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Author Archive: Bioethics Today

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04/24/2017

Fetuses and Full Disclosure

Medicine has a notoriously long history of paternalism, particularly with regards to reproductive health. The past century has seen everything from forced sterilization of people of color and those with intellectual disabilities to nondisclosure of sexually transmitted diseases. Physicians have fought to regain the trust of the community through disclosure of key medical information and shared decision making, both of which are essential underpinnings of the bioethical principle of autonomy. Given the incredible emphasis on these concepts in contemporary medical training, it is surprising that the following law has now passed Texas Senate approval:

SB 25. A cause of action may not arise, and damages may not be awarded, on behalf of any person, based on the claim that but for the act or omission of another, a person would not have been permitted to have been born alive but would have been aborted. (b) This section may not be construed to eliminate any duty of a physician or other health care practitioner under any other applicable law.

In short, there can be no legal penalty against physicians who knowingly choose to withhold information from pregnant patients if the physician thinks it will prevent an abortion. This does not absolve the physician in question from professional consequences, like action from the Texas Medical Board. However, it does set an important precedent – namely, that the belief structure of the physician takes precedence over the rights of the patient. From a bioethical standpoint, this is an inexcusable violation of autonomy. Disclosure of all relevant information is critical to informed decision making, which is the bedrock of autonomy in the complex, jargon-laden world of modern medicine. One of our key roles as clinicians is to promote patient autonomy by translating this jargon into information that can be easily understood by the patients, family members, or anyone with medical power of attorney. Her decisions about the future of her pregnancy hinge on information about fetal status, whether she decides to terminate or simply wants to be able to prepare for the effects of an abnormality. Clearly, allowing one’s own beliefs surrounding abortion to supersede a patient’s right to know about the status of her fetus is an obvious ethical transgression.

Furthermore, legal actions that protect doctors who fail to disclose important information to their patients harm the medical community at large. These laws undermine the trusting relationship between doctor and patient that we continue to build, particularly in vulnerable populations that have historically been ignored or exploited by medical professionals. Trust is especially important in sexual and reproductive healthcare as patients entrust their physicians with some of the most intimate details of their lives when seeking treatment in these matters. SB 25 is akin to codifying mistrust into law. 
Patients’ values may differ drastically from our own and the decisions they make may not reflect what we would do in similar situations. Almost all physicians have had patients make decisions with which they disagree thoroughly. However, it is our duty to behave in an ethically responsible way and to help patients make these decisions in a way that is consistent with their own belief structure, regardless of our own feelings. This means providing all relevant information in a nonjudgmental way and respecting the informed, autonomous decision of the patient. Passing a law exempting physicians from the legal consequences of paternalism doesn’t change what is right. Rather, it serves only to further divide patients from their providers in a way that harms us all. 

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.

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04/20/2017

Dueling BRCA Databases: What About the Patient?

The news release Monday morning grabbed my attention:

“Study finds wide gap in quality of BRCA1/2 variant classification between Myriad Genetics and a common public database.”

Myriad Genetics had been exclusively providing tests, for $3000+ a pop for full BRCA gene sequencing, for 17 years before the Supreme Court invalidated key gene patents back in 2013. Since the ruling a dozen or so competitors have been offering tests for much lower prices. Meanwhile, Myriad has amassed a far deeper database than anyone else, having been in the business so much longer. And it’s proprietary.

CLASSIFYING GENE VARIANTS

(NHGRI)

Public databases of variants of health-related genes have been around for years too. The best known, ClinVar, collects and curates data from the biomedical literature, expert panels, reports at meetings, testing laboratories, and individual researchers, without access to Myriad’s database. ClinVar uses several standard technical criteria to classify variants as “pathogenic,” “benign,” or “of uncertain significance.” (“Likely pathogenic” and “likely benign” were used more in the past.)

ClinVar lists 5400 variants just for BRCA1. The criteria come from population statistics, how a particular mutation alters the encoded protein, effects on the phenotype (symptoms), and other information. Bioinformatics meets biochemistry to predict susceptibility. The BRCA1 protein acts as a hub of sorts where many other proteins that control DNA repair gather. DNA Science discussed the genes behind breast and ovarian cancers here.

