Tuesday, December 4, 2012

Branded Vs Generic Drugs


Branded vs Generic: The Saga Continues

The Pharmacist Perspective

Laurie Scudder, DNP, NP
  Nov 29, 2012 Authors & Disclosures
 

Brand-Name vs Generic Agents: The Pharmacist Experience

Pharmacists, prescribers, and patients often voice concerns about the safety and efficacy of generic drugs that are substituted for brand-name drug products. No matter where they fall on the spectrum, most clinicians, however, acknowledge that they are here to stay. The US Food and Drug Administration (FDA) approves a generic substitute if it has proven to be "identical, or bioequivalent, to a brand-name drug in dosage form, safety, strength, route of administration, quality, performance characteristics, and intended use." [1]
The FDA's Orange Book provides the latest information on generic approvals. Approved generic agents have been demonstrated to have therapeutic equivalence -- although many clinicians have questioned whether that equivalence extends to all patients and all clinical scenarios. Jenny Van Amburgh, PharmD, an Associate Clinical Professor of Pharmacy at Northeastern University in Boston, Massachusetts, reminded readers in a previous discussion on Medscape that generic products are only compared with their brand-name products and not with generics made by other manufacturers.
Drugs that are known to exhibit a narrow therapeutic index (NTI), including levothyroxine, warfarin, phenytoin, and digoxin, are of greatest concern. Switching between generic NTI products made by different manufacturers may require particular vigilance to recommended monitoring.
James Lindon, PharmD, PhD, JD, in an earlier article on Medscape discussing pharmacist liability in the selection of generic agents, noted that the product liability law applied to prescription drug products usually only requires the manufacturer to disclose "adequate warning and instruction" to the prescriber or dispenser. There may be no duty for the drug product manufacturer to warn the patient. [2] In contrast, both the pharmacist and the prescriber may have a duty to counsel the patient when a particular generic product is prescribed or selected by the pharmacy. Laws regarding substitution vary by state.
What if the generic substitution is required by a patient's insurance carrier? Or the switch to a generic drug from a different manufacturer is made at the pharmacy and the prescriber is not aware of it? Is the pharmacist liable?
We asked our readers to participate in a survey describing their experience with generic agents and their opinions on the appropriateness of their use. Here is what the pharmacists had to say.

How Frequent Are Generic Substitutions?

We asked whether respondents had been required to make a generic substitution by an insurance carrier in the previous 6 months. Over 80% of respondents indicated that they had indeed been required to make a substitution. Most reported that that substitution was made without notification of the prescriber. Less than a third (28%) agreed that they had an obligation to notify a prescriber if a substitution was made.
Dr. Lindon notes that there are pragmatic concerns in implementing prescriber notification about medication substitutions, particularly when changing between generic manufacturers. Multiple pharmacist calls to clinician practices could be cumbersome for both the pharmacy and the prescriber and potentially disruptive and intrusive. He questions how often a prescriber would find such information useful, object to a change in manufacturer, or request more information about the manufacturer or generic product.
One pharmacist wrote that a change from a brand-name drug to a generic was as often made because of patient requests as because of insurance requirements, with patients citing higher out-of-pocket costs for brand-name medications.

The Generic Experience: The Safety Question

We posed the question: Are generics usually just as safe and effective as the corresponding brand-name product? An overwhelming majority of pharmacists (85%) agreed. This is in contrast to only 55% of prescribers who agreed with this statement. While over a quarter (27%) of prescribers disagreed with this statement, only 5% of pharmacists reported that they thought generics were less safe or effective and 10% of pharmacists vs 18% of prescribers were neutral.
A question about poor patient outcomes that were perceived to be due to a brand/generic interchange yielded somewhat conflicting results. Just under half (49%) of respondents believed the substitution had caused a bad outcome in a patient; in contrast, only 31% indicated that their patients had not had a negative experience. These percentages are virtually identical to the evaluation of patient outcomes provided by prescribers.

The Generic Experience: The Cost Question

A large majority (80%) of pharmacists agreed that after all costs are considered, generic drug products probably save money or reduce expenditures when they are used. However, 10% disagreed and 10% voiced no opinion.
A 2010 article in U.S. Pharmacist described generics as "the best bargain in health care" and asserts that implementation of the Affordable Care Act is likely to lead to an increase in their use. [3] The author of this article, John Coster, PhD, RPh, Senior Vice President for Government Affairs with the National Community Pharmacists Association (NCPA), cites an analysis of Medicaid claims data conducted by NCPA that concluded that the average price of a generic prescription was $20.61, a mere fraction of the average price of a branded product, which was $195.54, a difference that translates to almost $2000 per year for chronic medications. John Bishel, PharmD, a community pharmacist, points out that, given that the median hourly wage in the United States in 2011 was just under $17, [4] the average patient would have to work an additional 10 hours per month to make up that cost difference. He argues that, in many cases, there is little evidence to support the use of a branded product in place of an acceptable generic alternative and believes that if "prescribers were aware that some medications could cost the patient an additional $2000 per year with marginal potential benefit, it may alter prescribing habits, given that half of working Americans live on an hourly wage that equates to about $35,000 per year."

