Expanded prescription drug monitoring program balances privacy and public safety: Kathleen G. Kane. Prescription drug abuse and overdoses have escalated to a full- blown crisis for families and communities across the Commonwealth.
Violent drug trafficking organizations dedicated to the distribution of illicit 'street' drugs have expanded their product lines to include pharmaceuticals. The lucrative market and relative ease of which prescription drugs can be obtained has resulted in drug trafficking organizations dedicated solely to distributing them. One of the most effective tools for preventing prescription drug abuse is robust prescription drug monitoring programs. The programs collect data on dispensed controlled substances and make that data available to a limited number of authorized users utilizing a secure and restricted electronic database. The data is aggregated to identify major sources of drug diversion including prescription fraud, doctor shopping, forgery and improper prescribing. Unfortunately, Pennsylvania's prescription drug monitoring program only collects data on Schedule II narcotics such as Oxy. Contin, Percocet and fentanyl. THE PENNSYLVANIA PRESCRIPTION DRUG MONITORING PROGRAM. If you are a pharmacist, physician, physician assistant, or nurse practitioner, please read this Act. New Pennsylvania prescription drug monitoring program to start. If the monitoring program reduces prescription drug addicts’ ability to “doctor. What is a prescription drug monitoring program (PDMP)? According to the National Alliance for Model State Drug Laws (NAMSDL). There is no means to track other, highly- addictive Schedule III, IV and V controlled substances. Legislation introduced by state Sen. Pat Vance, R- Cumberland, would expand the state's existing database to allow for the collection of data for all dispensed Schedule III, IV and V narcotics like Vicodin, Xanax and Suboxone. Several provisions fully supported by law enforcement were added to the bill to guarantee that privacy rights are not violated: Law enforcement can only access the prescription drug monitoring program after a court order is obtained. Once access is granted, the information that authorized users can view is limited. Access to this information does not open the database up so authorized users can scroll freely through record upon record. Law enforcement's goal is to prevent the imposition of barriers that prevent access to life- saving information, not create open access to the information. This legislation demonstrates that privacy rights can be protected while supplying the tools needed to help law enforcement identify and prosecute criminals who profit from keeping our citizens addicted to drugs that can kill them. Those who suggest that law enforcement should be required to obtain probable cause before accessing the database ignore the fact that prescription drug monitoring programs are designed to be a proactive tool in the fight against prescription drug abuse. A probable cause standard would render prescription drug monitoring programs useless because once law enforcement has probable cause, a search or arrest warrant could be obtained independent of the information in the database, leaving little need to access the database. Controlled substances are strictly regulated for a reason - they can and often do lead to addiction, overdoses, and in many cases, death. The number of drug overdose deaths in Pennsylvania - a significant portion resulting from prescription drugs - has increased by 8. Additionally, Pennsylvania hospital admissions for opioids and synthetics increased 1. Abuse levels of illegal Schedule I narcotics, namely heroin, in many cases have been surpassed by prescription painkillers, anti- anxiety drugs and stimulants. This epidemic has also had a tremendous fiscal impact: misuse and abuse of prescription painkillers alone costs the country an estimated $5. Allowing criminal investigators to access data contained within a prescription drug monitoring program helps them identify abnormal prescribing or dispensing practices so that they can target and prosecute the traffickers and illegal prescribers responsible for overdoses and overdose deaths in our communities. There is a common misconception that prescription drugs are safer than street drugs because they are made in a controlled laboratory, prescribed by physicians and dispensed by licensed pharmacists. Prescription drug abuse poses just as much of a threat as the use of traditional, illicit narcotics. In fact, individuals who use prescription pills recreationally are 1. Too many people across the Commonwealth are in the throes of addiction, which takes thousands of lives each year, destroying families in its wake. Expanding Pennsylvania's prescription drug monitoring program as proposed by Sen. Vance would effectively help combat prescription drug abuse, while imposing privacy limitations that law enforcement not only honor, but support. Kane, a Democrat, is Pennsylvania's state