As gene sequences accumulate in the databases and troops of geneticists and genetic counselors annotate them, the proportion of pathogenic and benign entries will increase as that of the unsettling “variants of uncertain significance” — VUS — will decrease. Knowing will outpace not knowing. In the meantime, a woman with a VUS for a gene that confers susceptibility to develop breast and/or ovarian cancer, concerned that her DNA sequence isn’t “normal,” might have her at-risk organs removed. And then she might learn, as the databases grow, that her variant is really benign after all, because while she was being treated for a disease that she didn’t actually have, more patients emerged who have the gene variant but not the related cancers.

The reclassification of a VUS as something more meaningful depends on access to as much information as possible.

How many unnecessary surgeries are happening? Have happened? Myriad estimates hundreds to thousands.

DISCOVERING DISCORDANCE

The news release announced a paper from Myriad just published in The Oncologist that compared 4,250 unique BRCA1 and BRCA2 gene variants in the company’s database to entries in ClinVar, and found that 26.7% of the ratings do not fully agree. (ClinVar lists multiple sources for many of the variants, and 14.5% didn’t agree on all counts and 12.3% on only some.) According to Myriad, most of the VUS listings were in ClinVar. In fact, only 0.5% of Myriad’s BRCA1 sequences and 1.1% of their BRCA2 sequences are VUS. They’re clearly ahead of the game.

 

A breast cancer cell (NHGRI).

The discordance isn’t really news. It echoes earlier reports both from Myriad researchers for the BRCA genes and from a  non-Myriad, multi-center group that also found 26% discordance, but their analysis included several cancer predisposition genes; the most conflicting were CHEK2 and ATM. And another recent study found that about half of women with VUS undergo bilateral mastectomy, concluding that “many surgeons managed patients with BRCA1/2 VUS the same as patients with BRCA1/2 pathogenic mutations.” That’s terrifying. It means that the problem isn’t due just to overanxious patients, but also to surgeons who might not be genetics-savvy.

The news release doesn’t go to the obvious conclusion, that privatization of the database may be fueling inappropriate surgeries, or at least not preventing them, a point that Sharon Begley made elegantly in Stat News. Many of her expert sources countered the implication that variant classifications from ClinVar are just accepted and delivered to patients without further and often intense research and validation by health care providers.

MOTIVES

In the news release, William Gradishar, MD, from the Feinberg School of Medicine at Northwestern University and lead author on the new study from Myriad, provided the company view (slightly edited):

“The high degree of discordance seen in this study signals a cautionary note … it means that different labs are providing different results to patients for the same genetic mutation … some patients are receiving incorrect results that may have life-changing or -threatening implications… Although efforts are underway to resolve the quality problems within public databases, it is unlikely the issue will be resolved soon and users of public databases likely will continue to encounter discrepancies. At this time, labs should not use public databases in any way in clinical variant classification.”

Actress and activist Angelina Jolie had her breasts and ovaries removed to lower her risk of BRCA1-associated cancers.

Ron Rogers, spokesperson for Myriad, wrote in an email that the company provides database access for certain scientific collaborations, but then provided the business view:

“Myriad has invested hundreds of millions of dollars to develop our database over two decades, which is used to classify variants as part of the Company’s specific process. We encourage other commercial labs to make their own investments, which are required to offer a quality product. The problem is that some other commercial labs refuse to make the needed investments. Instead, they are trying to short cut the process by relying on inaccurate public databases, which has the potential to deliver inaccurate results and harm real people.”

If anyone remembers the race to sequence the first human genome, which pitted NHGRI and their public database against Celera Genomics and their proprietary one, the battle over BRCA is a little deja vu all over again.

Rogers added that if patients who have had bilateral mastectomies following a report of a VUS had come to Myriad, “we could have provided many of them with definitive answers and helped to prevent a significant number of these life-changing procedures.” About 85% of the BRCA testing market indeed uses Myriads products.

