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Misprescribing and Overprescribing of Drugs

http://www.worstpills.org/public/page.cfm?op_id=3

 

- Seven all-too-often-deadly sins of prescribing

- Evidence of Misprescribing and Overprescribing

- The Causes of Misprescribing and Overprescribing

 

The numbers are staggering: in 2003, an estimated 3.4 billion prescriptions

were filled in retail drugstores and by mail order in the United States. That

averages out to 11.7 prescriptions filled for each of the 290 million people in

this country.1 But many people do not get any prescriptions filled in a given

year, so it is also important to find out how many prescriptions are filled

by those who fill one or more prescriptions. In a study based on data from

2000, more than twice as many prescriptions were filled for those 65 and older

(23.5 prescriptions per year) than for those younger than 65 (10.1 prescriptions

per year).2 Another way of looking at the high rate of prescriptions among

older people is the government finding that although Medicare beneficiaries

comprise only 14% of the community population, they account for more than 41% of

prescription medicine expenses.3

 

There is no dispute that for many people, prescriptions are beneficial, even

lifesaving in many instances. But hundreds of millions of these prescriptions

are wrong, either entirely unnecessary or unnecessarily dangerous.

Inappropriate prescribing is an academically gentle euphemism for prescriptions

for which

the risks outweigh the benefits, thus conferring a negative health impact on

the patient. A recent comprehensive review of studies of such inappropriate

prescribing in older patients found that 21.3% of community-dwelling patients 65

years or older were using at least one drug inappropriately prescribed. Much

more so than age, per se, the total number of drugs being prescribed was an

important predictor of inappropriate prescribing, as was female gender.4 Another

study found that, conservatively—using very narrow criteria for inappropriate

prescribing—elderly United States patients were prescribed at least one

inappropriate drug at an estimated 16.7 million visits to physician offices or

hospital outpatient departments in the year 2000.5 Examples of specific drugs

that

have been inappropriately prescribed, including studies involving younger

adults and children, are given later in this section.

 

At the very least, misprescribing wastes tens of billions of dollars, barely

affordable by many people who pay for their own prescriptions. But there are

much more serious consequences. As discussed in Adverse Drug Reactions

[ http://www.worstpills.org/public/page.cfm?op_id=4 ], more than 1.5 million

people are hospitalized and more than 100,000 die each year from largely

preventable adverse reactions to drugs that should not have been prescribed as

they

were in the first place.6 What follows is a summary of the seven

all-too-often-deadly sins of prescribing.

 

First:

The “disease†for which a drug is prescribed is actually an adverse reaction

to another drug, masquerading as a disease but unfortunately not recognized

by doctor and patient as such. Instead of lowering the dose of the offending

drug or replacing it with a safer alternative, the physician adds a second drug

to the regimen to “treat†the adverse drug reaction caused by the first

drug.

Examples discussed on this web site (see later in this section and in

Drug-Induced Diseases) include drug-induced parkinsonism, depression, sexual

dysfunction, insomnia, psychoses, constipation, and many other problems.

 

Second:

A drug is used to treat a problem that, although in some cases susceptible to

a pharmaceutical solution, should first be treated with commonsense lifestyle

changes. Problems such as insomnia and abdominal pain often have causes that

respond very well to nondrug treatment, and often the physician can uncover

these causes by taking a careful history. Other examples include medical

problems such as high blood pressure, mild adult-onset diabetes, obesity,

anxiety,

and situational depression. Doctors should recommend lifestyle changes as the

first approach for these conditions, rather than automatically reach for the

prescription pad.

 

Third:

The medical problem is both self-limited and completely unresponsive to

treatments such as antibiotics or does not merit treatment with certain drugs.

This

is seen most clearly with viral infections such as colds and bronchitis in

otherwise healthy children or adults.

 

Fourth:

A drug is the preferred treatment for the medical problem, but instead of the

safest, most effective—and often least expensive—treatment, the physician

prescribes one of the Do Not Use drugs listed on this web site or another, much

less preferable alternative. An example of a less preferable alternative would

be a drug to which the patient has a known allergy that the physician did not

ask about.

 

Fifth:

Two drugs interact. Each on its own may be safe and effective, but together

they can cause serious injury or death.

 

Sixth:

Two or more drugs in the same therapeutic category are used, the additional

one(s) not adding to the effectiveness of the first but clearly increasing the

risk to the patient. Sometimes the drugs come in a fixed combination pill,

sometimes as two different pills. Often heart drugs or mind-affecting drugs are

prescribed in this manner.

