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Producers are confident, pharmacists concerned
The Y2K computer glitch could quickly create life-threatening problems if it impedes the flow of insulin from manufacturers to patients who need it on a daily basis.
The two insulin manufacturers in the United States say not to worry. Meanwhile, the American Pharmaceutical Association Foundation and industrial consultants warn a bit of concern is appropriate, advising diabetics to begin slowly to accumulate an extra 30-day supply of essential prescriptions, just to be safe.
They all agree on one thing: If health care providers, pharmacies, and patients worry too much and begin to accumulate larger stockpiles than 30 days, they could create a "self-fulfilling prophecy," resulting in a shortage of insulin.
The bottom line is that the Food and Drug Administration (FDA) is calling on pharmaceutical manufacturers to determine the vulnerability of the supply of prescription drugs in the face of the challenges presented — if computer programs won’t recognize the rollover to the year 2000.
Known by the shorthand Y2K, the problem arises from older computer systems programmed to recognized the year by two digits, as in "99" for 1999, which will refuse to function in 2000 because it will be unable to distinguish it from 1900. Business and industry are urgently implementing remedies for the problem, but some won’t finish before 2000, and others are dependent on vendors and those who could fail to be compliant in time.
Eli Lilly and Co. in Indianapolis, the country’s largest insulin producer, expects to be fully Y2K-compliant by mid-1999 and Novo Nordisk Pharmaceuticals in New York City says its compliance will be complete by the third quarter of this year.
But spokeswomen for both companies caution their ability to produce insulin will be based on the assumption that computer-dependent municipal electric and water supplies remain uninterrupted.
"It’s obviously a complicated issue," says Susan Jackson, spokeswoman for Novo Nordisk. "Our manufacturing process is very dependent on the delivery of electricity and water. If there was an interruption, all our manufacturing processes would stop and fermentation tanks would have to be emptied."
Novo’s plant in Clayton, NC, will continue its ordinary insulin production, which keeps ahead by three to six months, not including "any stores already sold but not in patients’ hands yet," Jackson says.
Lilly’s spokeswoman, Doyia Chadwick, says at the beginning of the fourth quarter (Oct. 1), her company will have a 40- to 80-day supply of insulin, based on normal buying patterns. She says Lilly always has a minimum of 45 days’ supply of insulin on hand. She confirms that Lilly’s Indianapolis manufacturing facility could be vulnerable to any power or water system failures from its surrounding community. "We’re doing everything in our means to be ready."
Both firms say they are concerned that fearful suppliers and patients may create shortages by stockpiling supplies of insulin. "We’re not recommending stockpiling in any way," Jackson says. "We believe patients will have the product they need."
In a story published in the Washington Post on March 22, the American Red Cross recommended patients have several days to a week’s supply of prescription medications on hand before the end of 1999.
Ben Bluml, RPh, the American Pharmaceutical Association Foundation’s senior director for research in Washington, DC, takes a more cautious stance by recommending that consumers get a month ahead on their medications. "People should start stocking up in late summer or early fall," he says. "If people all start to get prepared ahead of time, we’ll all start to feel comfortable without creating an excessive burden on the supply chain."
Bluml says health care professionals should be sure the message is delivered in a way that "ensures responsible behavior."
Bluml adds health care providers recommending their patients get an extra month’s supply of insulin should be aware that health plans often restrict prescription refills to one every 30 days, so patients may have to fight for reimbursement or finance the extra medications themselves.
The ECRI (Emergency Care Research Institute), a nonprofit global think tank in Plymouth Meeting, PA, is conducting its own research on Y2K issues, largely those involving the functioning of biomedical devices, and is offering telephone seminars on preparedness for health care professionals.
[Contact Susan Jackson at (212) 867-0123, Doyia Chadwick at (317) 277-6990, and Ben Bluml at (800) 237-2742.]