Although pharmaceutical drugs have been blamed for their role in the opioid crisis, they are not the only factors at play.  In addition to bad players in the pharma industry, including the producer of Oxycontin, clinicians have also played a role in the ongoing crisis–over-prescribing opioids to patients who do not require it any longer.  In this post, we will investigate some of the possible causes of the opioid crisis, as well as how the U.S. Food and Drug Administration (FDA) and other lawmakers have been responding to this crisis.  

The idea that patients should “feel no pain”

One of the tenets behind clinicians’ approaches to treating patients is what is called the “Patient’s Bill of Rights,” which purports that it is unacceptable for a patient to be in any sort of pain.  Although most health care providers aim to ensure that their patients are not in pain, there comes a point when their efforts are taken too far. When attempting to treat a patient, it is possible for clinicians to over-prescribe medication because they do not have an intimate knowledge of their patient’s pain.  It therefore becomes important that the patient inform the clinician about his or her pain needs, and what they require to adequately treat their pain.  

FDA Responses to the Crisis

In an effort to better address the opioid crisis, the FDA has been working to put into place what is called the Risk Evaluation Mitigation Strategies (REM) system.  This system is a drug safety program which would work toward mitigating some of the risks of opioids, as well as controlling the effects of opioid producers. It would require that health care providers undergo training to be better-informed about the safety risks of the drugs they are prescribing.  In addition to developing this system, the FDA has also strongly suggested the removal of certain opioids from the market.  The opioids that were targeted in this directive were those with a formulation that could be easily broken apart–making it easy to abuse by taking large doses together.  All of these steps were taken by the FDA as part of an effort to ensure that the benefits of opioids outweigh its risks.

Baseline Pain

Although it becomes easy to place blame solely on pharmaceutical drugs for the current opioid crisis, this ignores the responsibility that people have in fighting the crisis.  When it comes to doctors, there is only so much that they can know about a patient’s pain–it is up to the patient to judge what the best course of action for pain treatment is.  Patient accountability means that patients need to stop taking pain products when their pain is gone so that they are able to avoid potential addiction. This also means that, in cases where a patient’s pain has gone on longer than 3-5 days, they should consult with a doctor to consider alternative medicines such as Ibuprofen, which in some cases may actually treat their pain better than morphine.  

American society has normalized the idea that pain is unacceptable, however, it is important to keep in mind that a certain amount of pain is normal.  In the context of training at a gym, for instance, there is some quantity of pain that a person has to endure while working out that is unavoidable and not necessarily harmful.  When it comes to patients, debilitating pain should be avoided, however a certain baseline of pain might not require medication–particularly not prolonged use of opioids.  

How Long is Too Long?

Depending on the type of pain, it is necessary for individuals to talk with their doctor about the right amount of time to stay on pain medication.  However, it is also important to keep in mind that doctors do not have intimate knowledge of what your pain requires–patients must take accountability and decide whether opioids are truly necessary in their recovery process.  This discussion between doctors and patients needs to occur so that both parties can mitigate risk of addiction, and ensure that the benefits of opioids outweighs its risks.

Despite the blame that has been assigned to various groups for the opioid crisis–including clinicians, patients, and drug distributors–it seems that the focus should remain on attempts to address the epidemic, and steps being taken to prevent addiction to opioids.  By focusing on patient accountability, as well as training healthcare providers and taking certain opioids off the market, policymakers appear to be making strides in their efforts to curb the epidemic.

If you have any other questions about how the opioid crisis and how you can help, reach out to me on Twitter, LinkedIn, or send me a message here.

I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen to the podcast on Google Play or on Soundcloud.

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The opinions stated in this blog are the sole and present opinions of the blogger and do not necessarily represent the opinions of the Kulkarni Law Firm, PC and/or its attorneys. Such opinion(s) may change over time. Such opinion(s) should not necessarily be attributed to the institution for which these individuals may work or otherwise represent in any capacity. These blogs do not constitute legal advice and should not be construed as such.