Close-Up on Complaints


Close-Up On Complaints Logo

“Close-Up on Complaints” explores incidents reported to the College that have occurred in the provision of patient care and which present learning opportunities. Ideally, pharmacists and pharmacy technicians will be able to identify areas of potential concern within their own practice, and plan and implement measures to help avoid similar incidents from occurring in the future.


SUMMARY OF THE INCIDENT

A nine-year-old patient had to be taken to a hospital’s emergency department after experiencing an overdose due to a prescription filled improperly at the patient’s pharmacy.

The patient had a recent change in prescription. The patient’s mother indicated to the pharmacy that this was not a change in total dosage but in administration such that the patient was to take 1 mg in the morning and 2 mg in the evening rather than 3 mg at once. Unfortunately, the pharmacy dispensed the medication as three 3 mg tablets daily.


WHY DID THIS HAPPEN?

When entering the new prescription into the pharmacy computer system, pharmacy staff used the computer system’s “copy” function to copy the patient’s previous prescription. The previous prescription was ordered and entered as 3 mg, take one tablet every evening.

In the process of entering the new prescription, the old prescription was copied and inactivated and the original drug, strength and directions were inserted into the new prescription record. A note was made that the dose had been changed; however, while the instructions were changed to read “take 1 tab in the morning and 2 tablets in the evening,” the drug strength was not changed from 3 mg to 1 mg.

Copying prescriptions creates inherent risks including the potential for serious medication incidents. The pharmacist did not recognize this risk in the pharmacy process until an error occurred. Pharmacy professionals should be able to recognize the potential issues created by copying over old prescription information to a new prescription.

Moreover, the pharmacist reviewed the prescription and should have been able to catch the error by comparing the original prescription to the medication vial and the dispensing record when conducting both the technical and therapeutic checks. Since this prescription was dispensed for a child, a “red flag” patient, even greater care ought to have been exercised during all steps in the dispensing and verification process.

Ultimately, the pharmacist in this case was not fully cognizant of critical risks associated with the pharmacy’s established processes and their potential impact on patient care and did not take adequate time to ensure the accuracy of the medication and instructions given to the patient.


COMPLAINT OUTCOME

The College’s Inquiries, Complaints & Reports Committee oversees investigations of each complaint the College receives. A committee panel considers a pharmacy professional’s conduct, competence and capacity by assessing the facts of each case, reviewing submissions from both the complainant and the professional, and evaluating the available records and documents related to the case.

The pharmacist, who was also the pharmacy’s designated manager, accepted responsibility for the incident and addressed the situation appropriately once learning of the error. The pharmacist contacted the patient’s doctors and implemented a number of changes to the pharmacy’s processes, including ensuring prescriptions with changes are no longer copied and reinforcing step-by-step checks for data verification.

The pharmacist also changed the way directions are to be written to highlight the intended dose. One way to do this is to specify the total strength in brackets. For instance, 3 tablets (9 mg) in the morning and 2 tablets (6 mg) in the evening.

While it acknowledged that the pharmacist responded well to the error, the panel felt that the pharmacist did not recognize processes which created inherent risk prior to an incident occurring. The panel also felt that the pharmacist may not recognize other risks in pharmacy procedures and that, therefore, a further examination of the pharmacist’s processes was warranted. Additionally, they observed that the pharmacist did not engage in proactive remediation in response to a serious medication error involving a child.

In light of the above, the panel issued the pharmacist an Oral Caution and a requirement to complete specified remediation. The pharmacist in this case was directed to successfully complete the Root Cause Analysis workshop provided by the Institute for Safe Medication Practices (ISMP), which provides a “standardized approach to the retrospective analysis of critical incidents and near-miss events in healthcare.”

ORAL CAUTIONS

An oral caution is issued as a remedial measure for serious matters where a referral to the Discipline Committee would not be appropriate. Oral cautions require the pharmacy professional to meet with the ICRC in person for a face-to-face discussion about their practice and the changes they will make that will help avoid a similar incident from occurring in the future.

REMEDIAL TRAINING (SCERPS)

A SCERP is ordered when a serious care or conduct concern requiring a pharmacist or pharmacy technician to upgrade his or her skills has been identified. The ICRC orders SCERPs when they believe that remediation is necessary.

For all complaints filed after April 1, 2015, the College posts a summary of the oral caution and/or SCERP and its date on the “Find a Pharmacy or Pharmacy Professional” tool.

LEARNINGS FOR PHARMACY PROFESSIONALS

The Standards of Practice and Code of Ethics require that the patient’s best interests be at the centre of decision making and that pharmacists apply their medication and medication use expertise to ensure patients receive the appropriate therapy. Before dispensing a drug or counselling a patient, it is imperative to make sure that the right patient is receiving the correct medication at the correct dose with the correct instructions.

Pharmacists should take a systematic approach to screening prescriptions before dispensing, such as examining the dose, frequency, and the indications for drug use. In this case, an effective therapeutic assessment and technical check would have identified that the medication dosage was not appropriate for the patient.

Pharmacy professionals should also be aware of “confirmation bias” which refers to one’s tendency to “see” information that confirms one’s own expectations and the propensity for one’s mind to perceive what it thinks should be there as opposed to what really exists.

Additionally, pharmacy professionals must remember that a child is a “red flag”, or particularly vulnerable, patient and, as a result, more care and attention must be provided, given the potential seriousness of outcomes that could occur in this patient population. For any “red flag” patients, it is incumbent upon pharmacy professionals to take extra care when dispensing.

It’s important to emphasize that Designated Managers are responsible for ensuring that processes and procedures at the pharmacy are designed to minimize errors, protect the public, and enable staff to satisfy their professional and patient safety obligations. This includes implementing the Standards of Operation to warrant that the right medication, dosage, strength, and instructions are given to the patient, as intended by the prescriber.

The Standards of Practice also require Designated Managers to review errors and incidents to determine patterns and causal factors that contribute to patient risk and support staff in their obligation to report adverse events and close calls. This not only is a requirement, it is a core aspect behind the AIMS (Assurance and Improvement in Medication Safety) Program currently being rolled out to all community pharmacies across the province.

Lastly, pharmacy professionals are responsible for making sure that their knowledge and skills are up-to-date and must identify areas for improvement and engage in professional remediation as necessary, especially when specific incidents that could have been easily presented arise.