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Drug Shortage Update Progress Towards Solutions Erin R. Fox, PharmD, FASHP Director, Drug Information Service Disclosure • This presentation represents my own opinions. • University of Utah Drug Information Service receives some funding from Novation LLC for drug shortage content. No funds are directly paid to Erin Fox. National Shortages and University of Utah Drug Information Service • UU DIS provides drug shortage content to American Society of Health-System Pharmacists • Public website at www.ashp.org/shortage – Partners since 2001 – Receive voluntary reports submitted via web – Frequent communication with FDA drug shortage team Shortage Website Differences ASHP • www.ashp.org/shortage • Drugs impacting clinical practice (biologics, devices, dosage forms) • What is available at NDC level • How to access • Frequent updates • Alternatives • Contract information FDA • www.fda.gov/cder • Medically necessary drugs • Information from manufacturer Timeline Towards Progress 2002 AMA/ASHP 2011 FDA Workshop 2010 Summit 2011 Executive Order 2011 AMA Policy 2012 FDASIA FDA Strategic Plan for Shortages • Mandated as part of FDASIA law – Enhance mitigation efforts – Develop long-term prevention • Suggestions for external stakeholders – Manufacturing incentives – Use quality data when purchasing – Capacity, redundancy FDA’s Mitigation Tool Kit • Regulatory discretion – Require filters • Ask others to increase production • Expedite reviews (new product, longer expiration, new raw material, new manufacturing sites • Imports – Less than ideal, but helpful • NB – FDA can’t make any drug! Making a Difference? + FDA prevents hundreds – Ongoing shortages not resolving of shortages + More suppliers choose – Manufacturing problems to work with FDA early + Decreased rate of new – Continued patient impact shortages Current Trends New Shortages by Year January 2001 to September 30, 2014 300 267 250 211 204 200 150 149 140 145 129 120 88 100 166 73 58 74 70 05 06 50 0 01 02 03 04 07 08 09 10 11 12 13 14 Note: Each column represents the number of new shortages identified during that year. University of Utah Drug Information Service [email protected], @foxerinr Active Shortages by Quarter 350 300 239 250 273 299 295 299 294 288 320 260 211 200 150 246 256 282 305 306 152 167 176 188 100 50 0 Note: Each column represents the number of active shortages at the end of each quarter. University of Utah Drug Information Service [email protected], @foxerinr Top 5 Drug Classes Active Shortages 9/30/14 60 50 40 30 20 10 0 52 47 41 30 30 University of Utah Drug Information Service [email protected], @foxerinr Shortages of Basics • Frequent fliers • 10 medications short > 50 times between 2001 and 2013 – Dextrose, diazepam, epinephrine, fentanyl, lorazepam, morphine, ondansetron, nalbuphine, naloxone, promethazine What do these numbers mean? • The rate of new shortages has decreased, but recently has increased • The ongoing shortages are not resolving • Continued daily impact for patients, clinicians, health systems, health care http://www.gao.gov/products/GAO-14-194 Twitter: @foxerinr Why is this happening? Drug Manufacturing is a Business • • • • • • Profitability Manufacturing fixes Capacity – most factories running 24/7 Prioritization (new opportunities) Forecasting (contracts) Aging facilities Fragile Supply Chain Generic Injectables • Few suppliers • 3 manufacturers supply 71% of market • Only 1 or 2 manufacturers for > 1/3 products • Capacity is limited – Concentrated, “just in time” production – Multiple products made on single line – No back up manufacturing lines 17 IV Fluids, Irrigations Shortage • 3 suppliers • All suppliers state “increased demand” • Real reason behind the increased demand is unclear • Rolling shortages, unclear allocations (expect problems through 2015?) – Available fluid type, volume will vary – Imports – costs, access, packaging No Quick and Easy Fix • Complex manufacturing process – Quality problems are difficult to fix – Investigation of root cause takes time – Changes take time – Capacity or redundancy not available How did we get here? Cascade of Events Early 2000’s “Find production efficiencies” 2008 Dr. Hamburg FDA increases scrutiny 2009 Irvine plant closes New York plant closes Heparin Warning letters, 483’s document serious quality problems 2010+ 30% manufacturing capacity is closed Ohio plant closes Economic Drivers of Drug Shortages Quality No Incentive Clin Pharmacol Ther. 2013;93:170-176 Clin Pharmacol Ther. 2013; 93:145-147 Not Transparent Why Doesn’t the Free Market Fix the Problem? • Supply and demand doesn’t work for drugs • Consumers don’t choose products • Misaligned incentives • No suppliers to step in when others can’t produce • Shortages generally don’t impact profits • Patient impact, not suppliers No Requirement to Report Manufacturer of Product • Contract manufacturing means we don’t always know who makes the product • No requirement to disclose manufacturer (or location) in product label (or 483) • Your brand product may be manufactured by a generic company Import Bans • Ranbaxy, Wockhardt, import bans • Massive recalls due to falsified data, tablets that won’t dissolve • India’s Drug Controller General says US standards too strict New Ideas for Solutions International Society for Pharmaceutical Engineering • Survey -2013 – Key deficits in quality systems, aseptic processing equipment • Shortage initiative – Root causes of manufacturing problems • Prevention Plan (October 2014) – 6 dimension plan • http://www.ispe.org/drug-shortages-initiative New Ideas for Manufacturing • Janet Woodcock advocates continuous manufacturing for: – Faster, improved quality, lower prices, fewer shortages – Domestic plants – fully integrated from API to finished product Too little, too late • Hospitals are functioning in disaster mode • Patient care decisions based on incomplete information • Clinicians no longer trust critical therapies will be available for patients • Industry must fix itself Contact Information Erin R. Fox, PharmD, FASHP Director, Drug Information Service University of Utah Health Care Adjunct Associate Professor, University of Utah College of Pharmacy, Dept. of Pharmacotherapy 801-587-3621 [email protected] Twitter: @foxerinr