Pharmacists, emergency contraception, and the responsibilities of a profession

As someone who has been associated with colleges of pharmacy as student or professor for 25 years, I feel compelled to weigh in on the debate raging in the US between a pharmacist's right of conscientious objection to filling certain prescriptions and their responsibilities as a licensed health professional of the state. I originally intended this discussion to target the emergency contraceptive, Plan B. However, today's post by Tara about a pharmacist refusing to fill a Vicodin prescription for a relative after breast surgery reminds me of the slippery slope we face in permitting health professionals to reject the duties of their profession.

Should a pharmacist have a right to refuse filling a prescription on religious or moral grounds?

I argue "no," with the exception of extremely rare circumstances.

If you care to read more on both sides of this issue, I direct you to Cantor and Baum's 2004 NEJM paper (NEJM 2004; 351:2008-12) and Hepler's 2005 paper in the Journal of the American Pharmacist's Association (JAPhA 2005; 45:436-438, also available at Medscape with free reg.)

The arguments are as follows: on one side, pharmacists reserve the right to deny filling prescriptions they deem morally wrong. This argument most often relates to the filling of prescriptions for emergency contraception. On the other side, pharmacy is a profession that puts the rights of the patient and their autonomy ahead of the pharmacist's personal views. This argument holds that if a therapy is approved by the US Food and Drug Administration, a pharmacist has a professional duty to provide access to the therapeutic when accompanied by a valid prescription.

First, let us dispense with the rhetoric that Plan B is an abortifacient (i.e., induces abortion). This is untrue. Plan B is an emergency contraceptive that prevents ovulation and/or implantation, just like daily oral contraceptives. As pointed out by Dr Henri Manasse, Jr, of the American Society of Health-Systems Pharmacists, Pentel and colleagues have reported that it is the consensus of "the World Health Organization, the Food and Drug Administration, the American College of Obstetricians and Gynecologists, the Association of Reproductive Health Physicians, the American Public Health Association, and the American Medical Association" that emergency contraception is just that, not abortion. (Am J Health Syst Pharm 2004;61:1773-4)

But regardless, should a pharmacist have any rights regarding objection to filling a prescription? Hepler does the most concise job in making the argument for pharmacist rights:

Reasonable and strong arguments support conscientious objection. First, a pharmacist is not an automaton or a physician's valet but a necessary member of the health care team. Pharmacists complete at least 6 years of rigorous education and clinical training and prove their knowledge by passing a licensure examination...Second, conscientious objection is a necessary right -- actually an obligation -- of every citizen in a democratic society. It is supported by an honorable tradition regarding compulsory military service and civil rights, to name but two examples. Third, employed pharmacists should not be coerced by laws or an employer to carry out acts that violate their consciences. Allowing corporate ethics, especially, to trump individual professional ethics would lead to disaster. We would be naive to expect a pharmacist to forsake his or her ethics in one area (e.g., abortion) while applying them for the patient's welfare in every other area.

However, Hepler also notes that pharmacy plays a unique role in health care and, therefore, has serious responsibilities to patients who have supported the education and training of pharmacists:

Professions are, however, privileged monopolies. Safe and legal access to the most effective medications -- including emergency contraception -- is only through a pharmacist or physician, or more commonly both...Also, health care professionals seldom have paid in full for their professional educations. For most, some education was free and some was financed by scholarships, low-interest loans, and state and federal subsidies at state and other institutions. The clinical education of every physician, nurse, and pharmacist required cooperation by patients in teaching hospitals and clinics, who donated time and energy and who took the risks and occasional indignities of being objects of education.

When many of us were new assistant professors, we were amazed that our students would make far more than us (after our work for a B.S., Ph.D., and 2 to 8 years of postdoctoral training) in their very first year after graduation. Starting US pharmacist salaries outside California and Hawaii are over $85,000 per year, rising to six figures as more the rule than the exception. Pharmacy is also a great career for single parents because even part-time positions still pay at a rate of $40-50/hour. But, with such privilege should come considerable responsibility.

