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1 U.S. Senate Committee on Health, Education, Labor and Pensions Wade Ackerman on behalf of Chairman Tom Harkin (D-IA) Grace Stuntz on behalf of Ranking Member Lamar Alexander (R-TN) 525 Hart Senate Office Building, Washington, DC [Submitted electronically to: and RE: Effective Solutions to Curtail Prescription Drug Abuse in the United States Dear Working Group Staff: The American Pharmacists Association (APhA) appreciates the opportunity to provide comments and recommendations regarding potential solutions to curtail prescription drug abuse in the United States. APhA, founded in 1852 as the American Pharmaceutical Association, represents more than 62,000 pharmacists, pharmaceutical scientists, student pharmacists, pharmacy technicians, and others interested in improving medication use and advancing patient care. APhA members provide care in all practice settings, including community pharmacies, hospitals, long-term care facilities, community health centers, managed care organizations, hospice settings and the uniformed services. APhA recognizes the significant public health concerns associated with the abuse, misuse and diversion of prescription drugs. In 2011, the Centers for Disease Control and Prevention (CDC) declared prescription painkiller overdose an epidemic in the United States, estimating 75 Americans die each day involving opioids. While APhA acknowledges the significant problem with misuse and abuse of prescription drugs in the United States, we believe it is imperative that a proper balance be maintained in delivering appropriate pain management for the millions of patients with legitimate needs for controlled substances while taking steps to minimize inappropriate use and abuse. APhA urges the Prescription Drug Abuse Working Group staff to consider the possible effects that any policy change might have on legitimate patient access to prescription drugs. The Institute of Medicine (IOM) estimates that there are 100 million Americans living with chronic pain--a number that does not include the additional 46 million individuals the Centers for Disease Control and Prevention (CDC) estimates suffer from acute pain due to surgery. Given the sheer number of Americans impacted, policy changes that directly or indirectly restrict legitimate patient access to prescription drugs for pain will have far-reaching consequences.

2 APhA proposes the following recommendations to assist in curbing the illicit use of controlled substances: I. Communicate Health Care Professional Roles and Expectations APhA believes that consensus building and collaboration between federal and state regulatory agencies and health care professionals such as, physicians, midlevel practitioners, pharmacists, nurses, social workers, and mental health professionals are imperative to understanding the authorities, roles and, expectations of each player. Legislation such as H.R. 4709, the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, which passed the House by voice vote and was recently introduced in the Senate, focuses on the value of these discussions by assessing how collaboration between government and stakeholders can benefit patients and prevent diversion and abuse of controlled substances. We believe there is an increasing need for regulatory agencies, specifically the Drug Enforcement Agency (DEA), to view healthcare practitioners as partners in this endeavor and DEA should clearly define each health care professional s role and expected corresponding responsibility in the delivery of patient care requiring controlled substances. Prescriber and pharmacist uncertainty regarding what DEA views as the practitioner s responsibilities in verifying the appropriate use of controlled substances have left providers fearful and hesitant to prescribe or dispense controlled substances. Unfortunately, this hesitation has translated into a significant access barrier for patients in legitimate need of these medications. II. Leverage the Use Health Information Technology a. Expand electronic prescribing of controlled substances APhA supports the expansion of electronic prescribing (e-prescribing), which is the secure electronic transmission of prescriptions from prescribers to pharmacies, as a means to combat prescription drug abuse, misuse, and diversion. The direct transmission of a prescription using electronic prescribing standards and technology reduces the potential for hard copy prescriptions in the patients possession to be altered, forged, reproduced, or otherwise misused for unlawful purposes. Current standards and system safeguards are in place to ensure the integrity and security of controlled substance e-prescribing. While 49 states permit e-prescribing for varying classes of controlled substances, barriers impede the expansion of e-prescribing. For example, Drug Enforcement Agency (DEA) regulations, which include system certification criteria that are required by both the pharmacy management systems and prescriber e-prescribing systems, result in high variability in the readiness of providers to receive e-prescriptions despite the fact that e-prescribing is permitted under state law. b. Facilitate the sharing of relevant clinical information through the development of the infrastructure for interoperable data exchange between pharmacists and prescribers APhA recommends that mechanisms be established to facilitate the timely, bi-directional sharing of relevant clinical information between pharmacists and prescribers. This would 2

