Thursday, February 2, 2017
Is the government's Prescription Drug Monitoring Program reponsible for patient death?
For years, state and federal lawmakers have threatened doctors with the loss of their medical license in an attempt to stem the illegal use or sale by patients of prescription pain killers.
The following article was written by Dr. John D. Lilly and originally published on the Coach’s Team website in September of 2016. Dr. Lilly describes the methods by which the rights and privacy of countless patients have been infringed by intrusive and generally ineffective Prescription Drug Monitoring Programs.
Tragically, the intimidation of healthcare providers by government has too often resulted in the inability to obtain necessary prescription pain medications by many who suffer from excruciating, chronic pain. The article entitled “Why My Stepson’s Father Killed Himself”follows that of Dr. Lilly and relates the heart-wrenching story of a man whose doctors may have ignored a principle admonition of the Hippocratic Oath which requires that a doctor, “will use treatment to help the sick according to [his] ability and judgment, but never with a view to injury and wrong-doing.”
Upon finishing the story of Bruce Graham’s last days, decide for yourself if his doctors heeded the teachings of the Hippocratic school which instruct the doctor to, "Practice two things in your dealings with disease: either help or do not harm the patient." Ed.
The Failure of the Prescription Drug Monitoring Program
By Dr. John D. Lilly, Center for Self-Governance Student
Deaths in the U.S. due to prescription drug overdose are reaching crisis proportions. The increase in the death rate due to all prescription drugs has been primarily due to the increase in prescription opioid pain medications. State governments are looking for a solution to the problem. Historically, it has been very easy for people to obtain opioid prescriptions from multiple doctors; therefore, an obvious solution is to monitor who is receiving all opioid prescriptions. States enacted Prescription Drug Monitoring Programs (PDMP) which record who is filling opioid prescription medications at every pharmacy in the state. The information goes into a database that can be accessed by doctors and pharmacists. The assumption was that having access to this information would stop individuals from obtaining medication from multiple providers, commonly known as “doctor shopping.” However, the death rate due to opioids continues to rise despite the fact that every state except Missouri has a PDMP.
Prescription medications that are controlled by the Food and Drug Administration (FDA) are classified on five different schedules from I to V. Schedule II through V drugs are prescribed by physicians. Schedule II drugs are the most addictive and are the most controlled. They include opioid pain medicines like hydrocodone (Lortab®, Vicodin®), oxycodone (OxyContin®, Percocet®), morphine (Roxanol®, MS Contin®), and methadone (Dolophine®). Schedule IV drugs include benzodiazepines like alprazolam (Xanax®) and diazepam (Valium®). They are less addictive, but more habit forming.
A National Institute on Drug Abuse report shows the number of deaths caused by all prescription drugs for the entire country has increased from 7,885 in 2000 to 25,760 in 2014 and the number of deaths per 100,000 population, age adjusted, has increased from 2.81 in 2000 to 8.00 in 2014. That is a 226% increase over 15 years or 15% per year. A subset of that number is the deaths caused by opioid medication, which has increased per 100,000 population from 1.54 in 2000 to 5.91 in 2014. That is a 329% increase over 15 years or 22% per year. Another subset is the number of deaths caused by benzodiazepine medication (Valium and Xanax, for example), which has increased per 100,000 population from 0.46 in 2000 to 2.49 in 2014. That is a 512% increase over 15 years or 34% per year.
The increase in all prescription drug deaths is primarily due to the increase in opioid pain medicine deaths with a smaller proportion due to benzodiazepines. Those two classes account for almost all of the increase.
How did opioid pain medication become such a large problem? Before 1990, physicians were reluctant to prescribe opioid pain medication. It was only prescribed for a limited time for broken bones and after surgeries. Chronic use was limited to terminal cancer patients. During the 1990s, federal and state agencies started encouraging physicians to treat chronic pain with opioid pain medicine.
On the national level, the President’s Commission on Model State Drug Laws was formed in 1993. A bipartisan commission went on a fact-finding mission to obtain information at the local level about drug and alcohol abuse problems. The commission then created a nonprofit organization: the National Alliance for Model State Drug Laws (NAMSDL), to help disseminate information and be a resource for state legislatures. Initially, NAMSDL worked to curb illegal drug and alcohol abuse. Later it took on the task of curbing prescription drug abuse. Its solution was to push to enact PDMPs in every state.
Not surprisingly, the drug crisis was used to implement yet another government program to control individuals.
