When Wisconsin introduced its first prescription drug monitoring program (PDMP) system in 2013, doctors found the system clunky and cumbersome to navigate, recalled Noel Deep, MD, an Antigo, Wis.–based internist and president of the Wisconsin Medical Society.

Physicians had to click through several screens and were then directed to log into another website to enter patient information and scan records.

The state’s PDMP is much improved today, Dr. Deep said. The Wisconsin Department of Safety and Professional Services launched an enhanced version of the PDMP in January, giving doctors time to learn the new system before its use became mandatory for prescribers in April. The system takes fewer clicks and communicates with practices’ electronic medical record.

“It is very easy, compared with what it was before,” Dr. Deep said in an interview. “I was one of those people who were skeptical, but I’ve been happy with the PDMP. It’s extremely quick. I know it’s a few more clicks, but it has also shown that, in Wisconsin, this has significantly decreased the use of prescription [opioid] medications.”

Across the country, physicians are experiencing similar ups and downs with state PDMPs as they work to manage the systems, juggle patient caseloads, and make the best prescribing decisions. Currently, 49 states, the District of Columbia, and Guam have operational PDMPs. Most databases generally require that Schedule II, III, and IV prescriptions be reported, explained Natalia Mazina, a San Francisco–based attorney who specializes in health and pharmacy law.

“Some states also require Schedule V, and some states even require certain noncontrolled substances to be reported,” she said in an interview. “That’s the biggest difference. There are also different agencies responsible for enforcement.”

States differ in the time allowed for prescribers and dispensers to report data, Ms. Mazina added. States such as New York and Utah, for instance, require real-time reporting, while Alabama and Louisiana require daily PDMP reporting. South Dakota requires reporting within 7 days of a prescription, while Alaska allows for monthly reporting. Training hours required for PDMP participation also vary by state.

More states are moving toward mandatory rather than voluntary PDMP systems. At least 34 states now specify circumstances in which prescribers, dispensers, or both must access a patient’s PDMP prescription history, according to a summary by the National Alliance for Model State Drug Laws. For doctors, the push toward mandated PDMPs has generated mixed feelings and led to legislative battles in some states.

“From a safety standpoint, [PDMPs are] a good thing,” Dr. Deep said. “From a physician standpoint, [some] people feel this is restricting the physician-patient relationship and dictating how much we can prescribe, when we can prescribe, and what we can do. That’s one of the downsides.”

Beneficial or burdensome?

When Georgia legislators proposed a law earlier this year that would tighten reporting requirements for their state’s PDMP, physician leaders fought back against what they viewed as excessive regulations.

An initial bill included reporting requirements not only for standard controlled substances but for stimulants such as Adderall, Vyvanse, Focalin, and Ritalin, and all other nonopioid controlled drugs. The early version of the bill also recommended civil and criminal penalties for physicians who violated the regulations.

The American College of Physicians Georgia Chapter and the Medical Association of Georgia successfully advocated for the two provisions to be removed from the bill’s final version, said W. Cody McClatchey, MD, chair of the ACP Georgia Chapter’s health and public policy committee.

“We are in the midst of an opioid epidemic,” Dr. McClatchey said in an interview. “It would have been unreasonable and costly for state government to mandate that prescribers check PDMP for controlled drugs not related to the opioid epidemic. [In addition], I felt strongly that prescribers should not be subject to criminal penalties for not checking the PDMP. We are already subject to civil and criminal penalties for intentionally or knowingly overprescribing controlled drugs. That is adequate protection for patients.”

Georgia’s law, signed in May, requires physicians and up to two certified staff to seek and review information from the PDMP every 90 days for any prescription outlined in the law that exceeds 3 days/26 pills for medical care, or 10 days/40 pills for surgical care. In addition, physicians must make a notation in the patient’s medical record stating the date and time upon which such inquiry was made, among other requirements.

The new requirements mean it will take longer to manage patients with chronic pain, anxiety, and depression who may need opioids and benzodiazepines because of the time necessary to access the PDMP, document that it was reviewed, and properly counsel the patient, Dr. McClatchey said. However, he noted that the additional time may allow physicians to charge a higher level of evaluation and management services. Doctors can minimize the impact of the rules by delegating many of the tasks to certified medical assistants and using “smartphrases” to document completion, he said.

“In my opinion, the final version of HB 249 strikes a fair balance between the needs of patients and the administrative burden on physicians,” he said. “Most physicians do not prescribe opioids and benzodiazepines on a continuing basis to many patients. Physicians who prescribe chronic opioids or benzodiazepines now have the ability to more accurately know when patients may be abusing opioids and benzodiazepines, which can be a matter of life or death.”

‘Well-designed regs keep patients safe’

In California, prescribers are encouraged but not yet required to check the Controlled Substance Utilization Review and Evaluation System (CURES) database before prescribing controlled substances. Under state law, checking the database will become mandatory 6 months after the California Department of Justice certifies that the CURES system is ready for statewide use and the department has adequate staff to handle the technical and administrative workload. When that will happen remains unclear.

It’s too early to know how well CURES will work once fully implemented, said Patricia Salber, MD, a Larkspur, Calif.–based internist and founder of the blog TheDoctorWeighsIn.com, but access to statewide data about patients’ medical and drug history is a positive for doctors.

