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With stipulations, doctors acknowledge important place for generic drugs in eye care
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In 2012, community pharmacists dispensed generic drugs 77% of the time, according to the National Community Pharmacists Association’s yearly report.
Most of the doctors that spoke with Primary Care Optometry News reported that they see similar rates in their own practices.
“The majority of my patients in my clinic use generic drugs,” Bruce E. Onofrey, OD, RPh, FAAO, said in an interview with PCON. “We have an underserved population with significant limitations of financial resources.”
“A high percentage of my patients use generic drugs,” Andrew S. Gurwood, OD, FAAO, agreed. “That’s what their plan covers and it’s easy, usually just as effective, and filling out paperwork and making phone calls to ensure brand formulations takes time and manpower that most practices are not willing to spend.”
Walter L. Choate Jr., OD, FAAO, told PCON that the majority of his patients use brand-name drugs.
Mark Street, OD, explains to a patient the advantages and potential disadvantages of generic medications.
Image: Gurwood A
“About 15% to 20% of my patients use generic drugs,” he said. “This is generally in cases where insurance coverage necessitates it or due to patient affordability issues.”
The approval process
The U.S. Food and Drug Administration has closely monitored generic drugs since the passing of the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Waxman-Hatch Act. The legislation allows for the availability of generic drugs to be expedited.
According to the FDA’s website, generic drugs only have to establish bioequivalence, allowing them to reach the market much quicker than brand-name drugs.
“Generic drugs are required to have the same active ingredient, strength, dosage form and route of administration as the brand-name product,” the FDA states. “Generic drugs do not need to contain the same inactive ingredients as the brand-name product.
“Generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug),” the FDA continues. “One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug.”
“The process for approving generic drugs requires no clinical testing in humans or animals,” John A. Hovanesian, MD, FACS, told PCON. “There is no need to prove that a drug is effective or even safe. What they have to prove is that the main ingredients are present in similar quantities to what’s in the brand-name medication. But what else is in the bottle can differ significantly, and those preservatives and other ingredients can have a profound impact on the surface of the eye.
John A. Hovanesian
“In using drugs for eye care, we’re putting a medication directly on top of the target organ,” he continued. “That’s very different from prescribing, for example, a cholesterol medication where you take the pill and it dissolves and it has to pass through the entire body’s bloodstream before it gets to the target organ.”
Brand-name drugs face a much more rigorous approval process that can be lengthy.
“Drug companies seeking to sell a drug in the U.S. must first test it,” the FDA detailed on its website. “The company then sends Center for Drug Education and Research (CDER) the evidence from these tests to prove the drug is safe and effective for its intended use. A team of CDER physicians, statisticians, chemists, pharmacologists and other scientists reviews the company’s data and proposed labeling. If this independent and unbiased review establishes that a drug’s health benefits outweigh its known risks, the drug is approved for sale. The center doesn’t actually test drugs itself, although it does conduct limited research in the areas of drug quality, safety and effectiveness standards.”
The pharmacists’ role
In most cases, according to the doctors interviewed for this article, they are not the ones choosing generic medications for their patients. Pharmacists and pharmacies are changing the course of treatment for patients by providing generics.
The National Community Pharmacists Association’s (NCPA’s) yearly report found that pharmacists’ recommendations for a switch to generic drugs are accepted in 83% of cases.
Hovanesian is concerned about pharmacists who may not be knowledgeable to potential dangers of switching from a brand-name drug to a generic. He is also concerned about potential financial incentives to make the switch.
“There is no place else in health care where somebody gets paid to change a patient’s course of treatment, and it is wrong,” he said.
Cost as the driving force
When asked why patients use generic drugs, all of the doctors responded that the primary reason was cost, both in terms of what the patient can afford and what the insurance companies will allow.
“For the pharmacy, there is a greater profit margin in dispensing generic drugs than there is in brand name drugs,” Hovanesian said. “That is because they have purchased these at a very low price, they still get to collect their deductible and the insurance companies also get deeper discounts on generics than on brand name drugs. So everybody in the supply chain of that drug makes more money when a patient goes to a generic.”
“Many patients cannot afford most of the branded products,” Onofrey explained, “and the only way they can be treated is with a lower cost generic equivalent.
