A tale of insulin warnings
Insulin manufacturers say patients shouldn’t be switched from one type of insulin to another without proper medical supervision. Marketplace politics, however, have threatened to diminish the warnings, a pharmacist claims.
R. Keith Campbell, RPh, FAPhA, CDE, professor and associate dean of pharmacy practice at Washington State University in Pullman, watched in dismay when he says at least one drug manufacturer encouraged pharmacists to switch patients to its brand of insulin. A diabetic himself, he repeatedly has informed colleagues of the possible legal and clinical consequences of making such a switch.
Campbell first wrote an article when he heard that sales representatives from the drug manufacturer were telling pharmacists that it was "ok" to switch patients from Eli Lilly insulin to its brand. Many pharmacists then turned to diabetic specialists for their opinion. "The answer was, It probably won’t be too big of a deal for most patients. But if you change someone and you don’t tell the patient and the physician and something goes wrong with the patient, you would legally be dangling in the wind.’"
Switching is in a big gray area of legality and clinical impact, he explains. "There are different levels of protamine and different quality of protamine from one brand to another. There are different preservatives."
Campbell’s article looked at the issue of switching insulins and talked about the black box warnings. "I said that if you are going to do this, you have to talk to the patient about the switch." He says the manufacturer then offered legal help for anyone who switched a patient and got sued — as long as the pharmacist followed the guidelines in the package insert. Campbell wrote another article advising that the offer seemed deceptive. "If you read the package insert of the product, it says Warning, do not switch.’"
Now some retail pharmacy chains are being offered their own brand of insulin, a change that has upset some chain pharmacy managers, Campbell says. For example, Nova Nordisk provides Wal-Mart with ReliOn insulin. "If you go to a Wal-Mart pharmacy, they would switch you to their brand," Campbell says. "That would save you a few dollars." The black box warning, however, remains.
"The stupidity of the situation is that we have a shortage of pharmacists. They are overburdened with counting and pouring and are having a hard time doing disease state management and counseling patients about following the standards of care," Campbell says. "If they are going to do the switch right, they have to take the time to call the doctor." Contacting the physician costs the chain the time of the pharmacist. That reduces the profit margin of an already highly competitive product.
Lilly wrote a strongly worded statement in response to Wal-Mart pharmacists possibly switching Lilly insulin patients to ReliOn. "All insulin brands are NOT the same. We at Lilly firmly believe that a pharmacy should not switch your brand of insulin without your physician’s involvement," the statement says. "The type and brand of insulin you use has been carefully selected by your personal physician, based on your diabetes history and need for blood sugar control. Thus, your physician — not your pharmacist — is the medical professional who should be primarily responsible for any changes in your insulin therapy. In fact, a statement mandated by the Food and Drug Administration on every insulin product cautions that changing type or manufacturer of insulin should be done only under medical supervision."
Physicians also are upset that they may prescribe a brand of insulin, only to have the patient switched without their knowledge. If something happens to the patient because of the switch, the physicians wouldn’t know the reason unless they saw the patient’s bottle, Campbell says.
There also is concern of ending up with 20 brands of insulin that can confuse everyone. Wal-Mart has to carry more inventory for patients who refuse to switch brands of insulin, Campbell adds. "If I go to Wal-Mart and get insulin, I am going to request my own brand. I’m not willing to change. That means they have to carry twice as many bottles of insulin."
A cost-impact study would show Wal-Mart that switching patients to its own brand of insulin costs them money, he says. "One HMO thought it would save about $30,000 a year by switching. They then tracked all the expenses and it cost them $67,000 to educate all the health care providers and all the pharmacists and the patients about the switch."
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