Now that the Patient Safety Act is a mandatory requirement for all pharmacies throughout the nation, pharmacies for Medicare Part D must now record all adverse events, also known as quality related events (QRE), and properly document those outcomes.
What is an adverse event?
The most common cause of an adverse event for a pharmacy can be when a patient is given a wrong medication or wrong dosage, and either leaves the facility or the patient takes it. As part of the Patient Safety Act, the pharmacy is responsible for identifying the cause of the adverse event, documenting the adverse event and implementing a process so the event can be avoided in the future.
What are the top examples of adverse events in a pharmacy?
Here's a list of the most common examples of adverse event drug reactions found in a pharmacy. Print out this list and share it with your staff so you can better train your team to catch and avoid these outcomes.
Common Adverse Event Drug Reactions from the Physician:
- Physician’s written prescription is hard to read or incorrect
- Physician staff called in the wrong prescription
- Incorrect Sound-A-Like prescription is filled
Common Adverse Event Drug Reactions from the Pharmacy Intake Process:
- Staff did not understand the verbal order or written prescription
- Staff entered the incorrect drug and/or dosage strength
- Staff entered the incorrect prescription instructions
Common Adverse Event Drug Reactions from the Pharmacy Fill Process:
- Incorrect drug pulled from the shelf
- Sound-A-Like/Look-A-Like drug pulled from the shelf
- Incorrect medication placed in the vial
- Pharmacy label has the incorrect prescription instructions
- Medication is placed in the wrong patient’s prescription bag
Common Adverse Event Drug Reactions from Pharmacy Clerks and Delivery Drivers:
- Clerk doesn’t double-check the prescription and gives the medication to the wrong person
- Delivery driver delivers medications to the wrong patient
What is a serious adverse event?
In most pharmacy operations, a patient contacts the pharmacy and states that the medication didn’t look right or that he or she got sick from the medication. In this case, the patient usually returns to the pharmacy to determine the next steps. Often the pharmacy can look at the given medication and determine that the wrong medication was given to the patient. In some cases, patients have a serious adverse event and need to go to the hospital before an action can be corrected with the pharmacy. In rare cases of serious adverse events, patients have had a severe drug reaction and died. In those unfortunate cases, the typical cause is that the patient did not reveal that he or she was on other medications from another doctor and there was a direct interaction, causing a fatal reaction.
What happens when an adverse event leads to an injury or death?
When someone is injured and/or dies from a misfill or an adverse event, there is generally going to be a lawsuit. This situation can put your pharmacy at extreme risk and is where proper Quality Related Event documentation is extremely important. It's also a situation where using a Patient Safety Organization (PSO) is vital and can save your pharmacy.
What should my pharmacy do if an adverse event is discovered?
The first thing to do is develop a Quality Related Event Report!
The Quality Related Event Report should document:
- Report date
- Date of event
- Date event was detected
- Prescription number
- Type of event
- Severity level
- Workflow step
- Where detected
- Corrective Action Recommendation
If you have any questions about preventing adverse events or avoiding risks in your pharmacy, please contact our compliance strategists. Our Compliance Strategists are here to help you discover what your business is missing in order to be in full compliance. Our team will help you shine light on any compliance gaps and risks your business may have as well as share what helpful resources you may already have access to. After speaking to our team you'll feel knowledgeable and confident to take the next steps for your business to be 100% compliant.
