The Battle Rages On: Generic Drugs vs. Brand Name Drugs

“Talk to your doctor to find out if Ambien® is right for you.” I am sure that you have heard this commercial before, and can interchange Ambien® with any number of other drugs. As a consumer have you ever asked your doctor if zolpidem is right for you? Do you know what zolpidem is? If you are a nurse or medical practitioner you probably do, but if you are just an average consumer probably not. It is the active ingredient in Ambien® as well as over a dozen generic drugs. Myth or Fact: Generic drugs cost less than brand name drugs because they are inferior? Think about this for a moment. If you answered FACT then you are wrong! According to the Food and Drug Administration generics cost less because these manufacturers typically don’t engage in costly advertising, marketing and promotion, or significant research and development. If you answered incorrectly don’t feel too bad, many people believe this myth. There are many myths associated with generic drugs; the FDA has even devoted a page on their website to this topic. The real fact is that the generic drug industry is regulated by the FDA and these drugs must pass a bioequivalency review to ensure they perform the same as the brand names. According to the National Institute for Health Care Management this means that “essentially, a generic company must show unequivocally (via a series of mandated studies and tests) that the generic drug (a) contains the identical active ingredient or ingredients as the innovator drug in the same amount and (b) behaves in the body in the same way.” We will explore this matchup further.

Resources:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

http://www.nihcm.org/~nihcmor/pdf/GenericsPrimer.pdf

http://www.walmart.com/catalog/catalog.gsp?cat=547013

The Beginning

I am certain that all of us have been a patient or are going to be a patient in the future. When you had to fill a prescription did you pay attention to the name on the prescription and the name on the bottle? Were they different? If so then you have encountered the generic vs. trade name issue. The Drug Price Competition and Patent Term Restoration Act better known as the Hatch-Waxman Act of 1984 was the first major contributor to the generic vs. trade competition. By 1980 most states had enacted laws that allowed pharmacies to dispense generic name drugs even if the prescription called for a brand name or trade name drug, these laws also had a huge impact on generic sales. Certainly you are all familiar with the Medicaid program; this is just one of the government health programs that promote the generic substitution of drugs. Keeping these in mind it is easy to understand why generic vs. trade name drugs is such a hot issue. But if you are still asking why, then please keep reading!

Resources:

http://www.sanfordguide.com/PDA_Demo/SGdemo/images/plm_5_lrg.gif

http://www.cbo.gov/ftpdoc.cfm?index=655

http://www.healthpopuli.com/uploaded_images/Savings-Generated-By-Use-of-Generic-Drugs-During-742239.jpg

Steinman, M., Chren, M., & Landefeld, C. (2007, May). What's in a name? Use of brand versus generic drug names in United States outpatient practice. Journal Of General Internal Medicine, 22(5), 645-648. Retrieved September 23, 2009, from MEDLINE database.

Robb-Nicholson, C. (2007, January). By the way, doctor. I recently switched from Prilosec to its generic form, omeprazole. The generic form doesn't give me as much relief from heartburn as Prilosec does. Aren't generics supposed to be the same as the brand-name drugs?. Harvard Women's Health Watch, 14(5), 8-8. Retrieved September 23, 2009, from MEDLINE database.

Generic and Brand-Name Drugs.. (2009, January). CRS - Senior Health Advisor, Retrieved September 23, 2009, from Health Source - Consumer Edition database.

HOT off the press!!

With the country in a state of economic crisis, the issue of generic versus brand name drugs couldn’t be more significant. Health care is already expensive enough, why pay more for brand name when you can get the same essential thing with a generic drug. According to the FDA, “A generic drug is the same as a brand-name drug in dosage, safety, strength, quality, the way it works, the way it is taken and the way it should be used”. This basically sums up the debate on which is better medically… Neither! They are essentially the same, just in different packages under different aliases. So why would consumers continue to buy brand name? When new drugs are first introduced in the market they come patented and those patents last roughly 17 years, states the FDA. Therefore, for up to 17 years, no other manufacturers are allowed to sell a replica of the same drug, and the brand name has no other competition. After 17 years of using the same product and having good effects, most people are weary of switching to another name, much less a non brand name, because they think its not as effective. The problem is that a lot of people are unaware of the fact that generic brands are just as effective. In this time of economic crisis, more people should be made aware of the potential for saving money and this seems like a good place to start.

