Safety Culture in Pharmacy

From Pharmacy Times: Safety Culture in Pharmacy

I have never met a pharmacist who intentionally set out to make an error. Most pharmacists are detail-oriented individuals who take their roles seriously.
 
After all, pharmacists are the umpires of the health care game. They enter, verify, and triple check prescriptions, orders, and final products until they are satisfied.
 
Pharmacists make sure that the correct medication is going to the correct patient. I signed up for this when I applied to pharmacy school in 1993.
 
At the time, I didn’t know what I was signing up for except a nice salary. I had no idea about the culture of safety in many medical jobs, or that a career in pharmacy required perfectionism.

Fate would have it that I married a man in safety, as well. While he reduces on-the-job accidents along with the Occupational Safety and Health Administration (OSHA) and other safety organizations, I work in a hospital where helping patients become well is the goal.
 
Nevertheless, the Journal of Patient Safety estimates that more than 400,000 people die each year due to harm in the hospital, making it the fourth leading cause of death in the United States. If this were any other industry, the organization would be shut down until the cause of harm was fixed, but hospitals simultaneously save lives, and so they stay open.

Hospitals have cultures that blame people rather than processes. Blaming people reduces error reporting, which shuts down improvement in processes.
 
Health care needs to view all errors as opportunities to improve systems and processes to catch mistakes caused by human error. Keep in mind that humans build processes, as well.
 
But will blaming people instead of processes ever change?

I asked a pharmacist once why he didn’t report errors. He told me that he only reports the errors that matter.
 
Don’t they all matter, though? Choosing and picking which error to report is looking through a punitive lens rather than a process lens.

I try to make it my practice to report all errors, even my own, because it is the only way to shed light on things that need to be adjusted in the system. If there are duplications missed regularly and a trend develops, the system analysts can figure out how to adjust the alerts to be better.
 
Changing how pharmacists check for errors could help, but if we don’t report, then they don’t know. In the meantime, we shouldn’t pick and choose what we report.

In the automotive industry, safety falls under human resources. Many times, an employee safety group is developed to look at the issues affecting the company.
 
Hospitals should employ the same type of safety group that not only encompasses risk management, information technology, and nursing, but also includes actual clinicians who work with the systems and interact with patients and their orders.
 
There should be multiple pathways provided for employees to bring suggestions and concerns to the group to look at the system and make it better, rather than just reporting errors with no follow-up and breaking down the processes that lead to a particular mishap.

We have processes and rules in place to make hospitals safer, but the culture can be so tainted that no one follows the protocols that are in place. It is true that when you start looking at safety through the lens of culture, you see how challenging it is to change.
 
Safety culture starts at the highest level of an organization and trickles down. If management does not have safety as a priority, then I guarantee you that no one else will.

One of the most damaging messages a pharmacist can receive is leadership mishandling a medical error. If our leaders do not take the time to investigate the systems involved with the error and how the error happened, and instead rush to punitive action toward the clinician, then staff members will become more jaded and less involved.
 
Medical errors are almost always the result of systematic flaws, rather than a person’s incompetence. Rushing to judgment rarely improves safety culture in a hospital and turns clinicians into something worse.

Here’s what a culture of safety in the pharmacy would look like:

Order entry and verification would not be in an area where distractions are abundant. There would be a telephone, but mainly for outbound calls. Order entry/verification would be in a quieter environment separate from where phones are ringing. Why host tasks that require perfection in an area that isn’t conducive to patient safety? If the room isn’t separate, then there will be constant interruptions. Every interruption, while pharmacists are in the middle of doing their job, is a recipe for disaster, just as it is for a nurse on the floor.

There would be continuity of care with work assignments. If pharmacists or nurses are changing hospitals every day, then they never really learn their patients. Processes could also vary from one hospital to another, which can lead to confusion for the clinician. If a pharmacist regularly works in the same environment, then he or she can see what processes need to change to ensure patient safety. Relationships between nursing and physicians would improve due to continuity of care. 

Nurses and pharmacists would report every single error, no matter how small. Only situations where there was blatant disregard of policy or unsafe acts would be punitive. If there is a near miss, then praise, where the error was discovered prior to the patient receiving the wrong care, would be given. The system should be designed to catch errors at different levels, rather than to rely on one step of the process. 
A safety focus group would be set up where issues and processes are analyzed on a routine basis, and changes are evaluated based on these analyzes. This focus group in the pharmacy could report to a larger group in the hospital with each department represented if a particular issue affects other departments.

