Dataset Information

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

ABSTRACT:

Purpose

Understanding patient perceptions of prescription drug risks and benefits is an important component of determining risk-benefit tradeoffs and helping patients make informed medication decisions. However, few validated measures exist for capturing such perceptions. The purpose of this study was to develop and validate measures of perception of prescription drug risk, efficacy, and benefit.

Methods

We conducted a mixed-methods study to develop and validate the measures, including three waves of quantitative testing (item nonresponse, criterion-related validity, and convergent validity). We conducted quantitative testing with a probability-based online consumer panel of U.S. adults (n = 7635), eliminating weaker items after each testing wave.

Results

Upon completion of all testing, we identified 21 validated measures that represent 11 distinct risk/benefit constructs. The final measures demonstrated face validity, convergent validity, criterion-related validity, and scale reliability in both illness and general population samples, among patients with both symptomatic and asymptomatic health conditions, and in response to both television and print direct-to-consumer prescription drug advertisements.

Conclusions

Our study produced a set of items that researchers and practitioners can use to assess patient perceptions of prescription drug risk, benefit, and efficacy and to ensure greater future comparability between studies.

SUBMITTER: Kelly BJ

PROVIDER: S-EPMC8842561 | biostudies-literature | 2021 May

REPOSITORIES: biostudies-literature

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Publications

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

Kelly Bridget J BJ Rupert Douglas J DJ Aikin Kathryn J KJ Sullivan Helen W HW Johnson Mihaela M Bann Carla M CM Mack Nicole N Southwell Brian G BG West Sue S Parvanta Sarah S Rabre Alexander A Peinado Susana S

Research in social & administrative pharmacy : RSAP 20200806 5

<h4>Purpose</h4>Understanding patient perceptions of prescription drug risks and benefits is an important component of determining risk-benefit tradeoffs and helping patients make informed medication decisions. However, few validated measures exist for capturing such perceptions. The purpose of this study was to develop and validate measures of perception of prescription drug risk, efficacy, and benefit.<h4>Methods</h4>We conducted a mixed-methods study to develop and validate the measures, incl ...[more]

PMID: 32883618

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Project description:ImportanceSome drugs are heavily marketed through direct-to-consumer advertising.ObjectiveTo identify drug characteristics associated with a greater share of promotional spending on advertising directly to consumers.Design, setting, and participantsExploratory cross-sectional analysis of drug characteristics and promotional spending for the 150 top-selling branded prescription drugs in the US in 2020 as identified from IQVIA National Sales Perspectives data. Promotional spending data were provided by IQVIA ChannelDynamics.ExposuresDrug characteristics (total 2020 sales; total 2020 promotional spending; clinical benefit ratings; number of indications, off-label use; molecule type; nature of condition treated; administration type; generic availability; US Food and Drug Administration [FDA] approval year, World Health Organization anatomical therapeutic chemical classification; Medicare annual mean spending per beneficiary; percent sales attributable to the drug; market size; market competitiveness) assessed from health technology assessment agencies (France's Haute Autorité de Santé and Canada's Patented Medicine Prices Review Board) and drug data sources (Drugs@FDA, the FDA Purple Book, Lexicomp, Merative Marketscan Research Databases, and Medicare Spending by Drug data).Main outcomes and measuresProportion of total promotional spending allocated to direct-to-consumer-advertising for each drug.ResultsThe 2020 median proportion of promotional spending allocated to direct-to-consumer advertising was 13.5% (IQR, 1.96%-36.6%); median promotional spending, $20.9 million (IQR, $2.72-$131 million); and median total sales, $1.51 billion (IQR, $0.97-$2.26 billion). Of the 150 best-selling drugs, 16 were missing data and key covariates; therefore, the primary study sample comprised 134 drugs. After adjustment for multiple drug characteristics, the mean proportion of total promotional spending allocated to direct-to-consumer advertising for the remaining 134 drugs was an absolute 14.3% (95% CI, 1.43%-27.2%; P = .03) higher for those with low added clinical benefit than for those with high added clinical benefit and an absolute 1.5% (95% CI, 0.44%-2.56%; P = .005) higher for each 10% increase in total sales.Conclusions and relevanceAmong top-selling US drugs in 2020, a rating of lower added benefit and higher total drug sales were associated with a higher proportion of manufacturer total promotional spending allocated to direct-to-consumer advertising. Further research is needed to understand the implications of these findings.