Resources:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

Controversy

When it comes to controversy, it seems that money is always in the mix. Trade name drugs cost more to make than generic. The higher the percentage of generic sales equals more money that is taken away from large pharmaceutical companies that develop these drugs. The issue with some consumers is that trade name drugs can lead to higher costs of health care. One of the reasons for the incredible expense of trade name drugs is because the large pharmaceutical companies such as Pfizer have to research, test and market each drug. After they receive a patent for the drug they have the only rights to market the drug for many years but once this patent expires than any drug development company can create a generic version without worrying about upfront cost because the research has already been done.  

While generic drugs are cheaper many physicians and even patients such as you and I feel that trade names drugs are superior. Some may say that a brand name drug may not necessarily be better just because it is more expensive. We know that it is more expensive because it was first to hit the market. Some doctor’s will try a brand name if a generic drug is not working effectively, there may be a slight difference in the potency of the drugs. But it is FDA regulations that states that the generic version of a trade name drug must be formulated the same.  

They must have the same:

Active ingredients

Quality

Strength

Purity

Safety

Dosage Forms (pill, liquid, shot)

  

Generic drugs cannot look like trade drugs so some of the ingredients, such as color or other inactive ingredients may be different. Overall the risk of using a generic name vs. brand name is relatively low.  

Safety wise, many health professionals will argue that generic name drugs are the best. I would have to agree with this. Trade name drugs can have several different names for one drug. This can lead to mistakes in filled prescriptions, transcription errors that can lead to medication errors and even deaths. Please watch this video on: Avoiding Medication Errors with Multiple Brand Names

http://www.youtube.com/watch?v=zGGyHQJX5e0

As medical professions and future medical professionals it will be our job to make sure that errors like this don’t happen. I feel that this is why generic vs. trade name is a hot button issue and will probably remain that way for years to come.

Resources:

http://www.cbo.gov/ftpdoc.cfm?index=655

http://www.searchingforhelp.com.au/images/features/health/smoke/generic.jpg

 Steinman, M., Chren, M., & Landefeld, C. (2007, May). What's in a name? Use of brand versus generic drug names in United States outpatient practice. Journal Of General Internal Medicine, 22(5), 645-648. Retrieved September 23, 2009, from MEDLINE database.

Robb-Nicholson, C. (2007, January). By the way, doctor. I recently switched from Prilosec to its generic form, omeprazole. The generic form doesn't give me as much relief from heartburn as Prilosec does. Aren't generics supposed to be the same as the brand-name drugs?. Harvard Women's Health Watch, 14(5), 8-8. Retrieved September 23, 2009, from MEDLINE database.

Generic and Brand-Name Drugs.. (2009, January). CRS - Senior Health Advisor, Retrieved September 23, 2009, from Health Source - Consumer Edition database.

Who should care about this topic...consumers, nurses or both?

The difference between generic and trade name drugs is very slim. They both contain the same active ingredients, the same dosage, the same route of administering the drug. The small differences are the inactive ingredients, which can be the way the tablet looks or the size of the tablet, and how much the generic version costs. The generic versions are always cheaper than the brand name version. The question is, which one is really better for you? Which one should we buy? Is there really a difference as far as the effect the drug has on the patient that we have to buy the brand name rather than the generic name?

These are all important questions and probably all questions that a person asks themselves every time they go to the pharmacy and hear the price of their prescription or see the difference in prices on the over the counter medications. But who should really care about all of these questions? Should the consumer care? How about the nurses? Or do you think they should both care?

 

In my opinion, I feel like they both should care. I feel that the consumer wants to be aware that they are about to spend a lot of money on the medications that they have been prescribed to take. I know from experience that some of the medications I have been given before have an outrageous cost! A few months ago, I had to go see the dermatologist for some sun spots that were showing up on my skin. I wanted to be sure it was nothing serious. At the end of my appointment, she prescribed me a shampoo to use in the shower and a topical cream to put on after taking a shower. I went to the pharmacy to get them filled and when they were ready, she told me the price and I nearly passed out. For the topical cream, it was $235 for the SMALL bottle! I would hate to see the price of the big bottle! Luckily the nurse I had at the dermatologist office had given me a coupon so I didn’t have to pay more than $25 for it. In this position, I feel like the nurse cared about how much I was going to have to spend on this medication to help my skin. She sure did care enough to give me the coupon. If she didn’t, she could have kept the fact that they had the coupons there a secret and I would have had to pay a lot of money.

