PRESCRIPTION Medications...
A medico-legal dilemma


The patient is responsible for agreeing to take
any medication prescribed by a physician.



This opinion-piece concerns a most important medico-legal consideration for all doctors, all pharmaceutical manufacturers, all patients, and all lawyers... concerning the potentially injurious effects of ALL medications.




Selected from the on-going INTERNET BOOK, "This Doctor's Marvelous Medicine"
( http://www.terrific-tabs.com )
by
John N. Todd III, M. D. (link to "About the Author")


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Initiated 4/11/05; "Doctored" 4/05; 5/05; 6/05; 7/05; 11/05; 12/05; 1/06; 3/06; 4/06; 10/06; 4/07; 5/1/07

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Before long, sooner better than later.... all practicing physicians (and all pharmaceutical manufacturers) will find it necessary to present a "disclaimer" to every patient, explaining the potential danger of each and every prescription-medication now available. That "disclaimer" will say something like the following:



Dear patient,

It has become necessary to inform you, and warn you, that every medication now available is potentially harmful to you. You should understand that all medications have differing effects in different patients. Each of us humans (obviously) is distinct from all other human-beings. There are innumerable combinations of "genes" in each of us human-beings.... and, hence, there is potentially a great variation of chemicals ("enzymes") in the various digestive and metabolic systems of each of us.... enzymes that alter the absorption, and break-down, and excretion, and systemic effects.... of all medications.

In other words.... among all animals, including "human-animals", there is a great individual variation in responses.... some "good"; some "bad".... to any-and-all medications. Therefore, there is a potential risk to you, the patient, in taking any prescribed medication.... and any "over-the-counter" medication that you may choose to "prescribe" for yourself.

For example, it has long been known that certain widely-used anti-inflammatory medications, in some individuals, may cause intestinal bleeding. Even "aspirin".... one of the world's most widely-used and beneficial medications.... may induce various harmful side-effects -- including severe allergic reactions, gastric ulceration, asthma.... and alteration of the body's blood-clotting mechanism, leading to severe intestinal bleeding.

Other drugs may severely damage the kidneys, unpredictably. Or, the function of the liver may become impaired with the use of some medicines.... for reasons that no one can foresee.

In a few individuals, the bone marrow may be irreversibly suppressed by certain medications.... leading to "aplastic anemia", and other abnormalities of the blood-manufacturing capability of the bone marrow.

Various unforeseeable manifestations of severe "allergy" and hypersensitivity may develop in a few patients.... following the use of any specific drug.

In addition, there is the problem of "drug-interactions", in which the function of one medication (which an individual may already be taking) interferes with the anticipated effect of other medications. There may be unpredictable "synergistic" effects of one medication with another medication.... or there may be "potentiation" of the effect of one or more drugs that an individual may already be taking.

Furthermore, in an individual's metabolism of some medications, other pharmacologically active "by-products" may be produced by the liver.... and these active "by-products" may induce unexpected medicinal effects, in some people.

In all animals, there is the likelihood of "rebound" after taking certain medications. For example, if one takes a "sleeping-pill" (a sedative) for insomnia, the insomnia may seemingly be "improved" so long as the medication is continued. But then, when the "sleeping-pill" is discontinued.... the basic problem of insomnia returns.... perhaps even worse than before the sleeping-pills were first ingested. The same applies to medications for pain.... that is, when the pain-pills are discontinued, the pain may "rebound".... and seem to be even more severe than before the pain medication was taken.

This "rebound" phenomenon is largely responsible for the development of habituation or addiction to a medication.

Concerning "habituation" or addiction.... a patient must always consider the risk of habituation to any of a number of different classifcations of medications.... "pain pills", sleeping-pills, tranquilizers, anti-depressants, "diet-pills"; and others. Habituation is unpredictable.... but is clearly a risk to almost everyone.... so, nowadays, every patient who agrees to take any of these potentially "habit-forming" medications must personally acknowledge awareness of this danger, and must use extreme caution. Your doctor has no way to prevent habituation in an individual patient.... especially if the patient abuses the use of a risky medication.

