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David B. Brushwood
excerpted from: David B. Brushwood , RESPONSIVE
REGULATION OF INTERNET PHARMACY PRACTICE, 10 Annals Health L. 75 (2001)
The widespread and growing use of pharmaceutical products as a
favored therapeutic modality in modern health care poses significant
challenges for the pharmacy profession. Traditionally viewed as
guardians of the nation's supply of medically useful drugs, the
responsibilities of pharmacists are expanding because of the rapidly
increasing volume of prescription orders, and also because of the
heightened demand for expanded pharmacist services in drug therapy
monitoring. Pharmacists are responsible for assuring absolute accuracy
in their traditional dispensing role. This standard of perfection is an
unreachable benchmark for any system of service or product provision,
but pharmacists must nonetheless strive to achieve this ideal goal by
initiating "sufficient institutional controls" over their
order processing practices. In addition, pharmacists have increasingly
been held to have a "duty to warn" when the special
circumstances *76 of a prescription suggest to a pharmacist that a
patient may be at risk in a way that either the patient or the
prescribing physician may not appreciate. Pharmacists are being asked to
do more for each patient, and there are more patients whose needs
pharmacists are being asked to meet.
Owing to the increasing complexity of modern pharmacotherapy, and to
the uniform adoption of the clinically-oriented Pharm.D. degree,
contemporary pharmacists find themselves facing an unprecedented window
of opportunity, during which the practice of "pharmaceutical
care" could finally become a reality. Conceived as a complement to
medical care and nursing care, the purpose of pharmaceutical care is to
address the well-documented problem of preventable drug-related
morbidity. The value of reliance on those pharmacists who practice
pharmaceutical care to promote good outcomes for patients and to prevent
adverse drug effects has been empirically established. *77 Yet, despite
obvious advantages over the traditional product- oriented focus of
dispensing pharmacists, this new patient-centered approach to pharmacy
practice has been slow to evolve. Time constraints faced by pharmacists,
information deficits concerning specific patients and their unique
needs, and the limits of the physical settings in which pharmacists
practice, pose significant barriers to the maturation of pharmaceutical
care from academic theory to practice reality. There is a very real
possibility that the logistics of traditional health care will prevent
pharmacists from re- professionalizing to accept responsibility for the
outcomes of drug therapy.
Internet pharmacy has the potential to overcome barriers that exist
within traditional pharmacy practice, thereby enabling success with
pharmaceutical care. Through alliances between local pharmacies and
their Internet-based partners, prescription order processing can be
moved offsite to "central fill" locations, reducing the volume
of prescription orders to process at local pharmacies. Routine questions
about medications can be answered by online pharmacists using email or
other electronic (eventually real-time video) connections with patients,
further addressing the current workload constraints that exist at most
local pharmacies. Knowledge of a patient's diagnosis, results of
laboratory tests, and established drug monitoring parameters, largely
unavailable to pharmacists at present, can be made accessible to local
pharmacists through the Internet. Pharmacies *78 and pharmacists can use
the Internet to integrate themselves with other care providers and
institutions, opening up new opportunities for public service that
simply cannot occur in the current disconnected system that locks
pharmacists out of the mainstream of health care.
This article suggests that pharmacy regulators could best protect and
promote the public health through responsive Internet regulation that
facilitates expanded pharmaceutical care practices. Regulation of
Internet pharmacy should avoid restrictions that inhibit direct online
care and product provision by pharmacists. Tough regulation directed
toward Internet-based "rogue pharmacies" runs the risk of
replicating the "war on drugs" that has for many years been
fought by the Drug Enforcement Administration and other law enforcement
agencies with only modest success. This crusade to protect the public
from the scourge of drug addiction has prevented the diversion of many
narcotic controlled substances, but it has also had the unintended, yet
foreseeable effect of decreasing access to appropriate analgesic
medications, leading to uncontrolled pain for many patients. Tough
regulation of Internet pharmacy could similarly restrict beneficial
pharmaceutical care activities if regulations were so broad in scope and
uncompromising in application as to have a "chilling" effect
on even the most well intentioned of providers. Most pharmacists are
highly risk averse. They adopt practices that steer them far clear of
regulatory violations, and the threat of even an accusation of
impropriety is often sufficient to alter practice patterns. With regard
to Internet pharmacy, the challenge pharmacy regulators must meet is to
develop a regulatory *79 approach that is designed to prevent
inappropriately risky medication use, while leaving unaffected the
online innovations that can enhance the appropriate use of medications
and improve a patient's quality of life.
Part I of this article describes established principles of drug
regulation, and it explains how those principles can be applied to
Internet pharmacy. In Part II, the potential hazards of over-regulation
are reviewed. Outcomes-oriented responsive regulation is described as an
emerging trend, and opportunities are noted for use of the Internet to
improve outcomes for patients. Part III criticizes state paternalism, if
it restricts informed patient choice of a provider of pharmaceutical
products and services. This article concludes that the most appropriate
method for regulation of Internet pharmacy, in fact the only method that
has a reasonable chance of success, is the Verified Internet Pharmacy
Practice Site ("VIPPS") program of the National Association of
Boards of Pharmacy ("NABP").
