I am writing to comment on your regulation on opioids regulation and requesting that you consider alternative compliance for tramadol patients. 

I am almost 79 years old and suffer osteoarthritis.  I have j been informed by my doctor that she must see me quarterly in addition to the required schedule for urine tests. This is an unreasonable burden for me and most suffers of osteoarthritis.  I live 40 miles from my doctor, so making two additional visits, in addition to my annual physical and follow up, imposes both a cost and time burden.  I discussing your regulation with others in a similar situation, some will discontinue using tramadol and instead turn to an alternative that might not be as effective but could carry a higher risk.

As you know, osteoarthritis is primarily an ailment of the elderly and, according to the CDC, affects 30 million adults.  By 2030, it has been estimated that 70 million adults over 65 will be at risk of osteoarthritis.  Since the average annual income of Social Security recipients is roughly $25,000, the cost of complying with the regulation will be significant for at least 50% of the elderly.  While the opioid problem is very serious in Virginia as well as other states, I believe that providing regulatory flexibility for patients receiving regular and long term medical treatment will not jeopardize the primary objective of your regulation.

Although tramadol is an opioid, the risk of addiction is considered low.  In addition, the risk of addiction must be even lower in elderly patients who are not already addicted to medications, alcohol, or narcotics. The Board should consider alternative means of compliance that will not create a serious risk to its effectiveness for patients who can meet strict but reasonable compliance criteria. 

Let me offer one possibility. Doctors could complete an exemption request that provides relevant medical and patient information, including how long he/she has been a patient and length of time on tramadol. It would include the reason for use, and a brief summary of medical history, including any history of addiction or drug abuse.  The request for an exemption could be certified by another physician, unless the doctor is a sole practitioner. 

An objection to allowing such an exemption could be that doctors who are over-prescribing might not truthfully complete the form.  However, any doctor who would be guilty of that is also likely not to honor the requirements of your regulation.

Surely, you must realize that a “one size fits all” violates the principles ofrisk assessment and cost-effectiveness.  Treating a Class 4 drug the same as a Class 1 one on its face validates my conclusion.  In addition, from the literature I have read, the abuse is directly related to the consumption of illegal drugs such as heroin. 

It is unclear to me why Virginia’s Prescription Monitoring Program cannot be the primary means for alerting to abuse and over prescribing?

William O’Keefe

5450 Brickshire Drive

Providence Forge Va. 23140

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I am writing to provide supplemental comments concerning the Board’s Opioid regulation.  After reviewing more of the literature, I am even more puzzled about the justification for the current regulation, especially including Class 4 opioids like Tramadol, that is overly broad and too rigid.  I believe that empirical data justify a revision that at a minimum would be tiered, provide flexibility to physicians, and make the Prescription Management System a more effective management tool.

The National Survey on Drug Use found that the nonmedical use of prescription opioids peaked in 2012 while opioid overdose deaths continued to increase.  Professor Chinazo Cunningham, a recognized expert from the Albert Einstein College of Medicine, has reached the same conclusion. It appears that the view of most experts is that deaths are being caused by the use of illegal drugs.  The data also show that more people have died from heroin overdoses than from prescription overdoes. 

A 2014 study by the Journal of the American Medical Association found that just 13% of overdose patients were people on opioids for chronic pain.  A comprehensive review by the Cochrane Library found that the addiction rate for people on prescriptions was only 1%. 

Disturbingly, the CDC has reported that some people who take opioids for pain and who are cut off by their doctors turn to the illegal drug market as an alternative.  This strongly suggests that the Board’s regulation could be counterproductive because some people who must comply with quarterly visits to their doctor along with six month urine tests could turn to riskier alternatives as being less burdensome and costly.

The above conclusions were also confirmed in a health commentary this summer by Robert DuPont the first director of the National Institute of Drug Abuse and William Bennett the nation’s first drug czar.  They wrote, “70 percent of our nation’s opioid deaths do not come via prescription abuse. …  The main problem today, and the growth for tomorrow, is illegal opioids such as heroin, illegal fentanyl, and a hundred other synthetics, not legal drugs used illegally or in ways not as prescribed.”  In 2015, there were 33,000 opioid overdose deaths with heroin deaths constituting almost 13,000 and synthetic opioids (mostly illegal fentanyl) another 9,600 deaths.

As the Board’s staff reviews the additional comments that are filed, I urge you direct them to also review the literature.  It should lead to a conclusion that the current regulation needs to be revised because it will, at best, only have a marginal effect on overdosing while placing an unnecessary burden on doctors for complieance as well as patients who take opioids for chronic pain management.

Increasing the cost (which includes the imposed burden) of complying with the regulation for pain management patients as well as physicians, while most likely reducing effectiveness is compelling evidence of a need for revision.  The goal of any regulation should be the highest practical level possible with the lowest practical cost.  The current regulation does not do this.

William O'Keefe

5450 Brickshire Drive

Providence Forge, Va 23140

804-966-7370