Whose Prescription Pad Is It? Direct-to-Consumer Pharmaceutical Advertising Explained
Direct-to-consumer pharmaceutical advertising (DTCPA) is the industry that advertises directly to patients by pharmaceutical companies. Over the past few decades, this form of health communication has taken off and is now labeled to be the utmost prominent form of advertisement. These companies claim their goal is to educate patients and motivate them to take responsibility for their health. With the help of the media, pharmaceutical companies are able to infiltrate the homes of the average American and suggest a prescription medicine.
This report will touch on five main topics: policies in foreign countries regarding DTCPA, the rules and regulations applied in America, the link to the opioid crisis, the annual cost of advertising, and the potential effects on the public.
Policies in Foreign Countries
DTCPA is forbidden in Europe. The European Union argues that bypassing qualified healthcare professionals and communicating directly to patients is an unethical practice for pharmaceutical companies to partake in. In the European Community, abolishing the ban is a controversial issue as the pharmaceutical industry continues to grow. Those in support of abolishing the ban argue that DTCPA is an exceedingly effective marketing strategy (PMC). The European Parliament last met to discuss modifying the prohibition in 2007 but stuck with their decision that direct advertisement is not appropriate. Currently, DTCPA is accepted as a legal form of advertising in only two countries, New Zealand and the United States. In New Zealand, however, general practitioners have recently come forward and demand they be banned, as they “are particularly upset by the misleading content of many of the advertisements and the commercial pressure this puts them under to prescribe advertised drugs, even when they're no better than existing alternatives or are not suitable for the patient” (PubMed). Canada allows advertisements that either address a medical condition and encourage people to talk to their doctor regarding possible treatments, or they can name the product, include details on strength, dose, and cost, but cannot guarantee effectiveness. They can do simply one or the other, but not both (Open Medicine).
Rules and Regulations in America
Direct to consumer advertising is regulated by the Food and Drug Administration (FDA). In 1938, the Federal Food, Drug, and Cosmetic Act was passed, authorizing the FDA to approve pharmaceutical products for advertisement in the U.S. Later, the FDA was granted the power to regulate the labeling and marketing of prescription drugs by Congress. After a discussion in 1969, the final regulations placed on these advertisements included: must not be false or misleading, must present an equal balance of information explaining both the benefits and risks, must provide relevant details, and include a brief summary of every risk present on the medication’s label (NEJM). In 1997, the FDA issued a regulation stating that advertisements could include just the major risks to meet the requirement of a summary and direct viewers to obtain a full summary elsewhere, such as a toll-free number, their healthcare provider, or from the internet. In 2004, the FDA eased the rules a little more and stated companies just needed to provide a simplified brief summary, this change allowed companies to just touch on the major risks in simpler terms that would be easier for the average viewer to understand (PubMed). Today, Americans argue that the regulations placed on these ads are too relaxed, resulting in the amount of pharmaceutical advertisements on television (Journal of Ethics).
Link to the Opioid Crisis
The opioid crisis is a term used to group the mass increase and abuse of prescription drugs and Opium derived substances. The number of deaths caused by opioid abuse in America tripled between the years 1990-2007. Ensuing around the time DTCPA began to skyrocket, most looked to prescription drug ads as the cause. Evidence points to this being a cause of increased population drug-use rates, as the advertisement of a pain reducing medicine appealed to consumers (OpenMedicine). These advertisements for medications that claimed to be anti-inflammatories and reduce pain were being seen everywhere and patients began requesting the prescriptions by their name. This was demonstrated in a recent survey in which more than one-third of respondents reported requesting information from their physicians about a drug they had seen or heard advertised, and nearly three quarters of patients directly requested the drug by brand name (Emerald).
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The Annual Cost of Advertising
Direct-to-consumer advertisements have shown the fastest growth from 1996 to 2016 in terms of medical marketing. The expenses of DTCA were reported to be at $2.1 billion in 1997, representing 11.9 percent of the nation's spending. In 2016, $9.6 billion was invested in DTCA, reflecting 32 percent of total spending (JAMA). Before 2005, DTCPA was estimated to be growing by 20 percent per year, raising the price of every dollar spent on DTCPA by an approximated $2.20 to $4.20 (PubMed). It was reported in 2018 that pharmaceutical companies spent over $64 billion on advertising, a 4.8% increase from the year before. The well-known anti-inflammatory Humira, came out on top with having spent $487 million on media advertisements, a 13 percent increase from 2017. In second place was Lyrica, at $272 million. Following Lyrica was Xeljanz, spending $257 million. Spending for Lyrica is expected to decrease dramatically in the next year, as it lost patent protection. Since being approved by the FDA in 2004, Lyrica was deemed to be a best-selling product, bringing in sales of $3.46 billion (Kantar).