In a section on duties inherent in professional ethics, Hepler proposes the following:

Nobody is drafted into a health profession or a specific practice. Entry involves free choices, and it includes at least a tacit promise to do one's professional job according to recognized ethical standards. The Code of Ethics for Pharmacists adopted by the American Pharmacists Association states that each individual patient is the center of each pharmacist's practice. It states that a pharmacist should (1) be committed primarily to the welfare of individual patients, (2) recognize differing beliefs and values, and (3) respect each patient's right to self-determination. When values and beliefs collide, the pharmacist should consult with colleagues or refer the patient to a colleague.

Pharmacists control drug distribution and have ethical duties to provide patient care. Denial of care, therefore, should put a burden of accountability on the pharmacist. The pharmacist who conscientiously refuses to dispense a medication should be able to account for his or her understanding of the facts, science, and ethical reasoning. Society has no such mechanism for accountability. The result can be a chaos of different arbitrary actions that can injure and even kill patients. This is a slippery slope toward arbitrary refusals based on bigotry.

And this is where I feel the greatest degree of discomfort with any ruling that permits pharmacists to object to fulfilling their professional duties. If a pharmacist incorrectly believes that filling a prescription for an emergency contraceptive is collusion in objectionable abortion, what's to stop this pharmacist from denying pain killers to someone he/she thinks is an addict - or denying any prescription to someone on Medicare because they don't believe in public assistance?

Tara's story of a relative whose husband was denied a strong opioid painkiller is an example of where this could lead. In this case, the pharmacist illegally substituted a less effective, codeine-containing drug, and then was so incompetent as to suggest the pill did not contain codeine when the husband came back telling of he wife's intolerance to codeine. Instead, Tara's relative spent the night after breast surgery living through the pain with just aspirin, all due to the arbitrary imposition of values and misinformation of a pharmacist.

With regard to the case of emergency contraception, Cantor and Baum suggest a middle ground:

Although we believe that the most ethical course is to treat patients compassionately -- that is, to stock emergency contraception and fill prescriptions for it -- the totality of the arguments makes us stop short of advocating a legal duty to do so as a first resort. We stop short for three reasons: because emergency contraception is not an absolute emergency, because other options exist, and because, when possible, the moral beliefs of those delivering care should be considered. However, in a profession that is bound by fiduciary obligations and strives to respect and care for patients, it is unacceptable to leave patients to fend for themselves. As a general rule, pharmacists who cannot or will not dispense a drug have an obligation to meet the needs of their customers by referring them elsewhere. This idea is uncontroversial when it is applied to common medications such as antibiotics and statins; it becomes contentious, but is equally valid, when it is applied to emergency contraception. Therefore, pharmacists who object should, as a matter of ethics and law, provide alternatives for patients.

(FYI to anyone in need of emergency contraception with access to standard oral contraceptives: Planned Parenthood offers extensive educational information, including details about off-label use of many birth-control pills for emergency contraception.)

In stopping short of suggesting an absolute requirement for pharmacists to fill all valid prescriptions, Cantor and Baum note that pharmacists and other health care professionals have choices about where they practice:

In a secular society, [health care professionals] must be prepared to limit the reach of their personal objection. Objecting pharmacists may choose to find employment opportunities that comport with their morals -- in a religious community, for example -- but when they pledge to serve the public, it is unreasonable to expect those in need of health care to acquiesce to their personal convictions. Similarly, physicians who refuse to write prescriptions for emergency contraception should follow the rules of notice and referral for the reason previously articulated: the beliefs of health care providers should not trump patient care. It is difficult enough to be faced with the consequences of rape or of an unplanned pregnancy; health care providers should not make the situation measurably worse.

In response to letters in the NEJM telling Cantor and Baum that seeking a middle ground was unacceptable to supporters of either extreme (NEJM 2005; 352:942-944), they responded:

Two stopgap solutions emerge. First, consider physicians' distribution of emergency contraception. The current system may be nonsensically slow, especially if encounters at pharmacies are more frustrating than fruitful. Distribution by physicians would streamline the process. Alternatively, we may need to extricate both pharmacists and physicians from the process. These letters lend strong support to granting over-the-counter status to emergency contraception. This change would make pharmacists' objections moot. It would also leave a very private decision with the individual -- which is precisely where it belongs.