More: Hospitals Mess Up Medications in Surgery A Lot - Bloomberg Business October 2015

Pharmacists in the ER Equals Better Patient Care

One of the biggest impacts a pharmacist can make in the hospital setting is in the emergency department (ER). There has been a growing interest and trend in placing pharmacists in the ER to review medications, both reconciliation of home medications and medications administered in the ER to ensure correctness and cut down on medication errors and drug interactions that contribute up to 7,000 yearly deaths in the US. A pharmacist in the ER can review real-time orders that are typically bypassed by staff pharmacists due to the urgency of an ER patient.

Pharmacists can also improve flow of patients through the ER, educate prescribers and staff development about medications and their costs and also utilize the ER as a place to precept and mentor students and residents. Pharmacists can participate in codes, help with admissions in home medications and help with discharge medication reconciliation. Pharmacists in the ER can also be involved with the ER department in providing presentations, publications and other activities to the department. Pharmacists can monitor the use of expensive medications to make sure use is consistent with approved criteria (Factor VII, alteplase, etc.) and conduct MUEs in the emergency room setting. These pharmacists could also be involved with microbial culture follow-up. The emergency department is usually a place of unpredictability in acute illnesses and patient volume. High risk medications are used more often and a greater chance of a medication error reaching the patient.

Currently in most hospital settings, hospitals use a clerk to fill out a home medication sheet which typically can include errors in drug name, drug strength and directions. Many times staff pharmacists are clarifying home medications days later than what is optimal. I have personally witnessed mistakes in high-risk medications like warfarin that are discovered days later. In short, when a patient is admitted, they are prescribing for themselves with no oversight from a pharmacist, and physicians do not want to take ownership of what the patient takes at home since they are presenting with something acute that may have nothing to do with the herbals they take on the side.

The American Society of Health-System Pharmacists (ASHP) believes every hospital pharmacy department should provide its emergency department with the pharmacy services that are necessary for safe and effective patient care. The Joint Commission also has compliance requirements that can be met with a pharmacist in the emergency department (MM.4.10. which requires that all medication orders be evaluated by a pharmacist prior to administration of the first dose and MM 7.10 which identifies high-risk or high-alert medications and all the processes involved from procuring to monitoring and medication reconciliation). One of the National Patient Safety Goals is to accurately and completely reconcile medications across the continuum of care which would include the first stop in the emergency department.

One of the most common reasons most hospitals do not employ emergency room pharmacists is due to cost. Small hospital pharmacies are staffed at a bare minimum. Most hospitals do not realize that pharmacists working in the emergency room can reduce readmissions, medication errors and drug interactions to save money but more importantly increase patient safety while being treated for an acute illness.

1.       Impact of a prescription review program on the accuracy and safety of discharge prescriptions in a pediatric hospital setting. J Pediatr Pharmacol Ther. 2008 Oct;13(4):226-32. doi: 10.5863/1551-6776-13.4.226.

2.       Levy DB. Documentation of clinical and cost saving pharmacy interventions in the emergency room. Hosp Pharm. 1993;28:624-627,630-634,653.

3.       American Society of Health-System Pharmacists. ASHP statement on the role of health-system pharmacists in emergency preparedness. Am J Health Syst Pharm. 2003; 60:1993-5.

4.       Cohen V, et al. Effect of clinical pharmacists on care in the emergency department: a systematic review. – Am J Health-Syst Pharm. 2009;66;1353-1361

National Patient Safety Goals: The Joint Commission

Pharmacy Distractions

Yesterday, I decided to record the number of distractions I faced on a regular work day. This proved to be a distraction in itself considering the pharmacy where I worked is in an open plan where technicians, phones, cubicles and door to the hospital hallway are all within ten feet of where I sit. There are four or five telephone lines which ring regularly. There are usually one to two other pharmacists sitting within five feet and two to three technicians in the same vicinity.

Yesterday I recorded over 150 interruptions. I even faulted myself for starting personal conversations which distracted others. 

What are some things we can do to make the pharmacy workplace have less distractions? Interruptions contribute to medication errors and having a dedicated space where interruptions are not allowed should be implemented. Chemotherapy entry, preparation and checking definitely falls into this category. The Institute for Safe Medication Practices found that each interruption is associated with a 12.7% increase in errors. I have personally attempted to enter new chemotherapy on a patient in the noisiest place where phones are ringing consistently, technicians are interrupting the workflow with issues on the phone that they cannot handle and other staff are just walking by to chat, all while the TV is reporting the news and a radio in the back is piping out 80s music. It is enough to cause me to go into panic mode. Ask for a dedicated space with less distractions or a no-interruption zone. You may not get it but it is on the record that you asked. In the meantime, one tip I have tried is headphones with something soothing to completely block out all noise when concentration is key. Bose makes great noise-canceling headphones that work! Though I would love to work in silence, blocking out everything but one sound is better than ten sounds all interrupting and distracting what you are trying to do safely. 

