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Request for Information: Ensuring Patient Access and Effective Drug Enforcement

[Submitted electronically at [email protected]]

Brenda Destro, Ph.D
Office of the Assistant Secretary for Planning and Evaluation
Office of Science and Data Policy
U.S. Department of Health and Human Services
Attn: EPAEDEA Report Feedback
200 Independence Avenue SW, Room 434E
Washington, DC 20201.

Re: Request for Information: Ensuring Patient Access and Effective Drug Enforcement

Dear Dr. Destro:

ASHP is pleased to submit comments on the Department of Health & Human Services’ (HHS) Request for Information entitled “Ensuring Patient Access and Effective Drug Enforcement” (the “RFI”). ASHP is a national professional organization representing nearly 50,000 members including pharmacists, pharmacy residents, student pharmacists, and pharmacy technicians, who provide patient care services in acute care and ambulatory settings, including hospitals, health systems, and clinics. For 75 years, ASHP has been on the forefront of efforts to improve medication use and enhance patient safety.

I. Ensuring Patient Access to Treatment

a. Improving Access to Substance Use Disorder Treatment Through Better Utilization of Clinicians

ASHP appreciates the opportunity to provide feedback to HHS regarding methods to ensure patient access to effective, appropriate treatment while safeguarding against diversion. As our nation struggles with an opioid epidemic, we urge HHS to work with its subagencies, including the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Centers for Medicare & Medicaid Services (CMS), to better utilize pharmacists’ services for pain management and substance use disorder treatment.

Pharmacists are integral members of the healthcare team, practicing across the continuum of care. Pharmacists’ medication expertise is invaluable, and their education prepares them to provide patient care that extends far beyond simply dispensing medications. They receive clinically based doctor of pharmacy degrees (Pharm.D.), and many also complete postgraduate residencies and become board certified in a variety of specialties. Pharmacists in hospitals and ambulatory clinics work with physicians, nurses, and other providers on interprofessional teams to manage patients’ medications and ensure appropriate care transitions.

Patient care discussions often revolve around the pathophysiology of disease or chronic condition, but far too often patients receive little information regarding perhaps the most essential part of treatment — the medication prescribed to cure or manage the condition. In many cases, the prescribing clinician does not have the same medication expertise as a pharmacist. Pharmacists have expertise and experience in managing opioids throughout the entire medication use cycle, spanning medication procurement and storage, patient and prescriber education, dispensing, and disposal. Thus, if HHS’s goals are to ensure appropriate medication use as well as to manage pain and prevent and treat SUD effectively, pharmacists must play a more prominent role overall treatment, including medication selection and modification, patient education, and follow-up and monitoring of medication.Pharmacists can help combat SUD using a variety of approaches and tools. For instance, in patients with opioid needs exceeding 72 hours, a pharmacist can assist the provider in creating a patient-specific pain plan that includes the most optimal medication(s), duration, and a plan to discontinue, taper, or transition to a non-opioid therapy. This plan can then be electronically shared throughout all transitions of care including outpatient visits. Studies have documented the positive impact of pharmacists in treating pain and mental health disorders, including SUD:

  • Pain management in an integrated health system: Pharmacist clinicians with prescribing authority for controlled substances provided chronic non-cancer-related pain medication management services in a for-profit integrated health system. In a one-year time period, the pharmacist clinicians were able to show an improvement in mean visual analogue scale pain scores and save the health system over $450,000.

  • Depression management in a staff model health maintenance organization: A randomized controlled trial was conducted to measure the impact of a collaborative care model that emphasized the role of clinical pharmacists to provide drug therapy management and treatment follow-up in patients with depression. In this collaborative model, after six months, those patients with depression randomized to the services of a pharmacist compared with the control group had a significantly higher medication adherence rate (67% vs. 48%), higher patient satisfaction, and favorable changes in resource utilization.

Nevertheless, regulatory barriers prevent pharmacists from fully engaging in SUD treatment. Pharmacists are neither eligible to participate in Medicare Part B, nor are they required providers within accountable care organizations (ACOs). Pharmacists are also not considered “authorized other practitioners” for the purposes of getting the waiver (the “X-waiver) required to prescribe burprenorphine as part of medication assisted treatment (MAT). Despite pharmacists’ medication expertise, which is directly relevant to MAT, X-waiver eligibility was recently extended to certified nurse midwives, clinical nurse specialists, certified registered nurse anesthetists, physician assistants and nurse practitioners, but not to pharmacists.

