Macro Supply Chain

drug supply chain example

supplier(s) → manufacturer (which may go to repackager) → wholesaler distributor (primary) (which may go to secondary distributer) → pharmacy/hospital → patient

drug shortage definition

supply issue that affects how the pharmacy prepares or dispenses a drug product or influence patient care when prescribers must use an alternative agent

what are the most common drug classes to have shortages?

antimicrobials/antibiotics, CNS, and chemo

what percent of drug shortages are injectables?

about 50%, which is quite a lot

what government entities are key players in drug supply?

VA and DoD (Department of Defense)

reasons for drug shortage

increase in demand

reductions in capacity (manufacturing quality/challenges, regulatory barriers, environmental/man-made disasters)

other problems (transportation and import/export, geopolitical)

manufacturing quality challenges

active pharmaceutical ingredient shortages, finished dosage forms

what is the most common reason for shortage as reported by manufacturers?

unknown or would not provide, which may be due to business decisions quietly made

who are the biggest imports of pharmaceuticals to the US?

Ireland, Germany, China

where are the major hubs for active pharmaceutical ingredient (API) manufacturing facilities for the US?

China, EU, India, US

where are the major hubs for finished dosage form (FDF) manufacturing facilities for the US?

US, India, EU

manufacturing difficulties

FDA enforcement halts or delays

GMP noncompliance (antiquated equipment, shift of resources in companies, experienced personnel)

who evaluates FDA enforcement of halts/delays?

Center for Drug Evaluation and research (CDER), determines effect of a shut down

voluntary recall

generally, a temporary manufacturing problem—most recalls are like this

usually, a minor lapse in manufacturing procedures (not subject to FDA legal action)

usually, specific lots

lack of assurance that the recalled product is safe or technical problem (labelling issue)

manufacturer decisions

financial, industry consolidations

financial manufacturer decision factors

availability of generic products

market size

patent expiration

anticipated clinical demand

risk management

regulatory compliance requirements (REMS, black-box warnings)

how do industry consolidations affect manufacturer decisions?

mergers often narrow focus or move production lines

USP medicine supply map

essentially, AI can be used to analyze supply maps and predict where any problems may occur

pharmacy wholesalers

purchase, inventory, and distribute a manufacturer’s products to different entities (pharmacies)

there are also specialty distributors

pharmacy wholesaler examples

AmeriSource Bergen

Cardinal health

McKesson