22.01.2018 in Medicine
Generic Drugs

A generic-drug is a pharmaceutical product, often intended to be identical or similar to the actual product. The key innovator company manufactures generic-drugs without a licence.  Marketing of a generic-drug occurs after the after the expiry date of the patent rights attached to the main drug. Despite the fear for use of generic-drugs, they are as effective as the brand-name drugs and are even cheaper. For example, paracetamol is a chemical ingredient used in the manufacture of brand-name painkillers. It is sold like a generic-drug. Generic-drugs are easily affordable to the low-income earners within the society due to their low prices. The reduction in prices of drugs is a culmination of the adverse completion between drug companies and generic-drug companies after negotiations between drug companies in setting of drug prices failed. In particular, there has been a considerable debate in setting the prices of HIV/AIDs drugs.

A brand name is the name given to a product by the manufacturer of the product. In short, it is the real community name. A brand name distinguishes a product from other commodities. Let us not confuse a generic-drug and a counterfeit drug. A counterfeit drug is medicine that is not labelled correctly. The label given to such a drug does not tally with the actual drug name. Both generic-drugs and branded drugs can be fake. Counterfeit drugs are poorly packaged. They include products with the correct ingredients but lacking active ingredients or with correct ingredients but having incorrect quantities of active ingredients.

Every drug has a generic name. A new drug has both a generic name and a brand name. Approval of generic-drugs takes place under the Abbreviated New Drug Application process (ANDA). The body responsible for the approval of generic-drugs is the Food and Drug Administration (FDA). All generic-drugs that FDA approves have the same quality, strength, purity, and stability as the brand-name products. Generic products manufacturing sites also pass through the same quality standards as those of brand name drugs (Georgetown University Medical Centre, 2008)

Generic-drugs have to meet the requirements set by FDA in order to qualify for marketing. First, the drug must contain the same active ingredients as the innovator drug. The drugs ought to identical in strength, dosage form and route of administration. It has to be bioequivalent, and manufacturing should be under the same strict standards of FDA’s strong manufacturing practice regulations required for innovator products (Georgetown University Medical Centre, 2008).

Several theories on the ingredients of generic-drugs have come up. Many patients fear that the presence of inactive ingredients in generic-drugs may affect drug levels. The truth is that a generic-drug may have different recipients (fillers, binders, coatings, flavouring, and colouring) than competing branded (or generic) drugs. We should note that the range of recipients used in pharmaceutical manufacture is small and many companies use the same recipients. Before marketing, there has to be a bioequivalence study test performed on the final product.  If recipients affected drug levels, the drug would fail the test for bioequivalence. The result is that a patient may be allergic or intolerant to a recipient in a generic or branded drug.

There are also several perceptions on the effectiveness of generic-drugs. These perceptions about decreased effectiveness may be due to prejudice by a patient or prescriber against generic-drugs. Brand-name firms manufacture about 50% of generic-drugs. In case, a patient suspects product failure, the patient ought to notify the FDA. If possible, the patient should include the lot number and expiry date, patient-drug-therapy profile, and the basis for suspecting failure. Ensure to keep samples of the drug for testing (Hixon 2010)

Generic-drugs are more advantageous to use as compared to brand-name drugs.  The cost of generic-drugs is lesser than brand-name drugs. Secondly, generic-drugs decrease exposure to misleading promotional material. Most drug representatives deal with brand-name drugs. They will not bother anyone once they know the company specialises in writing generic-drugs. To ensure the safety of generic-drugs, there is a sequence of new drug development. First, it is essential to carry out lab studies to gain knowledge of similar drugs. The next step is to carry out all experiments on animals before any human studies. While introducing a new drug, we begin by giving a low dose with short exposures, then higher doses and longer exposures (Hixon, 2010).

As stated earlier, approval of generic-drugs takes place under the Abbreviated New Drug Application process (ANDA). During this process, several safety considerations need to be put in place. According to Dena Hixon, all drugs have risks. He also states that determination of drug safety is a risk, which has its benefits to the intended population. Therefore, we need to have a thorough knowledge of the drug when considering generic formulations that may differ from RLD.  It is vital to consider the well being of a patient when carrying out studies on generic-drugs. When administering medication to the patient, always continue with the intended individual dose. Another remedy is to ensure the patient is in a steady state.

Generic-drugs sometimes come in forms that may be difficult to take by patients. For example, an exceptionally large tablet or a tablet that sticks to a moist surface may be a chocking hazard. Such a drug is most likely to stick on the tongue while swallowing. The other drug is a tablet that disintegrates quickly when put in the mouth. This drug is often difficult to swallow. Some drugs cause irritation of the gullet. A drug that releases an offensive odour or taste ought to have a coating to protect the gullet from irritation.

Sometimes members of the public may discourage others from using generic-drugs. They have different reasons to support their views. Some also state that generic-drugs are not as effective as brand-name products.  When a patient has a worsening symptom after changing to generic-drugs, it is often accredited to the use of the generic-drug.

In conclusion, we can state that generic-drugs are effective and efficient to use just as brand-name drugs. We should not be cheated by the many perceptions on generic-drugs. We can now be confident that generic-drugs are not inferior inequality to branded drugs. In terms of contents, generic-drugs do not contain less active drug than branded pills. Inactive ingredients in generic-drugs do not affect absorption. It is a lot relevant to note that patients who are well controlled on branded medication can be switched to generic medication.  Therefore, with the lower costs, generic drugs get an automatic marketing advantage. Before using the drug, we need to consider the clinical implications of product differences. 

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