DRUG SHORTAGES 2011 Pharmacy Technician Conference July 21, 2011 Sara Nibbe Turnbow, PharmD, MS, BCPS Senior Pharmacist, MMCAP Objectives 2 Definitions Scope and Trends Causes Managing Shortages Facilitylevel Public policy Resources Questions Definitions 3 Drug Shortage A situation in which the total supply of all clinically interchangeable versions of an FDA-regulated drug is inadequate to meet the current or projected demand at the user level Short Term Backorders Long Term Backorders Recalls Definitions 4 Medical necessity A medication is considered to be medically necessary if it is used to treat or prevent a serious disease or medical condition, and there is no other available source of that product or alternative drug or therapy that is judged by medical staff to be an adequate substitute Patient inconvenience alone is insufficient to classify a product as a medical necessity Scope 5 Drug shortages are receiving a great deal of attention Drug Shortages Summit held on November 5, 2010 American Society of Health-System Pharmacists Institute for Safe Medication Practices American Society of Anesthesiologists American Society of Clinical Oncology Numerous supply chain entities CDC and FDA Scope 6 National Drug Shortages 2001 - 2010 200 178 180 166 160 149 140 129 120 120 100 88 80 73 74 70 58 60 40 20 0 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 Fox ER. Drug Shortages Overview and Trends. Available at: http://www.ashp.org/drugshortages/summitreport. Accessed: February 3, 2011. Scope 7 Recent examples Concentrated oral morphine solution Haloperidol decanoate Medroxyprogesterone injectable suspension Hepatitis A, Hepatitis B, and influenza vaccines Rabies vaccine Acyclovir capsules, tablets, and injection ASHP lists 195 national drug shortages (July 2011) Scope 8 Negative effects Clinical Delayed care Inferior clinical outcomes Medication errors Patient injury or death Business Higher drug acquisition costs Personnel costs High level of frustration (purchasing, pharmacists, nurses, physicians, patients) Scope 9 Provide seamless, safe, and therapeutically equivalent care at the same cost Causes 10 Can be one or a combination of factors throughout the supply chain Drug Shortages Summit categorized causes into 4 groups Regulatory and legislative factors Raw material sourcing and manufacturing factors Business and market factors Distribution factors Causes 11 Lack of FDA authority to require notifications Manufacturers can discontinue drugs without notifying the FDA unless the drug is considered medically necessary Six month notice required for manufacturers discontinuing medically necessary drugs No statutory authority for enforcing notification requirements FDA’s Unapproved Drugs Initiative Removal of pre-1938 drugs (availability prior to FD&C Act) Quinine, sublingual nitroglycerin tablets, colchicine, etc. Cost and complexity of New Drug Applications for unapproved drugs Changes in product formulations or manufacturers Causes 12 Primary or sole source manufacturer halts or delays production in response to FDA actions on current good manufacturing processes (cGMP) FDA actions are meant to protect the public FDA works with manufacturer to determine solution Examples: Ranbaxy, Apotex, Caraco/Sun Pharmaceuticals Causes 13 Raw materials Usually outsourced 80% of raw materials used in pharmaceuticals comes from outside the US* Often only one raw material supplier for several manufacturers Limited manufacturing capacity Multiple products may be produced on the same line An increase in production of one product will usually result in a delay for another product produced on the same production line Increasing production to make up a 20% market share impossible *American Society of Health –System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406. Causes 14 Market concentration Mergers and acquisitions (consolidation = fewer manufacturers) Resiliency in the supply chain decreases Manufacturers’ production decisions and economics Profitability Depends on availability of generic products (price is inversely related to the number of manufacturers) Market size FDA does not have the authority to require a company to make any product, even if it is medically necessary Causes 15 Supply ≠ demand Unexpected increases in demand New indications or usage patterns change due to new clinical guidelines Disease outbreaks Natural disasters Damage to manufacturing facilities or providers of raw materials Fires Hurricanes Floods Causes 16 Inventory practices “Just in time” inventory management to reduce the cost of inventory on hand and optimize cash flow Manufacturers and distributors may minimize end-of- quarter or end-of-year product inventories to limit shipments based on yearly quotas Poor ordering practices, stockpiling before price increases, hoarding, and unexpected delivery delays Managing Shortages 17 Plan ahead Drug Shortages Policy Define responsibilities Define decision makers (e.g., P&T Committee, finance) Short and long term plans Potential management strategies (e.g., removing product from automated dispensing cabinets, centralizing distribution, prescriber notification, non-traditional distributors, ask GPO to put alternative product on contract, compounding, rationing, etc.) Put strategies in place for or train using: Top X% of drugs by volume Drugs that are emotionally sensitive when use is rationed Managing Shortages 18 Operational assessment Validate the shortage and its duration National shortage versus availability through contracted