ASHP HOD Policy Review and Discussion

ASHP HOD Policy Review and Discussion WSPA Health Systems Leadership Meeting May 9 2016

Goals of Discussion • Review policies and resolution that will be discussed on the floor of the HOD meetings in June • Gather input on important, controversial and pivotal polices from WA State ASHP members • Determine any other areas related to pharmacy practice where policy discussions or recommendations might be made to ASHP for future review (eg, new business items)

WA State HOD Representatives 2016 • Roger Woolf • Andrea Corona • Janice Roe • Steve Riddle • Craig Pedersen (unable to attend) 4 Allotted

The New ASHP Policy Process • Changes • Implement new “virtual HOD” using ASHP Connect/web-based interaction and voting • Allow for year-round activity to speed response time for addressing critical policies and also manage some policies outside the traditional in-person process • Experience thus far • First round began earlier in 2016 • 4 polices: 2 passed and 2 moved onto to full HOD • What this means? • Increased need for better and more sustained communication between ASHP Councils, ASHP delegates and state affiliates/members

2016 HOD in Baltimore • 26 new policies or amendments to review • 1 resolution: ASHP Position on Assisted Suicide As expected, some policies are attracting more attention than others. Based on discussion to date on Connect and at RDCs, the “hot” policies are indicated in red font, yellow indicates some moderate interests and green seem to be moving forward with no substantial concerns. Regional Delegates Conferences (RDC) held April 30-May 3

Council on Therapeutics Policies • Stewardship of Drugs with Potential for Abuse • Appropriate Use of Antipsychotic Drug Therapies • Safety of Epidural Steroid Injections • Drug Dosing in Renal Replacement Therapy • Use of Methadone to Treat Pain • Therapeutic Indication of Prescribing

Stewardship of Drugs with Potential for Abuse • To encourage stewardship of drugs with potential for abuse; further, • To facilitate the development of best practices for prescription drug monitoring • programs and drug take-back disposal programs for drugs with potential for abuse. Key Comments: Items in lines 2 and 3 are covered in other ASHP policies (1526, 0614, 1408). “Pharmacists should have a leadership role in stewardship of Drugs with Potential for Abuse.” Need to better define “stewardship” in the context of this policy. Refer policy back to the Councilto review similar policies and/or create more detailed statement.

Appropriate Use of Antipsychotic Drug Therapies • To advocate for the documentation of appropriate indication and goals of therapy to • promote the judicious use of antipsychotic drugs and reduce the potential for harm; • further, • To support the participation of pharmacists in the management of antipsychotic drug • use, which is an interdisciplinary, collaborative process for selecting appropriate drug • therapies, educating and monitoring patients, continually assessing outcomes of • therapy, and identifying appropriate discontinuation; further, • To advocate that pharmacists lead efforts to prevent inappropriate use of • antipsychotic drugs, including engaging in strategies to detect and address patterns • of use in patient populations at increased risk for adverse outcomes. Key Comments: Amend lines 5-6 to read, “… which is an interprofessional collaborative process to achieve optimal patient specific outcomes.” Delegates recommend striking the remainder of lines 6-7 as this is inferred in the pharmacist role. Edit line 7 to read-- "...and, identifying appropriate discontinuation and dose reduction; further..."

Safety of Epidural Steroid Injections • To encourage healthcare providers to 1) inform patients about the significant risks • associated with epidural steroid injections, and 2) request their informed consent; • further, • To encourage healthcare organizations to prevent adverse events related to epidural • steroid injections by having pharmacists involved in the development of protocols that • promote the safe use of such injections. Key Comments: Fair amount of dialog with most delegates supporting language similar to this….

Drug Dosing in Renal Replacement Therapy • To encourage research on the pharmacokinetics and pharmacodynamics • of drug dosing in renal replacement therapy; further, • To support development and use of standardized models of assessment of the • pharmacokinetics and pharmacodynamics of drug dosing in renal replacement • therapy; further, • To collaborate with stakeholders in enhancing aggregation of data on the • pharmacokinetics and pharmacodynamics of drug dosing in renal replacement • therapy. Key Comments: Recommended to alter language of “renal replacement therapy” to say “different modalities of renal replacement therapy” throughout document to capture the concept that each of these methods has unique properties and impacts on drug clearance.