It must be understood by all patients that the effect of any and every medicine is to block or alter a normal physiological process in our human (animal) bodies. This "blocking" effect may be more profound in some individuals than in others, and may generate unexpected consequences, and/or symptoms.

There is no fool-proof way to determine.... before taking a certain medication.... how you or I will "respond" to that medication. As indicated above, there is a wide array of potential allergies, adverse side-effects, and individual responses and "reactions" to every medication.

There is no universally "safe" medication. Therefore, the effect of a specific medication, on you personally, is simply not predictable.... until the medication is "tried" -- in your own body's innate and unique metabolic "system". Yes, even aspirin (as mentioned above) has a variety of potential "side-effects".... some very serious, in some patients. And, the same for Tylenol.... and for all the "anti-inflammatory" drugs, and "arthritis pills". And remember, also, the huge variety of appetite suppressants ("diet pills").... many of which are not only harmful, but also habituating.

To repeat.... there is no "test" that can be performed on you or me, in advance, to determine the safety and the effect of a specific medication. In an individual, the only way to ascertain the beneficial effect or the adverse side-effects of a medication, is by administering the medication, and then observing and monitoring the results. No one can predict an adverse or harmful effect of any medication.

The question arises: should all "prescription-drugs", and all "over-the-counter" medications be taken off the market, because of potential harmful effects, in a few people? No! But.... ALL of us human-animals, as patients, must weigh the potential benefit of any medication, versus the risk of an unforeseeable adverse side-effect.... in our own body.

As your physician, I desire very much to prescribe only those medications which I believe will be beneficial to you. However, since harmful "side-effects" may occur with any-and-all medications, the time has now arrived that all physicians must warn all patients, in advance, about potentially injurious results following the ingestion or injection of any medication. With this advanced warning, the responsibility for taking a suggested medication falls-back upon the decision and agreement of the patient himself/herself.

Therefore, when I suggest certain medications for you, I will leave it up to you to decide whether or not you choose to take those medications. I will supply you with information that is available to me concerning a certain medication. You must then consult other sources of information and advice; and then, you must decide whether or not you are willing to take a prescription that I have suggested.

I will ask that you sign a "release", indicating that I have warned you about potentially harmful effects of any medicine that I have suggested or recommended to you. I will not give you a prescription for any medication until you acknowledge, in writing, your awareness of the unpredictability of the effect of any medication, in your own particular body. With your acknowlegement of the potential adverse side-effects of any-and-all medications.... you are accepting the responsibility for taking the medication.... and, therefore, you are not setting the stage to "blame" your doctor.... or the drug manufacturer.... for an outcome that no one can foresee.

In this way, I will hope to protect myself from "legal" liability, and from the rampant "medical malpractice" suits that some lawyers have caused to become so widespread, and so threatening to honorable and talented doctors.... those physicians who really care about the proper treatment and well-being of their patients.

Always remember (repeating from above).... there is no medication that is "safe" in all patients. And.... there is no way to foretell whether an individual's metabolic system will.... or will not.... "tolerate" a certain medicine. A doctor, and his patients, must always be aware of the "risk/benefit" ratio in considering any particular drug for treatment of any specific ailment. If the "benefit" far outweighs the potential "risk".... then it would become logical and proper for a patient to agree to take a certain medication. Contrariwise, obviously, if the risks are great.... then the patient should logically consider all other options.

In today's medico-legal climate, it is now you, the patient, who must make the ultimate decision about whether or not to take a medication that has been recommended or prescribed for you. The responsibility belongs to you. Doctors do not ever "dictate" to their patients.... doctors only suggest and recommend therapy.... which the patient may accept, or refuse.

Signed..... Your Doctor.




Additional "prescriptions" and suggestions....
for doctors and patients to consider:


(1.) For those patients who are unwilling to sign a "statement-of-personal-responsibility" for obtaining and ingesting a certain medication, the patients should be informed, cordially, that it may be possible for them to locate another physician who will prescribe medications for them.... without a signed release. That is, another doctor may be willing to assume the responsibility, and blame, and "malpractice" suits.... for whatever unpredictable injurious results may develop after his patients have taken a medication prescribed by him.

