Medication Errors

Medication errors occur in a pharmacy under the best of conditions. However, a previous Missouri court ruling regarding a pharmacy medication dispensing error clearly shows that a lack of proper supervision, documentation and up-to-date policies and procedures will not be tolerated when the public’s safety is placed in jeopardy as a result. In an excellent article just released in the Australian Journal of Pharmacy, an extremely valid point is made: the owner of the pharmacy is always ultimately responsible! The point was well made that although many pharmacies are owned by pharmacists (or non-pharmacists) who do not actually work in them, in the end it is the owner’s responsibility to make certain that current and up to date Policies and Procedures are maintained and followed by all of the pharmacy’s staff. Being an “absentee” owner will not stop the legal ramifications of dispensing errors and other mistakes by employees that could (and should) have been prevented.

The Missouri Case and Ruling

The Missouri Court of Appeals (Western District) reversed a lower court’s decision in late October that centered around a medication dispensing error by a pharmacist in Missouri. The dispensing error occurred when a pharmacy technician took several prescriptions over the phone from a Registered Nurse on behalf of the physician who was discharging his patient from the hospital. Although several mistakes were actually made by the technician, the most significant medication dispensing error was that the prescription phoned in by the RN for the patient’s metolazone was transcribed incorrectly to read methotrexate. The directions given to the patient for “once daily” administration of the drug inherently led to the patient’s death less than three weeks later (after she followed the directions on the Rx bottle and took a dose each day).

The family sued after the patient’s death and was awarded $2,000,000 in damages by a jury after a trial. Even though gross negligence was proven and admitted by the defendants in the initial trial, the damages awarded were reduced by a lower Missouri appeals court to $125,000 (based on Missouri statutory caps and limits to damages awarded by a jury). The victim’s family further pursued the ruling, which eventually led to the recent reversal by the higher court. The court upheld the jurors’ decision to award the patient’s family the additional damages that they initially awarded for pain and suffering caused by “aggravating factors and circumstances” resulting from the medication dispensing error by the pharmacy.

The Four (4) Medication Dispensing Errors as Noted By The Missouri Court

What makes this case so noteworthy is that the Missouri Court of Appeals actually broke down the case into four separate incidences of medication errors occurring in the pharmacy’s process of dispensing the prescription.
1. The first error cited by the court was that the technician took the prescription verbally over the telephone. Although currently Missouri is one of the seventeen (17) sates that allows pharmacy technicians to take prescriptions verbally by telephone, the court noted that the pharmacy’s own policies and procedures actually prohibited this practice and state that only RPh’s are allowed to accept prescriptions via verbal phone communication.

2. The second error was that the pharmacist did not question the methotrexate being administered once daily. In conjunction was the fact that the pharmacy’s computer system failed to “flag” the daily methotrexate dose. The court’s opinion stated that the pharmacist failed to properly review the medication and its administration, plus the court noted that there was a lack of a computerized “hard stop” for methotrexate prescriptions prescribed to be administered once a day.

3. The third error cited by the court was the failure by the pharmacy to provide the patient with the necessary education and the required patient counseling when dispensing a new Rx to a patient. Especially when the prescription is for a high risk medication (such as methotrexate is).

4. The fourth and perhaps most significant error cited by the court was the fact that the pharmacy “had made no meaningful changes to its procedures as a result of the patient’s death.” The court noted that in the twenty (20) months since the original verdict in February of 2016, the pharmacy had failed to update and document any changes to their policy and procedures manual. This included any documented updates to their procedures regarding a pharmacy technician’s role in the prescription dispensing process.

Minimizing Medication Errors and Pharmacy Dispensing Errors

The FDA defines a medication error as “any preventable event that may cause or lead to inappropriate medication use or harm to a patient”. A study released back in 2006 by The Institute of Medicine (a part of the US National Academy of Sciences) showed that medication errors result in harm to at least 1.5 million patients annually. Another study showed that over 400,000 patient injuries take place in hospitals in the US alone due to medication errors.  Medication errors occur for a variety of reasons. and everyone agrees that no one is perfect. Yet in today’s society of consumers having more access to drug information than ever before, medication dispensing errors by pharmacists are being reported much more frequently. As a pharmacy owner and/or practitioner, we all need to take a hard look at this and ensure that best practices are always being followed to the best of our abilities. As the National Institute of Health (NIH) points out: “Errors will always occur in any system, but it is essential to identify their causes and attempt to minimize the risks”.