Attorney General. Examining Limitations and Future Approaches. Abstract. Prescription drug abuse is a leading cause of accidental death in the United States. Prescription drug monitoring programs (PDMPs) are a popular initiative among policy makers and a key tool to combat the prescription drug epidemic. This editorial discusses the limitations of PDMPs, future approaches needed to improve the effectiveness of PDMPs, and other approaches essential to curbing the rise of drug abuse and overdose. INTRODUCTIONPrescription drug abuse is a leading cause of accidental death in the United States. Local, state, and federal agencies have implemented several policies to address this epidemic, including drug take- back programs, prescriber education, pain clinic laws, and prescription drug monitoring programs (PDMP). PDMPs are a popular initiative among policy makers, as they easily provide clinicians with scheduled medication histories, helping identify patients that may be diverting medications or abusing them. As of October 2. 01. PDMP in certain circumstances. However, enthusiasm for PDMPs as a key tool to combat the prescription drug epidemic may cause proponents and policy makers to overlook their potential limitations. This enthusiasm may also prevent the development of more comprehensive and evidence- based strategies to address this public health crisis and the conclusion that additional steps are needed to combat the opioid epidemic. Evidence to support the effectiveness of PDMPs comes largely from observational studies or surveys of providers. Recent data from Florida show a decline in prescription drug overdose deaths and doctor shopping after the implementation of their PDMP and pain clinic law. Virginia also reported a fall in the number of “doctor shoppers” after implementation. Additionally, national data from the Centers for Disease Control (CDC) show that overdose deaths due to opioid analgesics decreased by 5% from 2. It is not clear if PDMPs were responsible for this decline or if other interventions, such as laws limiting dispensing of medications from pain clinics and overall prescriber awareness of the risks of opioids, led to this decline. Contrary to this evidence, previous studies examining PDMP effects on opioid prescribing show mixed effects before 2. While PDMPs are likely contributing to the overall decline in drug diversion and prescription opioid overdoses, the true effect of PDMPs is to be determined and there are several substantial limitations that should be addressed. PDMP Data – Devil in the Details. PDMPs identify “doctor shopping” through unsolicited reports sent from government agencies to clinicians, surveillance of aberrant prescribing behavior to identify irresponsible prescribing and by clinician review of patient reports before prescribing. PDMP databases generate data from pharmacies directly reporting to the state when a prescription is filled. States have varying delays in how long it takes for the data to appears in the database, for example in Massachusetts, there is up to a three- week delay. For data to be accurate, the name and date of birth must be reported correctly by the patient, written correctly on the prescription, entered correctly by the pharmacy, and again entered correctly by the clinician searching for the report. Any error may generate an incorrect report. Currently only 2. Improved identification at both the point of prescribing and dispensing should be explored as a means to improve the effectiveness of PDMPs. The PDMP relies on Drug Enforcement Administration (DEA) numbers to identify prescribers. In the case of residents and moonlighting clinicians, many hospitals use hospital- based DEA numbers and the database reports the hospital name instead of the specific prescriber. If a patient sees multiple providers at the same clinic, the database is unable to indicate whether the providers are working together. Such a profile may lead a clinician to inappropriately conclude a patient is “doctor shopping,” when the patient is, in fact, following up correctly. The confusion created by DEA numbers could be remedied if further information was provided on the PDMP database that indicated a prescriber’s specialty and association with a specific clinic or group. Additionally, hospital- based DEA numbers should be registered with the state PDMPs to give prescriber specific information. To date, there is no agreed upon threshold to define questionable behavior, and each government agency or clinician is left to decide what criteria should cause them concern. The lack of objective criteria creates a challenge for clinicians who are balancing their duty to treat pain, to meet patient expectations, and to prevent misuse and diversion in their communities. The Massachusetts Department of Public Health recommends discussing concerning PDMP profiles with patients and to use the PDMP in the context of a complete patient evaluation, including review of outside medical records, and discussions with other