Do we need Patient Safety?
This week everyone’s been talking about the NYT article that was a scathing indictment of CVS and the working conditions for chain pharmacists. A main focus was how patient safety goes out the window in an operation like this. People, especially my fellow pharmacists, are pissed. Understandably so.
But what nobody in our industry is talking about is how we handle medication errors. They’re going to happen. I’ve seen plenty while serving as a consultant for pharmacies with Remedial Plans ordered by the Texas State Board. No error is too trivial to jeopardize your standing with the board. The difference in getting fined and punished is how you handle the errors.
The goal of this post isn’t to commiserate. The NYT article has already done that enough, and we all know full well the ways in which these things can happen. However, the goal of this post is to give you the tools you need to handle them properly when a medication error or close-call occurs.
We’ll cover everything you need to know about preventing and handling medication errors. In a nutshell, there’s some basic, low-hanging fruit you need: A med-error SOP, Root Cause Analysis template, proper phone etiquette and training.
Bookmark this page. When you encounter a med error at your pharmacy, pull this page back up, and use it as a tool to help you navigate the next steps. As a matter of fact, go find your patient safety SOP binder.
Open it and follow along with the outline below. If your binder doesn’t contain any of the items mentioned in this post then congratulations, you’ve got homework! Your assignment is to add whatever is missing. If you need help on getting started, I’ve got freebie outlines linked here for the SOP and the Error Form. Don’t have one at all? Use this post as a baseline. If you’d rather not have to do the work, email me at vanessa@pharmacyconsultantstx.com and we can discuss pricing.
Discovering a mistake SUCKS, let’s face it, we’ve all been there.
Yours Truly circa 2009.
I remember my first misfill, I was settling into my first job and management role.
I filled isosorbide dinitrate instead of mononitrate, at a higher dose for a sweet 80 year old lady. As soon as I realized what happened I called the patient.
First call…. No answer.
I start to panick, so I call again (and again). Still, no answer.
I thought I put her in the hospital, or worse. I was so upset with myself. After 3 days of agony, I finally get a call.
Turns out she was on vacation with her husband all weekend. I choked back emotion as I explained what happened and profusely apologized. Luckily she hadn’t even opened the bottle yet! When she brought the medication back to me that day along with a flower arrangement for me. She could feel my concern through the phone and wanted to let me know it was okay.
My story about my own misfill is lucky. Many of us have our own stories … many are harmless, but some are tragic. No matter where a medication error lands on the spectrum, every single one should be handled the same way.
2018-2019 Violations Resulting in TSBP Remedial Plans*
We took a look at the last two years of Disciplinary Actions taken by the TX Board of Pharmacy. Some of these were based on errors that occurred up to 6 years prior and in many instances, the pharmacy and the pharmacist involved were both penalized.
Rule of Thumb: Document and handle everything with the mindset your Board of Pharmacy is going to look at it.
Next Steps: implement a Patient Safety Program
Patient safety programs can be called a number of different things: Continuous Quality Improvement Program, Med Error Prevention, Adverse Quality Related Event (AQRE) SOP…. Whatever you decide to call it, it needs to be in the DNA of your SOPs. If you haven’t located your own SOP by now, find it. If you don’t have it, start one.
It’s basically broken down into two sections: Prevention of possible errors and handling them when they happen.
Creating a System of Communication and Documentation
Part A: Create Policies and Procedures
Section 1- Understanding what a misfill/ Med error/ AQRE is. Also why close calls are also important to recognize. Some examples of “events” besides the obvious can include:
Allergy not on file
Inadequate Directions
Incorrect duration of treatment
Therapeutic duplication
Misdelivery
Section 2- Identifying ways these errors can occur and how to prevent them.
An example from our SOP: “Use TWO identifiers (Name, Address, DOB) when a patient is picking up a prescription at the counter.”
Section 3- Handling Medication Errors
This includes identifying who handles each step when a med errors occurs
Make sure to have a standard Med Error Report Form
How to investigate an error to find the root cause
What are the parameters of follow up to a misfill
Section 4- Optional, but definitely recommended, is a continuous quality improvement program
This can include doing a self assessment
Reviewing errors with staff and addressing concerns
To build your own SOP, check out our outline.
