Generic VS Trade/Brand Name Drugs

WELCOME

arl6185 — Thu, 08 Oct 2009 17:48:32 +0000

A very controversial issue in health care today is over which drugs to take or administer: Generic Drugs versus Trade/Brand Name drugs. This includes Over-the-Counter (OTC) drugs and prescription drugs (those that require a doctor’s order). Why should you be attentive to this issue? Either yourself or someone you know will have to take medications at some point in life. This makes the information you are about to read essential!! Read on to get the hottest and exciting information on this controversial topic!!

First, Let’s take a look at these 2 common scenarios:

Scenario #1: Money

A 55 year old woman has been prescribed vitamin D pills. The brand name drug costs $150 per month. The generic drug costs $4 a month. Wow! Less money is always good… Right? The patient cannot afford the brand name drugs, because it exceeds her budget. She is very anxious about the safety of generic drugs. If it costs less does it work the same? She is scared she is sacrificing her health for the benefit of having more money in her wallet.

Consumer Question: Is it safe? How will this affect your health? Have you ever stopped a medication because it was too expensive to buy or refill?

Nursing Question: What do you do? What are the teaching points for your patients?

Scenario #2: Ouch!!

A 28 year old woman taking Brand Name Birth Control pills pays $20 per month. When its time to refill her prescription the pharmacists suggest the generic drug because its only $10 per month. She starts taking the generic and experiences severe breast pain and inflammation. She experienced discomfort upon hugging people and putting on her shirts were difficult. She did not have these side effects with the brand name drug. She is considering stopping the pills today, a common behavior among many patients instead of calling the doctor.

Questions to ponder:

Consumer question: Have you ever had side effects from the generic drug but not the brand name? Did you stop the medication without telling your doctor?

Nursing Question: What would you advise her to do?

Follow our Blog to the conclusion for the suggestions we have to offer.

The History Behind Generic and Brand/Trade Name Drugs

arl6185 — Thu, 08 Oct 2009 03:03:41 +0000

It has been a matter of debate and discussion among healthcare providers about the value, faults, compliancy, therapeutic efficacy, physicians’ prescribing patterns, and patient preference for brand name drugs and generic drugs. In order to understand this controversial issue one must first get a good definition of what generic and brand name drugs are.

What are brand name drugs?

According to the University of Michigan Health System, brand name drugs are “new drugs protected by patent and made by just one company.” A brand name drug cannot be produced or sold by any other company.The patent protects the investment in the drug’s development by giving the company the sole right to sell the drug while the patent is in effect. According to the FDA, brand name drugs are generally given patent protection for 17-20 years from the date of submission of the patent.

What are generic drugs?

A generic drug is the chemical equivalent of a drug. When a brand name drug’s patent expires, other pharmaceutical companies can produce the same active chemical compound and sell the drug under its generic name. According to U.S. Food and Drug Administration rules, generic drugs must contain the same active ingredients as the brand. Generic drugs can sell for less because their manufacturers don’t have to go through the same research and development process (which is very expensive) that the drug’s original maker did.

Source : VK Sharma, Pranav Sharma, Lubhan Singh, VP Yadav, Kamal Dua 2009

http://www.pharmabiz.com/article/detnews.asp?articleid=51151§ionid=46

FDA U.S. Food and Drug Administration, May 12, 2009

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingGenericDrugs/ucm144456.htm

University of Michigan Health System, August 11, 2008

http://med.umich.edu/1libr/aha/aha_genbrand_crs.htm

How Are Generic and Brand Name Drugs Alike/Different

arl6185 — Thu, 08 Oct 2009 02:56:18 +0000

Now that you have been informed of what generic and brand name drugs are it’s time to go a step further and look at the make-up of generic and brand name drugs. What really makes generic drugs different from brand drugs? How are they similar? Why pay more for a brand name drugs when you can get it cheaper as a generic? Does paying less money mean the drug is less effective? These are all questions I’m sure you have wondered when choosing between buying a generic or brand name drug. Below will help give an answer to some of these questions.

How are they alike?

A generic drug is the same as a brand name drug in strength, quality, dosage, safety, how it works, how it is taken, and how it should be used. The Food and Drug Administration (FDA) stated that all drugs must work well and be safe. Both generic and trade name drugs have the same risk and benefits. Generic drugs have the same active ingredients and effects as brand name drugs.

Before approving a generic drug product, FDA requires testing and procedures to ensure that the generic drug can be substituted for the brand name drug. By law, generic drug products must contain the identical amounts of the same active drug ingredient as the brand name product. Once all the equivalency test have been conducted and approved, the generic drug is considered a therapeutic equivalency. Therefore there should be no difference in therapeutic effects when substituting a brand name drug for a generic drug.

How are they different?