 

Seventh:

The right drug is prescribed, but the dose is dangerously high. This problem

is seen most often in older adults, who cannot metabolize or excrete drugs as

rapidly as younger people. This problem is also seen in small people who are

usually prescribed the same dose as that prescribed to people weighing two to

three times as much as they do. Thus, per pound, they are getting two to three

times as much medicine as the larger person.

 

Evidence of Misprescribing and Overprescribing

 

Here are some examples from recent studies by a growing number of medical

researchers documenting misprescribing and overprescribing of specific types of

drugs:

 

Treating Adverse Drug Reactions with More Drugs

 

Researchers at the University of Toronto and at Harvard have clearly

documented and articulated what they call the prescribing cascade. It begins

when an

adverse drug reaction is misinterpreted as a new medical condition. Another

drug is then prescribed, and the patient is placed at risk of developing

additional adverse effects relating to this potentially unnecessary treatment.7

To

prevent this prescribing cascade, doctors—and patients—should follow what we

call Rule 7 of the Ten Rules for Safer Drug Use (see Protecting Yourself and

Your

Family from Preventable Drug-induced Injury ): Assume that any new symptom

you develop after starting a new drug might be caused by the drug. If you have a

new symptom, report it to your doctor.

 

Some of the instances of the prescribing cascade that these and other

researchers have documented include:

 

• The increased use of anti-Parkinson’s drugs to treat drug-induced

parkinsonism caused by the heartburn drug metoclopramide7 (REGLAN) or by some of

the

older antipsychotic drugs.

 

• A sharply increased use of laxatives in people with decreased bowel

activity that has been caused by antihistamines such as diphenhydramine

(BENADRYL),

antidepressants such as amitriptyline (ELAVIL)—a Do Not Use drug—or some

antipsychotic drugs such as thioridazine (MELLARIL).8

 

• An increased use of antihypertensive drugs in people with high blood

pressure that was caused or increased by very high doses of nonsteroidal

anti-inflammatory drugs (NSAIDs), used as painkillers or for arthritis.9

 

Failing to Treat Certain Problems with Nondrug Treatments

 

Research has shown that many doctors are too quick to pull the prescription

trigger. In one study, in which doctors and nurse practitioners were presented

with part of a clinical scenario—as would occur when first seeing a patient

with a medical problem—and then encouraged to ask to find out more about the

source of the problem, 65% of doctors recommended that a patient complaining of

insomnia be treated with sleeping pills even though, had they asked more

questions about the patient, they would have found that the patient was not

exercising, was drinking coffee in the evening, and, although awakening at 4

a.m., was

actually getting seven hours of sleep by then.10

 

In a similar study, doctors were presented with a patient who complained of

abdominal pain and whose endoscopy showed diffuse irritation in the stomach.

Sixty-five percent of the doctors recommended treating the problem with a

drug—a

histamine antagonist (such as Zantac, Pepcid, or Tagamet). Had they asked

more questions they would have discovered that the patient was using aspirin,

drinking a lot of coffee, smoking cigarettes, and was under considerable

emotional stress—all potential contributing factors to abdominal pain and

stomach

irritation.

 

In summarizing the origin of this overprescribing problem, the authors

stated: “Apparently quite early in the formulation of the problem, the

conceptual

focus [of the doctor] appears to shift from broader questions like ‘What is

wrong with this patient?’or ‘What can I do to help?’ to the much narrower

concern, ‘Which prescription shall I write?’†They argued that this

approach was

supported by the “barrage†of promotional materials that only address drug

treatment, not the more sensible lifestyle changes to prevent the problem.11

 

In both of the above scenarios, nurse practitioners were much more likely

than doctors to take an adequate history that elicited the causes of the

problems

and, not surprisingly, were only one-third as likely as the doctors to decide

on a prescription as the remedy instead of suggesting changes in the patient’

s habits.

 

Throughout this web site, in the discussions about insomnia, high blood

pressure, situational depression, mild adult-onset diabetes, and other problems,

you will find out about the proven-effective nondrug remedies that should first

be pursued before yielding to the riskier pharmaceutical solutions.

