Drug Shortages - Intro to Ind.

drug shortage

period when the demand or projected demand for the drug within the united states exceeds the supply of the drug

effects of drug shortages

potential threat to public health, healthcare professionals need to find proper solutions, compromise the standard of care, produce waste, and increase costs

FDA

who determines a drug shortage?

ASHP

who has information on drug shortages and collects reports of drug shortage?

limited supply in certain regions, limited supply with certain wholesalers/distributors, limited supply of brand when generic is available

what are causes of limited supply from the wholesaler the pharmacy/hospital uses?

manufacturers

who reports shortages?

required

producers of life-saving medications or those intended to prevent or treat debilitating diseases are _____ to notify the FDA about shortages

six months in advance OR asap, but no later than 5 business days after the disruption

by when should mfg notify the FDA about drug shortages ?

2012 Food and Drug Administration Safety and Innovation Act (FDASIA)

law that requires notifying the FDA of changes in production of certain products to help FDA prevent and mitigate shortages

2020 Coronavirus Aid, Relief, and Economic Security Act (CARES Act)

law that requires reporting if

1) Permanent discontinuance in manufacturing

2) Interruption in manufacturing that could lead to drug shortage

3) Permanent discontinuance of the API of a drug

4) Interruption in the manufacturing of the API that could lead to drug shortage

hospitals and pharmacies

who can voluntary report drug shortage to FDA and ASHP?

[e-mail]

email to report drug shortage

sourcing of materials, and cost of drugs

what circumstances can cause drug shortages?

too low

some drugs are priced ____ relative to the full cost of reliably producing a predictable and high quality pharmaceutical product

costs of mfg, demand of drug, number of producers in the market

factors that influence decision to withdraw from the market

FDCA regulations for compounding medications, importation laws

what are government policy or regulations that impact manufacturing and supply chain decisions?

natural disasters, shortages with API, shortages with excipients, manufacturing problems

why are there shortages?

quality issues

largest reason for drug shortage in 2013-2017

preventing shortages, early identification of anticipates shortages, responding by remedying the underlying problems when shortages arise

3 pronged approach by FDA to mitigate drug shortage?

expedite inspections of new facilities used to mfg drug in shortage

expedite review of a new or generic drug application for drugs

review and approve extended expiration dates of mfg inventory

FDA’s role in mitigating shortages

analgesics, sedatives, bronchodilators, antibiotics, hydroxychloroquine

examples of drug shortages during Covid

active pharmaceutical ingredients and raw materials

what does China provide?

India

What country is the largest producer of generic drugs?

extended use dates

What did FDA do to assist with supply interruptions?

foundation of basic IV compounding for 100s of drugs that need further dilution

what is SVP (Small volume parenteral solutions) used for?

emergency syringes, sodium bicarbonate, small volume saline, amino acids, TPN components

what are some severe shortages that impact hospitals?

switch to oral drug, switch to IV drug, compound or outsource

what are some alternatives to help with shortages?

filling RX per patient script

503A compounding pharmacies

producing large volumes of medications in bulk

503B compounding pharmacies

USP requirements 795 and 797

what regulations must a 503A Pharmacy comply with?

USP requirements 795 and 797 and cGMP requirements

what regulations must a 503B Pharmacy comply with?

Drug Quality and Security (DQSA)

who mandates risk-based federal oversight ?

New England Compounding Center (NECC) Meningitis Outbreak

stated that they were only making drugs for patient specific prescriptions, but turned out to be routinely dispensing drugs in bulk without valid prescriptions

multistate fungal meningitis outbreak occurred

LARGEST public health crisis caused by a pharmaceutical drug

contaminated preservative-free MPA steroid injections

what was the contaminated product that pts got in the NECC case?

failure to steralize, proper testing for sterility, not waiting to get results before sending drug to pts, approved use of expired drug ingredients, mislabeling to deceive customers, unsanitary conditions

what are some causes of the NECC outbreak?

2013 DQSA bill

what bill did the NECC outbreak lead to?