I. State and Federal Regulation of Pharmacy
Pharmacists are required to comply with federal laws relating to the
distribution of drug products. Once a drug has enter interstate
commerce, any person subsequently holding it for sale must be in
compliance with both the Federal Food, Drug and Cosmetic Act ("FDCA")
and the Controlled Substances Act ("CSA"). Pharmacists must
also comply with state laws regulating *80 the practice of the
profession of pharmacy. In most states, professional regulation of
pharmacy is accomplished through a pharmacy act in which the legislature
creates and empowers a board of pharmacy. The state board of pharmacy
promulgates rules and regulations, which it enforces along with the
provisions of the pharmacy act.
Internet pharmacy does not fit well into the standard regulatory
scheme under which the federal government regulates the drug product,
while state government regulates the pharmacy profession. Distinctions
between product distribution and the provision of professional services
become blurred, and the separate states or countries in which providers
and recipients of services are located make it difficult to know who, if
anyone, has jurisdiction over a transaction. Consider the following
hypothetical example: Using the Internet, a Florida patient orders
pharmaceutical products from an Internet site that purports to be
located in Texas and promotes online availability of prescription-only
medications without a prescription. In reality, the site is linked from
a Texas site to another site in Nevada, and the patient never knows
this. A questionnaire filled out by the patient is reviewed by a
physician in Rhode Island, who receives the patient's
electronicallysubmitted information from the site in Nevada, and then
authorizes the patient to receive the requested prescription-only
medication. An email message is then sent to the patient by an Illinois
pharmacy, offering to discuss the medication with the patient if the
patient has any questions. This pharmacy includes in its message a
hyperlink to a Louisiana site that describes in detail how to use the
prescription-only medication, and the possible side effects of the
medication. Several days later, a parcel with a return address of a
North Carolina pharmacy arrives in Florida, and inside is a prescription
vial containing the medication, labeled with the name and address of a
different North Carolina pharmacy. If problems should arise for the
patient, it would be difficult to know what regulatory authority has
jurisdiction over the transaction. Even if substantive law is clear, the
procedure of enforcement is certain to be time- consuming and
unreliable.
The possible scenario described above is certainly not the only way
for an Internet pharmacy to operate; nor it is necessarily typical of
Internet pharmacies. There are some sites, many of *81 them
"offshore," that completely ignore the formality of requiring
a physician's authorization to dispense, and they readily ship
prescription-only medications to anyone who has the ability to pay for
them, without even the pretense of a physician-reviewed questionnaire.
On the other hand, the well-known dispensing-only sites, many of which
have developed alliances with large community pharmacy chains, will
meticulously follow all applicable legal requirements, and will not
provide prescription-only products unless a patient has provided a valid
prescription from the patient's own physician. These varied ways of
conducting an Internet pharmacy business lead to differing needs of
regulation to protect the public health.
A. Applying The Law To Internet Pharmacy
The outright sale of prescription-only pharmaceuticals without
authorization from a licensed prescriber is the dispensing activity that
most clearly violates the FDCA. Under the FDCA, a drug is classified as
prescription-only for one of two reasons: (1) either it is deemed unsafe
for use except under the supervision of a state-licensed prescriber, or
(2) it is limited to prescription-only use by its approved New Drug
Application. The act of dispensing a drug contrary to this prescription
requirement is an act that results in the drug being deemed misbranded
while held for sale. Misbranding is a serious violation of the FDCA that
can result in seizure of a product, criminal prosecution of those who
have distributed it, and an injunction to prevent further distribution.
Internet pharmacy sites that make no attempt to involve a physician in
an authorization to dispense prescription-only medications are clearly
in violation of the FDCA. They have misbranded the product.
When a prescription-only drug is dispensed pursuant to a physician's
authorization that results from the review of an online questionnaire
filled out by a patient, application of the FDCA is not so
straightforward. It has been suggested that when a physician prescribes
based solely on the review of an electronic message from a patient,
there is legally not a "prescription," because there is no
legitimate physician-patient relationship and/or because a legal
prescription results only when a physician has *82 physically examined a
patient. If this interpretation is correct, then dispensing pursuant to
an invalid physician's order would constitute a misbranding violation as
described above. However, this legal approach presents potential
difficulties, because in traditional prescribing there may not always be
a physician-patient relationship that meets these narrow legal
standards. Furthermore, problems might arise in the regulation of
desirable innovative approaches to telemedicine, where physicians and
patients may be remote from each other and not personally known to each
other, if regulators were to adopt a very narrow construction of what
physician behaviors are necessary to create a legally sufficient
prescription. Developing strict standards to evaluate the conduct of
physicians and patients, as a prerequisite to the recognition of a valid
physician-patient relationship, might be an approach that creates more
problems than it solves. Regulatory intrusion in the physician-patient
relationship may put a stop to inappropriate Internet pharmacy
practices, but it could also interfere with legitimate traditional
health care or with valuable innovation in medical practice.
