CP Activity 29 Adverse Drug Reaction HABAN Freddie Mark G

Pharmacy Preceptors Guild of the Philippines
HOSPITAL PHARMACY VIRTUAL INTERNSHIP PROGRAM

CLINICAL PHARMACY – ADVERSE DRUG REACTION (ADR) REPORTING
ACTIVITY ASSIGNMENT – 29
Name of Student: Freddie Mark Haban

School: Pines City Colleges
Objective:
● Able to assess and identify adverse drug reactions.

● To experience how to accomplish Philippine Food and Drug Administration (FDA) Adverse Drug
Reaction report form.
● To promote the culture of safety through proper assessment and reporting of ADRs.
Case:
The patient is healthy 55-year-old man who presented with acute onset rash and difficulty
breathing three days after incision and drainage and on Trimethoprim-sulfamethoxazole (TMP-
SMX) therapy for a gluteal fold abscess. He denied previous sexually transmitted infections,
Intravenous (IV) drug use, sexual relations with men, or high-risk sexual behavior. Two days after
initiating TMP-SMX, the patient developed a progressive, intensely pruritic rash spreading from
his trunk and covering most of his body, including his face, but sparing his palms and soles. On
the day of admission, the patient awoke to find his lips swollen and adherent, resulting in
difficulty breathing. His initial exam was significant only for mild respiratory distress, severely
swollen and tender tongue and lips, and diffuse perioral cracking with fissures. The exam was
negative for fever or lymphadenitis. The rash was a diffuse maculopapular rash with no signs of
desquamation, infection, or trauma. He was treated with supplemental oxygen, intramuscular
epinephrine, and methylprednisolone for suspected anaphylaxis. His labs were significant for
moderate elevation in alanine aminotransferase and aspartate aminotransferase and mild
leukopenia.
His rash evolved during hospitalization to include his left buccal mucosa and the base of the
penile shaft. The oral lesion was a collection of three small, white, painless ulcers on an
erythematous base. The penile lesions were two, 1-2 cm painless ulcers with smooth borders
and 2-3 cm of surrounding erythema. Given these new findings, he was evaluated for potential
infectious etiologies (Table 1). He was found to have a positive HIV viral load at a level consistent
with an acute HIV infection, which was subsequently confirmed with a 3rd-generation test 2
weeks later. He would later admit to having unprotected sex with two women he met at a
gentlemen’s club 15 days prior to initial presentation. He continued to improve and was
discharged five days following admission.
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Instruction:
1. Accomplish the ADR report form (Download:

https://ww2.fda.gov.ph/attachments/article/150840/ADR%20Form.pdf) OR (see attached
separate file)
2. Provide information needed in the table below:
Name of the Signs and Symptoms of Treatment Given What is/are your
medication ADR recommendation(s)
regarding his drug
therapy?
Trimethoprim (TMP) Progressive, intensely 72 hours of taking Cessation of the

Sulfamethoxazole pruritic rash spreading TMP-SMX. His medication.
(SMX) from his trunk and symptoms then rapidly
covering most of his resolved following the
body, including his cessation of the
face, but sparing his medication.
palms and soles.
Severely swollen and
tender tongue and lips,
and diffuse perioral
cracking with fissures
3. What type/class of adverse drug reactions based on the case of the patient?
Idiosyncratic adverse drug reactions result from mechanisms that are not currently understood.
This type of adverse drug reaction is largely unpredictable. This patient presented with a
suspected severe drug reaction, but further investigation during the evolution of that reaction
revealed acute HIV disease and provided potential clinical insight into how HIV may potentiate
an adverse reaction to TMP-SMX. This is the first reported case of new sulfa hypersensitivity in
primary HIV, further research is necessary.
REFERENCES:
 Types of Adverse Drug Reactions By Daphne E. Smith Marsh, By, Marsh, D. E. S., & Last full
review/revision Apr 2021| Content last modified Apr 2021. (n.d.). Types of adverse drug
reactions - drugs. MSD Manual Consumer Version.
https://www.msdmanuals.com/home/drugs/adverse-drug-reactions/types-of-adverse-drug-
reactions.
 Meyer, C., Behm, N., Brown, E., Copeland, N. K., & Sklar, M. J. (2015). An adverse drug reaction to
trimethoprim-sulfamethoxazole revealing primary hiv: A case report and literature review. Case
Reports in Infectious Diseases, 2015, 1–4. https://doi.org/10.1155/2015/691010
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Pharmacy Preceptors Guild of the Philippines

HOSPITAL PHARMACY VIRTUAL INTERNSHIP PROGRAM

Name of Student: Freddie Mark Haban

● Able to assess and identify adverse drug reactions.

1. Accomplish the ADR report form (Download:

Trimethoprim (TMP) Progressive, intensely 72 hours of taking Cessation of the

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