Note: The two case studies examined describe wrong dose/strength medication error scenarios associated with the treatment of attention deficit/hyperactivity disorder (ADHD) in children. A
September 2023 article in Pediatrics revealed that more than 124,000 medication errors related to the treatment of ADHD in children were reported to U.S. poison centers from 2000 through 2021. The frequency of ADHD medication errors increased by approximately 300 percent during this period. Therefore, we reviewed the
Pharmacist Professional Liability Exposure Claim Report: 3rd Edition (Claim Report) 2023 dataset to identify and analyze similar claims. Two claims involving pediatric ADHD medication errors were identified.
Average Total Incurred: $75,000
CASE 1
A 10-year-old male patient’s ADHD was treated with Vyvanse (lisdexamfetamine) 30 mg daily. When refilling the prescription, an insured pharmacist allegedly dispensed 70 mg capsules in error, although the label stated “30 mg”, as prescribed. About a week after filling the prescription, the child complained of chest pain and was taken to the emergency department (ED) of a local hospital. After finding no physical reason for the child’s complaint, ED personnel suggested a possible explanation might be increased anxiety due to the patient having recently entered a new school system. The patient was released to home with a referral to cardiology for follow-up.
Before the cardiology visit, the patient told his mother that he thought the medication caused the problem. Although the mother had noticed the capsules were a different color than in the past, she assumed that they were 30 mg, as stated on the prescription vial label. She contacted the pharmacy, and, based upon the discussion, the pharmacist concluded that the medication dispensed was, in fact, 70 mg capsules, rather than 30 mg as ordered. The pharmacy corrected the error by supplying the correct product strength. However, the child refused to take the ADHD medication.
Although the patient was no longer taking the medication, he complained of an electric shock sensation in his heart/chest with exertion a few days later. During a return visit to the ED, the patient’s EKG and other test results were within normal limits. The child continued to follow up with his cardiologist and complained of the “electric shock” feeling for more than three months. The mother and child were concerned and very anxious due to a previous family history that included two extended family members who had died prior to the age of 16 of heart conditions. As a result, the mother decided to file suit.
Resolution – Case 1
Liability in the case could not be disputed. Following a review of the healthcare information records, both the defense and plaintiff experts opined that the child suffered no permanent physical injury. However, the prior family history of sudden death, the patient’s alleged anxiety and mental anguish as a result of the error, and the relatively plaintiff-friendly court venue, supported the decision to seek an early settlement. Negotiations, followed by court-required mediation, led to a settlement.
Total Incurred – Case 1: Greater than $70,000.
(Note: Monetary amount represents the indemnity settlement and legal expense payments made on behalf of the insured pharmacist.)
CASE 2
This case involves an 11-year-old male child who had been treated for ADHD since approximately six years of age. His daily medication regimen included two Concerta (methylphenidate) 36 mg long-acting tablets in the morning.
The incident occurred as the child prepared for time away from home at a summer camp. His medication was supplied in daily dose packets by the insured pharmacy. Although the packet labeling indicated that two tablets were to be taken daily, each packet contained just one 36 mg tablet.
The summer camp employed a registered nurse who was responsible for receiving, storing, and administering medications during attendees’ summer camp experience. When the child received his medication packet, he advised the nurse that his daily dose should be two tablets and not one. The lawsuit that was later filed by the parents and child asserted that the nurse ignored the child’s concerns. Furthermore, she did not contact the pharmacy or the parents to confirm the prescribed dose.
Allegedly due to the pharmacy’s packaging error and the nurse’s failure to investigate the child’s statement about his daily dose, the parents were contacted a few days later to pick up their child from the camp due to his disruptive and inappropriate behavior.
Resolution – Case 2
As a result of the medication dose error, the plaintiffs filed suit against the insured pharmacy and the camp, as the nurse’s employer. The plaintiff alleged that the child became depressed and confused, leading to aggressive and inappropriate behavior, followed by expulsion from the camp. The plaintiffs asserted damages, including increased counseling expenses to help the child cope with the embarrassment, anxiety, depression, and mental anguish suffered as a result of the incident. The lawsuit demanded $70,000 in total compensation.
