Medication Safety Committee

Wednesday July 13, 2011 10:00 A.M. – 2:00 P.M.

California Hospital Association 1215 K Street, Ste. 800

Sacramento, CA

* ACTION ITEM ** REFER TO PREVIOUS MEETING’S MINUTES INCLUDED IN PACKET

MEDICATION SAFETY COMMITTEE July 13, 2011 / 10:00 a.m. – 2:00 p.m.

California Hospital Association

1215 K Street, Ste. 800 Sacramento, CA 95814

(916) 443-7401

Conference Call Options: (800) 882-3610, and pass code 5968133#

AGENDA

ITEM TIME SUBJECT REPORTING PAGE I. 10:00 CALL TO ORDER / INTRODUCTIONS HANNI / WHALEY –

WELTY 3

II. 10:05 *MINUTES OF MARCH 2, 2011 MEETING Recommendation: Approval

HANNI / WHALEY –WELTY

7

III. 10:10 OPERATIONS

CHA Vision, Goals, Mission Medication Safety Committee Guidelines

HANNI / WHALEY –WELTY

13 15

IV. 10:25 TOPICS OF INTEREST

NPDB Regarding Pharmacist FentaNyl Reference Chart Discharge Teaching Proposal Regarding Automatic Dispensing Anesthesia Groups Regarding TJC Medication Safety Symposium Record & Data Retention Schedule

HANNI / WHALEY-WELTY

SWANGER RICHTER

ALL GUTIERREZ

HANNI KARMALI

WHALEY-WELTY

19 25 ** ** 31 33 37

V. 11:30 WORKGROUP REPORTS & BREAK OUTS

*MERP *Emergency Medication Orders *High Risk/High Alert Drugs

o April 18, 2011 o June 20, 2011

HANNI MAAS

BENTON

39 41

12:30 LUNCH

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Medication Safety Committee Meeting — Agenda July 13, 2011

* ACTION ITEM ** REFER TO PREVIOUS MEETING’S MINUTES INCLUDED IN PACKET

Page 2

ITEM TIME SUBJECT REPORTING PAGE VI. 1:00 REPORTS

Board of Pharmacy

o Survey and Certification Issues CDPH Collaboratives

HEROLD

DEMARTINI WADE / LOPEZ /

SLININGER

**

VII. 1:30 LEGISLATION

AB 377

HARMS

43

VIII. 1:45 ADDITIONAL BUSINESS

Roundtable 2011 Meeting Schedule

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IX. 2:00 ADJOURNMENT HANNI / WHALEY-WELTY

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MEDICATION SAFETY COMMITTEE MEETING MINUTES

March 2, 2011 / 10:00 a.m. – 2:00 p.m. California Hospital Association

Sacramento, CA Members Present: Sylvia Banzon (via phone), Dawn Benton, Nancy Blake (via phone),

Carolyn Brown (via phone), Edna DeLeon, Loriann DeMartini, Mary Foley, Terri Gately, Amy Gutierrez, Jeannette Hanni, Nasim Karmali, Jan Kiely (via phone), Frank Maas (via phone), Richard Rabens, Pamela Richter, Allan Schaad, Philip Swanger, Jeffrey Uppington

Members Absent: Mary Ann Cone, Steve Gold, Jim Hauenstein, Virginia Herold, Randy

Kajioka, Pat McFarland, Robert Menet Invited Guests: None Regional Advisors: Mary Lopez (via phone), Lindsey Wade CHA Staff: Dorel Harms, Rory Jaffe, Debby Rogers I. CALL TO ORDER/INTRODUCTIONS

Self introductions were made.

II. *MINUTES OF AUGUST 18, 2010 MEETING Minutes approved after Jan Kiely and Phil Swanger were added as participants via phone.

III. OPERATIONS

CHA Vision, Goals, Mission No discussion

Medication Safety Committee Guidelines Reviewed

Work Group o Ground Rules

Reviewed

o Delegation of Duties The chairs should delegate minute taking, etc. to lessen the burden.

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o Participation

No discussion.

o April Meeting Cancellation The April meeting has been cancelled. The next Medication Safety Committee meeting is scheduled for July 13. Hanni will no longer chair the MERP work group. Richter will take over the MERP work group. Thank you to Hanni and Richter.

IV. TOPICS OF INTEREST

A2 Annual Fall Conference Survey Results

Review of results; it’s disturbing that 21 states did not see medication safety as a priority.

Nebraska Project o Dr. Gary Cochran, a Professor at the University of Nebraska, Omaha, had a

plan to address medication quality of care issues in critical access hospitals. In a review of the literature, Dr. Cochran was looking for a direct observation approach to detect medication errors and discovered the CALNOC Medication Administration Accuracy method. He contacted CALNOC. He attended two CALNOC conferences and CALNOC Observer Trainings and included the CALNOC method in his research. Dr. Cochran was awarded a five-year grant, AHRQ grant HS18059: Comparing the Effectiveness of Medication Use Systems in Small Rural Hospitals.

o The University of Nebraska Study uses the CALNOC Medication

Administration Accuracy nursing sensitive quality measure and also provides the initial nine enrolled hospitals with an introductory year of membership in CALNOC.

o In the first year, the nine hospitals will use direct observation to compare the

effectiveness and cost of bedside barcode administration to two other methods of medication dispensing and administration that are frequently used in critical access hospitals.

o The CALNOC Medication Administration Accuracy Observer training was

conducted in January with seven of the hospitals on-site in Nebraska and the other two hospitals by webinar with the CALNOC Director of Education, Mary Foley RN, PhD.

Question: Any psychiatric hospitals participating? Answer: Not at this time; labor and delivery will be added at some point. Psychiatric units are being cited for medication issues and need assistance.

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Survey & Certification Issues EHRs present a challenge regarding 30 minute rule. ISMP had article attempting a compromise. Huge push back from nurses because it is not always possible to do. Per DeMartini, this has been required since 2004. Ongoing conversations; certain medications are critical to be timely. Others are not. In LTC, have to determine if it jeopardizes patient. DeMartini will check with David Ettinger during their upcoming meeting. *DeMartini to report at next meeting. TJC is talking with CMS to propose middle ground. The software systems will need to be revised.

NPDB *Harms and Swanger to research as to how this affects pharmacist.

Discharge Teaching PSLS survey showed that discharge instructions are a concern. Are written discharge instructions that most hospitals use and are given by the nurse adequate to meet this provision? B&P 4074(d) talks about implementing a policy. Adequate as long as policy is in effect. One out of five readmissions is caused by patients not taking discharge medications as prescribed. Professionals must ensure the patient gets the correct information. We should be promoting quality. P&T committee and pharmacists must be involved in the process. Patient gets a great deal of information but may not understand what they are getting. Collaboration between nurses and pharmacists is to the benefit of the patients. Retail pharmacists are not aware of the issues with fentanyl and opioid naïve patients. Need to assure the written material presented to the patient is accurate. Further discussion or action? *Harms to place on next agenda.

Medication Shortage See handout from Benton regarding legislation. What is the state finding? They are not finding anything probably due to limitations of the survey. One hospital is rationing some oncology drugs. Others are buying generics from where ever they can get them. Generics have issues regarding look alike, sound alike. Per DeMartini, hospitals should have a policy on drugs in short supply. FDA is exercising stricter control which is also lending to shortage.

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Medication Reconciliation

Many vendors provide this service but it is very expensive. There are also privacy issues. Some think hospitals need to get consent from patients to do the search and there is no access to information if patients pay cash. Most continue to do patient interviews. Additional Discussion – Psycho-therapeutic drug consent for LTC patients LTC facilities are required to obtain informed consent for use of psycho-therapeutic, physical restraints and devices. This is a result of lawsuit CANA v. state. Department issued AFL in January that requires consent. SNFs cannot give psycho-therapeutic drugs until they get the informed consent. LTC folks are asking CHA to work with them. SNF can get clarification that consent was obtained from the hospital. Title 22 requirements may be different in GACHs. Contact at CDPH is Ed Hofmark. GACH pharmacists say they do not get separate consent for psycho-therapeutic drugs. So, it would be difficult to give SNFs the consent that they are requesting. CHA Consent Manual states that antipsychotic drugs need consent in GACHs. Most agree it would be difficult for GACH pharmacists to get this information and it is not required.

