Tag: mandatory reporting

Bioethics Blogs

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

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.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

DNA papers, please

Kuwait is planning to build a complete DNA database of not just citizens but all other residents and temporary visitorsThe motivation is claimed to be antiterrorism (the universal motivation!) and fighting crime. Many are outraged, from local lawyers over a UN human rights committee to the European Society of Human Genetics, and think that it will not be very helpful against terrorism (how does having the DNA of a suicide bomber help after the fact?) Rather, there are reasons to worry about misuse in paternity testing (Kuwait has strict adultery laws),  and in the politics of citizenship (which provides many benefits): it is strictly circumscribed to paternal descendants of the original Kuwaiti settlers, and there is significant discrimination against people with no recognized paternity such as the Bidun minority. Plus, and this might be another strong motivation for many of the scientists protesting against the law, it might put off public willingness to donate their genomes into research databases where they actually do some good. Obviously it might also put visitors off visiting – would, for example, foreign heads of state accept leaving their genome in the hands of another state? Not to mention the discovery of adultery in ruling families – there is a certain gamble in doing this.

Overall, it seems few outside the Kuwaiti government are cheering for the law. When I recently participated in a panel discussion organised by the BSA at the Wellcome Collection about genetic privacy, at the question “Would anybody here accept mandatory genetic collection?” only one or two hands rose in the large audience. When

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Legal Briefing: Mandated Reporters and Compulsory Reporting Duties

My latest legal briefing in the Journal of Clinical Ethics is out: “Mandated Reporters and Compulsory Reporting Duties”

This issue’s “Legal Briefing” column, one product of a Greenwall Foundation grant, reviews recent developments concerning compulsory reporting duties. Most licensed clinicians in the United States are “mandated reporters.” When these clinicians discover certain threats to the safety of patients or the public, they are legally required to report that information to specified government officials. Over the past year, several states have legislatively expanded the scope of these reporting duties. In other states, new court cases illustrate the vigorous enforcement of already existing duties. 

I have organized all these legal developments into the following eight categories:
1.   Overview of Mandatory Reporting Duties
2.   Controversy over the Benefits of Mandatory Reporting
3.   New and Expanded Duties to Report
4.   Criminal Penalties for Failing to Report
5.   Civil Liability for Failing to Report
6.   Disciplinary Penalties for Failing to Report
7.   Legal Immunity for Good-Faith Reporting
8.   Protection against Employers’ Retaliation

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.

Bioethics Blogs

Should we do more to help paedophiles?

By Rebecca Roache

Follow Rebecca on Twitter here

Luke Malone has published an extremely moving, disturbing, and distressing article in Medium, entitled ‘You’re 16. You’re a pedophile. You don’t want to hurt anyone. What do you do now?’ (warning: Malone’s article contains a graphic description of child abuse). The article focuses on ‘Adam’, a young man who, aged 16, was horrified to discover that he was sexually attracted to children. Disturbed by his sexual desires, and desperate to avoid acting on them, he suffered depression and initially used child pornography as an outlet for his feelings. (He subsequently stopped doing this.) Adam describes how he eventually went to see a therapist, who was unsympathetic, inexperienced in this area, and ultimately of little help. It turns out that, despite the fact that paedophilia is recognised as a mental disorder, there are major obstacles to helping people who, like Adam, are desperate to avoid harming children. Malone summarises some of the main problems:

There is currently no mechanism for treating someone who has pedophilic urges and hasn’t acted on them. A major roadblock is the existence of mandatory reporting laws, which dictate that people in certain professions must report suspicion of child abuse and neglect to Child Protective Services. … Mandated reporting revolutionized the way child abuse is handled in the U.S. and has brought many incidents to light, but it can be problematic for young men like Adam who haven’t abused children. The civil and criminal liabilities facing those who fail to report someone who goes on to molest a kid, combined with the fact that it need only be based on suspicion and not probable cause, means a report could be triggered when well-intentioned individuals reach out for help.

The views, opinions and positions expressed by these authors and blogs are theirs and do not necessarily represent that of the Bioethics Research Library and Kennedy Institute of Ethics or Georgetown University.