Definition/Introduction

As pharmaceutical companies continue to advertise directly to consumers and practicing clinicians, practitioners need to be aware of the implications of such marketing strategies on patient care. At the surface level, drug advertisements serve to update clinicians on advancements in treatment options as well as to increase awareness of pharmaceutical options for patients, allowing for greater confidence and patient participation in their health management.[1] Such advertising could take shape in different forms, including sending formal medical representatives to clinicians, sponsored trips, brochures, television/magazine/internet ads, etc. While drug advertisements and promotional literature have historically been targeted toward medical professionals, the landscape has shifted, and there is an increasing amount of emphasis placed on direct-to-consumer advertising.

Direct-to-consumer advertising (DTCA) is the direct effort of pharmaceutical companies to promote prescription drugs to the public.[2] DTCA has increased in prevalence over the past decade, and it is not uncommon for clinicians to be in the position to address pharmaceuticals that a patient has seen on T.V. or on the internet.

The Food and Drug Administration (FDA) has jurisdiction over the DTCA of prescription drugs, whereas the Federal Trade Committee oversees over-the-counter (OTC) drug ads. While the FDA oversees all prescription drug advertisements, drug ads do not need to be approved for compliance before being released to the public.[3]

The FDA requires that all products claim prescription drug ads (the typical, specific medication advertisement):

1. Give at least one approved use of the drug.
2. Provide the generic name of the drug.
3. Share all adverse effects listed in the drug's "prescribing information."

The full "prescribing information" is approved by the FDA prior to approval for marketing; this includes full details about the drug, including chemical properties, a complete list of adverse effects, and appropriate use cases.  In addition, the ad must explain the risks and benefits of the medication in a balanced manner.

In 1997, the FDA liberalized its policies on broadcast advertising by allowing for "adequate provision" of information about drug adverse effects and benefits by referring consumers to another source of information, such as a toll-free telephone number or a website.[4] This made advertising on broadcast media more feasible for pharmaceutical companies since they did not need to spend as much time listing all of the adverse effects during the ad. Since then, spending on DTCA has dramatically increased.[1][4] This restriction easing does not apply to prescription print advertising, which must still contain all adverse effects. Print drug advertisements must contain a "brief summary" to summarize all of a drug's adverse effects based on the prescribing information. These summaries do not need to include non-risk information about a medication, such as the mechanism of action, etc. There are no restrictions for product claim advertisements of drugs with known potential severe adverse effects.

The FDA also defines two other forms of prescription drug advertising: reminder advertisements and help-seeking advertisements. Reminder advertisements operate under the assumption that the public is already aware of a drug and its uses. The ads may not contain any information related to the drug, including its uses, benefits, or adverse effects. Any medication with a black box warning is not allowed to be advertised in this manner to the public. For example, a reminder ad might state "ask your doctor about" and then the drug's brand name and generic name, without describing the drug or for what conditions it is typically prescribed.

Help-seeking advertisements describe a constellation of symptoms and encourage the public to seek advice or help from their physicians. These ads typically contain a drug company's name and phone number to call to seek further information. For example, a help-seeking ad might list several symptoms for a particular disorder for which the drug company has a medication they are seeking to promote. Then, the ad suggests that if the person suffers from those symptoms, they should ask their health care clinician for more information without stating the name of the medication. Typically, help-seeking advertisements are not regulated by the FDA but rather by the FTC, given that they should not contain or recommend the use of any specific drug. However, in the case that a help-seeking ad suggests a particular drug, the FDA oversees the ad as a product claim advertisement.

