L8 Flashcards
(25 cards)
What does the promotion of medicines refer to?
All informational & persuasive activities by manufacturers/distributors where the intention is to induce prescription/supply/purchase & use of medicinal products
What are 4 general principles of regulating promotion & advertising?
Must be accurate/truthful/reliable
Any comparisons must be factual, fair & sustainable
Should not contain misleading info
Should not be designed to mislead/take advantage or disguise their real nature
Give 4 minimum info requirements
Approved brand name
Name & amount per-dosage-unit of active ingredients
Approved uses
Dosage form
In EU what is the advertising of medicinal products controlled by?
Combo of regulations & codes of practice issued by EFPIA
What do NCAs supervise?
Advertising of medicinal products on behalf of EC/EMA authority
What is the legislation from the HPRA about advertising?
Any activity which is designed in full or part to promote prescription, supply, sale or consumption of a medicinal product constitutes advertising & is subject to provisions of these regulations
What are 4 forms of advertising?
To general public
To persons qualified to prescribe them
Visits by medical sales reps to prescribers
supply of samples (depends)
Provisions of inducements
Sponsorship of promo meetings
Sponsorship of scientific congresses
Do companies self regulate advertising?
Yes
What are 4 additonal rules of advertising to general public?
Can’t take advantage of common health misconceptions
Cannot include narcotics/psychotropic
Cannot be directed at children
CANNOT INCLUDE PRESCRIPTION DRUGS
What happened in US after Kefauver-Harris Amendement in 1962?
Direct to consumer marketing of prescription drugs eg. Merck in 1981 & Boots in 1983
When did FDA relax rules on marketing of medicines?
1990s
What are similar rules in the DTC?
Brand name
Active ingredients
Indications
Major precautions
Name & address of manufacturer
Price
In 2012 how much moeny was spent on PSR interactions?
89.5 billion
What are Madison Ave. tactics?
approach of advertising for high street products
What are major uses of opiods?
Pain relief, anesthesia, cough suppression
What are 4 toxic s/es of opiods?
Lethargy
Unconsciousness
Respiratory depression
Death
What is Fentanyl?
Synthetic opioid for pain management in cancer patients & those recovering from painful surgeries
One of the most powerful opiods
What is Carfentanil?
Potent animal tranquilizer (elephants) - 100x more potent than fentanyl
What was the role of marketing in opioid crisis?
1990s - push in synthetic & semi-synthetic opioid marketing
Chronic pain identified as ‘undertreated’
Marketing campaigns claiming drugs were less addictive or non-addictive compared to morphine
What is opiophobia?
Fear of healthcare providers from prescribing opioids
Define pseudoaddiction?
Describes patient behaviors that may occur when pain is undertreated
How many people with opioid pain medication switch to heroin?
75%
Who created OxyContin?
Purdue Pharma in 1950s
What part of OxyContin is where the IP lies?
Contin coating - controlled release of formulation in GIT (slow process - people can’t abuse it)
