Understanding Prescription Drug Advertising


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 update clinicians on advancements in treatment options and increase awareness of pharmaceutical options for patients, allowing for greater confidence and patient participation in their health management.[1] Such advertising could take 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 targeted medical professionals, the landscape has shifted, and direct-to-consumer advertising (DTCA) is increasingly emphasized.

Direct-to-consumer advertising 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 discuss pharmaceuticals that a patient has seen on TV or 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 general population.[3]

The FDA requires that all product claim prescription drug ads in any media (the typical, specific medication advertisement):

  1. Give at least one FDA-approved use of the drug.
  2. Provide the brand and generic name of the drug.
  3. Share the most significant risks listed in the drug's "prescribing information."

The FDA approves the complete "prescribing information" before marketing approval; 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.[U.S. Food & Drug Administration. Basics of Drug Ads. 2015. Accessed February 21, 2024.]

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 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 recap the drug's adverse effects based on the prescribing information.[U.S. Food & Drug Administration. Basics of Drug Ads. 2015. Accessed February 21, 2024.] 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 box warning is not allowed to be advertised to the public in this manner. 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.[U.S. Food & Drug Administration. Basics of Drug Ads. 2015. Accessed February 21, 2024.]

Help-seeking advertisements describe a constellation of symptoms and encourage the public to seek physician advice or help. 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 seek to promote. Then, the ad suggests that if the person suffers from those symptoms, they should ask their 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 using any specific drug. However, if a promotional advertisement seeking assistance explicitly suggests a particular medication, the FDA regulates the advertisement as a product claim advertisement.[U.S. Food & Drug Administration. Basics of Drug Ads. 2015. Accessed February 21, 2024.]

Currently, the FDA has revised the rule that Direct-to-Consumer Prescription Drug Advertisement requires a clear, conspicuous, and neutral manner (CCN ) and mandates that prescription drug advertisements directed to consumers in television or radio format include the major statement on adverse effects and contraindications in a clear, noticeable, and unbiased manner.[Federal Register document 88 FR 80958: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a Clear, Conspicuous, and Neutral Manner in Advertisements in Television and Radio Format. Food and Drug Administration, Department of Health and Human Services (HHS). 2023. Accessed February 21, 2024.]

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 to their products to recoup their investment.[1] Advertising expenditures in the pharmaceutical industry often surpass investments in 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 58 studies showed a negative influence on 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 understand 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 of 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]

Common Drug Promotion Issues According to the FDA

  1. Exaggerating the drug’s benefits
  2. Missing or de-emphasizing risk
  3. Failing to offer a “fair balance” of risk and benefit information
  4. Misrepresenting data from the studies
  5. Creating claims that are not appropriately backed
  6. Omitting material facts about the drug
  7. Misbranding an investigational medication
  8. Making misleading medication comparisons

Clinical Significance

The clinical relevance of prescription drug advertisements significantly impacts prescribing decisions and patient care. In a cross-sectional survey of 78 physicians, physicians judged that prescriptions due to DTCA drug requests were substantially more unlikely to be indicated for similar patients than drug prescriptions not requested by patients.[9] While DTC advertisements empower patients and improve confidence in medication conversations, 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 understand 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 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.

The "Bad Ad" program initiated by the FDA is an outreach initiative to assist healthcare providers in identifying potentially inaccurate or deceptive promotion of prescription drugs. This program aims to enhance awareness among healthcare professionals, including physicians, physician assistants, nurse practitioners, nurses, pharmacists, and pharmacy technicians, regarding potential false or misleading prescription drug promotion. Additionally, it offers a convenient mechanism for these healthcare providers to report such instances to the FDA.[12]

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 medication safety and efficacy training and should actively participate in medication decision-making and patient education. Pharmacist involvement in educating medical professionals has also been associated with improved patient outcomes.[13]

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 for a drug they saw on the internet from a clinician. Nurses can help educate the patient regarding the medication and interface with the rest of the healthcare 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 the 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.[14]

Nursing, Allied Health, and Interprofessional Team Monitoring

All patient care team members, including nursing, allied health, and the interprofessional team, play a role in ensuring appropriate medication prescribing and monitoring. Patients talk with nurses and pharmacists when they request a medication refill. These team members are in an excellent position to help assess and report the drug's possible adverse effects and efficacy to the prescribing clinician and to help assist in deciding 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.[14] Promoting a culture of safety for all team members to feel comfortable raising patient concerns or concerns related to inappropriate medication prescribing is crucial.


