Drug Shortages by pptfiles

VIEWS: 0 PAGES: 32

									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?

								
To top