The thought of eliminating prescription writing and making all pharmaceuticals available over the counter probably seems radical to many. Surely, however, for anyone who accepts the moral power of the ethical principle of autonomy, such an option must be considered. Let us consider two policy options, one a more purely libertarian view that elevates autonomy to a central place, at least taking precedence over strong paternalism that would attempt to protect drug consumers from their own poor choices, and another that retains some features of moral paternalism while coming to terms with the recognition that prescription writing requires a value judg- ment about which clinicians cannot be presumed expert.
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The Libertarian Option
The first possible policy we can call the “libertarian option.” It is firmly grounded in the ethical principle of autonomy. It is the policy already in place for chemicals like alcohol, tobacco, and warfarin for pest control. Competent adults would be free to purchase drugs on the open market. They would, of course, also have the moral responsibility to become educated consumers learning about the evidence that the drug is effective (for which they might rely on websites such as those of NIH or WebMD), even if there would be no legal requirement that they become so edu- cated. They would also be able to consult experts and would, for serious drug choices, presumably want to talk to their physician. In doing so, however, they would rely on these sources for knowledge of the medical facts, or, if they asked for advice, they would do so after making a judgment about whether the source’s value judgments should be relied upon.
Libertarians since the days of John Stuart Mill (1956 [1859]) have recognized that the individual’s autonomy-based rights to consume something like a drug must be limited by the “harm to others” principle. Even a libertarian should accept the need for controls on methamphetamine and probably narcotics—drugs that pose a risk to third parties. This could be the basis for restricting purchase of a drug like pseudoephedrine. In our liberal democracy, we actually tolerate liberty at a higher threshold than libertarians would. We allow individuals to do many things that harm other unwilling people, for example, smoking in public or owning a gun. These activities pose a risk to those around the practitioners, but we tolerate them because of the premium we place on autonomy. If we are consistent, we would permit patients to make drug choices even when they pose similarly modest risks to third parties. Since relatively few drugs pose significant third-party risks, this is not a serious limitation to a libertarian policy of permitting competent adults to purchase drugs without a prescription.
Also, the libertarian option would have to come to terms with the fact that some potential consumers are not competent adults. Such a policy would presumably limit purchases by children and others who are not mentally competent. Not only would children not be permitted to make purchases, but adults as well would not necessarily be permitted to make purchases for them and administer the drugs based on their own value judgments. Just as society imposes limits on the right of adults to buy and give children alcohol and tobacco, so presumably some drug-use choices made by adults for a child would also be constrained.
These constraints on the use of pharmaceuticals by both incompetent and com- petent persons in a way that poses significant risks to third parties are consistent with libertarian principles, in particular, the notion that it is not paternalism to take action to protect those who are not substantially autonomous or to take action when the purpose is to protect not the consumer of the drugs but rather third parties.
This is a plausible conclusion for anyone who accepts a moral theory that places the principle of autonomy over the principle of beneficence when it is used in such a way to bring benefits to one who, while substantially autonomous, does not want
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
the presumed benefit. Still, many would find this goes too far. Some believe that, at least in extreme cases, autonomy is not a lexically ranked principle that always should take precedence over beneficence, even beneficence directed toward the one being benefited (Beauchamp and Childress 2013: 220–223 and passim). We may be worried that the libertarian option at least poses the risk that some drug-use decision- makers will not be acting in an adequately autonomous way because they are not adequately informed or free to choose. We may also be worried that some ade- quately autonomous decision-makers may make such bad choices that some limited form of paternalism may be justified, that is, we may hold an ethical theory that sometimes permits the ethical principle of beneficence to take precedence over autonomy. If so, we might consider a second, more conservative policy as an alter- native to the purely libertarian policy regarding the practice of prescribing.
The Certificate Option
The libertarian option poses a problem for those who are concerned about the pos- sibility that consumers will not be adequately informed in their drug-use choices.