What About Liability?

Given the murky legal waters regarding potential liability with the use of generics, we asked clinicians whether they believed that allowing the use of generic drug products for their patients increased their legal liability. Opinions were split: Just over half (56%) of respondents indicated that they did not feel they were at increased risk while almost a third (31%) voiced no opinion. A small percentage (12%) was concerned about increased legal liability.

The Bottom Line?

Prescribers in this survey pointed out that, ultimately, their patients often were more concerned about the use of generics than the healthcare professionals. The FDA provides extensive information aboutgenerics for patients that can be an important resource for clinicians in educating their patients about generic medications.

Autonomy & Patient’s Rights to Die


'You MUST Let My Bedsores Kill Me. You MUST!'

Arthur L. Caplan, PhD
  Nov 29, 2012 Authors & DisclosuresI am Art Caplan, from the Division of Medical Ethics at the NYU Langone Medical Center in New York, New York. I want to discuss an interesting, and in some ways disturbing, ethics consultation [I had not so long ago].
When we get into issues about stopping care for people, normally we move toward discussions about turning off the ventilator, withdrawing dialysis, or pulling the feeding tube, and we are usually caught up in considerations about how to manage life support when they involve technologies. This case had none of that, but it raises some very interesting and tough moral questions.
An older gentleman, in his eighties, was doing pretty well living by himself but sadly suffered a series of small strokes and wound up in the hospital. He was told that he was going to have to be transferred to a nursing home and his days of independent living in his home were over. He had only 1 daughter who lived about 30 or 40 miles away. This man had been independent. He was a World War II veteran, had distinguished himself in that conflict, and had lived by himself and enjoyed his life since that time, but in hearing that he was going to long-term care, he wanted none of that.
The nurses and people who were caring for him while he was in the hospital said, "One of the things we have to do is turn you because you are in bed and at great risk of developing bad skin ulcers." We all know that it doesn't take much to set that off, particularly in a man in his late eighties with aging and fragile skin. They turned him, but he began to develop small skin ulcers. They [then decided to provide him with] a special air mattress, but then this man began to think about his situation and he said to the doctors and nurses, "I don't want you to turn me anymore; stop turning me." They told him that they could not do that. They explained that these ulcers would become painful and he would develop infections and die. He answered that this is what he wanted to happen. And he refused to give permission to turn him in bed.
This set off quite a controversy at the hospital. Many of the nursing staff said they would not deal with this patient. It is standard of care to turn [immobilized patients]. Others warned that the administration and state authorities would be "all over us" if this man died of skin ulcers, saying that [developing infected skin ulcers] is an adverse event that could basically result in no reimbursement for this man's care and all kinds of penalties because we are not following basic standards that JCAHO and other organizations would expect. Some doctors said he must be depressed, he must be crazy. After evaluating him, the consulting psychiatrist said that he absolutely knows what's going on. He has decided that this is the way he wants to end his life. I cannot give you the excuse that he is somehow less than competent.
This went on for a while. His ulcers got worse. Some began to be infected, and the nurses complained even more loudly, saying that they did not want to care for him in this situation. The hospital was in a small rural area. They asked whether any long-term care facility would take this man. At this point the long-term care facility that was available said no. There was a small hospice program that consisted of volunteers in the community, but they could not deal with him. Ultimately he died in the hospital, with huge ulcers. Basically, his body fell apart, the nursing staff was in an uproar, doctors fighting about whether or not it was right to let this happen. It was quite divisive for the staff morale, and indeed they were investigated about how a person in their hospital could die from infected skin ulcers.
What are the lessons to be learned from this refusal-to-be-turned request? For one thing, we need to be sensitive to the idea that it is as likely that someone may say "don't turn me" as they may say "I don't want any more dialysis" or "I want you to shut off my ventilator" or "take out my feeding tube." Institutions may want to establish policies such as: "We always turn people and we do not shut off the heat in a patient's room. There are certain things we are not going to do, and as soon as someone says they do not want that, we need to talk about moving them home or moving them elsewhere because there are some steps that we will not take here." Patients need to know that. Hospital staff, ethics committees, and others may want to think about developing policies concerning requests that will not be honored.
At the end of the day, I think this man did have the right to say "don't touch me." I think he had the right to say "don't turn me." But if his decision started to affect nursing and staff morale and began to become a problem in the delivery of care for others, then I believe that is a factor that has to be considered when deciding whether to honor what he says. The nurses cannot work if the unit becomes a smelly, untenable mess, and although this man had his rights, other people have their rights too. If I thought the care of others was being compromised by these morale issues and staff problems, I might override a patient's wishes. I might not honor his request in the name of other people's rights. In my opinion, there may be limits to what you can request when it affects the care that others can receive. That is a tradeoff that has to be weighed at all times.
As tough as this case was, it provides lessons to take home. Autonomy and patient rights may have some limits when they begin to affect others and the care that others can get. It may be important to think about this kind of dilemma in advance, and be ready to say as soon as a request comes that this is the patient's right, but it is not something we can accept at this facility. I am Art Caplan at the Division of Medical Ethics at the NYU Langone Medical Center in New York. Thanks for watching.