Why There's No Such Thing as a 'Safe' Drug?

A point of view from a Medical Sales Rep

I strongly believe that the most effective insurance policy is not to get sick. But it is crucial to remember that not all illnesses are preventable, and some may require medical treatment, such as accidents or injuries.

 

So, it is still vital to have access to quality health care and health insurance, whether you are experiencing health issues or not. Taking preventative measures such as maintaining a healthy lifestyle, getting regular check-ups, and following medical advice can help reduce the risk of illness and avoid unnecessary hospital expenses.

 

During my pharmacology class, I learned that there are no safe drugs, only safe patients.

 

This highlights the importance of taking an individualized approach to medicine and considering a patient's unique medical history, current health status, and other relevant factors when prescribing medication. It also underscores the need for patients to communicate openly with their healthcare providers about any health concerns or issues they may have. This includes potential side effects or adverse reactions to medications.

 

Clinical studies play an essential role in determining the safety and efficacy of new drugs before they can be approved for the public.

 

These studies involve rigorous testing and monitoring of the drug at various stages of development, including pre-clinical and clinical trials. The results of these studies are carefully analyzed and scrutinized by regulatory bodies, such as the FDA in the United States. This is before a drug can be approved for public use.

 

In Malaysia, the National Pharmaceutical Regulatory Agency (NPRA) regulates and ensures the safety, efficacy, and quality of pharmaceutical products on the market.

 

One requirement for generic drugs to be approved by NPRA is to undergo bioequivalence (BE) testing, which compares the pharmacokinetic properties of the generic drug to its reference product. This ensures that the generic product has the same therapeutic effect as the reference product and is safe and effective for patients.

 

Although there are compulsory licensing countries, such as India and Brazil, that allow the production of generic drugs without waiting for patent expiration, most countries, including Malaysia, require the generic drug to undergo rigorous testing before being approved for use on the market.

 

Generic drugs are designed to be equivalent to the brand-name drug in terms of dosage, strength, route of administration, quality, and intended use. However, there may be slight variations in the inactive ingredients or formulation that can impact how the drug is absorbed or metabolized in the body.

 

This is why generic drugs may have slightly different side effects or efficacy profiles compared to their brand-name counterparts. However, the NPRA and other regulatory agencies require generic drugs to undergo rigorous testing to ensure that they meet the same safety, efficacy, and quality standards as the brand-name drug before they are approved for use.