Hearing: Freedom of Conscience for Small Pharmacies
House Small Business Committee, Washington, D.C. 25 July, 2005
Prepared Remarks of Ms. Linda Garrelts MacLean, R.Ph., CDE
Clinical Assistant Professor Pharmacotherapy, Washington State
University
Full Text
APhA recognizes the individual pharmacist's right to exercise
conscientious refusal and supports the establishment of systems to ensure
[the] patient's access to legally prescribed therapy without compromising
the pharmacist's right of conscientious refusal. . . . In sum, our policy supports a
pharmacist 'stepping away' from participating but not 'stepping in the way'
of the patient accessing the therapy.
Good morning. Thank you for the opportunity to appear before you today
and present the views of the American Pharmacists Association (APhA). I am
Linda Garrelts MacLean, a pharmacist and active member of APhA. I have been
in practice for 27 years and am the former co-owner of two community
pharmacies in Spokane and Deer Park, Washington. Founded in 1852 as the
American Pharmaceutical Association, APhA is the first-established and
largest national pharmacist organization in the United States, representing
more than 53,000 practicing pharmacists, pharmaceutical scientists, student
pharmacists and pharmacy technicians. APhA members practice in virtually
every area of pharmacy practice, including independent and chain community
pharmacy, hospital pharmacy, nuclear pharmacy, long term care pharmacy, home
health care and hospice.
Let me first commend the Committee for holding today's hearing to address
the effects that the Governor of Illinois' emergency order requiring
pharmacies to provide contraceptives based on a valid, legal prescription
'without delay' will have on small pharmacies. We greatly appreciate the
opportunity to provide the pharmacist's perspective on this important topic.
As you can see from the chart provided as Attachment A, pharmacists are the
most accessible health care providers on the health care team. Pharmacists
fulfill a vital role in rural communities and other communities suffering
from a shortage of health care providers. This role must be taken into
account when considering proposals that may affect pharmacists in rural
areas. For some of these patients, the pharmacist may be the only access
point into our health care system.
Recent activity at the state and federal level on the issue of pharmacist
conscience clauses has had and will have a direct impact on the ability of
pharmacists and pharmacies to provide care to their patients. This activity
has also magnified the issue to a degree which does not accurately reflect
the scope of the issue. The vast majority of pharmacists dispense the vast
majority of prescriptions. Regardless, pharmacists want to retain the
ability to opt out of providing services to which they personally object. My
testimony will focus on the actual professional side, the provision of
pharmacist services. Pharmacist services are a business. Intruding on how
and what I choose to provide my patients is an intrusion into how I run my
small business. To that end, I appreciate the Committee recognizing the
business aspect of a health care issue.
My comments today will discuss the pharmacist conscience clause,
pharmacists' activities to increase appropriate access to emergency
contraceptives, the impact of 'duty to fill' legislation has on the
pharmacist's clinical role, the scope of the problem, and potential next
steps. Whether expanding the pharmacist's role in improving medication use,
working to successfully implement the Medicare prescription drug benefit,
seeking adequate reimbursement in the Medicaid program, or enacting laws to
allow pharmacists to immunize patients, pharmacists are stepping up to the
plate to help ensure patients have access to medications and know how to
make the best use of those medications.
Pharmacist Conscience Clause
The ability of health professionals to opt out of providing services they
find personally objectionable is an important component of our health care
system. The pharmacy profession officially addressed this situation in 1998
through the APhA's policy-making process, our House of Delegates. Stimulated
in part by the legalization of physician assisted suicide in Oregon, the
policy applies to any situation where a pharmacist objects to dispensing a
medication for personal (religious or moral) reasons. APhA's policy states:
APhA recognizes the individual pharmacist's right to exercise
conscientious refusal and supports the establishment of systems to ensure
[the] patient's access to legally prescribed therapy without compromising
the pharmacist's right of conscientious refusal.
APhA's policy supports the ability of a pharmacist to opt out of
dispensing a prescription or providing a service for personal reasons and
also supports the establishment of systems so that the patient's access to
appropriate health care is not disrupted. In sum, our policy supports a
pharmacist 'stepping away' from participating but not 'stepping in the way'
of the patient accessing the therapy.
