Hot Topics: Pharmaceuticals

Blog Posts (47)

December 4, 2018

Deregulating Anti-Kickback: More Than A Kick in Patients’ Wallets.

by Craig Klugman, Ph.D.

Federal kickback rules state that a pharmaceutical manufacturer or medical device producer cannot pay providers or patients to recommend or prescribe their products.…

October 26, 2018

BioethicsTV (October 22-26): #TheResident, #NewAmsterdam, #ChicagoMed

by Craig Klugman, Ph.D.

“Exploring ethical issues in TV medical dramas”

Jump to The Resident (Season 2; Episode 5): Buying Thought Leaders and Handsy Docs; Jump to New Amsterdam (Season 1; Episode 5): Gun shootings; Jump to Chicago Med (Season 4; Episode 5): Genetic secrets and duty to inform

Resident (Season 2; Episode 5): Buying Thought Leaders and Handsy Docs

Bell negotiates a deal with a new start-up medical device company: For a substantial discount, he will make the company the sole source of medical devices at the hospital.…

October 5, 2018

BioethicsTV (October 1-5)

by Craig Klugman, Ph.D.

Jump to The Resident (Season 2; Episode 2): Rising drug costs Jump to New Amsterdam (Season 1; Episode 2): Cultural accommodation; medicating schoolkids Jump to Chicago Med (Season 4; Episode 2): Withholding support; withdrawing support

The Resident (Season 2; Episode 2): Rising drug costs

In its sophomore year, this show seems to be shying away from ethical issues and the gross incompetence of its fictional hospital and exchanging it for hope; hope that hospitals can cover their costs and meet patient needs.…

July 1, 2018

Confusion and Conscientious Objection in Arizona

by Steven H. Miles, MD and Arthur Caplan, Ph.D.

Nicole Mone Arteaga was trying to get pregnant. It had been difficult for her.…

May 8, 2018

Speaking to the Media about Antimicrobial Resistance: A Deeper Description of How I Wear Many Hats as a Bioethicist

by Craig Klugman, Ph.D.

Last week, I was interviewed by an academic news serviceabout antimicrobial resistance (AMR) after a study reported that giving antibiotics to children in selected African towns led to a decreased mortality rate.  …

January 9, 2018

Blindness Cure Is Out of Sight

by Craig Klugman, Ph.D.

The FDA has approved the world’s first gene therapy: Luxturna (voretigene neparvovec; AAV2-hRPE65v2) is a one-time intervention that can treat an inherited retinal disease (RPE65-mediated inherited retinal dystrophy).…

August 9, 2017

Right to Try: Why Logic and Facts Won’t Win This One

by Craig Klugman, Ph.D.

Last week the U.S. Senate passed bill S. 204, the Trickett Wendler Right to Try Act of 2017.…

June 20, 2017

Ethics of Transparent Pharmaceutical Pricing Laws: The Harms Do Not Outweigh the Risks

by Craig Klugman, Ph.D.

Despite campaign promises that drug prices would be lowered, the current administration and Congress seem on target for giving pharmaceutical companies more power over pricing, over keeping out competition and over expanding their monopolies.…

May 1, 2017

Increasing Access to Biosimilar Drugs

The development of ‘specialty drugs’ in the health care industry has created legal, ethical, and public policy issues because patients are not able to get access to their prescribed medications based on the expense.  Specialty drugs are usually biologicals, treat serious conditions, and  are very expensive with no cheap alternatives.[1] Although there is debate about how much finances should influence medical decision making, it is a conversation that can not be ignored when patients can not get access to treatment based on ability to pay. There should be increased access to these drugs but how to increase access is up for debate.

One posed solution has been the creation of biosimilar which are the generic version of a specialty drug. A biological medication is different from a traditional drug in molecular make up.[2]  “A biologic drug is ‘a substance that is made from a living organism or its products[,]’”[3]  while a traditional prescription drug is made up of simple molecules.[4]  This difference means that biologicals are scientifically more difficult to produce because a more elaborate research is necessary.[5]  This also means making a generic form, known as a biosimilar, is more expensive and harder to make.[6] Generally, a biological is “twenty times more expensive per patient than traditional small-molecule pharmaceuticals.”[7] There also are patent infringement concerns when making biosimilar.