ASHP requests that HHS use its regulatory authority to add pharmacists as an “authorized other professional” under Section 303(g)(2)(G)(iv) of the Controlled Substances Act for the purposes of providing MAT. We further request that HHS test SUD treatment models that are pharmacist-led or that otherwise fully engage pharmacists in SUD treatment. As noted above, pharmacists’ medication expertise is directly relevant to effectively addressing SUD generally. Testing pharmacist models, either through the Center for Medicare & Medicaid Innovation (CMMI) or some other means, could significantly expand patient access to high quality SUD treatment services.

b. Enhancing Provider Education

Collaborative care models are now the gold standard for patient care, so prescribers cannot operate in a vacuum. While prescriber education specific to opioids and pain management is necessary, it must be supplemented with corresponding education for the rest of the healthcare team. Each member of the healthcare team has a role to play in assisting patients in appropriate pain management. Comprehensive education regarding opioids should include a discussion of each team member’s role in identification, prevention, and treatment of opioid misuse, as well as strategies for harnessing each clinician’s unique practice experience and knowledge base to collaboratively target overprescribing and misuse of opioids. To facilitate better coordination among providers working to combat drug misuse, we encourage HHS to expand interprofessional educational opportunities rather than to focus solely on prescriber education. We also urge the agency to create incentives for clinicians and clinician educators to enhance or otherwise expand SUD training opportunities.

II. Ensuring Appropriate Access to Controlled Substances

a. Shortages

As HHS is aware, hospitals and other providers have been managing critical shortages of a number of injectable opioid medications, including morphine, hydromorphone, and fentanyl. Intravenous (IV) opioids are used in a variety of practice settings within hospitals and ambulatory surgical centers for the treatment of acute, acute on chronic, or chronic pain that cannot be managed because the patient has a contraindication for oral opioid medications. Some opioids, such as fentanyl, also are used for sedation. Injectable opioids are critical to treating the pain needs of patients undergoing interventional procedures (e.g., cardiac catheterization or colonoscopy) and surgeries. These medications are also frequently used in intensive care units for surgical, trauma, burn, or oncology patients, when it is not clinically appropriate to use oral opioids. Having diminished supply of these critical drugs, or no supply at all, can cause suboptimal pain control or sedation for patients in addition to creating burdensome workarounds for healthcare staff and increasing drug prices.

Given the scope of the problem, it is essential that HHS be aware of our ongoing discussions with the Drug Enforcement Administration (DEA) regarding shortages. ASHP has commented extensively to the DEA regarding the necessity of flexible Annual Production Quotas (APQs) to ensure an adequate supply of IV opioids. Due to ongoing shortage and the tendency of shortages to recur, DEA should explicitly consider the impact of shortages when setting APQ limits and making adjustments. To ensure that this occurs, ASHP recommends that DEA regulations be amended to add drug shortages as a factor for setting and adjusting APQ under Sections 1303.11 and 1303.13.

DEA should also be consulting with the Food and Drug Administration’s (FDA) drug shortage staff when setting APQs. The more data DEA has from FDA regarding shortages, the better equipped DEA will be to calculate APQs that meet those needs. Although we understand that DEA looks at the basic class of controlled substance when setting quotas, the FDA can provide shortage data broken down by dosage form, which will help contextualize the actual supply and availability of medications. This may also provide a clearer picture of diversion risk, as there are distinct differences among formulations. Injectable opioids dispensed in clinical settings pose a far lower risk of diversion than other dosage forms dispensed directly to patients. Proactively considering shortages when setting and adjusting APQs will safeguard patient health and safety and ensure critical needs are met.

b. Health Care Worker Diversion

ASHP shares HHS’s commitment to addressing and prevention diversion of controlled substances in all care settings. Despite strong prevention programs, diversion does still occur and when it does, it is essential that any risk to patients be minimized immediately. However, there is no clear federal guidance from HHS or the U.S. Centers for Disease Control & Prevention (CDC) regarding blood testing for healthcare workers who have diverted medications in a way that potentially exposes patients (e.g., through tampering with syringes) to blood-borne pathogens. Although CDC provides a number of helpful educational resources for identifying and preventing healthcare worker diversion, there is little federal guidance for minimizing patient risk after diversion has occurred. Recognizing that some states already have rules for testing healthcare workers for blood-borne pathogens in cases of diversion, we believe that best practices from HHS and/or the CDC would be beneficial for providers in states that do not have specific laws on this issue. Thus, we urge HHS and/or CDC to develop best practices for handling instances of healthcare worker diversion that potentially expose patients to blood-borne pathogens. ASHP stands ready to assist the agencies in developing these resources.

III. Streamlining State Prescription Drug Management Programs

Prescription Drug Management Programs (PDMPs) should be better integrated into existing workflow and should allow for the transmission of additional information, including patient-specific pain plans. To accomplish this, ASHP urges HHS to consider strengthening PDMPs, which could reduce overprescribing. Although PDMPs are in place in the majority of states, the platforms are not user-friendly, which creates barriers to usage for prescribers and dispensers. A robust, interoperable national PDMP system would allow prescribers and pharmacists to track patient-specific opioid use to prevent overprescribing and potential misuse at the point of prescribing. Additionally, better use of existing systems could also have a positive impact on overprescribing. We urge HHS to evaluate initiatives to enhance existing PDMPs and to improve current use of PDMPs by both prescribers and dispensers.

ASHP appreciates this opportunity to provide feedback on the RFI. Please contact me at [email protected] or at 301-664-8698 if you have any questions or if we can provide any additional assistance.


Jillanne Schulte Wall, J.D.
Director, Federal Regulatory Affairs