| Course | NURS 6521 Advanced Pharmacology |
|---|---|
| Week | Week 1 |
| Paper type | Adverse drug event review |
| Length | About 1,260 words, 7 pages |
| Format | APA 7 student paper |
| School | Walden University |
| Program | Master of Science in Nursing (MSN) |
| Updated | October 2026 |
Free sample paper for NURS 6521 Week 1
Adverse Drug Event Review: Theophylline Toxicity After Smoking Cessation in a Retired Welder With Chronic Obstructive Pulmonary Disease
Student Name
College of Nursing, Walden University
NURS 6521: Advanced Pharmacology
Instructor Name
Month Day, Year
Adverse Drug Event Review: Theophylline Toxicity After Smoking Cessation in a Retired Welder With Chronic Obstructive Pulmonary Disease
Case and Timeline
The patient and every date in this review are fictional. R.M. is a 67-year-old retired welder with chronic obstructive pulmonary disease who has taken extended-release theophylline for six years alongside an inhaled long-acting bronchodilator, prescribed by a previous clinician before he joined this practice. His serum theophylline levels have been stable and within the reference range at annual checks. He smoked a pack of cigarettes a day for 48 years. The events unfolded in the following sequence.
March 3: annual visit; theophylline level within the reference range; no symptoms of toxicity.
April 14: R.M. stops smoking abruptly after his granddaughter is born. He does not use nicotine replacement and does not tell the practice.
April 19: mild nausea after meals, which he attributes to quitting.
April 23: worsening nausea, one episode of vomiting, a fine tremor in both hands, trouble sleeping, and a sensation of his heart racing.
April 24: clinic visit. Heart rate 118 and regular, blood pressure 138/84, afebrile. Electrocardiogram shows sinus tachycardia without arrhythmia. Serum theophylline is above the laboratory's reference range. Theophylline is held.
April 27: nausea and tremor have resolved; heart rate 84; repeat theophylline level back within the reference range.
The sequence alone makes the change in smoking the leading suspect: the drug, its dose, and his other medicines were unchanged for years, and the only new event before the symptoms was quitting.
His other medications, a long-acting muscarinic antagonist inhaler, an albuterol rescue inhaler used about twice a week, lisinopril, and atorvastatin, had been unchanged for more than a year. He had not been prescribed any antibiotic, antifungal, or acid suppressant recently.
Causality Assessment
The Naranjo Adverse Drug Reaction Probability Scale was applied question by question (Naranjo et al., 1981). Each item is shown with its answer and the points assigned so that the total can be recomputed.
1. Are there previous conclusive reports on this reaction? Yes: increased theophylline exposure after smoking cessation is well documented (Zevin & Benowitz, 1999). Points: +1.
2. Did the adverse event appear after the suspected drug was given? Yes: theophylline was taken continuously before and during the event. Points: +2.
3. Did the reaction improve when the drug was discontinued? Yes: symptoms resolved within three days of holding theophylline. Points: +1.
4. Did the reaction reappear when the drug was readministered? Not attempted. Rechallenge at the previous dose would have exposed him to the same toxicity for no clinical gain, so it was not done. Points: 0.
5. Are there alternative causes that could on their own have caused the reaction? No, after the review of other factors below. Points: +2.
6. Did the reaction reappear when a placebo was given? Not applicable. Points: 0.
7. Was the drug detected in the blood in concentrations known to be toxic? Yes: the April 24 level was above the reference range. Points: +1.
8. Was the reaction more severe when the dose was increased or less severe when it was decreased? Not observed separately: the drug was held rather than reduced, so a dose-response relationship was not tested apart from question 3. Points: 0.
9. Did the patient have a similar reaction to the same or similar drugs in a previous exposure? No record of one. Points: 0.
10. Was the adverse event confirmed by objective evidence? Yes: the serum level and the electrocardiogram. Points: +1.
Total: 8, which falls in the probable category (5 to 8). The rating stops short of definite mainly because rechallenge was not attempted and a separate dose-response relationship was not observed, both for sound clinical reasons.
Mechanism: Induction Removed, Clearance Slowed
Theophylline is cleared mainly by hepatic metabolism, predominantly through cytochrome P450 1A2 (CYP1A2), with only a small fraction excreted unchanged by the kidneys (Rosenthal & Burchum, 2021). CYP1A2 activity is inducible. Polycyclic aromatic hydrocarbons in tobacco smoke, products of incomplete combustion, bind the aryl hydrocarbon receptor in hepatocytes and increase transcription of the CYP1A2 gene, so smokers make more of the enzyme and clear its substrates faster (Kroon, 2007). Nicotine itself is not responsible for this effect, which is why nicotine replacement does not maintain induction.
