Which Two of the Following Are Benefits of Consumer Programs

Which Two of the Following Are Benefits of Consumer Programs.

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  • five.36(10); 2011 Oct
  • PMC3278148

Introduction

Direct-to-consumer pharmaceutical advertizement (DTCPA) has grown rapidly during the by several decades and is at present the most prominent type of health advice that the public encounters.1

iii
The FDA regulates DTCPA, but critics say that the rules are likewise relaxed and inadequately enforced.4

6
Although simply limited data exist, research suggests that DTCPA is both beneficial and detrimental to the public health.4
,
6
,
7
The number of arguments that favor or oppose DTCPA is fairly evenly balanced, and viewpoints presented by both sides tin be supported with evidence.8
Although there have been calls to ban or severely curtail consumer drug ad, remedies to maximize the benefits and minimize the risks of DTCPA are more than frequently suggested.7
,
9

What Is Directly-to-Consumer Drug Advertising?

DTCPA can be defined every bit an effort (usually via popular media) made past a pharmaceutical company to promote its prescription products straight to patients.4
The U.S. and New Zealand are the only countries that let DTCPA that includes production claims.4
Virtually other countries don’t allow DTCPA at all; withal, Canada does allow ads that mention either the production or the indication, but not both.ten
,
11
The pharmaceutical industry and lobby groups take tried unsuccessfully to overturn bans confronting DTCPA in Canada and other countries or regions, such as in the European union (EU).12
,
13
Notably, in 2008, 22 of the 27 EU member states voted against proposed legislation that would take allowed fifty-fifty express “information to patients” to be provided.thirteen

Types of Advertisements

There are currently several types of DTC drug advertisements (Table i).5
,
11
One type is the “help-seeking advertizement,” which provides only information near a medical condition and encourages patients to contact their md but doesn’t mention a production.5
,
11
Another category is the “reminder advertizement,” which includes the product name; this blazon may provide information about strength, dosage form, or price, but it doesn’t mention the indication or make any claims.5
,
11
The third and most common type is the “product claim advert,” which mentions the product and its indication and includes efficacy or safety claims.iv
,
v
Each category of ads is bailiwick to different FDA regulatory restrictions (run into
Table 1).fourteen


Tabular array 1

Types of Direct-to-Consumer Drug Advertisements and FDA Regulatory Requirements

Blazon of Ad Requirement

Product claim advertisement:

Names a drug and the indication(s); makes claims regarding safety and efficacy
Product claims are fabricated, and then “fair balance” does utilize and risks are required to exist included in a “brief summary.”
or
(for broadcast ads only)
Risks must be included in “major statement,” and “adequate provision” for admission to a “brief summary” is required.

Reminder ad:

Names a drug, dosage grade, and perchance cost, but not its uses
No product claims are made, and so “fair balance” doesn’t apply and mention of risks in “brief summary,” “major statement,” or “adequate provision” is not required. However, the FDA does not let this type of ad for drugs with serious risks (i.east., a boxed warning).

Assist-seeking ad:

Describes a disease or condition but doesn’t mention a specific drug that treats information technology
No product is mentioned, nor are whatsoever claims fabricated, so “fair balance” doesn’t apply; inclusion of risks in “brief summary,” “major argument,” or “adequate provision” is not required.

Media That Distribute Directly-to-Consumer Drug Ads

Channels used to distribute DTCPA most unremarkably include television, print (magazines, newspapers), radio, the Internet, and other forms of mass media (billboards and direct mailings).four
,
5
Promotional brochures that are supplied to health care professionals to distribute to patients tin also be considered DTCPA, even though they aren’t provided direct to the consumer by the manufacturer.iv

Many marketers are besides beginning to recognize the enormous potential of online DTCPA, which reaches millions of potential consumers globally.xv
,
16
Though the vast majority of DTCPA budgets are even so allocated to traditional media (goggle box, newspaper, mag, radio), marketers are commencement to shift some of their promotional spending to digital promotion, such equally product Spider web sites, online display advertising, search engine marketing, social media campaigns, and mobile advertising.fifteen
,
16

History and Regulation Of Direct-to-Consumer Drug Advertising

The FDA’south Division of Drug Marketing, Advert, and Communications (DDMAC) is responsible for the regulation of DTCPA.five
The FDA was given the authority to approve pharmaceutical products for marketing in the U.S. as a issue of the Federal Food, Drug, and Cosmetic Act, passed in 1938.17
In 1962, Congress specifically granted the FDA statutory authority to regulate prescription drug labeling and advertising.17
In 1969, the bureau issued final regulations for prescription drug advertising, which stipulated that these ads must (1) not exist false or misleading, (2) present a “fair balance” of data describing both the risks and benefits of a drug, (3) include facts that are “material” to the production’s advertised uses, and (4) include a “cursory summary” that mentions every gamble described in the production’s labeling.17
During the 1980s, the political climate in the U.Due south. became more favorable to the pharmaceutical manufacture.four
In improver, a cultural shift occurred that caused patients to commencement actively participating in medical controlling with their health care providers.18
,
19
In response to both of these changes, an increase in DTCPA occurred.19
,
20
In 1981, Merck ran the showtime straight-to-consumer (DTC) print advertisement for its new antipneumococcal vaccine, Pneumovax(pneumococcal vaccine polyvalent) in
Reader’due south Digest.2
,
4
Shortly afterward, Boots Pharmaceuticals ran the first DTC circulate advert, which promoted the lower price of its prescription brand of ibuprofen (Rufen), compared with Motrin (McNeil Consumer), in 1983.2