V. WORKGROUP ITEMS

MERP

o Surveys Discussion ensued as to whether the MERP work group is still necessary. Consensus was that it can serve as an information resource and to help hospitals resolve related issues. It was also decided that the committee should annually review each work group to determine need and decide if other work groups are needed.

Emergency Medication Orders

See survey handout. Survey revisions reviewed. CHA to take to the Executive Management Committee for approval. Then send to hospitals via survey monkey. Will be aggregate report only. Stratify between large and small number of patients – question #1. Q. #2, last bullet, revise to TJC language. Add question regarding how many licensed beds. Would like EMS/Trauma Committee additions. *Harms to do CHA News article regarding the Medication Safety Committee and its work/surveys etc. and alerting everyone about the survey and the Fentanyl advisory.

High Risk/High Alert Drugs o High Alert Medication Handling Guidelines – Adult Population

No discussion

10

o Updated FentaNyl Reference Chart

Old one in packet; need to make sure that we get the latest one from Swanger; revised during meeting. Need intro paragraph. Still needs some work. Advise that group meet again and email comments to Dawn. WG will revise and send to the committee. When it does go out should go as list and ask for suggestions back. This is a trial balloon. Question: Are we setting ourselves up with L&C? Maybe but this is accepted practice.

o Guidelines No discussion

VI. REPORTS Board of Pharmacy

No report

CDPH o Medication Safety Leadership Program

The first one designed for medication safety leadership is being launched this fall. Comment: it’s expensive. State is behind on MERP surveys, 175 as of January. Bumped up to priority one. Trying to do 150 with heavy concentration in LA County the first 6 months of this year. About 85% have deficiencies. Dr. Horton is no longer Secretary of Health. Dr. Backer is the Interim Health Officer.

Collaboratives

Mary Lopez: Patient Safety First started in Sacramento and central valley. Pilot project to convene pharmacists in central valley. Hospital presentations given. Loriann provided input. Referred to Center for Healthcare Quality work. Beacon Annual Conference being held. Added another project with Hospital Association of Southern California to work on case management transformation project to help hospitals be successful in HCR. Lindsey Wade: Patient Safety First continuing. Lynn Jantzen attended first meeting to provide guidance. Patient Safety Council facilitated by Nancy Pratt began to look at standardizing dosing limits. Will be expanding the project. All the information is on patientsafetycouncil.org. The program is open to any hospital that wants to participate.

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Medication Safety Committee Meeting Page 6 March 2, 2011

7/7/2011 10:17 AM

VII. LEGISLATION

o AB 377

Because this is a repeat of 2010 legislation, a short summary was provided. The Governor vetoed last year. We now have a new Governor and another opportunity to pass the legislation.

VIII. ADDITIONAL BUSINESS

Roundtable

Pursue the anti-therapeutic issue. Not just a mental health issue. This is one issue in the transition of care. FDA guide use of medication as part of the Risk Evaluation Mitigation. It’s important for people to weigh in. Surveyors do not understand the technology changes regarding automated dispensing cabinets; need to be educated. Ask CSHP to facilitate a discussion between surveyors and vendors; double edge sword. *Gutierrez will write up proposal for Benton’s executive committee. Nurses, pharmacists etc. need competencies. Why don’t surveyors?

2011 Meeting Schedule

No discussion

IX. ADJOURNMENT

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V I S I ON

CHA’s vision is “an optimally healthy society.”

GOAL

CHA’s goal is that every Californian has equitable access to affordable,high-quality medically necessary health care. Only through high ideals and

practical, progressive steps can the health status of Californians be improved.This challenge must be shared by all stakeholders, including individuals,

employers, health care providers, payers and government.

M I SS I ON

The unity that CHA brings to the health care community is the foundationof its mission: Through effective leadership and member participation,CHA seeks to develop consensus, establish public policy priorities, and

represent and serve hospitals and health systems. In concert with its memberorganizations, CHA is committed to establishing and maintaining a

financial and regulatory environment within which hospitals can continueto provide high-quality patient care.

1215 K Street, Suite 800, Sacramento, CA 95814 • Telephone: 916.443.7401 • Facsimile: 916.552.7596 • Website: www.calhospital.org

Corporate Members: Hospital Council of Northern and Central California, Hospital Association of Southern California, and Hospital Association of San Diego and Imperial Counties13

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GUIDELINES FOR THE CALIFORNIA HOSPITAL ASSOCIATION

MEDICATION SAFETY COMMITTEE Revised 02/18/10

I. NAME

The name of this committee shall be the Medication Safety Committee. II. MISSION

The mission of the Medication Safety Committee is to provide leadership within the health care community to promote the highest standards related to the safe and effective use of medications. (revised 2/18/10)

III. PURPOSE

The purpose of the Medication Safety Committee is to provide a forum for diverse multi-disciplinary health care organizations, that include health care delivery organizations, patient safety organizations, discipline specific professional associations/organizations and regulatory agencies, to promote safe medication practices in the state of California. The Committee will focus on acting as a source of medication safety expertise, providing a venue for the coordination of medication safety activities and making recommendations related to medication safety legislation and regulations. (revised 2/18/10

IV. COMMITTEE

The Committee (the “Committee”) shall consist of a minimum of 16 representatives and not more than 35 representatives from the following organizations:

California Department of Public Health California Society of Health System Pharmacists California Board of Pharmacy Centers for Medi-Care and Medi-Caid Services Association of California Nurse Leaders California Medical Association California Hospital Patient Safety Organization Risk Management Association Representatives from the following CHA committees/centers:

Center for Behavioral Health Rural Health Center Quality Committee Joint Committee on Accreditation and Licensing Center for Hospital Medical Executives EMS/Trauma Committee Hospital Based Clinics Committee Center for Rehabilitation Services

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Hospital Services for Continuing Care Committee Governance Quality Directors Health Informatics and Technology Committee

A. MEMBERSHIP

1. Membership on the Committee shall be based upon membership in CHA, or

organizations that have a direct relationship to the purpose and mission of the committee. Non hospital member representatives can only be appointed to the Committee at the discretion of the CHA President.

2. In addition to the Committee/Centers named above, the CHA Committee

members shall consist of various representatives from large hospital systems, public institutions, private facilities, free-standing facilities, small and rural facilities, university/teaching facilities and specialty facilities. A member may fulfill more than one required membership.

3. Hospital members are appointed by CHA Staff.

4. Term:

(a) The initial term of office shall be three years, except that one-half

of the initial members shall be appointed to two-year terms to ensure continuity of committee members in the future.

(b) As the terms of the members appointed in 2009 expire, or members

otherwise leave, vacancies shall be filled to achieve the requirements of Article IV. Members are limited to two, three-year consecutive terms. An exception shall be granted in cases where a member is elected as a chair officer. Following two consecutive terms there must be a one-year interval before a member is eligible for another term.

B. MEMBER RESPONSIBILITIES

1. Provide hospital-industry leadership to the Committee. 2. Identify issues and develop possible solutions and best practices to improve the

safety of medication storage and distribution administration. 3. Work cooperatively with key stakeholders to develop creative solutions.

4. Provide communication to member hospitals regarding medication safety issues.

5. Maintain/increase awareness of the legislative and regulatory environment with

regard to medication safety issues.

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C. COMMITTEE MEETINGS

1. Meetings of the Committee shall be held quarterly in person. 2. To maintain continuity substitution of members is not acceptable.

3. Three consecutive unexcused absences by a Committee member will initiate a

review by the Chair and CHA staff for determination of the Committee member’s continued service on the Committee.

4. Special meetings may be scheduled by the Chair, majority vote or CHA staff.

D. VOTING

1. Voting rights shall be limited to members of the Committee, and each member present shall have one vote. Voting by proxy is not acceptable.

2. All matters requiring a vote of the Committee must be passed by a majority of a

quorum of the Committee members present at a duly called meeting or telephone conference call.