providers. There is, however, no guidance on how to interpret the report in this context. Recent studies have shown increases in mortality in patients with greater than four providers, greater than four pharmacies and using greater than 1. However, using any absolute value results in identifying patients as “doctor shoppers” or at risk for overdose who, in fact, are not. Many patients have multiple prescribers because of poor primary care access, visits to emergency departments (ED) for acute exacerbations of pain, and conditions requiring visits to multiple specialists. Having to interpret the PDMP in this context allows bias and other factors outside of objective data to determine who is labeled as at risk or not. PDMP and Sources of Opioids. PDMP effectiveness is dependent on the amount of misuse and diversion that results from clinician prescribing. Studies examining the PDMP profiles of those who died from prescription drug overdoses report the percentage of deaths related to “doctor shopping” range from 2. Among those using opioids for nonmedical purposes, a national survey identified that 2. It is unknown how much of diverted medications result from “doctor shopping.” Diversion may alternatively result from patients with one prescriber, theft, or falsified prescriptions. PDMPs are therefore unable to identify many important sources of diversion and interventions are needed to target the other causes of diversion. PDMP effects on prescribing. Clinical studies depict mixed effects of PDMP reports on prescribing. Baehren et al. 1. PDMP use changed emergency physicians’ prescription plans in 4. Another study by Weiner et al. PDMP data influenced prescribing behavior in only 9. Baehren et al. 1. Weiner et al. 1. 5 study that enrolled 3. The true effect of PDMPs on prescribing is likely closer to the results in the Weiner et al. Patients determined to deceive the system may do so by crossing state borders in states without effective data sharing or reporting false personal information when registering with hospitals and clinics. It also remains unclear if patients chronically treated with opioids will be adversely affected by PDMPs. In particular, pain patients with fragmented care and a poor primary care network are more likely to have a suspicious PDMP profile and may be undertreated. The promise of PDMPs is to improve data sharing among providers in order to avert diversion and prescribing to those at risk of abuse and overdose. However, this data sharing is limited to a few data points. PDMPs could provide means of communication between providers within the Internet portal that is compliant with privacy laws and allows better communication on opioid prescribing. This would also allow emergency providers to notify other prescribers of patients who have either overdosed, are at risk for overdose, or have a pain contract. If PDMPs are to be successful, further improvements are needed to improve accuracy, accessibility and interpretability of the data. Easy access with little effort on the part of the clinician is essential to increased usage. Even with legal mandates, enforcement will be challenging and clinicians are already overloaded with work, making PDMP review for all patients a challenge in many clinical settings. Further funding to integrate PDMP data into medical records is essential. Effective use of the PDMP will require studies determining how the PDMP should be used alongside the complete clinical encounter and to identify what values in a PDMP report should trigger intervention from the clinician. While PDMPs are one tool in the fight against the opioid epidemic, they are not the panacea and a more comprehensive approach is needed. Our profession must come to consensus on the indications for opioid pain medications and their appropriate use in managing acute and chronic pain. Training clinicians in chronic pain management and responsible opioid prescribing may do more to reduce opioid prescribing than access to PDMPs. Improved patient education for those receiving opioids is also needed so our patients fully understand the risks and benefits of opioid therapy. The aforementioned CDC data show a decrease in opioid analgesic overdose in 2. If current interventions are able to decrease abuse and overdose from prescription opioids, the overdose epidemic may rage on from opioids provided through the black market. It is not enough to simply refuse to prescribe opioids to those with a concerning PDMP profile, but physicians must have candid conversations with their patients, particularly in the ED. Adequate funding is needed for drug abuse treatment programs, which will allow ED referrals to be more effective. Additionally, overdose education and naloxone distribution has shown promise in reducing opioid overdose death. The ED is a particularly critical location where naloxone distribution could be effective and further research on ED distribution of naloxone is warranted.
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