Use of Methadone to Treat Pain • To acknowledge that methadone has a role in pain management and that its • pharmacologic properties present unique risks to patients; further, • To oppose the use of methadone as a preferred treatment option for acute and chronic pain; further, • To advocate that all healthcare practitioners who prescribe or dispense methadone • complete a standardized educational program specific to the drug; further, • To advocate that pain management experts, payers, and manufacturers collaborate • to provide educational programs for healthcare professionals on treating acute • and chronic pain with opioids, including methadone; further, • To advocate that all facilities that dispense methadone, including addiction • treatment programs, participate in state prescription drug monitoring programs. Key Comments: In Lines 3 and 4 delete the verbiage: "acute and chronic" and addition "in adults" Deletion of lines 5 and 6 Lines 10 and 11 "Methadone should not be exempted from reporting requirements in state prescription drug monitoring programs

Therapeutic Indication of Prescribing • To advocate that healthcare organizations optimize use of clinical decision support • systems by structuring them to include the indication for high-risk and problem- • prone medications. Key Comments: One recommendation for the following amended language, “…optimize prescribing systems by structuring them to include the indication for all medications when prescribed. Another recommendation: “To advocate that healthcare organizations optimize systems; such as clinical decision support systems when utilized; by structuring them to include the indication for all medications when prescribed.”

Council on Education & Workforce Development Policies • Pharmacy Technician Training and Certification • Career Opportunities for Pharmacy Technicians • Developing Leadership Competencies • Interprofessional Education and Training • Cultural Competency and Cultural Diversity

Pharmacy Technician Training and Certification • To advocate that Pharmacy Technician Certification Board (PTCB) certification • be required for all pharmacy technicians; further, • To advocate that all pharmacy technicians maintain PTCB certification; further, • To support the position that by the year 2020, the completion of a pharmacy • technician training program accredited by ASHP and the Accreditation Council • for Pharmacy Education (ACPE) be required to obtain PTCB certification for all new • pharmacy technicians; further, • To foster expansion of ASHP-ACPE accredited pharmacy technician training • programs. Key Comments: Most dialog is around the importance of specifically citing PTCB certification vs any other (current or future) certification program. Here is one current alternate policy language…

Career Opportunities for Pharmacy Technicians • To promote the image of pharmacy technicians as valuable contributors to healthcare • delivery; further, • To develop and disseminate information about career opportunities that enhances • the recruitment and retention of qualified pharmacy technicians; further, • To support pharmacy technician career advancement opportunities, commensurate • with training and education; further, • To encourage compensation models for pharmacy technicians that provide a living • wage. Key Comments: Line 1: To promote pharmacy technicians as valuable………. Line 5-6: To support pharmacy technician career advancement opportunities and compensation, commensurate with training, education, and responsibilities; further Line 7-8: Delete

Developing Leadership Competencies • To work with healthcare organization leadership to foster opportunities, allocate • time, and provide resources for pharmacy practitioners to move into leadership • roles; further, • To encourage leaders to seek out and mentor pharmacy practitioners in developing • administrative, managerial, and leadership skills; further, • To encourage pharmacy practitioners to obtain the skills necessary to pursue • administrative, managerial, and leadership roles; further, • To encourage colleges of pharmacy and ASHP state affiliates to collaborate in • fostering student leadership skills through development of co-curricular leadership • opportunities, leadership conferences, and other leadership promotion programs; • further, • To reaffirm that residency programs should develop leadership skills through • mentoring, training, and leadership opportunities; further, • To foster leadership skills for pharmacists to use on a daily basis in their roles as • leaders in patient care. Key Comments: Change line 1 to -- To advocate [or collaborate] with healthcare organizational leadership...." for a stronger message. In line 7, change to read "administrative, managerial, leadership and clinical roles. Questions about adding “mentorship programs” to the list on line 10.

Interprofessional Education and Training • To support interprofessional education as a component of didactic and experiential • education in Doctor of Pharmacy degree programs; further, • To support interprofessional education, mentorship, and professional development for student pharmacists, residents, and pharmacists; further, • To encourage and support pharmacists’ collaboration with other health professionals • and healthcare executives in the development of team-based, patient-centered care • models; further, • To foster documentation and dissemination of outcomes achieved as a result of • interprofessional education of healthcare professionals. Key Comments: Line 5: changes to “development of interprofessional team-based, patient-centered care models…”

Cultural Competency and Cultural Diversity • To endorse the development of cultural competency of pharmacy educators, • practitioners, residents, students, and technicians; further, • To educate providers on the importance of providing culturally congruent care to • achieve quality care and patient engagement; further, • To advocate for an ethnically and culturally diverse workforce. Key Comments: Policy is now making appearance for 3rd or 4th year in a row. Common suggestion has been to consider splitting off line 5 into a separate policy. One suggested amendments makes the case for all 3 components (cultural competency, culturally congruent care and a ethnically & diverse workforce) are important to optimally deliver care.