The FDCA offers an alternative to the potentially restrictive
regulatory approach centered on defining the attributes of an acceptable
physician-patient relationship. Rather than creating a new set of rules
that requires an evaluation of the character of a prescriber-patient
relationship (a perilous and potentially controversial activity),
regulators could instead consider using existing statutory requirements
that apply to those who dispense under prescriptive authority resulting
from a diagnosis made through the mail. As is so often the case with the
FDCA, this requirement depends heavily on the misbranding provisions of
the Act. Under the FDCA, current misbranding provisions require
extensive disclosure of information, at such a high level that
dispensers could not possibly comply. Yet, dispensers escape *83 what
would otherwise be a misbranding violation, through a specific statutory
exemption that relieves them of the need for compliance with exhaustive
information disclosure requirements. As long as their prescription vial
is properly labeled with the patient's name, prescriber's name and
directions for use, according to information provided in the
prescription being filled, they are eligible for the exemption. The FDCA
states, however, that the exemption from the extensive disclosure
requirement does not apply to "any drug dispensed in the course of
the conduct of a business of dispensing drugs pursuant to a diagnosis by
mail." Thus, an online pharmacy that conducts a business of
dispensing pursuant to diagnosis by email would lose the exemption, be
forced to comply with extensive misbranding provisions that cannot be
met, and would therefore be in violation of the misbranding section of
the FDCA. This statutory provision is, in effect, an exemption from an
exemption. It does not apply simply to the act of prescribing by mail,
or even to occasional acts of dispensing by mail. What is made illegal
by the FDCA under this provision is the conduct of a business that
promotes the availability of prescription-only drugs through diagnosis
and prescribing by electronic mail, and then dispenses prescription
drugs under such tenuous authority. Drugs dispensed in this way are
misbranded under the FDCA. Thus, no intrusive evaluation of the
physician-patient relationship is necessary. If email is considered mail
(not a huge stretch of the imagination), then Internet pharmacies that
conduct a business of dispensing medications prescribed through
evaluation of electronic information have violated the law.
The only online pharmaceutical dispensing practice that clearly
complies with the FDCA is the pharmacy practice that insists on a
patient presenting, in some way, a prescription issued by the patient's
local physician. In many ways, this pharmacy practice model is merely an
advanced version of mail-service pharmacy. Over the Internet, such
practices offer quicker, more consistent, and more comprehensive service
than the service that can be provided through the mail. Although
somewhat controversial when they were introduced several decades ago,
quality concerns about mail-service pharmacies have *84 been resolved.
This is an efficient and effective way to provide pharmaceutical
products to those patients whose drug therapy monitoring services are
furnished through another means. From a regulatory perspective, there
are no critical FDCA issues for Internet pharmacies that function as
mail-service pharmacies have. These are state- licensed businesses. They
are required to be licensed in most states to which they ship dispensed
pharmaceutical products, and they are subject to the same controls as
any pharmacy within the state to which pharmaceutical products are
dispensed. There is no evidence that these Internet pharmacies present
threats to the public health that differ significantly from those of any
other state regulated pharmacy practice.
B. Enforcing The Law With Internet Pharmacies
The enforcement of pharmacy laws by state boards of pharmacy and
other state regulators faces obvious obstacles when an allegedly
dangerous Internet pharmacy practice is located out-of-state. In the
absence of evidence that an in-state pharmacy poses a risk of harm to
in-state patients, state pharmacy regulators may have a difficult time
justifying the use of resources for the enforcement of state laws. When
a patient in one state is placed at risk of harm by a pharmacy in
another state, regulators in both states must cooperate for them to be
effective in their joint enforcement. Brick-and-mortar pharmacies can be
investigated through cooperative efforts of regulators in two states,
and problems with quality can be addressed in much the same way as is
done with in-state pharmacies. However, in the time it takes to
discover, investigate, and provide notice to an alleged Internet
pharmacy violator, the fast-paced entrepreneur responsible for the
original pharmacy site may very well have closed that site and moved to
a different Internet location. The ability of businesses to link sites
to each other makes it difficult for regulators to know against whom
enforcement action should be initiated. Moving targets are hard to
regulate, and the Internet facilitates frequent moving.
Despite these practical difficulties, there have been high-profile
actions by attorneys general in several states to stop illegal Internet
pharmacy practice. These actions usually charge that subject pharmacies
have dispensed prescription drugs without a license in the state. They
may also charge a violation of state *85 consumer fraud laws. As
well-intended as these actions may be, it remains to be seen whether
state attorneys general can maintain their level of commitment to this
resource-intensive issue. The results of the recent state actions are
not encouraging. One of the most active enforcers, Kansas Attorney
General Carla Stovall, has estimated that of 400 online pharmacies
believed to be selling drugs in the United States, only six were
operating within the law, and only a fraction of the illegal operators
were being investigated by a government agency. Meanwhile, the chief
investigator of unlicensed medical practice in Florida disclosed that he
had only two people to investigate the entire health care industry.
Given the national scope and technical complexity of the problem, in the
face of limited state resources, it is not surprising that state
regulators have turned to federal authorities for help.
As the agency primarily responsible for regulating drug approval,
production, distribution and marketing, the FDA finds itself not
particularly well situated to regulate professional practice. Yet, when
the professional practice of pharmacy is used as a charade to protect
large scale drug distributors from federal scrutiny, the FDA will not
hesitate to weigh in with enforcement of federal laws usually applied
only to manufacturers. For example, in the early 1990s, the FDA began to
enforce federal laws against massive compounding by a small number of
high-volume interstate distribution businesses that were masquerading as
local pharmacies. The federal enforcement action occurred only after
state regulators were unable to protect the public from what had become
an unregulated industry of clandestine*86 drug manufacturers. An
amendment to the FDCA was necessary to define FDA's regulatory authority
in this area.