 

From ethics perspective, one of the key aspects of justice is ensuring equal access to healthcare or at least fairly allocating available resources. For biosimilar drugs, it truly depends on what insurance company, what insurance plan, and what pharmacy benefit manager the patient has as to whether the patient will even have a chance to get these drugs. One could argue that it is hard to say we have a fair allocation system when it dependent on what backroom deals pharmaceutical companies have with insurance companies. On the other side, fairness includes ensuring that pharmaceutical companies are properly compensated for their time, energies, and resources used to develop these drugs. Yes, they are cheaper than brand name biologics but they are still expensive and arguably unaffordable. Competition has been the suggested method for decreasing prices to ensure better access. However, patents exclusivity and the Food and Drug Administration approval process make competition slow.

 

On April 27, 2017, The United States Supreme Court heard a case that addresses exactly this issue of access. The Court heard oral arguments in regards to an appeal by Novartis, Swiss pharmaceutical company, requesting the time for biosimilars to be on the market be sped up.[8] Amgen, a California pharmaceutical company who makes the name brand version Neupogen, had challenged the early release. The lower court decision had ruled in favor of Amgen, preventing Novartis from releasing its biosimilar until six months after the Food and Drug Administration approved it. The case revolves around a provision in the Affordable Care Act which aimed at creating an expedited path for approval of biosimilar drugs. The goal was to increase access of new innovations to the public as well as increase competition to decrease price. Zarxio, the biosimilar version of Neupogen, is projected to cost 15 percent less than Neupogen, which is a decrease in cost but not a substantial in cost. Part of the issue is health insurance companies expect biosimilar drugs to work like generic medications and they do not. Biosimilars themselves are still innovation and companies charge for the research and development that goes into innovations. The final decision is due to come in June and this case could determine whether justice will be respected in regards to how quickly consumers can get access to biosimilars.

 



[1] Joseph J. Hylak-Reinholtz & Jay R. Naftzger, Is it Time to Shed a “Tier” for Four-Tier Prescription Drug Formularies? Specialty Drug Tiers May Violate HIPAA’s Anti-Discrimination Provisions and Statutory Goals, 32 N. Ill. U.L. Rev. 33, 35 ? 36 (2011); Jim Sabin, How the U.S. Rations “Specialty Drugs,” Health Care Org. Ethics (Saturday, April 26, 2008) http://healthcareorganizationalethics.blogspot.com/2008/04/how-us-rations-specialty-drugs.html.

[2] Michael Callam, Who Can Afford it?: The Patient Protection and Affordable Care Act’s Failure to Regulate Excessive Cost-Sharing of Prescription Biologic Drugs, 27 J.L. & Health 99, 103 (2014).

[3] Id.

[4] Id.

[5] Id. at 104.

[6] Id.

[7] Callam, supra note 2, at 105.

[8] Andrew Chung, U.S. Top Court Grapples Over Making Copycat Biologics Available Sooner, Reuters (Apr. 26, 2017), http://mobile.reuters.com/article/idUSKBN17S2BF.

 

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.

March 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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Published Articles (4)

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

To report or not to report: Exploring healthy volunteers' rationales for disclosing adverse events in Phase I drug trials Lisa McManus & Jill A. Fisher

AJOB Primary Research: Volume 9 Issue 2 - Jun 2018

Undisclosed conflicts of interest among biomedical textbook authors Brian J. Piper, Drew A. Lambert, Ryan C. Keefe, Phoebe U. Smukler, Nicolas A. Selemon & Zachary R. Duperry

American Journal of Bioethics: Volume 18 Issue 4 - Apr 2018

Ethical Guidance for Selecting Clinical Trials to Receive Limited Space in an Immunotherapy Production Facility Nancy S. Jecker, Aaron G. Wightman, Abby R. Rosenberg & Douglas S. Diekema

American Journal of Bioethics: Volume 14 Issue 3 - Mar 2014

The Ethics of Advertising for Health Care Services Yael Schenker, Robert M. Arnold & Alex John London

News (145)

December 6, 2018 9:00 am

If you’re single with cancer, you may get less aggressive treatment than a married person (The Washington Post)

If you are divorced, widowed or never married and develop cancer, watch out. You may get less aggressive treatment than your married friends.