Another source of interruptions is when a medication is out-of-stock. This issue can completely lead a pharmacist into a rabbit hole of issues. First I have to ask if we have the medication which leads to comments of inventory failure and what process is to blame. Second we have to call other hospitals and ask to borrow a medication which interrupts them as well. We also have to call a courier service to deliver the medication which leads to delay in delivery of treatment to the patient. If we could reduce missing medications, we could reduce distractions and phone calls. This type of interruption falls under system distractions along with medication timing and other issues that causes distractions on how we handle system failures or deficits.

Alert fatigue is another source of distraction. It is common for me to receive five or more alerts per order when entering a medication with the majority being unnecessary. For example, when entering a sodium chloride IV fluid, I will routinely be alerted that the chloride in the IV fluid will be a duplication with the potassium chloride (chloride duplication). I will also receive an alert that sodium chloride is on national backorder. Most of the times medication alerts include what is formulary, nonformulary, to notify IT staff when medication is depleted, duplication of class that isn't clinically significant, insignificant labs that can include a time period longer than current hospitalization and even how to enter medications differently for a new process that can change quite often. It is used more times than not as an email to communicate inventory issues that should be saved for another time and not when entering a medication where the most important issues are drug, strength, indication, directions and allergies. All of the important stuff can be diluted quickly by things that are nowhere near as important than the task at hand.

Educating the staff is very important in handling distractions and improving patient safety. Educating the staff to know when to interrupt with something important that cannot wait a second and when to write a note for the pharmacist to handle a few minutes later is important. Placing phones with multiple lines in a separate area to lower distractions while the pharmacist is entering orders or checking orders and/or having a designated technician to answer phones and not filling is an idea to consider. Also educating a technician on how to answer the phone and troubleshoot is invaluable!

The Institute for Safe Medication Practices has looked at this issue and has an invaluable write-up about things that can be done to help pharmacists and technicians focus on what matters most... patient safety.

Alert Fatigue; Pop-up Fatigue and Drug Errors

It would be nearly impossible for me to meet the standard rate (number of entries per hour) of many hospital companies and properly investigate every single issue with a particular medication against disease state, interactions with other meds and allergies. We rely heavily on computer programs and screening programs to help facilitate this job. However, with the invention of alerts while we work is the issue of "alert fatigue."

The biggest problem I have encountered over the past several years is the sensitivity of alerts. I frequently not only get alerts for the things I NEED to know but the things that are not nearly as important. I receive an alert daily for Sodium Chloride 0.9% IV fluid and Potassium Chloride when entering the two.  The interaction is "chloride." Keep in mind, the potassium chloride is actually compounded into sodium chloride. This is mixed in with more important alerts like what the patient's potassium level really is. I also receive alerts about what is formulary and non formulary, what is in stock, what is on backorder, if I need to add an NDC to something for billing, if I need to pick another strength, if the med can only be ordered by one doctor and not another, and so on. This is all mixed in with the same level of importance as creatinine with metformin, INRs for warfarin, allergies entered, height and weight of the patient, and so on. With at least ten alerts per order and around fifty orders per hour, we are nearing 500 alerts per hour all the while answering phone calls, questions from the staff and people just walking into the room to chat and say hi. It's no wonder I feel so distracted.

The problem with this methodology is that we lose the real alerts that are important. Comparing an alert for someone with hyperkalemia with ordering potassium replacement vs letting me know that I need to change the potassium to another NDC vs that the med is on back-order is really changing the way the system was intended. Also, is anyone monitoring all the alerts that are bypassed daily? Is anyone noticing these and monitoring trends? 

Too many alerts turn into noise.

I know that if all facilities would start an initiative to reduce alerts, alerts would have more meaning and pharmacists would probably react more to the alert. 

And maybe... less errors. 

With the implementation of CPOE, this issue has risen to the forefront of what prescribers must wade through in selecting the best medication therapy for their patients. While the industry worries about prescribers becoming complacent to alerts due to overly sensitive drug-drug interactions or drug-allergy interactions, pharmacists have been battling this for years. Prescribers seemingly must worry about the meds and patients whilst pharmacists are wading through the leftover messages with safety along with pharmacoeconomic issues.

1. Alerts should be tiered. Level 1, 2, 3, etc or color coded based on severity.  Never allow one sweeping override reason count for multiple alerts.

2. Alerts that have nothing to do with patient safety, formulary comments, billing issues should be reserved at another level not mixed in with potentially life-saving messages!

