Managing Drug Shortages - Global Healthcare Applications
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Transcript of Managing Drug Shortages - Global Healthcare Applications
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7/31/2019 Managing Drug Shortages - Global Healthcare Applications
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Managing Drug Shortages:
Global Healthcare Applications
www.HealthcareMedicalPharmaceuticalDirectory.com
HealthcareMedicalPharmaceuticalDirectory
.COM
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Managing Drug Shortages:Global Healthcare Applications
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Drug shortages have wide impactin healthcare delivery
Patients
Doctors
Nurses
Pharmacists
Procurement
Payers
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Why are there drug shortages?
Manufacturing quality issues
Under-production
Active Pharmaceutical Ingredient (API) shortages
Changes in therapeutic preferences
Spiking demand for product as others becomeunavailable
High-demand, specialized products with fewsubstitute therapy options
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Why is product sometimesavailable to others and not me?
Reduced product quantity may not be partitionedenough to reach every market
It may not be available in all forms (ampoule, capsule,solution, syringe, tablet, vial, etc.)
Inventories may be depleted at a slower rate inmarkets which have less demand
Product use may be limited/restricted in othermarkets
Other providers may have a better method of sourcingand managing therapies which are in limited supply
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Establish a Drug ShortageManagement Program
Identify must have medications withconsistent supply issues
Formalize a Drug Shortage ManagementProtocol (DSMP) to maneuver throughperiods of particular drug shortages
Communicate DSMP with purchasing andclinical staff so they may collaborate on anongoing basis
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The DSMP should apply to routineinventory management
Identify must have medications with consistentsupply issues and/or with spiking demand
Maintain higher minimal inventory levels
Assess shelf life dates, use inventory prior toexpiration
Monitor key therapy market availability
Avoid stockpiling, it ties up funds and
contributes to inventory management issues
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Assertively develop and managealternative therapy options
In advance, determine specific substitutes (tothe NDC level) which can fill the gap during a
must have drug shortage
Setup product in procurement databasecomplete with sources
Conduct additional training and documentprotocol changes in advance
Integrate these measures into your DSMP
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Consult primary payers regardingtherapy options in advance
What is their policy if preferred orstandard product is not available?
How should use of alternative therapies bejustified and documented?
Get the approval standards in writing andinclude them in your DSMP documentation
Monitor policy changes closely
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For Must Have drugs, communicatewith manufacturers directly
Routinely meet with manufacturer salespersons,contact their customer service units
Inquire about specific must have therapiesavailability
Determine how manufacturers allocate products tobetter position your organization
If they provide email updates on urgent productavailability issues, subscribe to them and routinelymonitor
Setup a protocol with them in the event a therapy
shortage materializes
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Contact primary distributors andwholesalers frequently
Regularly inquire about specific key therapiesyou purchase from them and potential issues
Determine how they allocate products tobetter position your organization
If they provide email updates on urgent
product availability issues, subscribe to themand routinely monitor
Setup a protocol with them in the event atherapy shortage materializes
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Connect with your buying groups,GPOs and associations
Engage the business and professional entitiesyour organization is a member of
Determine their interpretation of the issues andassess the position you are in
What actions have they have taken to workthrough drug shortages on behalf of their
members?
How else may they assist you and what can theydo to influence the drug shortage events you areexperiencing?
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How are your peers managingdrug shortages?
Network with peers:
How are they sourcing product?
What is their version of a DSMP?
How may their methods be incorporated into yourDSMP?
Are there ways you may work together?
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Use global and governmenthealthcare information resources
Government websites may provideguidance:
Drugs currently or about to be in short supply
Reasons behind product shortages
Potential substitute therapies
Expected return to normal availability
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Global and government healthcarewebsites
Central Drugs Standard Control Organization (CDSC)-India: www.cdsco.nic.in
European Medicines Agency (EMA)-Europe: www.ema.europa.eu
Food & Drug Administration (FDA)-United States: www.fda.gov
Medicines and Healthcare products Regulatory Agency-(MHRA), UK: www.mhra.gov.uk
National Health Surveillance Agency (NHSA)-Brazil: www.anvisa.gov
Pharmaceuticals and Medical Devices Agency (PMDA)-Japan: www.pmda.go.jp
Saudi Food and Drug Authority (SFDA)-Saudi Arabia: www.sfda.gov.sa
Therapeutic Goods Administration (TGA)-Australia: www.tga.gov.au
World Health Organization (WHO)-Global: www.who.int
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Summary
Use a variety of resources, stay informed
Closely manage key therapies with inconsistentavailability
Establish a formal DSMP in advance
Build collaboration with clinical and procurementstaff in your organization
Identify and manage your optionsmoving forward
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