Transcript Surface Contamination on Packages and Vials of Hazardous Drugs

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
4
Allotted





Roger Woolf
Andrea Corona
Janice Roe
Steve Riddle
Craig Pedersen (unable to attend)
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
1.
2.
3.
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:
1. Items in lines 2 and 3 are covered in other ASHP policies (1526, 0614, 1408).
2. “Pharmacists should have a leadership role in stewardship of Drugs with Potential
for Abuse.”
3. Need to better define “stewardship” in the context of this policy.
4. Refer policy back to the Council to review similar policies and/or create more
detailed statement.
Appropriate Use of Antipsychotic Drug Therapies
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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:
1. Amend lines 5-6 to read, “… which is an interprofessional collaborative process to achieve optimal patient
specific outcomes.”
2. Delegates recommend striking the remainder of lines 6-7 as this is inferred in the pharmacist role.
3. Edit line 7 to read-- "...and, identifying appropriate discontinuation and dose reduction; further..."
Safety of Epidural Steroid Injections
1.
2.
3.
4.
5.
6.
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:
1. Fair amount of dialog with most delegates supporting language similar to this….
Drug Dosing in Renal Replacement Therapy
1.
2.
3.
4.
5.
6.
7.
8.
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:
1. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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:
1. In Lines 3 and 4 delete the verbiage: "acute and chronic" and addition "in adults"
2. Deletion of lines 5 and 6
3. Lines 10 and 11 "Methadone should not be exempted from reporting requirements in state prescription
drug monitoring programs
Therapeutic Indication of Prescribing
1. To advocate that healthcare organizations optimize use of clinical decision support
2. systems by structuring them to include the indication for high-risk and problem3. prone medications.
Key Comments:
1. One recommendation for the following amended language, “…optimize prescribing systems by
structuring them to include the indication for all medications when prescribed.
2. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
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:
1. Most dialog is around the importance of specifically citing PTCB certification vs any other (current or
future) certification program.
2. Here is one current alternate policy language…
Career Opportunities for Pharmacy Technicians
1.
2.
3.
4.
5.
6.
7.
8.
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:
1. Line 1: To promote pharmacy technicians as valuable……….
2. Line 5-6: To support pharmacy technician career advancement opportunities and compensation,
commensurate with training, education, and responsibilities; further
3. Line 7-8: Delete
Developing Leadership Competencies
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
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:
1. Change line 1 to -- To advocate [or collaborate] with healthcare organizational leadership...." for a stronger message.
2. In line 7, change to read "administrative, managerial, leadership and clinical roles.
3. Questions about adding “mentorship programs” to the list on line 10.
Interprofessional Education and Training
1.
2.
3.
4.
5.
6.
7.
8.
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:
1. Line 5: changes to “development of interprofessional team-based, patient-centered care models…”
Cultural Competency and Cultural Diversity
1.
2.
3.
4.
5.
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:
1. Policy is now making appearance for 3rd or 4th year in a row.
2. Common suggestion has been to consider splitting off line 5 into a separate policy.
3. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
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:
1. In general, delegates agreed with policy, but some comments around clarity in language and scope.
Surface Contamination on Packages and Vials of Hazardous Drugs
1.
2.
3.
4.
5.
6.
7.
8.
9.
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:
1. Lines 5-7: To advocate that the Food and Drug Administration require standardized labeling and package
design for hazardous drugs throughout the supply chain …
2. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
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:
1. Policy accepted as written by most all RDCs.
2. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
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:
1. Most RDCs accepted the policy as written.
2. 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
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.
1. Lots of dialog around this policy, predominantly driven by one passionate ASHP member.
2. Still unclear what amendments will stick in policy.
One example of changes…
Integrated Approach for the Pharmacy Enterprise
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
1.
2.
3.
4.
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 patientcentered 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
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
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:
1. Line 1: To advocate for pharmacy participation in the solicitation, assessment….
2. Line 2: …devices, and supplies, and any other relevant personal or environmental factor…
3. Line 5: To advocate that pharmacy personnel actively…”
4. 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:
1. 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 Pricegouging Laws
 Home Intravenous Therapy
 Drug Product Shortages
 Direct-to-Consumer Advertising for Prescription Drugs
and Implantable Devices
Off-Label Promotion by Pharmaceutical Manufacturers
1.
2.
3.
4.
5.
6.
7.
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:
1. Amend Line 3: “manufacturers and their representatives”
2. Amend line 4-5: “marketing be limited to the FDA regulated dissemination of... “
Timely State Board of Pharmacy Licensing
1.
2.
3.
4.
5.
6.
7.
8.
9.
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:
1. Reorder the clauses so that lines 7-9 are the first clause, lines 5-6 remain second and lines 14 are the last clause
2. 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 Pricegouging Laws
1. To urge state attorneys general to consider including shortages of lifesaving drug
2. products within the definition of events that trigger application of state price-gouging
3. laws.
Key Comments:
1. 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
1.
2.
3.
4.
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:
1. 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.
2. 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.
3. General support for this.
Drug Product Shortages
To discontinue ASHP policy 1118
Key Comments:
1. Policy needs WILL be covered by provisions in the 2012 Food and Drug Safety and Innovation Act.
2. 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.
3. In general, there is agreement to DC.
Direct-to-Consumer Advertising for Prescription Drugs
and Implantable Devices
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
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
DTC Advertising for Prescription Drugs and Implantable
Devices
Key Comments:
1. Lots of commentary.
2. 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.
3. Much discussion about pulling provisions that allow for promotion “if felt to be educational in nature”
4. 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:
1. To remain neutral on the issue of health professional participation in
assisted suicide of patients who are terminally ill; further,
2. To affirm that the decision to participate in the use of medications in
assisted suicide is one of individual conscience; further,
3. 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:
1. approve the motion to amend the policy;
2. defeat the motion to amend the policy;
3. 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
4. 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/?Commu
nityKey=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: [email protected]
• Corona, Andrea R: [email protected]
• Roe, Janice: [email protected]
• Riddle, Steve: [email protected]
• Pedersen, Craig: [email protected]