Posted on May 15, 2018 in: Member News
By Jesse Hogue, Pharm.D., pharmacy education coordinator, Bronson Methodist Hospital, Kalamazoo
The American Society of Health-System Pharmacists (ASHP) will convene its 70th Annual Session of the House of Delegates in Denver in June to address an agenda that includes considering 31 policy recommendations, receiving board and committee reports and addressing a variety of other society business items. Your elected delegates this year are Dave Bach, Jim Lile, Mike Ruffing and myself, Jesse Hogue. In addition to attending the two official “live” House sessions, I, and the other Michigan delegates, have participated in the Regional Delegate Conferences and will participate in various other forums and caucuses at the Summer Meeting to fully understand all the issues being voted upon. Included in this are discussions regarding 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 a few that I feel are of interest to Michigan Society of Health-System Pharmacists (MSHP) members.
Health Insurance Policy Design. This policy is of interest to Michigan pharmacists because Michigan Pharmacists Association (MPA) has been actively advocating for pharmacy benefit manager (PBM) transparency for several years. This policy recommendation updates an existing ASHP policy to include a statement that ASHP advocate that health insurance payers and PBMs provide public transparency regarding, and accept accountability for, coverage decisions and policies, which is very consistent with what MPA has been pursuing.
Availability and Use of Appropriate Vial Sizes. This policy calls for ASHP to advocate that manufacturers provide drug products in vial sizes that reduce waste. As any health-system pharmacist is aware, available vial sizes often do not align with typical doses, resulting in waste. In the rationale for this policy, it was noted that a study in 2016 estimated that the United States may spend close to $2 billion on oncology drug products that are discarded because they come in vials in which the volume of drug product exceeds what is needed for most doses. It was also noted that manufacturers are already producing the more logical vial sizes for use in other countries, but they are not approved for use here.
Use of Closed-System Transfer Devices to Reduce Drug Waste. This is another welcome policy targeted at reducing drug waste. There is research supporting use of closed-system transfer devices (CTSDs) to maintain sterility beyond the in-use time currently recommended by USP 797, when those devices are used with aseptic technique and following current sterile compounding standards. Unfortunately, CTSDs are not FDA approved for such use, and therefore USP 797 requires each institution to do their own (very time consuming and costly) studies prior to employing CSTDs in such a way. This policy seeks to foster research on standards and best practices for use of CSTDs for drug vial optimization, with the implied (although not clearly stated, which may result in an amendment) intent to convince standard-setting entities and regulators to permit the practice.
Impact of Drug Litigation Ads on Patient Care. Similar to ASHP’s strong stance opposing direct-to-consumer advertising, this proposed policy would set ASHP in firm opposition to drug litigation ads that could lead patients to modify or discontinue therapy without consulting their providers because such action could result in adverse patient outcomes.
Federal Review of Anticompetitive Practices and Price Increases by Drug Product Manufacturers. ASHP has existing policy strongly opposing anticompetitive practices by drug product manufacturers that adversely affect drug product availability and price. This policy recommendation seeks to update that policy to also delineate that manufacturers be required to provide public notification in advance of significant price increases. This is a very timely proposal, and of note, is consistent with current pending Michigan legislation (HB 5691).
Intravenous Fluid Manufacturing Facilities as Critical Public Health Infrastructure. This is another timely policy recommendation considering the very difficult experiences we have all been having with IV fluids this year. The Department of Homeland Security’s list of key infrastructure includes public health infrastructure. This policy would call for ASHP to advocate that public health infrastructure be defined to include manufacturing sites of IV fluids. The result would be that those sites would be afforded the same protections as other critical infrastructure and would call for the involved entities to make necessary changes to ensure that manufacturing is not at risk for supply disruption.
Responsible Medication-related Clinical Testing and Monitoring. Just like with medications, the Council on Therapeutics notes that overuse of clinical testing leads to unnecessary costs, waste and patient harm. Therefore, they crafted this policy recommendation which recognizes the impact pharmacists can make on ensuring appropriate but judicious use of testing and encourages pharmacists to further engage in these activities. I would note that this policy recommendation is relevant to all MSHP members, not just those of us who practice in the hospital!
Student Pharmacist Drug Testing. This policy recommendation has generated some interesting conversation, so I thought it was important to include here. Last year, the House of Delegates passed ASHP Policy 1717 which dealt with drug testing and recovery programs for pharmacy staff members. The ASHP Pharmacy Student Forum noted that pharmacy students would not be covered in the policy; however, their Executive Committee drafted this policy which advocates for drug testing throughout pharmacy education and prior to pharmacy practice experiences as well as encouraging colleges of pharmacy to develop policies and processes to identify impaired individuals, to facilitate access to programs for treatment and recovery and to use validated testing panels. Much of the discussion focused on how far ASHP policy should go when dealing with colleges of pharmacy. It was also noted that there is an American Association of Colleges of Pharmacy statement on the development of addiction and related disorders policies for colleges and schools of pharmacy. State laws may also dictate how colleges will deal with individual cases involving offenses that may prevent the student from obtaining licensure. There is a good chance this policy recommendation will be amended to remove the clause discussing treatment and recovery.
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 health-system pharmacists, so I 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: firstname.lastname@example.org; Mike: email@example.com; Dave: firstname.lastname@example.org; Jim: email@example.com). I have listed the titles of all the policy recommendations 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 within ASHP Connect. There has already been good discussion on ASHP Connect, so feel free to join the conversation!
Policy Recommendations to be Considered by the 2018 ASHP House of Delegates:
Council on Pharmacy Management
1. Medication Formulary System Management
2. Manufacturer-sponsored Patient Assistance Programs
3. Product Reimbursement and Pharmacist Compensation
4. Patient Access to Pharmacist Care Within Provider Networks
5. Health Insurance Policy Design
6. Pharmacy Accreditations, Certifications, and Licenses
Council on Pharmacy Practice
1. Use of International System of Units for Patient-related Measurements
2. Availability and Use of Appropriate Vial Sizes
3. Use of Closed-System Transfer Devices to Reduce Drug Waste
4. Collaborative Drug Therapy Management
Council on Public Policy
1. ASHP Statement on Advocacy as a Professional Obligation
2. Direct and Indirect Remuneration Fees
3. Impact of Drug Litigation Ads on Patient Care
4. Approval of Biosimilar Medications
5. 340B Drug Pricing Program Sustainability
6. Federal Review of Anticompetitive Practices and Price Increases by Drug Product Manufacturers
7. Federal Quality Rating Program for Pharmaceutical Manufacturers
8. Intravenous Fluid Manufacturing Facilities as Critical Public Health Infrastructure
9. Medical Devices
10. ASHP Statement on Principles for Including Medications and Pharmaceutical Care in Health Care Systems
Council on Therapeutics
1. Ensuring Effectiveness, Safety, and Access to Orphan Drug Products
2. Rational Use of Medications
3. Responsible Medication-Related Clinical Testing and Monitoring
4. Clinical Practice and Application on the Use Of Biomarkers
5. Medication Overuse
Council on Education and Workforce Development
1. Clinician Well-being and Resilience
2. Student Pharmacist Drug Testing
3. Collaboration on Experiential Education
4. Promoting the Image of Pharmacists and Pharmacy Technicians
5. Practice Sites for Colleges of Pharmacy
6. Pharmacy Practice Training Models