Opioids

  • Opioid Medical Record Review & Outsourcing Services

Opioids are a class of drugs that act on the nerve cells in the body and brain to relieve pain. There are different types of opioids like Buprenorphine, Butorphanol, Codeine, Fentanyl, Oxycodone. Hydrocodone, Hydromorphone, and Hydromorphone are opioids that are not commonly used.

Buprenorphine - Subutex - FDA Approved Oct 2002 - Actavis Elizabeth LLC, Hi-Tech Pharmacal Co., Inc, Mylan Pharmaceuticals Inc., Rhodes Pharmaceuticals L.P., Sun Pharmaceutical Industries, Inc, Teva Pharmaceuticals USA, West-Ward Pharmaceuticals

Butorphanol - Stadol - Discontinued, Generic formulations manufactured by Novex, Mylan, Apotex and Ben Venue Laboratories

Codeine - Used in cough syrups, or in a combination with paracetamol (acetaminophen) or a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin or ibuprofen. Tylenol/Elixir are brand names.

Fentanyl - Actiq, Duragesic, Fentora - FDA approved 1959 - Janssen

Oxycodone - OxyFast, OxyIR, OxyNorm, Roxicodone - FDA Approved 1995 - Actavis, Apotex, Endo Pharmaceuticals, Mylan and many more

Methadone - Dolophine - FDA approved in 1947 - Eli Lilly, Mallinckrodt Pharmaceuticals

Opioids are on the market for ages and have been used basically for pain relief for post-surgical pain, cancer-related pain, chronic or persistent pain. Opioids when used in a proper dosage and along with a combination of other pain treatments, work in relieving pain successfully, until unless there is a misuse or abuse of the drug.

Misuse/Abuse of Opioids

Companies manufacturing Opioids convinced the medical community that these medications were not addictive and were purely beneficial. This belief raised the number prescriptions and sales unwarrantedly, resulting in a mass misuse of these drugs, to the extent that this was identified by the U.S. Food and Drug Administration (FDA) as a public issue and named it an 'Opioid crisis'.

 

Serious Alleged Injuries may include:

  • Tolerance with continued use
  • Dependence with continued use
  • Neonatal Opioid Withdrawal Syndrome (NOWS)
  • Addiction
  • Overdose
  • Death

FDA SAFETY WARNINGS:

In the early 2000s, reports of abuse of Opioids started surfacing which are aggravating to date. Since then, the FDA has taken prompt actions to control the misuse in the form of issuing of warning letters, class-wide label changes, arranging workshops, designing awareness programs, and joint meetings.

The FDA also took an initiative to produce opioids, which are abuse deterrent. As defined by the FDA, Abuse-deterrent formulations target the known or expected routes of abuse, such as crushing in order to snort or dissolving in order to inject, for the specific opioid drug substance. OxyContin, Targiniq ER, Embeda, Hysingla ER, MorphaBond ER, Xtampza ER, Troxyca ER, Arymo ER, Vantrela ER, RoxyBond are approved by the FDA with a labeling describing abuse-deterrent properties. This is the consistency with the FDA's Guidance for Industry: Abuse-Deterrent Opioids - Evaluation and Labeling.

Lawsuit Allegations:

Allegations are made against manufacturers that they violated the rules by not informing the Federal authorities about the unusual size, suspicious purchases, or the frequency of bulk purchases. There is an allegation that huge benefits were reaped by manufacturers, and they intentionally failed to inform the medical providers about the addictive nature and consequences of Opioids.

Till date, large amounts of settlements have already been agreed upon by many manufacturers for the opioid crisis: McKesson, Mallinckrodt, Costco Wholesale, and Cardinal Health are to name a few among them, and the fight still continues.

National Prescription Opiate Litigation MDL No. 2804 ( (In Re: National Prescription Opiate Litigation) was formed in October 2017. Defendant names include wholesalers of opioid drugs, AmerisourceBergen Corporation, Cardinal Health, Inc., McKesson Corporation; the list also includes primary drug makers Purdue Pharma, Teva, Cephalon, Janssen, Endo, Actavis, and Mallinckrodt in certain litigations.

Evidences:

  • Indication of Usage in Medical and Pharmacy Records
  • Duration of Usage
  • Complications and their treatment after intake

Medical Record Review and claim validation of Opioids case should take approximately 4 hours in most instances; however, this approximation may vary in cases based on the volume of records.

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