The American Society of Health-System Pharmacists (ASHP) will convene its 71st Annual Session of the House of Delegates in Boston in June to address an agenda that includes considering 18 policy recommendations and a resolution, receiving board and committee reports and considering a variety of other society business items. Your elected delegates this year are Jim Lile, Mike Ruffing, Ryan Bickel and Jesse Hogue, with Curtis Collins and Dianne Malburg serving as alternates. In addition to attending the two official "live" House sessions, the Michigan delegates have participated in Regional Delegate Conferences, and will participate in various other forums and caucuses at the Summer Meeting to fully understand all the issues to be voted upon as well as to discuss possible amending language, new business items and recommendations of delegates. While a full discussion of each of the policy recommendations is beyond the scope of this article, I would like to highlight several that I feel are of interest to MSHP members.
Suicide Awareness and Prevention. Acting on a recommendation from a delegate last year, all five ASHP councils collaborated to develop this important policy recommendation. The ultimate aim of the policy is to support the goal of zero patient or healthcare worker suicides. The policy also notes that, while suicide awareness and prevention must be a collaborative effort, pharmacists and technicians can play a key role in those efforts.
Safe Administration of Hazardous Drugs. While ASHP has policy on closed system transfer devices (CSTDs), and USP has put forth standards for handling and administering hazardous drugs, there is a potential gap in the handling and administering of hazardous drugs by non-standard routes. This policy calls for ASHP to advocate for pharmacist involvement in the development of policies, procedures and operational (including risk) assessments regarding administration of hazardous drugs, including when CSTDs cannot be used. It also calls for manufacturers and FDA to develop more CSTD-compatible, ready-to-administer hazardous drug products.
Compounded Sterile Preparation Verification. This was an existing policy that the Council on Pharmacy Practice extensively reworked to more strongly call for adoption of automation and information technology to facilitate in-process and final verification of compounded sterile preparations (CSPs). Recognizing that this may not be realistic in the short term for all facilities, the policy recommendation calls for independent in-process and final verification of CSPs in the interim, and expressly opposes the syringe pull-back method or other proxy methods of CSP verification.
Notification of Drug Product Price Increases and Preventing Drug Product Shortages. These two ambitious policy recommendations from the Council on Public Policy touch on subjects near and dear to all health-system pharmacists' hearts - drug prices and shortages, which are areas in which ASHP is actively advocating on our behalf. These policies should help direct and target ASHP's advocacy efforts. The first policy calls for advocacy for drug manufacturers and suppliers to provide advance notice and justification for drug price increases, and for the manufacturers and suppliers to be transparent in their drug product pricing. The second policy takes a unique approach, calling for federal evaluation of whether drug product shortages present national security risks and for the FDA to require manufacturers to have contingency plans for maintaining drug supplies. It also calls for advocacy for drug manufacturers to be required to disclose manufacturing sites and sources of active pharmaceutical ingredients to facilitate the security risk assessment and for FDA to be required to publicly provide quality ratings for 503B outsourcing facilities preparing copies of drug products under the exemption for products on FDA's shortage list.
Credentialing and Privileging by Regulators, Payers and Providers for Collaborative Practice. In this time when we are trying to advance our practice in both the inpatient and ambulatory realms, this key policy calls for ASHP to advocate for expansion of collaborative practice agreements in which the pharmacist initiates, monitors and adjusts a patient's drug therapy, and for payment for these services. It also supports the use of clinical privileging in the same manner as other providers to assess a pharmacist's competence to engage in the services, which would further support our role as providers in these practices.
340B Drug Pricing Program Sustainability. As this is an area of significant interest to health system administrators and one in which ASHP is very actively advocating on our behalf, it should be noted that this policy recommendation shifts the advocacy approach slightly. Recognizing that the current legislative climate is antagonistic to the 340B program, the intent is to affirm the importance of the 340B program to our ability to provide services and to shift tactics away from expansion and toward conservation, stewardship and ensuring fair practices.
Pharmacist Authority to Provide Medication-Assisted Treatment. Recognizing this is a very important topic for our ambulatory members, the Council on Public Policy crafted this recommendation calling for ASHP to advocate for the role of pharmacists as providers in medication-assisted treatment (MAT) for opioid use disorder, including patient assessment, education and prescribing of pharmacologic therapies, since currently pharmacists are not eligible for the necessary waiver under the Drug Addiction Treatment Act of 2000.
