May 2018 | Galiher DeRobertis & Waxman LLP

Going forward, Purdue will halt promotion of opioids to doctors.

Privately held pharmaceutical manufacturer Purdue says that it will no longer market OxyContin, the most sold opioid painkiller in the world, to doctors. Multiple lawsuits blame the pharmaceutical company for helping to trigger the opioid epidemic and are putting pressure on Purdue. This has led to the termination of over half of its sales staff and scaled back promotion of the opioid drug.

What are Opioids?

Opioids are a class of drugs made from the naturally growing opium poppy plant or other synthetic sources. Mostly used to treat moderate and severe pain, opioids contain chemicals that relax the body by connecting to and activating opioid receptors on cells in the brain, spinal cord, and other organs. Because they can make people feel so relaxed and “high” as they release large amounts of dopamine into the body, opioids are highly addictive. Even when opioids are used in short duration, withdrawal symptoms can occur once a round of medication is concluded. Misuse can lead to overdose and slow or labored breathing, which can result in coma, permanent brain damage, or even death.

Common prescription opioids include:

Hydrocodone (Vicodin®) Oxycodone (OxyContin®, Percocet®)

Oxymorphone (Opana®)

Fentanyl

When women use these opioids during pregnancy, their babies have the potential to develop a birth defect such as spina bifida, hydrocephaly, microcephaly, congenital heart defect, and brain damage. Use during pregnancy can also lead to miscarriage and low birth weight.

OxyContin History

OxyContin, first approved in 1995 as a treatment for pain, works over a 12-hour period to keep a consistent level of oxycodone in a patient’s system. Opioid use has skyrocketed due to the aggressive marketing tactics pushed by the pharmaceutical manufacturers and distributors. The opioid drug companies have been producing misleading articles and advertisements that downplay the dangerous side effects of opioids. These deceptive techniques were effective in convincing doctors and regulators that the drugs were safe and effective, even for long-term use.

In 2007, Purdue and three of its executives pleaded guilty to misleading the public about the risks of OxyContin. The drug was reformulated in 2010 to lessen the risk of misuse. By doing so, Purdue recognized that its marketing had inflated the drug’s safety and downplayed the risk of addiction in consumers. Current lawsuits allege that drugmakers purposefully misled both doctors and patients about opioid dangers by using “front groups” and “key opinion leaders” to encourage over-prescription.

Larger doses may not be the problem in the opioid crisis.

According to a study of over one million commercially insured patients, the length of opioid prescriptions rather than the dosage is the prime determinant of ongoing opioid misuse among surgical patients. Misuse is defined as dependence, abuse, and/or overdose. Patients were considered opioid-naïve if their opioid use in the 60 days prior to surgery was seven days or less. Subsequent opioid refills after surgery were associated with a 44% increase in misuse among opioid–naïve patients. Along the same lines, with each additional week of prescriptions, opioid misuse increased by nearly 20%. Misuse again increased when patients received more than nine weeks of drugs.

Time vs. Dosage

According to Gabriel Brat, MD of Harvard Medical School in Boston, the recent study suggests that acquiring a refill increases one’s chances of opioid addiction. In turn, he suggests, “for surgical patients, it may be that we should focus less on the dose of opioids immediately after discharge and more on the length of time a patient is exposed to opioids.” In contrast to data from chronic opioid users, who are most routinely the group upon which guidelines are based, this study brings attention to the need to “develop protocols that are tailored for the patient population.” In other words, the one-size-fits-all approach is not working – we need multimodal pain strategies to solve the opioid crisis.

The Research

In the study, researchers pinpointed non-injected drugs with dominant ingredients of codeine, hydrocodone, hydromorphone, morphine, oxycodone, oxymorphone, or tramadol as opioids. The morphine milligram equivalent (MME) dosage was calculated for each individual prescription.

Over half of patients were prescribed opioids after surgery, and 90% of the prescriptions were filled within three days of leaving the hospital. Patient follow-up within 2.67 years demonstrated that opioid misuse took place in 0.6% of the cases. Within one year of surgery, misuse was 0.2%

While misuse percentages were small, they did increase in proportion to the number of prescription refills with just one refill doubling the misuse rate. When post-discharge prescriptions were for less than two weeks, misuse rates remained similar. However, when refills were given for at least nine weeks, misuse rates greatly increased from 475 cases per 100,000 persons to 8,087 cases of misuse.

With such large numbers of opioid misuse based on continuous use, there is still a need for more study to determine best practices for both prescribing medicine and monitoring patients. In response to varying cases and individual patient needs, recovery programs with multiple strategies for managing pain must be studied as well.

Manufacturers play a significant role in the number of opioid prescriptions issued across the country. Aggressive marketing tactics engaged by these companies have had a direct effect on resulting complications, including death.

Month: May 2018

OxyContin Manufacturer Changes Marketing Practices