On June 6th, 2017 Dutchess County of New York State filed a lawsuit against 11 pharmaceutical companies on several allegations regarding their production and distribution of prescription opioid painkillers. The lawsuit alleges that pharmaceutical companies have used deceitful tactics to market prescription opioid painkillers, an epidemic that has swept across the nation resulting in several deaths that only continue to increase by the year. Keep in mind, considering the date of the lawsuit, that nothing has come of the it and Dutchess County is not necessarily setting a precedent as 5 other New York State counties have filed similar lawsuits against pharmaceutical companies and individual providers. There are 62 counties in New York State.
As has become the norm in a capitalist society like the United States, money is a powerful and nearly undefeated entity. How often do you see money being the driving force behind evil and selfish acts? It’s safe to assume money is the driving force behind the companies and providers turning their back on a public health crisis, even if it didn’t start that way. Addiction is a disease, as is cancer, and the former is much easier to turn your back on.
In addition to the lawsuit against pharmaceutical companies, Dutchess County has named a handful of prescribing providers alleging that they were responsible for promoting opioids for sale and distribution locally and nationally. Dutchess County Legislator, Jerry Landisi, is quoted saying “We have been fighting this war on drugs and addiction, but the enemy has been supplied by these pharmaceutical companies who have chosen to put profit ahead of patient safety.”
The problem is spreading and there does not seem to be an end in sight. Several states are seeing the devastating effects of the opioid epidemic, including Vermont. In fact, Vermont ranks ninth among the National Safety Council’s top 10 states with the highest heroin fatality rates per capita.
So, what gives them a right to blame the companies and prescribers? Is it pure ignorance? As it is for many professionally licensed providers, there are annual continuing education requirements. Any responsible doctor would take note of the rise in deaths due to prescription opioid use.
Let’s look at the numbers
- In 1999 there were 7,523 deaths due to prescription opioids
- In 2015 there were 29,728 deaths due to prescription opioids
- In 1999 there were 2,675 deaths due to illicit opioids
- In 2015 there were 19,884 deaths due to illicit opioids
If you’re wondering why pharmaceutical companies and individual providers are being held accountable, the above statistics should be telling. Not only have patients become addicted to pain management medications prescribed by their doctors, they seem to be seeking out the drug after the prescription has lapsed.
To the naysayers that may point to our population growth in America, which has grown 14% between 1999 and 2015. The population growth of 14% pales in comparison to the 295% increase in prescription opioid deaths over the same time frame. If we’re aiming for population control then we have the answer.
There are some states that are considered to be doing it “right”, most notably, the state of Vermont, which is just a mere ninety miles from the center of Dutchess County, NY.
Now that we’re shifting away from the most recent lawsuit in New York, let’s see what their neighbors are up to, besides filing lawsuits.
- In 2010 there were 38 deaths in Vermont due to prescription opioids
- In 2016 there were 38 deaths in Vermont due to prescription opioids
Wait, the opioid deaths did not increase 295% in Vermont? Yes, the same number of people died at the hands of prescription drugs but they must be doing something “right” in Vermont.
Before we dive into the treatment programs and legislation associated with Vermont’s success let’s widen the spectrum again briefly. On a national level, for those addicted to opioids the people closest to them are the most dangerous enablers. In 2015, a survey determined that 36% of people that misused a prescription pain reliever received the drug directly from their doctor. Another 54% of misuses were taken, bought or given to the person by a friend or relative. The remaining 10% fell into the following categories:
- 9% bought from a drug dealer or stranger
- 9% obtained the prescription pain reliever “some other way”
It’s not the dark alley dealer we have to worry about. It’s the people that are supposed to care about our health and well-being.
How is Vermont Preventing Prescription Opioid Misuse?
While the following list is seemingly vague, we get an idea of what programs and prevention tactics are being employed and we’ll take a close look at a couple of the programs and the elements that make them successful. Vermont reportedly has the following prevention and treatment programs in place:
- Mandatory Prescriber Education
- Opioid Prescribing Guidelines
- Eliminating Pill Mills (VT doesn’t have them but also doesn’t have legislation to eliminate/prevent them)
- Prescription Drug Monitoring Programs
- Increased Access to Naloxone
- Availability of Opioid Use Disorder Treatment
Particular to mandatory prescriber education and opioid prescribing guidelines, at first glance, it could seem like just more charting in an attempt to decrease liability with a smoke screen of caring for the patient. However, it seems the amount of charting that needs to occur cannot be fudged or faked as there are too many stipulations in place that call upon the doctor to be, well, a responsible doctor! For example, when prescribing an opioid painkiller the prescriber must evaluate the benefits and risks, including risk of misuse. Additionally, the provider will need to produce a diagnosis that supports prescription opioids and consider and document the possibility of a non-opioid alternative as well as a non-pharmacological treatment.
