Introduction - overview What is it? Goals of DTC Types of DTC Pros/Cons DTC’s role in the drug spending/prescribing Laws with DTC in U.S. DTC in other countries – NEW ZEALAND DTC in other countries - INDIA Future of DTC Use examples: commercials, magazines, online websites Lipitor yaz – the recall one garadisil websites with ads
The promotion of prescription drugs through newspaper, magazine, television and internet marketing. Provided by drug companies, these ads are aimed at a general audience, and not at health care professionals such as doctors, nurses, and pharmacists. The ads are broadcast on TV and radio, and published in magazines and newspapers. They also appear online.
Getting accurate information about disease and treatment options to patients & consumers. To make doctors and patients better partners by encouraging patients to visit their doctors and ask important questions pertaining to their health.
The FDA describes three types of DTC advertisements: Product Claim Advertisements Help-Seeking Advertisements Reminder Advertisements
Product Claim Advertisements: The most common of the three, these typically include both the brand name and the condition the drug treats. They also describe the risks and benefits associated with taking the medication. &quot; Targets a specific prescription drug and must contain safety and efficacy information. Regulations require that these advertisements comply with adequate provision and fair-balance principles **Fair-balance rule: DTC advertisements must provide a fair balance between the benefits and risks of a drug.
Help-Seeking Advertisements: Also known as disease-awareness communications, these mention the disease or health condition but not the name of the drug that treats it. The purpose of this type of advertisement is to create an awareness of symptoms or conditions among consumers. (GAO, 2002) These advertisements are not required to provide risk information and are not regulated by the FDA. Encourages consumers with a particular set of symptoms to seek consultation with their physician and discuss treatment options. Does not mention a particular product. Forbidden if a product is the only available treatment for a specific condition, symptom, or disease.
Reminder Advertisements: This type of advertisement, which is exempt from risk disclosure requirements, names the drug and dosage form or cost information. It does not mention the condition it treats or make claims or representations about the product. Contains the name of the drug and very limited information; excludes all other claims about the product. Reinforces name and brand loyalty.
This is a page from Twitter . Each of the <140-character postings in the middle column is called a Tweet, purportedly written by American racecar driver Charlie Kimball , who “partners with Novo Nordisk to prove his high performance career is possible with diabetes”. This is what drug companies like Novo Nordisk call a “branded Tweet” and a “Direct to Consumer” (DTC) ad. All that very fine barely readable print on the left sidebar is about Novo Nordisk’s long-acting insulin called Levemir . The branded Tweet does not mention any benefits of Levemir because it’s a reminder ad, which is not required to include side effect information if it does not mention any benefits. Instead, this reminder ad for Levemir lets Charlie Kimball act as the schill for Novo Nordisk.
If patients are given faulty or misleading information, subsequently request a prescription, and are not denied the prescription by their physician (for a host of possible reasons), then it's possible that people will be getting the drug who don't need it, and the consequences of that run the gamut from wasteful (of resources) to contraindicated and life-threatening. That's a bad thing, obviously.
the pharmaceutical companies promise to hold off on consumer advertising of a new medicine until they spend an &quot;appropriate&quot; amount of time educating health care professionals about the medicine.
Omission of Risk Information - The FDA pointed out that by omitting risks associated with drugs promoted in the adverts, the adverts suggest that the named brands are safer than has been demonstrated Minimization of Risk Information Specifically, the advert text claimed that the drug has “Low Incidence of Side Effects “ . The FDA pointed out that “ the use of this claim, coupled with total omission of risk information, severely minimizes the risks of [the advertised drug] “. Inadequate communication of indication DA pointed out to one pharmaceutical company that their advert for a drug “ misleadingly broadens the indication of [the advertised drug] by implying that any patient with cancer who requires treatment for breakthrough pain is a candidate for [the drug's] therapy, when this is not the case. ” Overstatement of Efficacy The FDA warned “ By omitting this information, the link suggests that the drug can be used indefinitely, when this is not the case. ” Failure to use established brand names - All fourteen of the FDA’s letters warned of failure to use the full established names of the drug being promoted.