Myriad’s tests as well as their support (genetic counseling) are excellent. The company helped a friend of mine interpret and confirm BRCA1 test results from 23andMe, which her son had taken on a whim but the unexpected finding of a mutation had sent her family into a tailspin. 23andMe, the direct-to-consumer genetic information company, coaxes customers to provide their results for research (“Be part of something bigger”) and charges investigators for access to the data. Like Myriad, 23andMe also suffered a setback in 2013. FDA yanked some of their health-related carrier tests, but the agency reversed the ban on April 6, 2017.

23andMe and Myriad serve different types of individuals. Many of 23andMe’s customers, like my friend’s son, aren’t distraught over cancer, just curious and acting on their own. So here’s another comparison: Is Myriad’s protecting of their data similar to my reaction to people downloading my books for free? No. I’m just losing royalties.

My mother’s lost battle with breast cancer can’t help but influence my view that impeding accurate diagnosis for profit, to protect assets, may make sense in the business world but is not the right thing to do. I have trouble commoditizing patient tests and sequestering information that might help, and the many rock stars of genetics who have joined the Free the Data movement would agree.

Because the entire discussion makes me queasy, I thought instead I’d illustrate the distinction between a harmful mutation and a VUS, by comparing the BRCA1 gene sequence to the English language.

THE HANDMAID’S TALE

Most genes are thousands of DNA bases long, and therefore can vary in many ways. Gene variants – mutations – can affect health or not depending upon how they disrupt the proteins that they encode.

BRCA1 (the gene) is 125,951 bases long, only 5,589 of which are represented in the protein. Mutations near its ends are more damaging than those in the middle. One of the two Ashkenazi (Jewish) “founder” mutations, 185delAG, removes an A and a G at position 185, near the beginning. Because a gene sequence is read in triplets – every 3 DNA bases encodes an amino acid – adding or deleting a number that isn’t 3 or a multiple of it devastates the protein’s function. 185delAG is, then, a gene variant of very high significance. (My analogy below is not quite on target because the words in a sentence vary in length.)

I entered 125,951 letters into a publishing calculator that translates numbers of alphabet characters into a book of a particular size, and wound up with a 6” by 9” volume of 265 pages. That view of the BRCA1 gene’s enormity corresponds to approximately the length of Margaret Atwood’s dystopian masterpiece “The Handmaid’s Tale.” I’m rereading it, inspired by the “Make Margaret Atwood Fiction Again” signs at the March on Washington January 21.

I took a sentence about as far into the book as the 185delAG mutation is in the BRCA1 gene:

Everything except the wings around my face is red: the color of blood, which defines us.

Removing two adjacent letters – the “ex” in “except” – and then moving the other letters into the word-sizes, clearly disrupts the meaning:

Everything ceptth ewi ngsar oundmy fa ceis re dth: eco lorof bl oodwh ichde finesus

Gibberish, and it would continue to the end of the book. In a gene, the offset sequence would likely lead to a stunted protein, halted when reaching a “stop” signal in the mRNA. And when a BRCA1 gene loses meaning, control of DNA repair falters and other mutations go unchecked. Cancer results.

A VUS would do something less drastic, such as replacing a letter in a way that doesn’t obscure the overall meaning of the sentence (or gene). Substituting the “g” in “everything” with a “j,” for example, doesn’t alter the meaning. And many changes to a DNA sequence have no effect on the encoded amino acid sequence at all.

So that’s what a VUS is, a DNA sequence of a particular gene of interest that’s rather rare in a population, and that may or may not mean something. And their numbers will decline and then vanish as the databases build and their entries are annotated and validated. But until they do, I think that sharing all that we know about variants of possibly disease-causing genes, to prevent unnecessary treatments, is the only ethical path to take.

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.