With this introduction of DTCPA, the FDA had to consider new questions nearly how consumer drug advertising should be regulated. In 1983, FDA Commissioner Arthur Hayes asked the pharmaceutical industry to observe a voluntary moratorium while the agency studied the issue.2
,
20
In 1985, the FDA published a notice in the
Federal Register
challenge regulatory jurisdiction over DTCPA and stating that prior standards of “fair balance” and “cursory summary” that had been established for advertising to health intendance providers were sufficient to protect American consumers against deceptive or misleading claims.2
,
4

This ruling triggered an onslaught of widespread print, but not circulate, DTCPA.four
The need to include complete information almost risks from the bundle insert to satisfy the “fair remainder” and “brief summary” regulatory requirements could be satisfied with minor type in a product claim print advertising.4
However, the toll of purchasing enough time to include this data in product claim circulate ads was prohibitive.two
Therefore, the only types of DTCPA that pharmaceutical companies circulate on the radio and tv set were reminder, or help-seeking, ads, which do not make product claims, and so “fair balance” doesn’t apply and a brief summary doesn’t need to exist included (encounter
Table 1).4
,
5

In 1995, the FDA held a hearing to discuss easing circulate DTCPA regulations in recognition of the prohibitive time and expense that the rules then required.ii
In 1997, the FDA issued draft guidance on this topic (and final regulations in 1999) that allowed broadcast DTC product claim ads to include a “major argument” and “adequate provision” to satisfy the “fair balance” requirement, rather than the lengthier “brief summary,” which listed all product risks.2
,
four
Now, advertisers had to include only “major risks” and provide an “acceptable provision” that would direct viewers elsewhere to access consummate “cursory summary” data (from a toll-free number, a health intendance provider, a Web site, or a print ad).4

In 2004, the FDA further relaxed regulations concerning DTCPA, eliminating the need to reprint complete prescribing information in print production claim ads and allowing the inclusion of a “simplified brief summary” instead.20
,
21
This alter allowed pharmaceutical companies to nowadays information on only the “major risks” and in simplified linguistic communication that would be easier for the average consumer to sympathise.4
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xx
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21

Rapid Growth of Direct-to-Consumer Ads After FDA Regulations Were Relaxed

Many believe that the relaxation of the rules for DTC circulate advertizing in 1997 was responsible for the deluge of DTCPA that we experience today; still, in that location is evidence that this tendency began much before.2
,
four
For case, in 1980, full spending on DTCPA was $12 1000000; in 1990, it was $47 million; and in 1995, it was $340 one thousand thousand, representing a almost iii,000% increment in expenditures during a fifteen-year period before broadcast ad regulations had fifty-fifty been relaxed.2
In 1997, after the FDA issued revised typhoon guidelines for broadcast DTCPA, the budgets for consumer drug advertising more than tripled to $1.2 billion in 1998 (Figure 1).three
Spending on DTCPA almost quadrupled again during the following decade, topping $5 billion in 2006 and 2007, before dropping to $iv.5 billion in 2009.ii
,
iii
In 2008, spending decreased because of the fiscal crisis and subsequent economical slowdown—this was the first substantial reduction in DTCPA since the belatedly 1990s.22


An external file that holds a picture, illustration, etc.
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Direct-to-consumer (DTC) advertising, 1998–2009. November 14, 2008. (Graph prepared by Pharma Marketing News.3)

Prior to 2005, the Government Accountability Office (GAO) had estimated that DTCPA was growing at approximately twenty% per year, or twice as fast every bit spending on pharmaceutical straight-to-physician (DTP) advertising or on drug inquiry and evolution.23
The growth in DTC ad expenditures was not without reason, beingness that it was estimated that every dollar spent on DTCPA would increase sales of the advertised drug by an estimated $2.xx to $four.twenty.24

26
Withal, in 2005, DTCPA accounted for simply fourteen% of industry expenditures, whereas DTP advertising totaled 24%.half-dozen
,
26

Although the relaxation of FDA rules in 1997 might non have been totally responsible for the rapid growth of DTC drug advert, information technology did have an impact on the most preferred media for DTCPA.xv
,
17
Near of the budget for DTCPA is now spent on tv set commercials.26
,
27
The average American television viewer watches equally many as ix drug ads a twenty-four hour period, totaling 16 hours per yr, which far exceeds the corporeality of time the average individual spends with a primary intendance physician.5
,
23
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27

In recent years, drug marketers have too increased their expenditures for marketing efforts on the Cyberspace, every bit searching for health-related information has become the third most common activeness for online users.22
,
26
In 2003, the pharmaceutical manufacture spent $59 one thousand thousand on DTC promotion on the Internet, and spending is now estimated to have grown to $1 billion.15
,
26
This channel of promotion also promises to be lucrative; information show a five:i render on investment for online DTCPA, which is much meliorate targeted than print or television ads in reaching the intended audience.22

The boilerplate American Tv set viewer watches as many every bit 9 drug ads a day, totaling 16 hours per twelvemonth, which far exceeds the amount of time the average private spends with a principal care physician.