Project description:IntroductionTelevised direct-to-consumer advertising (DTCA) for prescription drugs is controversial, especially for tobacco cessation products such as varenicline, given safety concerns that arose only after its market approval. We aim to quantify the extent to which DTCA influenced varenicline use.MethodsWe linked monthly DTCA television ratings with monthly prescription data from IMS Health's National Prescription Audit across top 75 media markets in 2006-2009. We used Poisson models with Generalized Estimating Equations to analyze effects of exposures to DTCA for both varenicline and nicotine replacement therapies on rate of dispensed varenicline prescriptions among smokers, controlling for population characteristics and varenicline-related events.ResultsVarenicline prescriptions increased dramatically following DTCA launch and declined sharply after safety risks were publicized and US Food and Drug Administration (FDA) issued an advisory. DTCA had significant impact on new prescription dispensing in the subsequent month: before the FDA advisory, one additional exposure to varenicline DTCA was associated with a 1.8% (rate ratio [RR] = 1.018 [1.015-1.021]) higher rate of new prescriptions; no effect was observed after the advisory (RR = 1.000 [0.997-1.003]). Prior to the advisory, cross-product effects of nicotine replacement therapy advertising on varenicline prescribing were negligible (RR = 1.002 [0.999-1.004]); after the advisory, effects were positive (RR = 1.015 [1.012-1.019]).ConclusionsDTCA for varenicline had a significant impact on varenicline prescribing when the drug's safety profile was not well characterized, supporting arguments to limit DTCA for newly approved products whose real-world safety is unclear.ImplicationsWe examined the fluctuations in varenicline use in association with DTCA for varenicline and other tobacco cessation aids. To our knowledge this is the first study to quantify the effects of televised DTCA for varenicline and other tobacco cessation aids on varenicline prescription dispensing. We believe that understanding these relationships is critical for formulating effective public health policy and interventions.

Project description:ObjectivesThe factors determining individuals' self-reported behavioural responses to direct to consumer advertising of prescription drugs were explored with an emphasis on 'at-risk' individuals' responses.DesignNationally representative cross-sectional survey.SettingCommunity living adults in New Zealand.Participants2057 adults (51% women).Primary outcome measuresSelf-reported behavioural responses to drug advertising (asking a physician for a prescription, asking a physician for more information about an illness, searching the internet for more information regarding an illness and asking a pharmacist for more information about a drug).MethodsMultivariate logistic regressions determined whether participants' self-reported behavioural responses to drug advertising were predicted by attitudes towards advertising and drug advertising, judgements about safety and effectiveness of advertised drugs, self-reported health status, materialism, online search behaviour as well as demographic variables.ResultsIdentifying as Indian and to a less extent Chinese, Māori and 'other' ethnicities were the strongest predictors of one or more self-reported responses (ORs 1.76-5.00, Ps<0.05). Poorer self-reported health status (ORs 0.90-0.94, all Ps<0.05), favourable attitude towards drug advertising (ORs 1.34-1.61, all Ps<0.001) and searching for medical information online (ORs 1.32-2.35, all Ps<0.01) predicted all self-reported behavioural outcomes. Older age (ORs 1.01-1.02, Ps<0.01), less education (OR 0.89, P<0.01), lower income (ORs 0.89-0.91, Ps<0.05) and higher materialism (ORs 1.02-1.03, Ps<0.01) also predicted one or more self-reported responses.ConclusionsTaken together, the findings suggest individuals, especially those who are 'at-risk' (ie, with poorer self-reported health status, older, less educated, lower income and ethnic minorities), may be more vulnerable to drug advertising and may make uninformed decisions accordingly. The outcomes raise significant concerns relating to the ethicality of drug advertising and suggest a need for stricter guidelines to ensure that drug advertisements provided by pharmaceutical companies are ethical.