“Compliance is critically important and, in my population, compliance hinges in large measure on the ability to buy that drug,” he continued. “Some patients have to weight if they want to pay their rent or buy their food for themselves or their family vs. spending $150 a month on a drug, and that does not make sense to me when the same drug can be obtained for $20. A patient who cannot afford a drug is not going to use the drug.”
Drug companies invest a lot of money into new drug development and marketing, Onofrey said.
Bruce E. Onofrey
“Unfortunately, the trend has been to recover those dollars with massively expensive branded products,” he said. “Even those with drug coverage must pass those costs on to either the government or the insurance industry. Someone has to pay. Generics may not be perfect – nothing is – yet they allow many to be affordably treated who otherwise could not afford life- and/or sight-saving medications.”
According to the FDA, the cost of a generic drug can be 80% to 85% lower than the brand-name medication. FDA-approved generics reportedly saved consumers and the U.S. health care system $158 billion in 2010, as detailed on the FDA’s website.
Hovanesian, who blogs regularly for PCON as well as its sister publication, Ocular Surgery News, recently discussed the rising cost of generic drugs, however, and noted that consolidation of manufacturers, increased regulation, insurers seeking higher discounts as well as a greater demand for generic medications will continue to feed this trend.
Applications in eye care
One of the biggest concerns regarding generic drugs in eye care is the use of generic glaucoma drugs, the doctors told PCON.
Latanoprost, a widely prescribed glaucoma drug, was prescribed under the brand name Xalatan until its patent expired and several generic versions hit the market.
“With glaucoma drugs, a lot of glaucoma specialists will tell you that the generics don’t work as well, but not all the generics,” Hovanesian said. “Some are better than others. The problem is when the glaucoma specialists prescribe the glaucoma drug and ask for a specific generic. The pharmacy has no legal obligation to honor that and they are allowed to substitute another generic.”
“Some individuals have told me that certain generic glaucoma medications, specifically latanoprost, have resulted in a rise in pressure in their patients,” Onofrey said. “I personally have not seen that to be a major problem.”
Our sources also noted other instances where generics did not live up to their brand-name counterparts.
“Most generics are equivalent to the original brand-name drug they replace, with the exception of prednisolone acetate,” Choate said. “Any drug in a suspension or emulsion form can have issues in the generic form. I do not see more side effects, just less effectiveness in some cases.
Walter L. Choate Jr
“In some drug classes, generic drugs can be fine, but I prefer the newer drugs in general,” he continued. “I want the patient better fast, and I get better response from most new preparations.”
“Not every drug is poorly tolerated,” Hovanesian explained. “Some generics are just as comfortable as the brand-name drugs. Some are well made and nearly an equivalent substitute. Some manufacturers are diligent about copying everything exactly off the bottle that the brand-name drugs use, and, in theory, those should be just about equivalent. Others are just looking for the least expensive, legal way to get a drug on the market.”
Some doctors feel that patients should be monitored more closely if switched to a generic drug.
“You do not know exactly who is going to end up on a generic,” Hovanesian said. “If you did, yes, you would monitor them more closely. But, as a doctor, do not always assume that if the treatment does not seem to be working that the patient is not taking the drops or it is the wrong treatment. It may be an ineffective generic, so you need to ask the patients to bring in their bottles.”
“Any time any patient changes medication there should be a reassessment to ensure that the desired effect is being achieved,” Gurwood said. “That’s for all medications – even if one brand-name medication is changed to another brand name.”
Generics have their place
In the end, all the doctors that spoke to PCON acknowledged that generic medications have a place in health care and in eye care.
“Generic drugs, in many cases, are a cost-effective means of managing disease,” Gurwood said. “When they work, it is great. However, sometimes they do not work, and when that happens, clinicians should have a streamlined and easy way to remedy the issue without all the red tape.”
“According to the law, the generic is supposed to be the same drug in equivalent dose with equivalent eye availability and, therefore, you should have an expectation of similar efficacy,” Onofrey said. “As long as the efficacy is equivalent and there is a significant savings in cost, I would clearly prefer a generic in every situation.” – by Chelsea Frajerman