Level 5 Drug Therapy Requiring Intensive Monitoring for Toxicity

August 7, 2023

We get a number of questions on this topic, and for good reason: It’s complicated!

To simplify things a little, let’s start with some common examples of what does NOT qualify for intensive toxicity monitoring:

  • Drugs that have a high therapeutic index (low toxicity).
  • Short-term drug therapy (since there is no advantage to monitoring in such cases).
  • Treatment of chronic disorders (such as antihypertensive therapy), provided you can provide an adequate assessment using noninvasive methods such as blood pressure monitoring.

So, what does qualify for Level 5 toxicity monitoring? Let’s clarify.

  • Cytotoxic chemotherapy is always considered high risk when you monitor blood cell counts as a surrogate for toxicity.
  • Some drugs with a narrow therapeutic window and a low therapeutic index may qualify for intensive monitoring because they can show toxicity when concentrations are close to the upper limits of the therapeutic range. Below are some examples of such drugs (note that this is not a complete list).
Drug Category Drugs In That Category Treatment Use
Cardiac Digoxin, digitoxin, Quindine, Procainamide, Amiodarone Congestive heart failure, angina, arrhythmias
Anticoagulants Coumadin and intravenous
Heparin drip (Heparin must be provided in a hospital setting)
Prevention of thrombosis and thromboembolisms
Antiepileptic Phenobarbitol, Phenytoin, Valproic Acid, Carbamazepine, Ethosuximide, Gabapentin (sometimes), Lamotrigine (sometimes) Epilepsy, prevention of seizures, mood stabilization (sometimes)
Bronchodilators Theophylline, Caffeine Asthma, COPD (chronic obstructive pulmonary disorder), Neonatal apnea
Immunosuppressants Cyclosporine, Tacrolimus, Sirolimus, Mycophenolate, Mofetil, Azathioprine Prevent rejection of transplanted organs, autoimmune disorders
Anti-Cancer All cytotoxic agents Multiple malignancies
Psychiatric Lithium, Valproic Acid, Some antidepressants (Imipramine, Anitripyline, Nortripyline, Doxepin, Desipramine) Bipolar disorder (manic depression), depression
Protease Inhibitors Indinavir, Ritonavir, Lopinavir, Sqauinavir, Atazanavit, Nelfinavir HIV/AIDS
Antibiotics Aminoglycosides, (Gentamicin, Tobramycin, Amikacin, Vancomycin, Chloramphenicol, Cubicin, Zyvox) Infections with bacteria that are resistant to less toxic antibiotics
Insulin / Anti-diabetic Intravenous Insulin drip Hyperglycemia
Erythropoiesis-Stimulating Agents (ESAs) Procrit and Epogen (Epoetin Alfa) and Aranesp (Darbepoetin Alfa) Anemia
Biologic Agents Infliximab, Adalimumab, Ustekinumab Rheumatoid arthritis (RA), psoriasis, inflammatory bowel disease

Next question: How do you show toxicity monitoring in the dictation?
Some examples of places where you show toxicity monitoring:

  • Baseline assessments
  • Vital signs monitoring
  • ECG electrocardiogram monitoring
  • Blood tests (which are the most commonly used place in the dictation)
  • Imaging studies
  • Adverse event reporting (e.g., patients noticing adverse symptoms or changes in their condition)
  • Specialist consultations (toxicologists, cardiologists nephrologists, and hepatologists)

Patient education and compliance should be indicated in the dictation because patients need to be informed of potential toxicities associated with their medication and because of the need to adhere to the dosages and monitoring schedule. (Symptoms of drug toxicity should be reported to the physician immediately).

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Michelle Sergei-Casiano
Michelle Sergei-Casiano
Michelle Sergei-Casiano

Senior Manager, Regulatory and Coding Compliance