Pharmacists, like physicians and nurses, should not be forced to participate
in procedures to which they have moral objections. However, recognizing
pharmacists' unique role in the health care system, there should also be
systems in place to make sure that the patient's health care needs are
served. It is possible to address the rights of patients and the ability of
pharmacists to step away from an activity to which they object. Real world
experience has proven this to be true. And it does not require a
confrontation with the patient.
Types of Systems
Because APhA's policy supports the establishment of systems to ensure
patients receive access to their care, it is worthwhile to take a moment to
discuss these various types of systems. The first of several potential
systems begins when a pharmacist chooses where to practice. A pharmacist who
objects to physician assisted suicide would choose a practice outside the
State of Oregon, or outside a practice that participates. A pharmacist with
personal objections to dispensing hormonal contraceptives would avoid
practicing in a Title X clinic. Even when a pharmacist makes a thoughtful
decision about where to practice, the pharmacist may be faced with a
prescription to which they have moral or religious objections. Common
systems that are used to balance a pharmacist's moral or religious
objections and a patient's needs include staffing the pharmacy so that
another pharmacist in the same pharmacy can dispense the prescription, and
referring a new prescription or transferring a refill prescription to a
different pharmacy.
An active communication plan can also help navigate these situations.
When prescribers and patients are directed proactively to pharmacies that
carry certain drugs, such as emergency contraceptives, patients can be
directed to those pharmacies. The Association of Reproductive Health
Professionals operates a national hotline (1-888-not-2-late) that allows
patients to find a listing of providers who provide emergency contraception
services. The same group, in collaboration with Princeton University's
Office of Population Research, also operates a website (http://not-2-late.com)
that can help patients identify a provider of emergency contraceptives in
their area. This concept can be applied more informally at the local level
by proactive communications between pharmacists and prescribers.
Enacting pharmacist prescriptive authority for emergency contraceptives
is another system that I will discuss in greater length. Where these
programs are in place, patients are directed to the pharmacists who
prescribe and dispense emergency contraceptives and away from those who do
not. For example, in rural Washington State, potential patients are directed
to pharmacists who participate in the emergency contraceptive care program,
streamlining the process for the patient. Finally, in areas where no
pharmacist will dispense a medication it may be the prescriber who chooses
to dispense the product. What each of these systems has in common is better
communication between pharmacists and prescribers - a concept with broader
benefits than navigating these rare situations.
An important underlying concept of our proposed systems is that they are
established proactively - before a pharmacist is presented with a
prescription to which they object. The system should be seamless, with a
pharmacist - patient interaction that is very similar to the interaction
that occurs with any other prescription. Similar to the situation where a
medication is simply out of stock on any given day, if the pharmacist is
unable to dispense the prescription, then the patient must be made aware of
the options available to them to fulfill his or her medication needs. The
pharmacist should not use their position of power to berate the patient, to
share their own personal beliefs, or obstruct patient access to therapy-such
as refusing to return a patient's legally valid, clinically appropriate
prescription. In most states this activity is prohibited by law. When
alternative systems are established proactively, the patient is unaware of
the pharmacist's actions and both the patient's right to care and the
pharmacist's need to step away from certain activity are accommodated.
Ongoing Activities; Opportunities for the Future
As professionals, pharmacists continually strive to provide the best
patient care possible, including continuous review of practices and taking
steps to improve medication use and advance patient care. Unfortunately, the
press has highlighted a few negative situations rather than focusing on the
more broad reality of a significant number of pharmacists working to
increase access to therapy such as emergency contraception.
