Electronic Health Records (EHRs) Endanger Patients’ Lives Based on Patient Testimonies, and Expose Physicians to Potential Liability

 Reported to the Electronic Health Record Association
@EHRAssociation, October 1, 2020

INCIDENT #1:  Electronic Health Records (EHRs) must never automatically diagnose patients based on prescribed drugs.

A Patient’s Personal Testimony Reprinted with Permission

A lifelong hypotensive patient is taking a small dose of atenolol for abnormal heart rhythms (history of premature ventricular contractions) which is clearly documented in the patient's medical records.  However, the Electronic Health Record (EHR) software program automatically diagnosed this patient with "high blood pressure" based on the prescribed medication.  This patient's hypotension is so severe that the patient’s cardiologist prescribed fludrocortisone to raise his/her blood pressure; however, due to an adverse reaction, the patient had to discontinue the medication.

Several years ago, this patient provided a hospital with a written statement that he/she was taking atenolol for premature ventricular contractions (PVCs) — NOT for blood pressure issues.  The patient's medical records at this facility still reflect that this patient has "high blood pressure" in the patient's official medical records, which is a direct result of this critical glitch in the Electronic Health Record (EHR) software program.  Even though the patient had submitted a written statement to the hospital confirming the purpose for taking this drug, the patient gave up trying to correct this error in his/her medical record due to the "red tape nightmare" involved with effecting this correction.  Therefore, this patient will never be able to disclose to any other medical provider that he/she is taking this particular drug due to the automatic misdiagnosis of "high blood pressure" that will be recorded in the patient's official medical records.

In consultation with one of the subject patient's other physicians, the patient was forced to lie to this physician indicating the patient is no longer taking atenolol.  This patient indicated that he/she will inform his/her remaining medical providers that he/she is no longer taking this drug to guarantee the patient's safety and to maintain the integrity of the patient's official medical records.  The only medical record reflecting that the patient is taking this drug will be maintained by the patient's prescribing physician with an alert that this drug is prescribed for abnormal heart rhythms; however, there is still no guarantee that the Electronic Health Record (EHR) software program will not misdiagnose this patient in the future based on this prescribed drug. 

It is also important to note that the patient caught the misdiagnosis of  "high blood pressure" in his/her medical record while using the electronic tablet just prior to the patient’s appointment with the prescribing physician.  Therefore, it is of critical importance that all patients carefully review the "diagnosed medical conditions" indicated in their medical records with each physician consultation.   

Atenolol can be used to treat conditions unrelated to blood pressure control; however, the Electronic Health Record (EHR) software program automatically chose the predominant condition and applied it to this patient’s official medical records.

https://www.webmd.com/drugs/2/drug-11035/atenolol-oral/details

https://www.nhs.uk/medicines/atenolol/#:~:text=Atenolol%20belongs%20to%20a%20group,disease%2C%20heart%20attacks%20and%20strokes.

Conclusion:

The automatic diagnosis of a patient by a flawed, computer-generated software program endangers patients’ lives.  It also places physicians at risk for potential liability.  This patient’s hypotension was clearly noted in the patient’s hospital medical record prior to surgery.  What if an emergency situation had developed during this patient’s surgical procedure; and the surgeon treated this patient based on a diagnosis of "high blood pressure" due to the surgeon’s reliance on the diagnosis that was generated by the Electronic Health Record (EHR) software program resulting in harm, or even death, of this patient?   The liability for this critical medical error rests solely with the physician.

How many other patients’ lives are currently in danger due to the critically flawed Electronic Health Record (EHR) software program?

Since Electronic Health Records (EHRs) must never diagnose a patient based on prescribed medications, immediate attention to this issue is required.

INCIDENT #2:  Electronic Health Records (EHRs) must never "selectively censor" a patient’s allergens (or derivatives thereof).

The FDA states that people can suffer allergic reactions to more than 160 foods, but that only eight of these foods have been declared official allergens subject to FDA labeling requirements since these foods represent approximately 90 percent of allergic reactions.
https://www.fda.gov/food/food-labeling-nutrition/food-allergies

In response to my recent inquiry submitted to the FDA requesting documentation of the "90 percent" claim, Case #247585, the FDA provided me with the following cited article.