“As a former emergency physician who has taken care of many drug-seeking patients, having access to statewide data about an individual’s drug use will be a valuable tool to help stem the tide of scheduled prescription drug abuse,” she said. “Given our mobile society, I would also like to eventually see a nationwide system.”

As new systems roll out, it’s important for physicians to give the databases a chance and advocate fixing the bugs, rather than condemning them because of logistics or initial glitches, Dr. Salber added.

"As a former emergency physician who has taken care of many drug-seeking patients, having access to statewide data about an individual's drug use will be a valuable tool to help stem the tide of scheduled prescription drug abuse," says Dr. Patricia Salber.Courtesy Dr. Pat Salber

“I think sometimes people blame rules and regulations for making their lives difficult, when in fact it is clunky design and implementation of the regulations that cause the problem,” she said. “Well-designed regulations can keep our patients safe, for example, by requiring adequate testing of the safety and efficacy of therapeutics. If regulations are found to be effective but burdensome, I believe the first response should not be to overturn the regulation, but rather to improve the way the regulation is carried out.”

For example, she noted that the California Medical Association successfully fought for state law language requiring the CURES process to be certified ready before requiring physicians to use the system.

Are PDMPs working?

Although PDMPs may be causing headaches for some, data show that they are having effective results against opioid abuse and overprescribing.

In Florida, opioid prescriptions decreased in 80% of counties from 2010 to 2015 after the state established a PDMP in combination with tighter regulation of pain clinics. In the first month after implementation of Florida’s PDMP, oxycodone deaths dropped by 25%, according to a 2015 study published in Drug and Alcohol Dependence (2015 May 1. doi: 10.1016/j.drugalcdep.2015.02.010).

Opioid prescriptions in Kentucky, New York, and Tennessee dropped after mandates that prescribers check their state PDMPs, according to a summary by the PDMP Center of Excellence at Brandeis University. In Kentucky, doses dispensed declined for hydrocodone (–10.3%), oxycodone (–11.6%), and oxymorphone (–35%), while in Tennessee the number of opioid prescriptions fell by 7%. In New York, total opioid prescriptions have dropped by more than 9% since the state’s PDMP went into effect.

In Wisconsin, an analysis after enactment of the state’s PDMP found a nearly 12% reduction in opioid prescriptions and a 13% reduction in opioid doses dispensed between the fourth quarter of 2015 and the fourth quarter of 2016, according to a report by the Wisconsin Department of Safety and Professional Services.

PDMPs also have altered physicians’ prescribing behaviors and changed patient care decisions, studies show. A review of medical providers in Ohio emergency departments found that 41% of those given PDMP data altered their prescribing for patients receiving multiple simultaneous narcotics prescriptions, according to the Brandeis University summary. Of those Ohio providers, 61% prescribed no narcotics or fewer narcotics than originally planned.

A survey of prescribers in Rhode Island and Connecticut found that those who used PDMP data were more likely than nonusers to take clinically appropriate action in response to suspected cases of prescription drug abuse or diversion by patients, such as conducting drug screens or referring them to substance abuse treatment.

Despite the positive impacts, however, challenges for PDMPs remain.

Dr. Deep noted that physicians in solo and small practices may have a harder time than employed physicians when it comes to checking databases, recording data, and delegating duties. In addition, differing PDMP regulations may not catch prescription drug abusers who go across state lines.

Most states with PDMPs share their PDMP data with other state PDMPs or share data with authorized users in other states. Florida can receive PDMP data from other jurisdictions and provide that data to authorized users in Florida, but it does not share its data with other states. Oregon allows only prescribers in California, Idaho, Nevada, and Washington state to access its database information.

PDMPs also are limited in what they tell physicians about patients, said Gregory A. Hood, MD, an internist in Lexington, Ky., and former governor of the American College of Physicians, Kentucky Chapter.

“PDMP is only helpful to a point,” he said in an interview. “Any PDMP has the inherent limitation that it only reports what is reported to it. This doesn’t tell us about whether the patient actually takes the medicine, gives or sells it away, or whether they use it appropriately or not. Patients can overuse for 3 of 4 weeks, buy a week on the street, or from someone they know, and we’re none the wiser, absent an informant.”

Kentucky’s database, called the Kentucky All Schedule Prescription Electronic Reporting System (KASPER), requires that prescribers and dispensers of controlled substances query the state’s electronic monitoring system before issuing new prescriptions or refills. To track illicit use of opiates, Kentucky also recently made gabapentin a Schedule V controlled substance, Dr. Hood said.

Whether PDMPs have a positive effect depends on what doctors do with the information they learn from the database, Dr. Hood said.

“Generally, PDMPs can help identify at least some who are seeking adverse gain,” he said. “Properly identifying someone with a medical issue and arranging proper care is a positive. Rote dropping of someone with a ‘dirty’ PDMP – as has been known to happen in some primary care and specialty offices – is difficult to view as a positive, particularly given shortages in both primary care and in pain management.”

agallegos@frontlinemedcom.com On Twitter @legal_med

Prescription drug monitoring programs improve, but challenges remain