16-10-17 Advocacy for pain prevention and treatment in children Gary A. Walco, PhD Professor of Anesthesiology& Pain Medicine Adjunct Professor of Pediatrics and Psychiatry University of Washington School of Medicine Director of Pain Medicine Seattle Children’s Hospital October 21, 2016 University of British Columbia, Department of Pediatrics Disclosures • Special Government Employee, United States Food and Drug Administration, Anesthetic and Analgesic Drugs Products Advisory Committee • Chair, Pediatric Research Network for Pain (PRN- Pain), Co-Chair Pediatric Pain Research Consortium and member of executive committee, Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION) • Consultation to Pfizer Pharmaceuticals • Contributor to UpToDate Some inspiration “A small body of determined spirits fired by an unquenchable faith in their mission can alter the course of history.” “We must become the change we want to see.” Mohandas Gandhi 1
16-10-17 A field is born … 1977: Jo Eland: children get far less analgesia (almost none) for the same operative procedures than do adult counterparts 1985: Jill Lawson: neonatal surgery without anesthesia 1985: Neil Schechter: Pediatric Clinics of NA paper on reasons for undertreatment of pain in children and possible remedies 1987: First International Symposium on Pediatric Pain (Donald Tyler and Elliot Krane, Seattle) 1987: Sunny Anand: better survival rates in premature neonates with post-operative pain management 1988: IASP SIG on Pain in Childhood (including committee on advocacy) Education is not sufficient • Multiple studies show physicians do not follow evidence-based guidelines • Fear that evidence-based practice will suppress the “art” of medicine • Scientific evidence • Clinical judgment • Unacceptable practice deviations? • Didactic education is not sufficient • Practice-based with rehearsal is better Kenny NP. Can Med Assoc J 1997;157:33-36 An ethical issue The fundamental principle of responsible medical care is not “do not hurt” but “do no harm.” Since pain seems harmful to patients, and care givers are categorically committed to preventing harm to their patients, not using all the available means of relieving pain must be justified. All health professionals should provide care that reflects the technological growth of the field. The assessment and treatment of pain in children are important parts of pediatric practice, and failure to provide adequate control of pain amounts to substandard and unethical medical practice. Walco GA, Cassidy RC, Schechter NL. N Engl J Med 1994; 331:541-544 2
16-10-17 A policy approach The Assessment and Management of Acute Pain in Infants, Children, and Adolescents PEDIATRICS Vol. 108 No. 3 September 2001 Prevention and Management of Pain in the Neonate: An Update PEDIATRICS Vol. 118 No. 5 November 2006 What about the consumer? 2004 Celeste Johnston McGill University Lonnie Zeltzer UCLA 2005 G. Allen Finley Dalhousie University Gary Walco University of Washington 2006 Steven Weisman Medical College of Wisconsin 2007 Elizabeth Ely CHOP Jennie Tsao UCLA 2008 Bonnie Stevens University of Toronto Anna Taddio University of Toronto William Zempsky University of Connecticut 2010 Elliot Krane Stanford University 2011 Denise Harrison University of Ottawa Jennifer Stinson University of Toronto 2012 Christine Chambers Dalhousie University Renee Manworren Connecticut Children’s Lisa Peters Seattle Children’s 2014 Marsha Campbell-Yeo Dalhousie University Deirdre Logan Harvard University Some fruits of the labor S. 174/H.R. 963—Children’s Compassionate Care Act of 2005/2007 3
16-10-17 Chronic pain and healthcare reform Leading to this very important publication March, 2016 Weighing in on the issues … y 4
16-10-17 Needle pain Sponsors: • World Health Organization (Geneva, Switzerland) • Bill and Melinda Gates Foundation (Seattle, USA) • European Centre for Disease Prevention and Control (Stockholm, Sweden) • European Commission, Research Directorate General (Brussels, Belgium) • University Children’s Hospital Basel (Switzerland) • Adverse events case definitions • Pain • In response to immunization • Associated with immunization process Needle pain William Zempsky, MD Jane Gidudu, MD, MPH Anna Taddio, BScPhm, PhD University of Connecticut CDC University of Toronto Major initiative on needle pain http://phm.utoronto.ca/helpinkids/index.html 5