E. QUORUM

Except as set forth herein, a quorum shall consist of a majority of members present or not less than eight.

F. MINUTES

Minutes of the Committee shall be recorded at each meeting, disseminated to the membership, and approved as disseminated or as corrected at the next meeting of the Committee.

V. OFFICERS

The officers of the Committee shall be the Committee Chair, Vice Chair, Immediate Past Chair and CHA staff.

The Chair shall be elected by the Committee for a two-year term, except for the initial Chair, who shall be appointed by CHA staff for one year. Should a Chair vacate his/her position prior to the end of the term, CHA staff will appoint a replacement to complete the remainder of the term.

Past-chairs will remain as a member of the Committee.

A. SUB-COMMITTEES

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Operating Guidelines Revised February 18, 2010 Page 4 1. Task forces of the Committee may be formed at the discretion of the Committee

Chair and members and CHA staff for the purpose of conducting activities specific to a special topic or goal.

VI. GENERAL PROVISIONS

The strategic plan defining the goals, objectives, and work plans shall be developed annually by the Committee with approval by CHA staff. Quarterly updates and progress reports shall be completed by the Committee and CHA staff.

Staff leadership at the state level shall be provided by CHA with local staff leadership provided by Hospital Council, the Hospital Association of Southern California, and the Hospital Association of San Diego and Imperial Counties. The primary office and public policy development and advocacy staff of the Committee shall be located within the CHA office.

The Committee staff shall be an employee of CHA.

VII. AMENDMENTS

These Guidelines may be amended by a majority vote of the members of the Committee at any regular meeting of the Committee and with approval by CHA.

VIII. LEGAL LIMITATIONS

Any portion of these Guidelines which may be in conflict with any state or federal statutes or regulations shall be declared null and void as of the date of such determination.

Any portion of these Guidelines which are in conflict with the Bylaws and policies of CHA shall be considered null and void as of the date of the determination.

Information provided in meetings is not to be sold or misused.

IX. CONFIDENTIALITY FOR MEMBERS

Many items discussed are confidential in nature, and confidentiality must be maintained. All Committee communications are considered privileged and confidential, except as noted.

X. CONFLICT OF INTEREST

Any member of the Committee who shall address the Committee in other than a volunteer relationship excluding CHA staff and who shall engage with the Committee in a business activity of any nature, as a result of which such party shall profit either directly or indirectly, shall fully disclose any such financial benefit expected to CHA staff for approval prior to contracting with the Committee and shall further refrain, if a member of the Committee, from any vote in which such issue is involved.

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Resources

Legislation and Regulations

Why Is Section 1921 Important? Section 1921 authorizes the National Practitioner Data Bank (NPDB) to expand the information it collects. With this legislation, disciplinary records of allied health care professionals are now accessible to private sector hospitals, nursing homes, and other organizations so that they may be used when making employment, affiliation, certification, or licensure decisions.

The intent of this expansion is to protect beneficiaries participating in the Social Security Act's health care programs from unfit health care practitioners and to improve the anti-fraud provisions of these programs. The Final Rule for Section 1921 was published in the Federal Register on January 28, 2010 and Section 1921 was opened for querying and reporting to the Data Bank on March 1, 2010.

Section 1921 adds State licensure actions against all types of health care professionals, not just physicians and dentists, to the NPDB. In addition, Section 1921 collects any negative action or finding by State licensing agencies, peer review organizations and private accreditation organizations against all health care practitioners and organizations.

Hospitals and their human resource departments and nurse recruitment offices now have access to licensure actions on all types of health care professionals. They may query the Data Bank on all types of health care professionals including nurses, nurse aides, and other allied health care professionals when making their hiring decisions. The ability to perform pre-employment screenings of potential health care employees is an invaluable resource that can enhance the hiring process and increase an organization's efforts towards patient safety.

Registration and Section 1921

All organizations who wish to use the Data Bank must first register and certify their eligibility to access the Data Bank. The registration form includes a provision for Section 1921 eligibility, which must be completed by your Entity Data Bank Administrator. If your organization is already registered, you may update the registration profile from the Administrator Options screen with your Section 1921 preferences. See About Registration for more information.

Who Reports Under Section 1921?

State licensing authorities are required to report any publicly available negative action or finding that has been taken against a health care practitioner or health care entity. Peer review organizations or private accreditation organizations must report all final actions taken against a health care practitioner or

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organization.

Section 1921 broadens the NPDB by requiring the reporting of all adverse licensure actions, not just those based on professional competence or conduct. State licensing agencies that currently report to the HIPDB will also be required to report to the NPDB under the provision of Section 1921. The Data Bank will determine if the report is to be placed under the NPDB, the HIPDB, or both. See below for organization specific information.

Who Queries Under Section 1921?

Hospitals, including human resource and nurse recruitment departments, will now have access to all licensing board actions on all health care practitioners, not just physicians and dentists. All organizations that currently have access to the NPDB will also have access to Section 1921 of the NPDB. Organizations that are only allowed to query the NPDB through Section 1921 will receive Section 1921 information only. See below for organization specific information.

How Does Section 1921 Affect My Organization?Whether you are a hospital, nursing home, State Licensing Board or authority, accreditation organization, quality improvement organization, peer review organization, law enforcement agency, Federal or State health care program, or other health care organization, Section 1921 affects your organization. Reporting requirements and the types of licensure actions collected have been expanded through Section 1921. Eligible queriers will now have access to State licensure actions taken against all health care practitioners. Under Section 1921, this now includes limited querying by quality improvement organizations, Federal and State health care programs, State Medicaid Fraud Control Units, and other law enforcement agencies.

Hospitals, Nursing Homes and Other Health Care Organizations

Under Section 1921, hospitals, nursing homes, and other health care organizations have access to State licensure actions taken against all health care practitioners and health care entities, not just physicians. These practitioners include nurses, nurse aides, podiatrists, physician assistants, physical therapists, respiratory therapists, social workers and other allied health care professionals. The information is accessible to both public and private sector hospitals, nursing homes, and other health care organizations through the NPDB.

The information reported to the NPDB, as expanded by Section 1921, includes all actions taken against a practitioner. The action no longer must be based on competence and conduct. This information is valuable to human resource departments and nurse recruitment offices when performing pre-employment background checks and making hiring decisions. The information may also be beneficial for hospitals when placing patients in extended care, rehabilitation, or long term care facilities.

State Licensing Boards and Authorities

Under Section 1921 reporting requirements, State licensing authorities must report all publicly available adverse licensure actions, not just those based on professional competence and conduct. This includes actions taken against all health care practitioners and health care entities, not just those concerning physicians and dentists. Section 1921 information is an important resource to State licensing agencies when making licensure determinations about health care practitioners and organizations.

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Accreditation Organizations

Private Accreditation organizations are now required to report to the NPDB under Section 1921, certain types of final negative actions or findings against health care organizations. Private accreditation organizations are not authorized to query Section 1921 information.

Quality Improvement Organizations

Quality Improvement Organizations (QIOs), as defined in Section 1921 final regulations, are among the organizations that are newly authorized to query the NPDB under Section 1921. Information available under Section 1921 includes adverse licensure actions taken by a State licensing authority against health care practitioners and entities, as well as negative actions or findings that a State licensing authority, peer review organization, or private accreditation organization finalizes against a health care practitioner or organization.

Access to the information in Section 1921 of the NPDB can aid QIOs in their mission to protect and improve the quality of care for Medicare beneficiaries. For example, Quality Improvement Organizations will be able to query Section 1921 information when performing quality of care reviews and other related activities. There is no reporting requirement for QIOs in the Section 1921 final regulations.

Peer Review Organizations

Under Section 1921, peer review organizations, as defined in the Section 1921 final regulations, are required to report certain types of negative actions or findings against health care practitioners to the NPDB.

Only utilization and quality control peer review organizations under contract with the Centers for Medicare and Medicaid Services (referred to as Quality Improvement Organizations) are authorized to query Section 1921 information. Other peer review organizations do not have this authority. Section 1921 information, however, will serve as an invaluable resource for hospitals and other health care organizations with which peer review organizations work by improving employment screening, reducing the risk of negligent credentialing, and enhancing patient safety.