Even competent adults may be inclined to purchase pharmaceuticals without the benefit of adequate education about the pharmacology of the agents—the evidence of their effectiveness, the data on potential undesired effects, and the evidence regarding alternatives. Lay people may be unduly influenced by lay press accounts of wonder drugs or by advertising intentionally misleading consumers about the drug’s safety and effectiveness.
The Weak Paternalism Version
This is, in effect, a concern addressed by the notion of weak paternalism. Some who are, in principle, anti-paternalists worry about dangers to people who are not acting in a mentally competent manner based on adequate knowledge. They would support a limited use of paternalism to intervene long enough to determine if the consumer is, in fact, adequately competent and informed. Once that is determined, the weak paternalist will step aside and let the actor choose a course of action, even if observ- ers continue to believe that the consequences will be bad.
That is the policy that defenders of a “certificate option” would favor. They would restrict the purchase of legend drugs, those currently available only on pre- scription (or a shorter list of those that should only be available on prescription) to purchasers who have a certificate signed by a licensed physician, asserting that he or she has educated the patient adequately about the drug, its potential effects, and its alternatives.
This would look very much like the piece of paper that is currently called a pre- scription, but it would be very different philosophically. It would not be a written declaration that the physician believes the drug is best for the patient. It would
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merely be a testament that the patient is adequately informed. It would remain the patient’s decision to determine whether the drug is best. The certificate requirement would be a paternalistic attempt to make sure that the consumer is, in fact, acting in a substantially autonomous manner. Once that was determined, it would be the patient’s decision whether to use the drug and how it is used.
A Strong Paternalism Version
This may still be too risky for some who want to balance concern for the well-being of the consumer against the principle of autonomy. They may fear that getting the certificate could lead a consumer to buy and use a drug about which a physician had provided information that the drug poses serious risks and offers very little chance of benefit. If the certificate merely testifies to the fact that the patient has been edu- cated, this educated patient may still make what seem like bad choices that are not in the patient’s interest. How could someone who is willing to tolerate some pater- nalism in the strong form make use of the certificate given the realization that pre- scribing requires incorporating value judgments about which the physician cannot be presumed to be expert?
We could require that the certificate not only testify that the patient is adequately informed but also that he or she has a condition for which the drug has been judged adequately beneficial. Presumably, it should not be the individual clinician’s judg- ment that the drug is adequately beneficial since that would require the clinician to impose his or her personal, idiosyncratic values. We could rely on a more societal judgment, however. This should not be the judgment that is merely the consensus of the medical profession. Even the profession as a whole may have systematic biases.
For example, in the mid-twentieth century, the professional consensus was that ster- ilization should be available only to patients who were older or already had enough children.
There is no reason why the professional consensus on such matters should be authoritative any more than the individual clinician’s judgment is. If we are to be strongly paternalistic in protecting adequately informed consumers of pharmaceuti- cals from harms to themselves, the judgment about the benefits and harms should be as sound as possible. For example, if the best medical science finds no evidence that a drug is effective against a particular condition and it poses a risk of producing what most would consider a serious side effect, then a defender of strong paternal- ism might consider a policy that the drug not be sold to someone who wants it for that condition. We might rely on the FDA to compile a list of drugs paired with conditions for which the drug has been found effective. Since the determination of whether there is adequate evidence of a drug’s effectiveness always incorporates value judgments, the process should not be in the hands of professional groups.
Instead, it should be a democratic decision based on most people’s judgment that a drug should be permitted to use to treat a condition. This, of course, reintroduces strong paternalism and the imposition of the value judgments of the group compiling
Prescription Paternalism: The Morality of Restricting Access to Pharmaceuticals
the list of approved uses, but it at least avoids the serious mistake of permitting the medical professional to be the paternalist.
The result would be that the certificate would not only testify to the fact that the patient is educated but also that he or she has a condition for which the drug has been deemed effective enough that its use would be reasonable. Presumably, the worse the collective value judgment about the effects generally deemed bad, the more evidence of effectiveness would be required. A drug with little evidence of benefit might still be made available provided there is also little evidence of harm.