Here is a link to a journal that shows a survey done by three medical doctors from the Division of Geriatrics at the San Francisco VA Medical Center and the University of California: What's in a Name? This evidence shows that usually physicians will prescribe the brand name drug rather than the generic name (if the drug has a generic name) 79% of the time. This causes an excess in health care costs of an estimated $8.8 billion that is unnecessary when they could prescribe the generic name instead. It explains how some physicians use the brand name because they are easier to remember. If I was a physician, I would not be greedy and I would help my patient out by remembering the generic names too and prescribing them if they are available because everyone knows that patients are already spending a lot on health care. Why should we have to pay a lot more on prescriptions too?

In other aspects of the medicine, as far as the effect of the medication, I still feel that both should care about the topic of generic versus trade name drugs. Some people may not purchase the generic name medications because they feel that they will not work as well as the brand name drugs. But like I mentioned above, they all are required by the FDA to have the same active ingredients and same dosage requirements. Therefore, they would all have the same effect on the patient right? I would think so. But there are articles that have proven otherwise. In this article out of the magazine Neurology Now, there is an example of the drug phenytoin (Dilantin) that is an anti-seizure medication. Neurology Now Article. It tells how naybe the effects of using the generic version over the brand name can affect the patient in bad ways and is not worth saving the money if it is going to cost you even more money if you end up having to go to the emergency room or something. I would hope that the nurse would care enough about this topic to let the consumer or patient know that there could possibly be two different effects in regards to using the brand name or the generic name drug and which one would be the best to use for their condition.

Another problem with brand name and generic name drugs is prescribing errors. Different pharmacies carry different drugs under other names than the one that the physician may have prescribed. Also, some doctors may remember the medicines by different names than the other doctor the patient went to if they switched physicians for some reason. This could cause harmful problems to the patient if this is not caught. You see television ads all the time about ’if you have taken this medication please contact us so we can help you’. Watch this video explaining the harmful effects that prescription errors can have: Drug Name Confusion

Wrapping it up, I truly believe that both the consumer and the nurse should be worried about the many different topics having to do with generic and trade name drugs. It is very important on both sides for many different reasons. How about you? What is your opinion on the subject of who should care about the different types of drugs?

 

Resources: embedded within the article

Who is Involved? And What Does the Government Say?

Drug companies, federal organizations, scientists and consumers are all involved in the battle of generic drugs versus brand name drugs. The increase in demand for generic drugs has pushed more drug companies into synthesizing more of the drugs. There have been plenty of rumors and myths about the generic versions of drugs but the Federal Drug Administration (FDA) has put them all to rest. In order for the competition in the drug market to exist both generic drugs and brand name drugs must be available to consumers. Generic drugs can be supplied by more than one company so this increases the competition. If there are multiple companies selling the same drug, the only difference being the name on the box, consumers can choose which drug they trust or prefer to buy. However, the competition is weakened when drug companies cannot sell generic versions of brand name drugs. Most brand name drugs have patents that protect everything about them for 20 years so generic copies cannot be made. Therefore, not every brand name drug has a generic version available to consumers. The FDA has approved all drugs that are sold under brand names and generic names so consumers can be sure what they are taking are safe.

So when deciding whether or not to buy generic or brand name do not listen to the myths and rumors, know the facts. The FDA states that a generic drug must have the same quality, same safety and same strength as its brand name counterpart. In order for the FDA to approve the generic drug it must have the same ingredients, labeled strength, dosage form and administration as the brand name drug. There are many requirements the FDA sets in order for a drug to gain its approval. If just one of the requirements is not met then the FDA will not approve the drug for sale to consumers. It may be a long process for drug companies to go through but the benefits of having both generic and brand name drugs outweigh the lengthy process. The FDA states that “generic competition helps keeps drug costs down, encourages research, helps keep insurance premiums down, and saves consumers $8 to $10 billion yearly”. So the question remains, which should we buy? For most, the less expensive version is most practical. However, the brand name may seem safer to some consumers.

 

Resources:

https://www.blueshieldca.com/producer/documentlibrary/brand_vs_generic.jpg

http://www.fda.gov/downloads/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/UCM169232.pdf

http://invivoblog.blogspot.com/2008/02/generic-drugs-still-growth-market.html

http://images.google.com/imgres?imgurl=http://www.tva.gov/insidetva/sep08/images/generic.jpg&imgrefurl=http://www.tva.gov/insidetva/sep08/generics.htm&usg=__gC8uJ8NWbtifFjPAeKsjDpAl24=&h=209&w=450&sz=13&hl=en&start=60&um=1&tbnid=isA4Mz2dh7UJ2M:&tbnh=59&tbnw=127&prev=/images%3Fq%3DGeneric%2Bdrugs%26ndsp%3D20%26hl%3Den%26sa%3DN%26start%3D40%26um%3D1

In the News...