The FDA has begun a similar enforcement campaign against Internet
pharmacies, both foreign and domestic. However, the issues are more
complex than they were with compounding pharmacies, and the targets of
regulation are far more difficult to find. Federal enforcement
activities directed at Internet pharmacy sites outside the United States
have been of two types: (1) direct action against providers to put them
out of business, in cooperation with local law enforcement authorities,
and (2) distribution of an Import Alert to customs inspectors, designed
to deny entry into the United States of illegal shipments from offshore
Internet pharmacies. Actions directed toward domestic sites have been
equally as determined, but far less public. The agency has provided
support for state enforcement activities, and it has stressed the need
for more stringent self-regulation by the industry. Authority for
federal enforcement has been based primarily on a conclusion that
Internet sites are directed to the public, therefore strict rules for
promotion of drugs directly to consumers apply. Most Internet sites do
not comply with the rigid requirements for advertising of
prescription-only drugs directly to the public, thus they are considered
in violation of the FDCA. This is an indirect approach to regulation
that may be technically valid, but it uses statutory authority that was
clearly intended to address public health threats other than those
presented by Internet pharmacy. Meanwhile, the agency waits for Congress
to provide more specific statutory direction.
Ultimately, no matter how tough state and federal regulators may be
toward Internet pharmacies, their efforts will fall short of even the
most modest goals. Just as illicit drug use has not been significantly
curtailed, because enforcement authorities *87 cannot be on every street
corner, every hour, of every day, Internet pharmacy regulators will
discover that they cannot monitor all web sites at all times. The
decades-long failure of narcotic drug control authorities to prevent
importation of illicit drugs into the country should instruct that the
country's border cannot be made secure from anything but a small number
of shipments made by offshore Internet sites to domestic medication
users. And there is a terrible risk that strong regulation would stifle
the Internet's growth and innovation, while doing little to prevent
inappropriate medication use. Onerous Internet pharmacy regulation could
have the unintended effect of deterring the development of novel
approaches to care provision that reduce problems with drug therapy and
enable alliances that improve the quality of care.
II. The Costs of Over Regulation
As noted above, there is clear evidence of a correlation between
aggressive regulation of pharmacists and conservative pharmacy practices
that do not consistently meet the needs of patients. Given the choice
between a behavior that may raise a regulatory red flag but is clearly
beneficial to a patient and an alternative behavior that is safe from a
regulatory perspective but may not provide all available benefits to
patients, many risk-averse pharmacists will adopt the latter strategy.
This is a sobering lesson learned through recognition of the barriers to
effective pain management created by regulation of controlled substance
medications. The under-treatment of pain is a serous problem in the
American health care system, and one cause of the problem is a
perception that regulators are intolerant of innovative pain management
practices that challenge traditional notions of appropriate care. Even
though recent changes in policy-on-paper have clarified that
restrictions on drug diversion should not play any role in restrictions
on patient care, policy-in-practice has yet to reflect the more tolerant
perspective of regulators. Once the fear of regulatory action becomes
ingrained in the mind of a practitioner, it is difficult to dispel.
*88 Assertive and much-publicized enforcement directed against
Internet pharmacy sites has the potential to deter innovative Internet
pharmacy practices, in much the same way as aggressive regulation
directed at diversion of narcotics has deterred innovative pain
management practices. It is not always the reality of enforcement that
matters as much as it is the perception that one is subject to
enforcement action. Regulation is a powerful positive tool that can
enable practitioners to meet their responsibilities to patients and
improve outcomes for patients, but regulation can also prevent the
development of new and valuable approaches to practice. Long viewed as
being separate from the practice of health care and as a necessary evil
to be tolerated but not welcomed, health care regulation has recently
experienced a renaissance. Responsive regulation, as opposed to
restrictive regulation, has the potential to bring health care
regulators into the mainstream of health care. It is important that
regulators of Internet pharmacy recognize the need to be specific in
their enforcement activities and responsive to needs of the health care
system. They must complement enforcement and discipline with at least
equal emphasis on activities geared toward enabling productive change
through regulation.
A. The Promise of Responsive Regulation
Responsive regulation promotes improvements in the quality of care.
The quality improvement function of responsive regulation will be said
to have succeeded when aggregated data measuring the professional
performance of a group of licensed practitioners indicate that the mean
for performance has changed for the better in response to regulatory
activities. Most graphs illustrating the level of competence of a group
of practitioners will show there are two opposing "tails" on
either side of a bell-shaped curve plotting the number of practitioners
versus the competence of each individual practitioner. The vast majority
of practitioners will fall within the large body of the curve, near the
mean and just barely below or above either side of it. The least
competent practitioners will be represented in the low "tail,"
and the most competent practitioners will be represented in the high
"tail" of the curve.
There are two types of regulatory actions that can significantly
increase the mean for the group, thus showing an improvement in quality
for the group. The first action is "culling." The elimination
of truly incompetent practitioners from a group will raise *89 the mean
of the competency for the group. Slicing off the lower "tail"
of the curve shifts the curve in a positive direction, thus elevating
the mean of competence for the group. This is the traditional role of
the health care regulator. The second action, an alternative to the
traditional enforcement function, is really an array of activities which
emphasize removing systematic threats to quality and introducing
systematic incentives to quality. Regulation geared toward those
practitioners at or near the mean, and those at the higher
"tail" of the curve can also shift the curve in a positive
direction, just as can culling. These actions have a greater potential
to improve the overall competence of the group, because there are far
more individual practitioners near or above the mean than there are
practitioners well below the mean. Yet, despite its potential for
success, apple "polishing" has not be used by regulators
nearly as frequently as has apple "picking." New theories of
regulation suggest that cautious culling is necessary but far from
sufficient to meet the regulatory challenge of public health protection.
