Drug Shortage

Shortage of ofloxacin otic solution

Ball-and-stick model of ofloxacin contributed to Wikimedia by MarinaVladivostok

The American Society of Health-System Pharmacists reports a shortage of ofloxacin otic solution. As the name implies, this is a dropper bottle of the antibiotic for use in the outer ear. Besides bacterial infections which might start in the ear canal, it is used for infections in the middle ear that have broken through the eardrum into the outer ear.

This drug formulation is in short supply because Apotex discontinued it earlier this year. Sandoz and Valeant do not give a reason for the shortage. Since unstated reasons for shortages are a common feature of the ASHP reports, here are some possibilities.

Manufacturing Difficulties
Many factors can contribute to drug-manufacturing difficulties, including antiquated equipment, a shift of a company’s resources from manufacturing to research and development, loss of production and compliance personnel, and many others.2 …
Shortages of Raw Materials
Disruptions in the supply of raw or bulk materials are frequently responsible for drug shortages….
Voluntary Recalls
A major drug recall can have a rapid and significant effect on the availability of a product, especially when it is produced by a sole manufacturer.2 …
Natural Disasters
Natural disasters can profoundly affect drug product availability.2 Finished drug products or supplies can be affected by fires, hurricanes, tornadoes, and floods.2 … Sometimes natural disasters exacerbate drug shortages because they create an unexpected demand for drugs needed to treat disaster victims.2 …
Supply and Demand Issues
Occasionally, the demand for a drug can increase beyond expectations or production capacity.2 This can occur in response to the approval of a new indication for an existing product, changes in therapeutic guidelines, the spread of disease, or other unpredictable factors.2 …
Business and Economic Issues
Drug shortages can also occur because of a manufacturer’s business decisions. These may be based on a variety of factors, including insufficient profits, the introduction of generic products, market share, anticipated clinical demand, patent expiration, drug-approval status, regulatory compliance requirements, expense to correct manufacturing problems, or mergers.2 Manufacturers may permanently or temporarily reduce production quantities of certain drugs as they shift production or reallocate resources to another product.2 …
… Consolidation in the pharmaceutical industry has left only a few manufacturers for many older, less profitable products, meaning that when raw material runs short, equipment breaks down, or the FDA enforces compliance regulations, these problems can quickly give rise to drug shortages.1 …
Many of the drugs in short supply also tend to be generic medications, which aren’t very profitable, so companies don’t plan for backup capacity.15 Economic pressure on manufacturers can also lead them to maintain lower inventories of low-profit drugs or take them off the market.12 …
Regulatory Issues
Some industry representatives blame the drug shortage problem on increased oversight by the FDA, because the agency has made drug safety a higher priority after being criticized for being too lax.1However, FDA officials dispute that increased government oversight is a major factor in causing drug shortages.1 Instead, FDA officials have said that manufacturing problems are the cause of most shortages.1Data reported by the ASHP/UUHC for 2010 supports this contention, since manufacturing difficulties accounted for the largest percentage of known reasons for drug shortages (28%), whereas regulatory issues accounted for the fewest (1%).13
The FDA has been paying increased attention to quality control, an especially critical issue for injectable drugs.12 …
The limited resources of the FDA may also impede the timely inspection and recertification of manufacturing sites after a noncompliance shutdown.16 …
Supply Chain Issues and Health Care System Practices
Once a drug is manufactured, the drug supply chain is composed mostly of wholesalers or distributors, prime vendors, group-purchasing organizations (GPOs), and end-user hospitals and health care systems.2Business decisions made by these components of the supply chain can also contribute to drug product shortages.2 …
Poor ordering practices, drug stockpiling in advance of price increases, hoarding in response to rumors of an impending shortage, and delivery delays may also affect drug stock inventories in health care facilities.2 …

Pharmaceutical manufacturers do not take into consideration the needs of patients, or at least it is not a primary, secondary, perhaps not even a tertiary consideration in their business decisions. The harms may be found in a separate section of the same article.

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