Consumers: Case Study 1 – Drug Quality Problem
Karen D. is a 35 year old married Caucasian woman, employed as a occupational therapist at Anytown Medical Center in Anytown, Maryland who was seen by her regular skin doctor, Dr. Fleming, for a six week history of worsening redness and swelling of her feet. Karen had noted intense redness, itching and scaling of the skin around all toes on each foot, right more than left. She more recently had cracking of the skin between several toes and a small amount of clear drainage. Dr. Fleming’s examination suggested the diagnosis of a fungal dermatitis and a new antifungal solution was prescribed for application to the affected areas. On April 3, Karen purchased her medication, named FungusStop, at a nearby EZStop Pharmacy. The product is manufactured by XYZ Pharmaceuticals and is supplied in a 25 mL glass vial, 250 mg/cc with an applicator tip provided to be inserted in the sealed, stoppered neck of the vial.
On examining the vial after returning home and reading the package insert instructions, Karen noticed unusual particles within the glass vial. She opened the vial by taking off the stopper and removed three irregular pieces of what appeared to be glass, the largest of which measured approximately ¼ inch by ¼ inch. She returned to the pharmacy immediately and showed the medication to the pharmacist, who agreed that, while the vial appeared to be intact, there were particles within the solution.
The pharmacist examined the remaining vials that were received from the distributor from the same lot, and by visual inspection did not observe any other vials with partiicles in the solution. Nevertheless, she told Karen that she planned to set aside the entire remaining supply of the drug product in case further direct inspection was required.
Karen knew from her hospital work about reporting product quality problems to FDA and asked the pharmacist for the internet address for FDA’s MedWatch program, www.fda.gov/medwatch/report.htm. She also requested that the pharmacist provide the NDC number (12345-678-90) that identifies this specific brand, the type of medication, and the lot number, # A12345BC, for this specific ‘batch’ of vials.