Council on Pharmacy Management Polices • Controlled Substance Diversion and Patient Access • Surface Contamination on Packages and Vials of Hazardous Drugs • Pharmaceutical Distribution Systems • Patient Satisfaction

Controlled Substance Diversion and Patient Access • To enhance awareness by pharmacists, healthcare providers, and the public of drug • diversion and abuse of controlled substances; further, • To advocate that pharmacists take a leadership role in national efforts to reduce the • incidence of controlled substance abuse; further, • To advocate that pharmacists lead collaborative efforts by organizations of • healthcare professionals, patient advocacy organizations, and regulatory authorities • to develop and promote best practices for preventing drug diversion and • appropriately using controlled substances to optimize patient access and therapeutic • outcomes; further, • To advocate that the Drug Enforcement Administration and other regulatory • authorities interpret and enforce laws, rules, and regulations to support patient • access to appropriate therapies, minimize burdens on pharmacy practice, and • provide reasonable safeguards against fraud, misuse, abuse, and diversion of • controlled substances; further, • To encourage healthcare organizations to establish programs to support patients and • personnel with substance abuse and dependency issues. Key Comments: In general, delegates agreed with policy, but some comments around clarity in language and scope.

Surface Contamination on Packages and Vials of Hazardous Drugs • To advocate that pharmaceutical manufacturers eliminate surface contamination on • packages and vials of hazardous drugs; further, • To inform pharmacists and other personnel of the potential presence of surface • contamination on the packages and vials of hazardous drugs; further, • To advocate that the Food and Drug Administration require standardized labeling • and package design for hazardous drugs that would alert handlers to the potential • presence of surface contamination; further, • To encourage healthcare organizations to adhere to published standards and • regulations to protect workers from undue exposure to hazardous drugs. Key Comments: Lines 5-7: To advocate that the Food and Drug Administration require standardized labeling and package design for hazardous drugs throughout the supply chain … Add after line 9: “To encourage wholesalers and other trading partners in the drug supply chain to implement policies and procedures to mitigate the risk of exposure as hazardous drug products move through the supply chain.; such as consistent with United States Pharmacopeia Chapter 800 to mitigate the risk of exposure as hazardous drug products move through the supply chain.”

Pharmaceutical Distribution Systems • To support wholesaler/distribution business models that meet the requirements of • hospitals and health systems with respect to timely delivery of products, minimizing • short-term outages and long-term product shortages, managing and responding to • product recalls, fostering product-handling and transaction efficiency, preserving the • integrity of products as they move through the supply chain, and maintaining • affordable service costs; further, • To encourage wholesalers and other trading partners in the drug supply chain to • implement policies and procedures consistent with United States Pharmacopeia • Chapter 800 to mitigate the risk of exposure as hazardous drug products move • through the supply chain. Key Comments: Policy accepted as written by most all RDCs. One group stated…” Delegates did not support the added language to the policy and are proposing an amendment to the (previous policy) “Surface Contamination on Packages and Vials of Hazardous Drugs” so that all references to hazardous drugs are in one policy (see previous slide for amendment).

Patient Satisfaction • To encourage pharmacists to evaluate their practice settings for opportunities to • improve the level of satisfaction patients have with healthcare services and with the • outcomes of their drug therapy; further, • To educate pharmacists and pharmacy personnel about the relationship between • patient satisfaction and positive health outcomes, further, • To develop or adopt tools that will (1) provide a system for monitoring trends in the • quality of pharmacy services to patients, (2) increase recognition of the value of • pharmacy services, and (3) provide a basis for making improvements in the process • and outcomes of pharmacy services in efforts to engage patients and improve • satisfaction; further, • To facilitate a dialogue with and education of national patient satisfaction database • vendors on the role and value of clinical pharmacy services. Key Comments: Most RDCs accepted the policy as written. Two RDCs recommended the following changes…. For lines 11-12 To facilitate a dialogue and encourage patient experience database vendors to include the value of pharmacists and pharmacy services on patient experiences.

