Extemporaneously Compounded Sterile Medications

Abstract

The United States Pharmacopeia (USP) is the United States' congressionally authorized book of standards for pharmaceutical manufacturing in the United States. The most current edition of the USP includes a new chapter entitled Pharmaceutical Compounding-Sterile Preparations that sets standards for all health care professionals who prepare, store or dispense sterile preparations. Extemporaneously compounded sterile formulations are sometimes needed for symptom control in pain and palliative practice. The implications and relevance of this new USP chapter to pain and palliative care clinicians-and the importance of all clinicians understanding the implications of how their patient's compounded sterile products are prepared-are discussed.

Key Words:

• Sterile
• medications
• compounding
• United States Pharmacopeia
• USP

Additional information

Notes on contributors

William J. Rusho

Cherokee Layson-Wolf, PharmD, is Assistant Professor at the University of Maryland School of Pharmacy. At the time that this review was conducted, she was a Community Care Pharmacy Practice Resident at Virginia Commonwealth University.

Perry G. Fine, MD, is Professor of Anesthesiology, School of Medicine and Associate Medical Director, Pain Management Center at the University of Utah Health Sciences Center, Salt Lake City; and National Medical Director, VistaCare, based in Scottsdale, AZ. This commentary is based on an article in Dr. Fine’s VistaCare Palliative Medicine Monitor.

Jonathan R. Gavrin, MD, is the Internet editor for the Journal. He is Associate Professor of Anesthesiology and Adjunct Associate Professor of Medicine at the University of Washington School of Medicine; Associate Member, Fred Hutchinson Cancer Research Center; and Associate Director for Clinical Anesthesia Services, Harborview Medical Center.

Philip J. Wiffen, is the Regional Pharmaceutical and Prescribing Adviser, Anglia & Oxford Region of the National Health Service Executive, a member of the Oxford Regional Pain Relief Unit and Coordinating Editor of the Cochrane Collaboration Pain Palliative and Supportive Care Collaborative Review Group.

Philip J. Wiffen, BPharm, MRPharmS, MFPHM (Hon) is Regional Pharmaceutical and Prescribing Adviser, Anglia & Oxford Region of the National Health Service Executive, a member of the Pain Relief Unit, Churchill Hospital, and Coordinating Editor, Cochrane Collaboration Pain Palliative and Supportive Care Collaborative Review Group.

Howard A. Heit, practices pain medicine and addiction medicine in Fairfax, Virginia, and is Assistant Clinical Professor of Medicine at Georgetown University, Washington, DC. Dr. Heit was a member of the Liaison Committee on Pain and Addiction.

Last Acts is a Robert Wood Johnson Foundation funded campaign to improve end-of-life care by a coalition of professional and consumer organizations. This coalition works to improve palliative care, focused on managing pain and making life better for individuals and families facing death. Last Acts envisions a world in which dying people and their loved ones receive excellent care and are honored and supported by their community.

S. R. Ghooi, MBBS, is a Medical Consultant in New Delhi.

Gustavo G. De Simone is Medical Oncologist (with Diploma in Palliative Medicine) and Pallium Latinoamérica Association Medical Director and Chief, Section on Palliative Care, Hospital Bonorino Udaondo, Bonpland 2287 (1425) Ciudad de Buenos Aires, Argentina ( [email protected].

The Reverend John S. Lunn, RN, MDiv, is Palliative Care and Hospice Consultant, Global Ministries for the Disciples of Christ and United Church of Christ, and former President, Board of Directors, Kauai Hospice, Hawaii.

Jan Stjernswärd, MD, PhD, FRCP (Edin), is Former Chief, Cancer and Palliative Care, World Health Organization, Geneva, Switzerland, and International Director of the Oxford University International Centre for Palliative Care and World Health Organization Collaborating Centre for Palliative Care, Churchill Hospital, Oxford, UK. He also serves on the Steering Committee of the Diana Palliative Care Initiative, Diana Princess of Wales Memorial Fund in the UK, as a Consultant to the Open Society Institute in New York, and continues to serve as a World Health Organization advisor.

Barbara L. Kass-Bartelmes, MPH, CHES, and Ronda Hughes, PhD, wrote this report for the Agency for Health Care Research and Quality (AHRQ) of the U.S. Public Health Service.

Robert J. Adams, PharmD, was at the time of this study Primary Care Resident, Pharmacy Service, Carl T. Hayden Veterans Affairs Medical Center, Phoenix, AZ.

Stephen P. Lordon, MD, was at the time of this study, Attending Physician in the Pain Management Center, University Hospitals and Clinics, and Clinical Assistant Professor of Anesthesiology, School of Medicine;

Arthur G. Lipman, PharmD, is Professor of Pharmacotherapy, College of Pharmacy, Adjunct Professor of Anesthesiology, School of Medicine and Director of Clinical Pharmacology, Pain Management Center, University Hospitals and Clinics; University of Utah Health Sciences Center.

Christopher Stock, PharmD, is Clinical Pharmacist, Substance Abuse Treatment Programs Pharmacist at the George E. Wahlen Veterans Affairs Salt Lake City Health Care System, and Clinical Associate Professor, College of Pharmacy, University of Utah

William J. Rusho, MS, RPh, is Professor (Clinical) of Pharmacotherapy, University of Utah College of Pharmacy and a former member of the FDA Advisory Committee on Pharmacy Compounding. He was clinical coordinator of sterile product compounding at the University of Utah Hospitals and Clinics for 32 years.