For six years, R.M.'s theophylline regimen had been set, through levels and symptoms, against a liver whose CYP1A2 activity was raised by smoking. When he stopped abruptly, the inducing signal disappeared. Enzyme levels do not fall overnight; the existing enzyme is degraded and replaced by less newly synthesized enzyme over several days. As CYP1A2 activity declined, theophylline clearance fell while his intake stayed the same, and serum concentrations rose progressively. That gradual course explains why his first symptom appeared five days after quitting and why symptoms peaked around nine days: the timing matches the decay of induced enzyme rather than a sudden event (Zevin & Benowitz, 1999).
The consequence was serious because of the drug's narrow therapeutic range. The concentrations that relieve bronchospasm are close to those that cause toxicity, so a fall in clearance that would be harmless for a wide-margin drug moved him into the toxic range. His symptoms fit the known effects of excess theophylline: nausea and vomiting from central and gastric effects, tremor and insomnia from central nervous system stimulation, and tachycardia from adenosine receptor antagonism and phosphodiesterase inhibition in cardiac tissue. At higher concentrations, arrhythmias and seizures can follow, which is why the interaction warrants attention before, not after, a patient quits.
Other Factors Considered and Set Aside
Kidney function: his creatinine was unchanged from March, and renal excretion plays only a minor role in theophylline clearance, so renal decline cannot account for the rise.
Age: hepatic clearance of theophylline declines modestly with age, but that change is gradual over years and had already been reflected in six years of stable levels.
Genetic variation: CYP1A2 activity varies between individuals, but an inherited trait would have shown itself when the drug was started, not six years later.
New interacting agent: potent CYP1A2 inhibitors such as ciprofloxacin, fluvoxamine, and cimetidine can raise theophylline levels sharply; none had been prescribed or bought over the counter, as confirmed with R.M. and his pharmacy.
Intercurrent illness: fever, heart failure, and liver disease reduce theophylline clearance; he had none.
Revised Plan
The choice facing the prescriber is between keeping theophylline at an adjusted regimen and replacing it with an agent that has a wider margin of safety. Keeping it would require a reduced regimen calculated for his new, uninduced clearance, confirmed by serum levels until they are stable, and it would leave him exposed to the same problem in reverse if he relapsed to smoking and his clearance rose again, reducing effectiveness. Replacing it is supported by current guidance, which places inhaled long-acting bronchodilators ahead of theophylline for chronic obstructive pulmonary disease and reserves theophylline for situations where other long-term bronchodilators are unavailable or unaffordable (Global Initiative for Chronic Obstructive Lung Disease [GOLD], 2024). Since R.M. already uses a long-acting muscarinic antagonist, adding a long-acting beta agonist in a combined inhaler and discontinuing theophylline removes the narrow-margin drug altogether.
The plan recommended is substitution, with theophylline stopped and spirometry and symptom scores reviewed at follow-up to confirm that control is maintained. His quit attempt is supported with counseling and pharmacotherapy, and the practice notes in his chart that smoking status changes clearance of CYP1A2 substrates, so that any future prescriber reviewing his list is alerted. The event was reported to the practice's safety system and to the FDA MedWatch program as a clinically significant interaction.
References
Global Initiative for Chronic Obstructive Lung Disease. (2024). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: 2024 report. https://goldcopd.org/2024-gold-report/
Kroon, L. A. (2007). Drug interactions with smoking. American Journal of Health-System Pharmacy, 64(18), 1917-1921. https://doi.org/10.2146/ajhp060414
Naranjo, C. A., Busto, U., Sellers, E. M., Sandor, P., Ruiz, I., Roberts, E. A., Janecek, E., Domecq, C., & Greenblatt, D. J. (1981). A method for estimating the probability of adverse drug reactions. Clinical Pharmacology & Therapeutics, 30(2), 239-245. https://doi.org/10.1038/clpt.1981.154
Rosenthal, L. D., & Burchum, J. R. (2021). Lehne's pharmacotherapeutics for advanced practice nurses and physician assistants (2nd ed.). Elsevier.
