ASHP Health-System Pharmacy New Capsules

ASHP Sends Condolences, Applauds Rescuers in Oklahoma

Tue, 21 May 2013

ASHP sends its deepest condolences to the families who lost loved ones in the devastating tornado that hit Moore, Oklahoma. We also applaud the first responders and caring neighbors who have been working so hard to find and save the many casualties, the pharmacists and other health care providers at the Moore Medical Center which was heavily damaged, and the staff at the other hospitals who are caring for those injured.

Senate Introduces Revised Draft of Compounding Legislation

Wed, 15 May 2013

Senators Tom Harkin (D-Iowa), Lamar Alexander (R-Tenn.), Pat Roberts (R-Kan.) and Al Franken (D-Minn.) today introduced S. 959, “The Pharmaceutical Compounding Quality and Accountability Act,” legislation that clarifies the Food and Drug Administration’s (FDA) authority over commercial compounding outsourcers.

S. 959 establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” that compounds preparations without or in advance of a prescription and engages in interstate commerce. Hospitals and health systems are considered “traditional compounders” in the legislation and are exempt from a requirement to register with the FDA. The bill also provides additional clarification concerning pooling sterile products and repackaging drug products.

ASHP worked closely with the bipartisan group of legislators to develop the legislative language. Kasey K. Thompson, Pharm.D., M.S., Vice President of ASHP’s Office of Policy, Planning, and Communications testified last week at a hearing on an earlier draft of the legislation. The bill will be reviewed (or “marked up”) by the Senate Committee on Health, Education, Labor, and Pensions (HELP) on Wednesday, May 22.

ASHP will thoroughly review the new draft and provide additional information in the next few days. Once the HELP committee marks up the legislation, it will be sent to the full Senate for a vote.

Draft Compounding Bill is on the Right Track, ASHP Tells Senate

Thu, 09 May 2013

Proposed legislation that protects traditional compounding and expands the Food and Drug Administration’s authority to oversee commercial compounding outsourcers will assure that sterile products do not pose a threat to patients due to inadequate regulatory oversight, Kasey Thompson, Pharm.D., M.S., vice president of ASHP’s office of Policy, Planning and Communications, told legislators today during a Capitol Hill hearing.

Watch ASHP’s Testimony

Thompson represented ASHP at a hearing held by the Senate Committee on Health, Education, Labor, and Pensions (HELP) to get feedback on the proposed legislation. During his testimony, he noted that the legislation establishes a clear boundary between FDA jurisdiction and the jurisdiction of state boards of pharmacy, which will help prevent entities like the New England Compounding Center from inappropriately operating as pharmacies.

ASHP’s testimony also supported an exemption for health systems from the designation as “compounding manufacturers.” Thompson noted that the exemption is appropriate because in hospitals and health systems medications, compounded or otherwise, are administered to patients with patient-specific medication orders. The Society’s testimony further distinguished compounding in a hospital or health system, setting by noting that hospitals and health systems are not engaged in the retail sale of compounded products to other entities. “Hospitals are in the business of caring for patients, not selling compounded products,” Thompson said.

Final committee action is anticipated by Memorial Day. Look for more updates on the legislation, including an “Action Alert” urging ASHP members to write to their Senators asking for support of the legislation.

ASHP, HRSA Discuss 340B Guidelines

Fri, 26 Apr 2013

ASHP and representatives from The Health Resources Services Administration’s (HRSA’s) Office of Pharmacy Affairs discussed HRSA’s prohibition against participating in a group purchasing agreement for covered outpatient medications during a recent meeting.

340B hospitals now have until August 7, 2013 to show compliance with the exclusion.

ASHP encourages its members who work in participating hospitals to continue to highlight the intent of the 340B program and how it is helping hospitals and health systems expand access to services to underserved populations. ASHP will continue to work in concert with stakeholder organizations like the American Hospital Association as the Society continues to advocate for appropriate 340B usage.

