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Jill Wechsler is Pharm Exec's Washington Corespondent
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers, writes Jill Wechsler.
Drug shortages are declining, but they’re still a serious concern for regulatory authorities, policy makers and biopharma manufacturers. FDA officials recently reported that there were less than 40 new drug shortages last year, down from more than 250 in 2011. The agency noted that it was able to prevent nearly 80 short supply situations last year, largely due to enhanced communication with manufacturers that helped regulators identify alternative sources and assist firms in addressing supply and production problems.
Limited supplies of critical medical products, however, continue to plague the U.S. health care system and makes headlines when patients can’t access shortages involve critical, lifesaving medicines, particularly widely used sterile injectibles. The Canadian government recently unveiled new requirements for manufacturers to announce shortage situations, noting that its voluntary disclosure system was not sufficient. GlaxoSmithKline’s recent recall and resulting shortage in Nicorette lozenges drew cries of outrage from former smokers.
The ongoing drug shortage crisis has generated numerous advisories for how biopharma manufacturers should address the drug quality and production problems that appear to underlie most serious supply situations. The Pew Charitable Trusts recently published a report on an August 2014 Drug Shortages Summit that urges manufacturers to improve supply sourcing, and also calls on health plans and hospitals to pay more for quality product.
The Pew report further offers strategies for biopharma manufacturers to improve production systems and tighten contracts with suppliers. More specific is a new technical report from the Parenteral Drug Association (PDA), which outlines a risk-based approach for companies to assess the impact on patients of a disruption in drug supplies and the factors making it likely that such a situation will arise [http://www.pda.org/docs/default-source/website-document-library/scientific-and-regulatory-affairs/drug-shortage/tr68-drug-shortages.pdf?sfvrsn=2]. If a drug shortage would limit access to a treatment for a life threatening condition and if no alternative therapies are available, then the situation would be ranked as high-risk and warrant more company investment in safeguards and preventive strategies.
The report’s “ risk triage model” further considers factors likely to lead to a shortage, such as the strength of established system controls, ingredient sourcing (multiple or single supplier), inventory levels, and process capability. Companies should develop drug shortage prevention and response plans for every product, including the need to seek expedited approval of postmarketing changes that may help avoid shortages over a product’s life cycle.
For certain high-risk situations, a manufacturer may look to add manufacturing sites or lines, engage additional raw material suppliers, or install new equipment and technology. Manufacturers should identify appropriate inventory levels based on state of controls and the need for multi-sourcing strategies. And plans should address methods for communicating with health authorities, distribution channels, and users about shortage risks.
Shortage prevention related to high-risk situations may warrant upgrades in aging production facilities and investment in new analytical technologies. The advisors note the value of adopting single-use process technology to replace obsolete equipment, but also recognize that less dramatic upgrades may improve operations, reduce costs, and help avoid process or facility failures. “Enhanced redundancy” may be achieved through approval of an additional manufacturing site or line, as well as added raw material and API suppliers, container/closure components, and dosage forms.
This technical report is the product of more than two years of deliberations by PDA members through a series of workshops , proposals and comments. It aims to assist senior management at biopharma companies ensure continued supply of approved medicines and development of a “robust quality culture” to support quality improvement, ensure compliance with manufacturing standards, and foresee and avoid shortage situations.