wholesaler ASHP Drug Shortages website Manufacturer Determine the stock on hand Determine supply from alternate sources Determine purchase history and true use history Estimate time to impact on facility Determine supply and cost of alternative product American Society of Health –System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406. Managing Shortages 19 Therapeutic assessment Identify patient population affected Identify therapeutic alternatives Estimate impact on patient care Therapeutic differences Prescribing processes Distribution processes Administration processes Financial ramifications There may be no good alternatives American Society of Health –System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406. Managing Shortages 20 Establish the Final Plan Communicate Implement Shortage Information system changes Effective date Technological changes (e.g., Therapeutic alternative bar coding, etc.) Temporary guidance Inventory system changes Temporary procedures New procedures American Society of Health –System Pharmacists. ASHP guidelines on managing drug product shortages in hospitals and health systems. Am J Health-Syst Pharm. 2009; 66: 1399-1406. Stockpiling 21 Can lead to artificial shortages when facilities drain the supply chain Increased inventory is costly and may not be absorbed by normal usage if shortages do not occur as anticipated Diverts product away from patients in need Non-Traditional Distributors 22 Specifically obtain product in short supply for the purpose of reselling Aggressive marketing (e.g., faxes, phone calls) Limited supply Quality may be questionable (e.g., pedigree, storage, counterfeit, compounded) Important to ask about expiration dating Substantially higher prices (10-1000 times higher than the usual cost) Price Gouging 23 Pricing issues are not within the purview of the FDA Concerns regarding the price of medications may be directed to the Federal Trade Commission, which enforces federal antitrust and consumer protection laws More likely with gray market vendors Document and save purchasing information Allocations 24 Often put into place to address stockpiling and to ensure that supply remains available to those facilities that need product Based on past usage Problematic when multiple presentations exist (e.g., facility traditionally uses vials which are not available; facility tries to order syringes but allocations do not allow because past usage is for vials) Can sometimes be increased by contacting wholesaler Public Policy Recommendations 25 Explore expanding FDA authority to require manufacturer notification of market withdrawal (e.g., 9-12 months prior to planned market exit) Identification of critical drug therapies that are vulnerable to drug shortages Incentives (e.g., tax credits) to manufacturers that produce critical drug products or upgrade manufacturing plants to meet or exceed cGMP Improved processes for extending product stability for products in short supply Public Policy Recommendations 26 Require confidential notification to FDA when there is a single API supplier or manufacturing source Inform FDA of interruption in the supply of raw materials or manufacturing processes Reauthorization of the Prescription Drug User Fee Act (PDUFA) to provide FDA with additional resources to support timely reviews Expedited approval pathway for pre-1938 drugs Importation or reimportation - unlikely Public Policy S. 296: Preserving Access to Life-Saving Medications Act 27 Sponsored by Senator Amy Klobuchar Requires notification of a discontinuance, interruption, or other adjustment that would likely result in a shortage Requires 6 months notice OR notice as soon as practicable after becoming aware Types of adjustment for which a manufacturer must submit notice: Supply of raw materials Production capabilities Business decisions that may affect the manufacture of the drug Public Policy S. 296: Preserving Access to Life-Saving Medications Act 28 Requires identification and notification of drugs vulnerable to drugs shortage based on: The number of manufacturers of the drug The sources of raw material or active pharmaceutical ingredients The supply chain characteristics, such as production complexities The availability of therapeutic alternatives Enforcement: civil monetary penalties for failure to submit notification as required Summary 29 Major increase in critical drug shortages are a serious challenge Drug shortages are caused by regulatory and legislative factors, raw material sourcing and manufacturing factors, business and market factors, and distribution factors Supply planning must become a part of daily operations S. 296 – currently referred to Committee Resources 30 ASHP Drug Shortages website Current shortages (products affected) Reasons for shortages Estimated resupply dates Report shortages www.ashp.org/DrugShortages/Current/ FDA Drug Shortages website Focuses on shortages of medically necessary products Free e-mail alerts Current/resolved shortages and drugs being discontinued Report shortages www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htm Resources 31 ASHP Guidelines on Managing Drug Shortages in Hospitals and Health Systems. AJHP 2009; 66:1399-406. Available online at: www.ashp.org/DocLibrary/Policy/DrugShortages/ASHP_shortage_guide09.pdf Product manufacturer CDC Specifically for vaccine shortages Information on modifying immunization schedules 32 Questions? Discussion: How is your pharmacy managing drug shortages?
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