J. Bousquet, et al., confirm in their article "Scientific criteria and the selection of allergenic foods for product labelling" that although the Top 8 allergens account for over 90% of food allergies, ". . . there is a much longer list of other foods and food ingredients that have been associated with allergic reactions in sensitive individuals."  [emphasis added]
https://pubmed.ncbi.nlm.nih.gov/10100969/

A patient's official medical record must reflect all of a patient's IgE-mediated allergies (and derivatives thereof), whether it's an allergy to lettuce or peanuts.  Selectively censoring the option to record all of a patient's confirmed IgE-mediated allergies not only endangers the lives of patients, but also places the physician at risk for liability.  Bear in mind that there is usually a written account of a patient’s allergies in their medical records.  Selectively censoring a patient’s allergens in the EHR does not protect the physician from potential liability if the physician prescribes/administers a drug/biologic product containing excipients of the patient’s allergens, even though no contraindication warning is indicated in the package insert.

My Doctor Prescribed the Wrong Medication. Is It Medical Malpractice? By Prathyusha Chowdri
"The doctor prescribes a medication which contains an ingredient to which the patient is allergic." [emphasis added]
https://www.nolo.com/legal-encyclopedia/my-doctor-prescribed-the-wrong-medication-is-malpractice.html

It is the patient's responsibility to inform their physician of their IgE-mediated allergies; however, it is their physician's responsibility to verify that the prescribed drug/biologic products do not contain the patient's allergens or derivatives thereof; i.e., corn-allergic patients must be able to list the following corn products/corn-derived excipients in the EHR.

Corn Allergen Lists
https://cornallergyadvocacyresources.blogspot.com/2018/07/corn-allergen-lists.html

Without the ability to include these excipients in the EHR, the physician is required to contact drug/biologic manufacturers to verify if prescribed drugs contain corn-derived excipients; since most physicians are unfamiliar with the dangers of non-medicinal ingredients (NMIs) in these products. 

93 percent of medications contain 'potential allergens'
https://www.medicalnewstoday.com/articles/324681

"Inactive" ingredients in oral medications
https://stm.sciencemag.org/content/11/483/eaau6753

Non-medicinal ingredients don’t appear on drug labels
http://library.bcpharmacists.org/6_Resources/6-7_ReadLinks/ReadLinks-MayJun2007.pdf

PHARMACISTS CONFIRM THE STUDY OF NMIs (NON-MEDICINAL INGREDIENTS) IN DRUGS IS NOT PART OF CURRICULUM
https://cornallergyadvocacyresources.blogspot.com/2020/06/pharmacists-confirm-study-of-nmis-non.html

Please refer to the following articles which explain why the EHRs need to be expanded for patients with an IgE-mediated allergy to corn, e.g., corn-allergic patients must be able to list an allergy to fresh food products (treated with corn-derived antimicrobial chemical washes) and tap water (corn-derived water purification chemicals), in addition to non-ingestible products, e.g., surgical dressings, dyes, shampoo, soaps, cleaners, toilet paper, fabrics, etc.

"Corn: It's Everything" by Iowa Corn
https://www.iowacorn.org/education/corn-its-everything/

FDA  AND USDA CONFIRM THAT CORN-DERIVED ANTIMICROBIAL CHEMICALS APPLIED TO FRESH FOOD PRODUCTS ARE EXEMPT FROM PUBLIC DISCLOSURE
https://cornallergyadvocacyresources.blogspot.com/2020/06/fda-and-usda-confirm-that-corn-derived.html

A mother's desperate struggle to find safe water for her corn-allergic infant son.
https://cornallergyadvocacyresources.blogspot.com/2019/05/a-mothers-desperate-struggle-to-find.html

Contact-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/06/if-you-are-reacting-to-clothing.html

Inhalation-Reactive to Corn: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/10/inhalation-reactive-to-corn-personal.html

An IgE-mediated allergy to corn can be just as lethal as an allergy to any of the Top 8 allergens.

