As demonstrated in the data presented above, physicians frequently fulfill DTCA-drug requests despite reporting concerns about clinical appropriateness, and several studies demonstrate the potential for DTCA to cause inappropriate prescribing. However, none of these studies addresses the factors that contribute to potentially inappropriate prescribing in response to DTCA. We describe 3 important contributors and offer mitigating strategies for clinicians to consider when faced with DTCA-drug requests from patients. This is not intended to be an exhaustive list of the contributors to DTCA-influenced prescribing practices, but rather a description of consistently identified themes that we found in our literature review.
Assess the Appropriateness of a Medication Request and Address Patient Expectations
Advertising begets demand, an axiom that is borne out time and again in studies of the impact of DTCA on prescribing practice.6,7,8,9,10,11 One can logically conclude that parties with vested interests would not spend tens of billions on advertising otherwise. Because of this, DTCA is transforming the patient-physician relationship from a professional model requiring reliance on a learned intermediary with a fiducial responsibility to a consumer model, where patients enter with a preconceived notion of the service they would like to be rendered. Regardless of this dynamic, physicians must fulfill their fiduciary obligation to protect the best interests of patients. Patients have negative rights, including the ability to decline interventions based on their goals of care. They do not have positive rights or the ability claim that their health care provider must act in a certain way that is aligned with their priorities. How should clinicians evaluate the appropriateness of DTCA-drug requests and address patient expectations? Several studies indicate that providers often feel under-equipped to assess DTCA drug requests.12, 13 We propose a memory device: “ABCD” (adverse effects, benefits, cost, diagnosis) to aid in this process.
The guiding principles of greatest urgency are derived from consideration of potential clinical benefits and the likelihood of adverse effects. Ensuring efficacy and minimizing toxicity remain the most important considerations when deciding whether to prescribe a requested drug. This consideration is complicated by the fact that newly marketed drugs often have insufficient safety information available. Physicians should rely on information from randomized controlled trials to decide when a DTCA request is reasonable and to help correct misconceptions imparted by DTCA.
The United States Government Accountability Office (GAO) has repeatedly reported that newly marketed drugs (which are more heavily advertised) incur more costs to individuals and the healthcare system than generic drugs.1, 14,15,16 Indeed, of all the literature reviewed, this variable is the most frequently cited by clinicians when explaining their reasons to not fulfill a DTCA-related request.6,7,8 At the point of prescription, physicians should consider and discuss with the patient whether a drug presents a financial barrier that could result in the patient going untreated, or if there is a comparable but more cost-effective alternative. HMOs and formularies which incentivize cost-effective prescribing can help serve to minimize the burden of this consideration on the prescribing physician. Social workers and case managers are also exceptionally helpful in navigating cost concerns.
Finally, the patient’s diagnosis must be considered, as physicians have a fiduciary obligation to choose the most appropriate therapeutic agent that is clinically indicated. The gravity of the patient’s condition likely impacts the benefit that the patient receives relative to cost and adverse effects (e.g., prescribing Diclegis® for pregnancy nausea vs. switching warfarin to apixaban for atrial fibrillation). Physicians are generally already able to differentiate between indication priorities, but published guidance on this topic also exists.17, 18 Inappropriate prescribing has been shown to be more frequent for indications with fewer potential clinical consequences in the DTCA literature.11 What is critical in responding to DTCA-drug requests is that physicians are able to explain to patients whether the requested drug is clinically indicated in their case, and if not, why not.
In most instances, the decision to prescribe a new medication requires simple consent, involving an explanation of the change, and the patient’s implied or stated agreement after discussing risks, benefits, and alternatives.19 Multiple content analyses,20,21,22,23 as well as physician surveys, indicate that drug advertisements provide insufficient information to patients regarding alternative therapies, efficacy, and potential adverse effects. Incompletely informed requests coupled with physicians’ time constraints may drive inappropriate prescribing. Complicating this dynamic further is physician familiarity with newly marketed medications, which is frequently poor.24 Policy intervention is often cited as having the greatest potential to improve the educational value of drug advertisements, either in the form of more stringent guidance from the FDA or by creating tax-funded public-private partnerships to produce advertisements, which may reduce the influence of profit motive on DTCA.25 A slightly more impassioned remedy to this issue has been circulated in the patient safety literature, termed “strategic prescribing,” in which physicians who only utilize a limited number of medications with great frequency.26 Finally, if physicians feel that there is insufficient information exchange to produce simple consent in the case of a DTCA-drug request, referral to a specialist who is more familiar with its use is a viable option.
The Advent of Patient Satisfaction Metrics
Emphasis on improving healthcare quality by the Institute of Medicine created value-based reimbursement schemes for institutions, which employ measurement of patients’ satisfaction with their care.17 Several studies indicate that receipt of a prescription opioid for non-cancer-related chronic pain (an indication where opioids have no demonstrated benefit) is associated with higher patient satisfaction scores.27, 28 Other studies have demonstrated a strong positive correlation between patient satisfaction and an antibiotic prescription for upper respiratory tract infections (which are typically viral).29, 30 Examples like these demonstrate that financial pressures placed on physicians stemming from the interaction of their patient satisfaction evaluations and prescribing practices have the potential to contribute to grave public health crises such as the opioid epidemic and widespread antibiotic resistance. Strangely, physicians who oppose satisfaction-incentivized prescribing by practicing evidence-based medicine may be damaging their own interests. Combatting the negative impact of patient satisfaction surveys on appropriate prescribing begins with a better understanding of the problem, and more emphasis on researching this issue is necessary. This would permit the engagement of policymakers in efforts to improve the surveys themselves or alter their impact on reimbursement.