Part 1
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.
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:
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.
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.
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.
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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patient safety
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clinical research
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drug safety
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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
- patient safety
- clinical research
- drug safety
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