Generic drugs look different from brand-name drugs. This is because trademark laws do not allow generics to look exactly like brand-name drugs. Colors, flavors, packaging, and other inactive ingredients may be different. These differences may cause slightly different effects. Some brand-name drugs may be more easily absorbed by the body. Brand-name drugs may cause fewer or weaker side effects. Because of these differences, the generic drug manufacturers are required to submit additional paperwork to the FDA to prove that their product is manufactured in accordance with good manufacturing practices (GMPs), and is as pure and stable as the brand-name product. The main difference is cost. According to the FDA, on average, the cost of a generic drug is 80-85% lower than the brand name product.

So if the generic version has the same effectiveness and saefty as the brand-name version, what is the advantage of generic drugs? One word: price. Lower costs are often the reason why so many consumers have lean toward buying generic products rather than brand name. The reason Generic drugs are cheaper is because generic drugs do not have to go through the extensive testing that brand name drugs do. According to Melissa Jeffries, author of “How Generic Drugs Work”, it takes years to create a drug and once a company creates a drug, it must conduct expensive clinical trials to ensure the drug’s safety and efficacy. In order for companies to compensate for their financial loses they charge premium amount for their drug. Generic drug companies, on the other hand, are paying only for the production of the medication so they can afford selling their drugs cheaper.

Source:

FDA U.S. Food and Drug Administration, July 10, 2009

http://www.fda.gov/Drugs/EmergencyPreparedness/BioterrorismandDrugPreparedness/ucm134154.htm

FDA U.S. Food and Drug Administration, 10/13/2009

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

Melissa Jeffries, “How Generic Drugs Work”, October 11, 2007

http://health.howstuffworks.com/health-illness/treatment/medicine/medications/generic-drug1.htm

Scientific American, December 13, 2004

http://www.scientificamerican.com/article.cfm?id=whats-the-difference-betw-2004-12-13

Drug Naming

arl6185 — Wed, 07 Oct 2009 02:57:22 +0000

A marketed drug has three names: a chemical name, a generic name, and a brand name. The chemical name describes the chemical composition of the drug. The generic name is used most often in clinical practice and is the safest name to use. A generic name can have more than one trade/brand name. The trade/brand name is the name selected by the manufacturer of the drug. It is usually shorter and easier to remember than the generic name. Generic name drugs begin with lower case letters while brand/trade name drugs begin with a capital letter. Below are examples of drug naming you might be familiar with:

Generic	Brand Name	Drug Class
acetaminophen	Tylenol	Analgesics (pain relievers)
ibuprofen	Advil, Cramp End, Dolgesic, Excedrin IB, Genpril, Haltran, Ibren, Ibu, Ibuprin, Ibuprohm, Ibu-Tab, Medipren, Midol IB, Motrin, Nuprin, Pamprin-IB, Q-Profen, Rufen, Trendar	Non-steroidal anti-inflammatory drugs (NSAIDs)
potassium chloride	K-Dur	Potassium supplementation
propranolol	Inderal	Beta- blocking agent
warfarin	Coumadin	Anticoagulant
atorvastatin	Lipitor	HMG CoA Reductase Inhibitor (Statins)
digoxin	Lanoxin	Positive Inotropic Agent

Source: NeedyMeds, 2009

http://www.needymeds.org/drug_list.taf

Controversy within drug classes: switching from brand name to generic drugs

arl6185 — Tue, 06 Oct 2009 22:54:59 +0000

So what is the controversy with switching from brand name to generic name drugs? Even though the FDA requires generic and brand name drugs to have the same active ingredients and therapeutic effect, many still believe that some generic drugs do not work as good as brand name drugs. Many consumers expressed concerns that when switching from their brand name drug to generic, the generic counterpart was not as effective. So why might a generic drug work differently than brand name drugs? All ingredients, including inactive ingredients, that are used in a particular product formulation affects how the drug is absorbed in the bloodstream. If the inactive ingredients in generic drugs are different from the brand name counterpart do you think this might be a cause for experiencing slightly different effects on the body when switching between the two? The answer is yes, but it should not be a huge difference.The FDA has said that some variability does occur, but the FDA puts a limit on how much of a variability can occur. Inactive ingredients such as coating, stabilizers, fillers, binders, flavorings, diluents, and others are necessary to turn a chemical into a usable drug product. They can give a drug its color, size, and even taste. Inactive ingredients are usually harmless substances that do not affect the body. However a small number of people may react to these inactive ingredients. Because inactive ingredients can cause unusual and sometimes severe allergic reactions in a few people, one version, or brand, of a drug may be preferable to another. Having allergic reactions when switching from a particular brand name drug to generic DOES NOT necessarily mean the drug itself is less effective. Your body is unique in its own ways, so it is expected that not everyone will react the same to a certain drug. Since the human body is always changing, factors such as diet, metabolic rate, and hormones can also affect how a drug acts in the body. Drugs with narrow therapeutic ranges can also be a cause of concern because there is a thin line between therapeutic range and toxic range. The more narrow the therapeutic index is, the higher the risk for toxicity. It is these small differences that could effect how medication works in your body. Certain drug classes have become of particular interest when it comes to effectiveness of drugs when switched from brand name to generic. These drug classes include: antidepressants, antihypertensive drugs, and antiepileptic drugs, to name a few. The next several posts explore studies and research that address controversy within these drug classes.