Zevin, S., & Benowitz, N. L. (1999). Drug interactions with tobacco smoking: An update. Clinical Pharmacokinetics, 36(6), 425-438. https://doi.org/10.2165/00003088-199936060-00004
NURS 6521 Week 1 instructions, in plain terms
The first NURS 6521 week asks you to review an adverse drug event. Lay out the case and timeline, assess causality with a named scale, explain the pharmacologic mechanism, consider alternative causes and revise the plan. The mechanism carries the most weight, so saying a level rose restates the event; naming the enzyme, the inducer and the change in clearance explains it. Cite pharmacology sources in APA 7. A causality scale makes the judgment structured and checkable. The review can recommend monitoring and adjustment without a specific new dose. The case is fictional. A dated timeline makes the cause visible. A clear layout runs case and timeline, causality, mechanism, other factors and revised plan. A dated table of events, levels and symptoms makes the sequence easy to follow.
How this NURS 6521 Week 1 example is built
Four pages, in the order a pharmacovigilance report would use. The opening paragraph sets out the timeline in dated steps: a long-standing prescription, a decision to quit cigarettes, then nausea, tremor and a racing pulse some days later. A short table scores the event on the Naranjo scale, question by question, so the probability label at the bottom can be checked rather than trusted. The mechanism section explains that tobacco smoke had been inducing the hepatic enzyme clearing the drug, and that removing the inducer slowed metabolism until exposure climbed. Age, genetics and organ function are each considered and set aside in a sentence apiece. The closing plan says what the prescriber would change and what would be watched, stated as reasoning, without a number anywhere.
Where the marks sit in the NURS 6521 Week 1 rubric
Most sections weight the mechanism heaviest, and it is lost to description: saying a level rose restates the event, while naming the enzyme, the inducer and the direction of change explains it. Patient factors carry the next share, and the common shortfall is a list of every influence the textbook names with none applied to the person in the case. Causality is where careful reviews separate themselves, since a rating given without its working looks like a guess even when it is right. The plan row wants the change connected to the mechanism, so a revision that would fit any adverse event scores low. Remaining points go to how current the sources are and to APA accuracy, and an outdated drug reference costs more than a formatting slip.
Common NURS 6521 Week 1 mistakes, and how to avoid them
Adverse event reviews score low when they describe what happened without why. Name the enzyme and inducer. A second weakness is skipping causality. Use the Naranjo scale. Writers also ignore other causes. Consider and set them aside with reasons. Avoid vague plans. State what to monitor and when. Keep the timeline dated. A sentence explaining that tobacco smoke induces CYP1A2, so quitting slows theophylline clearance within days, shows the mechanism in one step. End with the check that would have caught it early.
Get a NURS 6521 Week 1 example written to your instructions
Share the case instructions and rubric from your section, and a custom review for NURS 6521 Week 1 gets built around the event type your prompt specifies. The first custom one is free, delivered within 24 to 48 hours. Should your prompt supply its own patient, the review works from that patient instead of the composite shown here.
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NURS 6521 Week 1 questions, answered
Was a real reaction used for the example?
No. The patient, the regimen and the timeline are composite, put together so a single pharmacokinetic factor could be isolated cleanly on the page. Where a prompt calls for an event witnessed in practice, the facts must come from your own experience, with identifying details removed. The part worth borrowing is the sequence itself: causality settled first, mechanism explained second, and the plan held back until both are done.
Why does the review use a causality scale at all?
Because the prompt asks what caused the event, and a claim of cause needs support that stands apart from the explanation. The Naranjo scale is a widely taught questionnaire for rating how probable it is that a drug produced a reaction. Some sections prefer a different instrument or none; the review keeps the rating in its own table so it can be swapped without disturbing the argument.
Does the review recommend a specific dose change?
It does not. The revised plan states which direction the prescriber would reason, and which agents or checks would be weighed, but it deliberately carries no amounts, intervals or target levels. Those depend on a real patient and current prescribing references, and your submission should take them from the sources your course assigns rather than from a sample page.
Where can I find a free NURS 6521 Week 1 sample paper?
The theophylline toxicity review is reproduced here with the timeline, causality assessment, mechanism, other factors and revised plan.
Why did stopping smoking raise the theophylline level in NURS 6521 Week 1?
Smoking induces CYP1A2, the enzyme that clears theophylline; when he quit, the enzyme activity fell and the drug built up.