HealthOctober 13, 2015

Drug shortages: Fixes for manufacturing and drug quality

Prescribers and pharmacists nationwide have encountered enough frustrating drug shortages recently that it has simply become a way of life for clinicians. But it shouldn’t have to be.

The keys to solving the drug shortage problem could lie in changes to the manufacturing and drug quality review processes.

Why shortages happen

In a 2011 report, the U.S. Government Accountability Office analyzed data from the Food and Drug Administration (FDA) to determine that the cause of these shortages is usually a manufacturer halting or slowing production to address quality problems, which then triggers a “supply disruption.” Other manufacturers don’t have the capacity to respond and fill the void.

The FDA has procedures in place to try and prevent shortages, including using regulatory discretion to allow the use of products that might otherwise be recalled. Examples of regulatory discretion include requiring filters and asking clinicians to double check product volume. The FDA can also ask other manufacturers to increase production or expedite reviews of new products and new manufacturing sites.

But the FDA can only do so much!

Causes and potential solutions

There are several reasons the FDA’s current measures alone can’t cure the drug shortage epidemic:

  • Drug manufacturing is a business. Suppliers need to prioritize activities with the business in mind, such as:
    • Profitability
    • Manufacturing fixes
    • Capacity – most factories are already running 24/7
    • Prioritization of new opportunities over dealing with current shortages
    • Forecasting (contracts)
  • Manufacturing sterile injections is complex
    • Quality problems may be difficult to fix
    • Investigation of problem root causes takes time
    • Changes take time
    • Capacity or a back up system is not available

Isn’t this a free market issue?

When it comes to drug shortages, the law of supply and demand doesn’t fix the problem. The primary reason is that consumers generally don’t choose the products that are administered or dispensed to them.

Competition isn’t a driving factor either: There usually are not alternative suppliers ready to step in when manufacturers can’t produce enough of their products.
In fact, there is little economic impetus for drug manufacturers to fix shortage issues because shortages generally don’t impact profits, and it’s the patients and clinicians who are adversely affected, not the suppliers.

So, what can we do to reduce shortages?

There are new ideas on the horizon that have the potential to reduce drug shortages in the U.S. But, in order to be successful, they will require changes on the part of both medication regulators and pharmaceutical manufacturers.

Goals to change quality metrics:

  • Modernize drug quality oversight
  • Institute risk-based inspection scheduling, predictive of drug shortages
  • Review objective criteria including:
    • Lot acceptance rate
    • Product quality complaint rate

New ideas for manufacturing

  • Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, advocates continuous manufacturing for:
    • Faster production, improved quality, lower prices, fewer shortages
    • Domestic plants – fully integrated from API to finished product
  • Move from batch processing to continuous manufacturing:
    • Includes product monitoring throughout instead of at the end of the process
    • Processing time in minutes to hours, instead of days to weeks

The ultimate fix for drug shortages will require transparency around manufacturing and the industry’s willingness to fix itself. But early identification of manufacturing issues and regulatory plans for quality improvement are encouraging signs. The trend of decreasing shortages is real.

Erin R. Fox, PharmD, FASHP, is Director of Drug Information at University of Utah Health Care and associate professor (adjunct) at the Department of Pharmacotherapy, University of Utah College of Pharmacy. She has led the ASHP Drug Shortage Resource Center since 2001.

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