Corn Allergy Symptoms: Personal Testimonies
https://cornallergyadvocacyresources.blogspot.com/2020/11/corn-allergy-symptoms-personal.html

When I advised my physician of my IgE-mediated allergy to corn, the EHR only indicated that I was allergic to corn oil.  As a result, I conducted the following survey in one corn allergy group which revealed that EHRs are selectively censoring allergens from a patient’s medical records. 

Survey:

With the advent of electronic health records, are any of you limited from listing all of the corn-derived ingredients we must avoid into your medical records; e.g., when I listed an allergy to corn, it only indicated that I was allergic to corn oil? 

Why is this important?

If your physician is prescribing a medication for you, and your medical records don't list all of the corn-derived ingredients you are to avoid; he/she wouldn't realize that a prescribed drug would be contraindicated for you.

With your permission, as with my other surveys, I would like to include your replies in the post using only your initials. 

Thank you very much!

Survey Responses Reprinted with Permission:

Corn wasn’t even an option for referring me to an allergist. My doctor had to select "unknown food allergies." My medical record didn’t have a space to put corn. My doctor couldn’t even put corn on the referral to get me tested. It’s not recognized by the medical network I was in prior to my diagnosis.  My PCP couldn’t believe he couldn’t select corn.

[My question to this respondent: So how was the matter resolved?]

It never was. I switched medical networks and it’s now in my file. It was added by my allergist, though, so I don’t know if I’d be able to add it myself. I know with my kid’s record, I can manually add allergies. – E.B.

My doctor has me listed as being allergic to corn meal. It was the only corn option on their list. – L.Z.

I was told that they would have to get clearance from a coder to add those as an allergy and that it would most likely never happen because they are rare "allergies."  I've worked in a lot of hospital systems that had different EHR programs. I know that it's possible. They can make a grouping of the corn derivatives. It's the fact that the medical coder doesn't want to build each one. If you could list all of the derivatives in the EHR, it would automatically alert the prescribing physician and pharmacist that the prescribed medication is contraindicated for the patient.  It could at least narrow it down to say can you call a compounding pharmacy to compound this drug without [insert ingredient], and would be a quick and easy tool to find the "cleanest" medications.  I was recently talking to a pharmacist at Express Scripts, and he indicated they could only list cornstarch and corn oil. When I showed him the corn derivative list, he stated that they don't have derivatives of anything on the EHR. This is important since your doctor is the first person responsible for prescribing drugs that do not contain your allergen.  The second person is the pharmacist who is referencing an EHR that is currently incomplete.  – A.C.

Literally went to the ER for an allergic reaction that was affecting my breathing, etc., and they tried to give me meds with corn even though it was listed on my chart. I actually left sicker than when I went in. I refused 2 of the 3 medicines.  The one I did take was anti-nausea and it made me throw up because it had corn in it, but they had already injected it in the IV so it was too late and I had to ride it out.  It scares me because what if I had been unconscious and couldn't say no? I was already going anaphylactic, and then they gave me more of what I was allergic to. I'm literally terrified of having to go to the ER in the future. – K.U.

I emailed a PDF, provided a physical copy, and personally discussed a list of corn allergy triggers with my doctor. They were able to attach it to my electronic chart. However, it cannot trigger the automatic pop-up that lets the doctor know that a prescription may be contraindicated. I still have to be alert to remind them of my allergy and discuss each prescription and procedure individually. – S.W.

My chart says I am allergic to "corn oil (food) " as well, as it was the only option to mark in their system. I don’t understand why they can’t just type something in. – M.H.

My doctor has the ingredients-to-avoid list. It is in my file but not sure about the electronic file. I give the list to every single doctor I see. Even then, they prescribe meds that are going to cause issues. I am actually being turned down repeatedly by gynecologists because of my allergy. They do not feel they can examine me safely. Seriously!  – D.D.

I've had to go back and ask for medical records to be changed.  I found so many errors. – J.K.