Because of the short timeframe involved in effective use of emergency
contraceptives, the opportunities for pharmacist involvement in expanding
patient access are many. APhA supports the voluntary involvement of
pharmacists, in collaboration with other health care providers, in emergency
contraceptive care programs that include patient evaluation, patient
education, and direct provision of emergency contraceptive medications.1
Pharmacists in Alaska, California, Hawaii, Maine, New Hampshire, New
Mexico and Washington have legal authority to prescribe and dispense
emergency contraceptives under collaborative agreements with doctors and
other prescribers. Legislation to establish similar programs was introduced
this year in Illinois, Kentucky, Maryland, Massachusetts, New Jersey, New
York (it is waiting for the Governor's signature), Oregon, Texas, and
Vermont.
In the states where pharmacists have this authority, patients do not need
to go to their physician first - something that could be difficult to
accomplish in the short time period of effectiveness. Instead, patients may
go directly to a participating pharmacist to receive their prescription for
emergency contraceptives. Participating pharmacists receive training and
work in collaboration with physicians and other prescribers through a
pre-established protocol detailing the situations where emergency
contraception should be used. Patients are first interviewed and counseled
by the pharmacist. If the pharmacist agrees that the patient meets the
clinical criteria for the medication, then the pharmacist will write the
prescription and dispense the medication. Patients who need additional
clinical care are referred to their physician.
While serving as President and President-elect for the Washington State
Pharmacist's Association, I was instrumental in helping enact emergency
contraceptive prescriptive authority in my home State of Washington, which
was the first state to enact this type of law. Pharmacists began providing
emergency contraception services in 1997. Since then, hundreds of
pharmacists and student pharmacists have been trained annually.
Approximately 1,200 emergency contraception interventions are done quarterly
by pharmacists in local, Washington chain pharmacies in forty-three
locations. Clearly the system is working well in Washington.
The states that have more recently adopted pharmacist emergency
contraception prescriptive authority laws appear to have strong support from
their pharmacists as well. Two to three times more pharmacists than expected
have attended emergency contraception prescriptive authority training
programs. These numbers and the experience of Washington State reflect the
growing movement in pharmacy to make better use of pharmacists' clinical
expertise while also helping to improve access to medications, including
emergency contraceptives. It is a reality that negates the perception the
media has created of pharmacists as obstructionists.
Pharmacists' Clinical Role
Another consequence of 'duty to fill' legislation is its impact on the
clinical role of pharmacists. ('Duty to fill' legislation would require
pharmacies or pharmacists to dispense 'legal' prescriptions. When
poorly crafted, such a requirement conflicts with the pharmacist's legal
responsibility to assess the clinical safety and appropriateness of the
prescription.) Much of the media coverage and the discussion around some of
the legislative proposals portray pharmacists as simply robots-transforming
individuals from thinking health care professionals into automatons
forbidden from having personal beliefs, and from exercising their
considerable professional judgment gained during years of education and
practice. Serving our patients and helping them make the best use of their
medication is our priority.
If the pharmacist's role were merely to dispense lawfully prescribed
medicines, that robot or automaton would fit the bill. But pharmacists are
professionals whose role on the health care team is to collaborate with
physicians and patients to help medications do what they should-and nothing
they shouldn't. The profession exists to help patients access medications
that will help them, and that means going beyond a 'lawful' prescription.
A prescription calling for a 10-fold overdose is 'lawful', but likely fatal
to the patient. A prescription calling for the antibiotic amoxicillin for a
patient allergic to penicillin is 'lawful', but again, potentially fatal to
the patient. A prescription calling for an oral contraceptive for a patient
with a history of thromboembolic disease is 'lawful', but may result in
patient harm.
'Duty to fill' legislation can cause problems for
pharmacists and our patients. Under Illinois Governor Blagojevich's original
April 1st order, for example, pharmacies that sell contraceptives
are required to fill valid, legal prescriptions for these medications
without delay. As written, the rule did not appear to permit pharmacists to
protect patients from medications contraindicated because of allergy or
drug-related interactions or to correct potential dosing errors. Nor did the
rule permit pharmacists to transfer prescriptions if they had any objections
to filling the prescriptions. According to the Governor, he was prompted to
issue the order by reports to state health authorities that two women were
unable to have prescriptions filled for emergency contraceptives at a chain
pharmacy in Chicago.
