Understanding Prescription Drug Advertising

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 8-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]

Clinicians also have an opportunity to intervene and improve care regarding pharmaceutical ads. Patients often speak with a clinician regarding a medication, such as requesting a prescription for a drug they saw on the internet. Clinicians 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 patient care team member, from clinicians to pharmacists, 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 clinicians 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 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 so that all team members feel comfortable raising patient concerns or concerns related to inappropriate medication prescribing is crucial.