3 enhance the pharmacist s ability to identify suspect prescriptions and determine the clinical appropriateness of prescribed controlled substances while reducing the potential for prescription drug abuse, misuse and diversion. Pursuant to the Controlled Substance Act, prior to dispensing a controlled substance, pharmacists have a corresponding responsibility to inquire about the legitimacy of the prescription; verifying not only the authenticity of the prescription and the existence of a valid patient-prescriber relationship, but also the clinical appropriateness of the order. Development of the infrastructure for timely, interoperable data exchange between pharmacists and prescribers would ease the burden on both pharmacists and physicians, while ensuring timely access to medications for patients with clinically appropriate, legitimate prescriptions. In order to enable such clinical information sharing between pharmacists and prescribers, existing pharmacy systems must be upgraded to operate on electronic health record (EHR) Health Level 7 (HL-7) platforms and a national infrastructure, which includes health information exchanges (HIEs) and/or secure direct messaging, must be built. At present, most pharmacists currently do not have access to pharmacy management systems or other electronic record systems that have EHR functionality, operate using HL-7 standards, or have the functionality to effectively communicate with other EHR systems through HIEs. As a result, pharmacists are unable to send and receive electronic information effectively between EHRs using structured electronic documents. Systems currently in place rely on faxed information or phone calls, leading to ineffective and often inefficient communication and patient management. Steps should be taken to support and incentivize the adoption, implementation, and use of systems with built-in EHR functionality for pharmacists. Additionally, state and regional based HIEs should be instructed to actively include and integrate pharmacies with EHR functionalities into their infrastructure. Secure direct messaging networks should integrate pharmacists into their systems, thereby providing an additional method for the effective bi-directional exchange of information to facilitate patient care and prevent diversion and misuse of controlled substances. Some of the barriers impeding the development of the infrastructure for interoperable data exchange include the lack of incentives for pharmacies and concerns over patient privacy. The Health Information Technology for Economic and Clinical Health Act (HITECH Act) legislation was designed to stimulate the adoption of EHR and supporting technology in the United States. However, pharmacists are not listed as eligible providers for the meaningful use of EHR, and therefore are not able to receive incentives under this program. The absence of these important cost-offsetting incentives for pharmacists significantly hinders the development of the infrastructure because pharmacy software vendors see little market demand to build pharmacy electronic record systems that are able to communicate with prescriber maintained EHRs. The second major barrier to the development of infrastructure supporting the interoperable exchange of data are prescriber concerns that the exchange may not be in compliance with the Health Information Portability and Accountability Act (HIPAA). Pharmacists are sometimes told that they cannot access appropriate clinical information contained in other providers EHR systems that is necessary for the care of their patients. However, this type of information-sharing is explicitly covered by HIPAA under patient care. Efforts should be 3

4 made to ensure that all providers and health care organizations are well-versed on HIPAA legal requirements so that the information-sharing necessary for effective coordinated care is not compromised. III. Strengthen the Prescription Drug Monitoring Program (PDMP) in the States a. Real-Time PDMP Upload APhA believes that government funding that supports the real-time upload of controlled substance prescription data into a state PDMP will reduce prescription drug abuse, misuse, and diversion. Without real-time technology, delays in the upload of such information to the PDMP may lead to controlled substance overprescribing and overutilization, because prescribers who rely on this information to aid their decision to prescribe do not have access to complete, up-to-date records in the PDMP. By attaching additional requirements on states to receive grant funding through the National All Schedules Prescription Electronic Reporting (NASPER) grant program, real-time upload of prescription data into the PDMP could be achievable. Pharmacies adjudicate prescription drug claims in real-time by electronically sending prescription information (or claims data ) to the payer. Claims data often includes information that pharmacies are required to send to their state s PDMP. We suggest that in order for a state to receive grant funding, a state must maintain an electronic switch whereby specific data in prescription claims for controlled substances can be captured and automatically uploaded into the state s PDMP. The automatic transfer of controlled substance claims data into a PDMP will make information available in real-time for the prescribers to aid in their clinical decision-making process. b. PDMP Workflow Integration APhA believes that PDMP integration into the prescriber s electronic prescribing tool or patient s EHR is imperative to the meaningful use of PDMP data. In response to the increasing shortage in primary care providers, prescribers are overworked and often overwhelmed by the number of patients seeking care. Currently, prescribers wishing to use a PDMP as tool to aid their clinical decision process must log into a separate web portal to request a patientspecific report. Once the report is generated, the prescriber must then analyze the data contained in the report to determine if the patient already has access to a controlled substance prescription that can treat the patient s symptoms. However, by integrating PDMP data into a prescriber s available e-prescribing tool, an alert can inform the prescriber of a previously filled controlled substance and the remaining days of supply as soon as the prescriber selects a similar controlled substance in the program. We believe that this level of PDMP integration into the prescriber s e-prescribing tool will increase PDMP data utilization by prescribers, thereby decreasing duplicative and inappropriate prescribing. c. State-to-State PDMP Interoperability APhA believes that government funding that supports the interoperability of PDMPs between jurisdictions (i.e. from state-to-state) will capture patient movement across state lines and 4