Effects on the Public
While DTCPA is a controversial issue in America, there are well-balanced arguments for the benefits and risks. Those who support DTCA claim these advertisements educate consumers and encourage them to take responsibility for their wellbeing and become aware of possible treatments (PubMed). Supporters also argue that it urges patients to contact their physician. A 2004 FDA survey revealed that 27 percent of Americans had made an appointment with their doctor to discuss a condition they had not previously mentioned after seeing a drug advertisement (Annals of Family Medicine). Those against DTCPA claim that patients are often misinformed by these advertisements. A point often made debates that important information is omitted from the ads. In one report, 82 percent of DTCPA advertisements made factual claims for the marketed drug; however, only 26 percent of ads identified the risks or causes of the disease (PubMed). Another argument is that the ads over emphasize the benefits. A study conducted in 2007 proved that television commercials promoting a drug spend more time on the benefits that the risks (ProQuest). New Zealand associate professor at the Christchurch School of Medicine and Health Sciences, Dr. Dee Mangin, is a critic of DTCPA and argues that, “The truth is direct-to-consumer advertising is used to drive choice rather than inform it,” most commonly seen in expensive name-brand companies. In addition, these big pharma companies are enticing doctors to prescribe their product. Surveys carried out in New Zealand and in the USA show that when a patient asks for a specific drug by name they receive it more often than not, as the doctors reported feeling pressured to prescribe the drug (World Health Organization).
While the exposure of DTCPA to the public remains a topic of great debate, existing evidence suggests that the influence direct drug advertising has on consumers is an equal balance of beneficial and damaging. Nonetheless, there is no doubt that improving current knowledge of the effects will produce significant results for the public of New Zealand and the United States, whether it be constructive or destructive and result in the abolishment of these ads. The opioid crisis in America is a problem still being resolved, but new evidence could potentially aid in understanding the roots of this epidemic.
- Dave, et al. “The Impact of Direct-to-Consumer Advertising on Pharmaceutical Prices and Demand.” NBER, 6 May 2010, https://www.nber.org/papers/w15969.
- “Direct-to-Consumer Advertising under Fire.” World Health Organization, World Health Organization, 4 Mar. 2011, https://www.who.int/bulletin/volumes/87/8/09-040809/en/.
- Harvard Health Publishing. “Do Not Get Sold on Drug Advertising.” Harvard Health, https://www.health.harvard.edu/drugs-and-medications/do-not-get-sold-on-drug-advertising.
- “How Advertising Shaped the First Opioid Epidemic.” Smithsonian.com, Smithsonian Institution, 3 Apr. 2018, https://www.smithsonianmag.com/science-nature/how-advertising-shaped-first-opioid-epidemic-180968444/.
- Iizuka, Toshiaki, and Ginger Zhe Jin. “The Effect of Prescription Drug Advertising on Doctor Visits.” Wiley Online Library, John Wiley & Sons, Ltd (10.1111), 28 July 2005, https://onlinelibrary.wiley.com/doi/full/10.1111/j.1530-9134.2005.00079.x.
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- Velo, Giampaolo, and Ugo Moretti. “Direct-to-Consumer Information in Europe: The Blurred Margin between Promotion and Information.” British Journal of Clinical Pharmacology, Blackwell Science Inc, Nov. 2008 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2661977/.
- Ventola, C Lee. “Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic?” P & T : a Peer-Reviewed Journal for Formulary Management, MediMedia USA, Inc., Oct. 2011, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3278148/.
- Weinmeyer, Richard. “Direct-to-Consumer Advertising of Drugs.” Journal of Ethics | American Medical Association, American Medical Association, 1 Nov. 2013, https://journalofethics.ama-assn.org/article/direct-consumer-advertising-drugs/2013-11.
- Wilkes, Michael S. “Direct-To-Consumer Prescription Drug Advertising: Trends, Impact, And Implications.” Health Affairs, https://www.healthaffairs.org/doi/full/10.1377/hlthaff.19.2.110.
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