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03/28/2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

This entry was posted in Health Care, Pharmaceuticals and tagged , . Posted by Bioethics Today. Bookmark the permalink.

03/28/2017

Mandatory Reporting of Pharmacy Prescription Errors?

Following the widely-reported 2014 case of a Cincinnati pharmacist incorrectly filling a prescription which led to a serious patient injury, the Ohio State Board of Pharmacy is now poised to promulgate a new regulation requiring pharmacists to report errors and to the board. This may be the first attempt by a US state board of pharmacy to require dispensing error reporting. (However, about six years ago, the Canadian province of Nova Scotia instituted a required reporting system that has resulted in over 20,000 reports of errors and “near-misses” each year.)

The facts of the 2014 case are direct: A pharmacist was responsible for mistakenly filling a prescription written to supply labetalol but instead dispensed lamotrigine. As a result, the patient suffered permanent kidney damage requiring long-term dialysis. However, because of more in-depth news reporting, an investigator for a local television station made the claim that pharmacists deal with mistakes in “secrecy” and recommended that prescription errors reporting be mandated.

Regrettably, dispensing errors are an unfortunately fact of a pharmacist’s life. In a 2003 observational study attempting to assess prescription dispensing accuracy in 50 pharmacies in six US cities, pharmacy researchers Elizabeth Flynn, Kenneth Barker, and Brian Carnahan showed that the error rate was 1.7% for the 4481 prescriptions reviewed. Of the 77 identified mistakes, the team considered five to “clinically important.” (J Am Pharm Assoc. 2003;43:191-200). Interestingly, the accuracy rate did not vary significantly by pharmacy type or city.

In a 1998 report, a national pharmacist liability carrier provided information to authors Walter Fitzgerald and Dennis Wilson that 85% of its claims resulted from “mechanical errors,” including dispensing the wrong drug or dose, or labeling the prescription incorrectly. [Drug Topics. 1998 (Jan. 19):84-86.] In an earlier dispensing errors study in California and Oregon, author Andrea Rock reported that each pharmacy made an average of 324 dispensing mistakes every year: almost one per day! (Money. 1998 (Apr.):114-117).

Look-alike/sound-alike (LASA) mistakes – such as the one noted in the 2014 Cincinnati case – are common and well-known in pharmacy practice circles. Despite decades of alerts and warnings and safeguards instituted (including placing the name of the medication on the label, mandatory counseling, automation and redundancies, double- and triple-checks, national and international safety campaigns, and numerous others), the errors persist. (PharmacyToday. 2016 (Feb.):32).

It will remain unclear for some time as to whether any new approach involving mandating that pharmacists report dispensing mistakes will have a positive impact on improved safety. Clearly both pharmacists and patients rightfully fear the possibility of a significant error with life-changing impact. However, given our track records at reducing errors it appears highly unlikely that such mistakes will be eliminated entirely. Perhaps a different tactic might be better here: no-fault insurance for dispensing errors? [Wallis KA. Learning from no-fault treatment injury claims to improve the safety of older patients. Ann Fam Med. 2015 (Sep.); 13(5): 472-474.]

Some may consider this an unnecessary a departure from traditional fault-based liability thinking. After all, dispensing errors are very often clearly negligence: the pharmacist failed to do something that a reasonably prudent pharmacist should have done to avoid injury to the patient. However, the same could be said of automobile accident insurance: a driver failed to do something that a reasonably prudent motorist should have done to avoid injuring another. And yet, some states allow no-fault motorist insurance. The underlying bottom line is the same for both driver no-fault insurance and pharmacist dispensing error liability: it’s an activity that involves human beings making decisions, and human beings will make errors, and sometimes that errors lead to severe injuries which financially impact all of society directly or indirectly. Of course, as with no-fault motor vehicle insurance, if the actor is “grossly negligent” or “recklessly” disregards reasonable safety precautions, then the individual responsible will still be held financially accountable for injuries and losses as under the traditional tort system.

A no-fault system to compensate persons injured from dispensing errors will not eliminate mistakes – something that is not possible – but it will shift the liability focus from identifying the persons or persons to blame to the goal of avoiding errors in the first place. 

The Alden March Bioethics Institute offers a Master of Science in Bioethics, a Doctorate of Professional Studies in Bioethics, and Graduate Certificates in Clinical Ethics and Clinical Ethics Consultation. For more information on AMBI’s online graduate programs, please visit our website.

This entry was posted in Health Care, Pharmaceuticals and tagged , . Posted by Bioethics Today. Bookmark the permalink.

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