Medications are critical to treat diseases. Unfortunately medications do not come without risks and their use can result in adverse drug reactions.
Listen in as Jennifer Goldman MD, MS discusses the importance that providers understand how to classify adverse drug reactions, how these reactions influence future prescribing of medications, and the importance of informing patients about adverse drug reactions.
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Pediatric Adverse Drug Reactions – What’s the Risk?
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Learn more about Jennifer L. Goldman, MD
Jennifer Goldman, MD, MS
Jennifer Goldman MD, MS is an infectious diseases physician at Children’s Mercy Kansas City and an Assistant Professor of Pediatrics at the University of Missouri-Kansas City School of Medicine. She also is a trained pediatric clinical pharmacologist. Her current research interests include adverse drug reactions experienced by pediatric patients. Her long term goal is to individualize therapeutic treatment in children that will allow for optimal care while minimizing undesired drug effects.Learn more about Jennifer L. Goldman, MD
Transcription:
Pediatric Adverse Drug Reactions – What’s the Risk?
Dr. Michael Smith (Host): Our topic today is “Pediatric Adverse Drug Reactions. What’s the Risk?” My guest is Dr. Jennifer Goldman. She’s an Infectious Disease Physician at Children’s Mercy Kansas City and an Assistant Professor of Pediatrics at the University of Missouri Kansas City School of Medicine. Dr. Goldman, welcome to the show.
Dr. Jennifer Goldman (Guest): Thanks for having me.
Dr. Smith: Let’s start off this way. Let’s discuss what truly is – what’s the formal definition of an adverse drug reaction? How are we classifying these and why is that important to our community physicians?
Dr. Goldman: Sure. An adverse drug reaction is a harmful or unintended reaction to a medication that occurs with a normal dosing regimen. What I mean by that is the patient is taking the dose correctly that was prescribed by the physician. These are not overdoses or taking the wrong medication or anything like that. Adverse drug reactions are classified really into two groups, side effects and then allergies or hypersensitivities.
It’s important to recognize the difference. Side effects are dose-dependent and predictable, and these account for 85 to 90% of all adverse drug reactions. An example of a side effect is gastrointestinal upset associated with an antibiotic. It could be expected. Where allergies, on the other hand, are not dose-dependent and they are completely unpredictable. It’s thought that the immune system plays a role. Examples of these are anaphylaxis or severe skin reactions like Stevens-Johnson Syndrome. These reactions are severe, but account – thank goodness -- for only 10 to 15% of all reactions
Dr. Smith: What medications most commonly cause adverse drug reactions at least in the pediatric population?
Dr. Goldman: Sure, so in children, antibiotics are by far the most common cause of these reactions both in the inpatient and outpatient settings and across all age groups. The most common antibiotics implicated include amoxicillin, Bactrim, and azithromycin. The reactions most commonly are allergic in nature when we’re talking about antibiotics. In adolescents, antipsychotics are also frequent causes of these reactions. When you compare it to adults, anticoagulants and diabetic medications are much more commonly implicated in adults than what we see, obviously, in kids.
Dr. Smith: Okay, so what’s the burden of adverse drug reactions in pediatrics both clinically, which you’ve touched on a little bit, but also economically to the hospital, to the community?
Dr. Goldman: Yeah, so ADRs – the adverse drug reactions are by far more commonly seen in adults, especially the elderly population because they’re on many medications often. The burden of these reactions in children is not insignificant. Adverse drug reactions affect approximately anywhere from 6 to 21% of children who are hospitalized. They account for up to 4% of all pediatric hospital admissions. These reactions have been shown to result in increased medical care costs, obviously, and prolonged hospital stays as well.
Dr. Smith: Are we doing – outside of the hospital in the communities, are we – are the physicians, the healthcare practitioners – are we doing a good job in clarifying and documenting adverse drugs reactions or is there a need there that we need to do better at this?
Dr. Goldman: Yeah, I think we can all step it up a little bit. As I mentioned a few minutes ago, there are different types of adverse drug reactions, and if the healthcare provider doesn’t take the time to clarify and ask specific questions regarding a reported reaction, then the medication prescribing decisions could be negatively impacted.