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04/12/2017

Rape, disability, and gender: A response to McMahan and Singer’s op-ed on the Anna Stubblefield case


Unfortunately, there have been numerous cases of sexual harassment and sexual assault in academia and particularly in more male-dominated fields, including my home field of philosophy. In these cases, professors use their position of prestige and power to sexually harass and abuse their students. UC Berkeley philosophy professor John Searle is just the most recent example. To my knowledge, all of these cases have involved male professors victimizing female students. The lone exception is Anna Stubblefield, a former professor of philosophy at Rutgers. Here is a summary of her case from Current Affairs


At issue is the case of Anna Stubblefield, a Rutgers University philosophy professor convicted of sexually assaulting her mentally disabled pupil, and sentenced to 12 years in prison. The case is, to say the least, extremely unusual. The student, D.J., was a severely impaired 30 year old man with cerebal palsy, who had never spoken a word in his life and communicated through “screams” and “chirps.” Stubblefield acted as his personal tutor, using a discredited pseudoscientific technique to elicit what she insisted were complex communications from D.J. Eventually, based on what she believed D.J. wanted, Stubblefield began engaging in sex acts with him, having become romantically attracted to him over the course of her time assisting him.  

Stubblefield’s case is not only different because she is a woman and her victim is a man, but also because she is one of the few professors to go through the legal system and be convicted.

There are many complexities to Stubblefield’s case and I don’t have the space to address them all here. Instead, I want to discuss a particular point Jeff McMahan, philosophy professor at University of Oxford, and Peter Singer, bioethics professor at Princeton, made in an op-ed piece in the New York Times regarding Stubblefield’s case. They argue that because D.J. is cognitively disabled, the sexual assault did not harm him in the same way or to the same degree as it would an individual who is not cognitively disabled because D.J. “cannot understand the normal significance of sexual relations between persons or the meaning and significance of sexual violation.” Not surprisingly, this op-ed piece has upset individuals in the disability community and advocates for individuals with disabilities. People such as Nathan J. Robinson have responded eloquently to the main argument of McMahan and Singer’s article.

I want to look more closely at a smaller point they make as part of their larger argument. They state, “It seems reasonable to assume that the experience was pleasurable to him [D.J.].” The assumption that sexual activity was pleasurable for D.J. even though he was not able to consent to it is troubling and reinforces problematic gender norms. There is a dominant cultural narrative that men are always interested in sex and that sex is always pleasurable for them. This narrative contributes to the popular perception that men cannot be raped by women because an erection is a sign of their consent. Yet, men can indeed be raped by women and an erection can occur even if men are not aroused or consenting to sexual activity. If D.J. were a woman and Stubblefield were a man, I doubt McMahan and Singer would argue that we could assume the experience was pleasurable for the victim. Yet because of our dominant cultural norms regarding gender and sexuality – namely that men always want sex and that sex is always pleasurable for them – McMahan and Singer seems to assume that this is the case even when DJ does not have decision-making capacity.

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.

 

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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.

Full Article

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.

Full Article

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.

Full Article

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.

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03/24/2017

Bioethics & Wine

I never thought I’d have the opportunity to use this blog title. Never, that is, until I stumbled across a company called Vinome, a California start-up that offers a curated wine service based on a customer’s individual taste profile. What makes this wine subscription service unique is not its price (although, at around $65 a bottle, it’s just a bit outside of the typical price-per-bottle for many wine club members). At Vinome, your taste profile includes not only a list of questions about your preferences, but also information from DNA sequencing from the saliva sample you provide to the company. The company website proclaims this is “A little science and a lot of fun,” but experts are skeptical about whether there is any science involved at all.

Holding aside the question of scientific plausibility, companies touting direct-to-consumer genetic screening for ancestry, medical issues, or just plain fun include information in the fine print that would give any bioethicist pause. While the Vinome website requires patrons to check the box indicating “I have read and understand the Vinome Informed Consent” prior to ordering, that “informed consent” is only available if the customer voluntarily clicks on the informed consent link. Buried at the bottom of the informed consent screen is a sentence that reads:

 

“You allow Vinome to retain your data as part of Vinome’s secure research database, for use by Vinome or its research affiliates, in an effort to improve and expand services. If any commercial product is developed as a result of the use of your data, there will be no financial benefit to you.”

