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The number of deaths from prescription pain relievers dropped 5% in 2012, and new tools are helping in the fight against opioid abuse.
There may be a light at the end of the tunnel in the fight against opioid addiction. A 2013 report from the Centers for Disease Control and Prevention (CDC) indicates that the number of deaths from prescription pain relievers dropped 5% in 2012, the first decline since 1999. This is in contrast to a three-fold increase in the United States from 2001 to 2011, according to the National Center for Health Statistics.
The Department of Health & Human Services is taking steps to address the opioid problem through an initiative that focuses on:
One of the other drivers behind the decrease in deaths from prescription pain relievers may be the shift of hydrocodone-containing combination products from Schedule III of the Controlled Substances Act to the more tightly regulated Schedule II by the Drug Enforcement Administration (DEA), effective Oct. 6, 2014.
DEA stated that the change affects several hundred brand-name and generic hydrocodone combination products, including cough suppressants that are currently marketed in the United States.
According to DEA, the rescheduling serves to alert prescribers, pharmacists, and others to the potential for addiction and highlights the need for careful monitoring and evaluation of use of the combination drugs.
Prescriptions for hydrocodone combination products that were written before October 6 may include refills, but not if they were dispensed after April 8, 2015. Prescriptions for Schedule II controlled substances are only allowed for 30 days maximum.
The Millennium Research Institute, a research, education and advocacy organization focused on toxicology, pharmacy and pain and practice management, conducted a study on the role of urine in drug testing in addiction treatment. In 51.5% of samples, liquid chromatography tandem mass spectrometry testing revealed the presence of unreported prescription medications or illicit drugs, while immunoassay tests showed clinical false positive and false negative results.
Steve Passik, Ph.D., vice president of clinical research and advocacy for Millennium Health, a health solutions company based in San Diego, says the enhanced information from the mass spectrometry tool presents opportunities in the clinical setting to intervene when relapses occur. It not only indicates that opioids have been taken, but goes a step farther to reveal the presence of unreported or illicit prescription medications. “The information can be put into a prescriber’s hand in 24 hours,” he adds.
Passik is not unaware of the difficulty balancing less abuse with ensuring that patients who need prescription controlled substances have access when necessary. He supports the move toward the use of opioids with abuse-deterrent features.
Jo-Ellen Abou Nader, senior director of drug waste solutions for Express Scripts, a PBM headquartered in St. Louis, Mo., says it’s easy for members to slip through identification for abusing prescription controlled substances -just by paying cash or using a drug card. Express Scripts uses predictive modeling to assist in finding these individuals.
If it finds that a member may be abusing prescription drugs, it reaches out to prescribers to verify drugs doses, to identify if the controlled substances are medically necessary to determine whether physicians have seen the patient in their office and if they have established a medication use agreement or contract with their patients spelling out a course of treatment.
The PBM’s ability to cross-check both medical and pharmacy data is a boon to detection and prevention. Nader says that it is important to get as much data as possible including doctor claims for office visits and multiple visits to the emergency room for drugs.
Express Scripts also communicates with pharmacies to verify that they actually filled and dispensed prescriptions. Nader says that electronic prescribing of controlled substances (EPCS) can help detect valid prescriptions and prevent doctor shopping but will not have much effect if physicians and patients are in collusion.
“You have to look at the big picture,” Nader says, “not just claims but also doses and combinations of drugs taken by members.” She agrees with Passik that the difficulty in solving abuse of prescription controlled substances lies with creating a balance between not locking in patients with long-term pain or cancer against too many prescriptions.
Ken Whittemore, senior vice president of professional and regulatory affairs for Surescripts, a health information network based in Arlington, Va., advocates for e-prescribing because he says it eliminates chances of tampering with prescriptions made possible by hand-written ones.
In 2008, the Minnesota Legislature enacted an e-prescribing mandate to improve quality outcomes and efficiency in healthcare. The mandate required prescribers, pharmacists and pharmacies and pharmacy benefit managers to be e-prescribing by Jan. 1, 2011.
New York’s I-STOP law for e-prescribing changes the way prescription drugs are distributed and tracked. It requires most prescribers to consult the Prescription Monitoring Program (PMP) Registry when writing prescriptions for Schedule II, III, and IV controlled substances. The PMP Registry provides practitioners with direct, secure, real-time access to view dispensed controlled substance prescription histories for their patients.