Issues of Concern

Despite their intent to educate, drug prescription ads are inherently complicated by financial incentives, which is a topic of great controversy. There are ethical concerns that such advertising strategies are predatory and cause harm to patients. Pharmaceutical companies devote large amounts of resources to the research and development of medications and therefore have reason to strive for greater exposure of their products to recoup their investment.[1] In many cases, pharmaceutical spending on advertising exceeds spending on research and development.[1]

In the case of advertising targeted at clinicians, it has been well studied that drug promotion to medical providers impacts prescribing habits and behaviors. A systematic review of fifty-eight studies showed a negative influence of medication selection by providers with greater exposure to information provided by pharmaceutical companies.[5] These negative influences included "higher prescribing frequency, higher costs, and lower prescribing quality."[5]

A similar influence is seen in DTCA. Conversations initiated by patients for drugs because of DTCA are common, and numerous studies have shown that such DTCA-prompted requests can influence prescriber behavior.[6] DTCA has been associated with increased prescription requests and increased likelihood of prescription, whether appropriate or inappropriate.[6] 

Research also suggests that while DTCA prompts consumers to seek more information, drug ads are insufficient for patients to make informed decisions.[7] Complicating the matter, patients commonly have misperceptions about DTCA. Few patients have a good understanding of FDA oversight of DTC advertisements and, in some cases, hold dangerous beliefs, such as "only safe medications are allowed to be advertised."[3] 

More recently, there have been concerns that FDA oversight of DTCA has weakened. A recent study looking at DTC advertisements from 2015 and 2016 showed that few broadcast DTC advertisements fully complied with FDA guidelines, promoting off-label use and providing low-quality information.[5][8]

Clinical Significance

The clinical relevance of prescription drug advertisements significantly impacts prescribing decisions and, ultimately, patient care. In a cross-sectional survey of seventy-eight physicians, physicians judged that prescriptions due to DTCA drug requests were substantially more unlikely to be indicated for similar patients compared with drug prescriptions not requested by patients.[9] While DTC advertisements empower patients and improve confidence in conversations about medications, declining a prescription request threatens the doctor-patient relationship.[6][10] The clinician must use sound clinical judgment when approached with a prescription request. General principles for appropriate prescribing of medications apply in this situation.

To minimize inappropriate prescriptions, it can be helpful to implement a systematic approach, such as the eight-step approach advocated by the World Health Organization.[11]

1. Evaluate and clearly define the patient’s problem
2. Specify the therapeutic objective
3. Select the appropriate drug therapy
4. Initiate therapy with appropriate details and consider nonpharmacologic therapies
5. Give information, instructions, and warnings
6. Evaluate therapy regularly
7. Consider drug cost when prescribing
8. Use computers and other tools to reduce prescribing errors

Clinicians must interpret drug advertisements and have a good understanding of the risks and benefits of any new medication. This includes indications for the drug as well as its contraindications. This information is often highlighted in the last section of an advertisement, which may include a list of co-prescribed medications or medical conditions that have been found in clinical trials to be correlated with adverse events. A thorough medical history must be obtained, and drug contraindications and safety profiles must be reviewed with patients before starting a new medication. When starting a new medication, the clinician should discuss with the patient the risks and benefits of starting the drug and other treatment options that may be worth considering.

Nursing, Allied Health, and Interprofessional Team Interventions

Due to the clinical significance of pharmaceutical advertisements and their influence, each patient care team member plays an essential role in patient education and appropriate prescription of medications. The pharmacist, in particular, plays an important role. Pharmacists undergo extensive training in medication safety and efficacy and should be actively involved in medication decision-making and patient education. Pharmacist involvement in educating medical professionals has also been associated with improved patient outcomes.[12]

Nurses also have an opportunity to intervene and improve care regarding pharmaceutical ads. Patients often speak with a nurse when calling their health care clinician regarding a medication, such as requesting a prescription of a drug they saw on the internet from their health care clinician. Nurses can help educate the patient regarding the medication and interface with the rest of the health care team regarding the potential appropriateness of a particular drug.  

Given how commonly DTC drug advertisements are misunderstood, it is crucial that each member of the patient care team, from nurses to pharmacists and clinicians, educate patients on DTCA to which they are exposed. Additionally, there must be interprofessional communication for any potentially inappropriate prescribing patterns and drug prescriptions to improve patient outcomes.[13]

Nursing, Allied Health, and Interprofessional Team Monitoring

All patient care team members, including nursing, allied health, and the interprofessional team, play a role in assuring appropriate medication prescribing and medication monitoring. Patients talk with nurses and pharmacists when they request a refill of a medication. These team members are in an excellent position to help assess and report the possible side effects and/or efficacy of the drug to the prescribing clinician to help assist in decision making on whether or not a medication should be continued or if dose adjustments might be beneficial.