Adding financial notes with the already overburdened system of patient safety is a recipe for disaster both in patient safety and also for pharmacist job satisfaction. 

ISMP mentions this: "Protect against ALERT FATIGUE through fewer, more appropriate alerts that need consideration by pharmacists before filling the prescriptions.

Optimize the sensitivity of alert systems by carefully selecting alert severity levels and allowing only the most significant alerts to appear on the screen during data entry." 

3. Hard stops should be built for certain high risk interactions (even if the money doesn't exist to build). 

4. Someone in the department should be trending overrides. What are the trends? Can the system be improved without waiting for an event that causes injury?

5. Allow pharmacists who use the system daily to report alerts that are not needed.  

"Encourage the reporting of invalid or insignificant warnings so they can be altered or removed from the computer system." -ISMP

This is a great article on alert fatigue from our perspective. 

Fungal Meningitis and the End of Lackadaisical FDA Involvement in Compound Pharmacies

New England Compounding Center (NECC) is at the center of this quite horrific tragedy that has affected the lives of many with fourteen already dead. I cannot personally fathom such a loss over something so seemingly accidental. As a pharmacist my thoughts immediately go to sterile technique and the FDA's regulation of our industry. You see, the states oversee the pharmacies compounding and normally that should be enough. However, something went terribly wrong here. But what is coming out lately is the role of compounding pharmacies and how in this case, there was a grey area they were working in. Basically compound pharmacies can make patient specific medications, what is not allowed is these compounding pharmacies acting as manufacturing and bulk shipping repackaged medications without FDA oversight.

It's all about the dollar, but in this case many priceless lives have been lost.

There are two fungi involved: aspergillus and Exserohilum rostratum.

In the past, these pharmacies have been the heroes making things like bioidentical hormones and other specialty concoctions.

Under the FDA's definition, compounding pharmacies are supposed to mix drugs to order only on a specific patient in response to a prescription from a doctor. Under this definition NECC was not operating as a compounding pharmacy but as a large-scale production of a drug. The FDa should have stepped in before these lives were lost.

Multilayers

One thing I have noticed about the errors I have made... distraction. I do not mean distraction with other team members or music, but the distraction within the order itself. Take for instance an order written for an IV fluid with no rate written from the ER. Immediately the info missing is the glaring distraction of the true issue: the MD wrote for incompatible fluids. It is easy for me to forget the multilayer dimension of errors. Overlook the error within the error. Those always seem to make me stop and think. Maybe errors come in pairs.

A pharmacist is like a detective trying to solve a case. May your cases always be easy and obvious!

Pharmacy Perfection

One of the biggest things I struggle with as a pharmacist is the idea of a profession that requires absolute perfection in everything you do; yet I am human. There is not a lot of room for error because it can detrimentally affect a patient. I remember back when I was as green as the spring grass freshly graduated from pharmacy school in 1999. I landed my first job with K-Mart, not exactly the job that I had dreamed of while I was attending pharmacy school, but they paid for my relocation from one city to another. They also did not do a lot of volume in the particular store where I was assigned. I do not remember the name of the pharmacist that worked there opposite from me initially. What I do remember about her is the words that came out of her mouth almost at her introduction, “I have never made an error while being a pharmacist.” I was too naïve at the time to realize that there was no way she was telling the truth. We are human; we will make mistakes. And at the time K-Mart did not have any mandates in place on flow or any bar-coding scanning to ensure more safety as Walgreens and CVS had. They were way behind the times as far as technological advances go.

I believe one of my first errors was dispensing Adalat CC 30 mg when the prescriptions called for 60 mg. Yes, I felt SICK. But over time I have come to realize that there are things you can do as a pharmacist to be more accurate whether it be hospital, retail, or anything in between.

According to a 2006 report by the Institute of Medicine, medication errors cause harm to roughly 1.5 million patients annually.5 Millions more are caught prior to administration, before they reach the patient. Not only do medication errors adversely impact the patient population, they are estimated to cost billions of dollars in additional treatment costs. Read more: http://www.uspharmacist.com/content/c/31431/

Here are some tips to help you become more accurate

1. Concentrate. Don’t allow distractions to stop your flow of thinking. If a technician comes up to you and needs something right away, go ahead, but realize when you start back on the order, you need to continue the exact same flow from beginning to end. Don’t try to “pick up where you left off.”

2. Do the same thing every single time. Consistency.

3. Do a second double check after you are finished checking. If that means pulling up the profile on the computer screen and holding up the order or pulling it back up electronically, just double check at the very end.

4. Any time you are going outside the usual, there is a higher incidence for errors. For example, if you have to build something from scratch in the computer on a new medication, you can be sure you are more likely to mess up on something else within the order than normal.

