Exterminating Y2K bugs: Contingency plan a must
Surveys find optimism, concern of stockpiling
A full 94% of 282 pharmacy managers surveyed by the American Society of Health-System Pharmacists (ASHP) say their computer systems have been "tested or certified" as Y2K compliant. The survey also found that 70% of the pharmacy managers feel confident that drug suppliers have compliant systems, meaning they believe the flow of order and delivery would not be disrupted by a system’s misreading of the calendar year.
The main concern from the survey was a relatively low 48% positive response rate as to whether hospital pharmacies have established contingency plans in case a drug shortage occurs. But much of that fear has been calmed by manufacturers and distributors themselves in a series of meetings with national pharmacy organizations.
Still, about half of the 282 pharmacy managers surveyed said they are planning to increase drug and product inventories in areas such as IV sets as 1999 nears an end.
That response has furthered the issue of where the fine line is between having an adequate stock on hand and outright stockpiling or hoarding, which the health care industry as a whole is discouraging. But in a related survey done by drug supplier Novation in Irving, TX, which includes the VHA chain and University Health System Consortium among its clients, about one-fourth of the supply managers surveyed said they have been asked by senior management to stockpile supplies.
"If people believe there will be a disruption of the drug supply, then there will be a disruption," says Gary Loeb of HBOC/McKesson Corp., a drug wholesaler in San Francisco. "Perception is going to drive the events leading up to the year 2000."
Public perception has led to pending legislation in California and New Jersey, where bills have been filed that would require pharmacists to refill 60-day prescriptions if patients request them and the pharmacists believe patient harm or medication disruption could occur. The bills are contingency legislation that would be in effect from Dec. 1, 1999, to Feb. 1, 2000, if passed.
Representatives from the Pharmaceutical Research and Manufacturers of America (PhRMA) and the National Wholesale Druggists Association met this spring with the Joint Commis sion of Pharmacy Practitioners (JCCP) to report on computer system readiness and drug supply plans. Suppliers normally decrease their inventory at the end of every year for accounting purposes by estimating monthly needs and trying to match them as closely as possible. That practice has led to year-end shortages in the past. The JCCP urged the two organizations not to try to pinpoint supply and demand this year because it could be thwarted by hoarding or could cause shortage misperceptions leading to stockpiling.
At the meeting, PhRMA shared survey results of its members, which are available on-line at www.phrma.org/news/y2k.html. PhRMA’s representatives say computer system compliance is on schedule, but they fear that "hoarding and stockpiling by patients could create a greater threat to the supply of medicines than any computer glitch."
The organizations also are cautioning that they are unsure how to gauge the readiness of overseas suppliers, which account for the majority of generic drugs used in the United States.
Meanwhile, a Department of Health and Human Services audit survey by its Office of the Inspector General states that billing and medical record systems should be fully compliant by year’s end. It was conducted between December 1998 and February 1999. The audit covered hospitals, nursing homes, medical equipment suppliers, and physicians, among other areas. The report is available at www.dhhs.gov/progorg/oei.
The American Hospital Association (AHA) says its survey of 583 hospitals found that 85% expected to have fully capable systems by year’s end or have systems not expected to be affected. The full report, which is broken down by hospital system categories, is available at www.aha.org/y2k/default.html.
As with drug suppliers, pharmacy organizations also have been involved in the White House Pharmaceutical Roundtable, which is part of the President’s Council on Year 2000 Conversion. The roundtable reported in March that 93% of "mission-critical" federal government systems were compliant at that time, specifying that Medicare claims systems should not be hindered after the new year.
The council has used information from groups like AHA and the Department of Health and Human Services to compile its information. The council’s summer 1999 quarterly report on Y2K compliance can be found on-line at www.y2k. gov/new/FINAL3.htm.
Among the pharmacy organizations involved in the roundtable is the Academy of Managed Care Pharmacy (AMCP), which is predicting computer problems extending even beyond Jan. 1, 2000. In a statement released after meetings with the pharmaceutical roundtable, AMCP notes, "Pharmacy relies more on computers than any other facet of healthcare. . . . Most embedded chip Y2K problems will not be easily tested or resolved before Jan. 1, 2000. Therefore, pharmacies should not relax just because they are operating normally on Jan. 1, 2000. Every pharmacist should be on the alert of any potential miscalculation when the output of the computer is not consistent with the current date through 2000 and 2001."
Sounding an even more contradictory tone on computer compliance, the Center for Y2K and Society in Washington, DC, which also had a representative on the White House Pharmaceutical Roundtable, cautions that too many people assume that systems will not fail and advocates certain levels of patient drug stockpiling.
"We’re recommending that the government, the pharmaceutical industry, insurers, health care providers, distributors, and patients share the responsibility for ensuring that everyone who is dependent on medications for survival have a 30-day supply by January 1," says Margaret Anderson, Center for Y2K and Society policy director and roundtable member. "I am encouraged to see the industry working cooperatively to address Y2K issues, but it is both naive and dangerous to recommend that caregivers and consumers conduct business as usual in their purchases of critical medications."
Anderson says she is basing the center’s stance in part on the simple interconnectedness of the drug delivery system. "The pharmaceutical industry does not have control over the purchasing decisions of health care institutions and patients, or over the nation’s distribution and transportation systems and telecommunications," she says.
Specifically, Anderson says patient hoarding, if not institutional hoarding, will happen and will affect the drug supply. She cites a recent recommendation by Consumer Reports that patients should have a 30- to 60-day supply on hand at the end of the year. That’s advice she says patients will take. She also believes that health care institutions will stockpile, a strategy alluded to in the Novation survey cited above. With statements coming from organizations like PhRMA, it’s unclear how dependent overseas suppliers will be.
Legal issues also a concern
While the course of liability claims and court interpretations relating to millennial system failures that may affect patient care is largely guesswork, pharmacy managers are wise to protect their departments as part of Y2K preparation, say pharmacy organizations.
The consensus among them is that two main areas of liability protection should be pursued: the creation of a contingency plan in case of system failures and detailed documentation of all aspects of Y2K preparation.
After that, pharmacy managers should review vendor contracts to see where the initiative lies for system upgrades or replacement, and they should review insurance policies to determine whether liability claims would be covered. But, cautions Fern Zappala, general counsel for ASHP, "Insur ance coverage may not be available with these types of claims because the insurance company may argue that the Y2K problem was foreseeable."
And that, she says, heightens the need for contingency and documentation. "What you are doing to minimize or avoid malfunctions in order to protect patients from injury may be very helpful in limiting future liability claims," she says.
Pharmacy managers should inventory all systems that use microprocessors to calculate dates, which could include dispensing systems, labeling devices, electronic medical records, drug interaction or adverse reaction software, third-party claims, order entry systems, IV pumps, refill records, and patient profiles, for example.
Zappalo also says managers should be aware of the Year 2000 Information and Readiness Disclosure Act passed by Congress last year. The act grants limited liability protection for Y2K statements and disclosures through July 14, 2001, to allow competing vendors, manufacturers or health care institutions to compare notes on Y2K problems or solutions.
You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content