These doctor and patient education attempts will help prevent the patients from confusing the drowsy eye warning on the bottle as a “wink, wink” suggestion, much like Lucille Bluth, of the cult television show, Arrested Development.
Beyond the Initiation Point
If you’re looking for a hole in Vermont’s approach, you must read on to determine if you feel it’s a credible approach. What’s been described in the preceding section is a small part of the process, the opioid initiation stage. How should we expect doctors, especially ones that see dozens of people on weekly basis, monitor opioid use after the initial prescription?
For general practitioners that aren’t seeing improvement in their patient’s condition they must be comfortable with a referral to a pain management specialist and/or a substance abuse specialist. Mainly, don’t be so damn arrogant! Some of the risk indicators are listed below:
- Treatment goals are not met despite escalating doses.
- The patient’s history and/or a screening indicate high risk for misuse, abuse, diversion, addiction, or overdose.
- The prescriber knows or suspects based upon reasonable grounds that the patient has engaged in misuse of opioids or other substances.
- The patient obtains prescriptions from multiple prescribers and/or multiple pharmacies.
- The patient has been prescribed multiple controlled substances
Relating back to the more charting phenomenon, it seems that a common theme within Vermont’s model is documenting their treatment of the patient. Vermont’s laws indicate that the patient must be seen within 365 days of the initial prescription, otherwise the provider will be held accountable for being in violation of a state law. The annual review of a patient’s prescription mirrors the initiation stage and what’s important about the annual requirement is that patients that are misusing or are addicted have to come back and evaluate their use themselves. That way the provider and patient are being held accountable. The annual reevaluation period has the following salient elements:
- Reevaluation of effectiveness and safety of the pain management plan and the patient’s adherence to the treatment regimen.
- Potential for non-opioid/non-pharmacological treatments.
- Functional status examination of the patient.
- Review of the Controlled Substance Treatment Agreement and Informed Consent, and any revisions to the conditions.
- Assessment of co-morbid conditions.
- Related actions that may prompt adjustments to treatment, including aberrant behavior, early refills, or other factors reasonably suggesting risks associated with misuse, abuse, diversion, addiction, or overdose.
Of the aforementioned elements, especially within the one year mark, what sticks out the most the requirement to assess for comorbidity. Yes, the patient may have come with back pain due to recent surgery however, he or she may have developed an addiction over time, especially due to the vulnerability a physical ailment can create. Those suffering from an injury or that are in recovery cannot always participate in regular activities, may be bed ridden at times and feel alienated from their social group. All of those elements could result in depressive symptoms, which put someone at much higher risk to misuse or abuse drugs.
As indicated earlier, addiction is a disease and must be recognized and treated as such. While Vermont is seeing their most significant decrease in prescription opioid misuse in the 18 to 25 age range, the Substance Use and Mental Health Services Administration found that the rates for mental illness and substance use disorders were the highest (35.1%) for people in the same age range.
While the opioid epidemic is alive and well, it’s a welcome sight to see Vermont attempting to increase their treatment capacity to deter the effects to their residents. Much like the tobacco industry’s settlement with 46 states in 1998, the wave of lawsuits may force the pharmaceutical companies to take more responsibility for ignoring or downplaying the addictive nature of opioids. In the tobacco settlement the tobacco industry agreed to make ongoing payments to the 46 states involved to fund anti-smoking campaigns and public health programs. With the current climate of healthcare and the increasing cost, a similar settlement could be applied to the opioid epidemic. In the meantime, other states should be following in the footsteps of Vermont because, just like tobacco, much of the damage is already done. The patients are hooked. What makes this even worse is that many of those hooked started with trying to get help. We’ve learned quite a bit since the time period of doctors recommending smoking. Let’s not be so naive again.