Can Mandatory Consultation of a State PDMP Reduce Overdose Morbidity? Maybe.

Every state now has a prescription drug monitoring program (PDMP) in place to record prescriptions of controlled substances, but they vary widely in the information they collect and whether and how physicians must consult the database. Beginning in 2013, New York instituted mandatory consultation for physicians: before they prescribe an opioid to a patient, they are required to consult the state PDMP database to determine if the patient may be at risk for abusing the prescription.

To explore the effectiveness of the system (called I-STOP, for “Internet System for Tracking Over-Prescribing”), researchers at Bassett Healthcare Network in Cooperstown, NY, examined prescription trends and opioid-related mortality before and after the implementation of I-STOP.

They found that while the number of opioid prescriptions declined after implementation, the total quantity of opioids in the supply chain increased. Hospital and emergency department visits for prescription opioid overdose were not significantly affected by the program, and visits for heroin overdose, which began to increase in 2010, continued to rise through 2016.

Despite not decreasing opioid-related morbidity, the program may nonetheless have prevented it from increasing. The authors concluded: “The overall significance of these findings shows a small impact of PDMPs on prescription opioid overdose morbidity in New York in the context of the increasing national trend during this time period.”

Reference

Brown R, Riley MR, Ulrich L, Kraly EP, Jenkins P, Krupa NL, Gadomski A. Impact of New York prescription drug monitoring program, I-STOP, on statewide overdose morbidity. Drug Alcohol Depend. 2017 Sep 1;178:348-354.

Opioids and Benzodiazepines: A Dangerous, and Common, Combination

More than a quarter of patients being tested for either prescribed opioids or prescribed benzodiazepines tested positive for both drugs, according to a new study in the Journal of Addiction Medicine.

“Our findings far exceed previous estimates of combining opiates and benzodiazepines based on prescribing databases alone, suggesting existing prescription databases and monitoring programs do not fully reflect the extent to which individuals may combine these drug classes in the United States,” said lead author F. Leland McClure, PhD, MSci, F-ABFT, Director, Medical Science Liaison, Medical Affairs, Quest Diagnostics.

In the study, over 144,000 samples from patients who were prescribed at least one of the two drugs were tested for both. The results showed that more than 25% of samples were positive for both an opioid and a benzodiazepine. Of those patients who tested positive for both, 52% had a prescription for only one of the two drugs, meaning they were using the other one outside of medical supervision. Both drug classes are central nervous system depressants. The combination of the two can suppress the respiratory system and cause cardiac distress, increasing the risk of death.

“Physicians should be aware of potentially dangerous drug interactions beyond the prescription level,” Dr. McClure said, “and our data demonstrate these interactions are happening with alarming frequency.”

Reference

McClure FL, Niles JK, Kaufman HW, Gudin J. Concurrent Use of Opioids and Benzodiazepines: Evaluation of Prescription Drug Monitoring by a United States Laboratory. J Addict Med. 2017.

Number of Opioids Prescribed Has Fallen Since 2010

The quantity of opioids prescribed in the United States peaked in 2010 and has been falling since, according to a new study from the Centers for Disease Control and Prevention (CDC). But the quantity prescribed in 2015, the last year for which comprehensive data are available, is still more than three times as high as it was in 1999. The study also found that counties with the highest quantity of prescribed opioids had higher levels of non-Hispanic whites, higher levels of unemployment and Medicaid status, higher prevalence of diabetes and arthritis, and more physicians and dentists per capita, and were more likely to be “micropolitan,” characterized by towns and small cities.

The study encompassed the years since the onset of the opioid epidemic, but before the issuance of the CDC guideline on opioid prescribing in 2016. The variation among counties “suggests inconsistent practice patterns and a lack of consensus about appropriate opioid use and demonstrates the need for better application of guidance and standards around opioid prescribing practices,” the authors wrote.

