Generics — brand-name drugs without the brand name — can save consumers big money. They’re pharmaceuticals that, because they’re no longer covered by patents, can be manufactured by any drugmaking firm and not just the ones that invented them. A generic drug’s active ingredients are the same as those in the name-brand version, as are their “dosage form, safety, strength, route of administration, quality, performance characteristics and intended use,” according to Food and Drug Administration regulations.
Generics have been a huge success. A generation after they entered the U.S. market, they represent nearly 70 percent of all filled prescriptions. They have saved the health-care system billions of dollars. The Congressional Budget Office estimated a savings in 2007 of $33 billion just for Medicare Part D and its beneficiaries. Add in everyone else who buys pharmaceuticals, and the savings are even greater. A report released last summer by IMS Health, a market research firm, concluded that generic drug use “saved the American health care system more than $824 billion over the past decade, and $139.6 billion in 2009 alone.”
It has worked so well in part because of the role played by pharmacists. In many states, the law mandates that pharmacists deliver a generic version whenever available, even when the doctor has prescribed a brand name.
An exception to the rule
But there’s an exception to this mandate, a provision that some might see as a loophole. It’s called “Dispense as Written.” In most states, those words on a prescription — usually in the form of a check mark beside a box with the letters DAW — overrides the mandate.
In the American Journal of Medicine article, researcher doctors noted that out of a sample of 5.6 million prescriptions written for more than 2 million patients, nearly 5 percent “were designated as dispense as written by physicians and patients.” This, perhaps, is not a very large portion, but the money that might have been saved is substantial. Noted the authors: “By substituting the generic alternative for each . . . brand that was filled . . . the patient population in this sample could have reduced their charges by more than $1.7 million and the health plans could have experienced more than a $10.6 million reduction in costs in the 1-month study period.”
How big is the price difference between generics and brand-name drugs? Quite big. Take, for example, the popular anti-cholesterol drug Zocor. According to Drugs.com, a 90-pill bottle costs $459.98. But 90 pills of simvastatin, the generic version of Zocor, are only $83.97. Buy simvastatin at Wal-mart or Target, which offer special pricing programs, and the cost comes down to just $12.
So why do some doctors prescribe a brand-name drug when a generic is available? Researchers report that many doctors still don’t trust generics. In one recent survey, published in the Annals of Pharmacotherapy, nearly 50 percent of the doctors participating acknowledged holding some negative perceptions about the quality of generic medications. According to William Shrank, an assistant professor of medicine at Harvard Medical School and the study’s lead investigator, those most suspicious of generics were older physicians — the same group (along with specialists) more likely to write DAW prescriptions.
It is also habit. Brand names are the names doctors most easily remember. Drug samples left in physicians’ offices — seemingly a free gift for doctors to dispense and patients to receive — make them more memorable. Often, sales representatives will treat a physician and his staff to lunch, and leave behind an array of pens, coffee mugs and USB memory sticks branded with the name of their drugs.
Advertising also has an effect, both on doctors and on patients, who ask for specific drugs they’ve heard mentioned on TV. Cumulatively, these tactics often succeed at what they are designed to do: sell the brand, instill trust in the name and make it the habitual choice.
What’s the difference?
Habits can be hard to break, but doctors who mistrust generics may want to rethink their assumptions. Study after study has shown that brand-name versions of drugs don’t offer patients any sort of medical edge.
Take the category of drugs designed to treat cardiovascular disease. A 2008 review in the Journal of the American Medical Association looked at nearly 25 years of research on how several commonly used brand-name blood-pressure and heart drugs matched up against their generic versions. The study’s authors concluded that “evidence does not support the notion that brand-name drugs used in cardiovascular disease” are any better than the cheaper alternatives.
A study this year in the journal Pharmacotherapy looked at Coumadin and warfarin. These are the brand-name and generic versions, respectively, of a blood thinner used by millions of Americans to treat clots and certain types of heart disease. Following a comprehensive review, the authors concluded that “generic warfarin products may be as safe and effective as brand-name products” and that patients “may be safely treated with these products.”
The same goes for anti-seizure medications, although in this category generics have met some especially stiff resistance. Indeed, the American Academy of Neurology is on the record opposing “generic substitution of anticonvulsant drugs . . . without the attending physician’s approval.” Yet last fall in the journal Drugs, a systematic review of 16 studies found that generics in at least three cases seemed to be the therapeutic equal of their brand-name twins.
An exception to this pattern may be levothyroxine, which is used to treat thyroid disease and is available as a generic and under such brand names as Synthroid.
The Food and Drug Administration has acknowledged some issues with the generic’s potency, based on reports that it may not exactly match the brand name in the amount of the active ingredient it contains or in the way it is absorbed and distributed in the body. The FDA is investigating these reports while narrowing the “potency specifications” the generic form must achieve, steps that are likely to ensure a generic product that is a closer match to the brand name.
That one instance aside, generics really can be thought of as interchangeable with brand-name drugs and can be used, says Lola Fashina, a pharmacist at Providence Hospital in the District, “with the full expectation” that they provide equivalent benefits.
Overriding the override
While some states require pharmacists to offer generic equivalents unless a doctor specifies “Dispense as Written,” a few jurisdictions are moving to limit the DAW override. In 2009, for example, Massachusetts began requiring doctors to explain in writing why they were insisting — via a DAW — on a brand-name medication as opposed to a generic. The results were dramatic. According to the Generic Pharmaceutical Association, the state’s Medicaid spending for drugs fell by $150 million within a year. (Maryland, Virginia and the District do not require pharmacists to substitute generics when available, according to a 2010 report by the National Association of Boards of Pharmacy.)
In that case, the link between generic use and saving money seems rather direct. But the cost benefits may run deeper, because several studies also show that patients taking generics are more likely to take them properly. According to Shrank, patients paying more for pharmaceuticals are “less likely to take their medication” as prescribed. Financially burdened by the cost of their drugs, they are more likely to skip doses so that their drug lasts longer, to cut the pill in half or, when they see the price rung up at the checkout counter, to leave the pharmacy with no medication at all. “And that,” he says, “is bad for clinical outcomes.” And expensive, too, when you consider the added burden to the system of people unwell because they are priced out of the medications they require.
Mishori is a family physician and faculty member in the Department of Family Medicine at Georgetown University School of Medicine.