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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