Law Enforcement Agencies

Law enforcement agencies and State Medicaid Fraud Control Units are among the organizations that are newly authorized to query Section 1921 of the NPDB.

Information available under Section 1921 includes adverse licensure actions taken by a State licensing authority against health care practitioners and entities, as well as negative actions or findings that a Statelicensing authority, peer review organization or private accreditation organization finalizes against a health care practitioner or entity.

There are no Section 1921 reporting requirements for law enforcement agencies.

Federal State Health Care Programs

Federal agencies administering Federal health care programs (and their contractors) as well as State agencies administering State health care programs are among the organizations that are newly

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authorized to query the NPDB under Section 1921.

Information available under Section 1921 includes adverse licensure actions taken by a State licensing authority against health care practitioners and entities, as well as negative actions or findings that a State licensing authority, peer review organization or private accreditation organization finalizes against a health care practitioner or entity.

There are no Section 1921 reporting requirements for Federal or State health care programs.

Section 1921 for Practitioners Practitioners may access information about themselves in the Data Bank at anytime. They may request information about themselves by submitting a Request for Information (Self-Query) on the Data Bank Web site. See About Searching for Your Own Reports for more information.

Additional Information About Section 1921

NPDB and HIPDB Comparison Chart (PDF - 87 KB) QRXS File Format Specifications (Sign In Required) Fact Sheet on Section 1921 (PDF - 62 KB) NPDB and Section 1921 at a Glance (PDF - 299 KB) NPDB-HIPDB and Section 1921 Comparison Chart (PDF - 120 KB)

1.800.767.6732

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1

Lori Woolsey

From: Dorel HarmsSent: Monday, April 25, 2011 2:51 PMTo: 'Richter, Pamela'; Philip Swanger; Allen Schaad; Amy Gutierrez; Catherine Carson; Dawn

Benton, Chair; Eddie Avedikian; Jeffrey Uppington; Jim Hauenstein; Loriann Demartini; Mary Foley; Nasim Karmali; Nasim Karmali WHHS Email; Sylvia Banzon; Virginia Herold; Lori Woolsey

Subject: RE: CHA Med Safety Committee- HRHA Medication Guidelines- Fentanyl Patch Final 4-18-11.doc

Thank you, I will add to agenda.  

From: Richter, Pamela [mailto:Richter.Pamela@scrippshealth.org] Sent: Monday, April 25, 2011 1:59 PM To: Philip Swanger; Allen Schaad; Amy Gutierrez; Catherine Carson; Dawn Benton, Chair; Dorel Harms; Eddie Avedikian; Jeffrey Uppington; Jim Hauenstein; Loriann Demartini; Mary Foley; Nasim Karmali; Nasim Karmali WHHS Email; Sylvia Banzon; Virginia Herold Subject: RE: CHA Med Safety Committee- HRHA Medication Guidelines- Fentanyl Patch Final 4-18-11.doc approved with Bob's changes and fixed hanging ISMP which was actually a link to their website on the fentanyl patch but was not clear. All changes incorporated in this document. Pamela M Richter Pharm.D. LAc, MSTOM Medication Safety Pharmacist Scrippshealth System Richter.Pamela@Scrippshealth.org 619.781.7535 cell 619.260.7166 office

This e-mail and any files transmitted with it may contain privileged and confidential information and are intended solely for the use of the individual or entity to which they are addressed. If you are not the intended recipient or the person responsible for delivering the e-mail to the intended recipient, you are hereby notified that any dissemination or copying of this e-mail or any of its attachment(s) is strictly prohibited. If you have received this e-mail in error, please immediately notify the sending individual or entity by e-mail and permanently delete the original e-mail and attachment(s) from your computer system. Thank you for your cooperation.

From: Philip Swanger [mailto:philip@cshp.org] Sent: Thursday, April 21, 2011 1:44 PM To: Allen Schaad; Amy Gutierrez; Catherine Carson; Dawn Benton, Chair; Dorel Harms; Eddie Avedikian; Jeffrey Uppington; Jim Hauenstein; Loriann Demartini; Mary Foley; Nasim Karmali; Nasim Karmali WHHS Email; Richter, Pamela; Philip Swanger; Sylvia Banzon; Virginia Herold Subject: FW: CHA Med Safety Committee- HRHA Medication Guidelines- Fentanyl Patch Final 4-18-11.doc

Please see Bob LeWinter’s comments attached with track changes on for your review. Please reply-all with either your approval or comments. Thanks,

PHILIP B. SWANGER DIRECTOR OF GOVERNMENT AFFAIRS

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CALIFORNIA SOCIETY OF HEALTH-SYSTEM PHARMACISTS 1314 H STREET, SUITE 200 SACRAMENTO, CALIFORNIA 95814 OFFICE (916) 447-1033 EXT. 108 FAX (916) 447-2396 E-MAIL philip@cshp.org WEBSITE www.cshp.org

From: Lewinter, Robert (CDPH-LNC) [mailto:Robert.Lewinter@cdph.ca.gov] Sent: Thursday, April 21, 2011 11:56 AM To: Philip Swanger Cc: Dorel Harms Subject: CHA Med Safety Committee- HRHA Medication Guidelines- Fentanyl Patch Final 4-18-11.doc See my suggested editorial changes. Bob LeWinter

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CHA Medication Safety Committee High Alert Medication Guideline - FentaNYL Transdermal Patch April 2011 

 

1 

Despite warnings from the FDA, manufacturers, and various patient safety agencies, transdermal fentaNYL patches continue to be prescribed inappropriately to treat patients with acute pain and patients who are not opioid tolerant.. Link to ISMP newsletter. This guideline document is intended to summarize safe use practices to reduce the preventable harm to patients in the hospital setting. FentaNYL patches are only for patients who are opioid-tolerant for the management of persistent, moderate to severe chronic pain that requires continuous, around the clock opioid administration for an extended period of time AND cannot be managed by other means. The patches are NOT to be used to treat sudden, occasional or mild pain, or pain after surgery. Opioid tolerance are those who have been taking opioids for a week or longer. Opioid tolerant is defined as taking oral morphine 60 mg/day or oral hydromorphone 8 mg/day or oral oxycodone 30 mg/day. Medication Use Step

Actions to Consider to Increase Medication Safety

General Define and educate staff on opiate tolerance Opioid tolerance are those who have been taking opioids for a week or longer. Opioid tolerant is defined as taking oral morphine 60 mg/day or oral hydromorphone 8 mg/day or oral oxycodone 30 mg/day.

Consider eliminating storage in Emergency rooms, PACU, Operating rooms, short day surgery, which are considered problem-prone areas for fentaNYL use

Pharmacy Purchasing, Storage and Product Labeling

Ensure manufacturer provides clear identification of patch contents once it is removed from the packaging. Be sure your product clearly identifies the ingredient fentaNYL and strength.

Secure utilizing ADC controlled substance cabinets in different lockers. If ADC is not available segregate your strengths in your locked storage system. Storage bins should utilize TALLman lettering fentaNYL

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CHA Medication Safety Committee High Alert Medication Guideline - FentaNYL Transdermal Patch April 2011 

 

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Unit Storage of Medications (includes automated dispensing cabinets- ADC such as Pyxis MedStation)

Hospitals with ADC configuration: With 24/7 pharmacy coverage

Never place on an override medication list. Consider bar code verification upon refill or a pharmacist check post load/refill. Stock in a single access pocket and not in a communal (matrix) pocket. Load only in ADC cabinets that are profiled and releases medication only after

the pharmacist order verification has occurred. In non profiled areas, have pharmacy send stock patient specific once

pharmacist order validation has occurred. Without 24/7 pharmacy coverage

Stock with caution* in all areas that are not profiled *Caution = limited quantities & strengths available, additional safeguards such

as 2 independent practitioners (double check) Utilize Pop-up alerts for opiate tolerance assessment (example below) in all

stocked cabinets Question: Review of patient opiate history confirms opiate tolerance? YES - proceed with removal NO - contact prescriber for alternative medications Hospitals without ADC-configuration:

Require second verification as to medication appropriateness Promote patient-specific pharmacy dispensing of doses on demand Segregate strengths in separate locations Label doses with warning against cutting patches

Prescribing FentaNYL patches should ONLY be prescribed to manage persistent, moderate-

to-severe chronic pain that requires continuous, around-the-clock opiate administration for an extended period of time, particularly when the pain cannot be managed by other means such as non-steroidal analgesics, opiate combination products, or immediate-release opiates.