 

Treating Viral Infections with Antibiotics or Treating Other Diseases with

Drugs That Are Not Effective for Those Problems

 

Two recently published studies, based on nationwide data from office visits

for children and adults, have decisively documented the expensive and dangerous

massive overprescribing of antibiotics for conditions that, because of their

viral origin, do not respond to these drugs. Forty-four percent of children

under 18 years old were given antibiotics for treatment of a cold and 75% for

treatment of bronchitis. Similarly, 51% of people 18 or older were treated with

antibiotics for colds and 66% for bronchitis. Despite the lack of evidence of

any benefit for most people from these treatments, more than 23 million

prescriptions a year were written for colds, bronchitis, and upper respiratory

infections. This accounted for approximately one-fifth of all prescriptions for

antibiotics written for children or adults.12, 13 An accompanying editorial

warned of “increased costs from unnecessary prescriptions, adverse drug

reactions,

and [subsequent] treatment failures in patients with antibiotic-resistant

infections†as the reasons to try to reduce this epidemic of unnecessary

antibiotic prescribing.14

 

Similar misprescribing of a drug useful and important for certain problems,

but not necessary or effective, and often dangerous, for other problems can be

seen in another recent study. In this case, 47% of the people admitted to a

nursing home who were taking digoxin, an important drug for treating an abnormal

heart rhythm called atrial fibrillation or for treating severe congestive

heart failure, did not have either of these medical problems and were thereby

being put at risk for life-threatening digitalis toxicity without the

possibility

of any benefit.15

 

A final example in this category involves the overuse of a certain of drugs,

in this case calcium channel blockers, which have not been established as

effective for treating people who have had a recent heart attack. The study

shows

that this prescribing pattern actually did indirect damage to patients because

their use was replacing the use of beta-blockers, drugs shown to be very

effective for reducing the subsequent risk of death or hospitalization following

a

heart attack. Use of a calcium channel blocker instead of a beta-blocker was

associated with a doubled risk of death, and beta-blocker recipients were

hospitalized 22% less often than nonrecipients.16

 

The Prescribing of More Dangerous and/or Less Effective Do Not Use Drugs

Instead of Safer Alternatives

 

There are 181 Do Not Use drugs listed in our book, Worst Pills, Best Pills

(available at https://www.citizen.org/wpbp ), for which we recommend safer

alternatives. Twenty-two of these Do Not Use drugs are for heart disease or high

blood pressure and make up 20% of all the drugs in the book for these problems.

Twenty-two of the Do Not Use drugs are for treating insomnia, anxiety,

depression, or other mental problems, and make up 43% of the drugs in the book

for

these problems. Another 22 of the Do Not Use drugs are for treating pain, and

make up 37% of the drugs in the book for these problems. Fifteen of the Do Not

Use drugs are for treating gastrointestinal problems and make up 31% of the

drugs in the book for these problems. Twenty-two of the Do Not Use drugs are for

treating coughs, colds, allergies, or asthma, and make up 47% of the drugs in

the book for these problems. Twenty of the Do Not Use drugs are for treating

infections and make up 31% of the drugs in the book for these problems.

Although the original determinations for these Do Not Use drugs were based on

their

use by older adults, we have concluded that the same warnings apply to use by

anyone.

 

Included in the book and on this web site are a number of drugs we label Do

Not Use Until Seven Years After Release. We have applied this warning to drugs

that have only recently appeared on the market, for which there is no evidence

of their superiority over older drugs about which we have much more

information as to long-term safety and effectiveness. Because of incomplete and

worrisome safety information, there is a risk that some of these newer drugs

will

have to be banned. But by the time they have been on the market for seven years,

it is much less likely that they will be banned, and it is much more likely

that, if they are still being used, there will be much better information about

their safety and effectiveness, such as a new black-box warning not present

when the drugs were first marketed.

 

Another category of drugs that is misprescribed even though there are safer

alternatives are drugs to which patients are known to be allergic, but about

which their physicians have not taken a careful medical history.

 

The Causes of Misprescribing and Overprescribing

 

The Drug Industry

 

The primary culprit in promoting the misprescribing and overprescribing of

drugs is the pharmaceutical industry, which now sells about $216 billion worth

of drugs in the United States alone.1 The industry uses loopholes in the law

not requiring proof of superiority over existing drugs for approval, and

otherwise intimidates the Food and Drug Administration (FDA) into approving

record

numbers of me-too drugs (drugs that offer no significant benefit over drugs

already on the market) that often have dangerous adverse effects. In addition,

the

industry spends well in excess of $21 billion a year to promote drugs17 using

advertising and promotional tricks that push at or through the envelope of

being false and misleading. This industry has been extremely successful in

distorting, in a profitable but dangerous way, the rational processes for

approving

and prescribing drugs. Two studies of the accuracy of ads for prescription

drugs widely circulated to doctors both concluded that a substantial proportion

of these ads contained information that was false or misleading and violated

FDA laws and regulations concerning advertising.18, 19

 

The fastest-growing segment of drug advertising is directed not at doctors

but at patients. It has been estimated that from 1991 to 2002 DTC

(direct-to-consumer) advertising expenditures in the United States grew from

about $60

million a year to $3 billion a year,17 an increase of 50-fold in just eleven

years,

employing misleading advertising campaigns similar to those used for doctors.

