Drug Products Not to Be Exposed to Postal Irradiation
If the United States Postal Service (USPS) implements a national system of irradiating the mail to kill pathogens, packages of prescription drugs will likely not undergo the treatment, said a postal spokesman. But if they do, FDA offers no assurance that the products will not be damaged.
Bradford W. Stone, an FDA spokesman, said agency officials have been discussing with the postal service "what we know and what we don’t know" about the effects of irradiation on ingestible and injectable products that are shipped through the mail.
"We are working with the postal service to make sure the quality of a product could be assured," he said. "We want to make sure that when something gets to a patient, it is safe and effective. We will make sure that there are methods and procedures in place for drug products that are sent through the mail."
Protection of the mail. USPS is evaluating the "best way to protect the mail" after Congress and the media received anthrax-tainted letters last fall, said postal service spokesman Gerry Kreienkamp.
Mail from postal facilities in Washington, D.C., and New Jersey, where anthrax spores were found was sent to be sanitized by machines that use large doses of electron beams to kill microorganisms. The postal service has contracts with Titan Corp. of San Diego, California, and Ion Beam Applications of Gaithersburg, Maryland, to irradiate federal mail at company-owned facilities in Ohio and New Jersey, respectively.
USPS has purchased eight of Titan’s irradiation machines for $40 million. However, Kreienkamp said, those machines have yet to be installed. The postal service may also buy 12 machines from Ion Beam, he added.
Prescription packages. Kreienkamp said that most of the "larger" mail-order pharmacies ship their products by bulk mail directly from central post offices. Those packages, he said, are from "known" mailers and would "more than likely" not be scanned or irradiated.
Mail addressed to the general public is not part of the current irradiation process, he added.
However, Kreienkamp said, some residential mail that was sorted in Washington and New Jersey soon after an anthrax-laiden letter was opened in a Senate office building was irradiated.
FDA’s Stone said it is his agency’s "understanding" that no drug products were included in that irradiated mail.
"But if somebody received a package [containing prescription drugs] that they know has been irradiated, or they have received information from the postal service to that effect, then it probably would be wise to have it checked out," Stone said.
The postal service sealed irradiated mail sent to residential customers in a plastic bag and attached a message with a warning that some irradiated items should not be used and should be discarded. The message warned, in part: "Drugs and medicines may not be effective and their safety could be affected."
Brett Martin, spokesman for the Pharmaceutical Care Management Association, a trade organization that represents mail-order pharmacies, said his group had not received a report of any mail-order drug products included in the irradiated mail.
Effects of irradiation on drug products. Irradiation has been safely used, according to FDA, to kill contaminants in some food products.
Although FDA has conducted tests on some of the active ingredients in drug products, Stone said, the agency has not widely tested the effects of irradiation on prescription drug products.
The effectiveness of injectables and other liquid-form drug products would be the pharmaceuticals most affected if those products were subjected to irradiation, according to a National Institutes of Health (NIH) biophysicist who said he did not speak on behalf of the government.
Does Irradiation Harm Mail Handlers?
At Congress's request, the General Accounting Office (GAO), held a conference after postal unions, postal equipment manufacturers, and major mailers, including mail-order pharmacies, raised concerns about the possible negative effects of irradiating the mail.
"We think it is a good and positive thing that they are aware of our concerns and are asking for suggestions from industry people," said Brett Martin, spokesman for the Pharmaceutical Care Management Association and an attendee at the December 2001 GAO conference.
But, is there a possibility of adverse effects to the people who open irradiated prescription-containing envelopes at the mail-order pharmacies?
Staffers in Senator Dianne Feinstein’s (D-CA) office have reportedly complained of minor ailments, including headache, nausea, and a tingling sensation in the fingers after opening irradiated mail.
But the United States Postal Service (USPS) countered that "mail is closely monitored before it is released to government agencies and meets federal guidelines for potential carbon monoxide and ozone emissions." In a statement released in January, USPS claimed it had not found any medical or scientific links between "irradiated mail and health-related complaints, such as itching and sneezing, cited by federal workers who have handled the specially treated mail."
Alternative technologies. As an alternative to irradiation, Kreienkamp said, the postal service has been evaluating equipment that could detect anthrax and other dangerous biological agents that might be sent through the mail.
Kreienkamp said some of that equipment involves technology that analyzes particle size and density and has been tested by the Department of Defense.
"Some of it is not exactly designed for the purposes for what we need it for, but if it is something we can integrate into our mail processing system and provides the most safety for what is most cost-effective, we will look at it," he said.
But according to the NIH biophysicist, it would be difficult to develop a system that could determine the biological nature of micrometer-sized particles residing in a tightly sealed envelope or package.
Any such system, he said, might not differentiate pet dandruff or other harmless micrometer-sized particles—which could easily get inside an envelope—from a dangerous biological agent. The only way to be sure, he said, would be to open the envelope and examine its contents.
Congress has reportedly provided $500 million to the postal service for technology to detect and remove dangerous biological agents and for expenses associated with the anthrax cleanup.
Lockheed Martin Distribution Technologies of Owego, New York, announced in January that it had developed a system that filters, tests, and analyzes micrometer-sized particles from an envelope’s outer side or those that leaked from an envelope during the mail-sorting process.
Lockheed’s system is "one of many" that USPS is evaluating, Kreienkamp said.
William R. Harris, an engineer and Lockheed’s program development manager, said his company’s letter-sorting system uses a ventilation process that cleanses the air around letters by pulling contaminants into special filters. If the system detects a pathogen, an alarm sounds and the sorting process stops, Harris said, but the filtration system remains on to prevent the spread of any contaminants.
The system does not kill bacteria, he added. If an alarm is triggered, a biohazard cleanup unit must be called in to analyze the pathogens that are trapped in the filtration system.
The company’s "vision" is to create a similar system for larger envelopes and packages, Harris said.