Pharmacy's reaction to Governor Blagojevich highlighted the reality that
the emergency order, as originally written, would conflict with provisions
in the Illinois Pharmacy Practice Act that require pharmacists to conduct
prospective drug utilization review. The profession stated, "The requirement
to dispense a valid, lawful prescription 'without delay' could require a
pharmacist to dispense a valid, lawful-but clinically
inappropriate-medication 'without delay."2
In response, on April 11th, the Illinois Department of
Financial and Professional Regulation published an open letter to Illinois
pharmacists in which it clarified that the April 1st emergency
rule was not intended to "interfere in any way with a pharmacist's
responsibility to conduct prospective drug utilization review." Governor
Blagojevich and the Department have pursued a permanent rule through the
regulatory process to replace the emergency amendment. Patients in Illinois
will be well served if the Illinois Pharmacist Association's efforts to
include pharmacist prescriptive authority for emergency contraception is
successful as it is one of the mechanisms to expand access.
As stated previously, pharmacists are professionals whose role on the
health care team is to collaborate with physicians and patients to help
medications do what they should - and nothing they shouldn't. To take away
their clinical judgment is a draconian step backwards in an era when we are
seeking to reduce the number of medication-related errors.
Impact on the Business of Pharmacy
'Duty to fill' legislation can also affect the business side of pharmacy.
As noted previously, it is a reality that health care is a business, and
pharmacy practice a component of that business. 'Duty to fill' legislation
affects business-and specifically small businesses-by dictating how a
business must accommodate its staff, in this situation, its pharmacists.3
For example, some proposals have defined the type of system a pharmacy must
implement in order to assure patients may access necessary medications, such
as requiring a pharmacy to order a product if the medication is not in
stock. With more than 10,000 medications on the market today, it is
impossible for a typical pharmacy to carry all medications-and unnecessary
as well. Decisions about which drugs to stock are based on the patient
population served, the health plans in which the pharmacy participates, and
the prescribing patterns of the physicians and other prescribers in the
community. Medications that are widely used in some geographic areas may be
used only infrequently in others. In some cases, a pharmacy may be willing
to order a drug that is typically not available at the practice. But
depending on the patient's needs, how quickly the pharmacy can receive the
drug, and how much more the drug may cost the pharmacy (special orders may
cost the pharmacy more - and the pharmacy may not receive any payment to
cover those additional costs), special-ordering the drug may not be a viable
option. In these situations, patients would typically be referred to other
pharmacy practices or alternative arrangements would be made.
In trying to address an issue that to some may be a legitimate access issue
and to others may be an issue of convenience, 'duty to fill' proposals would
compel health care providers and businesses to provide certain services.
Decisions about what services to provide and by whom should be left up to
individual health care providers. Decisions about which systems to implement
and how to implement them should be left up to pharmacy managers and
pharmacists. Patients will choose the pharmacy and pharmacists who best
serve their needs, and market forces will dictate what services the
pharmacies provide.
Is Legislation Necessary?
As with any policy discussion, it is critical to examine the situation in
context and to carefully review the potential impact - positive and negative
- of a legislative or regulatory proposal. With most, if not all, 'duty to
fill' proposals, both health care and small businesses are negatively
impacted.
The first challenge with such proposals is that they use a broad approach
to a statistically minor problem. While any instance of a pharmacist
obstructing access to medications must be addressed, such situations are
very rare. Nearly 3.3 billion prescriptions are dispensed each year in the
outpatient setting,4 averaging
about 9 million prescriptions per day. Proponents of 'duty to fill' laws
document approximately twelve examples of refusals to fill since 1996. One
must question the need for new laws or regulations to address a handful of
situations that may have been avoided through better communication and
alternative systems.
Additionally, APhA strongly objects to creating federal oversight of the
practice of pharmacy. The practice of pharmacy, both the profession and the
business, are regulated at the state level, just as all other health care
providers. We would oppose federal legislation to regulate the practice of
pharmacy at the federal level. Health care should be regulated at the local
level to reflect local needs. State Boards of Pharmacy should remain the
leader in regulating the practice, not state or federal legislators who may
not understand or appreciate a proposal's impact on local patient care,
local health care, or local pharmacies and physician offices.