Consider use of a pre-formatted order form that requires the prescriber to identify appropriate indications for use prior to pharmacist dispense.

Consider requiring the prescriber to document in the medical record that the patient meets criteria for using the patch. Ideally this documentation would list previous drug dosing history.

Provide guidance on appropriate starting dose and opioid dosing equivalence Consider prescriber limitations for use (specific trained prescribers or maximum

dosing of 25 mcg/hr patch for general practitioners) Consider pharmacist-driven protocol for use of fentaNYL patch Dosage modifications should not be made prior to 72 hours after initiation of

therapy, and not prior to 6 days after dose changes. (per package insert)

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CHA Medication Safety Committee High Alert Medication Guideline - FentaNYL Transdermal Patch April 2011 

 

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Pharmacist Order Entry Process

Have references and tools for pharmacist assessment of appropriateness. Establish requirements for minimum pharmacist review with the goal of

identifying the potential for adverse consequences. To include pharmacist assessment of:

o Appropriate indication (severe chronic pain) o Opiate-tolerance. Opioid tolerant defined as taking oral morphine 60

mg/day or oral hydromorphone 8 mg/day or oral oxycodone 30 mg/day o Appropriate starting dose based on dosing history and indication o Potential drug interactions o Validation of home dosing - last refill information o Change in patch strength – pharmacist to ensure that strength is not

changed prior to 3 days after initiation or 6 days after dose increase. Consider Black Box Warning (BBW) pop-up warning to remind pharmacist of

appropriate indications and to require documentation of pharmacist intervention through computer order entry.

Pharmacy Dispensing

Require pharmacist review for dispensing of all fentaNYL patches (remote review, on site review).

When a prospective pharmacist review is not conducted, a retrospective review to occur on all patients to assess for appropriateness of use

Nursing Administration

Never cut the patch Caregiver should use gloves when handling the patch and wash hands

immediately after handling the patch (for placement or disposal) Apply patch to non-irritated skin such as chest, back, flank or upper arm.

Do not shave skin; hair at application site may be clipped Add MAR warning note that includes monitoring parameters and appropriate

administration technique Avoid external heating sources (heating blankets, hot baths). Monitor patients

for core body temperature above 102, as heat may result in increased release of drug from transdermal system, leading to potential toxicity.

Monitor all patients for toxicity (alertness, respiratory drive, vital signs) Verify patch placement upon admission and transfer. Consider additional documentation requirements for:

o Documentation of patch placement o Daily check for presence of a patch o Removal of old patch BEFORE placement of a new patch

Monitoring Implement a monitoring policy that includes assessment of alertness, respiratory and cardiovascular systems throughout use of patch, with special emphasis on the initial 24 hours after patch placement or after dose increases.

Conduct periodic audits to monitor if healthcare staff are following policies and monitoring parameters at all steps in the med use process.

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CHA Medication Safety Committee High Alert Medication Guideline - FentaNYL Transdermal Patch April 2011 

 

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Other Considerations

Disposal: Do NOT flush patches. Dispose in secured pharmaceutical waste container per appropriate medical waste management regulations.

Implement hospital policy to identify appropriate actions for patients who undergo MRI, with detailed in place policy identifying who is responsible for identifying the presence of a patch with metal backing, who can remove it, how it is replaced after procedure and where this process is documented.

Define opiate tolerance and dose equivalence. Consider use of reference card for opiate equivalencies

Develop policy on escalation of medication orders (when pharmacist and prescriber do not agree) if the patient does not meet dosing criteria, or if initial dosing exceeds recommended criteria

Define emergencies - determine when appropriate for patch to be utilized in patients treated in non-profiled areas

Develop competencies for all clinical staff involved with process Consider adding naloxone to order sets or have emergency guidelines for

when naloxone is appropriate Consider the potential for suicidal tendency of a patient when prescribing

fentaNYL patch for ambulatory care use Consider discharge planning responsibilities to ensure the patients will not

suffer adverse health consequences upon discharge and that those who are given fentaNYL patch upon discharge are given discharge teaching and instructions related to the medication.

Ensure patients upon discharge understand how properly and securely dispose of used patches so children can’t find them

References Institute for Safe Medication Practices

Food and Drug Administration fentanNYL patch manufacturer package insert Black Box Warning FDA Safety Alert

Definitions ADC- Automated Dispensing Cabinets

Profiled ADC- an automated dispensing cabinet that requires a pharmacist to review and approve a medication before they are available for selection and administration by clinical staff, unless the medication is available on an override medication list

Override medication- a pre-approved list of medications that may be removed from a specific patient care area ADC for selection and administration without a prospective pharmacist review

MAR= medication administration record

 

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June 16, 2011 Volume 16 Issue 12

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realistic to expect. We have contacted Amgen tosuggest that an error could be prevented if thecompany either eliminated the red circle orindicated within it the final concentration of 250mcg/0.5 mL. We’ve also notified FDA.

Anesthesia groups ask TJC forchanges. ISMP and the American

Society of Health-System Pharmacists (ASHP)are aware of communications from severalanesthesia-related professional groups askingThe Joint Commission (TJC) to relax severalrequirements meant to assure safe injectionpractices. The American Society of Anesthesiol-ogists, the American Association of NurseAnesthetists, the American Academy ofAnesthesiologist Assistants, and the AnesthesiaPatient Safety Foundation have asked TJC tooverturn its ban on pre-labeling of syringes andallowing anesthesia personnel to carry medica-tions on one’s person, and to reverse TJC’srequirement to label all syringes used in thesterile field during certain procedures. They alsoasked for changes regarding the security oflocking medications in carts as well as changesto restrictions that prohibit one practitioner fromadministering a medication prepared by anotherpractitioner without verification of the preparationby a second individual. In an April 26, 2011, letterto the anesthesia-related professional groups,TJC acknowledged that it will reverse its ban onpre-labeling of syringes. No other changes orreversals were acknowledged, although theagency referred the anesthesia groups to currentstandards that address several of the raisedissues, such as carrying medications on one’sperson, and suggested that it would deliberatefurther on the merits of some of the otherissues. With regards to lifting the ban on pre-labeled syringes, ISMP still has concerns aboutthe difficulty of controlling how pre-labeledsyringes (commercially available or pre-labeledby staff) might be used. To cite one concern,some may pre-label more than one syringe at atime, rather than just pre-labeling the syringe fora single medication under preparation. Such apractice greatly increases the risk of drawing thewrong medication into a syringe pre-labeled for adifferent drug. ISMP and ASHP have communi-cated with the anesthesia groups, asking for ameeting to review these requests and assure thatour common goals of efficient and safemedication use are being met. We expect thatTJC will also participate in the meeting. We will

event precipitated by a healthcare profes-sional. This suggests that without theparents’ interventions, some critical eventsmight have continued without correction.The authors determined the potentialharm from continuation of the detectedcritical events to be severe in 4 cases,moderate in 6 cases, and minor in 1 case.All of the events detected by parentsoccurred only after around-the-clockvisiting hours were made available. Thisobservation suggests that it is easier forparents to detect safety problems if theyspend more hours at their child’s bedside,observing and participating in their care.

Parents contributing to safety problemsThe most common safety problemsprecipitated by parents involved thedisconnection of tubes and drains,medication errors, and physical trauma.Examples include:

A mother accidentally disconnected acentral venous line while breast feedingher babyA mother accidentally disconnected a

pleural drain while holding her infantA father fell off a chair with his child

on his lap.