To perform the study, the authors obtained prescribing information from a national medical data collection company, whose database contains information from approximately 59,000 pharmacies and from 88% of the prescriptions written in the US.

From 2006 to 2010, prescribing rates for opioids increased from 72.4 to 81.2 prescriptions per 100 people. They remained at that level through 2012, and then declined to 70.6 per 100 people by 2015.

In 1999, opioid prescriptions totaled 180 morphine milligram equivalents (MME, commonly used to compare doses among opioids) per capita nationwide. The new study revealed that figure had risen to 782 MME by 2010, and fallen to 640 MME by 2015, still 3.5 times the 1999 level.

The authors suggested that two prescribing changes may account for the drop in the quantity of opioids prescribed per capita in recent years. First, the daily dose in the average prescription fell. They note that the largest decrease in the average daily MME per prescription occurred between 2010 and 2012, concurrent with two national guidelines, one from the American Pain Society and American Academy of Pain Medicine, and the other from the Department of Veterans Affairs, that defined “high-dose” prescribing as more than 200 MME per day. At the same time, studies were published showing that opioid overdose deaths correlated with prescription opioid use. Second, the prescribing rate fell, perhaps due to “a growing awareness among clinicians and patients of the risks associated with opioids,” according to the study.

However, the authors of the study noted, those changes were opposed by a countervailing trend to write longer prescriptions. “This pattern, along with the trends in overall numbers of opioid prescriptions, might reflect fewer patients initiated on opioid therapy after 2012, whereas patients already receiving opioids were more likely to continue receiving them,” the authors suggested. That may be problematic, they argued, since research has shown that patients receiving opioids for more than five days are at risk for long-term use, and those receiving them for more than 90 days are unlikely to discontinue, “highlighting both the importance of minimizing unnecessary initial opioid exposure and potential challenges in reducing opioid use among patients already receiving them,” they concluded.

The national patterns were a composite of widely varying state- and county-wide trends that in many cases ran in the opposite direction. Between 2010 and 2015, the study found, “half of counties in the US experienced reductions in the amount of opioids prescribed,” while the other half experienced an increase (22.6% of counties) or no change (27.8%), despite the nationwide increase in awareness of this health epidemic. The states of Florida, Ohio, and Indiana experienced statewide decreases in MMEs prescribed per capita, while increases were the rule in northern New York and Vermont, large portions of Wyoming, and many counties in Iowa, among other locations.

The total number of opioids prescribed varied dramatically by county. The average MME per capita in the quartile of counties with the highest per capita MME was more than six times as high as that in the quartile with the lowest: 1,319 MME vs. 204 MME. That dramatic prescribing difference may be explained by much less dramatic, but still statistically significant, differences between these counties in multiple aspects of socioeconomic and health status. In the highest-MME counties, diabetes was diagnosed in 12.1% of residents, and arthritis in 26.3%, versus 11.1% and 24.8% in the lowest-MME counties. The highest-MME counties also had lower income, higher poverty, less education, a higher proportion of Medicaid-eligible residents (23.3% vs. 20.6%), and a higher proportion of non-Hispanic whites (83.6% vs. 80.1%), and were more likely to include urban clusters with population between 10,000 and 50,000.

The authors suggested the wide variation in prescription patterns reflects differences in awareness and application of opioid prescribing guidelines. They recommend primary care clinicians treating adult patients with chronic pain pay wider attention to the CDC Guideline for Prescribing Opioids for Chronic Pain. “The guideline can help providers and patients weigh the benefits and risks for opioids according to best available evidence and individual patients’ needs and safely taper opioids if risks outweigh benefits. The Guideline recommends the use of non-opioid therapies, such as acetaminophen, nonsteroidal anti-inflammatory medications, exercise therapy, and cognitive behavioral therapy for chronic pain.

