On Back Order RT Whiteman, Pharm.D Pharmacy Practice Resident St. Luke s Boise Medical Center Learning Objectives By the end of the presentation the audience members will be able to: Explain the most likely possible reasons for drug shortages in the United States Characterize the medications most affected in the shortage State the resources available that list and / or allow reporting of a drug shortage Scope of the Problem Currently, ASHP 1 lists over 200 drugs on shortage (not all are critical) Many are critical medications without alternative therapy Sterile injectable medications (~75%) Chemotherapy, anesthesia Many do not have a resolution date in sight Impact on Pharmacies 1. American Society of Health-System Pharmacists, Drug Shortages: Current Drugs. Available at: http://www.ashp.org/drugshortages/current/ (August 31, 2012). 10. Kaakeh R, Sweet BV, et al. Impact of Drug shortages on U.S. Health Systems. Am J Health-Syst Pharm [Internet]. 2011 Oct 1 [cited 2012 Aug 31]. 68: 1811-19. Available from: http://c.ymcdn.com/sites/higpa.site-ym.com/resource/resmgr/research/drugshortages.pdf 1
The Real Problem A Scary Trend 2 2. Knox R. Shortages Lead Doctors to Ration Critical Drugs [Internet]. NPR; 2011 Oct 3 [cited 2012 Aug 31]. Available from http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs What happened 2? 2. Knox R. Shortages Lead Doctors to Ration Critical Drugs [Internet]. NPR; 2011 Oct 3 [cited 2012 Aug 31]. Available from http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-ration-critical-drugs 2
Background Limited numbers of companies make the drugs that are currently in short supply Group Purchasing Organizations The market for these medications is behaving differently than other products in the free market Competing Theories Drug shortages CAUSED by the Food and Drug Administration (FDA) and other government programs / policies Assertion made by the Committee for Government Oversight and Reform, US house of representatives Oversight Committee 3 Few companies making drugs GPOs In 2010, 90% of generic injectable oncology drugs were produced by three or fewer manufacturers Overbearing FDA FDA effectively shut down 30% of drug production, spread over 4 companies Nearly 60% of drugs on shortage list were made by companies where production was affected by FDA remediation 3. U.S. House, Committee on Oversight and Government Reform. FDA s contribution to the Drug Shortage Crisis. Staff report 2012 Jun 15 (112 H). Available from: http://oversight.house.gov/wp-content/uploads/2012/06/6-15-2012-report- FDAs-Contribution-to-the-Drug-Shortage-Crisis.pdf 3
Oversight Committee Partly to blame: Medicare Modernization Act Interference with free market competition Prevention of price increase >6% Inelastic market pricing conditions 340(b) pricing Low prices, low margins Government Accountability Office 4 Analysis similar to Oversight Committee, but does not blame FDA for the problem Instead asserts that FDA needs to be strengthened to help with the crisis Mandatory reporting? Cites instances of prevented shortages 4. Crosse M. Drug Shortages: FDA s Ability to Respond Should be Strengthened. Statement before Committee on Health, Education, Labor, and Pensions, U.S. Senate. 2011 Dec 15 [cited 2012 Aug 31]. Available from: http://www.gao.gov/assets/590/586979.pdf Economics Price inelasticity on the demand side Mirrored on the supply side New generic approval From the manufacturer s perspective Why Increase production? Medicare Modernization Act ASPE DHHS Economic analysis of drug shortages - Kevin Haninger, Amber Jessup, and Kathleen Koehler of ASPE s Office of Science and Data Policy. 2011 Oct. Available from http://aspe.hhs.gov/sp/reports/2011/drugshortages/ib.pdf 4
Executive order 13588 6 Basically the manifestation of GAO s recommendations Enforce adequate reporting of shortages Expedited regulatory review Review of certain behaviors by market participants 6. Obama B. Reducing Prescription Drug Shortages. Executive Order 13588 [Internet]. 2011 Oct 31. Available from: http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drug-shortages FDA s Six-Month Checkup 7 States that the strongly encouraged voluntary reporting to FDA has resulted in prevention on many new drug shortages Importation of other drugs Prevention of propofol shortage? 7. Hamburg M. FDA Voice Six Month Check-Up: FDA s Work on Drug shortages [Internet]. U.S. Food and Drug Administration; 2012 May 3 [cited 2012 Aug 31]. Available from: http://blogs.fda.gov/fdavoice/index.php/2012/05/six-month-check-up-fdas-work-on-drugshortages/ Legislation Food and Drug Administration Safety and Innovation Act 8 Signed by the President July 9, 2012 Mandatory reporting of hiccups in manufacturing or plans to discontinue production Doesn t address gray market Problem solved! 8. Sullivan T. The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics [Internet]. 2012 Jul 19 [cited 2012 Aug 31]. Available from: http://www.policymed.com/2012/07/the-food-and-drug-administration-safety-andinnovation-act-fdasia-summary-of-gdufa-mdufa-bsufa.html 5
