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

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.

Ativan Drips and Precipitation

If you happen to run short of the lorazepam 2 mg/mL vials to compound your ativan drips, be mindful of the possibility of precipitation when using the lorazepam 4 mg/mL vials.  AHFS Drug Info states:

Precipitation-- The choice of commercial lorazepam concentration to use in the preparation of dilutions is a critical factor in the physical stability of the dilutions. Both the 2- and 4-mg/mL concentrations utilize the same concentrations of solubilizing solvents. On admixture, the solvents that keep the aqueous insoluble lorazepam in solution are diluted twice as much using the 4-mg/mL concentration than if the 2- mg/mL were used, resulting in different precipitation potentials for the same concentration of lorazepam. Care should be taken to ensure that the compounding procedure that is to be used for lorazepam admixtures has been demonstrated to result in solutions in which the lorazepam remains soluble.

Lorazepam concentrations up to 0.08 mg/mL have been reported to be physically stable, while occasional precipitate formation in admixtures of lorazepam 0.1 to 0.2 mg/mL has been reported. The precipitate has been observed in both containers and in administration set tubing.

In one case, a visible precipitate formed in a lorazepam 0.5-mg/mL admixture in sodium chloride 0.9% in a glass bottle.  However, a 0.5-mg/mL concentration may remain in solution longer if prepared from the 2-mg/mL concentration, yielding a higher concentration of organic solvents in the final admixture.

Concentrations of 1 and 2 mg/mL have been reported to be physically stable for up to 24 hours as well as concentrations below 0.08 mg/mL.

Concentrations in the middle range of 0.8 to 1 mg/mL may be problematic.  In one report, use of lorazepam 2 mg/mL to prepare lorazepam 1-mg/mL admixtures in dextrose 5% or sodium chloride 0.9% was acceptable but use of the lorazepam 4-mg/mL concentration to prepare the same solutions resulted in almost immediate precipitation.

Lorazepam solubility in common infusion solutions has been reported. Its solubility in sodium chloride 0.9% is approximately half that found in the other tested solutions. This result was attributed to the pH of the sodium chloride 0.9% (pH 6.3) being essentially the same as the isoelectric point of lorazepam (pH 6.4), where aqueous solubility would be the lowest. Dextrose 5% was the best diluent for lorazepam.

If you are a hospital or facility that mixes the middle range of 0.8mg to 1 mg/mL you have to be more mindful of other factors.  This is the reason I had no idea of this problem since other facilities where I have worked we mixed a much less concentrated solution.  I found out the validity of this information and wasn't too pleased.

The bottom line is that it would be nearly impossible for a pharmacist to know every single intricacies of different hospitals and compounding practices.  If knowledge like this is indeed something we should all 100%  know, then someone somewhere dropped the ball on training and/or education.  I am mostly wondering, how does your facility compound ativan drips?  What scenarios caused precipitation?

For more about this issue read here.

Bring on a Pharmacist... Please

WASHINGTON –  Federal health officials are alerting doctors to the recall of an injectable antibiotic made by B. Braun Medical, due to floating particles found in vials of the drug. The Food and Drug Administration posted the notice late Tuesday, warning health professionals that the company has recalled lot H3A7444 of its Cefepime for Injection USP and Dextrose Injection USP. Visible particles were found in a sample from the lot, including specs of metal, cotton fiber and hair.

The agency warned that using the drug could result in blood clots causing stroke, heart attack and other catastrophic problems.

The drug was distributed to hospitals, pharmacies and medical suppliers nationwide, according to the agency's release.

Patients experiencing health problems should contact their physician and report all issues to the company at 1-800-854-6851.

Hearing the newsanchor mispronounce cefepime threw me off.  Initially thought he was talking about some drug I had never heard of.  If news can bring on a Dr. Oz or the Doctors show, how about bringing in a pharmacotherapy specialist to discuss medications?

Medical Errors: A Never Event

A patient that needed a kidney to survive found a perfect match in her brother who agreed to donate.  However, a nurse at a hospital threw away the donor kidney thinking it was medical waste.