Pharmacists are sometimes viewed by the public as the folks behind the counter who just pour, count, lick, and stick. But the movement of pharmacy in the late 80s to a 6-year doctoral degree was motivated by the proposition that pharmacy be considered a profession like medicine or nursing, rather than a simple service. To be considered a health professional, however, requires putting the needs of patients ahead of your own. If a pharmacist chooses to object to filling any valid prescription, I object to their licensure by my state.

Making an exception for a scientifically invalid moral stance opens the door to all kinds of abuses that ultimately compromise the pact between a profession and the public.

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Pharmacists are sometimes viewed by the public as the folks behind the counter who just pour, count, lick, and stick. But the movement of pharmacy in the late 80s to a 6-year doctoral degree was motivated by the proposition that pharmacy be considered a profession like medicine or nursing, rather than a simple service.

I think most people's early exposure to pharmacists is at a counter at the head of a line with someone impatiently waiting behind them. This setting is not conducive to instilling in people a view of pharmacists as professionals (i.e. as decision making agents.) It's not how we deal with lawyers or architects or dentists, etc. In order to really change the "pour, count, lick, and stick" view, the way patients interact with pharmacists needs to change. And that probably means changing the way insurance deals with managing that interaction. Good luck with that.

If a pharmacist chooses to object to filling any valid prescription, I object to their licensure by my state.

This is pretty much my position as well (as a citizen, I have no other qualification to comment.)

I agree with your position on this. I would like to elaborate on this point:

Also, health care professionals seldom have paid in full for their professional educations. For most, some education was free and some was financed by scholarships, low-interest loans, and state and federal subsidies at state and other institutions.

I don't know about pharmacy, but I've been told that the tuition paid by medical students only covers about a third of the actual cost of the education. Thus, even if one pays the tuition entirely, one is paying only a fraction of the cost.

Still, I don't think the financial issue is very compelling in this case. What is more important is that the knowledge passed on in the educational process is passed on with the understanding that it will be used in accordance with the ethical standards of the profession. When one departs from those standards, one betrays the trust of one's teachers.

Perhaps this analogy is too extreme to be entirely appropriate, but it is sort of like Timothy McVeigh using his training in demolition to blow up a federal building. I don't mean to imply that withholding a contraceptive is as malicious a crime as blowing up a building with people inside; rather, that when one is given special knowledge by educators, one has a responsibility to use that knowledge appropriately.

I'm merely a layperson with no relevant training or experience. Having read a few articles on this topic (and taken the opportunity to discuss it with our pharmacist, who is indeed a professional in the best sense), I've arrived at a simple formulation: a pharmacist should not be forced to dispense something which violates some personal position. They should always have the obvious option - take up some other line of work.

By Scott Belyea (not verified) on 29 Jun 2006 #permalink

Excellent analysis Pharmboy. I work in a profession (secondary teaching) that has considerably more worthless participants than yours so I understand your sentiments very well.

However, in a profession that is bound by fiduciary obligations and strives to respect and care for patients, it is unacceptable to leave patients to fend for themselves. As a general rule, pharmacists who cannot or will not dispense a drug have an obligation to meet the needs of their customers by referring them elsewhere.

In our medical school ethics course we talked about this case specifically -- I actually think it is based on a real case in North Dakota where the pharmacist was the only one in the town.

Our conclusion in discussion -- and the one of our professors -- was that physicians and pharmacists are there to assist in decisions of health and provide care to facilitate those decisions getting carried out. Absent cases where we know a treatment would harm a patient, you either have to provide the care or find someone else who will.

"First, a pharmacist is not an automaton or a physician's valet but a necessary member of the health care team. Pharmacists complete at least 6 years of rigorous education and clinical training and prove their knowledge by passing a licensure examination.."

But the question is what, in the duties of a pharmacist, is so important that you need all that education? I would like to see a Pfizer machine next to the coke machine outside my local walgreens. I scan my prescription, insert credit card for payment and ID, and out pops my viagra...er my plan B... whatever.