The Gray Market Gray Market Also known as Secondary Purchasers Normal end-purchasers acquire medications, then sell small amounts to other end-purchasers at a large markup Not likely a cause of shortages Story-time! Gray Market Senate Committee on Commerce, Science, and Transportation Report 9 : The investigation has identified a number of businesses holding pharmacy licenses that appear to operate for the sole purpose of acquiring short-supply drugs that can be sold into the gray market What choice do we have? What are the consequences? 9. U.S. Senate, Committee on Commerce, Science, and Transportation. Shining light on the Gray market : An examination of why hospitals are forced to pay exorbitant prices for prescription drugs facing critical shortage. Staff report 2012 Jul 25 (112 S). Available from: http://democrats.oversight.house.gov/images/stories/7.25.12%20staff%20report%20shining%20light%20on%20the%20gray%20mar ket.pdf 6
Shortages Really Cause Problems Tiny Triumphs - http://www.colbertnation.com/video/tiny+triumphs What is our Role? Report drug shortages ASHP FDA Report gray marketeers Problems with this Involvement with GPOs Outcomes Manufacturers are increasing production Slow process FDA is mediating Duct tape fix New normal? 7
Assessment Questions Which of the following is most likely NOT a reason for current drug shortages in the United States? A. Few manufacturers making critical drugs B. Grey Market scalpers C. Compromised manufacturing processes under updates D. Price Inelasticity in the drug market Assessment Questions Which of the following medications is most likely to be affected by the shortage? A. Normal Saline 1000ml IV bags B. Seroquel XR 100mg tablets C. Danorubicin Hydrochloride injection D. Omeprazole 20mg OTC tablets Assessment Questions Which of the following groups give online access to report / list current drug shortages A. ASHP.org B. FDA.gov C. Tevapharm.com D. Both A and B 8
References 1. American Society of Health-System Pharmacists, Drug Shortages: Current Drugs. Available at: http://www.ashp.org/drugshortages/current/ (August 31, 2012). 2. Knox R. Shortages Lead Doctors to Ration Critical Drugs [Internet]. NPR; 2011 Oct 3 [cited 2012 Aug 31]. Available from http://www.npr.org/blogs/health/2011/10/04/140958404/shortages-lead-doctors-to-rationcritical-drugs 3. U.S. House, Committee on Oversight and Government Reform. FDA s contribution to the Drug Shortage Crisis. Staff report 2012 Jun 15 (112 H). Available from: http://oversight.house.gov/wpcontent/uploads/2012/06/6-15-2012-report-fdas-contribution-to-the-drug-shortage-crisis.pdf 4. Crosse M. Drug Shortages: FDA s Ability to Respond Should be Strengthened. Statement before Committee on Health, Education, Labor, and Pensions, U.S. Senate. 2011 Dec 15 [cited 2012 Aug 31]. Available from: http://www.gao.gov/assets/590/586979.pdf 5. ASPE DHHS Economic analysis of drug shortages - Kevin Haninger, Amber Jessup, and Kathleen Koehler of ASPE s Office of Science and Data Policy. 2011 Oct. Available from http://aspe.hhs.gov/sp/reports/2011/drugshortages/ib.pdf 6. Obama B. Reducing Prescription Drug Shortages. Executive Order 13588 [Internet]. 2011 Oct 31. Available from: http://www.whitehouse.gov/the-press-office/2011/10/31/executive-order-reducing-prescription-drugshortages 7. Hamburg M. FDA Voice Six Month Check-Up: FDA s Work on Drug shortages [Internet]. U.S. Food and Drug Administration; 2012 May 3 [cited 2012 Aug 31]. Available from: http://blogs.fda.gov/fdavoice/index.php/2012/05/six-month-check-up-fdas-work-on-drug-shortages/ 8. Sullivan T. The Food and Drug Administration Safety and Innovation Act (FDASIA): Summary of GDUFA, MDUFA, BsUFA and Pediatrics [Internet]. 2012 Jul 19 [cited 2012 Aug 31]. Available from: http://www.policymed.com/2012/07/the-food-and-drug-administration-safety-and-innovation-act-fdasiasummary-of-gdufa-mdufa-bsufa.html 9. U.S. Senate, Committee on Commerce, Science, and Transportation. Shining light on the Gray market : An examination of why hospitals are forced to pay exorbitant prices for prescription drugs facing critical shortage. Staff report 2012 Jul 25 (112 S). Available from: http://democrats.oversight.house.gov/images/stories/7.25.12%20staff%20report%20shining%20light%20 on%20the%20gray%20market.pdf 10. KaakehR, Sweet BV, et al. Impact of Drug shortages on U.S. Health Systems. Am J Health-Syst Pharm [Internet]. 2011 Oct 1 [cited 2012 Aug 31]. 68: 1811-19. Available from: http://c.ymcdn.com/sites/higpa.site-ym.com/resource/resmgr/research/drugshortages.pdf 9