Troyen Brennan and Donald Berwick have described a plan for the
implementation of responsive regulation to enable success rather than
punish failure. In their landmark book, New Rules: Regulation, Markets,
and the Quality of American Health Care, Brennan and Berwick propose a
systematic approach to health care regulation, based on the principles
of Continuous Quality Improvement ("CQI"). Their plan for
responsive regulation encourages risk-taking as long as risks are
monitored and controlled. They suggest that safe harbors from regulation
should be carved out for major innovation, and that successful
innovation should be rapidly spread throughout the health care system
through the use of regulatory incentives. They contend it is
anachronistic to regulate fragments in an era when the primary goal is
to reconnect the parts into a whole.
In a similar way, the much-publicized report of the Institute of
Medicine, To Err is Human, describes an unhealthy United States health
care system. The report suggests regulation can play a more significant
role in public health protection, and that problems with medication use
are among the most significant threats to quality in health care. The
report concludes that almost *90 all accidents in health care result
from human error, and these errors are usually induced by faulty systems
that "set people up" to fail. In order to learn from error,
health care regulators should require health care organizations to
establish and maintain environments and systems for analyzing accidents
and errors, so that redesign of processes is informed and productive.
B. Pharmacy Systems and the Internet
The absence of explicit design, lack of shared goals, and the failure
to use empirical evidence to correlate inputs with outputs, make it
difficult to refer to medication use in the United States as a
"system." Non-systematic medication use by physicians,
pharmacists, and patients stands in stark contrast with the highly
systematic drug development, production, and distribution by
pharmaceutical manufacturers. It is the lack of a system that poses the
greatest threat to quality in medication use, and the potential of the
Internet to provide the framework of a medication use system is the
greatest opportunity for responsive regulation of Internet pharmacy.
During new drug development, decisions about the safety and efficacy
of recently discovered molecules are made based on randomized,
controlled clinical trials that are evidence-based and protocol-driven.
Once approved for human use, the production and distribution of
pharmaceuticals is restricted by a requirement for adherence to current
Good Manufacturing Practices ("cGMP"). CGMPs mandate
documentation, monitoring, and remediation when goals have not been met.
The value of this highly organized system early in the drug therapy
chain may be virtually nullified by the non-systematic last links of the
drug therapy chain, when actual medication use is based on unguided,
(and largely unevaluated) professional judgment, along with misplaced
faith that patients use their medications appropriately and are
satisfied with the results of their drug therapy.
*91 Problems associated with drug therapy have been widely attributed
to a need to re-engineer the system of medication use. With pharmacists
as the focal point of system change, federal regulatory requirements
have been initiated for Drug Regimen Review in nursing homes, and for a
comprehensive program of Drug Use Review aimed at outpatient pharmacy
settings. Courts of law have begun to recognize that pharmacists have a
legal duty to evaluate drug therapy for every patient, and that
technical accuracy in order processing is necessary but not sufficient
to meet pharmacist professional responsibilities. State boards of
pharmacy have begun to shift their regulation from structure and process
only, to an emphasis on outcomes that are linked to structure and
process. Mandatory CQI, as a component of administrative regulation of
pharmacies, has been adopted by several states. The pharmacy profession
is emerging from its isolation on the street corners of the community
and the basements of hospitals to accept responsibility for
systematizing medication use. A key component, that is lacking in
traditional medication use, is a means to facilitate communication among
those who participate in medication use.
The Internet has the potential to be a key means of communication
within a more systematic approach to drug therapy management. Two of the
critical challenges to finding a solution to the problem of
inappropriate medication use are the inaccessibility *92 of information
describing the ideal for appropriate medication use and the deficiency
of data defining the problems experienced in actual medication use.
Through the Internet, physicians, pharmacists, and patients can access
criteria and standards for medication use, and they can develop
strategies for improving therapy to reflect evidence-based,
consensus-developed, clinical practice guidelines. The Internet can host
real-time threaded discussions about therapy; some of which can be open
to all Internet users, others of which can be password protected for
access only by health care providers. Patients can report their
symptoms, progress, and satisfaction with therapy on the Internet.
For example, assume that a patient who has been diagnosed with atrial
fibrillation is treated with digoxin or another similar drug. The
patient is not prescribed an anticoagulant. Data from drug studies with
many patients indicate that of patients diagnosed with atrial
fibrillation, approximately 70% should be treated with an anticoagulant.
However, data also show that only approximately 40% of the atrial
fibrillation patients for whom anticoagulation therapy is indicated
actually receive this beneficial therapy. By answering questions
presented over the Internet, patients for whom the therapy is indicated
but who are not receiving it can be identified and evaluated for
anticoagulation therapy. This evaluation can be facilitated by online
access to clinical practice guidelines. The questions asked of patients
can be prompted by the dispensing of digoxin, a marker drug for atrial
fibrillation. Once begun, anticoagulation therapy requires close
monitoring. The results of laboratory tests and other observations by
the patient can be reported on the Internet, and care providers can
review this information to assure that standards for anticoagulation
therapy are being met.
Not only can a health care provider use the Internet for the benefit
of individual patients, aggregated data can be uploaded (with
appropriate protection of patient confidentiality) to a central *93
location for analysis and use in generating new guidelines. For example,
experience with the use of anticoagulants by patients who have been
diagnosed with atrial fibrillation can be reported to regulators and
other reviewers for use as a performance database in the evaluation of a
medication use system. These are not advantages that affect only the
relatively few obvious beneficiaries in remote rural communities without
adequate health care services, they are benefits for all users of
medications, even those being treated at the most sophisticated urban
medical centers. By facilitating communication from standards-setting
groups, through health care professionals, to patients; and back from
patients, through health care professionals, to standards-setting
groups, a comprehensive program of medication use can be designed, with
measurable goals and with correlated inputs and outputs. The Internet
can be the tool through which medication use becomes a system.
