Are you an advocate of your patient's therapeutic rights?

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Jun 01, 2002

In the April issue of DVM Newsmagazine (p. 48) we considered application of seven diagnostic axioms with the goal of enhancing patient care.

In review, Axiom 1 emphasized the difference between knowledge (facts) and wisdom (the ability to properly apply knowledge). Axiom 2 emphasized the value of accurate definition of a patient's problem(s) in context of subsequently identifying solutions for the problem(s). Axiom 3 emphasized the importance of discerning the difference between observations (facts) and interpretations of observations (inferences or assessments). Axiom 4 focused on the process of collection and interpretation of relevant clinical data about a patient's illness with the objective of reducing numerous diagnostic possibilities to few diagnostic probabilities. Axiom 5 emphasized the difference between organ disease and organ failure, especially in context of prognosis and therapy. Axiom 6 emphasized the difference between clinical signs induced by disease and the body's compensatory response to disease induced signs. Axiom 7 emphasized the fact that just because two or more events occur in consecutive order does not prove a cause and effect relationship.

Once a diagnosis is established, it is our ethical responsibility to ensure the safety and efficacy of various types of treatment given to our patients. This month's Diagnote consists of the application of 10 axioms or principles that I have designated as our patients' "therapeutic rights".

In order for therapy to safely reach its maximum potential in each patient, the 1) right motive based on the 2) right knowledge should be used to 3) prescribe the right drug for the 4) right patient at the 5) right time in the 6) right amount using the 7) right dosage form and the 8) right route of administration to bring about the 9) right response. Then, the 10) right results should be recorded in the right record in a timely fashion.

The right motive

In recent months, there has been considerable discussion about the ethical difference between generating value-based free enterprise fees-for-service to maintain the fiscal vitality of a properly staffed and equipped veterinary hospital, and the motive behind recommending unnecessary services and therapy to increase fees to a maximum determined by what the traffic will bear.

There is no disagreement that responsible and ethical business management practices are vital to generate adequate hospital income needed to offer the standard of patient care that we all took an oath to provide. However, ethics also directs us to put the interest of our patients above our own financial interest. Therefore, formulation of our plan of therapy should not be motivated by self-gain of profit.

Recall that by definition the veterinary profession has a service rather than a profit motive. It follows that in caring for our patients, we must care about our patients. Thus, we would not endorse the unethical practice of prescribing "a pill for every ill."

In some situations, an ethical alternative is to dispense reassurance that self-limiting diseases do not require treatment. Our motive for recommending therapy should be solidly based on the principle that we are committed to the welfare of our patients and our clients first...and last.

The right knowledge

The admonition primum non nocere - first do no harm - is attributed to Hippocrates and infers that therapeutic intervention will be based on accurate knowledge, wisdom and understanding. Thus, both the benefits and risks of therapy should be considered in context of each patient. Drugs should not be given without a working knowledge of their pharmacokinetics and pharmacodynamics.

Pharmacokinetics refers to how drugs are absorbed, distributed, metabolized and eliminated from the body. Pharmacodynamics refers to the mechanisms of action of drugs, and the body's physiological, biochemical or psychological response to a drug or a combination of drugs.

Other factors that should be considered include: 1) species differences in drug actions and interactions, 2) probable effects of organ failure on drug pharmacokinetic parameters and pharmacodynamic processes, and 3) possible interactions of combinations of drugs. The package insert that accompanies each drug should be reviewed before prescribing for the first time and in those situations when specific drugs are used infrequently.

Unfortunately, drugs used to prevent, control or eliminate various diseases also have the potential to induce disease. Recall that many pharmacokinetic and toxicity studies designed to minimize adverse drug events have been performed in healthy animals.

However, these same drugs often are prescribed for patients with disease or dysfunction of one or more body systems that play a vital role in the drug's absorption, biotransformation and elimination.

Pharmacokinetic data derived from studies of healthy animals may not apply to animals with various diseases. If doses of drugs designed for patients with normal organ function are not appropriately adjusted for patients with organ dysfunction, the likelihood of adverse drug events is enhanced. To the unsuspecting therapist, such adverse drug events may be erroneously attributed to progression of the underlying disease or may be misinterpreted as an unusual manifestation of the underlying disorder.

