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.