Therapeutic Use of Cannabidiol. This is a very hot topic, but one that is likely to generate a LOT of discussion and debate. The policy recommendation supports continued research and education on cannabidiol (CBD), which likely will be universally supported. Where it gets controversial is that the recommendation opposes use of CBD-containing products not approved by FDA and advocates for enhanced public education regarding safe use of CBD and the risks of unapproved CBD-containing products. Many delegates have suggested that because the FDA approved CBD product is unaffordable for many patients who can or do benefit from CBD, actively opposing use of non-FDA approved CBD products may not be in the best interest of our patients. Delegates also noted that there are not clear, established guidelines for converting between CBD products from a formulary standpoint and FDA-approved CBD is not always easily available for purchase by health systems.
Pharmacy Technician Training and Certification. Consistent with MSHP's efforts, this policy continues to call for ASHP to foster expansion of ASHP/ACPE-accredited technician education and training programs. Considering updated PTCB standards, the Council on Education and Workforce Development is recommending an update of the current policy to shift the advocacy for the completion of an accredited training program for all new pharmacy technicians from 2020 to 2022. To support the ongoing advancement of pharmacy technician as a profession, the policy also continues to advocate for maintenance of PTCB certification. On a side note, delegates were given good news at the Regional Delegate Conference. The requirements for sterile compounding and retail billing were removed from the core ASHP/ACPE technician education and training program accreditation standards, moving them into specialized certifications, in response to feedback from both health-system and retail employers.
Safe Medication Preparation at All Sites of Care. This policy recommendation calls for ASHP to advocate that all sites of care be required to meet the same regulatory standards for medication preparation and compounding. While you might think this would be very non-controversial stance, the rationale given for this stance was entirely due to financial considerations around payors forcing patients toward lower cost-of-care options, with no attention given to quality or patient safety. As it stands, many delegates are vehemently opposed to this non-patient-centric approach to the topic and will likely vote against it unless something along the lines of "to ensure safety and quality" is added and the rationale is reworked to be less overtly self-serving.
Pharmacy Technician Student Drug Testing. This year is the inaugural year for the Pharmacy Technician Forum. They have been very active, including drafting this policy recommendation. It is very similar to the policy statements on pharmacist and pharmacy student drug testing passed in the last two years. The unique aspect is that the technician recommendation calls for use of pre-enrollment, random and for-cause drug testing as a mandatory component throughout any accredited or unaccredited pharmacy technician training program and practice experience, based on define criteria with appropriate testing validation procedures.
This discussion merely scratches the surface of the policy recommendations. Many of the other policy recommendations will also be of significant interest to MSHP members and will affect us as health system pharmacists. We would encourage all of you to review the proposed policies and contact one of the delegates with any questions or comments you may have (Jesse Hogue: firstname.lastname@example.org
; Mike Ruffing: email@example.com
; Ryan Bickel: firstname.lastname@example.org
; Jim Lile: email@example.com
). Titles of all the policy recommendations are listed below for your review. Members can view the official language of the policy recommendations at the ASHP House of Delegates website
as well as follow online discussions via the House of Delegates community via ASHP Connect
. There has already been quite a bit of good discussion on ASHP Connect, feel free to join the conversation!
Policy Recommendations to be considered by the 2019 ASHP House of Delegates:
JOINT COUNCIL POLICY RECOMMENDATION
- Suicide Awareness and Prevention
COUNCIL ON PHARMACY PRACTICE
- Safe Administration of Hazardous Drugs
- Compounded Sterile Preparation Verification
COUNCIL ON PUBLIC POLICY
- Notification of Drug Product Price Increases
- Preventing Drug Product Shortages
- Emergency Refills
- Credentialing and Privileging by Regulators, Payers and Providers for Collaborative Practice
- 340B Drug Pricing Program Sustainability
- Pharmacist Authority to Provide Medication-Assisted Treatment
COUNCIL ON THERAPEUTICS
- Therapeutic Use of Cannabidiol
COUNCIL ON EDUCATION AND WORKFORCE DEVELOPMENT
- Pharmacy Expertise in Sterile Compounding
- Pharmacy Technician Training and Certification
COUNCIL ON PHARMACY MANAGEMENT
- Pharmaceutical Distribution Systems
- Safe Medication Preparation in All Sites of Care
- Pharmacy Department Business Partnerships
- Intimidating or Disruptive Behavior
PHARMACY TECHNICIAN FORUM
- Pharmacy Technician Student Drug Testing
SECTION OF INPATIENT CARE PRACTITIONERS
- ASHP Statement on the Role of the Medication Safety Leader