Details

Author

Brandon K. So

Editor:

Peggy Y. Kim

Updated:

2/27/2024 4:29:15 PM

References


[1]

Jacob NT. Drug promotion practices: A review. British journal of clinical pharmacology. 2018 Aug:84(8):1659-1667. doi: 10.1111/bcp.13513. Epub 2018 Feb 20     [PubMed PMID: 29349812]


[2]

Ventola CL. Direct-to-Consumer Pharmaceutical Advertising: Therapeutic or Toxic? P & T : a peer-reviewed journal for formulary management. 2011 Oct:36(10):669-84     [PubMed PMID: 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. Pharmacoepidemiology and drug safety. 2020 Feb:29(2):134-140. doi: 10.1002/pds.4914. Epub 2019 Dec 12     [PubMed PMID: 31833141]

Level 3 (low-level) evidence

[4]

Donohue J. A history of drug advertising: the evolving roles of consumers and consumer protection. The Milbank quarterly. 2006:84(4):659-99     [PubMed PMID: 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 medicine. 2010 Oct 19:7(10):e1000352. doi: 10.1371/journal.pmed.1000352. Epub 2010 Oct 19     [PubMed PMID: 20976098]

Level 2 (mid-level) evidence

[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 communication. 2020 May:35(6):739-746. doi: 10.1080/10410236.2019.1584781. Epub 2019 Apr 11     [PubMed PMID: 30973021]

Level 1 (high-level) evidence

[7]

Frosch DL, Grande D, Tarn DM, Kravitz RL. A decade of controversy: balancing policy with evidence in the regulation of prescription drug advertising. American journal of public health. 2010 Jan:100(1):24-32. doi: 10.2105/AJPH.2008.153767. Epub     [PubMed PMID: 19910354]

Level 3 (low-level) evidence

[8]

Klara K, Kim J, Ross JS. Direct-to-Consumer Broadcast Advertisements for Pharmaceuticals: Off-Label Promotion and Adherence to FDA Guidelines. Journal of general internal medicine. 2018 May:33(5):651-658. doi: 10.1007/s11606-017-4274-9. Epub 2018 Feb 26     [PubMed PMID: 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 : Canadian Medical Association journal = journal de l'Association medicale canadienne. 2003 Sep 2:169(5):405-12     [PubMed PMID: 12952801]

Level 3 (low-level) evidence

[10]

Bell RA, Wilkes MS, Kravitz RL. Advertisement-induced prescription drug requests: patients' anticipated reactions to a physician who refuses. The Journal of family practice. 1999 Jun:48(6):446-52     [PubMed PMID: 10386488]


[11]

Pollock M, Bazaldua OV, Dobbie AE. Appropriate prescribing of medications: an eight-step approach. American family physician. 2007 Jan 15:75(2):231-6     [PubMed PMID: 17263218]


[12]

O'Donoghue AC, Boudewyns V, Aikin KJ, Geisen E, Betts KR, Southwell BG. Awareness of the Food and Drug Administration's Bad Ad Program and Education Regarding Pharmaceutical Advertising: A National Survey of Prescribers in Ambulatory Care Settings. Journal of health communication. 2015:20(11):1330-6. doi: 10.1080/10810730.2015.1018649. Epub 2015 Jul 15     [PubMed PMID: 26176326]

Level 3 (low-level) evidence

[13]

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. The Cochrane database of systematic reviews. 2010 Jul 7:2010(7):CD000336. doi: 10.1002/14651858.CD000336.pub2. Epub 2010 Jul 7     [PubMed PMID: 20614422]

Level 1 (high-level) evidence

[14]

Köberlein-Neu J, Mennemann H, Hamacher S, Waltering I, Jaehde U, Schaffert C, Rose O. Interprofessional Medication Management in Patients With Multiple Morbidities. Deutsches Arzteblatt international. 2016 Nov 4:113(44):741-748     [PubMed PMID: 27890050]