Source:

FDA U.S. food and drug administration, October 13, 2009

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

Harold M. Silverman, April 2007

http://www.merck.com/mmhe/sec02/ch017/ch017b.html

Original Drugs, November 24th, 2008

http://www.originaldrugs.com/blog/general/brand-vs-generic-drugs/

In The News: Generic Vs Brand Name Heart Drugs…Are They Equally Effective?

arl6185 — Sun, 04 Oct 2009 16:27:04 +0000

Below is a video clip from CBS in which Dr. Travis Stork, host of “The Doctors”, visits “The Early Show” to discuss a study on heart drugs that suggests generic drugs are just as safe and effective as brand name drugs. Brand name drugs, such as Plavix, Toprol XL, and Zocor were among some of the major heart drugs studied. Dr. Stork also dismisses common myths assosiated with generic drugs, such as generic drugs not being as safe as brand name drugs. What is your opinion?

Source: CBS, December 03, 2008

http://www.youtube.com/watch?v=kTwFdr07HgE

Doctors swaying towards generic drugs

makeatha — Fri, 02 Oct 2009 23:18:03 +0000

Rising costs of prescription drugs in healthcare has forced state officials to figure out a method of reducing it. The state of Pennsylvania spendsa million dollars a year on a program geared towards decreasing the cost of prescription drugs. Some cholesterol drugs range from 13 cents for generics to $4.53 for a brand name. Leigh Bradshaw,a registered nurse, holds educational seminars with doctors in hopes of deverging them towards greater use of generic drugs, specifically cholesterol lowering drugs, instead of trade named drugs. A switch to generic named drugs significantly aids the elderly in an economy with rising health care costs. Doctors are responding favorable to the seminars and switching to cost controlled generic drugs.

Source: The Associated Press, 2008, MSNBC

http://www.msnbc.msn.com/id/23436690/

The World Health Organization’s Definition of Generic Drugs

crw7096 — Thu, 01 Oct 2009 22:30:26 +0000

Below is a link to the WHO’s definition of generic drugs. They give a background of what generic drugs are and how they are related to their brand name counterparts.

They have an interesting statement regarding the belief that competition between generic and brand name drugs has been more effective at lowering the cost of drugs than negotiations between drug companies would be. They also note HIV/AIDS drugs support this point.

Source: WHO (World Health Organization), 2009

http://www.who.int/trade/glossary/story034/en/

Generic Antidepressants May Cost Less, and Perform, Less

crw7096 — Thu, 01 Oct 2009 15:27:30 +0000

Patients taking antidepressants like Wellbutrin XL may want to think twice before switching to a generic form of the drug to save money. An MSNBC report states that in the particular case of one woman, panic attacks and suicidal thoughts came back after leaving the brand name drug for a more affordable alternative.

The report goes on to mention an independent lab testing both drugs and finding that the generic form (Budeprion XL) released its active ingredient at a significantly faster rate than Wellbutrin XL. This would mean that the patient on Budeprion XL would have less or no active ingredient toward the end of the dosage cycle.

The drug did meet all FDA approval requirements, but given the severity of the complications experienced by some of the drug’s users, you may want to think twice about whether the money savings are worth the costs.

Source: MSNBC, By Jacqueline Stenson, 2007

http://www.msnbc.msn.com/id/21142869/

Are Generic Antiepileptic Drugs Safe?

arl6185 — Thu, 01 Oct 2009 01:46:07 +0000

Generic prescribing for epilepsy has recently become a controversial topic. Many antiepileptic drugs (AED) are considered to have narrow a therapeutic index. This is a cause for concern because the more narrow the therapeutic index, the greater the risk for toxicity and possible adverse effects. Not all AED’S have narrow therapeutic ranges, but many, such as Tegretol (carbamazepine ) has been known to have narrow therapeutic range, which can increases the likelyhood for therapuetic differences. There have recently been reports of individuals experiencing adverse events such as breakthrough seizures and toxicity upon switching from brand name AED to generic.

According to “Science Direct”, in one study, a survey was taken in which a great number of neurologist respondents reported problems with breakthrough seizures and increased side-effects in at least one of their patients with epilepsy upon switching from brand name to generic AED. Ultimately this study and other findings suggest that benefits related to generic prescribing of antiepileptic drugs are outweighted by its negative adverse effects.

Source:

Kristina Fiore, Med Page Today, August 24 2009

http://www.medpagetoday.com/ProductAlert/Prescriptions/15665

P. Crawford, M. Feely, A. Guberman, and G. Kramer, Science Direct, April 2006

http://www.sciencedirect.com/science?_ob=ArticleURL&_udi=B6WWW-4JCBPJF-1&_user=10&_origUdi=B6WDT-4CRY54X-1&_fmt=high&_coverDate=04%2F30%2F2006&_rdoc=1&_orig=article&_acct=C000050221&_version=1&_urlVersion=0&_userid=10&md5=30c774e13d048233d79f807f0f437e64