The pharmacy is a logical focal point for an Internet-based
medication use system. Every pharmacy has a computer, unlike other
practice sites that may or may not be computerized, and Internet-access
is readily available in pharmacies. Formal alliances between
brick-and-mortar pharmacies and Internet pharmacies have been
established so that seamless provision of pharmaceutical products and
services between local and remote practice sites is possible. Patients,
their caregivers, and health care providers can all log in to the
pharmacy Internet site to share information. Patients do not always go
to the same physician for all medical needs, but they usually go to the
same pharmacy for their prescriptions. Thus, the pharmacy database is
likely to be the most up-to-date record of a patient's medication use.
When patients request refills of prescribed medications to continue
therapy at times when a visit to the physician need not occur, valuable
information about success or failure with drug therapy, and satisfaction
with drug therapy, can be elicited if the appropriate questions are
asked. Responses to these questions are valuable data that can be used
to close the quality loop between the providers of care and the
recipients of care. Individual *94 patient responses that signal a need
for medical attention can be queued up for evaluation by a pharmacist
and then for referral to the patient's physician if necessary.
Aggregated responses that indicate a common problem with many patients
can be referred to standards-setting organizations for review and
possible modification of practice guidelines.
III. Enabling Patient Responsibility for Drug Therapy
The Internet does not increase the possibilities for pharmaceutical
care; it increases the practicality of pharmaceutical care. Any
health-related activity that can be done electronically over the
Internet can also be done physically, within the traditional medication
use non-system. But the burdensomeness of physically looking up practice
guidelines or interviewing patients about outcomes from drug therapy
makes it unlikely that these activities will consistently be done
without facilitation by the Internet. Use of the Internet not only opens
up possibilities for enhanced communication up and down the chain of
medication use, it shifts the balance of power from providers of care to
recipients of care. The Internet changes the perspective of which end is
"up" in the chain of medication use.
Other advances in technology have had significant effects on public
participation in decisions about the use of products and services. The
printing press made it possible to widely disseminate information, as
did radio and television. Yet the information disseminated through these
media is controlled by the provider. The active provider of information
chooses what to communicate to the passive recipient of information. The
telephone is qualitatively different, because it is interactive for
information exchange, although the number of participants in telephonic
communication by voice is limited. By way of contrast, Internet users
are active, their communication is interactive, and the number of
participants is almost limitless. Through the Internet, the recipient of
information has the opportunity to select whatever source of information
she or he chooses from hundreds of thousands of possibilities. Internet
users can interact with each other, either on a real- time basis, or
with only a *95 short delay. Recipients of information now control the
message they receive, due to Internet access. The Internet shifts the
power over information exchange from the provider of it to the recipient
of it.
A. Patient Autonomy and State Paternalism
A regulatory focus on providers of products and services makes
perfect sense when the providers control the dissemination of
information about their products and services and when providers can be
readily located for enforcement activities. However, since the Internet
shifts the control of information from providers to recipients, and
since Internet providers are difficult to locate, it makes better sense
to focus regulation on the recipients of Internet-based products and
services. When the products and services are pharmaceuticals, a shift in
regulatory focus from health care providers to patients requires
reconsideration of deeply held beliefs about public health protection
and about the need for centralized decision making about risk.
Within the traditional scheme of drug therapy regulation, most
decisions about risk are made for patients, and not with patients. If a
molecule has been discovered or synthesized, and there is evidence
indicating that the molecule might be useful as a therapeutic agent,
patients will nonetheless be denied the opportunity to use the molecule
in their own therapy until years of testing and data analysis show the
molecule to be relatively safe and effective for a population of users.
Even after safety and efficacy issues have been satisfactorily addressed
and a new drug is approved for human use, the new drug will likely be
restricted to "Rx Only" status. Only if a state- licensed
prescriber then gives permission will a patient be authorized to use
this new drug. While informed consent is a cornerstone of medical care
and of health care regulation, the concept is rarely applied to drug
therapy, and empirical data suggest patients are largely uninvolved in
the choice of their drug therapy. Physicians decide *96 what drugs
patients will use, and they prescribe how the drugs will be used.
Patients are given the choice of either following doctor's orders or
developing their own medication use behavior at the risk of being
labeled as "noncompliant."
Despite the emergence of a huge industry of alternative and/or
complementary therapies that circumvent this costly and
difficult-to-access traditional system, the appropriateness of state
paternalism in drug therapy is seldom questioned. Drugs seem complex and
mysterious. They are known to be both injury-reducing and
injury-producing. It seems so sensible for government to protect
citizens from the bad choices they might make in drug therapy, if given
the opportunity to choose for themselves, even when only their own
personal interests are at stake. The reality that adverse drug effects
are rampant within the current paternalistic system of drug regulation
is seldom considered by those who challenge the notion that autonomous
individuals could make good drug therapy decisions for themselves if
enabled to do so.
In theory, restrictive regulation of drug therapy serves several
useful purposes: (1) it prevents overuse of drugs on which patients
could become dependent, (2) it improves therapeutic outcomes by assuring
that patients receive therapy that will make them better and not worse,
(3) it brings patients back to physician offices on a consistent basis,
so that necessary examinations and tests can be routinely performed, (4)
it protects the financial resources of people who might otherwise
squander their assets on useless nostrums, and (5) it protects the
community from self-serving behaviors (i.e., antibiotic overuse) that
are of limited value to individuals and are harmful to the population.
