Drug Safety Issues Covered by Lay Media: A Cohort Study of Direct Healthcare Provider Communications Sent between 2001 and 2015 in The Netherlands (original) (raw)

When direct health-care professional communications have an impact on inappropriate and unsafe use of medicines

Clinical pharmacology and therapeutics, 2013

Serious safety issues relating to drugs are communicated to health-care professionals via Direct Health-Care Professional Communications (DHPCs). We explored which characteristics determined the impact of DHPCs issued in the Netherlands for ambulatory-care drugs (2001-2008). With multiple linear regression, we examined the impact on the relative change in new drug use post-DHPC of the following: time to DHPC, trend in use, degree of innovation, specialist drug, first/repeated DHPC, DHPC template, and type of safety issue. DHPCs have less impact on use of specialist drugs than nonspecialist drugs (P < 0.05). The DHPCs' impact increased after availability of a template emphasizing the main problem (P < 0.05), and for safety issues with a risk of death and/or disability (both P < 0.05) (adjusted R² = 0.392). Risk communication can be effective, specifically in case of well-structured information, and very serious safety issues. Effectiveness may improve by tailoring DHPCs ...

Public engagement and the role of the media in post-marketing drug safety

Routledge eBooks, 2020

The potential for harms from adverse drug reactions (ADR) constitutes wawcritical patient safety and public health challenge, especially with increased medication usage as populations age. The research reported here explores explanations for a sudden increase in ADR reporting in New Zealand after a new formulation of a medication to treat hypothyroidism, Eltroxin ® (levothyroxine), was phased in. The formulation was adjudged to be bioequivalent to the old formulation, yet following its introduction, a sharp increase in the reporting of adverse reactions to this drug occurred. The paper analyses public engagement and the role of print media coverage, press releases and minutes of meetings of relevant agencies in order to describe the unfolding of this health controversy. Early interpretations of the sharp increase in reporting of reactions explained it as an outcome of a combination of factors, including a mistrust of state drug subsidising agencies and media attention that provoked anxiety in this vulnerable population. This paper offers an alternative explanation arguing that, as adverse drug reactions are known to be significantly underreported, the Eltroxin ® 'health scare' illustrates enhanced pharmacovigilance triggered by the interaction between patients and the media. The Eltroxin® controversy is an illustrative case example of the amplification of ADR reporting by patients following increased media attention in the context of a low consumer reporting environment. The case of Eltroxin ® indicates that drug safety can be enhanced by actively using media sources and by encouraging patient engagement and reporting of ADRs.

Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters

2015

Background For the purpose of understanding the Food and Drug Administration’s (FDA’s) concerns regarding online promotion of prescription drugs advertised directly to consumers, this study examines notices of violations (NOVs) and warning letters issued by the FDA to pharmaceutical manufacturers. Methods The FDA’s warning letters and NOVs, which were issued to pharmaceutical companies over a 10-year period (2005 to 2014) regarding online promotional activities, were content-analyzed. Results Six violation categories were identified: risk information, efficacy information, indication information, product labeling, material information issues, and approval issues. The results reveal that approximately 95% of the alleged violations were found on branded drug websites, in online paid advertisements, and in online videos. Of the total 179 violations, the majority of the alleged violations were concerned with the lack of risk information and/or misrepresentation of efficacy information, suggesting that achieving a fair balance of benefit versus risk information is a major problem with regard to the direct-to-consumer advertising (DTCA) of prescription drugs. In addition, the character space limitations of online platforms, eg, sponsored links on search engines, pose challenges for pharmaceutical marketers with regard to adequately communicating important drug information, such as indication information, risk information, and product labeling. Conclusion Presenting drug information in a fair and balanced manner remains a major problem. Industry guidance should consider addressing visibility and accessibility of information in the web environment to help pharmaceutical marketers meet the requirements for direct-to-consumer promotion and to protect consumers from misleading drug information. Promotion via social media warrants further attention, as pharmaceutical manufacturers have already begun actively establishing a social media presence, and the FDA has thus begun to keep tabs on social media promotions of prescription drugs.

Direct-to-Consumer (DTC) Prescription Drug Advertising on Television and Online Purchases of Medications

PsycEXTRA Dataset, 2007

The present research explored several aspects concerning hazard/risk communication in direct-to-consumer (DTC) television advertising. Results indicated that participants frequently encounter DTC ads and some report information seeking as a result. Participants reported that their physicians will fill their requests for DTC advertised drugs. They report infrequently making online (Internet) purchases of prescription drugs possibly due to safety and legal concerns. Implications of the findings for factors/ergonomics (HF/E) professionals are discussed.