A study by Consumer Reports of 28 such ads found that “only half were judged

to convey important information on side effects in the main promotional text,â€

only 40% were “honest about efficacy and fairly described the benefits and

risks in the main text,†and 39% of the ads were considered “more harmful

than

helpful†by at least one reviewer.20 This campaign has been extremely

successful. According to a drug industry spokesman, “There’s a strong

correlation

between the amount of money pharmaceutical companies spend on DTC advertising

and

what drugs patients are most often requesting from physicians.†The

advertising “is definitely driving patients to the doctor’s office, and in

many cases,

leading patients to request the drugs by name.â€21 The problems with DTC

advertising are best summed up in an article written by a physician more than 15

years ago in the New England Journal of Medicine, before the current binge had

really begun: “If direct [to consumer] advertising should prevail, the use of

prescription medication would be warped by misleading commercials and

hucksterism. The choice of a patient’s medication, even of his or her

physician, could

then come to depend more on the attractiveness of a full-page spread or

prime-time commercial than on medical merit...such advertising would serve only

the

ad-makers and the media, and might well harm our patients.â€22

 

The Food and Drug Administration (FDA)

 

Attempting to fend off FDA-weakening legislation even worse than that which

was signed into law in 1997, the FDA has bent over backwards to approve more

drugs, culminating in 1996 and 1997 when the agency approved a larger number

than had ever been approved in any two-year period. Thousands of people were

injured or killed after taking one of three such recently approved drugs (which

have subsequently been recalled from the market). These drugs were the

weight-loss drug dexfenfluramine (REDUX), the heart drug mibefradil (POSICOR),

and the

painkiller bromfenac (DURACT). Other drugs that would not have gotten approved

in a more cautious era at the FDA have also been approved, but are likely

either to be banned or to be forced to carry severe warnings that will

substantially reduce their use. Many of these are included on this web site and

listed

as Do Not Use drugs.

 

In the more than 30 years since the Public Citizen’s Health Research Group

started monitoring the FDA and the drug industry, the current pro-industry

attitude at the FDA is as bad and dangerous as it has ever been. In addition to

record numbers of approvals of questionable drugs, FDA enforcement over

advertising has all but disappeared. From a peak number of 157 enforcement

actions to

stop illegal prescription drug ads that understate risks and/or overstate

benefits in 1998, the number has decreased to only 24—an 85% decrease—in

2003.23

There is no evidence that the accuracy or legality of these ads has increased

during this interval, and the amount of such advertising has clearly increased.

The division at FDA responsible for policing prescription drug advertising

has never been given adequate resources to keep up with the torrent of newly

approved drugs. More recently, however, it has also been thwarted by marching

orders from higher up in the agency to, effectively, go easy on prescription

drug

advertising. As a result, the drug industry correctly believes it can get

away with more violative advertising than in the past. The role of the United

States Congress in pushing the FDA into approving more drugs, and passing, with

the FDA’s reluctant approval, legislation to further weaken the FDA’s

ability

to protect the public, cannot be overlooked.

 

Physicians

 

The well-financed promotional campaigns by drug companies would not have as

much of an impact as they do were there not such an educational vacuum about

proper prescribing of drugs, a serious problem that must be laid at the feet of

medical school and residency training. The varieties of overprescribing and

misprescribing of drugs by doctors—the seven all-too-often-deadly sins of

prescribing referred to above—are all strongly enhanced by the mind-altering

properties of drug promotion. The best doctors, of whom there are many, do not

waste

their time talking to drug sales people, toss promotional materials away, and

ignore drug ads in medical journals. Too many other doctors, however, are

heavily influenced by drug companies, accepting free meals, free drinks, and

free

medical books in exchange for letting the drug companies “educate†them at

symposia in which the virtues of certain drugs are extolled. Unfortunately, many

of these doctors are too arrogant to realize that there is no such thing as a

free lunch. The majority of doctors attending such functions have been found

to increase their prescriptions for the targeted drugs following attendance at

the “teach-in.â€24

 

Beyond traditional advertising and promotion and their influence, bias of

drug-company-sponsored research, as published in medical journals, also can sway

doctors toward more favorable impressions about drugs. An analysis was done of

56 trials that were paid for by drug companies and reported in 52 medical

journals about drugs for arthritis and pain—NSAIDs. (These

drug-company-sponsored

studies represented 85% of those that the researchers originally looked at.)

