PPM Exam 2

Drug shortages in the united states predominantly involve

generic drugs
there have been dramatic increases in

the types of drugs in short supply
Recent drugs in short supply
- epinephrine
- hydromorphone
- propofol
- cancer chemotherapy
Gray market suppliers
- secondary wholesalers
- repackage and sell for higher amount to make profit
- consequences for patient care
FDA and Drug Shortages
- FDA is criticized for not being as assertive as they should be
- FDA is criticized for being lax in oversight of drug mfg
- lack of oversight of precursor chemicals from foreign sources
FDA allows importation of
- methotrexate
- doxorubicin
Importing heparin from china
- need to have more safeguards in place
- need quality control and GMP to be verified in other countries
FDA regulatory authority reguarding discontinuation of drug manufacture
- FDA can only ask that mfg will let them know when discontinuing manufacture of a drug
- cannot mandate
Reimbursement fraud
- mfg may see these penalties as cost of doing business
- harms medicare and medicaid recipients
Major issues in mfg
- breakdown or total absence of quality assurance
- unstable water used
- production line problems
- contamination of products
- batch mix ups
major issues in supply chain
- fraud and abuse in pricing by mfg
- online predators: websites, advertising, foreign sources
- drug recalls

Author

Rx2013

141786

Card Set

PPM Exam 2

Description

Drug Shortages

Updated

2012-03-15T18:05:02Z