Difficulty Enforcing FDA Regulations

The FDA has the potency to enforce regulations and take action confronting companies that do non abide by DTCPA rules.4
,
5
Nonetheless, the FDA’s capacity to enforce drug advertizement regulations seems to have essentially. weakened.6
In recent years, the number of regulatory deportment taken by the FDA confronting DTCPA violations has fallen off dramatically, which could reflect ameliorate manufacture compliance but could also be a result of a decline in FDA oversight.6

Several factors may be responsible for the apparent weakening of the FDA oversight of DTCPA. In 2002, the Secretarial assistant of Health and Human Services (HHS) began requiring that all draft regulatory warning letters be reviewed and approved by the FDA’south Office of Main Counsel before they are issued.half dozen
A GAO report noted that this required legal review seems to take resulted in a reduced number of alarm letters to exist issued as well as in delays that frequently caused them to be sent long after an advertising campaign concluded.vi
This conclusion was based on the fact that more than twice the number of regulatory letters (68 vs. 28) were sent past the FDA in 2001, compared with 2002, the year the legal review requirement was implemented (Effigy 2).6
This refuse in regulatory letters has continued, since in 2006, the FDA issued just 21 citations, in dissimilarity to 142 that were sent in 1997.6
,
24
Interestingly, during the aforementioned time period, the proportion of regulatory letters citing problems with DTCPA increased from xv.five% to 33.3%.six


An external file that holds a picture, illustration, etc.
Object name is f2-PTJ3610669.jpg

Trends in FDA enforcement of direct-to-consumer drug advertising regulations, 1997–2006. (Data from the FDA’s Sectionalization of Drug Marketing, Advertising, and Communications.)

Difficulties are likewise encountered because the number of FDA staff members dedicated to reviewing drug ads has remained relatively abiding.6
In 2009, only 59 total-fourth dimension employees were reportedly responsible for reviewing 71,759 industry submissions of both DTCPA and DTP promotional material, and they could cope with only a fraction of them.28
With respect to DTCPA, in September 2006, fewer than one-half a dozen people were assigned to review more than 15,000 DTC advertisements and brochures.20
In 2008, only 35% of broadcast DTCPA materials had been reviewed as a result of staff shortages.20

This difficulty of keeping upwardly with pharmaceutical advertising review, including DTCPA, seems to exist due to the disproportionately depression funding of the FDA, in comparing to the pharmaceutical industry’s expenditures on advertising.24
In 2010, the industry’s budget for DTCPA alone was reportedly nearly twice the entire budget for the FDA.2

Demand for Regulations Regarding Online Direct-to-Consumer Ads

The FDA has not yet issued formal guidelines regarding online DTCPA.15
,
28
However, in April 2009, the FDA did send warning letters to more than a dozen pharmaceutical manufacturers regarding company-sponsored search engine links that failed to mention production risks.1
The ads typically independent the product name, the disease or condition it treats, the potential benefits, and a link to a product’south Web site.ane
The FDA stated that because the links mentioned the product name and its employ (and sometimes fifty-fifty other product claims), risk information also had to be provided.12
In response, drug company–sponsored links now include the indication
or
the proper noun of the drug—but not both.28

In the absence of formal guidelines regarding online media, drug companies have asked the FDA for guidance about what is acceptable, particularly in the context of social media. In response, in November 2009, an FDA hearing on online drug marketing was held, during which pharmaceutical companies argued in favor of assuasive the use of infinite-limited online media for DTCPA.1
Many companies too requested that the FDA rule on whether companies or their surrogates could directly collaborate with patients or physicians via online conversation rooms or social media Web sites.ane
Participants at the hearing also debated whether companies were responsible for identifying reports of adverse reactions made online past individuals as well as the need for transparency regarding company-sponsored content.1

Calls for Banning Straight-to-Consumer Drug Ads

There have periodically been calls for the FDA to severely curtail or ban DTCPA.9
Yet, free oral communication arguments regarding the right of a manufacturer to market place its products, for the most part, foreclose this.5
In a serial of cases dating back to the 1970s, the courts had ruled that product advertisements were a form of “commercial oral communication.”9
Banning or restricting commercial advertisement therefore violates the First Subpoena protections of freedom of speech.nine
By 1980, the Court had developed a set of criteria, the Primal Hudson test, which is nevertheless used today for determining whether a ban on commercial speech is permissible.9
This exam examines whether the advertising is misleading, whether banning it directly advances a substantial authorities interest (e.yard., preserving public health), and whether the government’southward involvement could be accomplished through a less restrictive route, such as by adding a special characterization.nine
Some scholars object to this test, but still, the Court has repeatedly referred to information technology when overruling prohibitions on the ad of alcohol, tobacco, and medications.9
Legal scholars therefore believe that the courts would overturn a complete ban on DTCPA on the ground that it is unconstitutional.9
,
eighteen
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29

However, some experts suggest that increased regulation of DTCPA, rather than a ban, could satisfy the Central Hudson test and survive ramble scrutiny.12
Other measures have also been proposed, such as the Say No To Drug Ads Act, beginning introduced by Representative Jerrold Nadler (D-Due north.Y.) in 2002, and reintroduced most recently in February 2011.five
,
30
This Act would amend the Internal Revenue Code to prevent drug manufacturers from claiming the cost of DTCPA as a tax deduction.5
Other representatives have introduced or supported legislation similar to Mr. Nadler’s.5

Arguments in Support of Direct-to-Consumer Drug Ads

Although one might retrieve that positions against DTCPA would predominate, the debate is really quite balanced. Opinions and information in support of DTCPA are every bit follows. DTCPA:

Informs, educates, and empowers patients.
Proponents claim that DTCPA educates patients and allows them to accept charge of their wellness.5
In the U.S., it is thought that informing consumers volition benefit the bulldoze for wellness intendance reform.nineteen
Consumers can also benefit from having access to multiple information sources about drugs and other treatment options rather than relying solely on wellness intendance providers.19