Collaborative decision-making between prescribers and pharmacists leads to improvements in medication management.[13] It is crucial to promote a culture of safety for all team members to feel comfortable raising patient concerns or concerns related to inappropriate medication prescribing.

Review Questions

• Access free multiple choice questions on this topic.
• Comment on this article.

References

1.

Jacob NT. Drug promotion practices: A review. Br J Clin Pharmacol. 2018 Aug;84(8):1659-1667. [PMC free article: PMC6046507] [PubMed: 29349812]

2.

Ventola CL. Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic? P T. 2011 Oct;36(10):669-84. [PMC free article: PMC3278148] [PubMed: 22346300]

3.

Sullivan HW, Aikin KJ, David KT, Berktold J, Stein KL, Hoverman VJ. Consumer understanding of the scope of FDA's prescription drug regulatory oversight: A nationally representative survey. Pharmacoepidemiol Drug Saf. 2020 Feb;29(2):134-140. [PMC free article: PMC7325631] [PubMed: 31833141]

4.

Donohue J. A history of drug advertising: the evolving roles of consumers and consumer protection. Milbank Q. 2006;84(4):659-99. [PMC free article: PMC2690298] [PubMed: 17096638]

5.

Spurling GK, Mansfield PR, Montgomery BD, Lexchin J, Doust J, Othman N, Vitry AI. Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review. PLoS Med. 2010 Oct 19;7(10):e1000352. [PMC free article: PMC2957394] [PubMed: 20976098]

6.

DeFrank JT, Berkman ND, Kahwati L, Cullen K, Aikin KJ, Sullivan HW. Direct-to-Consumer Advertising of Prescription Drugs and the Patient-Prescriber Encounter: A Systematic Review. Health Commun. 2020 May;35(6):739-746. [PMC free article: PMC8218606] [PubMed: 30973021]

7.

Frosch DL, Grande D, Tarn DM, Kravitz RL. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. Am J Public Health. 2010 Jan;100(1):24-32. [PMC free article: PMC2791253] [PubMed: 19910354]

8.

Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. J Gen Intern Med. 2018 May;33(5):651-658. [PMC free article: PMC5910340] [PubMed: 29484575]

9.

Mintzes B, Barer ML, Kravitz RL, Bassett K, Lexchin J, Kazanjian A, Evans RG, Pan R, Marion SA. How does direct-to-consumer advertising (DTCA) affect prescribing? A survey in primary care environments with and without legal DTCA. CMAJ. 2003 Sep 02;169(5):405-12. [PMC free article: PMC183290] [PubMed: 12952801]

10.

Bell RA, Wilkes MS, Kravitz RL. Advertisement-induced prescription drug requests: patients' anticipated reactions to a physician who refuses. J Fam Pract. 1999 Jun;48(6):446-52. [PubMed: 10386488]

11.

Pollock M, Bazaldua OV, Dobbie AE. Appropriate prescribing of medications: an eight-step approach. Am Fam Physician. 2007 Jan 15;75(2):231-6. [PubMed: 17263218]

12.

Nkansah N, Mostovetsky O, Yu C, Chheng T, Beney J, Bond CM, Bero L. Effect of outpatient pharmacists' non-dispensing roles on patient outcomes and prescribing patterns. Cochrane Database Syst Rev. 2010 Jul 07;2010(7):CD000336. [PMC free article: PMC7087444] [PubMed: 20614422]

13.

Köberlein-Neu J, Mennemann H, Hamacher S, Waltering I, Jaehde U, Schaffert C, Rose O. Interprofessional Medication Management in Patients With Multiple Morbidities. Dtsch Arztebl Int. 2016 Nov 04;113(44):741-748. [PMC free article: PMC5159681] [PubMed: 27890050]

Disclosure: Brandon So declares no relevant financial relationships with ineligible companies.

Disclosure: Peggy Kim declares no relevant financial relationships with ineligible companies.