Each of these assertions is subject to challenge, particularly as *97
applied to a relatively sophisticated group of individuals, such as
those who use the Internet. It is not at all certain that users of
Internet pharmacy would act against their own self interest, or against
the interest of the community.
In response to those who paint a dire picture of potential widespread
tragedy resulting from anything other than consistently aggressive and
occasionally repressive regulation of Internet pharmacy, it is perhaps
equally as plausible to assert that Internet users who are enabled to
make good drug therapy decisions for themselves would do so. Responsive
regulation, as opposed to restrictive regulation, has the potential to
increase the availability of valid drug-related information and to
facilitate assistance with medical decisions made by patients through
access to online treatment algorithms. Responsive Internet regulation
could reduce health care costs and increase access to health care. This
is not a claim that such benefits necessarily would result from
responsive regulation of Internet pharmacy. The only way to know whether
appropriately enabled Internet users could adequately protect themselves
from harm caused by adverse drug effects and produce benefits from
available therapies would be to compare outcomes in two populations:
passive patients in the traditional system and active Internet users. In
a sense, Internet pharmacy could be seen as an experiment in patient
autonomy. This may be the time to find out whether technically
sophisticated medication users really need government protection from
themselves. This an opportunity for major innovation that should be
taken seriously and empirically studied, as are other experiments. The
question is not whether Internet pharmacy should be permitted; it is an
unstoppable development that is certain to increase in popularity.
Regulators should be asking how they can guide this inevitable
technology through regulation that appropriately protects and promotes
the public health.
B. Defining Relationships in Drug Therapy
The physician-patient relationship is one of the most highly
respected bonds in our society. It is a covenental relationship of
trust, which is based on an ideal of altruism and a reality of
scientific *98 complexity. There are special legal rules of
confidentiality, privilege, and duty that apply to this most important
of non-familial relationships. The medical profession has established
standards of practice that reflect questions not only of technical
expertise within the care provider role but also fundamental questions
of role for the care provider. It is considered beneath the standard of
care for a physician to provide incompetent services or to provide
competent services in an uncaring way. The "what" and the
"how" of medical care both matter. Patients must feel
comfortable in their relationship with their physician, or else they
will come to distrust the health care system and refuse to participate
in it--all to the detriment of individuals and the population.
Threats to the physician-patient relationship have been seen in
government oversight of the profession, as well as in corporate
ownership of practice and in managed care. Interference with the
physician-patient relationship has even been used as justification for
restricting legal recognition of emerging expanded responsibilities of
pharmacists for drug therapy management. Not unexpectedly, the Internet
has been viewed with suspicion by the medical establishment, fearful
that electronic communication could reduce the physician-patient
relationship to a physician- patient interface.
Within other contexts, the medical profession has struggled to define
what activities of physicians comprise a satisfactory relationship with
patients. For example, informed consent is now considered a necessary
prerequisite to surgery, and the elements of a sufficient informed
consent are generally well defined, although they remain somewhat
controversial. But informed consent does not have a long history in
medicine, and views persist among some physicians that patients are
better off not being involved in complex medical decisions. Drug therapy
presents different challenges for relationship definition because,
unlike *99 surgery, there is no requirement that a "touching"
occur for a physician to provide pharmaceutical treatment. The natural
requirement for physical proximity in surgery need not logically lead to
the human imposition of such a requirement in drug therapy. Physical
proximity of physician and patient, of a type that will permit a
hands-on examination prior to authorization to use any medication, seems
unnecessary under all circumstances.
When a physician knows a patient already, or when a patient is known
to another physician within a practice, and documentation of impressions
from earlier care is readily available in a patient care record, it is
not always necessary for the patient to physically visit a physician.
Forcing a patient who is physically incapacitated or who has significant
transportation barriers to visit a physician to secure permission to
continue treatment of a recurrent or chronic condition seems wasteful of
resources and unnecessarily inconvenient. On the other hand, a
physician's brief review of a checklist submitted by a patient hundreds
or thousands of miles away clearly cannot create a new physician-patient
relationship within the model for practice that the medical
establishment has developed. The difficult challenge is knowing how much
physician-patient contact is enough for safe and effective treatment,
and how much is too burdensome for patients who will forego all
treatment when barriers to access are overwhelming. The inevitable
conclusion is that one- size-fits-all descriptions of activities that
comprise a sufficient physician- patient relationship, from a medical
perspective, will fail to accommodate individual patient differences and
varied personal circumstances.
The difficulty of using a medical model to define the character of a
sufficient physician-patient relationship raises the possibility that
other models might be more useful, including perhaps a patient-centered
model. A sufficient physician-patient relationship might be one the
patient believes to be sufficient, based on whatever criteria the
patient chooses to apply. Deference to patients as the arbiters of the
sufficiency of their relationship with physicians would require trusting
patients to act responsibly on behalf of themselves and the community.
