In today’s climate of rising health insurance costs and more financial responsibility being placed on patients, many welcome free drug samples.  The patients avoid the co-pay, and frequently, get to sample a new drug that has improved features.  For these reasons, it builds rapport between doctor and patient.

The use of sample pharmaceuticals can also be beneficial to physicians. It provides an opportunity to determine effectiveness at no cost to the patient. And – that determination can be valuable feedback for the manufacturer as well.

But, even with all the benefits, providing drug samples in an “informal” manner can present problems for both doctor and patient.

It has long been settled that physicians should document all aspects of the care being rendered.  Prescriptions are part of that written record.  In the typical situation where drugs are prescribed, the physician identifies the drug and sets forth the rules for usage in a written document.  There may be multiple copies of that document maintained by the physician, patient and pharmacist.  Therefore, in the event there is every any question relative to what was to be taken and when, a written record exists to answer those issues.

In the context of drug samples, however, many physicians fail to recognize the potential problems associated with a more relaxed dispensation of those samples.  Often, the physician will grab the samples, hand them to the patient with oral instructions, and rely on documenting the chart as to what was said.  However, nothing exists that conclusively proves the patient was made aware and understood the purpose of the drug and its usage requirements.  This issue is exacerbated by the fact that many drug samples given to physicians do not contain instructions for use.

In that situation, the physician can have great difficulty defending a claim where the patient overdoses or otherwise misuses the narcotic.  Any such claim would invariably turn into a “he said/she said” situation, leaving a court to determine who was truthful.  In the event of a patient’s death as a result of using the drug, the dilemma is magnified, and the physician’s credibility will be viewed with greater scrutiny.

To properly manage the risks, the physician should be just as vigilant in documenting sample drug prescriptions, and disregard the fact that they are samples.  This means that dispensing the free samples should be accompanied by a written set of instructions to the patient, and ideally, a copy of those instructions that has been signed and dated by the patient should be placed in the patient’s file.  The patient’s chart should also be documented with the same instructions, and as to any informed consent issues that occurred relative to the subject drug.

Since the beginning, Keystone Mutual has provided secure and trusted protection  to our policyholders, regardless of market developments.  It is times like these that show just how important it is for you to have that refuge.

In the past three months, the Missouri med-mal market has been thrown into a state of turmoil – largely as a result of actions taken by other market participants.  Those events have stunned many, and rightly so.

Our policyholders know that we honor our commitments, and give them what they are entitled to.  We put our policyholders’ ownership rights in writing.  We were the first, and remain the only, Missouri insurer to create and fund a member retirement savings plan – Keystone Capital™.

And, we provide accountability by selling direct – eliminating a middleman that’s “asleep at the wheel,” failing to protect you and often not acting in your best interest.

Keystone Mutual policyholders have always appreciated the safety and stability we provide, but it’s at times like this, when the market is in a state of unrest, that they realize the value of our promises and guarantees. We stand strong while others falter.

If you have not already done so, now is the time to join the Missouri physicians who have made Keystone Mutual the fastest growing med-mal carrier in the state. Let us show you what it means to put your interests first. Waiting for your renewal could put you at even greater risk – please call us today.

Regards,

Jim Bowlin
Chief Executive Officer

The concept of informed consent was long since codified, and has been the subject of numerous writings.  The informed consent doctrine requires that each patient be fully apprised – made aware of the risks and advantages of treatment, the same aspects of alternative options, as well as the risks and benefits of doing nothing, etc.

The current approach generally consists of a “form document” that everyone uses, and is usually sold to physicians by organizations for profit – in many instances, their sponsoring professional associations.  While new legal developments as to informed consent occur infrequently, relegating the concept to a “one size fits all approach” contains in significant risks.

Informed consent is anything but standard.

Most physicians recognize that no two situations presented to them are exactly alike, regardless of the overriding commonalities and their training, specialty or experience.  It is virtually impossible for two or more cases to present facts that warrant precisely the same diagnoses, treatment, etc.  So, why do some physicians try to inform patients with the same standardized form?  Today’s society tends to treat everyone the same so that efficiencies (of business, finance, etc.) can be maximized.  But that is usually ill-advised in the learned professions.  In fact, they are specifically trained to identify the esoteric distinctions that may exist among superficially similar cases.