Yes. It is so frustrating! Please include my and my daughter's experiences with this issue. My daughter's chart doesn't even say she's allergic to Dextrose. And when I mention it to the doctors and the nurses they say her corn derivative allergy list is too long to enter into the allergy list that is up front for all to see, but that other nurses can find it in their records and that the word "corn" is enough — but the other nurses can't see the full list! And they have no idea about what comes from corn and what doesn't! It takes them too long to search her chart for her allergy list document and the nurses give up. When I tell them that it's important because she has an anaphylactic allergy to those corn derivatives, and some of them are the names of medications, and I have a list of the derivatives with me, then they just copy the paper that I bring with me, and then enter it again; but no one can ever find it. I have to bring it with me every time she has any kind of appointment in the hospital, or procedure, or emergency visit — which is a lot right now. And the fact that these things are not listed in her chart on the first page with the rest of the allergies and they can't find them right away and I tell them she is anaphylactic to them — that makes them act weird around me, treat me differently — it's like they don't believe me. This has also caused doctors to prescribe medications to my daughter on a regular basis that either the medication itself is directly listed by its name on the list (for example: Polyethylene glycol) and/or medications that have multiple excipients in them that are on the list. I then have to work with the pharmacist (which means the pharmacist hands me the paper from the manufacturer out of the prescribed medication container and I have to search all the fine print; and if the information isn't there, I have to contact the manufacturer) to see if there are corn derivatives in the medication.  If there are corn derivatives, then the pharmacist will look to see if there is a similar medication that she can take that doesn't have anything she's allergic to, or if I have to try to get it compounded, or if she has to go to an alternative type of treatment. – L.H.

Based on using EMRs, I can't imagine that the entire derivatives list would fit under the allergies section.  I do wonder if there could be a subsection under each allergen that would allow the derivatives to be listed where they also list the reaction type. – B.M.

I can never list every derivative we are allergic to. There is no option available. My children’s pediatrician just sits down with me to review the package insert whenever she needs to prescribe anything. If it’s an antibiotic, it gets really complicated and usually takes days to find one for one of my kids, for the other one it must be compounded. – G.D.J.

Prevalence of Corn Allergies:

Corn allergies are NOT rare.  Since corn is ubiquitous and is currently exempt from FDA labeling requirements (including the majority of drug/biologic products), allergic reactions to corn are categorized as idiopathic which results in suppression of corn allergy statistics.  Membership in corn allergy support groups (13.5K) is more than double the membership in sesame seed allergy support groups (6.4K), yet the FDA is considering declaring sesame seed an official allergen subject to FDA labeling requirements.

October, 2020, Month-End Corn Allergy Statistics: 977.7% Increase in 88 Months
https://cornallergyadvocacyresources.blogspot.com/2017/04/corn-allergy-statistics-monthly.html

Published Corn Allergy Studies (". . . Maize major allergen . . . ")
https://cornallergyadvocacyresources.blogspot.com/2017/05/published-corn-allergy-studies.html

Conclusion:

The Electronic Health Record (EHR) system must never engage in "selective censorship" of a patient’s allergens (or derivatives thereof) from a patient’s medical records.  The consequence of this censorship not only endangers the lives of patients, but also places physicians at risk for potential liability if they prescribe/administer drug/biologic products containing excipients derived from a patient’s allergen(s).

Recommendations:

1.  Immediately prohibit Electronic Health Record (EHR) systems from diagnosing patients based on prescribed medications.

2.  Immediately prohibit Electronic Health Record (EHR) systems from "selectively censoring" a patient’s allergens, or derivatives thereof, from their official medical records.

3.  Physicians should appeal to the FDA to mandate contraindication warnings on all drug/biologic products based on the "source of excipients."

 

Diane H., Corn Allergy Advocate
Corn Allergy Advocacy/Resources
https://cornallergyadvocacyresources.blogspot.com/
Email:  cornallergyinitiative@gmail.com
Twitter:  @CornAllergy911

Additional Reference

Corn Allergy References, Surveys, Studies (". . . Maize major allergen . . ."), Statistics, & Petitions
https://cornallergyadvocacyresources.blogspot.com/2018/04/corn-allergy-reference-links.html

 

Blog Post Reference Link

Electronic Health Records (EHRs) Endanger Patients’ Lives Based on Patient Testimonies, and Expose Physicians to Potential Liability
https://cornallergyadvocacyresources.blogspot.com/2020/11/electronic-health-records-ehrs-endanger.html

Note:  This blog post has been distributed globally, including to all 535 members of Congress.