This necessity of requiring patients to sign a "release" may seem harsh to the non-medical "public" .... but it is not as drastic as imposing-upon a competent and dedicated doctor a lengthy malpractice suit, blaming him for an absolutely unforeseeable adverse effect of a certain medication.... in a specific patient.

Patients should be reminded, by their doctors, that "over-the-counter" (OTC) medications.... those drugs which can be bought at any drugstore, without a prescription.... have just as many potential risks as most "prescription" drugs. But, in a "medico-legal" sense, the implications are very different. If a patient voluntarily "prescribes" a medication for himself, and purchases that medicine at the corner drugstore.... then that patient has assumed the personal responsibility for any adverse side-effects of that medication. Similarly, when a patient understands that all medications have potential risks, and when the patient agrees to accept responsibility for taking a medicine.... even a medication prescribed by his doctor.... then no one except the patient can be "held responsible" for an adverse effect. That is, the patient and his lawyer then have no one to sue for an adverse medicinal result.... and therefore the patient's doctor is not repeatedly threatened with "malpractice", every time a patient is harmed by a medication.

IF a patient says that he will not take responsibility for injury from a medication that is recommended by his doctor.... that is almost like telling the doctor that "If I get a bad effect from your prescription, it's your fault.... not the fault of my body's chemicals.... and therefore I will sue you." (The doctor should tell that patient to find a doctor who will not require the patient to accept responsibility for "negative" effects of a medicine.)

(2.) We now see countless advertisements on television, from various pharmaceutical organizations, and drug-manufacturers.... urging patients to ask their physicians for a prescription for such-and-such a medication. Invariably, a long list of potential adverse side-effects is mentioned in the advertisement (such as an "erection" that lasts longer than four hours). Then, without fail, the advertisement requires that the listener "check with your doctor". In other words, the ad says that if you develop any complication as a result of taking the advertised medication, "Blame your doctor. Sue him. Don't call us; call him.... and remember, we who marketed the medication warned you in advance.... therefore, we are blameless."

So, now, doctors must protect themselves, and must warn patients in advance, before prescribing any-and-every medication.... and the patient must acknowledge each warning.... in advance.... in writing.

Unfortunately, there are many attorneys, in today's litigious world, who make a handsome living.... just waiting to sue a blameless doctor whose patient has developed an unpredictable adverse effect (a so-called "mal-occurrence") after taking a prescribed medication. And, similarly, there are many hapless patients, who hope they can "catch" a doctor, or a drug manufacturer, in this malpractice trap.... so that patient-and-lawyer can reap an extravagant-but-unmerited "settlement".

(3.) Re-statement of a main point.... If a patient allows his personal physician to prescribe a medication for him, that patient must acknowledge (in writing) his understanding that no doctor can foresee how an individual's inborn metabolic system will respond to that medication.

(4.) Some potentially very beneficial medications are (necessarily) held off the pharmaceutical market, because of a rare adverse side-effect.... in a few patients. Since "medical science" currently has no way to detect, in advance, which patients will get an "atypical" effect from a certain medication.... these potentially very helpful medications are, unfortunately, never released for widespread use.

(5.) The beneficial effects.... or the "negative" effects.... of any medication must always be considered in light of the well-known "placebo" effect of any form of therapy. "Placebo".... from the Latin word, meaning "I shall please". It has been said that as much as 40% of the beneficial effect of any medication relates to this psychological "placebo" effect. That is, when a patient takes a medication, that patient "looks-for", and anticipates, the beneficial effect that has been reported or "advertised" for that medication.
The true effect of any medication must be measured against this placebo effect of that medication. That is one of the main reasons that laborious "trials" of all new medications are carried out.... to measure a true medicinal effect of a medicine, versus the placebo effect of a "dummy" pill (a "sugar-pill", or other medicinally inert chemical).
When the medication and the "dummy-pill" are taken by a large number of "volunteers".... some of the volunteers taking the "real medication", and some taking the "sugar-pill".... the results are then compared.... to determine if the "true" effect of the real medication was any more beneficial than the placebo effect of the dummy-pill?
Similarly, "negative" effects (headache, nausea, malaise) of a dummy-pill may be reported by a small number of volunteers. These, too, must be considered in evaluating the true effect of a real medication.




More to follow.... including a suggested "release" for patients to sign.