New York also recently extended the implementation of mandatory EPCS for another year, until March 27, 2016; however, e-prescribing of both controlled and non-controlled substances is already permissible in New York.
According to Surescripts, 70% of pharmacies are able to receive electronic prescriptions for controlled substances, while only 6% of prescribers are ready to e-prescribe. That served as an impetus for Surescripts to develop a step-by-step video guide and tools to educate prescribers about EPCS.
Whittemore says that because more requirements exist for providers than pharmacists to deploy e-prescribing, the former are not moving forward as quickly. “E-prescribing is not always popular with doctors,” he adds.
Surescripts expects to increase the number of electronic prescriptions of controlled substances in 2015 by 400% over last year. At press time, EPCS was legal in 48 states and the District of Columbia.
Cathy Starner, principal health outcomes researcher for Prime Therapeutics, a PBM based in St. Paul, Minn., says the PBM is not doing anything that unusual in terms of clinical programs addressing prescription controlled substance abuse and fraud, but that Prime does stand out in one way: It measures the success of programs and shares results with others.
Prime Therapeutics developed a controlled substance score that identifies high-risk users. By analyzing the scores, the PBM found a significant association between scores and health outcomes, including hospitalization and emergency room visits, drug costs and total cost of care.
“There is a linear relationship between higher scores and more utilization, which leads to higher costs. It is important to identify members with high scores and intervene,” she says.
In a study, Prime examined the number of claims, prescribers of the drugs and pharmacies dispensing them, as well as the rate of use of controlled substances, of 11 million commercial plan members over three months of claims. Prime then looked at 1 million members who had a score of 2.5 or higher and had been enrolled continuously during 2012 and 2013, and found that a one point increase in a score is associated with:
Prime’s earlier research indicated that there was a 1.4 point reduction in members’ controlled substance scores when prescribers received letters about their patients with higher scores. Starner says the majority of prescribers found the letters useful.
Medicare Part D does not permit prescription drug plans or Medicare Advantage prescription drug plans to limit patients with a history of abuse to one prescriber and/or pharmacy. Bills have been presented to change this scenario.
On the other hand, 46 state Medicaid agencies currently operate lock-in programs that prevent recipients from obtaining excessive quantities of prescription drugs. Program design varies widely between states in terms of defining high-risk controlled substance use, the scope of actual lock-in restrictions and length of program enrollment. In addition, there is a lack of peer-reviewed literature evaluating the design and effectiveness of Medicaid lock-in programs.
Every state but Missouri has established Prescription Drug Monitoring Programs (PDMPs), which maintain statewide electronic databases of prescriptions dispensed for controlled substances. The programs help identify drug abuse and diversion and prescription drug-addicted individuals to enable intervention and treatment; educate individuals about abuse; inform public health initiatives; support legitimate use of controlled substances; and confirm for prescribers that a drug is being used for a legitimate medical condition.
Information includes a patient’s personal information, the name of the medical practitioner doing the prescribing, the dispenser, the type of medication and the dosage. Medical practitioners are then encouraged-and in some states, such as Kentucky, required-to access this information from the electronic database, prior to writing a prescription for a potentially addictive drug.
At first Passik says the monitoring programs offered little value but now that they are moving to real time, he considers them to be more effective-especially in conjunction with urine drug testing. He points out that each state determines if it will operate a monitoring program, including how often data are collected, who can access the data, when it can be accessed and whether communication can cross state lines.
In light of a study revealing that care providers in the highest prescribing state wrote almost three times as many opioid painkiller prescriptions per person as those in the lowest prescribing state, a July 2014 CDC brief makes recommendations to states about PDMPs. The report suggests that these different patterns arise from disagreement in different parts of the country over when to use prescription painkillers and how much to prescribe.
The CDC recommends that states increase use of their monitoring programs by making data available in real time, ensuring that all prescribers for all controlled substances use the program and that prescribers receive alerts when problems are identified. It also recommends that healthcare providers use the drug monitoring programs to identify patients who might be misusing prescription drugs.
In early April, the U.S. Food and Drug Administration issued a final guidance to help drug manufacturers develop opioid drug products with potential abuse deterrent properties. The guidelines recommend how manufacturers should conduct studies that demonstrate the drugs are abuse deterrent.
The California State Legislature introduced a bill recently that facilitates doctors in prescribing “abuse-deterrent formulation” opioids in place of traditional ones to reduce the use of narcotics.
Mari Edlin is a freelance writer in Sonoma, California.