Empowering patients on treatment options allows the proper understanding of expectations and enables active participation in health care decisions. One component of empowerment is information. Understanding what drugs safety is, promotes better treatment conformity and facilitates the recognition of side effects that may become a serious issue. This book contains information every person that is taking either prescription or over the counter medications should have access to. Drug safety is ultimately the most important goal of the pharmaceutical industry, but what does it means for ordinary people? One of the issues regarding drug safety is that drug information on their safety and efficacy in lay language is scarce and not easy accessible. It is not always easy to understand what drug safety means and how it can affect your life. This book provides patients with a simplified approach to drug safety. Concepts are clearly presented, easy to read and with take away points were incorporated to allow further reference. The topics covered include: • The drug safety concept • Brief his-tory of drug development • The randomized controlled clinical trial and evidence based medicine • Risk/benefit assessment and how the decision is made • Drug effects, benefits • Variability in drug response • Personalized medicine and patient centered care • Drug tolerance • Side effects • Participation in treatment decisions • Quality of life • Compliance to treatment • Drugs with special pharmacology • Pharmacogenomics • Dose, dos-age, and length of treatment • Dosage forms • Off label use • Slow release/timed re-lease/extended release forms. As a continuous improvement process, I update the book once more to give you the most current information on drug safety and health care. I even shortened the title to make it easier to buy. In this revision, I included three concepts of health care and medicine that creates confusion when discussed and presented as a new solution to you. Therefore, I included a detailed review of Patient Centered Medicine vs. Patient Centric Medicine and vs. Personalized Medicine.

You can read more and buy the book here: https://www.createspace.com/6067915

Clinical Research for Beginners

What everybody should know about prescription drug safety

Part 1

Introducing to the issue of drug safety

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”.

These posts about drug safety are written to bring awareness about the issue, and to start a healthy conversation on the topic, bringing also the patients on board to assist the drug development industry and regulators to fine tune on drug related adverse events.

It is needless to say that the pharmaceutical industry has played a major role assisting in the control of diseases that have crippled humanity since the beginning of time. Antibiotics and vaccines are at the forefront of the struggle humanity has to achieve optimal health and reduce suffering.

However, it is interesting to point out that people take for granted that prescription drugs are safe, as long as they use them as indicated by the doctor.

Main issues about drug safety is "perception"

Let’s tackle first two important issues:

The first issue here is that the perception of safety has to do with the assumption that if a drug is approved by the FDA, is deemed safe.

It is important to understand that “when the FDA or another health authority deems a drug safe for use in humans, it means that randomized controlled clinical trials (RCT) have been conducted on a selected sample of the patient population for the intended disease, and that it has been demonstrated that, under limited ideal conditions of treatment, the drug had a favorable risk/ benefit ratio.” Therefore, patients have to recognize that when they use any medication, prescription or OTC there is an implied RISK. That risk can be foreseeable (because it was observed previously) or unknown (the most important variable in this equation).

Another issue is that people accepts the safety of drugs as per its definition of “free from harm”.

The other issue is the implied definition of the word safe, which means free from harm. In the world of pharmaceutical products, a safe product means only that was deemed appropriate for human use, but risks exist and harm can happen due to the risk involved. Clearly, nothing is 100% safe, even water in large amounts can be toxic. However, prescription or OTC drugs have a more clear potential of risk that we are willing to realize, and proper disclosure to the patient should be provided to make an informed decision on the use of medication.

These assumptions cannot be farther from the reality.

I recently published a book on the matter to answer some of the most common questions people have regarding their prescription drugs. In this part 1, I highlight several key areas about the safe use of prescription drugs:

PATIENT EDUCATION

There is not enough information available in lay language to provide patients with the critical information about the safety of the medications they consume. Conversely, unreliable information circulates in the internet about drug safety. Presently, there are minimal efforts on educating patients about how to correctly assess, take and report about the safety of prescription drugs. The media mostly focus on serious concerns about drugs and vaccines after the fact, where compelling cases speak for themselves. What we hear time and time again is that patients are not aware of all the risks. The truth of the matter is, sometimes we neither. The sample sizes in clinical trials allows us to see only a tip of the iceberg, and the real truth may be somewhat different. Nevertheless, if patients are empowered though education, the risk can be greatly reduced.