The Internet, including online DTC ads, has go an increasingly popular source of medical information for consumers. The results of a 2005 study of more than 6,000 adults indicated that although the doc was withal the nearly trusted source of information, 48.6% of the subjects went online first then consulted their physician, whereas simply x.9% talked to their physician commencement.31
Online DTCPA or other pharmaceutical company–sponsored Spider web sites can also exist used to inform patients by communicating safety risks and public wellness data, public and individual health warnings about topics such as online drug purchasing, and adverse reactions.15

Encourages patients to contact a clinician.
A common claim is that DTCPA prompts patients to consult a wellness intendance provider to seek medical communication.17
A 2004 FDA consumer survey institute that exposure to DTCPA prompted 27% of Americans to make an date with their doctor to talk about a condition they had non previously discussed.32
Another study found that the small-scale print in a drug advertising was strongly associated with patients contacting their health intendance providers.17
The event of DTCPA in increasing patient contact with wellness care providers could also exist benign by promoting dialogue about lifestyle changes that meliorate patients’ health, whether or not a drug is prescribed.17

Promotes patient dialogue with health care providers.
Almost health care professionals seem to agree that DTCPA is beneficial considering it promotes dialogue with patients.32
In the 2004 FDA survey, 53% of physicians said DTCPA led to meliorate discussion with patients and 73% believed that consumer drug advertising helped patients inquire more than thoughtful questions.32
In addition, in a survey of 221 American oncology nurse practitioners (ONPs), 63% of participants felt that DTCPA promoted dialogue with patients.4
DTCPA may besides benefit patients by promoting heightened sensation and detection of adverse reactions, which also may lead to a discussion with a health care provider.nineteen

Exposure to DTCPA prompted 27% of Americans to brand an appointment with their doctor to talk about a status they had non previously discussed.

There is show that dialogue inspired by DTCPA doesn’t always benefit the manufacturer of the advertised drug, because physicians exercise not usually prescribe a medication simply because information technology is requested by a patient.34
In a November 2006 report from the GAO, merely 2% to vii% of patients who requested a drug in response to DTCPA ultimately received a prescription for information technology.12
,
33
,
34
In another study, DTCPA increased the likelihood that a patient would initiate a dialogue with a physician to request an advertised drug.35
However, in this study, doctors usually prescribed requested drugs but for patients who had been advised by other wellness care providers, such as pharmacists and other physicians, not by the mass media.35

Information also prove that patients who discuss a prescription medication with their doctor after seeing DTCPA oft receive a dissimilar recommendation or treatment.31
Co-ordinate to a 2006 survey conducted past
Prevention Magazine, of the patients who had a discussion with their doctors later seeing DTCPA, 77% reported that their doctors suggested health and lifestyle changes instead; 55% said they were prescribed a generic prescription; and 51% said their doctor suggested nonprescription treatments, such every bit over-the-counter medicines.31

Strengthens a patient’southward human relationship with a clinician.
Studies generally concur that participation of an informed patient in clinical decision-making benefits the patient–clinician relationship.19
Ane enquiry study of print DTCPA suggested that DTC ads reinforced the patient–clinician relationship: 83% of the ads focused on physician–patient communication, 76% explicitly promoted dialogue with health care providers, and 54% clearly placed the md in command.31
Some other written report showed that the minor impress in DTCPA encouraged patients to seek the communication of their doctor, whom they described equally their well-nigh preferred and trusted source of information.fifteen

Encourages patient compliance.
The information consistently show that minor, only statistically significant, improvements in adherence occur amongst patients exposed to DTCPA.one
This increased compliance is believed to be due to drug ads serving equally a reminder nearly a patient’due south medical conditions and prescriptions.18
DTCPA is also thought to reinforce physician recommendations and brand patients more probable to follow treatment instructions.vii

The beneficial effect of DTCPA on patient adherence has been detected in several enquiry studies.31
In the 2004 FDA study, 33% of physicians reported that DTCPA increased patient adherence.32
In another written report by Harvard University/Massachusetts General Hospital and Harris Interactive, 46% of physicians said that they felt DTCPA increased patient compliance.31
In addition, a study utilizing the Rx Remedy database (which follows drug utilization by 25,000 monthly diary panel participants) found that patients who requested a prescription afterward seeing DTCPA were the nigh compliant of any group tested.31

Reduces underdiagnosis and undertreatment of conditions.
DTCPA has been credited with decreasing the under-diagnosis and undertreatment of medical conditions.18
Drug ads enhance patient perceptions about weather that could exist medically treatable and encourage dialogue with health care providers.18
The 2004 FDA survey also establish that DTCPA improved the underdiagnosis of illnesses, since 88% of patients who had inquired about a medication in response to a drug ad had a condition that the drug treated.32
The 2003 Harvard University/Massachusetts General Hospital/Harris Interactive study also found that 25% of patients who visited their doctor subsequently seeing DTCPA received a new diagnosis; of these, 43% were considered to have a high-priority wellness status.31
DTCPA has also been shown to increase class-wide (rather than product-specific) sales, thereby helping to meliorate the underuse of drugs that might not be promoted merely are available to treat chronic weather condition.half-dozen

Epoetin alpha (Procrit, Ortho Biotech) provides an interesting example of how DTCPA can accept a positive affect on the underdiagnosis and undertreatment of a status.4
Procrit is used to treat anemia by stimulating the production of hemoglobin-containing reddish blood cells, which tin counteract fatigue.4
This drug was rarely prescribed before a DTC advertisement campaign was conducted, partly considering chemotherapy patients were not telling their doctors that they were fatigued.4
The ads for Procrit suggested that chemotherapy patients who were experiencing fatigue should talk over possible treatments with their physicians.4
This DTC advertizing entrada spurred patient sensation and dialogue with their health intendance providers virtually chemotherapy-associated fatigue.4
This led to a dramatic increase in the use of Procrit to treat anemic chemotherapy patients.4

Patients who requested a prescription subsequently seeing DTCPA were the most compliant of any group tested.