(Consider homeopathic remedies as an example.)
We would consider this a strong paternalism. The patient, even when certified adequately educated and mentally competent, would not be able to purchase the drug unless he or she had a condition on the list of approved uses. This would, of course, run the risk of jeopardizing the rational, if idiosyncratic, judgments of those who have unusual values that would lead them to rule out standard treatments and prefer a drug that most would find inadequately supported. A pure libertarian would object to the certificate option in either of its forms, especially in the latter form that imposes a societal judgment on the rationality of the consumer’s decision that the drug offers enough promise of benefit to be worth pursuing.
Conclusion
The practice of limiting pharmaceuticals to prescription access is so deeply entrenched that most would not question it. On reflection, however, it is an odd custom given the propensity, especially in American culture, to accept the right of competent adults to engage in practices based on their own judgment of risk and benefit as long as they do not significantly jeopardize the welfare of others. Since most drugs pose very little if any risk to third parties, it seems strange that a liberal society would routinely presume that drugs cannot be purchased on the open market except in the case of those found most innocuous. This practice is even more puz- zling given the strong consensus that access to some very potent and dangerous chemicals should be open and without the review and approval of medical profes- sionals. Even for one who is not a libertarian, the appeal to consistency would seem to require that, if admittedly dangerous chemicals like alcohol, nicotine, and rat poison are readily available to adults, most pharmaceuticals should be as well.
The most likely explanation is that for too long Western culture bought into the traditional medical model, which assumed that only physicians could know when a drug was good for a patient. That model changed in the modern period so that it was the consensus of the professional group that would determine whether a drug should count as beneficial. Until late in the twentieth century, the question of when a drug was “indicated” or a “treatment of choice” was conceptualized as a matter of medi- cal science. Physicians who were expert on the science of medicine were also assumed to be experts on the value judgments that were necessary to decide that a treatment was beneficial. That error was slowly discovered, first with a few “ethically
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exotic” medical interventions surrounding terminal care and fertility decisions, but now the necessity of nonmedical value judgments to determine if a treatment is beneficial is increasingly seen as logically necessary.
Given the critical role of these nonmedical value judgments about which physi- cians cannot be presumed to be expert, the practice of prescribing no longer makes sense. A prescription is merely the recording of some physician’s value judgment that a particular medication in a particular dosage form at a particular strength (and perhaps by a particular manufacturer) is better for his or her patient than any alterna- tive. Since the patient may not share that value judgment, logically the reasoning that supports the writing of a prescription is flawed.
An alternative policy is called for. We present two options. The defender of the lexical priority of the principle of autonomy will be a militant antipaternalist and will support the open access to all pharmaceuticals by competent adults except for those posing serious risk of harm to others. That defender of autonomy will plausi- bly accept limits on the right of competent persons to transfer pharmaceuticals to incompetents including children, but not on the right of those persons to consume the drugs themselves.
For those more willing to balance the duty to produce benefit against autonomy, a second policy should be considered, a certificate policy. Such a policy would come in two forms. One form merely certifies that the patient has been adequately edu- cated to purchase a particular pharmaceutical. This view could be defended on grounds of acceptance of weak paternalism: The right of society to intervene to assure that the actor is, in fact, substantially autonomous. A second form of a certifi- cate policy would also require health professional certification that the patient has a condition that those best able to judge consider to be adequately responsive to the drug in question. The therapeutic suitability of a drug would be determined not by the consensus of the medical profession, which may have biases, but by some broader, interdisciplinary group representing a wide range of societal perspectives.
This second form of a certificate would cross the line into strong paternalism in that it would override an individual judgment that a drug should be purchased (and pre- sumably used), even though the broader society considers that there is no adequate evidence that the risks are justified by the potential benefits.
Even this second, more conservative form of a certificate would avoid the no- longer- defensible assumption that health professionals are presumed experts on the value judgments that go into the practice of prescribing. The practice of physician prescribing is not defensible in a postmodern society. Some alternative is needed.
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