5. If you work retail, utilize every program they have to improve accuracy. In the hospital, just do another last review of MAR prior to moving to the next order. If in doubt; ask. It’s always better to phone the office if you work in retail or phone the nurse if you work in hospital to bounce off what you are seeing.

The most important thing is to make sure you have enough staff to safely fill medications and orders.

Criminal Charges Pressed Against a Healthcare Provider. A First.

This case has really bothered me.  For the first time that I can find, a pharmacist has been criminally charged in the death of a child in Ohio.  Eric Cropp, a pharmacist, made a fatal error when checking a chemotherapy solution for Emily Jerry.  CLEVELAND — Former pharmacist Eric Cropp was found guilty of involuntary manslaughter Wednesday in the death of a 2-year-old girl killed by a lethal injection of a salt solution during a cancer treatment.

Cropp, 40, of Bay Village, pleaded no contest to the charge at a hearing in Cuyahoga County Common Pleas Court. Judge Brian Corrigan will sentence Cropp on July 17. The maximum sentence is five years in prison and a $10,000 fine.

Prosecutors dropped a reckless homicide charge as part of a plea deal.

Cropp was the supervising pharmacist at Rainbow Babies and Children's Hospital on Feb. 26, 2006, when pharmacy technician Katie Dudash prepared a chemotherapy solution for Emily Jerry that was 23 percent salt. The formula called for a saline base of less than 1 percent.

The child died on March 1 after slipping into a coma.

As the supervising pharmacist, Cropp's duty was to inspect and approve all work prepared by the technicians before it was given to patients. Dudash agreed to testify against Cropp and was never charged.

The Ohio Board of Pharmacy stripped Cropp of his license in 2007. Since then, he has been unable to find steady employment, his attorney Richard Lillie said recently. Cropp has worked odd jobs, cleaning boats and walking dogs.

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Cropp served 6 months in jail, paid fines, has tons of community service hours, lost his license for life, etc...

I realize that this case is very sad in that a little girl has died.  But I have read this case inside and out and it's fairly certain that the hospital hung Cropp out to dry.  The hospital settled for millions with the family.  The mother was on a witch hunt for the pharmacist to pay.  The tech faced NO CHARGES AT ALL.  This is unreal!!  First of all, we are humans.  Humans make mistakes.  I get nervous thinking about cases and situations like this and I look at what happened and wonder "Could this happen to me as a pharmacist?"

Eric's mistakes were that he didn't take a break that day.  He had a friend bring him lunch.  He was way behind because of a printer problem.  The hospital IV setup was not condusive to safety.  There was a bag of NS laying near  where the compound was finished.  WHO in the world makes NS from hypertonic?????  The tech was planning her wedding.  She gets to resume her life with no issues at all.

Medication Errors

More of a serious post here but contemplating the concept of humans and errors.  We're going to have them as pharmacists because we are human; we just hope the errors we make aren't of the fatal variety.  Putting things in place to help reduce these errors is always a good thing.  In my previous gig, a nurse would enter the order (hospital pharmacy) and a pharmacist would review it against the scanned in order.  Other places I have worked, the pharmacist did both functions.  Although it is quicker for the pharmacist do go ahead and enter the order, I feel that two brains is always better one.  Even if one of the brains is a pharmacist and the other a desk clerk, it is still two brains as we all know that a lot of the times the errors are keystroke in nature. I like the way Walgreens has tackled errors with their hi tech computer system.  I like the way that they have reduced misfills, but have they tackled the initial entering of the order yet?  There's nothing to compare it to, unless you have a scanner to scan in and then a robot to read what is scanned.  Are we moving to that?

Are You Kidding Me?

My mouth just dropped open.  It's obvious to me that physicians do NOT read medication reconciliation forms for home meds at all.  The ones that do, kudos, but the ones that don't make my job more interesting and at times really get to me. Case-in-point:  50-something presenting to the hospital with lower GI bleed.

The doctor signed off to CONTINUE HER HOME MED OF PHENTERMINE FOR WEIGHT LOSS.  Are you kidding me?

I guess the nurse could have written "Purina Dog Chow - take one cup by mouth daily" and the physician would have signed off on it.

Way to go Joint Commission on putting in a requirement with no means of adhering to any sort of THINKING for anyone involved.

Except for the pharmacist of course to wade through the BS and find what is really needed.

I really like the one where the physician wanted to continue the patient's viagra while in the hospital.  THAT should keep the nurses on the floor on their toes running from a man who is looking for some fun.  Not good.

Medication reconciliation forms.  The bane of my existence.