Removes the stigma associated with sure diseases.
Consumer drug advertising for wellness bug that could be embarrassing to a patient, such as depression or erectile dysfunction (ED), can reduce the stigma associated with these conditions.v
For example, an advertising campaign for finasteride (Proscar, Merck), a handling for benign prostatic hyperplasia, is widely regarded as having successfully raised awareness of a medical status that men had been reluctant to discuss with their doctors.31
A poll of people who called a toll-free number in response to a 1997 DTC campaign for a genital herpes treatment was also conducted.five
The poll revealed that 45% of callers had been prompted to make an appointment to discuss the trouble with a doctor within 3 months after seeing an ad.five

Encourages product competition and lower prices.
DTCPA is often assumed to be a major driver of rising pharmaceutical costs; nevertheless, economic theory and prove propose that pharmaceutical prices are instead largely influenced by consumer, physician, and payer perceptions of product value rather than advertising costs.vi
,
36
Consumer drug ads may spur manufacturer price increases because of need, but the evidence for this is mixed.6

Supporters of DTCPA also claim that drug advertisements stimulate increased competition, which leads to lower prescription drug prices.5
,
25
They argue that DTCPA as well encourages early pharmacological management, resulting in cost-savings from avoiding more expensive surgical interventions.xiii
Unfortunately, these claims are not verifiable, because data bachelor regarding the effect of DTCPA on drug costs are express.13

Arguments Opposing Directly-to-Consumer Ads

Critics too commonly vox arguments against DTCPA. Opinions and data opposing DTCPA are equally follows. DTCPA:

Misinforms patients.
Although DTC advertising may brainwash patients, it also has the ability to misinform them.4
A common complaint is that DTCPA omits important information.7
,
27
For case, in one report, 82% of DTCPA ads fabricated some factual claims and rational arguments for employ of the advertised drug; however, only 26% of the ads described chance factors or causes of the condition, and but 25% mentioned prevalence.27
DTCPA also tends to suggest that health improvement comes from a medication, perhaps in combination with salubrious activities, but never from behavior modification alone.25

For example, one study establish that although 19% of DTC ads mentioned lifestyle changes equally an adjunct to medication, none mentioned them as an alternative to drug handling.27
Past promoting a drug as the solution to a health problem, these advertisements may lead viewers to believe that adopting healthy behaviors, such equally a good diet and exercise, are ineffective or unnecessary.25
Because DTCPA rarely focuses on public health letters about nutrition, practice, addictions, social bug, and other treatments, it can also cause people to falsely believe that they are well informed, reducing their motivation to search for more reliable data.7

Patients may also lack the skills needed to evaluate comprehensive medical information, even if it has been provided.4
This is because the content in DTCPA oft exceeds the 8th-grade reading level, which is typically recommended for information distributed to the general public.18
In addition, few lay-people have the avant-garde skills that are required to evaluate the psychology, logic, economics, and semiotics behind DTCPA.7

Consumers accept besides been found to place unwarranted trust in DTC ads.5
Ane survey of consumers found that 50% of respondents thought that the ads were approved by the authorities, 43% thought that a medication had to be completely safe for it to be advertised; and 22% thought that a drug known to accept serious side effects could not be advertised.5

Paradoxically, the inclusion of data about risks and adverse events in DTCPA may also promote an unnecessary fear of side effects.1
,
18
This concern has been expressed past physicians equally well every bit by proponents of DTCPA, who request farther deregulation. They say that the required take a chance warnings are so farthermost that they crusade consumers undue concern about drug safety and may cause noncompliance.1
,
eighteen
,
19

Overemphasizes drug benefits.
Opponents to DTCPA warn that ads for drugs overemphasize potential benefits.i
In support of this view, content analytic studies take found that most DTC ads emphasize drug benefits over risks.18
A 2007 report in the
Periodical of Health Advice
also found that the average DTC idiot box commercial devotes more time to benefits than to risks.25
Disciplinary action by the FDA during 1997 to 2006 also confirmed that this has been a mutual problem.six
During this time, nearly 84% of the regulatory letters for DTCPA cited ads for either minimizing risks (due east.g., omitting information nigh side effects) or exaggerating a drug’due south effectiveness (east.k., portraying the indication too broadly or making unsubstantiated claims of superiority over other drugs), or both.6

Physicians besides report that near patients who initiate a request for a new drug understand the benefits much better than they understand its risks.37
Studies have plant that when a claim presents a drug as being very efficacious, consumers practise non brand much try to process the balance of the information within the message.nineteen
Information about risks is likewise typically presented in often-ignored smaller print or as office of a big, undifferentiated cake of text or audio.37
In improver, ads frequently show a mismatch between visual imagery and exact messages when take chances information is presented.18
For example, a person may be seen enjoying a walk in a park while the narrator lists serious side effects.18
Enquiry has shown that when visual and verbal messages are discordant, visual messages tend to predominate, which tin upshot in insufficient processing of verbally presented risk information.eighteen

Current FDA regulations may contribute to this trouble past permitting a variety of approaches to gamble communication that may confuse consumers and reduce their agreement of drug-associated risks.37
DTCPA regulations allow advertisers to select the “major risks” to exist included, make up one’s mind the club in which adverse effects are presented, and decide whether to include quantitative data or results in comparing to those of a placebo group.37

