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Name Brand Drugs Vs Generic Drugs

By Docta, Aug 17, 2013 | | |
  1. Docta
    While walking down the medicine aisle at the pharmacy, you may find yourself confused. There are two of the same exact versions of every product on the shelf — except one costs 85 percent less than the one next to it.You may find yourself debating whether to dish out the extra cash on the name brand drug or opt for the generic drug that costs much, muchless than the branded pill.

    You may decide to reach for the name brand. You may have heard the name from a trusted friend, or maybe your doctor, or maybe you saw the latest ad on TV. Either way, chances are you have positive feelings affiliated with the drug will predispose you to make the

    But if you are like most people, you'll probably go with the generics. According to the Food and Drug Administration (FDA), nearly eight out of 10 prescriptions filled in the United States are for generic drugs, and it's likely that these pills will continue to see a growth in popularity over the next few years. As more well-known drugs begin to end their patent life of 20 years, in 2015, generic drugs will begin to flood the market. However, many consumers of name brand drugs fear that the cheaper alternative means lower quality and less pain relief. The FDA assures consumers that name brand drugs and generic drugs are tested under the same regulations, and are required to have the same active ingredient.

    In a June 2013 study, researchers looked at over 66 million over-the-counter drug purchases and found an interesting pattern: pharmacists and doctors buy generics 90 percent of the time, while "regular" folks went with generics 70 percent of the time.

    If you're one of the 30 percent shelling out the extra cash for brand name drugs, are you getting your money’s worth? Or should you follow the "expert" advice, go generic, and save the extra cash?

    Ingredients In Name Brand And Generic Drugs
    The FDA requires generic drugs to have the same active ingredient, strength, dosage form, and method of consumption (i.e., how the drug is taken into the body) as the name brand version. Generic drugs must meet all aspects as the name brand drug in order to be approved by the administration for public consumption.

    However, a generic drug does not need to have the same inactive ingredients as their costly counterparts. The inactive ingredients can be derived from food products, fillers, and coloring agents and can differ between various forms of the medication: strength, dosage form, and even manufacturer. For example, amoxicillin, an antibiotic, is produced by 31 different manufacturers and repackers, says Kidswithfoodallergies.com. These manufacturers can make different strengths of the antibiotic in chewable tablets, regular tablets, and capsules, all of which may have varying inactive ingredients.

    Inactive ingredients also vary within the same name brand product depending on the dosage. A 10 milligram (mg) tablet of Singular contains lactose as one of the ingredients, while a 4 mg tablet of a Singular contains mannitol and aspartame, but does not include lactose.

    Testing and Approving Generic Drugs
    In order for generic drugs to hit the market, the manufacturer of the drug must prove to the FDA that it's the same as the brand name drug. The manufacturing, packaging, and testing sites of these generic drugs are judged under the same criteria as the brand name drugs, and must meet the same specifications. The FDA says a good quantity of the generic drugs are even made in the same manufacturing plants as their expensive counterparts.

    The two drugs must work exactly the same on the human body. “As long as the medication is stored at room temperature and away from heat, humidity, and cold, generic medications and their name brand counterparts should work exactly the same,” said Nicole Gattas, Pharm.D., BCPS, assistant professor of pharmacy practice at St. Louis College of Pharmacy to Medical Daily. The FDA reviews and tests the generic over-the-counter (OTC) and prescription medication to make sure they work the same way in the body.

    To test whether the generic drug is just as effective as the name brand, the amount of the drug in the bloodstream is measured to see if it matches up to the same levels found when the patient uses the costly alternative.

    In a 2008 study published in the Journal of the American Medical Association, researchers examined the results of 38 clinical studies that compared the effectiveness of generic drugs to name brand drugs for treating cardiovascular disease. The comparative analysis of the clinical trials that took place in January 1984 to August 2008 did not show evidence that name brand drugs were more effective than generic drugs in cardiovascular disease treatment.

    Difference In Absorption
    While name brand drugs and generic drugs are practically identical, they do differ in their level of absorption into the body. The FDA says based on human studies, the average difference in absorption between the two versions of a given drug was 3.5 percent, where some generics absorbed more or some less. The 3.5 percent difference is deemed to be acceptable by the administration and can even be found in a comparison between a name brand drug tested against the same name brand drug with a different dosage, like Singular. The slight difference in absorption is not medically important, claims the FDA.

    The Reason Why Generic Drugs Less Expensive
    You may be asking, if generic drugs and name brand drugs are the same, then why is there an 85 percent price difference between the two?

    Unlike name brand drugs, generic companies do not need to spend much money on drug research and development, clinical trials, marketing, and advertising, says Mayo Clinic. Once the patent and sales rights of the name brand drugs expire, the generic drugs are given the green light to enter the market.

    Choosing Generics
    If you want to opt for a cheaper alternative, you can talk to your doctor and ask if there is a generic drug they can prescribe that is available for your particular ailment.