For an outline of our Error Report Form, click here.
Part B: Develop the Pharmacy Culture
Create a culture in the pharmacy concerning dispensing errors that promotes honesty and integrity with employees:
Encourage staff to notify the PIC or pharmacist on duty as soon as the “possibility” of a med error has occurred or if there is a “close call” (meaning it could have been a misfill but it didn’t reach the patient")
It is easy to become upset when an error occurs and look for blame, but this is the wrong approach and can cause individuals to conceal mistakes. This can get dangerous and also put licenses on the line no matter how insignificant the mistake.
Encourage the culture that pharmacy management won’t be punitive in nature when mistakes are discovered. The policy should be to find the root cause and create training based on this, not to find blame in an individual.
This can be easier said than done, but we will go into why this is so important.
Part C: Train.Your.Staff.
Binders collecting dust on the shelves won’t save you if you don’t follow them.
Initial training and regular in-services are the key to keeping patients safe and your pharmacy up to date with all the possible ways mistakes can occur.
Making them vigilant in this with you is key to recognizing and fixing close calls that could lead to patient harm, insurance claims, state board investigations and license revocations.
Your staff needs to know-
What to do if a suspected error is caught by a doctor or patient
Where the med error reports are and what steps to take
Who is responsible and what time frame to accomplish certain reports
How to perform root cause analysis
A Mistake was discovered….
Now what?
Step 1: Reporting System
All your staff should be aware of what to do when a patient, caregiver, or doctor calls questioning a drug. Phone etiquette is key to set the tone of empathy and priority for concerned patients.
If clarification is asked, the call should immediately be forwarded to a pharmacist. We all know that generics get switched out daily by distributors, but this question should not be dismissed. A pharmacist should handle these calls EVERY time.
This is important because IF an error is discovered, the pharmacist is already on the call to make decisions in the next steps. The last thing you want to happen is a non-pharmacist staff person reveal a mistake was made, then that person gets put on hold. Addressing and resolving these issues needs to be done attentively as a top priority.
This should also be applicable to “close calls” that don’t reach the patient but could result in patient harm had it not been caught. These can highlight patterns or gaps in the system that need to be addressed and resolved.
Step 2: Complete the Medication Error Report
As soon as an error or “event: is discovered. The pharmacist designated to handle the situation should start a report. This should be done whether or not the patient took the medication.
Your report should have at minimum the following sections:
Patient Information
Practitioner Information
Incident Information: Who it was reported by, the nature of the error, what staff was involved in the process, the potential seriousness, was the medication ingested/used, patient outcomes (dr visit or hospitalization)
Pharmacy Actions: Document all communication with the patient and the practitioner, including dates, topics discussed, who was involved in the conversation.
If the patient ingested/used the medication, the practitioner MUST be notified.
Patient Outcome: Describe any actions taken on behalf or by the patient
Dr visits, check ups, additional treatments, emotional state, if they transferred out of your pharmacy or stayed
Incident Investigation: Create standard questions to address what possible factors could have contributed to the event occurring:
Examples of things to address: Was staff trained? Working conditions that day? Was there an indication on the prescription? Was the patient counseled? Was there critical information missing?
Optional:Root Cause Analysis: See Step 3
Pharmacy Outcomes:Based on your investigation and RCA, your pharmacy needs to document any corrective actions performed. This can include retraining staff, in-services, changing policies and procedures, etc.
Step 3: Perform a Root Cause Analysis
A Root Cause Analysis (RCA) is an investigation that reviews the systems in place that could the reason an event occurred. An RCA is important because it looks at the process, environment, SOPs, rather than the actions of the pharmacist/tech/clerk.
When should an RCA be performed:
If the patient was seriously injured or a fatality occurred.
If a pattern on the same event continues to occur regardless of the severity.
Other factors, as determined by your SOPs.
Some State Boards of Pharmacy will require this to be done if a patient was seriously injured or died.
The Institute for Safe Medication Practices has developed a robust RCA Workbook, linked here.
