Global Research Pharma Canada


"The false sense of safety of either prescription or over-the-counter drugs comes from assuming in advance that, if they are sold in pharmacies, they must be safe..."

..."The acceptability of the safety profile of a drug is based on expert opinions of leading scientists and medical experts on the condition the drug intends to treat..."
..."In summary, DRUG SAFETY refers to a perception of risk and benefit in function of many variables that depend on the nature of the disease and the outcome expected, as well as on potential liabilities..."

A summarized expert review on drug safety written for everyone to understand

By Dr. Vera M. Madzarevic



Just recently, I was reviewing the FDA MedWatch reports on safety issues of marketed drugs in the United States, and started thinking that regardless the best efforts of regulators in US, Canada and Europe, patients are seldom informed promptly, if ever,  about serious safety concerns regarding the very same drugs that they are prescribed.

It is my opinion that patients have to actively participate on the decision of taking a medication if serious safety concerns exist. The industry invests billions of dollars on research and development every year, provide for all the information as obtained in clinical trials for review by the regulators and now available to other scientists for independent review, and still emergency rooms are filled with patients who developed serious side effects or even died because of prescribed medications used, in general, within the safety parameters established by the manufacturer. We are all very familiar with several personalities who lost their lives due to prescription drugs use or misuse. So where is the problem?

It is not an easy answer since there are many factors that play an executive role in this catastrophe of widespread proportions.

Throughout the 15 chapters in this book I will walk you through many concerns and issues that you have to know when you take a drug. Ultimately, your health is in your hands.

Note that I use the word drug as an abbreviated version of the words prescription drug or medications to simplify the reading.

Here is Chapter 1 for you

Issues that are important to underline


One of the issues I can identify very easily is that drug information on the safety and efficacy of medications in lay language is scarce and not easy accessible. That is true even though on the internet there is an ocean of data available. The other issue regarding drug information is that it has to be qualified before you make any rational use of it as a decision making tool.

Qualifying information is establishing the source as valid and truthful as is for example the FDA or other regulatory agency web site. Patients have to be aware that not all information is the same and disinformation abounds about prescription drugs especially their efficacy and safety.

Today, blogs, discussion groups, social media sites, and others are inundated with personal opinions without scrutiny or scientific reviews. You will find websites for any ailment you may have that also include which medications exist and how to use them. Those sources of information are more what I consider background noise, and you should always consult with your doctor or pharmacists about any concerns regarding prescribed or OTC (over the counter) drugs.

On the other hand, some patients do not have the initiative to explore issues regarding their medications, considering them safe if they are authorized for sale and prescribed by their doctors. Some patients rely absolutely on professional opinions, rarely question, and sometimes not even understanding as of why they are prescribed something or how to use it.

Also, in my own family I had discussions regarding the use of over-the counter medications like painkillers, marketed as the most recommended by doctors. When I asked the question as of why would you take it, I got the answer …”if it is over the counter and available for sale, it is safe and I can take as much as is explained on the label….well, sometimes even more..” I was shocked with the answer and realized that people do not think as I do, and that regardless of the fact that we, as clinical research professionals, invest massive efforts in proving safety and efficacy of drugs that reach the market, the key safety information that we provide with them in the labelling does not transpire to the most important person, YOU!

Therefore, I concluded that something has to be done; and that is not pointing fingers, but creating solutions and starting a conversation.  Firstly, drug safety information should be available to all people in an easy and understandable language.

The informed patient is more compliant to treatment, and is less likely to suffer side effects due to lack of understanding in the proper use and the warning signs of side effects.

Of course it is important to remark that as each of us are unique, we may react differently to drugs and therefore we may suffer a unique reaction not described anywhere because was not previously observed, and that is unavoidable, as allergy to peanuts  or seafood – that is an implied risk.

Every year there are, according to the CDC (Centers for Diseases Control and Prevention), approximately 123.8 million visits to the ER (emergency room) in the US, of which up to 38% are due to drug reactions, that is more than 47 million ER visits, all that at a cost of approximately 173 billion dollars. Not to mention the pain and suffering that it may produce, and all that largely avoidable.

If you wish to read more, you can buy this 

ebook on click here, or 

you can also order a print copy here