 

In case the business interests are still unclear, here is more from their Terms of Service:

 

“By submitting DNA to Vinome, you grant Vinome a perpetual, royalty-free, world-wide, transferable license to use your de-identified DNA, and to use, host, sublicense and distribute the anonymous resulting analysis to the extent and in the form or context we deem appropriate on or through any media or medium and with any technology or devices now known or hereafter developed or discovered.”

 

That’s quite a sweeping consent, and one of which I suspect most customers will never be aware. Individuals who are just hoping for some scientific guidance on whether to buy the merlot or the syrah are also unwittingly sending their genetic information into the stream of commerce to be collected, analyzed, bought, sold, and mined for data. We might be willing to give up some of our personal information in exchange for cheaper groceries, but buying and selling our spending habits seems a lot less invasive than doing the same to our DNA. Despite our best efforts, genetic information can never truly be de-identified – DNA itself is our best identifying information.

Direct-to-consumer marketing of genetic screening has seen much growth in the past few years. In addition to Vinome, the consumer genomics firm Helix has partnered with several entities to offer services, including National Geographic (offering ancestry tracing), ExploraGen (offering “personalized epicurean experiences”), and Invitae (offering interpretation of genetic screening to provide “actionable findings” related to various diseases – requires clinician authorization). While use of genetic information in research is heavily regulated and a source of ongoing debate, should consumers of commercial genetic testing be protected as well? Are these customers aware of the information they are freely giving, and the myriad ways their most personal information may someday be used? And how does informed consent fit into this middle ground between medicine and commerce? It seems to me, at the very least, the consumer should be required to give explicit consent beyond merely “checking the box” – whether such consent could ever really be “informed” is another question altogether.

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.

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03/14/2017

De-stigmatization of the disgraceful mark of stigma in the opioid crisis

After attending Albany Government Law Review’s symposium, Script to Street: Opioids and the Law in the Capital District this past Thursday, there was several issues addressed but the one overarching concern was about the role of stigma in this opioid crisis. Many different types of stigma were identified and the different ways our negative judgments have impacted society. As one speaker during the first panel discussion stated, addiction is not a new problem. He described one historic painting that showed different reactions of society to addiction: disgust, numbness, shock, or simply ignoring the problem. All of these reactions illustrate stigma and shows how despite all our social advancements, we still have not eliminated (or destigmatized) stigma of the addiction problem. 

Some definitions of stigma include a mark of disgrace, society disapproval of something, or a negative set of beliefs society has about something.  All definitions include this perceived negativity and describe stigma as bad. Stigma is not something one like to face and usually, a judgment one tends to try avoiding. 

The issue with stigma our current opioid crisis is that it is not just one type of stigma, it is layers of stigma on top of one another. There is the stigma of being a drug user and the stereotypes of who is a drug user (the poor, African American, Hispanic). Drug-users are perceived to be “bad” people who only care about drugs.  This perception becomes a barrier to treatment as individuals do not want to seek treatment in fears they will be labeled as a drug user, even if these individuals are suffering from chronic pain. There is a list of characteristic behaviors of a drug-seeker based on our own judgments, even though there is a consensus that these behaviors do not accurately capture or describe drug-users. There is also the stigma of that those who are using mediated assisted treatment as still drug-users and that this medication is just going to back into the illegal drug market.  This goes into the ethical debate of harm reductionist approaches and whether this still violates non-maleficence. There is the stigma that physicians face for their role in prescription opioids and the stigma methadone clinics face. One physician speaker described the negative reactions of other business when she opened her clinic in a business area.  She was told her clinic was not in the right part of town, asked to leave, and her neighboring businesses were concerned about the type of people her clinic would treat.  There is the stigma of being mentally ill for those individuals who have a dual diagnosis or misdiagnosis of mental illness along with drug addiction.  There is the stigma of a felony for those individuals who only can get treatment through drug court.  With all these negative judgments that one person can face, it is no surprise that drug-users wish to remain unknown. 