We’ve often heard about studies showing that married adults are more likely to survive cancer than singles. But buried in those same studies is another finding that hasn’t made the headlines. When surgery or radiotherapy is the treatment of choice, patients with spouses are more likely to get it.

December 4, 2018 9:15 am

‘From Nothing to Gangbusters’: A Treatment for Sickle-Cell Disease Proves Effective in Africa (The New York Times)

A drug that protects children in wealthy countries against painful and sometimes lethal bouts of sickle-cell disease has been proven safe for use in Africa, where the condition is far more common, scientists reported on Saturday.

More research remains to be done, experts said, but knowing that hydroxyurea — a cheap, effective and easy-to-take pill — can safely be given to African children may save millions of youngsters from agonizing pain and early deaths.

“I think this is going to be amazing,” said Dr. Ifeyinwa Osunkwo, who directs a sickle-cell disease program in Charlotte, N.C., but was not involved in the new study.

November 27, 2018 9:15 am

Task Force Calls for Offering PrEP to All at High Risk for H.I.V. (The New York Times)

An influential government task force has drafted a recommendationthat would for the first time urge doctors to offer a daily prophylactic pill to patients who are at risk for contracting H.I.V. The recommendation would include all men and women whose sexual behavior, sex partners or drug use place them at high risk of contracting the virus that causes AIDS.

November 20, 2018 10:39 am

Adverse reactions to antibiotics land thousands of kids in the ER each year. What parents should know (The Washington Post)

Nearly 70,000 children end up in emergency rooms every year after experiencing adverse reactions to antibiotic drugs, according to an analysis by the Centers for Disease Control and Prevention (CDC) published in August in the Journal of the Pediatric Infectious Diseases Society.

About 74 million antibiotic prescriptions are doled out to kids each year, the study notes, and past research has indicated that at least one-third of these pediatric antibiotic prescriptions are unnecessary.

November 15, 2018 9:00 am

What if the Placebo Effect Isn’t a Trick? (The New York Times)

But as ubiquitous as the phenomenon is, and as plentiful the studies that demonstrate it, the placebo effect has yet to become part of the doctor’s standard armamentarium — and not only because it has a reputation as “fake medicine” doled out by the unscrupulous to the credulous. It also has, so far, resisted a full understanding, its mechanisms shrouded in mystery. Without a clear knowledge of how it works, doctors can’t know when to deploy it, or how.

November 9, 2018 1:00 pm

23andMe’s genetic test for how you’ll react to medication is ahead of its time (The Verge)

The doctor still isn’t supposed to suggest changing medication until they have you genetically tested again by an independent lab. “It seems to me that if a patient has an interest in their pharmacogenetic profile that could impact medication decisions, they’re probably better off just asking the physician about what testing can be done

November 8, 2018 9:00 am

F.D.A. Approves Powerful New Opioid Despite Warnings of Likely Abuse (The New York Times)

The Food and Drug Administration on Friday approved a new form of an extremely potent opioid to manage acute pain in adults, weeks after the chairman of the advisory committee that reviewed it asked the agency to reject it on grounds that it would likely be abused.

October 31, 2018 9:00 am

FDA set to approve potent opioid for market despite adviser’s objections (The Washington Post)

The Food and Drug Administration is poised to approve a new form of a powerful opioid for use in hospitals and emergency rooms despite opposition from the head of the committee that reviewed the drug.

October 26, 2018 9:00 am

Drugmakers may have to disclose prices of medicine in television ads (The Washington Post)

The nation’s top health official proposed on Monday that pharmaceutical companies be required to include the list price of medicines in television advertisements to consumers.

September 26, 2018 9:00 am

As China builds biotech sector, cash floods U.S. startups (Reuters)

Brii is one of many biotech startups riding a wave of money from Asia that so far this year has poured $4.2 billion into private U.S.-based biotech companies. That is over 43 percent of the total amount of venture funding invested in the biotech sector, according to PitchBook, up from just 11 percent in 2016.

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