I’ll give you an example. For instance, it’s a provider’s responsibility – it’s all providers’ responsibilities to take good adverse drug reaction histories. This is so important with antibiotics because up to 10% of patients report having a penicillin allergy. However, we know that often the reported allergy is a side effect of the drug, such as diarrhea or an upset stomach. These types of reactions -- which are side effects, not allergies -- should not prevent the child from getting penicillin in the future. We know when providers don’t clarify the type of reaction a patient has the penicillin, for instance, and when there’s limited information gathered, the prescriber is more often to select broader spectrum antibiotics instead of narrow, safer, or less expensive options. As tempting as it is for the clinician to quickly ask, “Do you have any drug allergies?” And when the patient says, “Yeah, penicillin,” it’s easy for us all just to stop there--
Dr. Smith: Just to write it down, yeah [LAUGHTER].
Dr. Goldman: Right, and label them for a long period of time or a lifetime, but I really encourage everyone to take the few additional steps to clarify what that patient means by the reaction so that we can clearly document it in the chart and make good prescribing decisions based on that information.
Dr. Smith: What’s the process for physicians and patients in reporting an adverse drug reaction to the FDA?
Dr. Goldman: Sure, it’s really important for everyone to know – patients, clinicians, consumers, everyone – that the FDA has something called FAERS, which is spelled F-A-E-R-S, and it’s the FDA Adverse Event Reporting System. This is a database that contains information on severe adverse events and medication errors reports submitted to the FDA.
The database is designed to support the FDA’s post-marketing safety surveillance program for drugs and therapeutic biologic products. The important point is anyone can report a severe, unexpected reaction to a medication – healthcare professionals, consumers, and patients. Again, this system is completely voluntary, and anyone can go to the Med Watch website – you can just Google FDA Med Watch, and complete an online form. There’s a phone number available or you can just snail mail in the form.
Dr. Smith: Oh, okay.
Dr. Goldman: Yeah, the FDA’s system is really intended to detect safety hazards for medications or medical products and to then be able to provide the medical community information about product safety or product recalls, medication label changes, and things like that.
Dr. Smith: Right, it’s a very important program, and I’m glad that you mentioned that consumers could also be a part of that reporting process. Dr. Goldman, thank you, so much, for the work that you are doing at Children’s Mercy, and thank you, for coming on the show today. You’re listening to Transformational Pediatrics with Children’s Mercy Kansas City. For more information, you can go to ChildrensMercy.org, that’s ChildrensMercy.org. I’m Dr. Mike Smith. Thanks for listening.
Pediatric Adverse Drug Reactions – What’s the Risk?
Dr. Michael Smith (Host): Our topic today is “Pediatric Adverse Drug Reactions. What’s the Risk?” My guest is Dr. Jennifer Goldman. She’s an Infectious Disease Physician at Children’s Mercy Kansas City and an Assistant Professor of Pediatrics at the University of Missouri Kansas City School of Medicine. Dr. Goldman, welcome to the show.
Dr. Jennifer Goldman (Guest): Thanks for having me.
Dr. Smith: Let’s start off this way. Let’s discuss what truly is – what’s the formal definition of an adverse drug reaction? How are we classifying these and why is that important to our community physicians?
Dr. Goldman: Sure. An adverse drug reaction is a harmful or unintended reaction to a medication that occurs with a normal dosing regimen. What I mean by that is the patient is taking the dose correctly that was prescribed by the physician. These are not overdoses or taking the wrong medication or anything like that. Adverse drug reactions are classified really into two groups, side effects and then allergies or hypersensitivities.
It’s important to recognize the difference. Side effects are dose-dependent and predictable, and these account for 85 to 90% of all adverse drug reactions. An example of a side effect is gastrointestinal upset associated with an antibiotic. It could be expected. Where allergies, on the other hand, are not dose-dependent and they are completely unpredictable. It’s thought that the immune system plays a role. Examples of these are anaphylaxis or severe skin reactions like Stevens-Johnson Syndrome. These reactions are severe, but account – thank goodness -- for only 10 to 15% of all reactions
Dr. Smith: What medications most commonly cause adverse drug reactions at least in the pediatric population?