Council on Pharmacy Practice Policies • Automated Preparation and Dispensing Technology for Sterile Preparations • Integrated Approach for the Pharmacy Enterprise • Preventing Exposure to Allergens • Accreditation of Compounding Facilities

Automated Preparation and Dispensing Technology for Sterile Preparations • To encourage health systems to adopt automation and information technology for • preparing and dispensing sterile preparations when such adoption is (1) planned, • implemented, and managed with pharmacists’ involvement; (2) implemented with • adequate resources to promote successful development and maintenance; and (3) • supported by policies and procedures that ensure the safety, effectiveness, and • efficiency of the medication-use process; further, • To foster further research, development, and publication of best practices regarding • automation and information technology for preparing and dispensing sterile • preparations. Lots of dialog around this policy, predominantly driven by one passionate ASHP member. Still unclear what amendments will stick in policy. One example of changes…

Integrated Approach for the Pharmacy Enterprise • To advocate that pharmacy department leaders promote an integrated team • approach for all pharmacy professionals involved in the medication-use process; • further, • To advocate a high level of coordination of all components of the pharmacy • enterprise across the continuum of care for the purpose of optimizing (1) • medication-use safety, (2) quality, (3) outcomes, and (4) the value of drug therapy; • further, • To encourage pharmacy department leaders to develop and maintain patient- • centered practice models that integrate into a team all pharmacy professionals • engaged in the medication-use process, including general and specialized clinical • practice, drug-use policy, product acquisition and inventory control, product • preparation and distribution, and medication-use safety and other quality initiatives. Delegates generally agree with the policy mainly as written. Lines 1-3 should be deleted as they are repetitive. In line 4, the following change should be made: "To advocate that pharmacy leaders promote a high level of coordination of all components..." The delegates also suggested that the term "pharmacy enterprise either be defined in the rationale or that literature citations be included provided structure around what that term encompasses.

Preventing Exposure to Allergens • To advocate for pharmacy participation in the assessment and documentation of a • complete list of allergens pertinent to medication therapy, including food, excipients, • medications, devices, and supplies, for the purpose of clinical decision-making; • further, • To advocate that pharmacy departments actively review allergens pertinent to • medication therapy and minimize patient and healthcare worker exposure to known • allergens, as feasible; further, • To advocate that vendors of medication-related databases incorporate and maintain • information about medication-related allergens and cross-sensitivities; further, • To advocate that pharmacy departments be actively involved soliciting information • about patient food and environmental allergies that may indicate a potential for • medication interaction or adverse event; further, • To encourage pharmacist education on medication-related allergens. Key Comments: Line 1: To advocate for pharmacy participation in the solicitation, assessment…. Line 2: …devices, and supplies, and any other relevant personal or environmental factor… Line 5: To advocate that pharmacy personnel actively…” Line 13: To encourage pharmacy personnel education on medication-related allergens.

Accreditation of Compounding Facilities To discontinue ASHP policy 0617, To encourage facilities where extemporaneous compounding of medications occurs to seek accreditation by a nationally credible accreditation body. Key Comments: No comments.General agreement that this goal has been achieved.

Council on Public Policy…Policies • Off-Label Promotion by Pharmaceutical Manufacturers • Timely State Board of Pharmacy Licensing • Inclusion of Drug Product Shortages in State Price-gouging Laws • Home Intravenous Therapy • Drug Product Shortages • Direct-to-Consumer Advertising for Prescription Drugs and Implantable Devices

Off-Label Promotion by Pharmaceutical Manufacturers • To advocate for authority for the Food and Drug Administration to regulate the • promotion and dissemination of information about off-label uses of medications and • medication-containing devices by manufacturers; further, • To advocate that such off-label promotion and marketing be limited to the responsible • dissemination of unbiased, truthful, non-misleading, and scientifically accurate • information based on authoritative, peer-reviewed literature not included in the New • Drug Approval process. Key Comments: Amend Line 3: “manufacturers and their representatives” Amend line 4-5: “marketing be limited to the FDA regulated dissemination of... “

Timely State Board of Pharmacy Licensing • To advocate that state boards of pharmacy grant temporary licensure to pharmacists • ho are relocating from another state in which they hold a license in good standing, • permitting them to engage in practice while their application for licensure reciprocity is • being processed; further, • To advocate that the National Association of Boards of Pharmacy (NABP) collaborate • with state boards of pharmacy to streamline the licensure reciprocity process; further, • To advocate that NABP collaborate with state boards of pharmacy to streamline the • licensure process through standardization and improve the timeliness of application • approval. Key Comments: Reorder the clauses so that lines 7-9 are the first clause, lines 5-6 remain second and lines 1-4 are the last clause Delegates discussed the policy with regard to pharmacists providing remote order entry and other telepharmacy services, and the practice of pharmacy across state lines. It was suggested that the policy would be improved if the word "relocating" in line 2 were replaced with "seeking reciprocity."