Its like some mafia is in control of drug access, and is deciding what is best for themselves, rather than the patient. Someone please make an arguement for what a pharmacist is good for...

Abel, I responded to your post here http://scienceblogs.com/retrospectacle/2006/06/the_role_of_pharmacists_…

Also, didn't doctors used to be the ones in control of the meds-dispensing? There's a museum of old-ish medical supplies here at UM and in many of the doctor's bags are old bottles with 'tincture of opium' etc on them. So at what time were pharmacists deemed necessary? I'd bet it came about as an extra mesure to reduce the abuse of prescription drugs by patients AND doctors.

But having a vending machine is a great idea, but more like ATMS. That way they couldn't be stolen or jacked.

Doctor's routinely dispensed their own drugs in rural areas -- I can still remember my mother maintaining a stock of 100 or so medicines in the late 70's at her rural practices.

Doctor's got out of the business of dispensing for a few reasons.
1) Effeciency & Scale. A walgreens will have a much broader selection and availability than any but the largest physician's group can support. Pharmacists are experts at not just the "pill counting", but drugs in general. Your average pharmacist knows more about a broad range of drugs than your average physician -- who often is only familiar with the "big ones" and the ones they use regularly in thier practice.

2) At least in my state, hand dispensing. This means that a physician (not a nurse, not a medical asst, but a physician) or a pharmacist must individually label and count each pill. It was cheaper to pay a pharmacist to do this.

3) Unification. With specialists, etc., it was better for patients to build up a relationship with one person for drug dispensal. This means that interaction checking, side effect profiles, and other monitoring is more effective and more likely to happen.

Sometimes, the absurdly extreme cases can highlight the problems of a position ... Onion headline: "Christian Scientist pharmacist refuses to dispense any prescriptions at all." Speaks for itself, IMO. :-)

By Scott Simmons (not verified) on 01 Jul 2006 #permalink

Abel

This is fascinating- that SSRIs compete for the same receptor as Oxy is even more fascinating. I have a million questions. But for now, know that I am intimately familiar with this question and set of circumstances and will be forever grateful for your link to that paper that you left on Aetiology.

My first question is this: How as a medically uneducated layperson can I EVER hope to relay this information to a physician without looking like a fool. So far this has been an unanswerable question, because MOST physicians seem annoyed by the "internet information" and discount it outright. The GOOD pharmacists on the other hand- who are worth their weight in gold- are more than willing to make connections.

As well, can you answer another burning question. Is it truly possible to test the efficacy of one drug with another drug that works with a COMPLETELY different mechanism of action? I can furnish with specifics if necessary, but right now I am just curious.

I am so glad you made the move to Science Blogs- I LOVE it here.

By impatientpatient (not verified) on 01 Jul 2006 #permalink

Chronic pain patients and cancer patients with pain often struggle with depression and are treated with SSRI's. Which pain killers are most effective for pain patients on SSRI's?
Are Tricyclics or welbutrin better options for pain patients? Know that tricyclics often used in pain management but often at low doses.

"...conscientious objection is a necessary right -- actually an obligation -- of every citizen in a democratic society." Oh, really? Try peddling that pap to a member of the armed forces. They too swear an oath, and part of THEIR obligation is to obey lawful orders from superiors, no matter how odious or objectionable to their personal sense of morality. Hey soldier, you don't want to fight in a war you feel is unjust, illegal and immoral? Well boohoo. You made a commitment, and the rest of us are perfectly justified in expecting you to fulfill your legal and ethical obligations for the greater good. If that doesn't work for pharmacists, let them take a page from people who really do have something to lose, and take up a new career. And good riddance.

Well, I pretty much have to agree with everyone who have so emphatically agreed that pharmacists have a duty to put their professional responsibilities ahead of their personal views. I love drb's discussion of commitment, Craig and Joseph's view of the interplay of pharmacy and society, and everyone else who offered suggestions and support.

I'll have a separate post later on why pharmacy is separate from medicine, but there are some idealistic needs for pharmacists that are not reflected in today's market. I'm surprised that we haven't gotten input from pharmacists, but pharmacy has often been its own worst enemy in not advocating strongly enough their purpose in health care.