Reliance on patients to make this determination could be based on
respect for individual *100 autonomy, a basic principle of biomedical
ethics. The market failure of information asymmetry, which is often
cited to justify state paternalism in drug therapy, may not be a
persuasive rationale when applied to patients who are able to use the
Internet and have access to virtually limitless information. There is
always the question of individual liberty and the challenge a free
society must face in justifying any choice of the risks from which its
members will be protected by government. It is difficult to understand
why people can be allowed to eat snack foods with no nutritional value,
participate in hazardous sporting events, and elect whomever they wish
to govern them, but not be allowed to choose their own medicine. This
observation is not intended to be an absolute claim that all patients
could always appropriately define their relationship with a physician,
but it is a suggestion that those who advocate strong regulation of
Internet pharmacy in ways that perpetuate traditional physician- patient
relationships should explain the basis of their advocacy. It may well be
that harm resulting from a decision by a well-informed Internet user to
acquire medication without medical authority should not be viewed as a
regulatory failure.
C. Operationalizing Patient Responsibility
Conceptualizing and describing an ideal of informed and rational drug
therapy choice by Internet pharmacy users is easier than is putting this
laudable goal into practice. Responsible use of Internet pharmacy
requires that users know the choices available to them and reflect on
the consequences of their choices before they engage in potentially
risky behaviors. Users of Internet pharmacies need to know significant
therapeutic aspects of the medications they consider using. They also
need to know the identity and qualifications of those from whom they
acquire medications. If they choose to take risks with medications, or
to acquire medications from unreliable or unidentified sources, then
they must understand that protections ordinarily provided by regulatory
agencies are being foregone.
The only means yet developed to enable Internet pharmacy users to
protect themselves from risks that are unacceptable to *101 them is the
VIPPS program established and operated by NABP. VIPPS is a voluntary
program. Internet pharmacy sites that opt for VIPPS certification must
apply to the NABP. The application is reviewed by NABP to assure that
the Internet pharmacy is in compliance with relevant state and federal
laws. VIPPS pharmacies must also maintain a quality assurance or quality
improvement program. They must report to NABP any changes of information
provided as part of the initial certification process. Once issued,
certification is renewable annually following an update of the
registration information and re- verification of licensure status.
VIPPS certified Internet pharmacies are granted authority to use the
NABP/VIPPS hyperlink seal on their web sites. Visitors to the site may
click on the seal to receive real-time verification that the site is
certified. Any site that pirates the "click to verify" seal
will soon discover the online, real-time verification process does not
work for any site other than the certified site. "Rogue" sites
are immediately exposed to the Internet user. Through the VIPPS program,
Internet pharmacy users receive assurance that their certified provider
has met exacting quality standards. They know who is providing their
pharmaceutical products and services, and to whom to complain when
things have not gone well. Although VIPPS is not a regulatory program,
it provides assurance to Internet pharmacy users that certified sites
are being overseen by pharmacy regulators.
The most significant drawback of VIPPS is that it is not well known
to Internet pharmacy users. Even the best program is of little value if
those who would benefit from it do not know about it. Pharmacy
regulators should feel comforted that they have made significant strides
toward adequately protecting the public health by endorsing and
participating in the VIPPS program. However, until public knowledge of
VIPPS increases to the level of, for example, the Good Housekeeping Seal
of Approval or the Consumer Reports product ratings, there will continue
to be significant regulatory challenges to meet in Internet pharmacy.
Fortunately, there is a readily available medium to use in getting the
word out about VIPPS to Internet pharmacy users; that medium is the
Internet itself. By requiring search engines to provide streaming
cautionary statements to any Internet user who enters a search term that
suggests the intent to *102 acquire prescription-only drugs over the
Internet, the user who is uninformed about VIPPS has the opportunity to
discover the protections this program provides. It might be possible to
require this same streaming cautionary statement be displayed any time
an Internet user enters a Uniform Resource Locator ("URL")
with similarly suggestive terms. The objective would not be to forbid
use of the Internet, but to inform users that they may be going to a
site where the presence or absence of the VIPPS seal would be a
significant factor for them. Some Internet pharmacy users would continue
to use sites not certified by the VIPPS program, but only after being
informed of the VIPPS program and making a conscious choice to forego
the protection it provides.
Conclusion
Traditional enforcement-oriented regulation will continue to have a
role to play in government oversight of Internet pharmacy, when the
pharmacy can be physically located, when resources necessary for
enforcement are available, and when enforcement does not have a chilling
effect on beneficial telehealth activities. However, it would seem
sensible to steward scarce regulatory resources and devote them
primarily to enforcement directed at those who distribute addictive
controlled substances, or highly toxic drugs, to users who have ordered
them over the Internet. Interfering with the acquisition of hair
restoratives or drugs intended to enhance sexual function is an exercise
of state paternalism that goes beyond what is necessary or expected
under the circumstances. To be successful, any regulatory agency has to
be credible with the public it serves, and the targeting of
"lifestyle" drugs has the potential to adversely affect the
credibility of pharmacy regulators. Mounting a taxpayer-funded crusade
against bad choices that adversely affect nobody other than the person
making the choice could have the appearance of economic protectionism,
no matter how well intended as a public health measure.
Regulation of Internet pharmacy to protect the public health will be
most effective when it empowers Internet users to protect themselves
from risks the users believe to be unacceptable. Promotion of the VIPPS
program is the best assurance regulators can provide to the public that
individual Internet pharmacy users are being protected by the
professionalism that state-licensed pharmacists offer through their
oversight of the medication *103 use process. Pharmaceutical care can be
made more successful through Internet alliances within pharmacy; and
between pharmacists, physicians and patients. In the end, this is simply
a matter of trusting people to make good choices for themselves and
providing them with the means to make their choices as good as they can
be.
. Professor of Pharmacy Health Care Administration, The University of
Florida College of Pharmacy. This article is based on remarks presented
at the Loyola University Institute for Health Law, April 12, 2000. |
