Pharmaceuticals--one person's research

greenspun.com : LUSENET : TimeBomb 2000 (Y2000) Preparation Forum : One Thread

The following was written six months ago. Little has changed.

In his testimony before the Senate Y2K Committee in October last year, Ronald J. Streck, President and CEO of the National Wholesale Druggists' Association (NWDA), voiced his concern about patients and providers stockpiling pharmaceuticals. While he freely admitted NWDA, which services 130,000 pharmacy outlets, was greatly concerned and disturbed by Congressional and GAO reports that many federal agencies will not be ready for Y2K, Streck recommended against stockpiling.

In addition to governmental worries that federal agencies may not be prepared by the time Y2K rolls around, other drug industry representatives have cited concerns about difficulties with overseas suppliers of pharmaceuticals and pharmaceutical ingredients. Even so, the unanimous recommendation is against stockpiling medications, either by patients or suppliers.

At a March 8, 1999 Department of Veterans Affairs Pharmacy Acquisition and Distributing meeting on the issue of Y2K pharmaceutical stockpiling, Denny Steele of AmeriSource, (DVA Prime Vendor) said he believes there are approximately eight to nine months' supply of product in the supply chain. (Manufacturers most likely have six months, distributors about one month, and hospitals, pharmacies, etc., anywhere from ten days to one month.) Steele believes there is enough in the supply chain to handle Y2K setbacks but says "consumer hoarding" will hurt the process. AmeriSource recommends consumers keep no more than an extra one- to two-week supply of medication on hand.

Other industry representatives added their agreement, except that Ed Harvey of the Association of Military Surgeons of the US, disagreed with the amount in the supply chain, saying there is closer to three rather than six months supply. But Harvey added, "The main issue is to assure the public that there is no need to hoard." [Note: AMSUS is "supported" by sustaining members, among whom are drug firms.]

John Koskinen, Chair of the President's Council on Year 2000 Conversion, said at the VA meeting: "the industry needs to give a clear, factual understanding that will assure without providing a false sense of security," a message which seems self-contradictory. He explained the White House believes the best way to handle the issue is by "industry self-evaluation."

George Patterson, of the VA National Acquisition Center, warned there is not enough money for stockpiling throughout the supply chain. Patterson opines that pharmaceutical manufacturers should develop measures to prevent unnecessary stockpiling.

Although the consensus seems to be that patients and suppliers not stockpile, manufacturer Eli Lilly intends to boost its supply of insulin stock from 30 to 45 days, according to Mark Fogelsong, General Manager of US Manufacturing. Lilly has anywhere from 40 to 90 days supply of other products. Harvey said some in the industry have already increased stocks by 20%. Citing Generic Pharmaceutical Association figures, Harvey pointed out that "90 percent of the substances needed to manufacture generic pharmaceuticals originate overseas." Transportation, particularly in regard to China and Eastern Europe is also a concern.

Concerns about the very high percentage of drug ingredients supplied by other countries, as well as their potential transportation problems, also were voiced by participants in surveys conducted last year by various pharmaceutical interests. Paradoxically, none of those surveyed expected supply disruptions. It should be noted that survey participation was less than 50 percent in nearly all cases. In his October, 1998, testimony, Streck noted that many patients are prohibited under their insurance plans from obtaining more than a 30-day supply of their prescription, Streck concluded: "Clearly, stockpiling or hoarding prescription drugs is not the answer." A VA survey confirmed Streck's statement, showing that 31 state Medicaid programs have set 30- to 34-day limits on all prescriptions. And several pharmacists contacted for this article said that most insurance companies limit prescription dispensing to a 30-day supply.

The majority of Strecks' testimony centered around the intricate computer network integrating suppliers and customers and providing daily (sometimes twice-daily) deliveries to customers. Any stockpiling by providers or patients would disrupt the finely-tuned system.

Besides being to the advantage of the distributors that supply and demand not deviate from their programmed courses, Streck said, "Not only are there cost and efficiency concerns, but more importantly, there are safety and efficacy issues revolving around the integrity of the product due to expiration dates and sensitive storage requirements."

However, a Kerr Drugs pharmacist, contacted for information on shelf-life, said many prescription drugs are viable for three to four years, depending on the expiration date on the original container. The pharmacist recommended asking for the sell-by date at the time of prescription refill. While there are storage problems for opened insulin vials, for example, three drugs in particular (for diabetes, high blood pressure and migraine), if dispensed from a "fresh" box, will last from three to four years. When asked if there was any evidence of stockpiling, the pharmacist replied, "Not yet!" Was stockpiling expected, then? "Well, we understand there may be problems with stockpiling, but we haven't seen any--yet," came the reply.

To cement his product freshness argument, Streck commented that "all wholesalers provide daily deliveries with a growing number of wholesalers providing twice-a-day deliveries to their customers." In addition, NWDA provides member services, such as marketing and advertising support, product sourcing programs and special handling services. More pertinent, Streck added, are "the computer and information programs that include third party claims processing and receivables services, inventory management, pharmacy computer systems for dispensing and care, and point-of-sale systems."

In his concluding remarks, Streck emphasized that the drug industry was doing its part but that seemed not to be the case for government agencies. Contingency plans, he said, would be based on what government services will be available.