16-10-17 International efforts Neil Schechter, MD G. Allen Finley, MD Harvard University Dalhousie University Rockefeller Institute, Bellagio Bellagio Declaration “Pain is a universal experience among children in healthcare facilities. There is now overwhelming evidence that pain has both short term and long term negative consequences for the physical and emotional health of the child. The uniform application of available knowledge will significantly reduce the burden of pain and its consequences on children and their families. We believe that all health care facilities should commit to the developmentally appropriate prevention, assessment, and management of pain in children and adolescents aged 0 to 18 years.” 6
16-10-17 ChildKind International • Policy • There is a facility-wide, evidence-informed, written policy on pain assessment, prevention, and management. • Education • There are comprehensive and on-going education and awareness programs for all staff, students/trainees, patients, and caregivers. • Assessment • All children have pain assessed using an evidence-informed, developmentally appropriate process, and recorded in the patient record. ChildKind International • Protocols • There are specific, evidence-informed protocols for pain prevention and management, • Self ‐ Monitoring/Quality Improvement • There is a regular institutional self-monitoring program of the above criteria. This program should review protocols, policies, and patient outcomes, with feedback to staff, within the framework of a continuous quality improvement. ChildKind International: Progress to date • Five hospitals have been site visited and certified • Boston Children’s Hospital • Connecticut Children’s Hospital (Hartford) • Seattle Children’s Hospital • Hospital for Sick Children (Toronto) • Minnesota Children’s (Minneapolis) • Other centers now being considered • http://childkindinternational.org/ 7
16-10-17 Pediatric drug development: Choices for pediatricians Do not treat children with potentially beneficial medications because they are not approved for use in children Treat with medications based on adult studies with limited data or anecdote (off label use) Drug labeling for children • What percent of the medications used in pediatrics are labeled for indications in children? Label, 20% Off Label, label, 50% 50% Off label, 80% United Europ States e Limited or no data on … . • Safety Pharmacokinetics (PK) • • Pharmacodynamics (PD) • Serious adverse events (SAE) • Efficacy • Long-term use • Long-term sequelae 8
16-10-17 United States Food and Drug Administration • 1994: survey data to establish sufficiency for pediatric use and labeling • 1997: FDAMA (FDA Modernization Act): pediatric studies lead to patent extension • 1998: Pediatric Rule (challenged in 2000, enjoined by the Court in 2002) • 2002: Best Pharmaceuticals for Children Act (BPCA) • 2003: Pediatric Research Equity Act (PREA) replaced Pediatric Rule • 2007: FDAAA (FDA Amendments Act): reauthorization of BPCA and PREA • 2012: FDASIA (FDA Safety and Innovation Act) • Makes BPCA and PREA permanent • Pediatric development plans submitted earlier during drug development BPCA and PREA PREA BPCA • Drugs and biologics • Drugs and biologics • Mandatory studies • Voluntary studies • Requires studies only on • Studies relate to entire indications under review moiety and may expand indications • Orphan indications exempt from study • Studies may be requested for orphan • Pediatric studies must be indications labeled • Pediatric studies must be labeled Analgesics with pediatric indications (US) Note: for the 0 to 6 month age group, there are 0 Acetaminophen, Aspirin, NSAIDs Opioids • APAP (>2 y) • Fentanyl transdermal (>2 y) • ASA • Buprenorphine injection • Ibuprofen (> 6 m) • Fentanyl citrate injection • Meperidine JIA indication (not pain per se) Combination Products • Celecoxib • Codeine/APAP (> 3 y) • Diflunisal • Hydrocodone/APAP (>2 y) • EtodolacXL • Pentazocine/APAP • Indomethcin • Dihydrocodeine/ASA/Caffeine • Ketorolac • Codeine/ASA/Butalbital/Caffeine • Mefenamic acid • Oxycodone/Ibuprofen • Meloxicam • Pentazocine/Naloxone • Naproxen • Carisoprodol/ASA/Codeine • Oxaprozin • Butalbital/APAP • Tolmetin • Butalbital/APAP/Caffeine • [Rofecoxib was on the list] 9
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