In studies identifying the company’s drug as less toxic than another drug, in

barely one-half of the studies was there justification for the finding of less

toxicity. This certainly explains why, contrary to fact, newer arthritis

drugs almost always “seem†safer than older, usually much less expensive

ones.25

 

A final example demonstrates the ignorance of many physicians, especially in

dealing with prescribing drugs to older adults. A study of physicians who

treat Medicare patients found that 70% of the doctors who took an examination

concerning their knowledge of prescribing for older adults failed to pass the

test. The majority of physicians who were contacted for participation in the

study

refused to take the test, often giving as their reason that they had a “lack

of interest in the subject.†The authors concluded “many of these physicians

[who failed the exam] had...not made good use of the best information on

prescribing for the elderly.â€26

 

Pharmacists

 

A small fraction of pharmacists have, in our view, betrayed their

professional ethics and are working for drug companies, engaging in such

activities as

calling doctors to get them to switch patients from drugs made by a company

other than the one the pharmacist works for to the pharmacist’s employer’s

drugs.

In addition, pharmacy organizations such as the American Pharmaceutical

Association and others have fought hard to prevent the FDA from requiring

accurate

patient package information to be dispensed with each prescription filled.

 

Too many pharmacists, despite having computers to aid them, have been willing

to fill prescriptions for pairs of drugs that, because of life-threatening

adverse drug interactions if used at the same time, should never be dispensed to

the same person.

 

• Sixteen (32%) of 50 pharmacies in Washington, D.C., filled prescriptions

for erythromycin and the now-banned terfenadine (SELDANE) without comment.27

These two drugs, if used in combination, can cause fatal heart arrhythmias.

 

• In another study, of 245 pharmacists in seven cities, about one-third of

pharmacists did not alert consumers to the potentially fatal and widely

publicized interaction between Hismanal, a commonly used but now banned

antihistamine,

and Nizoral, an often-prescribed antifungal drug. Only 4 out of 17

pharmacists warned of the interaction between oral contraceptives and Rimactane,

an

antibiotic that could decrease the effectiveness of the oral contraceptive. Only

3

out of 61 pharmacists issued any verbal warnings about the interaction

between Vasotec and Dyazide—two drugs for treating hypertension—which may

lead to

dangerously high levels of potassium in the blood.28

 

• In yet another study, concurrent use of terfenadine (SELDANE) and

contraindicated drugs declined over time. The rate of same-day dispensing

declined by

84%, from an average of 2.5 per 100 persons receiving terfenadine in 1990 to

0.4 per 100 persons during the first six months of 1994, while the rate of

overlapping use declined by 57% (from 5.4 to 2.3 per 100 persons). Most cases

involved erythromycin. Despite substantial declines following reports of serious

drug-drug interactions and changes in product labeling, concurrent use of

terfenadine and contraindicated antibiotics such as erythromycin and

clarithromycin

(BIAXIN) and antifungals such as ketoconazole (NIZORAL) continued to occur.29

 

Patients

 

For too many patients, the system is stacked against you—drug companies,

doctors, and pharmacists are too often making decisions that ultimately derive

from what is best for the drug companies, doctors, and pharmacists, and not

necessarily from what is best for you. This web site has been researched and

written to help you come out ahead in the struggle with our health care

industry.

 

In the sections on Adverse Drug Reactions and Drug-Induced Diseases, you can

learn which common medical problems—depression, insomnia, sexual disorders,

parkinsonism, falls and hip fractures, constipation, and many others—can

actually be caused by drugs. Once you recognize these problems, you will be

enabled

to better take care of yourself and your family, and bring such problems to an

end by discussing safer alternatives with your physician.

 

On this web site, we list the drugs we and our consultants think you should

not use. For each of these, we recommend safer alternatives. Each drug profile

lists drug combinations that should not be used because of serious

interactions.

 

In Protecting Yourself and Your Family from Preventable Drug-induced Injury,

we present a detailed strategy, beyond information on specific adverse effects

and drugs, to help you to use drugs more safely, including Ten Rules for

Safer Drug Use and how to use and maintain your own Drug Worksheet for Patient,

Family, Doctor, and Pharmacist. This is your personalized plan for avoiding

becoming a victim of overprescribing or misprescribing.

 

Finally, in Saving Money When Buying Prescription Drugs, we discuss the

latest information about generic drugs and show you how and why you can and

should

save hundreds of dollars a year or more. In short, this web site is intended

to help you and your family to improve your health by using drugs, if

necessary, more carefully and recognizing those you should avoid.

 

-

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