I was appalled when I read this, but let us all face it.  The medical community is filled with human beings who will make errors.  It's never did you make an error, it's when did you make an error.  Then I think, did the error harm or have major potential to harm?  Then lastly, what happened to cause the error?  It is very easy to point the finger, though I can say I would have to point the finger at a nurse who threw away an organ; most of the time it is the process.  This case would be termed a "Never Event" as in it should never happen.

So, when you have an error at the pharmacy, what are the steps taken to make sure it is corrected?  Do you have meetings where you discuss the error openly and try to figure out how to correct it?  Or, do you automatically assume that the pharmacist is lazy or needs education?  Do you assume that he/she is incompetent?  Whatever your group does it is so important to step outside of your group and realize that human beings will always err.  Processes must change to create a scenario that has taken into account all of the possible things that could have happened wrong.

Have you ever seen the same type of error or even the same identical error twice from two different medical professionals?  This is a huge red flag that process should be addressed.

The term "Never Event" was first introduced in 2001 by Ken Kizer, MD, former CEO of the National Quality Forum (NQF), in reference to particularly shocking medical errors (such as wrong-site surgery) that should never occur. Over time, the list has been expanded to signify adverse events that are unambiguous (clearly identifiable and measurable), serious (resulting in death or significant disability), and usually preventable. The NQF initially defined 27 such events in 2002. The list has been revised since then, most recently in 2011, and now consists of 29 events grouped into 6 categories: surgical, product or device, patient protection, care management, environmental, radiologic, and criminal.

Source: Sentinel Event Statistics. September 30, 2009. The Joint Commission Web site.

Source: Adverse Health Events in Minnesota. Fifth Annual Public Report. St. Paul, MN: Minnesota Department of Health; January 2009. Available at: http://www.health.state.mn.us/patientsafety/publications/ consumerguide.pdf. Accessed December 30, 2009.

Table. Never Events, 2011

The National Quality Forum's Health Care "Never Events" (2011 Revision)

Surgical events

Surgery or other invasive procedure performed on the wrong body part

Surgery or other invasive procedure performed on the wrong patient

Wrong surgical or other invasive procedure performed on a patient

Unintended retention of a foreign object in a patient after surgery or other procedure

Intraoperative or immediately postoperative/postprocedure death in an American Society of Anesthesiologists Class I patient

Product or device events

Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the health care setting

Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used for functions other than as intended

Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in a health care setting

Patient protection events

Discharge or release of a patient/resident of any age, who is unable to make decisions, to other than an authorized person

Patient death or serious disability associated with patient elopement (disappearance)

Patient suicide, attempted suicide, or self-harm resulting in serious disability, while being cared for in a health care facility

Care management events

Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration)

Patient death or serious injury associated with unsafe administration of blood products

Maternal death or serious injury associated with labor or delivery in a low-risk pregnancy while being cared for in a health care setting

Death or serious injury of a neonate associated with labor or delivery in a low-risk pregnancy

Artificial insemination with the wrong donor sperm or wrong egg

Patient death or serious injury associated with a fall while being cared for in a health care setting

Any stage 3, stage 4, or unstageable pressure ulcers acquired after admission/presentation to a health care facility

Patient death or serious disability resulting from the irretrievable loss of an irreplaceable biological specimen

Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results

Environmental events

Patient or staff death or serious disability associated with an electric shock in the course of a patient care process in a health care setting

Any incident in which a line designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or is contaminated by toxic substances

Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in a health care setting

Patient death or serious injury associated with the use of restraints or bedrails while being cared for in a health care setting

Radiologic events

Death or serious injury of a patient or staff associated with introduction of a metallic object into the MRI area

Criminal events

Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed health care provider

Abduction of a patient/resident of any age

Sexual abuse/assault on a patient within or on the grounds of a health care setting

Death or significant injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of a health care setting

From the National Quality Forum

I do think the answer lies in evaluating all errors and making time to do so.  Just sending a report of an error doesn't evaluate why or how it happened.