Oftentimes, a standardized informed consent form will “carry the day.”  But there will be cases where the doctrine of informed consent requires far more than the standard form.

In those situations, an adverse outcome can be catastrophic.  A cursory review of medical malpractice cases filed against medical professionals will reveal that there are many cases which were handled very well, but that were decided against the physician or settled solely because informed consent was either absent or lacking.  In many instances, the absent informed consent item related to only one or two rarely needed elements that just happened to arise in a particular case.

Informed consent is, literally, central to every case.

To understand why that occurs requires revisiting the underlying reasons for informed consent.  Every patient is entitled to know exactly what can result from the proposed treatment, its benefits and consequences, the likely outcomes of doing nothing and pursuing other treatment, and so forth.  This is not a requirement that rests on an elementary understanding of the issues; rather, it is a mandate that is unique to each patient that requires that that patient to fully understand all key issues relevant to his or her treatment, however comprehensive and detailed the informed consent must be.  The distant chance that a particular matter might occur is irrelevant.  If it could reasonably occur, then it must be disclosed.

Therefore, although the “form” informed consent can be satisfactory, because many cases will fall outside of those generalized boundaries, the astute physician must be able to recognize those instances where and be aware of the fact that the standardized form will inevitably fall far short.

Unfortunately for physicians, the strictures of good business management, exhaustive credentialing requirements, and other practice pressures result in the need to efficiently allocate time and resources.  The situation is exacerbated by the various organizations and associations that make informed consent forms readily available at minimal cost (and, in some instances, with little thought).  Regardless of those influences, true informed consent should never be relegated to a standardized form where that may reasonably result in misinformation and misunderstandings on the part of the patient.

Juries will readily discharge a case based on a patient’s decision after full disclosure of the facts and risks.  The same juries are equally willing to assess fault to a physician that did not fully explain those issue, particularly when it resulted from a misplaced and ill-advised focus on efficiency.

Practically speaking, if a form is used, then it should contain a blank section that allows the physician to insert his or her personalized items that are unique to the particular case.  Most forms fail in that regard.  If they do not include such an area, then the physician must be willing to write his or her own addendum to properly address the given situation.  The physician must always be mindful of the need to fully inform the patient – regardless of the time or format required to do so.

Perhaps the best way to place proper focus on this issue is to ask yourself:  what would you want to know if you were the patient?  Then you w ill often see that the standardized forms fall far short.

Like most things, good risk management usually takes more time and effort.  Proper informed consent will often go beyond the basic disclosures.  Always ask yourself what you would want to know, and disclose, discuss and document all of that with your patients.   No two cases are alike, and when in doubt, it is always best to disclose and discuss more, rather than less.

One final note – the physician who relies on only his or her notes in the chart as to whether informed consent occurred risks a “he said/she said” situation.  That is not the better approach because in that instance, the jury will be left to determine who is truthful – and the jury may not be right.   The best approach is to always obtain the patient’s signature to whatever document is ultimately used.

As with undertaking proper informed consent, getting the patient’s signature may take longer, but it is usually irrefutable as to whether the patient was properly informed.

How to Handle Bad Outcomes

It is commonplace for treatment to produce unexpected or unintended results.  In some cases, these unanticipated outcomes are positive.  With other cases, however, the treatment result may be far less than desired or intended.

Such poor outcomes may, but often do not, result from a negligent act on the part of the physician.  Multiple variables are part of every patient’s unique situation.  It is frequently difficult, if not impossible, to fully predict with complete accuracy the results that will occur from treatment.

When unexpected or poor outcomes occur, it is important for the practitioner to recognize the best way in which to handle the situation from a risk management standpoint.  For example, issues such as whether and when to inform the patient, whether refunds are in order, and whether to notify the doctor’s professional liability insurance company are some of the issues that must be considered and addressed.