All of the disconnected tubes and drainshappened in young infants, from 4 days to1½ years old. It took healthcare profes-sionals between 0-29 hours (median 0.25hours) to detect a critical event precipitatedby a parent. The authors note that thisfinding suggests that healthcare profes-sionals are providing appropriate super-vision of parents and hospitalized children.Most of these events caused moderateharm (10 cases) before being detected. Inall but one event, quick discovery of theproblems averted severe harm.

Parents affected by safety eventsThe most common types of problemsaffecting parents involved miscommuni-cation and feeding mix-ups. One canexpect parents to be emotionally affectedby most critical events that involve theirchildren, especially those leading to harm.However, with some critical events,parents were directly affected in ways thatwere not anticipated. One of the most

common examples included mothers whowere subjected to viral testing becausetheir breast milk was accidentally fed toanother child. Failures such as thisincrease parental stress during a child’shospitalization.

SSAAFFEE PPRRAACCTTIICCEE RREECCOOMMMMEENNDDAATTIIOONNSS::Consider the following recommendationsto strengthen the partnership between thetreatment team and a hospitalized child’sparents, prevent parental contribution tocritical events, promote parental detectionof errors, and protect the hospitalizedchild from harm.

EEdduuccaattee ppaarreennttss.. Teach parents about thedisease/condition, medical tests, andtreatment plan for their hospitalized child.Specifically tell parents about all themedications their child is receiving, theprescribed doses (including the fact that itdiffers from the dose taken at home, ifapplicable), potential side effects, andwhen and how they are given. Write downimportant information for parents toreference as needed. Parents who knowwhat to expect can help recognize whensomething is not right.

UUppddaattee ppaarreennttss.. Provide parents withtimely and comprehensive updatesregarding their children in language theyunderstand. Some children’s hospitalsencourage parents to be part of “family-centered” rounds, allowing them to gain abetter understanding of their child’s totaltreatment plan and current status sincethe entire medical team is available toanswer questions and address concerns.

AAnnttiicciippaattee iinnvvoollvveemmeenntt.. Be aware ofincreasingly independent parentalinvolvement in the medical care of theirchildren. A 2001 study by Hurst showedthat parents continuously analyze hospitalprocedures and develop an action plan toprotect their babies.2 A fundamentalchallenge for mothers in this study was toincrease their position of authority relativeto the medical team, thereby safeguardingtheir babies. Parents may intervene duringthe care of their children, which can leadto prevention and detection of a critical

SafetyBriefs continued from page 1 Parents continued from page 1

continued on page 3 — PPaarreennttsscontinued on page 3 — SSaaffeettyyBriefs

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Join Us In celebrating Healthcare Risk Management Week - June 20-24, 2011. For details, visit: www.ashrm.org/hrmweek.31

June 16, 2011 Volume 16 Issue 12

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advise our readers regarding the outcome of thismeeting in a future newsletter.

FDA puts limits on simvas-tatin. As you may have heard last week,

the US Food and Drug Administration (FDA) ischanging simvastatin labeling to limit the use of80 mg doses due to the increased risk of muscledamage in patients taking this dose compared topatients taking lower doses of this drug or otherdrugs in the same class. Simvastatin is currentlyavailable in 10, 20, 40, and 80 mg tablet strengthsas a generic product and under the brand-nameZOCOR. It is also a component of VYTORIN invarious strengths, including 80 mg, in combinationwith ezetimibe 10 mg. Many hospitals have chosensimvastatin as their formulary cholesterol-loweringdrug due to potential cost savings. Therapeuticinterchanges are often made if a hospitalizedpatient is taking a different cholesterol-loweringdrug at home. Unfortunately, dosing issues as wellas dangerous drug interactions may occur if therisk is overlooked when switching a patient tosimvastatin due to a therapeutic interchange. Justthis past week, a woman with HIV was admittedto a hospital where an inappropriate therapeuticinterchange was made. The patient had beentaking pravastatin 80 mg along with her proteaseinhibitors at home. The pharmacist changed hercholesterol-lowering medication to the formularydrug, simvastatin 80 mg. Not only was the 80 mgdose a problem, simvastatin is also contraindicatedwith protease inhibitors. An additional danger isthat the physician discharging the patient may notswitch back to the patient’s original cholesterol-lowering drug when prescribing the dischargemedications, so the problematic therapy mightcontinue at home. Ensure that drug interactionwarnings and dose restriction reminders arefunctional for the cholesterol-loweringmedication(s) on your formulary. Also evaluateyour standard order sets to ensure an 80 mg doseof simvastatin is not included. FDA states thatsimvastatin 80 mg should only be used in patientswho have been taking this dose for 12 months ormore without evidence of myopathy. The 80 mgstrength should not be started in new patients orpatients already taking lower doses of the drug.FDA is also requiring changes to the simvastatinlabel to add new contraindications and doselimitations for use of the drug with certainmedications that increase the level of simvastatin.For a complete list of these medications andadditional information from FDA, go to:www.fda.gov/Drugs/DrugSafety/ucm256581.htm.

event, or contribution to a critical eventdespite good intentions. Close parentalinvolvement in the child’s treatment planshould be encouraged, supervised, andmonitored.

EEnnccoouurraaggee ppaarreennttss ttoo ssppeeaakk uupp..Encourage parents to report any concernsor worries they have regarding theirchild’s care. Frey et al. suggests periodi-cally asking parents these two questions:“Are there aspects of your child’s care thatyou find concerning?” and “What do youworry about when you leave your child?”Encourage parents to keep askingquestions or voicing concerns until theyreceive an answer with which they arecomfortable and fully understand.Remind parents that they know theirchild better than anyone on the medicalteam; thus, communication of theirobservations is extremely important.

RReessppoonndd ttoo ppaarreennttss’’ qquueerriieess aapppprroopprriiaatteellyy..Parents do not want to be labeled as being“difficult” or “demanding;” they fear no onewill want to take care of their child if theyare perceived this way.2 Some may evenview basic questions or requests for infor-mation about their child’s condition as aslight to the medical team’s competence.So, when parents do speak up, healthcareprofessionals should perceive and reflecttheir actions in a manner that fosters truecollaboration and empowerment, andshould encourage and reinforce theparents’ role in making queries by providingthoughtful and complete answers.

PPrroovviiddee aacccceessss ttoo aa rraappiidd rreessppoonnssee tteeaamm..Allow parents to activate a rapid responseteam if they feel no one is addressing theirexpressed concerns regarding their child’scondition and/or medical treatment.Instruct parents, upon their child’sadmission, regarding the purpose of therapid response team and how to activate it.

EEssttaabblliisshh ssaaffee hhaannddlliinngg gguuiiddeelliinneess.. Toreduce the risk of tubing disconnections,establish guidelines for safe handling ofinfants and children with lines and drains,teach these guidelines to parents, andmonitor adherence to the guidelines.

TTeeaacchh ppaarreennttss nnoott ttoo rreeccoonnnneecctt ttuubbeess..Orient parents to the tubes or drainsattached to their child. Teach them aboutthe dangers of reconnecting tubes anddrains themselves and how to call forimmediate help from a healthcare profes-sional if their child’s tubes or drainsbecome dislodged or disconnected.

RReeffeerreenncceess:: 11)) Frey B, Ersch J, Bernet V, Baenziger O, et al.Involvement of parents in critical incidents in aneonatal-paediatric intensive care unit. QualSafHealth Care. 2009;18(6):446-449. 22)) Hurst I. Vigilant watching over: mothers’actions to safeguard their premature babies in thenewborn intensive care unit. J Perinat NeonatalNurs. 2001;15(3):39-57.

SafetyBriefs continued from page 2

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Please encourage your patients and staff to visit www.consumermedsafety.org often. It may save a life!

