LA GUERRA DE CASTAS

More information about consent is available from the Canadian Medical Protective Association’s (CMPA) Member Portal at cmpa-acpm.ca.

Emergency treatment

The general rule that consent must be obtained before treatment is adminis- tered comes with an important excep- tion: in cases of medical emergency when the patient (or substitute decision-maker) is unable to consent, a physician has the duty to do what is immediately necessary in the interests of the patient, without consent. For the physician to declare any clinical situa- tion an emergency for which consent is not required, there must be demonstra- ble severe suffering or an imminent threat to the life or health of the pa- tient. It cannot be a question of prefer- ence or convenience for the healthcare provider; there must be a clear and cer- tain need to proceed at the time. Fur- ther, in medical emergency situations,

treatments should be limited to those necessary to prevent prolonged suffer- ing or to deal with imminent threats to life, limb or health.

Even when the patient is unable to communicate in medical emergency situations, his or her known wishes must be respected. Before proceeding, the physician will want to be satisfied there has been no past indication, by way of an advance directive or other- wise, that the patient does not want the proposed treatment. Further, as soon as the patient is able to make decisions and regains the ability to give consent, a proper and informed consent must then be obtained for additional treat- ment. In some provinces, legislation permits the designation of a substitute decision-maker to provide or refuse consent on behalf of the incapacitated patient. If the substitute decision- maker is immediately available, emer- gency treatment should proceed only

with the consent of that individual.

In urgent situations, it may be necessary or appropriate to initiate emergency treatment while steps are being taken to obtain the informed con- sent of the patient or the substitute decision-maker, or to determine the availability of advance directives. How- ever, the instructions as to whether to proceed or not must be obtained as quickly as practicably possible. When an emergency dictates the need to proceed without valid consent from the patient or the substitute decision- maker, a contemporaneous record (at the time) should be made explaining the circumstances that forced the physician's hand. If the circumstances are such that the degree of urgency might be questioned at a later date, arranging a second medical opinion would be prudent if possible.

The bottom line

When the patient (or substitute decision-maker) is unable to consent and there is demonstrable severe suf- fering or an imminent threat to the life or health of the patient, a physician has the duty to do what appears immedi- ately necessary without consent. Emer- gency treatments should be limited to those necessary to prevent prolonged suffering or to deal with imminent threats to life, limb or health. Even when the patient is unable to commu- nicate, his or her known wishes must be respected. ⌧

The CMPA

The Canadian Medical Protective Association (CMPA) is a not-for-profit, physician-owned medical liability protection organization providing educa- tion, advice and legal assistance to physicians in Canada. The CMPA also assists physicians in iden- tifying and managing risk in promoting safer med- ical care. Any physician licensed to practice in Canada (including medical residents) is eligible for CMPA membership. The CMPA’s membership fees are based on specialty or type of work; they are also calculated on a regional basis. There are three fee regions in Canada: Ontario, Quebec and Rest of Canada. CMPA fees are paid by members directly to the Association. In all provinces and territories, the government provides a reimbursement program to physicians for their liability protection fees.

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Adverse events and ligitation

Patients and families litigate for a variety of reasons. While financial need is certainly a factor, disappointment and anger over poor clinical outcomes or unfulfilled expectations also play signif- icant roles. Surprise at unanticipated outcomes or the incidental discovery of important undisclosed details in and around an adverse event are also strong motivators. Patients and families some- times state that litigation is an attempt to find out what happened after other attempts at communication and inquiry have not successfully answered their questions. Litigation may also be an attempt to change the system so that similar events do not recur.

There is some evidence to suggest that physicians who have a good bedside manner and a caring attitude, and who support their patients through an adverse event, may be less likely to be sued. Physicians react to unexpected compli- cations and poor clinical outcomes for their patients in a variety of ways. Most want to understand what went wrong. Moreover, most physicians ex- perience a great sense of personal re- sponsibility and are self-critical when an adverse event affects a patient. There is sometimes a tendency to at- tribute the cause of the harm to others before all of the contributing circum- stances and facts are even known. All physicians are motivated to prevent, to the extent possible, the adverse event from happening again.

What is an adverse event?

Adverse clinical outcomes are not usu- ally caused by negligence or fault. In fact, most adverse events—events that result in unintended harm to the patient and that are related to the care and/or services provided to the patient, rather

than to the patient’s underlying medical condition—are an inevitable part of clinical practice, even with the best of care. In the courts, the medical stan- dard of care to determine a physician’s negligence or fault is not one of perfec- tion, but rather the standard of care that might reasonably have been ap- plied by a colleague in similar circum- stances. The courts rely heavily upon the testimony of other physicians work- ing in a similar specialty in the same kind of practice to help establish the applicable standard of care.

The term “medical error” is often used instead of “adverse event”; however, many of those charged with improving patient safety dislike the term because it carries a sense of blame or fault that may be inappropriate, especially when it is used before all the circumstances and facts about a case are known.