From the testimony, it appears that rather than recommend prudent stockpiling by patients, the drug industry wants government to "fix" its agencies. If disruption occurs and patients are without their required medications, then the drug industry can point its finger at the government--or, as a back-up, overseas suppliers.

It is difficult to understand the drug industry's stance on stockpiling. Vendor Managed Inventory systems, in heavy use by other industries, are also making their presence felt throughout the drug industry. (The VA uses a VMI system.) In the April 1998 issue of Repertoire, an article on VMI describes how Schein Pharmaceuticals began its policy of offering VMI to customers in 1995. "The basis for this effort was to generate demand forecast based on usage rather than historical ordering data and a customized replenishment system for each customer. . . Schein learned what specific needs they had from service levels, to lead times, to target inventory turns. Customization also included details as to preferred delivery days and inventory levels. The basis for this effort was to generate demand forecast based on usage rather than historical ordering data and a customized replenishment system for each customer."

As a result, the article says, "By going to this system, Schein got a better idea of customer demand and thus a more accurate forecasting picture. . . By maintaining and controlling the customer's inventory Schein was able to better manage more customers." A VMI program can be up and running in as little as from 30-90 days..

The April 1999 issue of State Legislatures Magazine repeated concerns over insurance industry limits on prescriptions, and noted that with over 70,000 licensed pharmacies in the United States and a complex network of manufacturers and distributors, there could be serious problems next January 1.

On January 26 this year, the Wall Street Journal interviewed another drug industry representative who spoke against stockpiling. Charles Popper of Merck & Co. noted that FDA regulations and factory capacity limits prevent speed-ups in drug production. If patients try to stockpile certain drugs at home it could result in empty shelves and/or higher prices, he said.

In an interview for this article,Todd Andrews, spokesperson for the 41,000 store CVS Pharmacies chain, with the largest number of outlets in the US, also says there is no need for stockpiling and (as of mid-May 1999) had not seen any evidence of stockpiling. CVS, he said, is currently working with overseas suppliers to ensure uninterrupted deliveries of ingredients and pharmaceuticals. Andrews recognizes patient concerns about availability of pharmaceuticals, but says, "They should consider their needs in consultation with physicians and insurers." He noted that 85% of pharmaceuticals are covered by insurance or managed care.

Also at the VA meeting, Cathy Hotka of the National Retail Federation said neither retail stores nor manufacturers are increasing stock because of Y2K. She gave as an example batteries. Batteries are not unrelated to pharmaceutical concerns because of their use in home medical devices (such as glucometers, thermometers, and blood pressure monitors).

In the VA survey of drug suppliers and manufacturers, 100% of respondents said they were Y2K compliant. However, only 42 percent of those contacted responded to the survey. It might not be unreasonable to conclude that of the 58 percent who did not respond to the survey, the majority are not Y2K-compliant. Georgia was the first state to introduce legislation requiring expanded requirements for health insurance coverage of crucial medications. The measure failed. Other similar measures are passing through pipelines now.

On the other side of the issue are a combination of consumers, the government and independent pharmacists--and at least one hospital.

The Argus Observer (Idaho), reported that Weiser Memorial Hospital Administrator Susan McGough,, at the final 1998 meeting, directed staff to have on hand a three-month inventory of supplies by October 31 , 1999, to meet the hospitals' maintenance and operations needs. The plan, McGowan explained, is a hedge against predicted stockpiling, hoarding and shortages, which are expected to result.

Independent pharmacist, Charlie Miller of the Medicine Shoppe, Yucaipa,CA, takes what he describes as a realistic view of drug supplies. He says that although manufacturers should be in good shape, "the trouble, as always, is how many computers does it take to pull a leaf from a bush in, say, Kenya and have it result in a bottle of tablets on my shelf? Or, how much will it cost in money and delay if a chemical plant near, say, Budapest goes down? My biggest worry is that over 80% of the raw materials are imported."

Miller says, "I would recommend two to three months' supply." He says on big-ticket pharmaceuticals he'd be out of stock in three days because, "Wholesalers deliver daily and cost pretty much dictates inventory." His wholesalers, Miller says, shoot for a 30-day inventory, but "rumors about a particular product can drain them in a day."

The Government Services Administration web site suggests that patients ask pharmacists if they're aware of the Y2K problem and what they've done to prepare. It recommends asking: "Do you think I should get an extra supply of my prescription during the Y2K transition?" GSA also recommends patients discuss the question with their family doctor.

From available information it appears that the prescription stockpiling dilemma is translating to drug industry convenience vs. patient health. If the industry had been a little more forthcoming at the Senate Y2K Committee meeting in October last year and if, as a result, insurance prescription limitations had been relaxed, patients could have set aside extra medication without causing serious shortages and disruption to the complicated network of computer services provided by suppliers.

Because there has been no encouragement to prudently stockpile, it is conceivable that we may see a scenario beginning with information showing that various government health bureaucracies will not be ready in time. There may also be information from the drug industry with pessimistic news about overseas suppliers. The result inevitably will be a run on supplies and shortages and possible price hikes,as patients and their doctors resort to various subterfuges to obtain extra medication or pay full price without claiming on insurance,. Pharmacy shelves will quickly empty (probably within three days as Charlie Miller indicated), and some panic will ensue. The longer information is withheld, the more likely shortages and price hikes will occur, all affecting the weakest members of society--the ailing and elderly.

-- Name (withheld@writer's.request), November 04, 1999


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