    However — particularly when purchasing over-the-counter drugs — make sure that there is an EXACT generic available. “If you are looking for generic Tylenol, also known as acetaminophen, make sure you get the correct product; don't accept a generic that has other or additional ingredients,” Gattas advises.

    If there is no exact generic available for a drug, it is best to talk to your pharmacist to decide what is the best option for you.

    By Lizette Borreli | Aug 16, 2013


  1. opiatebattler
    I choose generic brands wherever possible and have always been happy.

    The only contradiction to this I have come across is with generic salbutamol inhalers. Both my father and my daughter report a 'powdery' feeling in the mouth after using a particular generic inhaler. Both say this generic isnt as effective as the Ventolin brand in relieving their asthma.

    On discussion with the pharmacist I was informed he had had other customers report the same.

    I have always wondered why. Now I have a possible answer, it could possibly be these inactive ingredients that make the difference.

    Thank you for bringing this to attention. I now want to research further into what could cause this for my family, just out of personal interest.
  2. HarmRedThera
    In most cases, this information is true. However, there are some problems with medications with narrow therapeutic ranges, such as anticoagulants and antiepileptics. Also, there was a big problem with a generic manufacturer of Buproprion in a little bit ago and their quality controls.

    Anticoagulants Meta-analysis can be found at pubmed. Here's the abstract from the journal Pharmacotherapy:

    The use of generic drugs has become increasingly common in clinical practice. However, for drugs with a narrow therapeutic index, such as warfarin, there may be some concern regarding the definition of bioequivalence. Clinical studies that compared brand name and generic warfarin products provided conflicting results. Therefore, we performed a systematic review of the literature to better assess the characteristics of each generic warfarin product. Several sources were searched, including MEDLINE and EMBASE, electronic records of meetings' abstracts, and reference lists of included articles. Articles were considered relevant if they were original studies, enrolled patients receiving oral anticoagulant treatment, and compared any approved generic warfarin with brand name warfarin in at least one clinical, laboratory, or management outcome. Eleven studies, with a total of more than 40,000 patients, were included; five were randomized controlled trials, and six were observational studies. In three crossover trials evaluating the mean difference of the international normalized ratio (INR) after switching to the alternate formulation of warfarin, no statistically significant difference was found between patients randomly assigned to receive brand name or generic warfarin. The two other randomized trials found no significant differences in the magnitude or number of dosage changes between patients switched to brand name or generic warfarin. The results of the observational studies are more conflicting, suggesting different features for different generic warfarin products. In these observational studies, the time in the therapeutic range and the number of thromboembolic and hemorrhagic complications were similar in studies that compared the anticoagulation control before and after the switch to a generic warfarin product. In one observational study, however, a change in therapeutic INR control after the switch to generic warfarin was reported at the individual patient level. The results of our systematic review suggest that generic warfarin products may be as safe and effective as brand name products and that patients may be safely treated with these products. However, closer monitoring may be reasonable when switching brands, as variations in individual INR response may be seen.

    Anti-epileptics Meta-analysis can be found at pubmed. Here's the abstract from the journal Drugs:

    The automatic substitution of bioequivalent generics for brand-name antiepileptic drugs (AEDs) has been linked by anecdotal reports to loss of seizure control. To evaluate studies comparing brand-name and generic AEDs, and determine whether evidence exists of superiority of the brand-name version in maintaining seizure control. English-language human studies identified in searches of MEDLINE, EMBASE and International Pharmaceutical Abstracts (1984 to 2009). Randomized controlled trials (RCTs) and observational studies comparing seizure events or seizure-related outcomes between one brand-name AED and at least one alternative version produced by a distinct manufacturer. We identified 16 articles (9 RCTs, 1 prospective nonrandomized trial, 6 observational studies). We assessed characteristics of the studies and, for RCTs, extracted counts for patients whose seizures were characterized as 'controlled' and 'uncontrolled'. Seven RCTs were included in the meta-analysis. The aggregate odds ratio (n = 204) was 1.1 (95% CI 0.9, 1.2), indicating no difference in the odds of uncontrolled seizure for patients on generic medications compared with patients on brand-name medications. In contrast, the observational studies identified trends in drug or health services utilization that the authors attributed to changes in seizure control. Although most RCTs were short-term evaluations, the available evidence does not suggest an association between loss of seizure control and generic substitution of at least three types of AEDs. The observational study data may be explained by factors such as undue concern from patients or physicians about the effectiveness of generic AEDs after a recent switch. In the absence of better data, physicians may want to consider more intensive monitoring of high-risk patients taking AEDs when any switch occurs.

    Bupropion XL article can be found at ProPublica, Forbes, and the FDA has a press release about it. It involves the generic manufacturer Teva.

    The last article also has a link to another testing issue when it comes to FDA approval for generics. Again, generics are less expensive and definitely increase the accessibility of useful medications for people, but I am concerned by the lack of mention of these cases in the original article.

    I originally tried to post the links to the articles I had to back up my statements, but I can't post links yet until I hit 50 posts. I apologize for the inconvenience.
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