Inclusion of Drug Product Shortages in State Price-gouging Laws • To urge state attorneys general to consider including shortages of lifesaving drug • products within the definition of events that trigger application of state price-gouging • laws. Key Comments: Most of the discussion has centered on the term “lifesaving” in line 1. many delegates feel this should be removed. One group noted the need to keep the word “lifesaving” in the policy since this would be important for inclusion in the state laws the policy in intending to have certain drugs be part of current legal statutes or, at least, interpretable by the Ags, while making it “all drugs” would create need for new and possibly unmanageable policy.

Home Intravenous Therapy • To support the continuation of a home intravenous therapy benefit under federal and • private health insurance plans, and expand the home infusion benefit under Medicare • at an appropriate level of reimbursement for pharmacists’ patient care services • provided, medications, supplies, and equipment. Key Comments: This policy simply dropped the “B” in line 2 after Medicare to allow for a broader policy that would encourage CMS to address fixing the gap for home care products, supplies and services. The new Medicare Alternative Site Act represents a new bill (in the House and Senate) that seeks to cover these currently uncovered products and services under Part B. General support for this.

Drug Product Shortages To discontinue ASHP policy 1118 Key Comments: Policy needs WILL be covered by provisions in the 2012 Food and Drug Safety and Innovation Act. Some concern that no policy will be on the books until FDSIA goes into effect later this year. However, this is one drug shortage policy still in place for ASHP. In general, there is agreement to DC.

Direct-to-Consumer Advertising for Prescription Drugs and Implantable Devices • To advocate that Congress commission an evidence-based review of direct-to-consumer • (DTC) advertising for prescription drugs and implantable medical devices in the United • States to determine the impact of such DTC advertising on the patient-prescriber • relationship, healthcare costs, health outcomes, and the public health; further, • To advocate that Congress ban DTC advertising for prescription drugs and implantable • medical devices until the results of such a review are publicly available; further, • To advocate, in the absence of a Congressionally mandated review, that the FDA, other • appropriate federal agencies, and the pharmaceutical and medical device industries • conduct or fund research on the effects of DTC advertising on the patient-prescriber • relationship, healthcare costs, health outcomes, and the public health, and make the • research results available to the public; further, • To oppose, in the absence of a ban, DTC advertising for prescription drugs and • implantable medical devices unless it is educational in nature about prescription drug • therapies for certain medical conditions, appropriately includes pharmacists as a source • of information, and is conducted so as to mitigate potential harmful effects on the • patient-prescriber relationship, healthcare costs, health outcomes, and the public • health. Comments next slide Key Comments: ”

DTC Advertising for Prescription Drugs and Implantable Devices Key Comments: Lots of commentary. The general trend is to simplify and toughen the policy position around “ban DTC” until research showing its benefit and lack of harm is completed. Much discussion about pulling provisions that allow for promotion “if felt to be educational in nature” An example of the most recent recommendation for amendment is shown here.

Resolution

ASHP Position on Assisted Suicide Motion: To amend ASHP policy 9915, ASHP Position on Assisted Suicide, to read as follows: • To oppose pharmacist participation in assisted suicide; further, • To reaffirm that pharmacists have the right to decline to participate in assisted suicide without retribution. Current Policy 9915: To remain neutral on the issue of health professional participation in assisted suicide of patients who are terminally ill; further, To affirm that the decision to participate in the use of medications in assisted suicide is one of individual conscience; further, To offer guidance to health-system pharmacists who practice in states in which assisted suicide is legal.

ASHP Position on Assisted Suicide Options for addressing the resolution include: • approve the motion to amend the policy; • defeat the motion to amend the policy; • refer the motion for further study by a committee or task force to be determined by the Board of Directors (the option recommended by the Committee on Resolutions); or • amend the resolution, which would then require due consideration by the Board of Directors at its next meeting in September.

Get & Give Information • ASHP Connect> Communities> House of Delegates • http://connect.ashp.org/ASHP/Communities/ViewCommunities/CommunityDetails/?CommunityKey=03e7fe4d-b0d9-4c26-8055-ec8564b0f325 • Contains all discussions and up-to-date recommendations for amended language • All ASHP members can access this info and make comments • ASHP Delegates Contact Info: • Woolf, Roger: Roger.Woolf@virginiamason.org • Corona, Andrea R: Andrea.Corona@providence.org • Roe, Janice: Janice.Roe@providence.org • Riddle, Steve: Steve.Riddle@wolterskluwer.com • Pedersen, Craig: Craig.Pedersen@virginiamason.org

ASHP HOD Policy Review and Discussion