Antimicrobial Shortages
The events of September 11, 2001 have focused unprecedented attention on the availability of antimicrobial agents and vaccines. The potential need for large amounts of specific antimicrobials was highlighted by the subsequent use of anthrax as an instrument of terror and the depletion of stocks of canadian ciprofloxacin HCI (Cipro drug, Bayer), the preferred agent for prophylaxis in patients exposed to anthrax. The increased demand for generic ciprofloxacin led to geographic shortages of this agent and a threat to patient care in general. Fortunately, that episode appears to have been limited in scope and duration. The effects, however, emphasize the vulnerabilities of the health care system to the finite supplies of specific antimicrobials. A more sustained absence of antimicrobials has been shown to adversely affect health care on a far wider scale.
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The unavailability of drug products has become an all-too-frequent occurrence over the past decade. Shortages can be temporary and affect only a segment of the industry or geographic area, or they can be global in scope and result in the absence of certain agents in the marketplace. Difficulty anywhere along the supply chain, from raw material to inventory management practices of end-users, can result in a disruption of product availability. Temporary disruptions in availability or local supplies should be distinguished from true shortages; because these temporary disruptions usually result from unique circumstances, they will not be covered extensively in this review.
According to the Food and Drug Administration (FDA), a shortage is defined when:
- The total supply of all versions of the approved product available at the market level will not meet the current demand.
- A registered alternative manufacturer will not meet the current and/or projected demands for the potentially medically necessary use(s) at the user level.
The FDA works actively with pharmaceutical manufacturers to identify and correct circumstances that can lead to shortages. Despite these precautions, shortages still occur.
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Penicillin G was the first antibiotic affected by a shortage, beginning late in the summer of 1999. A recall of products by Marsam Pharmaceuticals, a subsidiary of Schein Pharmaceuticals, was linked to regulatory concerns, expressed by the FDA, concerning the production facility in which penicillin G was manufactured. As a result of those concerns, the availability of meropenem (Meronem or Merrem, AstraZeneca) and cefazolin (Ancef or Kefzol, Braun Medical Inc), both of which were also produced at that facility, was also decreased. The shortage of penicillin G was further aggravated by the absence of alternative producers of this generic antibiotic.
As a result of these shortages, the Infectious Diseases Society of America (IDSA) Emerging Infections Network (EIN), in November 1999, organized a survey of its members across the country concerning the availability of antimicrobial agents. This was followed by a second survey in August 2000, the results of which have recently been published. In that report, in which 67% of the members responded, 77% reported a lack of penicillin G. In addition, respondents reported shortages of gentamicin (50%), meropenem (38%), ticarcillin with or without generic clavulanate (24%), cefazolin (20%), and nafcillin/oxacillin (13%). Although respondents to the second survey indicated improvement in the availability of most agents, penicillin G remained in short supply. During 2001, piperacillin-tazobactam (Zosyn, Wyeth) experienced similar shortages. Antibiotics have not been the only agents affected. Delays in production and distribution resulted in decreased availability of influenza vaccine in 2000 and 2001, and tetanus vaccine in 2001.
In the case of tetanus vaccine, the decision of one manufacturer, Wyeth-Ayerst, to discontinue production of all products containing tetanus toxoid (Td, for adults and children seven years of age or older; diphtheria and tetanus toxoids adsorbed, DT, for children six years of age or younger; and diphtheria and tetanus toxoids with acellular pertussis vaccine, DTaP.
Antimicrobial Shortages
Children six years of age or younger) led to a critical shortfall in vaccine availability. The other manufacturers of the tetanus vaccine components, Aventis Pasteur and GlaxoSmithKline, have increased the availability of their products to fill the void. Naturally, this process requires time for production facilities, raw materials, FDA certification, and distribution systems to be brought on-line. In the interim, a vaccine was made available on an allocation basis, and guidelines for the use of tetanus vaccine had to be revised to ensure an adequate supply of the vaccine without compromising public health.