries are facing a "opioid crisis."

Halprin, Michael, was a pioneer in opening one of the first Outpatient Programs offering Subutex and Suboxone, and has been identified as operating an agency that leads in the treatment of people dependent on classic pain medications and/or Heroin. Halprin has patented a compounded version of the retail medication, which allows people to taper off this medication.

The rationale for approving medication-assisted treatment, defined in the Drug Abuse Treatment Act (DATA), was to provide a accessible and affordable treatment modality for individuals who found themselves dependent on pain medications. Many persons are prescribed scheduled ( Control II and III) medications which help by controlling and lessening the chronic pain associated with their illness or accident. However, the medications have other consequenses. These consequenses may involve one's mental health, and a person may experience higher anxiety, less concentration, difficulty sleeping, lower libido related to hormone changes, depression and a development of a dependency both physical and mental in nature.

Physicians and other mid-level practitioners were supported in their ability to provide treatment with medication, by both regulatory and professional agencies like SAMHSA, DEA, and NAABT. SAMHSA, a governmental agency working with the DEA wrote specific guidelines on who, what and where a physician or nurse practitioner may obtain the "waiver" or "X" number so that this medical professional is now licensed and knowledgable in an effort to provide the medication-assisted treatment required to stop the need to take classic opioids - both prescribed such as Oxycodone, Fentanyl, Hydrocodone, and those products derived from the poppy seed such as Heroin.

Many physicians became educated in respect to the physical and mental dependence that opioid related medications and street drugs may cause. Halprin, a nurse practitioner was one of the pioneers in providing an Out-patient Program where M.D's and ARNP's evaluated an individual and offered a unique and specialized medication program which allowed a person to stop the use of their prescribed or street opioids within 24 hours. The program, which followed all regulatory guidelines was, and remains a huge success in the battle against opioid over-use, abuse and dependency. Patients could stop their use of prescription opioids and return to a life where a person did not require these opioids to simply function. People started feeling normal, eating and sleeping properly, anxiety and depression features were lifted, and people were enjoying life again. The cessation of the classic opioids without having to suffer physical withdrawal and chronic fatigue-like symptoms was "miraculous" as many people voiced who entered into the program.

Now the issue became: how long does a person want or need to take this "miraculous" medication - Buprenorphine? Many characteristics of full opioid antagonists mimic those of the partial agonist - Buprenorphine HCL. However, because the new medication provides relief from the dependency on the classic opioid; it also serves to diminish the pain associated with the damage from the person's injury or illness. What Halprin provided, was a lozenge, which in pharmacy language, is referred to as a "troche". These 2mg - 8 mg troches are compounded and scored in quarters thereby allowing patients to divide and minimize their dosage; where this was impossible to accomplish using the retail versions of Buprenorphine. The retail versions are "Subutex" and "Suboxone". Halprin and his medical staff educate the person/patient in respect to lowering the dosage by one (1mg) every 3-5 days, and thus taper down or off the medication as indicated. The patient is in charge of how much medication is required for their pain condition. The person is no longer required or needs to take the high dosage(s) of classic opioid medication in order to feel quasi normal. The patient is now actively involved in lowering the dosage of Buprenorphine via a taper schedule. The goal for many patients is to take no medication once their body and brain receptors are repaired and have returned to a steady state. The medication approved (DATA) was perfect. The one component lacking, was the retail formulation of the medication. The tablets or film did not allow for decreasing the dose or tapering off the medication, once the person had recovered from becoming dependent upon pain pills or Heroin. Chronic pain patients were also able to lower their dosage, but many continued to use Buprenorphine for pain control.

Halprin was able to patent his troche, named "Butro" and remains confident that the future studies and patient successes shall prove to be valuable in the treatment of chronic pain, and in the fight against the "opioid crisis." The medical professionals who provide medical detoxification using Buprenorphine recogize the need to utilize a compounded product in order to accomplish the task of tapering a patient down or completely off of medication.