Any newspaper or media outlet you visit, there is at least one article that covers the current opioid crisis (#opioid). This epidemic doesn’t just impact low income neighborhoods or vacation areas. It impacts all neighborhoods and socio-economic levels. The headline you see above might be a headscratcher since they do have regulations about prescriptions drugs. But I will explain why the federal government could stop this epidemic tomorrow but won’t (#opioidcrisis). And as you probably guessed it, it has everything to do with money.
Brief Background of an Opioid Medication
So we begin with a basic explanation of what is an opioid? An opioid is a substance or chemical that interacts with opioid receptors to produce morphine like effects. These receptors are located in the brain, spinal cord and digestive tract. These receptors in our body produce their own natural opioids that do everything from appetite control (dynorphins) to pain resistance/ relief (endorphins) to mood changes/ disorders (nociception). These natural chemicals are produced by the body in small quantities as a natural defense to injury or outside influence. The best way to describe it is they create this morphine-like high feeling which in a sense numbs pain sensors in the body.
Problems come when additional large quantities are introduced into the body from outside (pills/syrups). Introduction of such opioids like morphine, codeine, tramadol, kratom, opium, hydrocodone, oxycodone, fentanyl, buprenorphine, heroin and oxymorphone will alter this balance. These opioid medications will replace or compete with the naturally occurring chemicals in your body. Everyone has a different pain tolerance, there will be some individuals who will be unaffected by opioid medications. For others, they will experience one of the side effects of opioids which is addiction. Their need to maintain that high to get but for others, their body will crave more and more.
The Opioid Crisis Cycle
In order to understand the opioid crisis, we need to somewhat map it out. After the commercialization of Vicodin and oxycodone, laws were put in place to manage these prescription drugs. These drugs were considered Schedule II substances and were regulated by the Drug Enforcement Agency (DEA). Schedule II substances are approved drugs that have a high potential for abuse which may lead to severe psychological or physical dependence. In terms of regulation, that is before you can make, ship or sell, you had to fill out forms along the supply chain process so the DEA can see where the drugs are at any given moment. This monitoring was not on a pill by pill case but rather on a batch by batch basis.
Each step of the way involves forms to be submitted with the most common form being the DEA 222 form. Suppliers need it to ship the active ingredient to a qualified manufactured with a controlled substance license. The final manufactured product is then shipped to a distributor like Cardinal health using the form. Pharmacies are no different and require a form filled out to ship product to the designated location like a local CVS. Each step requires inventory count, dual verification and strict access controls for these opioids. At each step, you get a sense of where product is going based on demand and supply.
Doctors are important because they are the source of sales. Doctors are influenced by the sales force of the manufacturers. Sales people attempt to influence the prescription habits of doctors in various ways. Office visits are the most common and you can generally tell by seeing sharply dressed representatives sitting in the waiting area. Working lunches are another way of provide drug information. Conferences whereby doctors are invited to hear guest speakers and field experts speak about topics or drugs can also be influential. I am sure there are additional methods but we can stick with these three. the goal is to influence the prescribing habits of doctors towards your medications. All drug manufacturers do this.
After the influence comes the most important part which is the pain management of the patient. Whether it is in a hospital setting or private practice, there are rules regarding pain management. Prior to 2017, in New Jersey, if you were admitted into a hospital or clinic, a pain assessment was done from 0-10. The doctor had to try and manage your pain while being treated. Keep in mind that pain is subjective and each individual has a different threshold for pain. Feedback is also subjective and based on your responses. This aspect although had good intention, resulted in different outcomes. Doctors were now being rated or judged based on how well they treat pain management. Speed is rewarded while accurate dosage was discarded. What is the fastest way to treat pain? Opioid prescription drugs. This is one piece to the opioid crisis.
The wholesaler is in my opinion where the whole chain can be controlled with amazing visibility. Wholesalers fill in the orders from the pharmacies. Pharmacies need a prescription in order to dispense these drugs. There are a small amount of pharmacies that can abuse the system but they can quickly be brought down. Wholesalers have all the data of how much goes where and this seems to be where the system breaks down. The top 3 Distributors last year were Cardinal Health, AmerisourceBergen and McKesson. Their purpose is to buy large portions of prescription drugs from the manufacturers and resell them in smaller quantities to pharmacies. The price difference is their profit zone.
Unfortunately, these large corporations report to shareholders and need to ensure that the sales are met. So if a pharmacy in a small town in Kentucky orders a million Vicodin pills, they happily refill it. The goal is not to take into account if its too much for a given population size. No research is done to ensure that these prescription drugs are feeding the opioid crisis. Common sense will tell you if the population of that town is 10,000, and an order of 1 million pills is received, a big red flag should pop up saying something is wrong. One would think that an alert would be triggered. Instead they blame the pharmacy for filling the prescription. Keep in mind that prescription pads are regulated by the government with a DEA# on it and each one is serialized. This is piece of the opioid crisis.
Initially the DEA went after the pharmacies and the doctors that operated what was known as pill mills. Florida used to be the number one state for pill mills. Drug addicts knew that if you needed oxycodone or Vicodin, then simply go to Florida, get a prescription from any of the fly by night clinics and have it filled at a legitimate pharmacy. Pharmacies have some blame in this situation but at the end of the day, they are filling a legitimate controlled government form. Distributors do have all the power to limit the supply and have the obligation to limit supply.
They have to follow the Controlled Substances Act whereby these distributors are to report and stop suspicious orders such as unusually large or frequent shipments of opioids. On top of this was the Prescription Drug Marketing Act which was enacted in 1987. It was passed in response to the development of a wholesale sub-market (known as the “diversion market or black market”) for prescription drugs. The attempt was to put curbs in place to prevent legal prescription drugs to enter illegal supply chains.
Regardless of how many doctors you put in jail, it becomes a case of whack-a-mole. Another doctor that wants an influx of cash can easily replace the one in jail. Distributors are really the key to stemming the flow of opioids. Unfortunately, they have shareholders who want the company to provide a profit for their investment. Opioid prescriptions are just too lucrative to avoid. Instead, they turned to the government via their PAC (special interest) and changed the laws in their favor to prevent the DEA from seizing their products as well as putting employees in jail. The story is linked below:
So if our government wanted to really stop the opioid crisis, it could simple give back the power to the DEA. Let the DEA confiscate shipments that are deemed going to the diversion market and put people in jail. If the penalties were stiffer, the opioid crisis would be much smaller and more manageable. Unfortunately money has all the power in politics and we rely on distributors to be our drug supply chain for all prescription drugs. Until the laws are reversed, enforcement agencies are given the tools to be effective, the government is responsible for this. No matter how much they spend on prevention or treatment, supply will always win due to demand.
What do you think?