It is not unusual for a good policy to have unintended consequences. Some of
the proposals that would create a 'duty to fill' could result in a pharmacy
choosing not to stock a certain product to avoid the situation of forcing
their pharmacists to dispense. Other pharmacies could decide to rescind the
conscience clause protections they had had in place, and which were working
well, because they do not believe that they can allow pharmacists to 'step
away' and still meet the law's requirements. And a seemingly simple law,
depending on how it is written, could compel pharmacists to participate in
current 'opt-in' programs such as Oregon's physician assisted suicide
program.
Next Steps
One individual's rights should not outweigh another's. Our policy
balances the needs of the patient and the individual needs of the
pharmacist, as well as the pharmacist's professional responsibility.
Implemented well, patients will receive care and pharmacists will not be
forced to ignore their personal moral beliefs. With planning, there are no
winners or losers - both persons are accommodated. Rather than designating a
profession as robots or automatons that ascribe to one set of beliefs, a
different approach is available. And it works. It takes more time, and
proactive implementation, but then, many of the best solutions do.
As a portion of the recently adopted American Medical Association (AMA)
pharmacist conscience clause resolution indicates, pharmacists and
physicians agree. Patients should receive their medications without
harassment and interference, but pharmacists should not be compelled to
participate in activity they find objectionable. The resolution directs the
AMA to have a dialogue with APhA on this issue. We welcome a dialogue that
will ensure this continued recognition of the need to serve patients and
recognize the individual beliefs of pharmacists and physicians. Just like
physicians, pharmacists abide by a Code of Ethics for the delivery of health
care. Just as physicians are not required to provide all medical services,
pharmacists should not be required to provide all pharmacy services.
Physicians and pharmacists collaborate every day to improve medication
use and advance patient care-including navigating issues of conscience. We
look forward to working with the AMA on this issue, much as our individual
members are working together with physicians today and everyday in your
districts. It is a great opportunity for the profession to lead the efforts
to address an issue facing health care professionals and patients.
Additionally, APhA will continue to help state pharmacy associations
enact legislation that would provide pharmacists the legal authority to
increase access to emergency contraception. These programs support the
clinical role of pharmacists in counseling and educating patients and also
increase the awareness among consumers and prescribers about these drug
products. Lack of patient and prescriber awareness is a significant barrier
to care.
Thank you for the opportunity to provide pharmacists' perspective on this
important issue. APhA offers our assistance to the Committee as you continue
your valuable work on this important issue and would welcome the opportunity
to facilitate communications with state pharmacy associations so that
Members of Congress can better assess the situation in their districts.
1. APhA policy adopted in 2000.
(JAPhA
NS40(5)Suppl.1:S8. September/October, 2000) (JAPhA NS43(5) Suppl.
1:S58. September/October 2003)
2. April 5, 2005 letter to the Honorable Rod R.
Blagojevich, Governor, State of Illinois, from the American
Pharmacists Association, the Illinois Pharmacists Association and
the American Society of Health-System Pharmacists. Accessed at
http://www.aphanet.org/AM/Template.cfm?Section=Federal_Government_Affairs
&CONTENTID=3201&TEMPLATE=/CM/ContentDisplay.cfm
3. Some of the 'duty to fill' proposals have
attempted to accommodate the individual pharmacist's ability to
opt-out of objectionable activity by placing the requirement on the
'pharmacy'-the business-rather than the individual, the pharmacist.
But for a small business like an independent pharmacy operated by a
single pharmacist, the distinction between the two is minimal. Even
in larger operations, a 'pharmacy' does not exist without a
'pharmacist', and rigid requirements regarding dispensing certain
products compromise the individual pharmacist's activities.
4. 2004 data for retail pharmacy prescriptions
(including mail-service), prepared by National Association of Chain
Drug Stores' Economic Department using data from IMS Health.
Accessed at
http://www.nacds.org/user-assets/PDF_files/2004results.PDF