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U.S. Department of Health and Human Services

Consumers: Case Study 1 – Medication Error


Timmy L., an 8 year old child in the public school system in Texas, has autism spectrum disorder and is monitored by the school nurse practitioner, Karen. Timmy generally handles school activities well with only occasional periods of agitation. Last year the episodes of agitation became more frequent and he became more difficult to handle in class. Timmy’s teacher reported this behavioral change and the disruption it caused in the classroom to Karen. After observing Timmy in class, the nurse contacted Timmy’s physician, who recommended a trial of XYZ Pharmaceutical’s Attention Deficit Hyperactivity Disorder (ADHD) medication, 1mg tablet three times a day. Within 2 weeks of beginning the medication in April 2011, Timmy’s behavior improved both in school and at home, and he experienced no major side effects.

In September, Timmy's mother called in a 90 day refill for Timmy’s prescription to E-Z Drug Store and received it by mail. In December, Timmy’s mother returned to the store to pick up another refill and noticed the medication looked different from the pill he had been taking for the last 90 days. The pharmacist pulled up Timmy’s history and saw that another pharmacist had incorrectly filled the previous prescription, giving Timmy First Pharmaceutical’s dopamine agonist medication, also a 1 mg tablet taken three times a day, instead of his prescribed XYZ Pharmaceutical ADHD medication. The pharmacist apologized for the mistake and explained that the two medications have similar dosing, are stored side-by-side on the same shelf in the pharmacy, and they have similar sounding names, both beginning with the letter, "R".

Section A – About the Problem

What kind of problem was it? (Check all that apply)

Did any of the following happen? (Check all that apply)

For a problem with a product, including

  • prescription or over-the-counter medicine
  • biologics, such as human cells and tissues used for transplantation (for example, tendons, ligaments and bone) and gene therapies
  • nutrition products, such as vitamins and minerals, herbal remedies, infant formulas, and medical foods
  • tobacco and nicotine products, including those to help you quit
  • cosmetics or make-up products
Go to Section B

For problems with a medical device, including

  • any health-related test, tool, or piece of equipment
  • health-related kits, such as glucose monitoring kits or blood pressure cuffs
  • implants, such as breast implants, pacemakers, or catheters
  • other consumer health products, such as contact lenses, hearing aids, and breast pumps
Go to Section C
(Skip Section B)
Section B – About the Product
Did the problem stop after the person reduced the dose or stopped taking or using the product?
Did the problem return if the person started taking or using the product again?
Do you still have the product in case we need to evaluate it? (Do not send the product to FDA.
We will contact you directly if we need it.)
Go to Section D (skip section C)
Section C – About the Medical Device
Was someone operating the medical device when the problem occurred?
If yes, who was using it?

For implanted medical devices ONLY (such as pacemakers, breast implants, etc.):

Go to Section D
Section D – About the Person Who Had the Problem
Go to Section E
Section E – About the Person Filling Out This Form

We will contact you only if we need additional information. Your name will not be given out to the public.

Did you report this problem to the company that makes the product (the manufacturer)?
May we give your name and contact information to the company that makes the product (manufacturer) to help them evaluate the product?