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The Gist on Generic Drugs

By: Darleth Romana-Bantiles, MDThe Gist on Generic Drugs

There used to be only one or two popular pharmacies in the country where a patient may purchase prescribed medications. Nowadays, there is a surge of ‘generic’ pharmacies that carry medications at a lower cost. “Generics now account for 65 percent of the total pharmaceutical market in terms of volume sales whereas originator products account for only 35 percent of the total pharmaceutical market industry,” said Dr. Paulyn Jean Ubial during the Patient Forum on Access to Medicines in 2017.

What are generic pharmacies and generic drugs? Generic pharmacies are stores that sell unbranded medications or non-patented medications produced by reputable companies that are regulated by the Food and Drug Administration (FDA). A medication for a specific ailment is known as a ‘drug’; it usually has a chemical name that may be long and cumbersome to remember. Short or popular names for drugs are usually termed generic.

As a practicing physician, I jot down a preferred brand with the mandatory generic name on a case-to-case basis. Sometimes, patients have preferred brands. They tell me they are ‘hiyang’ to specific medications because they experience minimal or no adverse effects from it. However, when a patient has no preference, I write down a brand I am most familiar with (occasionally this even means that I have used it when I got sick before).

As effective as the innovator

Certain pharmaceutical companies engage in research and development to come up with drugs that address health ailments via high potency and low adverse events. As they come up with an original drug, they obtain a patent for its sole distribution so that they may have a return of the investments made for the endeavor. The original drug with a patent is known as an innovator. Once the patent for an innovator expires, other companies may venture to produce a ‘copy’ that has the same generic or active ingredient.          

In a local study in 2014, it was observed that some people are still skeptical about the quality of generic medicines compared with branded innovators. However, according to pertinent Philippine laws — Republic Acts 6675 (also known as the Generics Act of 1988) and 9502 (Cheaper Medicines Law of 2008) — “drugs with generic names are an alternative of equal efficacy to the more expensive brand name drugs.” This means that generics and branded medicines are ideally bioequivalent, producing a similar availability in the human body and healing effect. Generic medicines are sold at a lower cost only because they do not carry the expenses of drug research, development, and marketing.

According to the US Food and Drug Administration (USFDA), generic medicines may only differ in physical characteristics (size, shape, or color) from branded ones. They may also have inactive ingredients that are allowed to modify flavor or act as a preservative, provided that the FDA renders the said inactive ingredients as safe.

Given all the universal guidelines for generic medicines, one may still ask if all are effective and without serious threats to health. As a physician, I have encountered medications that are not as efficacious as their claim, generic or otherwise. Inactive ingredients also spell a difference, especially when a patient is allergic to it. Also, as with any product and even branded medications, fakes abound. Thus, it is really important to compare available brands or generics. Also, consumers should only buy from reputable pharmacies or drug outlets. These are the ones with legitimate registrations and permits posted in their establishment and with an in-house pharmacist. The FDA is mandated to ensure that generic medicines are bioequivalent to branded counterparts. The agency utilizes standards to assess not only the products but the drug companies too.

The FDA, as a regulatory agency, is doing its best despite limitations. However, there is a need for personal vigilance from the end of consumers. After all, each person has a responsibility for his or her own health.

How does one become smart in buying generics?

A patient may clarify notions about available drugs with his or her doctor, or the drugstore pharmacist, before making a purchase.  Here are some questions that a consumer may ask:

1. What is the active ingredient that renders the drug’s claimed therapeutic effect?

2. What are the options for branded and generic products; and their respective prices?

3. What are the forms and dosages available?

4. Is the drug’s manufacturer regulated by the FDA? (You may check the FDA registry number.)

5. What is the manufacturing date and the expiration date of the product to be purchased? (You may note the batch number if it is indicated.)

It is important, just like in buying any other product, to check the label of what you will purchase (medications). Ensuring the good reputation of the product’s manufacturer is important, as well as verifying the required dates. If the item is bought in retail, and the whole packaging may not be obtained, expiration dates should still be visible. Regarding the information about the manufacturer, consumers may inquire at the FDA or research may be done via the Internet.

Patients can save a lot by buying registered generic medicines. Even over-the-counter drugs that you can buy anywhere have generic counterparts. But precaution must be exercised when dealing with medicines that have a narrow therapeutic index (NTI). Some examples of these drugs are digoxin (for heart ailments), warfarin (a blood thinner), and theophylline (for lung diseases, especially asthma). These medications are considered with NTI, because a slight overdose from the safe and effective amount may result in toxic or fatal consequences.

Moreover, medicines must not be taken without consulting a doctor. Not only is consultation necessary to obtain a prescription, but the doctor will also address any concern or any unusual side effects that may arise when switching from a branded to a generic drug.

At the end of the day, whether one uses generic medicines or not, it is important to practice healthy habits. Even if a patient completes a course of drug treatment, without adequate rest, a balanced diet, and peace of mind, one may still not get well.

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