Parents continued from page 2

IISSMMPP MMeeddiiccaattiioonn SSaaffeettyy AAlleerrtt!! AAccuuttee CCaarree (ISSN 1550-6312) ©©22001111 IInnssttiittuuttee ffoorr SSaaffee MMeeddiiccaattiioonn PPrraaccttiicceess((IISSMMPP)). Permission is granted to subscribers to reproduce material for internal communications. Other repro-duction is prohibited without permission. Report medication errors to the ISMP Medication Errors ReportingProgram (MERP) at 11--880000--FFAAIILL--SSAAFF((EE)). Unless noted, published errors were received through the MERP.ISMP guarantees confidentiality of information received and respects reporters' wishes as to the level of detailincluded in publications. EEddiittoorrss:: Judy Smetzer, RN, BSN, FISMP; Michael R. Cohen, RPh, MS, ScD;Russell Jenkins, MD. IISSMMPP,, 220000 LLaakkeessiiddee DDrriivvee,, SSuuiittee 220000,, HHoorrsshhaamm,, PPAA 1199004444..Email: ismpinfo@ismp.org;Tel: 215-947-7797; Fax: 215-914-1492. This is a peer reviewed publication.

ISMP Webinar: On July 26, ISMP willpresent Exploring Medication Safety Offthe Beaten Path: Unique MedicationSafety Challenges in Diagnostic andProcedural Areas. Have medication safetyimprovements been made in areas such asinvasive radiology, GI suites, perioperativeareas, or ambulatory clinics? Take a tour ofthese distinct locations with ISMP consultingstaff to learn what unique medication safetyrisks have been uncovered “off the beatenpath.” For details, visit: www.ismp.org/educational/webinars.asp.

Unique 2-day program: AttendISMP’s Medication Safety INTENSIVEworkshop, a one-of-a-kind, interactiveprogram that will teach you how to approachmedication safety “through the eyes of ISMP.”The next workshop will be held in SanFrancisco, CA, on September 22-23.For details, visit: www.ismp.org/educational/MSI.

Special Announcement s . . .

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Lori Woolsey

Subject: FW: Medication Safety Symposium - Aug. 31

Medication Safety Symposium Wednesday, August 31, 2011

8:30 am - 12:30 pm 8:00 am Check-in and Continental Breakfast

- Complimentary -

Washington Hospital Conference Center 2500 Mowry Avenue, Fremont, CA

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Join your colleagues from hospitals throughout the East and South Bay for a day of learning, peer-to-peer sharing and discussion of the operational challenges of medication safety in our hospitals and the best practices and lessons learned from across the region to accelerate change and improvement.

Program Description: This Medication Safety Symposium will bring regional pharmacists, hospital clinical and regulatory leaders, along with our regulatory colleagues from the California Department of Public Health, to explore findings throughout California regarding medication system vulnerabilities and how changes are helping to improve safety within the system. Regional hospitals will share lessons learned that resulted in successful strategies to ensure safe medication delivery systems and practices.

Symposium Objectives:

• Identify Medication System Safety Vulnerabilities (MSSV) • Identify regulations that drive the development and implementation

of medication safety strategies • Share "best practices" and "lessons learned" to accelerate change

and improvement

Featured Speaker: Loriann De Martini, PharmD Center for Healthcare Quality, California Department of Public Health Joint Conference Leaders:

• Nasim Karmali, RPh Medication Safety Officer, Washington Hospital Healthcare System

• Shideh Ataii, PharmD Director of Pharmacy, Contra Costa Regional Medical Center and Clinics

• Rebecca Rozen, Regional Vice President, Hospital Council • Jo Coffaro, Regional Vice President, Hospital Council • Mary Lopez, MSN, RN Senior VP, Quality and Education, Hospital

Council

Topics Include:

• "State of the State of Medication Safety in CA" • Operational Opportunities and Challenges in Effective Medication

Safety Plans • Successful Strategies to Improve Medication Safety --

Presentations by Regional Hospitals • Opportunities for Future Collaboration and Peer-to-Peer

Networking

Who Should Attend: Hospital leaders and managers of Pharmacy, Nursing, Quality, Regulatory Compliance and all others interested in improving medication safety.

Provider approved by the California Board of Registered Nursing, provider number CEP14560,

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for 4.5 contact hours.

Registration Questions?

Contact Alexandra Carvalho Meeting Coordinator (925) 7461552

Content Questions?

Contact Mary Lopez, MSN, RN Senior Vice President, Quality Initiatives and Education (559) 650 5692

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Record and Data Retention Schedule This CD contains an electronic version of CHA’s Record and Data Retention Schedule.

Files Files on this CD are formatted in Adobe Acrobat and are not available in Microsoft Word. Files are secured from printing or editing and are in Read Only format. How to Use this CD The files on the CD have several interactive elements. Below is a description of how to navigate through the document using the new tools.

Table of Contents The Table of Contents is a live document. Use your cursor to click on any level or page number within the Table of Contents and you will automatically be taken to that page within the document.

To return to the Table of Contents at any time, simply click on the “Record and Data Retention Schedule 2011” header in the top left corner of each even-numbered page. Interactive Links Cross-references and websites are called out by blue dashed lines. These links are live and interactive; use your cursor to click on any of these links and you will automatically be taken to either the referenced page, or to the website.

To return to the beginning of the section at any time, simply click on the section title header in the top right corner of each odd-numbered page.

Additional Resources at www.calhospital.org CHA’s website includes information on all our manuals as well as additional free resources available for download.

To visit the website at any time, simply click on the “California Hospital Association” footer at the bottom of each page.

Questions If you have questions, feel free to contact Lois J. Richardson, Esq., vice president, legal publications and education, at (916) 552-7611 or lrichardson@calhospital.org. For questions regarding copyright issues, please contact Amy Larsen, director, publishing and marketing at (916) 552-7508 or alarsen@calhospital.org.

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April 18, 2011

TO: Medication Safety Committee Members FROM: Dawn Benton, EVP/CEO, CSHP SUBJECT: High Risk/High Alert Subcommittee Workgroup Minutes from 4-18-11 Participants: Eddie Avedikian, Dawn Benton, Tony Evans on behalf of Jim Hauenstein, Nasim Karmali, Pamela Richter, and Philip Swanger

Discussion: Benton called the meeting to order at 3:02 PM. The group was asked to provide feedback on the High Risk/High Alert (HR/HA) guideline regarding FentaNYL. After taking comments from the HR/HA subcommittee members, Richter made modifications to the FentaNYL guidelines. The group agreed that once the modifications were made, the FentaNYL guidelines would be considered ready for submission to CHA for final approval before public posting. The HR/HA subcommittee discussed that they would like there to be a mechanism once the guideline is released for end-users to comment on the FentaNYL guideline. The intent behind this request is to ensure the document addresses any necessary changes. The group then determined what topic the HR/HA subcommittee should create a best practice guideline for next by reviewing survey results from pharmacists. Based on the results, the group will create a best-practice guideline for anticoagulants. The group concluded their call at 3:37 PM. Next steps: 1. Richter to forward revised FentaNYL guideline to Swanger. 2. Swanger to send final FentaNYL guideline to CHA Medication Safety Committee. 3. Richter to take the template from the FentaNYL guideline and create a template for

anticoagulants. 4. HR/HA members to input information into anticoagulant template prior to June conference call. 5. Next meeting to be doodled for June.

Parking Lot: 1. Standardization for pediatric dosing. 2. Guidelines surrounding sterile water for injection.

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June 20, 2011

TO: Medication Safety Committee Members FROM: Dawn Benton, EVP/CEO, CSHP SUBJECT: High Risk/High Alert Subcommittee Workgroup Minutes from 6-20-11 Participants: Eddie Avedikian, Sylvia Banzon, Dawn Benton, Jim Hauenstein, Nasim Karmali, Virginia Herold, and Philip Swanger

Discussion: Benton called the meeting to order at 3:05 PM. The group reviewed the to-do list from the April 18, 2011 High Risk/High Alert (HR/HA) Subcommittee meeting. The group determined how it would like to move forward in terms of inputting information to the next best practice guideline on anticoagulants. The group concluded their call at 3:28 PM. Next steps: 1. Using the new guideline template, HR/HA members are to be requested to send their

anticoagulant policies to Karmali directly by Friday, July 1. 2. Karmali to incorporate HR/HA members’ guidelines into the subcommittee’s anticoagulant

guideline and send back to the HR/HA subcommittee by Tuesday, July 12 in preparation for the Wednesday, July 13 Medication Safety Committee meeting in Sacramento.