5 will reduce prescription drug abuse, misuse and diversion. The interstate sharing of information related to an individual s utilization of controlled substances will give prescribers and pharmacies in areas in proximity to one or more bordering states the ability to see patient specific controlled substance utilization data. Access to this information, unencumbered by state boarders, will help the prescriber properly determine whether issuing a controlled substance prescription is appropriate. Therefore, we suggest that grant funding be made available to create a standardized platform where states can share information though a secure communication exchange. Authorized PDMP users in those states will be able to see a more complete history of patients controlled substance prescriptions, helping health care providers identify possible misuse or abuse. One example of this work is the National Association of Board of Pharmacy (NABP) s PMP InterConnect program, now standardizing and linking 25 PDMP s. IV. Enhance provider education on prescription drug abuse APhA supports comprehensive efforts to educate health care professionals, including prescribers and pharmacists about prescription drug abuse, and mechanisms to prevent it. The training should incorporate ways to identify patients susceptible to addiction, and behaviors of addiction, abuse, misuse or diversion. The training should also educate health care professionals on various ways prescription drugs are diverted, common street names, and the different ways abusers are manipulating and administering the drugs. In addition, providers should receive education about rehabilitation services and the process for intervention and referral of patients. Last, keeping in mind that every patient has their own unique pain sensitivities and thresholds, the training should offer basic guidance on the appropriate level of pain control required to offset pain in common minor injuries and medical procedures. V. Increase patient education on prescription drug abuse awareness APhA supports more robust and incentivized pharmacist-delivered patient education focused on prescription drug abuse. Pharmacists are accessible providers who are able to provide patient education on the risks and benefits associated with taking prescription drugs with a potential for abuse. This education could be delivered as part of a Medication Therapy Management (MTM) session or could also be provided as a targeted intervention when the patient s prescription is filled. Aspects of patient education could include what to expect from the medication, what other medications, foods, and activities to avoid while taking the medication, signs of addiction, and how to best store the medication to limit exposure to family and friends. VI. Increase Prescription Drug Take Back Sites and Times APhA believes that increasing the public s access to prescription drug take back opportunities will decrease the likelihood that unwanted controlled substances will be used by persons other than to whom they were prescribed. According to a May 8, 2014, DEA press release, over the last four years only seven take back days have been organized by DEA, but an astonishing 4.1 million pounds (2,123 tons) of unwanted, unused and expired prescription 5

6 medications have been removed from the public domain. Often an abuser s initial exposure to controlled substance prescription drugs comes from a family member or friend s prescription in their medicine cabinet. The likelihood of missing quantities of drug product going unnoticed by the person it was prescribed for increases if the remaining quantity is unwanted or abandoned. If take back programs were more publically accessible, prescribed users will be more likely to dispose of these unwanted drug products rather than storing them indefinitely. Therefore, we believe that federal government action to reconcile conflicting federal law and preempt restricting state law on drug take back programs is necessary. Government legislation or regulation should provide a pathway to cover the costs of participating entities who offer take back services, to incorporate them into daily work flow operations so as not to disrupt the delivery of patient care, and to provide guidance on how to store and reverse distribute the drug products. In addition to the direct costs associated with receiving unwanted prescription drugs, cost coverage shall also reflect the indirect maintenance costs and risks, such as the security of the site as well as exposure to blood borne pathogens from sharps and contact with toxic substances. VII. Increase Access to Opioid Reversal Agents APhA believes that expanding access to opioid-reversal agents, such as naloxone, will decrease opioid-related deaths. We believe that the development and implementation of government action that permits pharmacists, other health care professionals, and emergency personnel to furnish opioid reversal agents will help prevent opioid related deaths due to overdose. Pharmacists are our nation s most accessible health care professionals who possess the requisite training and education to independently assess appropriate candidates to receive opioid-reversal agents. We believe that pharmacists can play an important role in selecting, dosing, and initiating appropriate opioid-reversal therapy while providing education to patients and caregivers on the proper use of these agents. However, current legislation in many states prohibit the pharmacist s ability to furnish opioid-reversal agents. Federal action that preempts restrictive state law would help expand access to these lifesaving agents. Thank you for the opportunity to provide comments on this important issue. If you have any questions or require additional information, please contact Michael Spira, Senior Lobbyist, Government Affairs at mspira@aphanet.org or by phone at (202) Sincerely, Thomas E. Menighan, BSPharm, MBA, ScD (Hon), FAPhA Executive Vice President and CEO cc: Stacie Maass, BSPharm, JD, Senior Vice President, Pharmacy Practice and Government Affairs 6