Stigma is an ethical concern because it impacts how we treat each other in the clinical setting and in the public setting.  It impacts who gets care and how they receive that care. For example as the moderator, Professor Anthony Farley stated, when the stigma of this crisis was a "black problem," there was not the same amount of attention to this crisis as there is currently.  This racial-stigma blocked access to care. Yet, this crisis affects everyone and is not a “black problem.” Stigma influences patient autonomy, as it is an external influence that inhibits a patient’s expression of autonomy. Negative judgments are also not beneficent as stigmatized plans of care are realistically not in the patient's overall best interest.

Due to the potential negative impact of stigma in patient care, we ideally aim to eliminate it completely or reduce it. However, this may not be done. 

Societal stigma is so broad that we may not even see that it is happening. Assuming we can identity it, how then does one change someone else’s views even if it is negative or untrue about someone else? If it is a professional such as physician, we have regulations and codes of ethics to prevent judgments but what about on the broader public level? As one speaker suggested, one of the best ways to combat stigma is changing language and how we talk about addiction and drug-users. But if we can not eliminate it, the next best option is acknowledging the powerful impact these unnoticed perceptions. 

It was a powerful symposium where a diversity of professionals (lawyers, judges, nurses, physicians, and advocates) discussed our options in the opioid and heroine drug crisis. There is hope to have a follow-up meeting to continue these important conversations in order to come to a solution to address the opioid drug crisis and still treat legitimate pain needs. 


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.

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03/09/2017

The End Of The Affordable Care Act and Its Critics’ Hollow Moral Rhetoric

From the 1940’s to the present, it’s hard to think of a major topic on the American political agenda that has been subjected to more tortured language and ideological extremism than healthcare. By no means am I saying that healthcare proposals to expand access to healthcare over the years should not have been subjected to rational scrutiny and disagreement. But it seems, by and large, disagreement over healthcare policy proposals have always been about the opponents of progressive options to expand insurance coverage tapping into a certain segment of voters’ deepest fears and biases to predispose them against any alternative for change.

All progressive leaders who have attempted reform in healthcare, like Earl Warren (Governor of California from 1943-53) and President Harry Truman (mid-late 1040’s), to President John Kennedy and Lyndon Johnson in the 1960’s, to the Clintons in the 1990’s, to Barack Obama in 2009, have been met with fierce opposition from lobbying groups representing big business, including insurance and pharmaceutical companies, and often physicians through the American Medical Association. The essential line of attack has been that government would become overly involved in medical decision-making and overshadow the influence and judgment of physicians in the care of patients. But to win this argument decisively, the hired consultants devised plans to associate expanded healthcare coverage or universal healthcare with “socialized medicine” and even the “red scare”—clear demeaning associations with undemocratic countries, unlike the United States, that quickly appeal to irrational sentiments and undermine any consensus for reform. These basic underhand, scare tactics continued to be effective against the failed Clinton proposal in 1993 and, later, President Obama’s signature achievement—the Affordable Care Act—which currently in the process of being repealed and radically scaled down in terms of benefits.

It is noteworthy that a trend developed during the Reagan administration in the 1980’s that added ideological vitality to arguments against expanded access to healthcare: not only was any move toward expanded healthcare a move toward socialism, something assumed to be inherently repugnant, but also, that government, compared to free market mechanisms, was particularly inept to bring about any desire change—as Reagan stated in his 1981 inaugural speech. Just as it is not unreasonable to question the viability of various healthcare proposals, it is not unreasonable to question the legitimate and reasonable extent government should be involved in providing public goods and services. But from the outset, Reagan’s critique of government was simultaneously an outcry of how government was providing benefits to undeserving people, like the infamous “welfare queen” who was abusing the system. It’s hard not to discern from his message clear racial overtones that were meant to appeal to crass biases and prejudices of White working people. It became easy to see government services and benefits as “free stuff” that undeserving people received because those who worked were being coerced to support with their tax dollars.