Project description:ImportanceConsumers in the US are exposed to unprecedented high levels of direct-to-consumer advertising (DTCA) for prescription drugs, yet there is limited evidence regarding their effect on health-related intentions and beliefs.ObjectiveTo provide evidence on the association of DTCA for prescription drugs with consumer health-related intentions and beliefs.Design, setting, and participantsThis cross-sectional study recruited participants from a nationally representative sample of individuals at high risk of cardiovascular disease. Participants were randomly assigned into 1 of 3 study arms: (1) exposure to DTCA for heart disease medications (treatment 1 [n = 926]), (2) exposure to DTCA for heart disease medications with price disclosure (treatment 2 [n = 921]), (3) and exposure to nonpharmaceutical advertising (control group [n = 902]). Each study arm viewed five 1-minute video advertisements, totaling 5 minutes of advertising exposure. The 2 treatment arms viewed pharmaceutical advertising videos for 4 heart disease medications, and the control arm viewed nonpharmaceutical advertising videos. Participants then completed a survey questionnaire to measure medication- and lifestyle-related intentions and health-related beliefs and perceptions.ExposuresDirect-to-consumer advertising for heart disease medications (treatment 1), DTCA for heart disease medications with price disclosure (treatment 2), and nonpharmaceutical advertising (control group).Main outcomes and measuresThe primary outcomes included ordinal measures of medication- and lifestyle-related intentions, health-related beliefs, and brand perceptions.ResultsAmong the 2874 included participants (mean [SD] age, 53.8 [7.1] years; 1549 [54%] male) χ2 tests confirmed that there were no statistically significant differences in baseline demographic characteristics across study arms. There was a positive association between DTCA and medication-related behavioral intentions, including intention to switch medication (marginal effect [ME] = 0.004; P = .002) and engage in information-seeking behaviors (ME = 0.02; P = .01). There was no evidence that pharmaceutical DTCA discouraged use of nonpharmacological lifestyle interventions that can help manage heart disease (eg, diet and exercise), and DTCA exposure also had a positive association with consumers' favorable perceptions of pharmaceutical manufacturers (competence: ME = 0.03; P = .01; innovative: ME = 0.03; P = .008). There was no evidence for differential associations of price disclosures in DTCA.Conclusions and relevanceIn this cross-sectional study, results showed that brief exposure to pharmaceutical DTCA had a large and positive association with medication-related demand intentions with no offsetting negative spillovers on lifestyle-related intentions. Lack of associations with price disclosure in DTCA suggests that policy makers should consider alternative strategies to promote value-based decision-making for prescription drugs.

Project description:Direct-to-consumer advertising (DTCA) of prescription drugs can be both beneficial and harmful to healthcare consumers. Therefore, DTCA for prescription drugs is a topic that should be considered crucially, at this point, when the interests of patients as well as pharmaceutical companies in DTCA of prescription drugs are growing in South Korea. The goals of this study were to investigate Korean college students' perceptions and attitudes about DTCA of prescription drugs through a survey as well as to analyze data according to their college majors in order to identify differences in their perceptions and attitudes about prescription drug DTCAs as future health care professionals and consumers, respectively. A descriptive, cross-sectional survey was conducted between September and November 2015. Participants were recruited from Chosun University in Gwangju, South Korea. Ethical approval for this study was obtained from the Chosun University Institutional Review Board. Of 1,040 questionnaires initially distributed, 774 were collected, and 742 were included in the analysis. The results of this study indicated that most students who had participated in the survey did not have sufficient knowledge of DTCA for prescription drugs. Approximately, 17% reported being cognizant of DTCA for prescription drugs. More healthcare students (24.6%) knew this term than non-healthcare students did (6.3%). In this study, most of the students were likely to feel that healthcare professionals (e.g., doctors and pharmacists) had the responsibility of delivering information about prescription drugs to patients, and that all prescription drugs DTCA, if it were permitted, had to be pre-approved by the Korean government. The results of this study indicated that DTCA for prescription drugs had to be permitted under the condition of pre-approval of the DTCA contents by the Korean government, and prescription drugs should not be advertised through the Internet. It is recommended that the Korean government cautiously examine whether DTCA of prescription drugs should be permitted, after considering the current marketing strategies of pharmaceutical companies on the Internet and the effects of online electronic-DTCA on Korean consumers.

Dataset Information

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

Purpose

Methods

Results

Conclusions

Publications

Development and validation of prescription drug risk, efficacy, and benefit perception measures in the context of direct-to-consumer prescription drug advertising.

Similar Datasets

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