FDA regulations also don’t address the apply of qualifying linguistic communication in DTCPA.37
Opponents mutter that information in DTC ads is often described in vague, qualitative terms that exaggerate the magnitude of drug benefits.18
Qualifying language with respect to side effects may therefore exist misleading and open up to multiple interpretations considering of the use of words such as “balmy,” “usually,” “brusque time,” “if,” and “may.”37
It has been found that statements that use qualifying language to communicate side effects actually contribute to the benefit, not the adventure, side of the “fair balance” equation, because they reduce the adventure potential that a patient perceives as being associated with a drug.37
Take a chance information is also often missing quantitative data regarding the incidence of adverse events, which studies have shown would assistance consumers in evaluating drug risks.37

Promotes new drugs before safety profiles are fully known.
New drugs have been associated with previously unknown serious agin events after they have been introduced to the marketplace and a substantial amount of employ has occurred.ix
This is particularly true for “first-in class” drugs.nine
Clinical trials required for FDA approval are typically non designed to detect rare adverse effects, and current methods of postmarketing surveillance often fail to connect adverse events that have a loftier rate of background prevalence with the use of a detail drug.6
Drugs that are expected to be “blockbuster” sellers are also about heavily promoted early in the production’due south life bike, which can present a public health hazard because the drug’s prophylactic profile is not fully known at that point.15

The prophylactic problems with rofecoxib (Vioxx, Merck) are perhaps the almost oft cited case regarding this issue.ix
Vioxx was among the most heavily promoted drugs in the U.S. from 1999 to 2004.9
During that fourth dimension, Merck spent over $100 meg per yr to build the drug into a blockbuster seller, with almanac sales of more than $1 billion in the U.S.9
Patients requesting Vioxx thought that they were advocating for themselves by request for a drug that they thought was better than its competitors, not knowing that it could lead to stroke or myocardial infarction.four
,
ix
On September 30, 2004, Merck voluntarily withdrew Vioxx from the marketplace.4
,
9

Other drugs that were heavily promoted to consumers have also been linked to safety advisories, FDA black-box warnings, and withdrawals from the market.15
,
18
These include benoxaprofen (Oraflex, Eli Lilly) for arthritis, troglitazone (Rezulin, Parke-Davis) for diabetes, cisapride (Propulsid, Janssen) for gastric reflux, ceriva statin (Baycol, Bayer) for high cholesterol, and tegaserod (Zelnorm, Novartis) for irritable bowel syndrome in women.fifteen
,
18

Manufactures disease and encourages drug over-utilization.
DTCPA has been criticized as contributing to the “medicalization” of natural weather, cosmetic bug, or trivial ailments, resulting in an overmedicated guild.5
,
12
,
25
For this reason, some commentators accept even referred to DTCPA every bit a threat to public wellness.5

I often-cited example is DTC ads for ED drugs, which seem to target men who may be experiencing normal variations in sexual performance.25
Studies testify that just 10% of American men feel a full disability to achieve an erection.v
Therefore, many requests for ED drugs seem to be for occasional problems, which may actually be “normal.”v
Similarly, DTC drug ads have also been criticized for redefining menopause equally a hormone-deficiency disease rather than a normal midlife experience.5
,
12

Opponents also complain that DTCPA exacerbates unhappiness about normal experiences and also creates heightened expectations of drug benefits.7
These effects can cause severe distress when a drug is unaffordable or when the response to a medication is disappointing.7
A survey of men who used sildenafil (Viagra, Pfizer) for ED found that DTCPA raised expectations and therefore had an agin effect on the morale of the patients for whom it didn’t work.7

Leads to inappropriate prescribing.
If a patient’s request for an advertised drug is clinically inappropriate and the health care provider is unable or unwilling to correct the patient’due south perception that information technology is a expert selection, this situation may atomic number 82 to unnecessary or harmful prescribing.18
An additional problem mentioned by critics is that patients may withhold data to fit a detail profile that they saw in DTC ads in an attempt to get the doctor to prescribe a drug they want but that might not be appropriate for them.5

Information regarding whether DTCPA leads to inappropriate prescribing take been mixed. Although studies take shown that only 2% to 7% of drug requests past patients are successful, one report reported that such requests were made during about 40% of md visits and were successful more than than half the time.12
,
34
,
35
Furthermore, more one-half of the physicians in this study said that they prescribed the drug in gild to accommodate the patient’s request.35
Similarly, 94% of ONPs (northward = 221) reported having had a patient request for an advertised drug, and twoscore% said they experienced one to five requests per week.4
Alarmingly, 74% of the ONPs said patients asked for an inappropriate drug, which 43% said they sometimes felt pressured to prescribe.four

A 2005 randomized clinical trial using “patient–actors” also reported interesting results.4
,
38
The participants (n = eighteen) were randomly assigned to one of six roles—a patient with major depression or an adjustment disorder who requested a brand-specific drug, a generic drug, or no medication.four
The report participants were assigned to make a full of 298 visits to the offices of chief intendance physicians (n = 152) over a one-twelvemonth period.four
After explaining that they had seen a television program well-nigh depression, the subjects requested paroxetine (Paxil, GlaxoSmithKline), a nonspecific antidepressant, or no medication.4
Results showed that prescribing rates for patients with depression were 53%, 76%, and 31%, respectively (P
< 0.001, for charge per unit differences).4
In contrast, for patients who said they had an adjustment disorder (which is unremarkably treated without medication), prescribing rates were 55%, 39%, and 10% (P
< 0.001), respectively.iv