Step 4: Report to any Agencies, if required.
Know what your state board, accreditation organizations, and other affiliations require.
Patient Safety Organizations (PSO) like ISMP use information submitted to improve their analysis and content as well. For more information on PSOs and what they do, click here.
Step 5: Follow up/ Continuous Quality Improvement Program (CQIP)
Once an investigation (and possible RCA) is complete, the pharmacy needs to decide what parts of the system need to change in order to prevent the event from happening again.
Examples include:
Changing SOPs
Training or Retraining Staff- make sure to document any additional training
Performing a Self Assessment or Hiring a consultant to perform an assessment
Developing a CQIP
A Continuous Quality Improvement Program’s purpose is to provide a feedback system for a pharmacy to review events/patterns and improve patient care.
The pharmacy develops metrics that analyze patient safety and quality. These can be called Quality Measures or Performance Measures.
Examples can include: Checking all new patients for Allergies entered into the profile, Checking for RPh verification on compounding worksheets, etc.
These metrics are reviewed by designated staff on a regular basis.
Goals are created for each Quality Measure to keep the pharmacy attune to the progression of the program.
Pharmacies that have been ordered to have a Remedial Plan by their SBOP, or are required to have a performance improvement program through an accreditation will have a CQIP in place already.
Step 6: Record Retention
Keep all reports and documents together in one file. Keep for at least 3 years or whatever your SBOP requires.
This includes copies of the prescription at the center of the error.
Deactivate in your system but NEVER delete. It is important to maintain data integrity IF an investigation was to occur.
With the recent NY Times article, the mumblings in our profession are being sounded in the public arena. So let’s make sure we are following up on our end of the bargain.
What if you don’t have a program in place….
Get one. Now.
The BARE minimum your pharmacy may survive on:
SOP for Dispensing
SOP for Counseling
SOP for Medication Errors
Standardize Form to Report/Investigate Medication Errors
These will be the first things the SBOP Investigator will ask for when investigating a complaint concerning a misfill.
PBMs and Accreditation Auditors will also require these to approve contracts and during the credentialing process. If you don’t have an SOP dedicated to this it can jeopardize your standing.
But don’t just have it collecting dust on the shelf… Follow what it says.
The Consequences
2018-2019 Summary of TSBP Imposed Penalties For Pharmacies and Pharmacists*
First, and foremost- increased risk of patient harm.
Patients have every right to file a complaint with your SBOP, regardless if the medication was not ingested or there was no harmful outcome. And it’s their prerogative to investigate or not. So be ready.
If the SBOP walks in your pharmacy and you have done nothing to follow up on an error, here’s what to expect:
Multiple requests for documentation (which you don’t have)
At least one on-site inspection
An order to appear in front of the board of pharmacy
A fine for the pharmacy
Fines for the PIC and maybe any other pharmacists involved
Probation for all licenses involved (revocation depending on the severity of the error and the lack of action on the pharmacy side)
Required CE for pharmacists
The pharmacy will have to enter into a Remedial Plan as ordered by the Board for a certain time period- Usually five years in Texas.
Development of a CQI Program that includes quarterly Peer Review Meetings
The board may also require you to hire a consultant to perform quarterly to annual assessments
As a consultant, I have seen these happen to pharmacies where the error did not harm a patient but no documentation occurred. I have also been on the receiving end of a TSBP request where I had all documentation and no further actions were taken.
Make a program. Protect your patients, your staff, and your pharmacy. It’s up to you.
Take care of yourself while you are taking care of others.
My Resources for this Article:
Institute for Safe Medication Practices. www.ismp.org
Guidelines for Establishing Peer Review Committee, Texas State Board of Pharmacy, May 2019. https://www.pharmacy.texas.gov/files_pdf/guidelines-for-rph-peer-review.pdf
Patient Safety Evaluation Systems, Alliance for Patient Medication Safety
What is a Patient Safety Organization, https://www.centerforpatientsafety.org/pso/what-is-a-patient-safety-organization-pso/
“There seems to Be A Mistake with My Prescription”, Michael J Gaunt, 2016 www.pharmacytimes.com