The trafficking of widely-prescribed opiate painkillers such as oxycodone and hydrocodone has led to widespread access for these highly addictive medications. Other drugs are also highly trafficked for abuse – including sedatives and ADHD medications – because they have non-medical uses and because they are addictive.
Estimates suggest that at least 20% of opiates are diverted from legitimate to illicit use, but the real magnitude of diversion is unknown (diversion is defined in a information box below). A recent FDA-mandated trial of an opiate product concluded that 36% of the medication supplied in the study went missing. [ref] Because patients in clinical trials are followed intensively, when compared with routine medical care, a diversion level of 36% could represent a minimum estimate of diversion in the U.S.
Current methodologies for managing these medications after they leave the pharmacy can be fairly described as rudimentary, particularly in light of the fact that many of the prescribed Controlled Substances are the most addictive substances known.
It is estimated there are at least 7 million individuals taking painkillers for non-medical purposes every month, yet this underestimates the problem because pain medications are only one among many categories of Controlled Substances that are abused.
The non-authorized use of prescription drugs has become the major gateway to illicit drug use among teenagers, exceeding marijuana as the most prevalent drug of initial exposure.
“FDA estimates that more than 33 million Americans age 12 and older misused extended-release and long-acting opioids during 2007.”
- U.S. Food and Drug Administration [ref]
The Current Prescription Monitoring System is Not Effective
The DEA estimates that in 2009, on average six thousand people per day abused prescription pain relievers for the first time.
The magnitude and acceleration of the problem has led to physicians adopting defensive medical practices, such as written contracts that mandate patient behaviors and require extensive drug testing, all in an effort to establish protection from liability.
Treatment contracts are recommended by most state medical boards; we are aware of no other area of medicine where patient behavior is contractually mandated.
Patient drug testing is typically semi-annual with the cost per test averaging $1,000-3,000. [ref] Testing has grown to be a $2 billion industry but a recent federal court case has judged that urine testing is not a defensible measure of compliance. [ref]
Repairing the essential relationship of trust between physician and patient will improve our healthcare system and decrease costs.
In the 2011 Government Accounting Office publication “Prescription Pain Reliever Abuse” (GAO-12-115), DEA officials report that “based on the available prescription and sales data, there is no method to calculate which prescriptions are issued for a legitimate medical purpose by a practitioner acting in the usual course of professional practice and which are not.” [ref]
In other words, there are no current tools effective at identifying when a drug is misused or trafficked.
Why and How are Prescription Medications Trafficked?
Strong drivers for trafficking include either a individual’s addiction, the potential for financial gain, or both.
Oxycodone can be sold on the street for ten to twenty times its purchased value.
The DEA estimated that prescription drug trafficking in the U.S. was a $25 billion criminal enterprise when last studied in 1993 [ref]. Because the U.S. distribution of prescribed stimulants and opioids have each increased by approximately 1800% since then [ref], it is clear that the black market has fully infected our healthcare system.
Because no one can differentiate between real patients and criminals, fear and uncertainty surround the prescribing of these important therapeutics. Costs, risks, and inconvenience have risen greatly.
"We clinicians have the ultimate irony — good hard working Americans with real, painful conditions buying overpriced narcotics off the street from others who fake a condition to get a prescription to sell."
Anthony McEldowney, M.D., co-founder of RAMM Technologies [ref]
The ways medications are obtained for trafficking include:
- pharmacy and hospital theft
- internet purchases
- forged and altered prescriptions
- doctor shopping (obtaining similar prescriptions from multiple physicians)
- fraudulent prescribing by physicians
- transfer of medications from patient to others
- duping clinicians with fictitious identification or feigned symptoms
- sponsored relationships between a network of patients and organized criminals
Interviews of patients at methadone clinics reveal the most common ways they obtained opiates: [ref]
- 82% from dealers
- 50% from friends and family
- 31% from physician prescriptions
- 14% from emergency room visits
- 6% from theft
- 3% from forged prescriptions
- 3% from internet purchases
Vatex is developing Divert-X, a drug-safety system that will decrease the supply of trafficked medications and also serve to identify patients becoming addicted to their medications or involved in illegal practices. Only internet purchases would be outside Divert-X scrutiny.
How does Divert-X Work Compared to Monitoring in Use Now?
State Prescription Monitoring Programs (PMPs) collate and follow prescribing paperwork in order to identify over-prescribing by physicians or individuals obtaining similar prescriptions from multiple doctors.
Our solution is to monitor the pills.
The Vatex system will monitor pill access to identify diversion in real-time and enable coordinated intervention that will result in the reduction of drug trafficking. White papers are available to explain many aspects of the system.
Why PMPs Aren’t Sufficiently Effective
"I wouldn't declare any victory," Gualtieri said. "We still see the same stuff going on. We can go out and make these [prescription drug diversion] cases every day. …We're making progress but we're also going in circles in some respects."
-Pinellas Sheriff Bob Gualtieri, commenting on the situation in Florida
after the state enacted a robust PMP system [ref]
The prescribing of medications is under state rather than federal control and so is not standardized. PMPs also are state-specific and are designed to create a database of Controlled Substance prescribing – the frequency of prescriptions issued by doctor’s offices or issued to registered patients is reviewed.
Unusual prescribing patterns from physician’s practices or multiple prescriptions obtained by a single patient can be detected. Because of this, state PMPs are critically important.
However, a U.S. Department of Justice sponsored study estimates that the PMP initiative is only ten percent effective at reducing abuse and trafficking. [ref]
"Although a number of states have recognized the value of evaluating PMP activities, to our knowledge no states have completed systematic empirical studies of their effectiveness using health outcome data."
2012 PMP White Paper, Brandeis University PDMP Center of Excellence [ref]
The combination of all current measures - PMPs, physician and patient training, drug take-back programs, drug reformulation, regulatory action, patient contracts, and patient drug testing are evidently insufficient to decrease the problem. Nationally, DEA data show that trafficking is accelerating.
Trafficking continues to escalate because criminals possess the tools and resourcefulness to dupe the medical system, because an active market in controlled medications exists, and because addicted individuals are driven to avoid withdrawal.
Medical System Accountability
PMP systems could be far more effective if they were commonly used by healthcare practitioners. For several reasons, PMPs are only rarely accessed prior to Controlled Substance prescribing and dispensing.
“We are opposed to programs where there is required access to Prescription Monitoring Programs. Just as I choose to look at old records or not, I think the same should hold for the Prescription Monitoring Programs. If I find the information useful, I would like to be able to go get it. I would not want to be required to go get it – which some states are implementing. It adds several minutes of time which we really don’t have in the busy department.”
Robert O’Connor, MD, Representing the American College of Emergency Physicians before a FDA Hearing [ref]
Medical insurers are the customers for the Divert-X system. Participating pharmacies will be contractually obligated to assess the automatically-generated Divert-X risk score and apply clinical judgement prior to dispensing additional Controlled Substances. This enhanced level of clinical involvement and data access elevates the status of pharmacists in the care continuum. Prescribers will have free access to all Divert-X data on their patients.
The Vatex Solution to Rx Trafficking
Vatex is assembling an integrated medical device-IT system, trademarked as Divert-X, to monitor patient access to individual doses of medications in order to identify patient behaviors inconsistent with prescribed medical use and consistent with misuse and trafficking.
Response to irregular behavior will enable evidence-based intervention by healthcare providers consisting of counseling, modifications to the prescribed regimen, or referrals to law enforcement.
It is our expectation that the approach will significantly decrease trafficking - causing a reduction in drug seeking and in the supply of diverted medications.