For ethical reasons, therapeutic plans should include the expected outcome (or goal). Therefore, we should be able to describe the rationale for the treatment we are recommending, and be familiar with the scientific evidence supporting our choice of therapy. Why? Because, goal-setting fosters precision, and precision fosters quality patient care. No patient should be worse for having seen the doctor. Once the goal of therapy is defined, the feasibility of such therapy must be assessed.

In many situations the final choice will represent a balance between the optimum therapy for the problem(s), the availability of optimum therapy, and the type of therapy our clients can or are willing to afford. There must be no misunderstanding about what is wanted and what is given. In a symbolic way, we must determine whether our clients want "a dog, a cat, a horse, etc." or "this dog, this cat, this horse, etc.", while at the same time trying to be our patient's advocate.

The right drug

Drugs may be given with the goal of providing specific, supportive, symptomatic or palliative therapy. Specific treatment is given to eliminate, destroy or modify the primary cause(s) of the disease process. Examples of specific treatment include use of antibiotics for bacterial infections, antidotes to counteract toxins and replacement hormone therapy.

* Supportive treatment consists of therapy that modifies or eliminates abnormalities that occur secondary to primary disease. Treatment designed to correct deficits and excesses in fluid, electrolyte, acid-base, endocrine and nutrient balance caused by primary renal failure is an example of supportive therapy. Successful specific therapy is often dependent on successful supportive therapy.

* Symptomatic treatment consists of therapy given to eliminate or suppress clinical signs. Examples of symptomatic treatment include use of antiemetics to control vomiting, and use of glucocorticoids to control pruritis.

* Palliative treatment consists of therapy chosen to suppress the clinical signs of patients with diseases for which the underlying cause cannot be cured and is likely to be progressive.

* Inappropriate therapy consists of therapy that is not needed by the patient, or therapy for which the associated risks outweigh the probable benefits.

Choice of the right drug should encompass knowledge of the patient's previous history of adverse drug events (e.g. rash, tremors, anorexia, vomiting, diarrhea). To minimize adverse drug interactions, it is best to avoid unnecessary use of multiple combinations of drugs.

The right patient

Giving the right drug with the right motive based on the right knowledge to the wrong patient is obviously of no benefit. It may even be detrimental. When a hospital team approach is used to dispense and administer various types of medication, specific names of drugs and accurate prescribing orders for in-hospital use should be identified by the patient's name in addition to the patient's location. In addition, clients should be advised of the hazards of giving medications prescribed for home treatment of one patient to another animal that develops illness with similar signs.

The right time

The effectiveness or toxicity of many drugs is influenced by the frequency (so-called maintenance intervals) with which they are given. For example, a common reason that antimicrobial therapy is ineffective in eliminating infections is that clients are unwilling or unable to follow recommended dosing intervals.

For example, rather than following directions to give the total daily dose of the antibiotic in two equally spaced subdoses, they may give one-half the total daily dose once per day. Thus, the right drug becomes ineffective because it dos not attain therapeutic concentrations at the site of infection.

Lack of compliance with administering drugs at the proper time intervals is especially common when multiple drugs are to be given at frequent or varying time intervals. Improper dosage intervals may also be associated with inability of clients to administer drugs by the oral or parenteral route. Before prescribing complicated therapeutic protocols, the client should be asked if they are willing and able to comply with the therapeutic plan.

The right amount

Several factors may influence selection and administration of the right amount of drug. They include counteracting or potentiating effects of multiple drugs. The influence of organ function or dysfunction on the absorption, biotransformation and excretion of drugs is also of great significance. For example, in addition to the potential effect of renal dysfunction on reducing the elimination of drugs and their metabolites by the kidneys, consumption of reduced quantities of dietary protein may further reduce renal clearance of some drugs and their metabolites.

Therefore, if drugs primarily excreted by the kidneys are given to patients with renal failure, appropriate adjustments in dosage should be considered. The same caveat applies when drugs that are metabolized by the liver or eliminated via the hepatobiliary route are being considered for patients with hepatobiliary disorders.