“Given the associations between opioid prescribing, opioid use disorder, and opioid overdose rates, states and local jurisdictions can use these findings to target high-prescribing areas for interventions such as academic detailing for clinicians or individual educational visits to clinicians, and increased access to medication-assisted treatment for patients with opioid use disorder. Innovative approaches, such as virtual physical therapy sessions with pain coping skills training, can be used to improve access to effective treatment for chronic pain. In addition, states can consider policies that can reduce opioid overdose, including mandated PDMP use and pain clinic laws. Changes in opioid prescribing can save lives. The findings of this report demonstrate that substantial changes are possible and that more are needed,” the authors said.

The full report can be read HERE, and is accessible as a PDF HERE.

States Vary Widely in What They Collect, from Whom, and When, for their PDMPs

It is clear that the prescription opioid epidemic is a nationwide problem, but for now, one of the most important weapons against it is being wielded inconsistently from state to state. Prescription Drug Monitoring Programs (PDMPs) are state-run electronic databases of prescribing and dispensing information from healthcare providers and pharmacies. They can be accessed by providers and pharmacists, as well as law enforcement personnel and state health officials to identify patients at high risk for opioid abuse or drug diversion. However, who has to report, what they report, and when they report it varies widely by state.

According to information compiled by the PDMP Training and Technical Assistance Center, 21 states, including New York and Florida, have no mandatory reporting at all. Twenty-three states, including California, Ohio, and West Virginia, require both prescribers and dispensers to report, while five states require only prescribers, and three states require only dispensers.

Eleven states, including California, Florida, and Maine, collect information only on prescriptions for drugs classified as Schedule II through IV. Twenty-two states collect information on prescriptions for drugs in Schedules II-IV, plus “drugs of concern.” Thirteen states, including New York and Pennsylvania, collect information on Schedules II-V only, while five states collect information on these plus “drugs of concern.”

Drugs of concern are a group of drugs not currently controlled by federal statute, but which have the potential for harm or abuse. They include DXM, kratom, and salvia.

Timely reporting is critical to prevent misuse of prescription opioids. States vary widely in their reporting requirements. Only one state—Oklahoma—requires reporting at the point of sale. Reports are due within one day in 36 states, but not for 3 days or more in 13 other states. According to the Centers for Disease Control and Prevention, “If there is a long interval between dispensing and submission into the state PDMP, providers and other PDMP users will not have information on patients’ most recent prescriptions. Timely data, like in a ‘real-time’ PDMP, maximizes the utility of the prescription history data, with significant implications for patient safety and public health.”

Updated Guidelines from the Federation of State Medical Boards on Prescribing and Testing for Opioids

The Federation of State Medical Boards (FSMB) recommends that urine drug testing be used as part of a comprehensive management strategy for patients receiving prescription opioids for chronic pain.

“Periodic and unannounced drug testing (including chromatography) are useful in monitoring adherence to the treatment plan, as well as in detecting the use of non-prescribed drugs,” the authors state. “In drug testing in a pain practice, it is important to identify the specific drug and metabolites, not just the class of the drug.”

The FSMB is a national organization representing the 70 medical and osteopathic boards in the United States and its territories. The recommendations are included in “Guidelines for the Chronic Use of Opioid Analgesics,” an updated report released by the FSMB in April 2017, meant for use by state medical and osteopathic boards in setting their own guidelines for physicians.

Before prescribing

The decision to prescribe an opioid for chronic pain must be preceded by a thorough medical and family history, and documentation of “the presence of one or more recognized medical indications and absence of psychosocial contraindications for prescribing an opioid analgesic,” the authors say. Evaluation of the relative risk for substance use disorder (SUD), including the use of validated screening tools, “should be part of the initial evaluation.”

Patients with a history of SUD require special attention, which may involve consultation with an addiction specialist, before and potentially during opioid treatment. “Clinicians who treat patients with chronic pain are encouraged to also be knowledgeable about the identification and treatment of substance use disorder, including the role of replacement agonists such as methadone and buprenorphine,” they say.

