Case Study: Wrong drug repeatedly dispensed over nine-month period leads to hospital admission
Pharmacist and Medical Malpractice
Case Scenario with Risk Management Strategies
Presented by HPSO and CNA
Total incurred: $400,000
(Monetary amounts represent the indemnity settlement and legal expense payments made on behalf of the individually insured pharmacist.)
Medical malpractice claims may be asserted against any healthcare provider, including pharmacists. This case scenario involves an individually insured pharmacist working in a large chain pharmacy franchise.
The 12-year-old female patient (plaintiff) had been recently diagnosed with Wilson’s disease, a hereditary disorder in which an individual cannot properly metabolize and excrete copper. Initially, there was a nine-month delay during which the child was diagnosed with a liver disease. A further delay ensued due to referral to a pediatric hepatologist for treatment. However, when the patient was ultimately diagnosed, the pediatric hepatologist/co-defendant prescribed a 30-day supply of the chelating agent Penicillamine, a medication that binds with copper, helping the body excrete it, as well as Zinc Acetate and Vitamin B6. Each medication was noted to have three refills.
The insured pharmacist (defendant) was an independent contractor working at a chain pharmacy (co-defendant). She had been working for the pharmacy only a few days when the electronic prescription for the patient was sent to the pharmacy. The insured made an error in filling her prescription for a 30-day supply of Penicillamine 250mg BID, with a 30-day supply of Penicillin 250mg, BID. Because the pharmacist was hired to work only on a short-term basis, she was not working at the pharmacy when the Penicillamine prescription was picked up by the patient.
Over the next nine months, the pharmacy compounded the insured’s error by continuing to incorrectly fill the Penicillamine prescription with Penicillin. At one point during the nine months of taking Penicillin, the patient’s hepatologist increased the dosage from BID to TID because the patient’s serum liver enzymes and copper levels in her urine were not improving.
During month eight of taking the incorrect medication, the patient was brought to a local emergency department (ED) by her mother due to a two-day history of a rash with little relief from taking an over-the-counter (OTC) antihistamine. The ED physician (co-defendant) consulted the child’s hepatologist, who stated that the rash was unlikely to be a reaction to Penicillamine or related to Wilson’s disease. Both agreed that the child should begin a steroid dose pack, increase the dosage of the (OTC) antihistamine and follow-up with the pediatric hepatologist in two days. During the follow-up appointment, the medication error still failed to be identified notwithstanding the ED listing her medication as Penicillin 250 mg TID, rather than Penicillamine.
A few weeks later, the mother took the patient to a different ED due to her rash worsening, fever and new onset joint pain. During the ED visit, the decision was made to admit the child for possible Drug Reaction with Eosinophilia Systemic Symptoms (DRESS) syndrome. The medication error was ultimately discovered once the patient was admitted by a hospital pharmacist.
Risk Management Comments
The mother filed a lawsuit against several individuals, including the insured pharmacist, the pharmacy, all subsequent pharmacists that dispensed the wrong drug, the child’s pediatrician, the pediatric hepatologist and the ED physician and nurses associated with the first ED visit. The mother contended that the child suffered emotionally and physically from the delay in diagnosis and appropriate treatment of Wilson’s disease.
The plaintiff also asserted that the diagnosis was initially delayed by more than a year due to the co-defendant’s medical mismanagement and delayed further by nine-months due to the insured’s prescription dispensing error. As a result of the overall delay in treatment, the plaintiff alleged that the neurological effects of the disease, which include motor, cognitive and psychological deficits, were permanently impaired. The plaintiff also argued that the injury for a months-long hypersensitivity reaction to the extended Penicillin use resulted in a hospitalization for treatment of DRESS syndrome.
With respect to the issue of negligence, the insured improperly dispensed a thirty-day supply of Penicillin, rather than Penicillamine, when the plaintiff’s first prescription was presented.
Although the original prescription filled by the insured called for three refills, the pharmacy’s records demonstrated that the prescription was never refilled. Instead, the following month, a new prescription for Penicillamine was electronically sent to the pharmacy and that prescription was miss-filled by another pharmacist (co-defendant) with Penicillin.
The defense responded that at worst, the insured pharmacist was responsible for an additional 30-day delay in receiving Penicillamine, in the setting of a patient who had untreated Wilson’s Disease, and untreated liver disease, for at least two years. During that same 30 days, the patient was receiving Zinc and Vitamin B6, and reported improving symptoms.
The defense argued that any injury caused by a 30-day delay in instituting Penicillamine was minimal to non-existent. The insured pharmacist filled only one prescription, at the beginning of treatment, which was never refilled. Therefore, the defense contended that the insured pharmacist should not be liable or responsible for the actions of pharmacists who filled prescriptions after her. The later prescriptions were independent of the initial prescription, rather than refills of the insured’s original mistaken medication.
The defense expert supported the defense that a 30-day delay in instituting Penicillamine had no impact upon the patient’s ultimate condition. The expert testified that the pharmacy’s continued dispensing of the penicillin should have raised a red flag for antibiotic overuse/misuse and the possibility that the child could develop a drug resistance.
The defense experts believed our insured’s exposure was in the range of 10-15% of the overall settlement.
The parties agreed to pursue mediation in this matter. In connection with planning the mediation, plaintiff’s counsel instituted a global settlement demand of $4 million. Mediation, which lasted two-days, was unsuccessful, and the case was prepared for trial.
On the day of the trial, a global settlement was reached by all parties. The total incurred for the insured pharmacist’s professional liability claim, including indemnity and defense payments, was $400,000.
Risk Management Recommendations
- Follow pharmacy protocols when entering the drug order into the pharmacy computer, using only approved Sig codes or mnemonics.
- Never assume similar sounding names are equivalents. Sound-alike names represent one of the major factors in pharmacy errors. Effective measures should be taken to separate and clearly identify sound-alike drugs, including use of conspicuous warning labels.
- Ensure that all prescriptions are checked prior to dispensing, preferably by a second pharmacist, for additional safety. In a single pharmacist setting, the pharmacist must check each prescription against the original order; verify that the proper drug, dosage and quantity are dispensed; and confirm that the label, patient instructions and any warnings are correct.
- Do not dispense any unfamiliar drug without performing appropriate research regarding its uses, contraindications and hazards.
- Ensure that each pharmacy computer is programmed to offer comprehensive, current drug research, which is automatically updated or otherwise regularly provided for each pharmacy staff member.
- Once the drug is researched and understood, clarify the patient’s clinical history, diagnosis and drug history to ensure that the prescribed drug is appropriate for the clinical effect desired.
- Consider any override of a computerized warning to be an incident, and regularly review all overrides to identify system errors, incomplete formulary, inadequate or improper Sig codes, practitioner ordering issues, or pharmacist and pharmacy technician competency issues.
- Contact the prescribing practitioner regarding any question related to the prescribed drug, including contraindications and potential interactions, and consult with the supervising pharmacist or pharmacy director, as needed.