Maddox to Receive ASHP John W. Webb Lecture Award

Fri, 26 Apr 2013

Ray Maddox, Pharm.D., FASHP, director, Clinical Pharmacy, Research & Pulmonary Medicine at St. Josephs/Candler Health System in Savannah, Ga., is the recipient of the 2013 John W. Webb Lecture Award.

Dr. Maddox is also clinical professor of pharmacy practice at the South University College of Pharmacy and adjunct professor of pharmacy practice at the University of Georgia College of Pharmacy. He is a well-respected researcher who has received more than 100 clinical research grants and contracts. He is also a popular presenter on patient safety (especially safety of i.v. administration of medications), pain management, automation, pharmacokinetics, clinical research, and advances in pulmonary medicine.

The Webb Award honors health-system pharmacy practitioners or educators who stand apart from others because of their extraordinary dedication to fostering excellence in pharmacy management and leadership. Dr. Maddox will present his award lecture in October 2013 at the ASHP Conference for Leaders in Health-System Pharmacy and as Visiting Professor in Hospital Pharmacy at Northeastern University.

ASHP Gets Advance Look at Proposed Compounding Bill

Fri, 26 Apr 2013

ASHP attended a briefing this morning with Republican and Democrat staffers from the Senate Committee on Health Education, Labor, and Pensions (HELP) on the provisions included in an early version of bipartisan legislation to address regulatory gaps in oversight of compounding outsourcers. The Society has been actively engaged with HELP Committee staff as they have developed legislative language and has sought to distinguish patient-care driven hospital and health-system compounding from commercial compounding provided by compounding outsourcers. The draft legislation establishes a boundary between traditional pharmacy compounding and defines a new entity, “compounding manufacturer,” which compounds preparations without or in advance of a prescription and engages in interstate commerce. It also preserves the states’ primary role in regulating traditional pharmacies. Most importantly for hospital pharmacies, interstate shipment within a hospital system will not cause a hospital pharmacy to be considered a compounding manufacturer and subject to registration with the FDA. ASHP is initially encouraged with the draft legislation developed by the bipartisan working group of the Committee. "Based on a preliminary assessment, ASHP is pleased with the direction the Senate is heading on this very important legislation that includes key provisions we have advocated for over the past six months,” said ASHP CEO Paul W. Abramowitz, Pharm.D., FASHP. “We are particularly pleased that the committee recognizes the role of the states in overseeing traditional compounding, including that which occurs in hospitals and health systems, while creating a new definition of a "compounding manufacturer" that would be overseen by the Food and Drug Administration (FDA)." ASHP will thoroughly review the discussion draft and submit comments to the Committee by its May 3 deadline. Final committee action is anticipated by Memorial Day. Look for more updates on the legislation in the coming days.

ASHP, Partners Explore Solutions for Ongoing Drug Shortages Crisis

Mon, 22 Apr 2013

ASHP and the co-conveners of the 2011 Drug Shortages Summit, the American Hospital Association (AHA), the American Society of Anesthesiologists (ASA), the American Society of Clinical Oncology (ASCO), , and the Institute for Safe Medication Practices (ISMP) met last week to touch base on their ongoing efforts to address drug shortages. Meeting attendees discussed the status of implementing the Food and Drug Administration Safety and Innovation Act (FDASIA), which was passed last year to address the ongoing drug shortages crisis. Representatives from the FDA were on hand to discuss the strategic plan and task force on drug shortages that were mandated by the legislation. FDA officials noted that the early warning requirements included in FDASIA have helped the agency prevent new shortages and better manage existing ones. The meeting also served as a platform to explore further solutions to the drug shortage problem like exploring redundancies and other manufacturer incentives, working with the FDA task force to prevent and mitigate shortages, and the industry-sponsored accelerated recovery initiative, which is designed to gauge manufacturing capacity to anticipate potential shortage situations. Also participating in the meeting were representatives from the American Medical Association, the American Society for Parenteral and Enteral Nutrition, the Centers for Disease Control and Prevention, the Children’s Hospital Association, the Generic Pharmaceutical Association, the Healthcare Distribution Management Association, the Healthcare Supply Chain Association, Hospira, group purchasing organizations Premier and MedAssets, and Westward Pharmaceuticals.