These results propose that brand-specific requests were more powerful for a questionable, rather than “standard,” indication.iv
These findings as well demonstrate that patients who made either a general or brand-specific request for a prescription were much more than probable to receive it compared with those who didn’t.vii

Strains relationships with health intendance providers.
DTCPA is often criticized for its potential impact on the patient–clinician relationship.iv
Drug ads can accept an influence in diminishing a patient’s trust in their health care provider’s clinical decisions.5
,
39
Clinicians may also find themselves challenged with increased work and frustration when a patient questions their clinical authorisation with a piece of “evidence” obtained from an ad or Web site.4
,
nineteen

Ane study that surveyed primary care physicians (n = 1,080) and physician administration (n = 704) in Arizona listed several hypothetical patient scenarios.4
Clinician responses to the described scenarios showed that if patients asked a question inspired by DTCPA, clinicians were more probable to go bellyaching (P
= 0.03), compared with those who were asked a question inspired past the
Physicians’ Desk Reference.iv
Clinicians were likewise less likely to answer the patient’s questions (P
= 0.03) and to provide a prescription (P
< 0.001) for drugs seen in DTCPA.4
In a national survey, 39% of physicians and 30% of patients felt that DTCPA interfered with the physician–patient relationship.xviii

The negative impact that denying a prescription request can have on the therapeutic relationship has been well documented.18
More specifically, denial of a prescription asking has been shown to decrease patient satisfaction and increase doctor switching.xviii
In one study, nearly one-half of the patients reported feeling disappointed about not receiving a requested medication.18
One-quarter of the patients said they would endeavour to change their doc’s mind or go the drug elsewhere, and 15% said they were considering switching physicians.18
,
35

Wastes appointment time.
Supporters of DTCPA argue that doctors should act as learned intermediaries and should educate consumers about prescription drug indications, benefits, and alternatives.xviii
However, many physicians oppose DTCPA considering they feel it is difficult and time-consuming to have to convince patients that a requested drug is inappropriate.5
Data suggest that the average patient–doctor visit lasts between xvi and 21 minutes.18
If give-and-take of an inappropriate prescription request needs to occur, this leaves little time for a dr. to address other more important issues.18
Discussions about advertised drugs tin affect patient goals, divert time abroad from affliction screening or examinations, or pre-empt dialogue about healthy lifestyle changes or mental wellness bug.39
Many clinicians besides resent beingness put in the role of a gatekeeper for an advertised commodity rather than being able to focus strictly on evidence-based medicine.39

Is not rigorously regulated.
Some critics argue that FDA regulations apropos DTCPA are likewise relaxed.5
They complain that FDA rules don’t preclude DTCPA violations, because drug manufacturers are held liable only afterwards a violation has been identified.v
Because drug companies are non required to obtain clearance for DTCPA prior to broadcasting (“pre-clearance”), a misleading advertisement could complete its run by the time the DDMAC bug a letter.20
The FDA can request that a DTC ad be amended in response to a violation; however, critics say that this won’t brand consumers forget the misleading information they saw in the original ad.five
Fifty-fifty if pharmaceutical manufacturers voluntarily submitted more than DTC ads to the FDA for pre-clearance, the agency has stated that “electric current FDA resourcing for this piece of work would probably result in delayed reviews and discourage [manufacturers] from submitting the materials.”half-dozen

The lack of FDA regulations that mandate a DTCPA waiting flow for newly canonical drugs is also criticized.5
The pharmaceutical manufacturers merchandise group, Pharmaceutical Enquiry and Manufacturers of America (PhRMA), has issued suggested guidelines regarding submission of DTCPA to the FDA for clearance as well equally waiting periods for consumer ads for new drugs.5
However, these guidelines are criticized as existence highly discretionary, voluntary, and unenforceable.v

Increases costs.
Another common complaint is that manufacturers often use DTCPA to promote expensive “me-as well” or “copycat” drugs that might not offer any pregnant benefits over older and cheaper medications.5
,
25
For example, two heavily promoted diabetes treatments, rosiglitazone (Avandia, GlaxoSmithKline) and pioglitazone (Actos, Takeda), were found to be no more effective—or rubber—than older drugs, fifty-fifty though they were much more than expensive.25
In another study, older drugs for the treatment of schizophrenia were institute to be every bit effective and to cost as much as $600 per month less than olanzapine (Zyprexa, Eli Lilly), quetiapine (Seroquel, AstraZeneca), or risperidone (Risperdal, Janssen).25

Critics say that cost information that could benefit consumers is rarely included in DTCPA.xviii
They advise that, at a minimum, ads should note whether generic drugs that might be a less expensive culling are available.18
Patients too don’t know that they might not be able to obtain a new drug that they saw advertised, because it costs ten times more than than an older, every bit effective drug and is non on formulary.4
Some opponents also advise that DTCPA increases health care costs considering visits to the md prompted past a drug advert can exist a waste of fourth dimension and money.19

Industry analysts have suggested that increased drug sales resulting from DTCPA allow companies to spread fixed overhead expenditures over a greater number of units, making drugs more affordable for the population as a whole.36
However, studies accept found that long-term prescribing practices for several drugs (clopidogrel, mometasone, etanercept, and tegaserod) were not increased by DTCPA, and an increase in units sold doesn’t always upshot in cost declines.36

Suggested Remedies

Both supporters and opponents of DTCPA hold that even though it might not be possible to severely curtail or ban DTC ads, measures should at least be undertaken to maximize the benefits and minimize the risks of consumer drug advertisements.

