managing drug shortages - global healthcare applications

7/31/2019 Managing Drug Shortages - Global Healthcare Applications

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Managing Drug Shortages:

Global Healthcare Applications

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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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