As a pharmacy owner or manager, ask yourself the following questions:
– Do you ensure that if a mistake is made that you have documentation that will prove that you made changes to your written Policy and Procedures to show that you take every step possible to avoid medication dispensing errors?
– Is your staff properly trained and able to document situations where a mistake is made? Do you have job descriptions for your technicians and support personnel?
– When was the last time that your pharmacy took a good look at how it dispenses prescriptions and medications, plus how you document patient counseling?
– Are you following “best practices” and limiting the chance for potential medication dispensing errors (and therefore reducing your risks of potential lawsuits and bad publicity)?
If your answers are “not lately”, then we strongly advise that you get a qualified pharmacy consultant to take an objective look at your policies and procedures. An objective third party review may mean the difference between a court ruling like the damaging case seen in Missouri and your pharmacy maintaining its good reputation.

Pharmacy consulting is an area that most pharmacy owners don’t take advantage of until it is too late. At HCC we stress that addressing and preventing issues before they occur is the key to avoiding future problems, lawsuits and bad publicity. The old cliché that “an ounce of prevention is worth a pound of cure” has never been more relevant than it is today.

About Healthcare Consultants

Healthcare Consultants has been in the business of Pharmacy Consulting for over 29 years now. Known as one of the nation’s leading full service pharmacy staffing companies, HCC is also one of the industry leaders in providing a full range of professional pharmacy consultation services to its vast array of clients. Owned and operated by pharmacists, Healthcare Consultants can provide proven expertise and experience in all facets of pharmacy operations, including retail, hospital and specialty pharmacy venues. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all areas of your business. Contact us online or call us today at (800) 642-1652 for a free consultation to see how we can help you.

 

 

 


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Medication Dispensing Errors – Policies & Procedures – Pharmacy Consulting

Medication Dispensing Errors – Policies & Procedures:

Medication dispensing errors are a Pharmacy “fact of life” and we all deal with them. Having Policies and Procedures in place to assure that your Pharmacy adheres to current best practices is a must. This pertains to both preventing medication dispensing errors, as well as dealing with the documentation and reporting of errors that do occur.

A study performed over a 7 month period at a major hospital revealed the following regarding medication dispensing errors:

-A total of 140,755 drug dosages were prepared by Pharmacy technicians and 3.6% contained an error.
– 0.75% of the medications prepared left the Pharmacy with an error after verified by the Hospital Pharmacist. The Pharmacist “caught” only 79% of the medication errors using the hospital’s “routine verification” procedures.
– 23.5% of the medication errors that left the Pharmacy undetected could have resulted in an adverse effect if given to the patient. Of these, 28% were considered “serious” and 0.8% were classified as “life threatening”.
– The results of the study then revealed that the dispensing errors were:
Incorrect Medication: 36%
Incorrect Dosage or Strength: 35%
Incorrect Dosage Form: 21%

Many medical professionals found these numbers to be “scary” and “unacceptable”. It was noted that had the Hospital Pharmacy instituted up to date policies and procedures with better documentation, that a majority of the medication dispensing errors would have been “easily avoided”. This study directly ties in to the latest data released recently by The Institute for Safe Medication Practices (ISMP). ISMP diligently works to identify major medication safety issues, plus promoting the sharing of procedures and strategies that would lead to a reduction & prevention of medication dispensing errors in order to protect patients and consumers.

At ASHP Midyear, ISMP revealed the classes of drugs most frequently documented for errors and suggested that safety strategies were the key factor that we all must develop and adhere to going forward.

Darryl S. Rich, PharmD, MBA, FASHP, medication safety specialist for ISMP, presented the top 5 high-alert medication classes based on data from 2016. Opioids, antithrombotics, and insulins topped the list, followed by antipsychotics and antibiotics. Rich noted that data pegged wrong dosage as the top reason for adverse events in most cases, except in the use of antibiotics, for which wrong drug was the top reason.