Some measures that have been suggested to achieve those goals are summarized as follows.

Manufacturers often utilise DTCPA to promote expensive “me-as well” or “copycat” drugs that might not offer whatsoever significant benefits over older and cheaper medications.

Delay Advertising for New Products

Later Vioxx was withdrawn from the market in 2004, at that place were widespread calls for the FDA to found a mandatory waiting period for new drug DTCPA.4
,
9
In July 2005, Senator Pecker Frist, a onetime practicing physician, chosen for a 2-yr ban on DTCPA and asked for the GAO to study the result.4
The Establish of Medicine (IOM) besides ended that DTCPA contributes to early widespread apply of new drugs and recommended a two-year advertising moratorium to deport adequate postmarketing safety surveillance.9
The IOM recommended that a special symbol announced on packaging for the starting time 2 years that a new drug is on the market.9
Despite endorsement of the delay in DTCPA by many sources, governmental regulations for such a moratorium have not been established.9

In response to the Vioxx recall, PhRMA also issued guidelines recommending that new drug DTCPA be delayed until the drug’s prophylactic profile is fully established and health care professionals are educated as to the drug’due south proper utilise.12
In response, several drug companies announced a voluntary, time-limited moratorium on DTCPA for new products.eighteen
However, it is unclear how well companies are adhering to these voluntary moratoriums for new drug DTCPA. In 2007, tracking by TNS Media Intelligence, a marketing information service, constitute that companies waited an average of xv months from the fourth dimension a new drug was approved before initiating DTCPA.9
However, for some new drugs, DTCPA began inside one year of approval.9
,
12

Ban Product-Specific Ads

DTCPA is said to be designed to instill production preferences in people who often don’t have the information, preparation, or incentive to compare risks, benefits, and costs of bachelor treatment options.5
,
11
It has therefore been proposed that DTCPA exist replaced with non-branded informational campaigns, which would have comparable educational benefits merely would exist safer, more constructive, and more economical than DTCPA.five
Rather than invest and so much money in DTCPA, information technology has been proposed that drug manufacturers could sponsor an advisory advertisement that lists the benefits of a drug class and encourages patients to see their doctors to hash out treatment choices.4
It has likewise been suggested that the tax system be used to create incentives for public and private mass media campaigns aimed at educating patients nigh common, serious medical weather and encouraging them to discuss prove-based therapies with their health care providers.7

Crave Pre-clearance by the FDA

The FDA has besides been urged to establish a mandatory pre-clearance process for DTCPA, particularly for television commercials.5
Pharmaceutical companies could besides conduct consumer pre-tests to demonstrate to the FDA that the ads comply with regulations and that any flagged issues accept been addressed before an ad is aired to the public.one
,
xviii
Because the FDA already lacks the staff to review DTCPA, many commentators agree that the pharmaceutical manufacture volition need to pay user fees to foot the bill for a pre-clearance procedure.28
Many proposals made past both industry and consumer groups to increment the personnel resource at the FDA are in understanding that user fees should be created to defray the costs of more proactive monitoring.i
In 2008, however, the FDA appear that the planned user-fee programme for manufacture promotional material monitoring would not commence because of inadequate funding by Congress.20

Plant Regulations for Online Advertising

The institution of regulations for online DTCPA has as well been urged. These regulations could include mandatory public notification when online content is sponsored by a pharmaceutical company.15
It has also been recommended that drug companies be made responsible for correcting user-generated content that makes unverified, negative, or clinically inappropriate comments.15
Proposals for drug manufacturers to use the Internet to collect agin-outcome reports from consumers have also been presented.fifteen

Include Quantitative Information

It has been suggested that the FDA establish regulations that eliminate qualifying statements and crave the inclusion of quantitative data in DTCPA.37
Ads could provide specific quantitative data near potential benefits and risks of advertised drugs instead of the current qualitative and oft emotionally driven messages.i
,
xviii
,
37
It has been shown that exaggerated perceptions of drug benefits can be easily corrected by including quantitative information in DTCPA ads.eighteen
A serial of studies found that the add-on of a table displaying quantitative data to DTCPA led to a more realistic appraisal of a drug’s benefits relative to a standard print advertizement that lacked this information, even for participants with niggling formal education.eighteen

Improve Patient Comprehension

All information included in DTCPA, including product risk, could be presented at an eighth-grade literacy level to ensure comprehension by a larger segment of the population.18
Health centers with computers should include user-friendly interfaces, such as impact screens, vocalism recognition, and hand-held remote controls, to reach patients who lack computer skills or take low literacy levels.21

Include Drug Cost Information

Consumers would besides benefit from being provided with drug toll information. However, price comparisons of different drugs are hard because this information is rarely publicly accessible.18
Until such information are disclosed, ads could, at a minimum, annotation when a generic alternative is available.eighteen

Conclusion

Current available prove, although limited, indicates that the effect of DTCPA on consumers is both positive and negative.8
An increased understanding of the effects of DTCPA will accept important implications for public health in the U.South. and New Zealand besides in other countries and regions where the ban on such advertising is being challenged.half-dozen
Although a ban or severe curtailment of DTCPA has occasionally been chosen for in the U.South., remedies that will maximize the benefits and minimize the risks of DTCPA are more frequently proposed.7
It is hoped that these measures volition allow this controversial, but powerful, medium to be ameliorate utilized for the improvement of public health.7

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Which Two of the Following Are Benefits of Consumer Programs

Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/