Anjou and impatient patient: The active component of Vicodin (hydrocodone) is a pretty reasonable analgesic on its own - although 2D6 does metabolize it to a more potent hydromorphone, it seems that its utility is minimally affected by 2D6 inhibition or poor metabolizers. However, the codeine and Oxycontin interference by SSRIs is one area where pharmacists should be playing a major education role. To clarify for impatientpatient, its not that oxycodone and SSRIs compete for the same receptor of action, but rather that they compete for metabolism and, in the case of oxycodone, its bioactivation to the more active oxymorphone.

I think that the issue is simpler than that. We would not accept a doctor who refuses to give blood transfusions to people because of a personal interpretation of the Jehova's Witness dogma. His only choice is to not be a practicing doctor. This is the same for pharmacists.

By ParanoidMarvin (not verified) on 01 Jul 2006 #permalink

Thank you. I will now spend the day re-reading the article and looking up all that you wrote so that I can see it in my head- LOL!!! (and it is a very small head)

One of the biggest things that I have learned is that doctors (and some nurses, but that is another story and it pisses me off) will often prescribe drugs or make prescription recommendations that are "cool". By this I mean whatever drug is the fashion of the day is what they prescribe. There is no digging into what side effects could happen with multiple drugs. And when side effects do happen they are treated as psychological.

Case in point: SSRI, OXY and amyltriptiline (sp?) and Neurontin---------- every day, for a long time. HMMMMMM.... considering that at least two of these drugs have CNS slowing down effects, and two of them COULD cause a serotonin "overload" would there be a chance that these drugs in combination at ridiculous doses could cause changes in psychological and mental function? I think so, but silly me- I am only a spouse. I only live with the effects, but because pain is interpreted in this society as a psychological weakness and not a biological condition- well, our marriage must have underlying issues.

Pretty much that was it. SNAP- get off of this stuff, or most of it. Take a year to get your ability to think coherently back. Take another year to get back to old calm self. And now, with minimal drugs at minimal doses I have a regular- albeit not able to work because the pain is still debilitating- sane person again.

I researched things to death. I still do. I was mocked by health professionals. I was told that I was the problem- not the drugs. I overcompensated for my spouse and THEY should be taking charge of the info, not me. Yeah- thanks. And bite me. If I had cancer and was on drugs that made me sleep all day, and interfered with concentration and cognition etc.... my spouse would be the one I would rely on to find what I needed and if there were options.

There are pharmacists who try to pull rank and explain how dangerous the drugs I pick up for my spouse are. There are some who question me every time a dose is upped or dropped. There are some who treat me with disdain. Now I just tell them politely to do their job. Please get me this- I will pick it up tomorrow. When i go to pick it up, I need to tell them that it will be in lock up- EVERY SINGLE TIME!! They do not believe me...... every time I am right, and I cannot get the fifteen minutes of my life back that has just been taken away from me by their refusal to believe me. (unfortunately my drug plan only covers prescriptions filled at this particular chain... happy capitalism!!)

The pharmacists that I respect are those who look stuff up. They listen when I talk about 22 micron hoods, and how to make an intrathecal injection. They phone the doctor long distance to get the exact formula and reason for use. They refer me to people who can get drugs made if they cannot do it. They are highly involved with their local pharmacists association. Many do not want the responsibility of prescribing. They are able to let me know what side effects to look out for with certain drug combinations. (these are not my chain store pharmacists)

And If I make a mistake in how I have read something they correct me and do not make me feel like an idiot.

By impatientpatient (not verified) on 03 Jul 2006 #permalink

Why does the pharmcists professional body not investigate and punish these pharmacists for failing to discharge their duites correctly?

If I remmember correctly, the professional body was part of the group that lobbied the government for a conscience clause that allowed pharmacists to pick and choose which drugs they would dispense. That is where I am from.

Who knew that what you believe was of more importance than the science behind the medicine, hey?