The Role of Informed Consent

Before addressing the way in which to handle bad outcomes once they have occurred, the best place to begin the analysis is with the informed consent process.  Physicians should never guarantee a particular treatment result.  It is impossible for the physician to know with certainty the likely treatment outcome because so many of the relevant variables are beyond the control of the doctor.  Will the patient take all medications as directed?  With there be an intervening cause, such as an unrelated illness or injury that negatively impacts treatment?

In fact, it is best if the informed consent process always include advising the patient that treatment results cannot be guaranteed.  This should be explained orally and acknowledged in writing by the patient in a written informed consent form.  The presence of these disclosures at the outset of treatment will often make the difference between whether the physician is ultimately held liable for the poor treatment result.

Was it Malpractice?

Before any action is undertaken, the first step is to objectively assess whether any negligence occurred.  A poor result, in and of itself, does not necessarily mean that negligence was involved.  However, if malpractice has occurred in any respect, then the manner in which the matter should be handled will differ greatly.  For example, if malpractice was involved, then the physician’s professional liability insurer should be immediately notified, and no action should be taken without prior approval from that carrier.

Informing the Patient

Once the doctor is aware that an unexpected poor treatment result has occurred, there will likely be a tendency to assess whether, and if so how, the patient should be informed.  This is particularly the case in those instances where the patient is unable to ascertain the fact that a poor result has occurred.

Regardless of whether the patient is aware of the bad outcome, the physician is under a legal and ethical duty to promptly advise the patient.  How this is done is equally important, and no discussions with the patient should occur without prior approval of the doctor’s malpractice insurer if negligence was involved in any respect.

As a general rule, it is best to inform the patient as soon as possible after the occurrence of a poor outcome.  Unless there is good reason to delay (such as to obtain additional facts as to alternative treatment options, records, etc.), then it is best to advise the patient at once.  In doing so, the doctor will avoid the perception on the part of the patient that something was being hidden from him or her.

With respect to informing the patient, the rule is to be mindful of the patient’s emotions.  Addressing a poor result with a patient by phone is not the preferable method.  The same goes for handling it via correspondence.  Meeting with the patient in the doctor’s office at a convenient time for the patient is the better approach.  Patients will respect the physician’s honesty and manner in which the bad news is relayed.

Without intending to lessen the need for imparting full information to the patient, it is important to recognize the “less is more” rule.  There is no need to discuss collateral and irrelevant issues.  As the saying goes, “just the facts, please.”  While only relevant and basic information should be provided, it should be relayed in a caring manner.

It is also critical to pay particular attention to the demeanor of the patient during the discussion where the bad news is delivered.  Immediately after the meeting, the doctor should enter what was said by all parties at the meeting on the patient’s chart.

Refunds and Payments

In bad outcome situations, patients will frequently desire a refund of fees for the services or other remuneration.  This can occur without regard to whether any act of negligence has occurred.

If no malpractice is involved, then the question of whether to refund or pay any monies to the patient is essentially a business decision.  The same goes for the amount that is paid.  However, if malpractice is involved, then it is generally far better to pay an amount to the patient outside of the legal system (but not without the knowledge and consent of the doctor’s professional liability carrier).  The same may also apply in those instances where no act of negligence occurred, but the patient presents a difficult demeanor or has unreasonable expectations.

Before paying any funds to the patient, it is imperative that the physician obtain a full and complete release from the patient before making any such payment.  This document will contain several items, including an acknowledgement on the part of the patient that the physician is not admitting any fault or liability by virtue of making the payment.

Legal counsel should typically be involved in any situation involving the payment of money to a patient.

Conclusion

Poor outcomes are never pleasant for either the patient or the doctor.  Handling such outcomes can be challenging, depending on the terms of the informed consent, the patient’s persona, the type of poor outcome involved, and whether malpractice has occurred.  However, utilizing proper informed consent, advising the professional liability insurer at the outset, informing the patient in the right way, and utilizing releases where necessary can mitigate an otherwise dangerous situation.

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