The point is that it is now critical that all Pharmacies develop Policies and Procedures that both minimize the occurrence and potential for medication dispensing errors, plus have a plan in place to deal with the errors that inevitably will occur. This is being called “the Age of Documentation” by many and everyone must show that they have “best practices” in place, PLUS follow these “best practices” to the best of the their ability. Without doing this crucial documentation, not only will the occurrence of medication dispensing errors increase, but liability will exponentially increase as well.

We at HCC strongly advise that you develop Policies and Procedures that ensure “best practices” are implemented at your Pharmacy operation immediately. In addition, document and report all medication dispensing errors that occur (and we all know that they will). Another instance of the old cliche that “an ounce of prevention is worth a pound of cure” that we here at HCC have been advising our clients to adhere to for over 27 years now.

As always, please contact us here at HCC if you have any questions regarding development of policies and procedures related to medication dispensing errors. If you already have them in place, perhaps a review by an objective (and experienced) third party is a good idea? With over 27 years in the Pharmacy Consulting business, HCC can assist with expert advice in any area of your pharmacy business or practice. We urge you to contact us today to see how our Pharmacy Consulting services can help. With a full-time staff of in-house Pharmacy Consultant specialists, HCC can answer any questions that you may have in all Pharmacy settings. Contact us online or call us today at 800-642-1652 for a free consultation.


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Pharmacy Technician Errors – Policy & Procedure Reviews

Policies and Procedures for Pharmacy Technician Errors:

Pharmacy technicians are an integral part of every pharmacy team. Whether in a retail, hospital, institutional or specialty setting, pharmacy technicians are taking on increasingly important roles with expanding responsibilities. However, as  roles expand, so does the potential for pharmacy technician errors to increase and prove dangerous or even fatal. The 2006 death of a young two-year old girl named Emily Jerry spurred the initiation of numerous intensive studies regarding pharmacy technician dispensing errors. In the 2006 tragedy, the conclusion was clear that her death was due to a preventable pharmacy technician error that took place. Basically the infant died during her final chemotherapy treatment after receiving a dose of an improperly diluted IV prepared by a hospital pharmacy technician. An investigation revealed that the hospital pharmacy was short-staffed on the day of her death, the pharmacy computer was not properly working, and there was a backlog of physician orders.

It is important to note that the above case took place in Ohio and resulted in numerous legislative changes. At that time (2006) pharmacy technicians in Ohio were only required to have a high school diploma with no certification or oversight by the Ohio Board of Pharmacy. The passing of Ohio Senate Bill 203, or “Emily’s Law,” in 2009 now requires all Ohio pharmacy technicians to pass an exam and to be approved by the Ohio Pharmacy Board.

Medication dispensing errors are on the rise according to many studies. A study released in 2006 (at the time of the technician error that resulted in the infant’s death) by The Institute of Medicine stated that medication errors harm at least 1.5 million patients every year. Another study showed that over 400,000 patient injuries take place in hospitals in the US alone due to medication errors. Yet even if a Pharmacist is “overwhelmed”, when pharmacy technicians contribute to dispensing errors, the pharmacist is still ultimately responsible and liable for the error.

If you utilize pharmacy technicians in your practice, when was the last time that you took a good look at your policies and procedures regarding their roles and utilization?? Are you following “best practices” and limiting the chance for potential medication dispensing errors (and therefore reducing your risks of potential lawsuits and bad publicity)? If the answer is “not lately”, then we strongly advise that you get a qualified Pharmacy Consultant to take an objective look at your policies and procedures! Being in the business of Pharmacy consulting for over 25 years now, HCC has been stressing for decades that addressing and preventing issues before they occur is the key to avoiding future problems and bad publicity that pharmacies so frequently encounter these days. With the rise of social media, digital mass media and internet “real-time” news, our advice that the old cliché that “an ounce of prevention is worth a pound of cure” has never been more relevant. Although we all hope that we will never personally deal with such situations cited in the example above, HCC strongly urges you to be prepared. Contact us on line or call us today for a Free Consultation at 800-642-1652 to discuss how we can help you.

Bob Miler
8/18/2015


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