Legal Review & Commentary

Negligent drug dispensing alleged: $3.8M settlement

News: A young girl was brought to a hospital for an infection following the removal of her appendix and was admitted to the pediatric intensive care unit. An antifungal drug suitable for children was prescribed, but due to an alleged pharmacy error, the adult version of the drug was dispensed and administered. The girl had an adverse reaction to the drug and suffers from post-traumatic stress disorder (PTSD). A settlement was reached between the parties for $3,850,000.

Background: A 9-year-old girl was brought to a hospital by her parents. She was admitted to the pediatric intensive care unit for a systemic infection following the removal of her appendix. Physicians at the hospital prescribed an antifungal drug suitable for the girl's condition. Despite the fact that the prescription specified that the children's version of the drug should be dispensed, the hospital pharmacy dispensed the adult version. After administering the drug, the girl began convulsing, bleeding from various orifices, and experiencing system failure. The girl's sister was present in the room and witnessed her sister's declining condition. Once the nurse noticed the girl's reaction, she discontinued administration of the drug. The girl was resuscitated and was sent to another hospital that had specialized pediatric services. While at this hospital, the girl again coded and had to be resuscitated. During her hospitalization, the girl went through numerous blood transfusions. She was discharged six weeks later and continues to suffer from PTSD.

The parents sued the hospital and its staff pharmacists, alleging medical malpractice. Also included were claims for emotional distress.

According to reports, the defense conceded liability but emphasized the good recovery the girl made due to the quick and thoughtful action on the part of the hospital's nursing staff.

A similar situation occurred in 2006 but involved the death of a 2-year-old girl. The girl had been diagnosed with an abdominal tumor and had been undergoing chemotherapy at a children's hospital in Ohio. Following her last treatment of chemotherapy, the girl woke up in severe pain, vomiting violently. It was later found that the hospital pharmacy technician had compounded her own normal saline base solution using more than 23 times the concentration of sodium chloride instead of using a commercially pre-packaged IV solution bag. The compound poisoned the girl, who slipped into a coma and died. In that case, the hospital settled, and the pharmacist was arrested and criminally charged.

What this case means to you: This is a case of a 9-year-old girl who was readmitted with a postoperative infection following an appendectomy. An antifungal medication was prescribed to treat the infection. The case background does not specify what antifungal medication was prescribed; however, it does appear that the patient was admitted to receive this medication intravenously. Antifungal medications also are known to cause anaphylaxis. The symptoms of anaphylaxis include abdominal pain, confusion, diarrhea, breathing difficulties, dizziness, hives, nausea, vomiting, rapid pulse, and palpitations. An anaphylactic reaction can be life-threatening.

The young girl in this case suffered severe trauma due to the anaphylactic reaction. She experienced a cardiopulmonary arrest and was promptly resuscitated; however, her condition after resuscitation warranted a higher level of medical care, and she was transferred to a hospital that that specialized in pediatric medicine. According to the information given, this patient experienced another cardiopulmonary event, was given numerous blood transfusions, and remained confined to the hospital for six weeks.

The patient developed PTSD, which has traditionally been associated with combat veterans and disaster victims but has now evolved to include medical disorders. There is growing literature on PTSD among medical patients. People with PTSD tend to avoid places, people, or other things that remind them of the event and are extremely sensitive to normal life experiences. The statistics on PTSD in children reveals that up to 40% have endured at least one traumatic event, and a higher percentage involves females. The research shows that children seem to have a greater risk in developing PTSD after a traumatic event. Treatment for this type of disorder involves teaching the patient new ways to think about the trauma, giving him or her practical approaches to coping with disturbing symptoms, providing family counseling and the use of antidepressants, as well as other medications to improve the patient's mood and to decrease anxiety.

It appears that the main cause attributed to this patient's abrupt decline is the administration of the antifungal medication, which was later discovered to be the wrong dosage for a pediatric patient. Hospitals are required to have safety systems in place so that an event such as this can be prevented. This case demonstrates several system failures in the medication management process.

According to The Joint Commission (TJC), medication errors are among the top five sentinel events reported each year. TJC has been collecting sentinel event data and issuing Sentinel Event Alerts since 1995. Many of the Sentinel Event Alerts have focused on medication issues such as high-alert meds, look-alike/sound-alike meds, and unsafe use of medication abbreviations. Despite the focus on medication safety, the number of voluntarily reported medication sentinel events has not demonstrated any significant improvement.

The safety measures that failed in this case occurred in the pharmacy and in nursing care. The issues involved include medication preparation, review, and administration. TJC and the Centers for Medicare & Medicaid Services(CMS) publish medication management and pharmacy services standards that address the responsibility of the hospital pharmacist. The pharmacist is responsible for reviewing all medication orders. The orders are reviewed for allergies, potential interactions, appropriateness of the medication dose, frequency, and route of administration, impact on lab values, and other contraindications. (Editor's note: See TJC MM. 05.01.01 EP1, EP4-10.)

There also are TJC and CMS Standards governing medication administration which affect nursing. Before the administration of medication, the nurse must do the following: verify that the medication matches the medication order; visually inspect for discoloration; verify that the medication has not expired; verify that no contraindication exists; and verify that the medication is being administered at the right time, in the correct dosage, by the correct route. Before the medication is administered, the patient and family need to be informed about any potential significant adverse drug reactions or concerns with this new medication. (Editor's note: See TJC MM. 06.01.01 EP 3-9.)

The pharmacist in this case missed the dose error by not verifying it was prepared correctly before dispensing it to the patient care unit and allowed this patient to be put at risk. The nurse was responsible for verifying the medication before administration to ensure patient safety. The verification process includes verifying the following: right patient, right medication, right dose, right time, and right route. The verification process is an essential step that was missed by both professionals, thus placing this child in a dangerous situation and causing a serious event.

This case is clearly one of liability and demonstrates the need for strict medication management systems, including redundancy. Many hospitals are using bar coding to prevent such medication errors at the point of administration. While there is technology in the pharmacy to keep high alert and look-alike medications separated, the pharmacist needs to be diligent in reviewing orders when comparing them to the medication preparation.

The situation cited from 2006 involving the little girl receiving the wrong dose/concentration of chemotherapy falls under the same medication standards. The pharmacy technician should have used a premixed concentration for the base solution. It appears that the pharmacist did not review the mixture prior to dispensing the medication for administration. It is unusual that the pharmacist was criminally charged rather than pursuing disciplinary procedures through the State Board of Pharmacy. This pharmacist was negligent, but a prison term seems excessive. He or she certainly made a mistake and should have had disciplinary sanctions applied to his/her practice as a licensed pharmacist, but placing this pharmacist in jail sends a different message to other pharmacists, as well as to all health care providers. It discourages health care professionals from reporting errors. This can have a significant effect on the health care provider's ability to learn from their mistakes and to have an effect on improving the quality of health care.

Reference

• Superior Court of New Jersey, Law Division, Bergen County, BER-L-2816-07.