ABSTRACT Title of Dissertation: THE RELATIONSHIP BETWEEN MEDIA EXPOSURE IN DIRECT-TO-CONSUMER ADVERTISING (DTCA) OF PRESCRIPTION DRUGS, PATIENT DEMAND AND PATIENT SATISFACTION: A SECONDARY DATA ANALYSIS OF THE PUBLIC HEALTH IMPACT

Direct-to-Consumer Advertising (DTCA) of prescription drugs is one of today's most controversial marketing techniques employed by pharmaceutical companies. DTCA is the promotion of prescription drugs through newspaper, magazine, television, and internet marketing. The objectives of this study were to add to the small but growing body of empirical literature on DTCA of prescription drugs, understanding the influence of media exposure of DTCA prescription drugs on patient health outcomes, and further describe the effects DTCA is having on the public health of U.S. consumers. Specifically, the study explored the health determinants of patient demand, whether people with higher levels of exposure to media are more likely to have increased patient demand compared to lower levels of exposure to media, and people with a higher level of exposure to media are more likely to have patient demand with the status of health insurance. Finally, the study explored whether patients who demanded DTCA prescription drugs, are patients with higher levels of media exposure associated with patient satisfaction, adjusting for adverse drug events, health related quality of life, socio-demographic variables, and health status.

The Tip of the Iceberg of Misleading Online Advertising; Comment on “Trouble Spots in Online Direct-to-Consumer Prescription Drug Promotion: A Content Analysis of FDA Warning Letters”

2016

Kim’s overview of Food and Drug Administration (FDA) regulatory actions from 2005 to 2014 is a comprehensive analysis of the US regulatory experience with online direct-to-consumer advertising (DTCA) of prescription medicines. This experience is of relevance internationally as online DTCA reaches the English-speaking public globally, despite the illegality of DTCA in most countries. The most common violations were omissions or minimizations of risk information, overstatements of efficacy, unsubstantiated claims, and promotion of unapproved (“off-label”) use. Nearly one fourth of violations involved cancer drugs, raising additional concerns about patient vulnerability, limited treatment advance, and high costs. Based on content analyses of online DTCA, these cases likely reflect a small proportion of unbalanced and misleading promotional information available on the web. The FDA is only able to review a small proportion of promotional materials submitted to them, due to limited staffing, and the delay between first posting and regulatory action means that many people may be exposed to messages that are found to be inaccurate and misleading. The sheer volume of online DTCA, combined with the ability for content to shift continually, poses unique regulatory challenges.

Communication on Safety of Medicines in Europe: Current Practices and General Practitioners' Awareness and Preferences

Drug safety, 2017

National competent authorities (NCAs) for medicines coordinate communication relating to the safety of medicines in Europe. The effectiveness of current communication practices has been questioned, particularly with regard to reaching general practitioners (GPs). The aim of this study was to assess current European NCA safety communication practices and to investigate European GPs' awareness of and preferences for safety communications on medicines. Web-based surveys were distributed among European NCAs and healthcare professionals (HCPs). The survey among regulators was emailed to a representative of each of the 27 European countries participating in the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. HCPs from nine European countries (Denmark, Spain, Croatia, Ireland, Italy, The Netherlands, Norway, Sweden, and the UK) were asked about their preferences through a link to the survey on websites, in newsletters, and/or in a direct emai...

Safety Communication Tools and Healthcare Professionals' Awareness of Specific Drug Safety Issues in Europe: A Survey Study

Drug safety, 2018

National competent authorities (NCAs) use Direct Healthcare Professional Communications (DHPCs) to communicate new drug safety issues to healthcare professionals (HCPs). More knowledge is needed about the effectiveness of DHPCs and the extent to which they raise awareness of new safety issues among HCPs. The objective was to assess and compare general practitioners' (GPs'), cardiologists', and pharmacists' familiarity with DHPCs as communication tools, their awareness of specific drug safety issues, and the sources through which they had become aware of the specific issues. GPs, cardiologists, and pharmacists from nine European countries (Croatia, Denmark, Ireland, Italy, the Netherlands, Norway, Spain, Sweden, and the UK) completed a web-based survey. The survey was conducted in the context of the Strengthening Collaboration for Operating Pharmacovigilance in Europe (SCOPE) Joint Action. Respondents were asked about their familiarity with DHPCs in general and their ...