3. HR/HA Subcommittee to potentially discuss and revise the guideline during the July 13 Medication Safety Committee meeting attendance and time permitted.

Parking Lot: 1. Standardization for pediatric dosing. 2. Guidelines surrounding sterile water for injection.

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AMENDED IN ASSEMBLY APRIL 14, 2011

california legislature—2011–12 regular session

ASSEMBLY BILL No. 377

Introduced by Assembly Member Solorio

February 14, 2011

An act to amend Sections 4029 and 4033 of the Business andProfessions Code, relating to pharmacy.

legislative counsel’s digest

AB 377, as amended, Solorio. Pharmacy.Existing law, the Pharmacy Law, provides for the licensure and

regulation of pharmacies, including hospital pharmacies, by theCalifornia State Board of Pharmacy, and makes a knowing violation ofthat law a crime. Existing law prohibits the operation of a pharmacywithout a license and a separate license is required for each pharmacylocation. Under existing law, a hospital pharmacy, as defined, includesa pharmacy located outside of the hospital in another physical plant.However, as a condition of licensure by the board for these pharmacies,pharmaceutical services may only be provided to registered hospitalpatients who are on the premises of the same physical plant in whichthe pharmacy is located and those services must be directly related tothe services or treatment plan administered in the physical plant. Existinglaw imposes various requirements on manufacturers, as defined, andstates that a manufacturer does not mean a pharmacy compounding adrug for parenteral therapy, pursuant to a prescription, for delivery toanother pharmacy for the purpose of delivering or administering thedrug to the patient or patients, provided that neither the components forthe drug nor the drug are compounded, fabricated, packaged, orotherwise prepared prior to receipt of the prescription.

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This bill would provide that a hospital pharmacy also includes apharmacy, licensed by the board, that may be located outside of thehospital in either another physical plant on the same premises or on aseparate premises, located within a 100-mile radius of the hospital, thatis regulated under a hospital’s license, but would impose limitations onthe services provided by a centralized hospital pharmacy. The bill wouldeliminate the conditions of licensure by the board that limit the servicesprovided by the pharmacy in the other physical plant, but would requirethat any unit-dose medication produced by a hospital pharmacy undercommon ownership be barcoded to be readable at the patient’s bedside.The bill would authorize a hospital pharmacy to prepare and store alimited quantity of unit-dose medications in advance of a patient-specificprescription under certain circumstances. The bill would also providethat a “manufacturer” does not mean a pharmacy compounding orrepackaging a drug for parenteral therapy or oral therapy in a hospitalfor delivery to another pharmacy or hospital under common ownershipin order to dispense or administer the drug to the patient or patientspursuant to a prescription or order. The bill would require a pharmacycompounding or repackaging a drug pursuant to this provision to notifythe board of the location of the compounding or repackaging within aspecified period of time. Because a knowing violation of the bill’srequirements would be a crime, the bill would impose a state-mandatedlocal program.

The California Constitution requires the state to reimburse localagencies and school districts for certain costs mandated by the state.Statutory provisions establish procedures for making that reimbursement.

This bill would provide that no reimbursement is required by this actfor a specified reason.

Vote: majority. Appropriation: no. Fiscal committee: yes.

State-mandated local program: yes.

The people of the State of California do enact as follows:

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SECTION 1. Section 4029 of the Business and ProfessionsCode is amended to read:

4029. (a)  “Hospital pharmacy” means and includes a pharmacy,licensed by the board, located within any licensed hospital,institution, or establishment that maintains and operates organizedfacilities for the diagnosis, care, and treatment of human illnessesto which persons may be admitted for overnight stay and that meets

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123456789

10111213141516171819202122232425262728293031323334353637383940

all of the requirements of this chapter and the rules and regulationsof the board.

(b)  A hospital pharmacy also includes a pharmacy, licensed bythe board, that may be located outside of the hospital, in eitheranother physical plant on the same premises or on a separatepremises, located within a 100 mile 100-mile radius of the hospital,that is regulated under a hospital’s license. A centralized hospitalpharmacy may only provide pharmaceutical services to its ownpatients who are either admitted or registered patients of a hospitalwithin the same health care system. Nothing in this subdivisionshall be construed to restrict or expand the services that a hospitalpharmacy may provide.

(c)  Any unit-dose medication produced by a hospital pharmacyunder common ownership, as described in Section 4033, shall bebarcoded to be readable at the patient’s bedside.

(d)  A hospital pharmacy may prepare and store a limited quantityof unit-dose medications in advance of receipt of a patient-specificprescription in a quantity as is necessary to ensure continuity ofcare for an identified population of patients of the hospital basedon a documented history of prescriptions for that patient population.

(e)  Nothing in this section shall limit the obligation of a hospitalpharmacy, hospital, or pharmacist to comply with all applicablefederal and state laws.

SEC. 2. Section 4033 of the Business and Professions Code isamended to read:

4033. (a)  (1)  “Manufacturer” means and includes every personwho prepares, derives, produces, compounds, or repackages anydrug or device except a pharmacy that manufactures on theimmediate premises where the drug or device is sold to the ultimateconsumer.

(2)  Notwithstanding paragraph (1), “manufacturer” shall notmean a pharmacy compounding or repackaging a drug forparenteral therapy or oral therapy in a hospital for delivery toanother pharmacy or hospital under common ownership for thepurpose of dispensing or administering the drug, pursuant to aprescription or order, to the patient or patients named in theprescription or order. A pharmacy compounding or repackaginga drug as described in this paragraph shall notify the board inwriting of the location where the compounding or repackaging isbeing performed within 30 days of initiating the compounding or

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repackaging. The pharmacy shall report any change in thatinformation to the board in writing within 30 days of the change.

(3)  Notwithstanding paragraph (1), “manufacturer” shall notmean a pharmacy that, at a patient’s request, repackages a drugpreviously dispensed to the patient, or to the patient’s agent,pursuant to a prescription.

(b)  Notwithstanding subdivision (a), as used in Sections 4034,4163, 4163.1, 4163.2, 4163.3, 4163.4, and 4163.5, “manufacturer”means a person who prepares, derives, manufactures, produces,or repackages a dangerous drug, as defined in Section 4022, device,or cosmetic. Manufacturer also means the holder or holders of aNew Drug Application (NDA), an Abbreviated New DrugApplication (ANDA), or a Biologics License Application (BLA),provided that such application has been approved; a manufacturer’sthird-party logistics provider; a private label distributor (includingcolicensed partners) for whom the private label distributor’sprescription drugs are originally manufactured and labeled for thedistributor and have not been repackaged; or the distributor agentfor the manufacturer, contract manufacturer, or private labeldistributor, whether the establishment is a member of themanufacturer’s affiliated group (regardless of whether the membertakes title to the drug) or is a contract distributor site.

SEC. 3. No reimbursement is required by this act pursuant toSection 6 of Article XIIIB of the California Constitution becausethe only costs that may be incurred by a local agency or schooldistrict will be incurred because this act creates a new crime orinfraction, eliminates a crime or infraction, or changes the penaltyfor a crime or infraction, within the meaning of Section 17556 ofthe Government Code, or changes the definition of a crime withinthe meaning of Section 6 of Article XIII B of the CaliforniaConstitution.

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January 13, 2011 TO: Medication Safety Committee Members FROM: Dorel Harms, MS, RN

Senior Vice President, Clinical Services SUBJECT: 2011 Meeting Schedule Following is the meeting schedule for 2011 Medication Safety Committee in-person meetings:

MARCH 2, 2011 SACRAMENTO, CHA OFFICE BOARD ROOM

JULY 13, 2011 SACRAMENTO, CHA OFFICES BOARD ROOM OCTOBER 12, 2011 SACRAMENTO, CHA OFFICES BOARD ROOM

The Medication Safety Committee meetings will be from 10:00a.m. – 2:00p.m.

You will receive an official call approximately one month prior to each meeting indicating the exact location. Thank you and if you have any questions, please feel free to call me directly at (916) 552-7574. DFH:lw

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