Because of all of the information circulating in the news about health care and who should get it, what it should include, etc., many news stations and newspapers have reported on the costs of over the counter and prescription drugs in today’s world.

Abcnews.com quoted Dr. Sidney Wolfe, director of the Washington-D.C.-based Public Citizen's Health Research Group in the article “Generic Drugs: Dangerous Differences?” saying "The FDA already looked into this and concluded that the generic version of the drug was equivalent to the brand name," said Dr. Sidney Wolfe. "The FDA requirements include measuring blood levels in patients using the drug, the only reliable way to examine bioequivalence. ConsumerLab.com looked, I believe, only at test tube dissolution, which is not sufficient."

In other news, Foxnews.com quoted Dr. Aaron Kesselheim of Brigham and Women's Hospital and Harvard Medical School in Boston in the “Study: Brand Name Heart Drugs No Better than Generic”. "Brand-name drugs for cardiovascular disease can be as much as a few dollars a pill, whereas generic drugs might be as little as a few cents a pill," said Dr. Aaron Kesselheim who led the study.

And finally, in their article, “Helped by Generics, Inflation of Drug Cost Slows”, the New York Times said, “Economists say the slowdown has come about because more people are turning to generics and because generic versions of some of the most common drugs have recently come on the market.”

Basically, more and more information is available to the public, it’s just up to them to utilize their resources and start saving themselves money when it’s at all possible.

**To read more on these articles and see where this information was attained please visit the links below**

 

Resources:

http://www.nytimes.com/2007/09/21/business/21generic.html?_r=1 

http://abcnews.go.com/Health/Depression/Story?id=3731555&page=2

http://www.foxnews.com/story/0,2933,460909,00.html?sPage=fnc/health/heart

Why Educate Yourself About This?

An important question you are probably asking is “Why would somebody educate themselves about generic drugs versus brand name drugs?” Surely your doctor will make the right choice for you. Your insurance company will also make the right choice for you too. So let’s just leave this to the professionals. Not so fast. Doctor’s are inundated with pharmaceutical sales representatives. My roommate recently had a doctor’s appointment and guess who was also waiting in the lobby to speak with the doctor? If you guessed a sales representative you would be correct! Drug companies are not only in the business of saving lives, but also in making money. They use some of this money to continue to research other drugs. According to the National Institute for Health Care Management “the brand name industry spent approximately $23 billion in 2001 promoting and marketing prescription drugs to doctors and consumers”. If the doctors aren’t prescribing their drugs they aren’t making any money. Your doctor’s first priority isn’t in saving you money on your prescriptions. So as a consumer you may have to ask your doctor if there is a generic alternative. But if you forget to discuss this with your doctor, talk to your pharmacist. Most states allow pharmacists to substitute generic drugs. As for insurance companies, they are interested in saving themselves money. However not all insurance companies require a generic drug when available. So you can’t rely solely on them to save you money. On this site there is a calculator that could show you the amount of savings possible.

http://www.priorityhealth.com/medicationcenter/savingscalc/

You also should educate yourself because there are a lot of drugs commercials. I mentioned earlier the advertising spent in 2001. However drug companies continue to reformulate their drugs to basically extend their patents. So as a consumer you need to know this. Your doctor may prescribe you the new time released alternative that does not have a generic equivalent yet. This might be the right choice for your condition but knowing that there might be options you must be willing to discuss with your doctor all your concerns. If that fails ask your nurse to speak to your doctor. We are there to ensure that you are receiving the care you need.

Now you may not need to save money. You may prefer to have the brand name drugs. That is perfectly acceptable. Not everyone needs to take only the generic drugs. Drug companies need to sell the brand names in order to keep funding research of new drugs. People will also pay more for the perception of higher quality. And sometimes that perception is correct. The FDA does regulate the generic drug industry; however, many generic drugs are manufactured overseas. Sometimes these companies take short cuts. Unfortunately the FDA can’t always prevent these occurrences before they happen. According to an article in the Washington Post India and China produce the majority of generic drugs. They quote William Hubbard, a former FDA associate commissioner, as saying, “this is very serious stuff, because a contaminated drug hitting the market could cause lots of injuries or worse before it got tracked down." He also discusses the lack of quality inspections. As a consumer or nurse it is critically important to stay abreast of this issue. Nurses should be aware of these developments as they occur. Patients look to their health care providers for guidance. As a nurse you are a crucial line of defense to ensure that patient care isn’t compromised.