A PDMP is a statewide, electronic database which collects designated data on specific medication dispensed in the state. The program is housed within a specified statewide regulatory, administrative, or law enforcement agency. The purpose of the program is to eliminate “doctor shopping” which is the practice of one patient going to two or more physicians to obtain prescription pain medication and having the prescriptions filled at two or more pharmacies. It has often been the intent of such patients to sell the medication.
Since Missouri is the only state without a program, it should be at the top of the list of deaths by prescription drug overdoses if these programs actually work. Looking at the number of deaths in 2014 due to all prescription drug overdoses per 100,000 population, Missouri (see arrow) is 24th.
Limiting the deaths to those caused by prescription opioid pain medication, Missouri is 22nd. The deaths from prescription drugs since 2000 have been getting worse in every state. If the goal is reducing the death rate, then every PDMP is a failure.
Proponents claim that a PDMP is required to catch all of the “doctor shopping” that makes opioid medications readily available to the public. According to the 2014 National Survey on Drug Use and Health, obtaining pain relievers (opioids) from more than one doctor is minimal. In this survey, the total percentage of users aged 12 and older who obtained pain relievers for non-medical use from more than one doctor was 5%. 85% got pain medicine from one doctor themselves, got it free from a friend or relative, or bought or took it from a friend or relative who obtained it themselves by one of these four methods. Clearly, doctor shopping is not the massive problem the proponents of PDMPs would have us believe.
Is there any research indicating that PDMPs are effective? The proponents will point to small studies which, however, reveal a limited effectiveness in a few programs (one in Tennessee and one in Florida). Both states have a worse problem than Missouri. A 2011 original research article in Pain Medicine that evaluated prescription drug deaths from 1999 to 2005 found that, “PDMPs were not associated with lower drug overdose mortality rates for any of the study years or with decreases (or even with lesser increases) in the rates of death resulting from drug overdoses.”
There are specific scenarios that will not be flagged by a PDMP: When one patient consistently gets the same pain medication from the same physician every month. That is not doctor shopping. But that is how the 85% get their medications. In these instances, there is no PDMP that will catch this type of diversion.
If the PDMPs are ineffective, why do they continue and even expand? The National Alliance for Model State Drug Laws is the organization that is behind the expansion. It believes the PDMP should proactively provide data to every profession and governmental agency which could have access to the database that they might look for potential signs of misuse or diversion. Proponents argue that if such programs save just one life, it is worth the massive invasion of privacy forced upon countless patients nationwide.
However, the liberty of millions of citizens must not be infringed because a certain number of patients make a poor decision.
The solution to the problem of prescription drug overdose deaths will not be found in one program or project. The burden of unearthing and preventing diversion of prescription medication mainly falls to the physician. The two primary methods to identify individuals who divert prescription medications are random urine drug screens and pill count visits. There are several sophisticated urine drug tests that will tell the physician if the patient is taking the medication properly by checking for the actual drug and its metabolites in the urine. Doing these tests at random times helps ensure that patients are taking the medication consistently. The second method is a pill count visit. Someone who sells or misuses their medication after getting the prescription filled at a pharmacy generally will do so within the first two weeks of obtaining the medication. In a pill count visit, the physician contacts the patient three to four weeks after writing the prescription and tells them to come in for an office visit and to bring their prescription medication in the bottle dispensed by the pharmacy. If they refuse to make an appointment or if they do not show up for the appointment, that is a good indicator that they did not have any pills left because they had already sold or used their monthly amount. Does government have a role in this solution? The Centers for Disease Control and Prevention (CDC) released a Guideline for Prescribing Opioids for Chronic Pain. It has finally admitted that it should not be encouraging physicians to prescribe opioids for chronic pain patients.
The Prescription Drug Monitoring Programs are another way for centralized government to collect information and maintain control over citizens without ever solving a problem - which ensures its perpetual existence. This can only be reversed if citizens use their civic authority to control the proper boundaries of centralized government.
John D. Lilly, MBA, DO is a physician in Springfield, Missouri and President of the Locke and Smith Foundation. For more information, visit drjohnlilly.com.
The Language of Liberty series is a collaborative effort of the Center for Self Governance (CSG) Administrative Team. The authors include administrative staff, selected students, and guest columnists. The views expressed by the authors are their own and do not reflect the views of CSG. They may be contacted at firstname.lastname@example.org To learn more, go to CenterForSelfGovernance.com.