Even though manufacturers specify therapeutic dosage ranges for drugs, drug doses must be individualized for each individual patient. In addition to considering body weight, proper dosage may be influenced by such factors as magnitude of weight loss, magnitude of obesity, state of hydration or abnormal accumulation of substantial quantities of extravascular fluid (e.g. ascites). For example, if doses are calculated for patients at one body weight, but not subsequently adjusted in association with substantial weight loss or weight gain, overdosing or underdosing might be a consequence. Consider also that highly fat-soluble drugs may have increased duration of effect in obese patients. Likewise, drugs that are safe in normal adults may create problems in pediatric or aged patients.

The effect of food on absorption of orally administered drugs may also be a factor. Absorption of drugs may be decreased, delayed, increased or unaffected by physiological changes that occur in the gastrointestinal tract during fed and fasting states. In general, food reduces the bioavailability of drugs. Likewise, the bioavailability of drugs may be affected by administering them with food through nasogastric tubes or gastrostomy tubes.

The right dosage form

Drugs are available in a variety of forms, including powders, capsules, tablets, liquids, lotions, ointments, suppositories, nebulizers and injectables. Numerous factors influence choice of dosage form, including ease of administration, patient tolerance, rate of absorption, state of hydration, status of the gastrointestinal tract and desired timing and duration of effect. Clients should be advised not to crush tablets that have special coatings, because this will negate the purpose of the coating. They should be advised of what action to take if they are unable or unwilling to administer drugs in the dosage form prescribed.

The right route of administration

As with dosage forms, numerous factors influence choice of the route of administration of drugs. Vomiting, diarrhea or impaired ability to swallow all have an impact on whether to choose orally administered medications. Likewise, inability of a client to give an animal the proper dosage and frequency of oral medication will have an impact on the choice of route of administration of a drug. Likewise, the magnitude of dehydration influences whether rehydrating fluids will be given by the intravenous, subcutaneous or oral route, or a combination of these routes. Desired onset and duration of drug action, as well as cost of drugs, are also important.

The right response

The definition of the right response is that which accomplishes a therapeutic goal. How can we determine if we are making satisfactory progress toward accomplishing our therapeutic goals?

An effective and practical method that will facilitate evaluation of the effectiveness of therapy is use of therapeutic-specific databases (see example in Table 1). The simplicity or complexity of therapeutic-specific databases is influenced by the nature of the disorder being treated, as well as the probable safety and efficacy of the treatment selected for use.

Use of therapeutic specific databases as reference points often help in educating clients about the nature of problem(s) identified in their animals. The probable future course of events (prognosis), and the reasons and schedule for therapy.

The veterinarian's prediction of the progress of the case should be discussed with the owner with the goal of helping him/her to recognize deviations from the expected course of events, and also providing him/her with a balanced perspective of the significance of such deviations. Then if significant changes from the expected occur, the clients will be more likely to call for help or return the patient to the hospital for reevaluation.

The right issues

Recording the right results in the right record. Properly designed and completed medical records play a key role in enhancing proper care of patients. Why? Because medical evidence is usually transient; it can be preserved only by recording it.

The strongest memory is weaker than the palest ink. Medical records facilitate: 1) planning of patient care, 2) communication between the doctor and other individuals involved with patient care, 3) monitoring the progress of the patient's illness, and 4) a basis of review which in turn serves as an excellent source of continuing self-education.

Properly constructed medical records provide important reminders that foster effective and timely medical action. Notes about therapeutic plans, and entries about drugs that have been dispensed, should be entered into the medical record in a timely fashion, and in a legible and reproducible form that is readily retrievable. Hospitals with inaccessible, incomplete or poorly constructed medical records have little advantage over hospitals that do not keep medical records.

Epilogue

It is our ethical responsibility to be strong advocates of the therapeutic rights of our patients. The motivating force that will help us to consistently uphold and apply these "rights" to all of our patients is the Golden Rule.

Specifically, we should take the initiative to provide the quality of therapy that we would desire if we were the patients, rather than the doctors. When uncertainty exists as to whether or not a particular drug, medical or surgical procedure is or is not in the best interests of the patient, please consider the following questions.

* Based on the information available, would I choose this course of therapy if I were the patient?

* Based on my assessment of my own knowledge, skill and experience with this type of problem, would I consent to the proposed plan of therapeutic action if I were in this patient's exact situation?

* What therapeutic goals are likely to be achieved?

* If I follow the proposed plan of therapy, in all probability will the overall benefits of this plan justify the associated risks and costs?