PHAR 509: Final Exam

PHAR 509: Final Exam Direct to consumer Advertising (DTC) ads made by pharmaceutical companies directed towards the general public with the aim to promote prescription products directly to patients How do companies communicate? television, magazines, newspapers, radio and internet. these communications often feature a celebrity spokesperson, actors, or computer generated characters generally portraying happy and satisfied patients Types of DTC Advertising help-seeking reminder product claim Help seeking DTC describes the disease state and encourages patients to contact their providers requirements: no product of claims being made so fair balance does not apply. brief summary, major statement, or providing sources or prescribing info not required Reminder DTC states product name but does not mention indication or make any claims requirements: no claims made so fair balance doesn't apply, brief summary, major statement, or providing sources of prescribing info not required. cannot be used for drugs with serious adverse effects Product claim DTC names drug and condition and includes efficacy and safety claims requirements: must fair balance of risks and benefits. for print ads all risks must be included in a brief summary. for broadcast ads most important risks must be included in major statement and must provide sources of prescribing info FDA role in DTC advertising regulation division of drug marketing, advertising, and communications ensures that all prescription drug advertising is truthful, balanced and accurately communicated. "fair balance"- 1997 Evolution of DTC regulations: 1938 FDCA gave FDA authority to approve pharmaceutical marketing Evolution of DTC regulations: 1969 FDA issued regulations: 1. not false or misleading 2. fair balance 3. include facts of product's advertised uses 4. include brief summary of risks Evolution of DTC regulations: 1983 FDA issues voluntary suspension on DTC advertising Evolution of DTC regulations: 1985 FDA lifted suspension- standards of fair balance and brief summary that had been established are sufficient to protect consumers Evolution of DTC regulations: 1995 FDA held hearings on easing regulations on TV ads Evolution of DTC regulations: 1997 FDA relaxed regulation on TV ads- product claim ads to include major risks and provide info on where to find prescribing info Evolution of DTC regulations: 2004 FDA eliminates the need to reprint complete prescribing info in print product claim ads- only need to present major risks Who does most advertising target? most advertising remains directed at prescribers and other health care professionals DTC advertising average annual spending is now how much? over $6 billion annually (past 2015) Leading drug classes with DTC ads (2005) statins- $16,000 million sales vs $292 million advertisement PPIs- $12,900 miilion vs $301 million advertisement SSRIs or SNRIs- $12,500 million vs $122 million advertisement Leading drugs with DTC ads (2005) Nexium- $224 million Lunesta- $214 million Vytorin- $155 million How does advertising pay off? - Medications ranking high in sales are heavily advertised. - a 10% increase in advertising= 1% increase in sales of drugs in the class - Every additional $1 spent on advertising= $4.20 in additional sales - DTC is an important but not primary driver in prescription drug spending Who are among the the most targeted? Women's magazines More view Rx drug ads as positive than negative (T/F) True Effects of DTC on patient adherence Little to none Effects of DTC on physician prescribing behavior there seems to be a potential correlation Latest Developments for DTC ads- 2017 - actions to stop DTC advertising (legislation and professional orgs) - measure effect of DTC on prescribing - improving the message delivered in DTC ads (changing content- less is more, improve stress in format) Pros of DTC advertising - informs, educates and empowers patients - encourages patients to contact their healthcare provider - promotes dialogue between patients and healthcare provider - encourages patient compliance - may enhance placebo effect - removes stigma associated with certain diseases Cons of DTC advertising - misinforms patients and overemphasizes drug benefits - sets false expectation of efficacy - promotes new drugs before safety profiles are fully known - leads to inappropriate prescribing - strains relationships between patients and providers - capitalizes on practices not rigorously regulated what countries allow drug DTC advertising as product claim ads? only the US and New Zealand. many other countries allow help seeking ads why is professional technical writing important? - nobody is born a good writer - to become a respectable scientific writer one needs instruction and feedback - scientific writing is not like composition and prose - professional writing is a skill that employers value - professional writing is more important in today's pharmacy than it was ten years ago causative factors for poor writing performance - procrastination - ignorance - hoodwinked: didn't fully understand the primary literature - carelessness - bloat: tried to impress the audience - deception: tried to deceive the audience - surrender: not reworking the material - off target: did not prepare for or know the audience framework for success - start immediately - collect all or most suitable articles, then select the ideal/topic - make notes on the primary lit to assist later as needed - prepare an outline - work fast when the thoughts are clicking - solicit help from likely and useful resources - pay attention to concision and efficiency - pay attention to reference format choice of words - KISS technique - be explicit - provide scientific data the first time, not in sentences to explain - avoid flip flop of like terms - avoid jargon, slang, figures of speech, thesaurus writing improvement tips - sentence length: 15-20 words - use parallel sentence structure - avoid using certain suffixes and prefixes - avoid using too many prepositions, dangling participles, the passive voice do not speak in 1st or 2nd person general rules about numbers 10 are spelled out unless tied to a unit of measure, or unless another number in the sentence or phrase is a numeral 10 expressed as numerals different approaches for evaluating drug literature - individual heuristic approach - checklist approach (common considerations) - methodologic approach checklist approach for evaluating drug literature - is this a clinically relevant research study? - is the design appropriate to address the research question? - are the recruitment and selection of the subjects explained? - are the study methods appropriately explained? - are the endpoints relevant for patient care? - are the statistical analyses appropriate for the study? - what are the key research findings? - are there any study limitations? - how can the research findings be used in clinical practice? surveying the article - read the title - read the study objective skim the results and discussion sections - critically read the complete article the introduction - introductory text: purpose, unbiased viewpoint and language - study objective - no initial reporting of results/conclusions extensionalization being as specific as possible on a subject methodology intent, validity, error, valid measured outcome, reliability, bias, study designs, subject selections, types of validity internal: inherent to the study external: application of results others: construct, statistical, content, criterion related methodology cont'd reliability: a measure is accurate intent framework the investigator employs to control extraneous or confounding variables. important for assessment of the validity of the study