By impatientpatient (not verified) on 04 Jul 2006 #permalink

Although I'm along time supporter of the right of women to control their own reproduction, I'm also a supporter of the traditional liberal principle of freedom of conscience. I must object to the argument that pharmacists, or any professionals, need to subordinate their personal moral beliefs to the duties of their profession. I'm not sure what theory of professionalism, or what account of professional duties underlies such a view, but it seems at odds with the notion that a professional is supposed to cultivate personal integrity. Is a professional who lacks the courage of her own convictions someone we should trust to safeguard our intersts?

By Bob Koepp (not verified) on 04 Jul 2006 #permalink

Mr. Koepp, yours is the most valid expression of objection I can find in this discussion. Certainly, it is the expectation of a profession to define personal integrity and we spend semesters drumming this into medical and pharmacy students. And you very correctly note that the concept of objection due to conscience is a basic tenet of liberal philosophy. The difficult question here is that once a therapy is approved by a federal governing body, assuming after both medical and moral discussions, should the pharmacist be required to bow to the professional responsibility to the patient?

We're now talking idealism - in reality, the best situation is for there to be room for conscientious objection of individual professionals AND options for women who would rather use EC than have an abortion later. Unfortunately, the paucity of pharmacists holding this wide spectrum of beliefs puts women in rural areas at a disadvantage where they might be at the mercy of a single pharmacist with an EC-refusal philosophy.

Because we are talking about federal and state laws and the good of public health, one cannot help but be compelled by the previous commentor about the lack of freedom within the military. So, does federal approval of a pharmacotherapy constitute an "order" to licensed pharmacy professionals?

I think questions about the duties of healthcare professionals need to be sensitive to nuances of notions like "medically indicated" and "therapeutic interventions." While it is obvious that control of reproduction can be medically indicated, and thus serve the therapeutic goal of preventing or ameliorating pathological conditions, usually this is not the case. The question, then, is whether the role obligations of healthcare professionals extend to the provision of non-medically indicated interventions. Federal approval of a pharmacological agent certainly doesn't constitute an "order" analogous to a "medical order" that reflects an informed judgment about "medical indications."

I think it is "realistic" to look for a way to respect both the right of women to control their own bodies and the right of conscience claimed by some pharmacists. And I don't think we have to look very far. If the FDA would follow the recommendations of it's own reviewers and make Plan B available over the counter, women would have more and better access than they now do to Plan B, and pharmacists' objections to dispensing it would be mooted. It's the FDA that should be the object of our wrath.

By bob koepp (not verified) on 05 Jul 2006 #permalink

In the UK, EHC is widely accepted, and there have been few cases of pharmacists refusing to supply, though there were cases of pharmacies being boycotted when it was first introduced as a pharmacy only medicine. The RPSGB's code of ethics does allow pharmacists to refuse to dispense or sell medication on ethical grounds, but they must provide information on where to obtain the product. This seems reasonable to me.

Could you clarify what over the counter means in the USA? In the UK we have three classes of medicines - prescription only, pharmacy only (i.e. available without a prescription but only from a pharmacy under the pharmacist's supervision) and general sales list (can be sold from anywhere that can be closed to the public).

By almost MRPharmS (not verified) on 06 Jul 2006 #permalink

In the USA, when a drug is available "over the counter," it can be sold in virtually any venue. If emergency contraception gained OTC status, it would quickly become available in neighborhood grocery stores, just like most cold remedies.

My personal opinion is that if a drug can be safely and effectively self-administered, there's no good reason to require people to go to a physician or a pharmacist to get it. There seem to me to be two social forces working against reason here -- first, a lot of people haven't come to grips with human sexuality and, second, the tendency to "medicalize" all sorts of human problems.

By bob koepp (not verified) on 07 Jul 2006 #permalink

1. The emergency contraception link is broken. Here is an updated reference so you can fix the link:
http://www.plannedparenthood.org/health-topics/emergency-contraception-…

2. Just a side note: It is really good news that EC is now available over the counter, although EC should be available over-the-counter at any age. Access to a full range of SRH services is even more important to any patient under 17 who needs them.

3. As for "conscientious objection," you pretty much nailed it. I am a pacifist, so I didn't join the military. Problem solved.
Nobody is drafting people to be pharmacists.

By culturegeek (not verified) on 08 Dec 2009 #permalink