The dispensing error was not contested. Settlement negotiations were pursued on behalf of the insured pharmacy, resulting in a settlement payment that was less than the plaintiff’s initial demand. However, the co-defendant camp did not agree to participate in settlement negotiations. Therefore, the outcome of the case against the co-defendant camp is unknown.
Total Incurred – Case 2: Greater than $70,000.
(Note: Monetary amount represents the indemnity settlement and legal expense payments made on behalf of the insured pharmacy.)
Risk Management Comments
Claims associated with wrong dose/strength errors represent the second most common allegation (21.9 percent) in the
Claim Report findings. This category also reflected a 46 percent increase in average total incurred from $49,901 to $72,972 since the previous report. However, wrong dose/strength errors were not as common among incidents reported to poison centers. The most appropriate error categories of those described in the
Pediatrics article for the two incidents are “other incorrect dose” (8 percent) or “health professional or iatrogenic error (pharmacist or nurse)” (2 percent). The top three error types described in the article were:
- Inadvertently took or given medication twice (53.9 percent)
- Inadvertently took or given someone else’s medication (13.4 percent)
- Wrong medication taken or given (12.9 percent)
According to the study authors, “ADHD is among the most common pediatric neurodevelopmental disorders and pharmacotherapy is a first-line treatment.” On a positive note, 83 percent of incidents did not require healthcare facility treatment. However, 2.3 percent of reported events resulted in patients being admitted to a facility and 4.2 percent of individuals reportedly had a serious medical outcome.
Risk Management Recommendations
Although the approximately 300 percent increase of ADHD medication-related therapeutic errors is substantial, the authors of the
Pediatrics article also found that the increase in these errors “parallels the increase in ADHD diagnoses” over the same time period. The authors note, however, that therapeutic medication errors are preventable, and that most of the reported errors involve “inadvertently” taking or giving the wrong medication, dose, or strength. Key prevention strategies proposed for the pharmacist to consider are:
- Emphasize and improve patient/caregiver education.
- Include information on methods to track doses scheduled/administered and/or the use of child-resistant medication organizers.
- Consider unit-dose/convenience packaging (e.g. blister packs) to simplify tracking scheduled and administered doses for the patient/caregiver.
Although 93 percent of the ADHD medication-related incidents reported to poison centers involved home-based errors, pharmacists and other healthcare professionals must remain vigilant by implementing strategies to reduce all medication errors. Such strategies may include, but are not limited to:
- For unit-dose/convenience packaging:
- Ensure that written repackaging policies, procedures and checklists are established, implemented and readily available to facilitate compliance. Conduct and document all training.
- Designate a repackaging area discrete from other pharmacy activities, and minimize all potential distractions.
- Consider limiting the repackaging process to specific days/times when staffing is sufficient to assign an individual to focus solely on this activity.
- Develop, implement, and adhere to standard operating procedures designed to prevent and/or identify medication errors prior to dispensing. To help confirm that effective methods and systems are established and implemented, refer to the Institute for Safe Medication Practices (ISMP) Medication Safety Self Assessment® for Community/Ambulatory Pharmacy.
- Implement automated identification systems, such as barcode scanning, to reduce the risk of selection and packaging errors. Barcode scanning is one of several error mitigation strategies included in the 2023-2024 ISMP Targeted Medication Safety Best Practices for Community Pharmacy. Refer to this document for further details.
- Apply an independent double check process. Consider implementing this step for prescriptions generally, and to confirm medication selection before repackaging tasks begin.
- Use a checklist to perform a systematic final check, comparing the prescriptions with the vials to be dispensed, or with the repackaged medications.
Disclaimers
These are illustrations of actual claims that were managed by the CNA insurance companies. However, every claim arises out of its own unique set of facts which must be considered within the context of applicable state and federal laws, as well as the specific terms, conditions and exclusions of each insurance policy, their forms, and optional coverages. The information contained herein is not intended to establish any standard of care, serve as professional advice, or address the circumstances of any specific entity. These statements do not constitute a risk management directive from CNA. No organization or individual should act upon this information without appropriate professional advice, including advice of legal counsel, given after a thorough examination of the individual situation, encompassing a review of relevant facts, laws, and regulations. CNA assumes no responsibility for the consequences of the use or nonuse of this information.