Recommended additional elements of patient evaluation and risk stratification include:

  • Personal and family history of mental health disorders
  • Depression screening
  • Information from family members and/or significant others
  • Screening for obstructive sleep apnea
  • Diagnostic support from urine, blood, or other biological samples
  • Consultation with the state prescription drug monitoring program (PDMP)

Treatment planning and treatment agreement

In line with guidelines from the Centers for Disease Control and Prevention, the FSMB recommends a thorough discussion of risks and benefits of opioid treatment before beginning therapy. Written informed consent should be obtained. The FSMB report also recommends development of a Treatment Agreement. “Agreements outline the joint responsibilities of the clinician and patient, including the patient’s agreement to periodic and unannounced drug testing for opioids and other medications when deemed appropriate by the clinician,” they write, adding that the agreement should also include discussion with the patient about “how and when the PDMP will be reviewed as part of the patient’s care.”

The treatment agreement should include:

  • Treatment goals
  • Patient responsibility for safe medication use, storage, and disposal
  • Patient responsibility to obtain an opioid prescription from only one practice, and to have the prescription filled at only one pharmacy
  • Patient agreement to periodic drug testing
  • Clinician responsibility to respond to unforeseen problems and to prescribe scheduled refills

Periodic and unannounced drug testing

Drug testing is an integral part of opioid therapy for chronic pain, as outlined in the FSMB guidelines. “Drug testing is an important monitoring tool because self-reporting of medication use is not always reliable and behavioral observations may detect some problems but not others,” the authors state. “It is strongly recommended that patients being treated for addiction be tested as frequently as necessary to ensure therapeutic adherence, but for patients being treated for pain, clinical judgment trumps recommendations for frequency of testing.”

According to the guideline, forensic standards for collection and transport are generally unnecessary, but observed collection is preferred, especially in pain clinics. Initial testing may include class-specific immunoassay drug panels, most of which do not identify specific drugs. Drug-specific gas chromatography/mass spectroscopy testing can follow if necessary. Point-of-care immunoassay testing, has limitations, including high rates of false-positives and false-negatives, “such that point-of-care testing may not be appropriate for making definitive changes in medication management in populations at high risk for adverse outcomes until the results of confirmatory testing with more accurate methods…are obtained.”

When ordering drug tests, they note, “Clinicians need to be aware of the limitations of available tests (such as their limited sensitivity for many opioids) and take care to order tests appropriately. For example, when a drug test is ordered, it is important to specify that it include the opioid being prescribed.” They add, “because of the complexities involved in interpreting drug test results, it is advisable to confirm significant or unexpected results with the laboratory toxicologist or a clinical pathologist.”

View the complete guidelines here.

The Role of Urine Drug Testing in Pain Management

Opioids and other medications (non-opioid analgesics, benzodiazepines, antidepressants, anticonvulsants, muscle relaxants) are prescribed to treat chronic pain of non-cancer origin. Ongoing monitoring of these patients is important to ensure safe and effective therapy. Drug testing is one tool utilized to identify patients who qualify for therapy and then to evaluate the continued effectiveness of pain relief; assess the potential for misuse, addiction or diversion; and ensure adherence to an agreed upon treatment plan.

What a PDM Program Can Offer Your Practice

For patients with chronic pain, opioids may offer important relief from suffering and help support activities of daily living. At the same time, if they are not used according to your prescription, opioids can do great harm. A prescription drug monitoring (PDM) program can help you maintain the maximum benefit of a patient’s opioid prescription, while minimizing the risks of misuse.

Maine’s Diversion Alert Program Aids Physician Decision-Making

Physicians must take into account many factors when making decisions about opioid prescriptions, including the risk that the individual patient may divert prescription medications for illegal use. To aid physician decision-making, the state of Maine in 2013 instituted its Diversion Alert program, a program that gives physicians access to state records of arrests or summons for prescription or illegal drug-related crimes.