By the 1990’s government was under attack by the political right and when the Clinton healthcare reform effort began to crack in 1993, the opponents pounced. Healthcare reform was not on the public agenda during the Bush administration and many of thought it was a dead issue for at least another generation. However, the election of President Obama revived interest in healthcare reform, which resulted in the passage of the Patient Protection and Affordable Care Act (ACA). In spite of the fact that this bill was developed by Heritage Foundation, a conservative, pro-free market think tank, and implemented rather successfully in Massachusetts by a Republican governor and future Presidential candidate, the political right attacked it from the outset. The passage of the ACA gave right wing media handlers all the talking points they needed to incite public outrage on the part of many White, working Americans, most in need of healthcare coverage, not less.

The ACA was adopted and pushed through by our country’s first African American president, whose success his opponents wanted to subvert, even if they agreed with him. The ACA was predicated on the use of mandates and expanded a Medicaid program, and provided healthcare coverage for many millions of more Americans. Though it used the private insurance market, the ACA was viewed by its strongest opponents, viz. Republicans in the House of Representatives, as a new government, welfare program that provided more free stuff to non-working people on Medicaid; was paid for by those who chose to work; and interfered in the physician-patient relationship, as critic Dr. Tom Price, the new Secretary of Health and Human Services, was wont to say. There were many ways that reasonable people could have made their critiques, but for the Republican Congressional Representatives, the ACA became a bizarre obsession, attempting to repeal without success 60 times. That is, until the unexpected outcome of the 2016 presidential election. Since then, they have been somewhat like the proverbial dog who finally caught the car he had been chasing.

Now the Republicans are in control of the White House and both houses of Congress, and are unwinding of the ACA. Many on the extreme right are eager to see its full repeal in spite of the lack of any clear consensus on the plan for what will replace it and the consequences that will ensue. All along, we have heard promises that the replacement will provide healthcare that is cheaper and better quality care – but so far those promises seem to ring hollow.

At this point the Republican proposal repeals the individual and employer mandates as well as the subsidies based on a sliding scale according to income; the replacement would distribute subsidies based on age, not income, which in effect greatly benefits those in higher income brackets and harms those in lower brackets.

States would allow to cover Medicaid patients using block grants, which would give states broad discretion over how care is provided and greater emphasis would be placed on health savings accounts (which presupposes people have money to save and would only affect the fairly well-off) The new proposal would continue to guarantee that patients with preexisting conditions will not be denied access to healthcare coverage and that children can remain on their parents’ healthcare insurance until age 26.

This proposal will cause many millions of people—ironically many poor people in states that supported the current president like Kentucky and West Virginia—to lose their healthcare coverage. Moreover, with the demise of the ACA there is the real risk that millions of Americans will not only be without healthcare, many more will die unnecessarily.

Let me say again, I fully realize that rational people could disagree about the wisdom of the ACA and which healthcare policy makes the most sense. But attack on the ACA and the insistence on its repeal have been irrational. It is only in the context of a tradition of distorted information, hype, and ideological zealotry that Speaker Paul Ryan could make statements like he did on Twitter on February 21:

Freedom is the ability to buy what you want to fit what you need. Obamacare is Washington telling you what to buy regardless of your needs.”

 It is a moral tragedy that such statements about an essential human service, like healthcare, is even taken seriously by anyone who knows anything about healthcare. All human beings are vulnerable to illness and accidents and when their bodies, or the bodies of those we are caring for, fail acutely, we seek and expect help in hospital emergency rooms.  This expectation will continue and the result will be greatly increased healthcare costs and human suffering, since more people will lose access to primary care and be forced to enter the healthcare system at the acute stage with no insurance, rather than earlier on with medical problems can be more easily managed.

But Ryan’s words also offer a distorted, truncated view of freedom that likely only appeals to the well off with blinkered moral concerns about their fellow human travelers. Freedom for him and his ilk is like saying, “I got mine, let those without fend for themselves; after all, they are free.”  This is a hollow, simplistic view of freedom and our society is paying the price for decades of distorted information about healthcare policy.

We can only hope the fight for universal healthcare continues and eventually a consensus emerges to do the right thing.

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.

 

 

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