PATIENT UNIQUENESS

We all respond differently to drugs, and that depends on intrinsic and extrinsic factors. Since we vary in our genetic makeup, we may react different to drugs, and in the case when a drug has a very limited therapeutic index, risk increases.

THE REALITY

Of the 123.8 million visits to the ER per year in the US, 38% are linked to drug reactions. This means about 47 million ER visits are drug related at a cost of $173 billion US dollars a year.

EFFECTIVE MARKETING

A sense of safety has been attributed to drugs though effective marketing. It is important to understand that the pharmaceutical industry is a business that has to produce drugs (the commodity) that are marketable and profitable. Positioning a drug in the market requires a great effort and large investments, and is time limiting due to the patent lifespan. As such, we, the consumers, have to understand that the marketing approach is to sell a product that is going to satisfy shareholders as well as keeping the company from liability. The very fine line between liability and profitability is where drug safety lies on. Effective marketing is a necessity to keep revenues coming.

"The very fine line between liability and profitability is where drug safety lies on"

As I state in my book, …“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”.

In my next post I will be talking about pharmacology and drug safety, to better introduce you to the challenges the pharmaceutical industry is facing in function of patients expectations.

About the author: Dr. Vera M Madzarevic has more than 25 years of industry and academic experience and has dedicated her entire life on developing safe drugs. She is the Director of Research and Development of Global Research Pharma Canada and the Clinical Research Institute of America. She conducts GCP (Good Clinical Practices ) audits in compliance with FDA, Health Canada and EMA, as well as conducts clinical trials worldwide. She also educates medical and scientific professionals on clinical research and drug development. She is a published author.

If you want to see inside Vera's book on drug safety, it is available at Amazon.com.click here

If you want to see inside Vera's book on Clinical Trials Audit Preparation, a Guide to Good Clinical Practices Inspections, it is available at Amazon.com, click here

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In 2013 alone the FDA received 117,752 reports of deaths and 711,232 reports of serious outcomes (including death, hospitalization, life-threatening, disability, congenital anomaly and/or other serious outcome) involving drug therapy. 

These events almost doubled since 2009. Patients are the ones reporting almost half of these events. This is only the tip of the iceberg. In the majority of cases these reports are never filed!

We are crowdfunding to provide for a unique approach to Empowering Patients. You can help us make a difference in educating patients in the US and Worldwide to avoid unnecessary ER visits, serious drug related events and death!

Visit our web page 

image from gualberto107 at Freedigitalphotos.net

You always wondered if the medication you are taking is safe. As a matter of fact we all have. I recently published a book titled " Have you ever wondered if your prescription drugs are really safe?: A summarized expert opinion on drug safety written for everyone to understand ". I always considered that empowering patients on treatment options allows the proper understanding of expectations and allows them to actively participate in their health care decisions. One component of empowerment is information. Understanding what drugs safety is, permits for better treatment conformity and facilitates the recognition of side effects that may become a serious issue. This book contains information every person that is taking either prescription or over-the -counter medications should have access to. Drug safety is ultimately the most important goal of the pharmaceutical industry, but what does it means for ordinary people? One of the issues regarding drug safety is that drug information on their safety and efficacy in lay language is scarce and not easy accessible. It is not always easy to understand what drug safety means and how it can affect your life. This book provides patients with a simplified approach to drug safety. Concepts are clearly presented, easy to read and with take away points were incorporated to allow further reference. The topics covered include: • The drug safety concept • Brief history of drug development • The randomized controlled clinical trial and evidence based medicine • Risk/benefit assessment and how the decision is made • Drug effects, benefits • Variability in drug response • Personalized medicine and patient centered care • Drug tolerance • Side effects • Participation in treatment decisions • Quality of life • Compliance to treatment • Drugs with special pharmacology • Pharmacogenomics • Dose, dosage, and length of treatment • Dosage forms • Off label use • Slow release/timed release/extended release forms. You can browse the book at Amazon.com (http://www.amazon.com/Have-wondered-prescription-drugs-really/dp/1502532409/ref=sr_1_1?ie=UTF8&qid=1415204947&sr=8-1&keywords=vera+madzarevic)
Image from Naypong at Freedigitalphotos.net

Empowering patients on treatment options allows the proper understanding of expectations and allows them to actively participate in their health care decisions. One component of empowerment is information. Let me know what you think.