ASHP, Partners Publish Summary of Compounding Summit

Mon, 22 Apr 2013

Together with its partners, the American Hospital Association (AHA) and The Pew Charitable Trusts, ASHP has published the proceedings from the Pharmacy Sterile Compounding Summit.

In February, ASHP, AHA, and Pew convened wide array of stakeholder groups including pharmacists, physicians, hospitals and health systems, the U.S. Centers for Disease Control and Prevention, State Boards of Pharmacy, the Food and Drug Administration (FDA), and other experts. Based on stakeholder discussions, ASHP, AHA, and Pew developed recommendations to improve oversight of pharmacy compounding at the federal and state levels.

Discussion at the summit focused on three key areas: the scope of compounding practice today, quality standards, and state and federal oversight of these activities. Recommendations include a call to clarify federal and state roles on oversight of sterile compounding to ensure the safety of these medications no matter where they are made. Other recommendations can be found in the proceedings.

ASHP continues to work closely with policymakers, including members of Congress and the FDA on strategies to address regulatory gaps in oversight of sterile compounding.

Candidates Selected for ASHP Treasurer

Fri, 19 Apr 2013

The ASHP Board of Directors recently approved the following candidates for ASHP Treasurer:

Philip J. Schneider B.S., Pharm.D., Director of Pharmacy Services, Olathe Medical Center, Olathe, KS.
Eric Hola, M.S., MLS, FASHP, Pharmacy Director, Saint Barnabas Medical Center, Livingston, NJ.

The Treasurer will be elected by members of the ASHP House of Delegates during its session at the Summer Meeting in June. Delegates will also elect the chair of the House and approve the slate of candidates for the Board of Directors.

Candidates Announced for ASHP Board of Directors

Fri, 19 Apr 2013

The ASHP Committee on Nominations recently approved the following candidates:

President-Elect

Christene M. Jolowsky, M.S., R.Ph, FASHP, Executive Director, Applied and Experiential Education, University of Minnesota College of Pharmacy, Minneapolis, MN.
Janet L. Mighty, BS Pharm, M.B.A., Assistant Director, Investigational Drug Service, Johns Hopkins Hospital, Baltimore, MD.

Board of Directors

Michael B. Cockerham, M.S., Pharm.D., FASHP, Associate Dean for Academic Affairs, University of Louisiana at Monroe College of Pharmacy, Shreveport, LA.
Richard Demers, M.S., R.Ph., FASHP, Assistant Executive Hospital Director, Pharmacy Services, Hospital of the University of Pennsylvania, Philadelphia, PA.
Donald E. Letendre, Pharm.D., Dean and Professor, The University of Iowa, Iowa City, IA
Ranee Runnebaum, Pharm.D., Medication Safety Manager, Oregon Health & Science University Hospital, Portland, OR.

Chair, House of Delegates

Ernest R. Anderson, Jr., M.S. FASHP, FMSHP, President, Ernie Anderson Consulting, Brockton, MA.
James A. Trovato, Pharm.D., M.B.A., BCOP, FASHP, Associate Professor, University of Maryland School of Pharmacy, Baltimore, MD.

The Committee’s report is subject to the approval of the House of Delegates during its session at the Summer Meeting in June. Delegates will also elect the chair of the House and the ASHP Treasurer during the session.

ASHP active members may vote for the President–Elect and Board of Directors by either online or mail ballot. Voting will begin in July.

A podcast of the “Meet the Candidates” session held at the Summer Meeting, featuring information about the candidates’ experience and qualifications will be available online in the “About ASHP” section of www.ashp.org.