There are constantly stories in the news about generic drugs. The FDA has a tremendous amount of information on its website as well. I can also guarantee that your insurance company also has information about generic drugs. Especially if you are currently taking any medications you should check out these resources. But don’t only look at that side of the argument, make an informed decision. Also check out the pharmaceutical companies websites. And finally talk to your doctor to find out if generics are right for you.

 

Resources:

http://www.washingtonpost.com/wp-dyn/content/article/2007/06/16/AR2007061601295_pf.html

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

http://www.nihcm.org/~nihcmor/pdf/GenericsPrimer.pdf

What is the Bottom Line?

A lot has been presented and undoubtedly you may feel a little overwhelmed. However, especially in the age of the internet, there is a tremendous amount of information accessible to both nurses and consumers. We no longer have to blindly accept drug advertisements as our sole source of information. The Hatch-Waxman Act of 1984 was an important step in consumer rights. As a nurse we need to ensure that our patients are getting the right care regardless of what big pharmaceutical companies want us to believe. While it is important for those companies to make money in order to further research new drugs, not all consumers can afford those brand name alternatives. Consumers should also keep themselves up to date. As a consumer you should not rely on everyone else to have your best interests at heart. If you can’t afford a brand name don’t hesitate to tell your doctor. Here are a few links that provide easy to understand information to help you begin your own research:

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm167991.htm

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm100100.htm

http://www.nihcm.org/~nihcmor/pdf/GenericsPrimer.pdf

Hopefully this has made you more informed about the ongoing debate involving generic vs. brand name drugs. This is not an issue that will go away. However knowledge is power and the more you know the better. We invite your comments.

A Small Quiz to See What You Learned!

After taking the time to read our blog and learn a lot of valuable information, take out a piece of paper and answer each question. Test yourself to see how much you learned about the issues concerning generic versus brand name drugs. When you finish, just highlight in the bottom area and see all the correct answers. Good Luck!!

1. The FDA approved generic drugs must only have the same active ingredients as the brand name. No other components are required.


     A) True
     B) False


2. All brand name drugs have generic counterparts


     A) True
     B) False


3. What was the number one event leading to generic vs. trade name competition in the United States?


     A) Roe vs. Wade
     B) Brown vs. Board
     C) Hatch-Waxman Act of 1984


4. In what ways, as specified by the FDA, do generic drugs have to be formulated as trade drugs?


     A) They must look alike.
     B) They must taste alike.
     C) They must have the same quality, strength, and purity.
     D) They must be different in pill form.


5. Approximately how much unnecessary spending occurs on brand name drugs?




     A) $800,000
     B) $8.8 Billion
     C) 8.8 Million
     D) 8 Billion


6. Who should mainly care about the difference in drug types?




     A) The nurse.
     B) The consumer.
     C) Neither should care.
     D) Both should care.


7. Generic drugs are as effective as brand name drugs.




     A) True
     B) False


8. What does it mean for a drug to be “patented”?


     A) The company that made the drug first is protected.
     B) It doesn’t allow anyone else to make or sell the drug until the patent is expired.
     C) The drug has been tested and approved by the FDA.
     D) All of the above


9. Approximately how much money did the brand name pharmaceutical industry spend promoting their drugs to doctors and consumers in 2000?

     A) $1 billion
     B) $105 million
     C) $57 billion
     D) $23 billion

10. According to an article in the Washington Post which 2 countries produce the most generic drugs?

     A) China and India
     B) Mexico and Canada
     C) Taiwan and Egypt
     D) Egypt and Australia


Answers:
1. B
2. B
3. C
4. C
5. B
6. D
7. A
8. D
9. D
10. A

Fun & Games

Here are some fun activities to do pertaining to our blog!!!

Crossword Puzzle - You cannot complete the puzzle online. You can write down your answers and then check in the blog to see if you were correct!!

Brand Name Word Search - You cannot compete this puzzle online. You can print it off though and have fun searching for the words!

Generic Name Word Search - You cannot compete this puzzle online. You can print it off though and have fun searching for the words! The list corresponds with the brand names in the Brand Name Word Search

Hope you enjoyed our fun puzzles!!!