Disclosure of adverse events to patients

It is an ethical, a professional and a legal obligation to disclose to patients the occurrence and nature of adverse outcomes as soon as is reasonable to do so. Ideally, the communication of adverse events should be done in a gentle, non-rushed manner in a private setting. It is important to formulate a plan of communication prior to approaching the patient and/or family. But remember: Prior to communicating directly with patients who have commenced legal action against them, members should consult the CMPA and/or legal counsel.

Tips for dealing with adverse events:

 Deal with any emergencies and im- mediate health concerns.

 If time allows, you may wish to seek

telephone advice from the CMPA prior to communicating with the patient, family or hospital involved.  Give your patient factual clinical information about what has happened and the clinical nature of his or her con- dition as it now exists. Avoid specula- tion about what may have happened if a different course of action had been followed. Avoid attribution of blame, particularly concerning the care provided by others.

 Provide recommendations to deal with the medical condition as it now exists, including alternate treatments

New in Practice 2009: What medical residents need to know before entering practice

Disclosing adverse events to patients

and the risks and benefits of any other investigations and treatments. This is an informed consent discussion on how to move forward. Answer your patient’s questions about the proposed treatments.

 Maintain close communication with your patient and the family (with the patient’s consent) about the ongoing clinical condition and any further plans for treatment.

 Facilitate any necessary treatments and consultations.

 Transfer the care to another physi- cian if your patient requests or prefers it, or if the condition requires care that you cannot provide.

 Express your feelings of empathy, sorrow and concern as appropriate. Sharing your sincere regret about what

has happened, or wishes that the event had not occurred, is an entirely accept- able and desirable response. Some- times, if the outcome is indisputably due to your improper care, you may acknowledge your responsibility.  Inform your patient about any process through which the incident may be investigated, but be aware that there may be limitations on what infor- mation may be made available from further analysis.

 Document your care and the discus- sions that occurred in a factual way after the adverse event. Never alter the record or change what had been writ- ten previously in any way.

 Call the CMPA and your lawyer if you are concerned about potential medico-legal problems as a result of the incident. ⌧

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NEW

Fibromyalgia pain is real.

And so is treatment

with LYRICA.

LYRICA® _{C.P. Pharmaceuticals International}

C.V., owner/Pfizer Canada Inc., Licensee 2009

The efficacy of LYRICA in the management of pain associated with fibromyalgia for up to 6 months was demonstrated in a placebo-controlled trial in patients who had initially responded to LYRICA during a 6-week open-label phase.

There have been post-marketing reports of angioedema in patients, some without reported previous history/episodes, including life-threatening angioedema with respiratory compromise. Caution should be exercised in patients with previous history/episodes of angioedema and in patients who are taking other drugs associated with angioedema. In clinical trials and in post-marketing experience, there have been reports of patients, with or without previous history, experiencing renal failure alone or in combination with other medications. Caution is advised when prescribing to the elderly or those with any degree of renal impairment.

The most commonly observed dose-related adverse events in LYRICA-treated patients were: dizziness (22.7-46.5%), somnolence (12.9-20.7%), weight gain (7.6-13.7%), peripheral edema (5.3-10.8%). The most commonly reported (r5% and twice the rate of that seen in placebo) treatment-related adverse events were: dizziness (37.5%), somnolence (18.6%), weight gain (10.6%), dry mouth (7.9%), blurred vision (6.7%), and peripheral edema (6.1%). Adverse events were usually mild to moderate in intensity. Discontinuation rates due to

adverse events for LYRICA and placebo, respectively, were 20% and 11%. There was a dose-dependent increase in rate of discontinuation due to adverse events.

LYRICA is contraindicated in patients who are hypersensitive to pregabalin or to any ingredient in the formulation or component of the container.

Dosage reduction is required in patients with renal impairment (creatinine clearance <60 mL/min) and in some elderly patients as LYRICA is primarily eliminated by renal excretion.

See Prescribing Information for complete Warnings and Precautions, Adverse Reactions, Dosage and Administration and patient selection criteria.

References: 1. LYRICA Product Monograph. Pfizer Canada Inc., March 2009. 2. Mease PJ et al. A randomized, double-blind, placebo-controlled, phase III trial of pregabalin in the treatment of patients with fibromyalgia. J Rheumatol 2008;35:502-14. * A multicenter, double-blind, 13-week, randomized trial. 748 patients who met the ACR criteria for fibromyalgia and who had an average mean pain score of r4 on an 11-point numeric rating scale (NRS) during the baseline assessment were randomized to LYRICA 300 mg/day (n=185), 450 mg/day (n=183), 600 mg/day (n=190), or placebo (n=190). Patients were allowed to take acetaminophen up to 4 g/day as needed for pain relief. The number of completers was: LYRICA 300 mg/day (n=123), 450 mg/day (n=121), 600 mg/ day (n=111), or placebo (n=130). The primary endpoint was the reduction in endpoint mean pain scores (mean of the last 7 daily pain scores while on study medication). Pain-related sleep difficulties were assessed using the Medical Outcomes Study-Sleep Scale (MOS-SS), a scale that runs from 0-100. Mean baseline MOS-SS score for overall sleep problem index was 65.0.

See prescribing summary on page XX.

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