Dr. Goldman: Sure, so in children, antibiotics are by far the most common cause of these reactions both in the inpatient and outpatient settings and across all age groups. The most common antibiotics implicated include amoxicillin, Bactrim, and azithromycin. The reactions most commonly are allergic in nature when we’re talking about antibiotics. In adolescents, antipsychotics are also frequent causes of these reactions. When you compare it to adults, anticoagulants and diabetic medications are much more commonly implicated in adults than what we see, obviously, in kids.
Dr. Smith: Okay, so what’s the burden of adverse drug reactions in pediatrics both clinically, which you’ve touched on a little bit, but also economically to the hospital, to the community?
Dr. Goldman: Yeah, so ADRs – the adverse drug reactions are by far more commonly seen in adults, especially the elderly population because they’re on many medications often. The burden of these reactions in children is not insignificant. Adverse drug reactions affect approximately anywhere from 6 to 21% of children who are hospitalized. They account for up to 4% of all pediatric hospital admissions. These reactions have been shown to result in increased medical care costs, obviously, and prolonged hospital stays as well.
Dr. Smith: Are we doing – outside of the hospital in the communities, are we – are the physicians, the healthcare practitioners – are we doing a good job in clarifying and documenting adverse drugs reactions or is there a need there that we need to do better at this?
Dr. Goldman: Yeah, I think we can all step it up a little bit. As I mentioned a few minutes ago, there are different types of adverse drug reactions, and if the healthcare provider doesn’t take the time to clarify and ask specific questions regarding a reported reaction, then the medication prescribing decisions could be negatively impacted.
I’ll give you an example. For instance, it’s a provider’s responsibility – it’s all providers’ responsibilities to take good adverse drug reaction histories. This is so important with antibiotics because up to 10% of patients report having a penicillin allergy. However, we know that often the reported allergy is a side effect of the drug, such as diarrhea or an upset stomach. These types of reactions -- which are side effects, not allergies -- should not prevent the child from getting penicillin in the future. We know when providers don’t clarify the type of reaction a patient has the penicillin, for instance, and when there’s limited information gathered, the prescriber is more often to select broader spectrum antibiotics instead of narrow, safer, or less expensive options. As tempting as it is for the clinician to quickly ask, “Do you have any drug allergies?” And when the patient says, “Yeah, penicillin,” it’s easy for us all just to stop there--
Dr. Smith: Just to write it down, yeah [LAUGHTER].
Dr. Goldman: Right, and label them for a long period of time or a lifetime, but I really encourage everyone to take the few additional steps to clarify what that patient means by the reaction so that we can clearly document it in the chart and make good prescribing decisions based on that information.
Dr. Smith: What’s the process for physicians and patients in reporting an adverse drug reaction to the FDA?
Dr. Goldman: Sure, it’s really important for everyone to know – patients, clinicians, consumers, everyone – that the FDA has something called FAERS, which is spelled F-A-E-R-S, and it’s the FDA Adverse Event Reporting System. This is a database that contains information on severe adverse events and medication errors reports submitted to the FDA.
The database is designed to support the FDA’s post-marketing safety surveillance program for drugs and therapeutic biologic products. The important point is anyone can report a severe, unexpected reaction to a medication – healthcare professionals, consumers, and patients. Again, this system is completely voluntary, and anyone can go to the Med Watch website – you can just Google FDA Med Watch, and complete an online form. There’s a phone number available or you can just snail mail in the form.
Dr. Smith: Oh, okay.
Dr. Goldman: Yeah, the FDA’s system is really intended to detect safety hazards for medications or medical products and to then be able to provide the medical community information about product safety or product recalls, medication label changes, and things like that.
Dr. Smith: Right, it’s a very important program, and I’m glad that you mentioned that consumers could also be a part of that reporting process. Dr. Goldman, thank you, so much, for the work that you are doing at Children’s Mercy, and thank you, for coming on the show today. You’re listening to Transformational Pediatrics with Children’s Mercy Kansas City. For more information, you can go to ChildrensMercy.org, that’s ChildrensMercy.org. I’m Dr. Mike Smith. Thanks for listening.