lecture 8: advertising of sales of medicinal products

schools can ask to be given a salbutamol inhaler for emergencies, came into effect 2014

• have to be bought

schools can also have adrenaline such as epipens

naloxone- antidote to opioid overdose

• POM, law now allows people to give out naloxone if engaged with helping ppl who deal with opioids

what are examples of things not allowed for advertising of medicines

• door to door canvasing

• samples

can be sponsored events or sales reps to medical centers

what are good practice guidances?

• high standards

• responsible

• not misleading

• not cause offense

what is SPC?(summary of product characteristics)

sets boundaries for what can be claimed in the advert

• different rules for POM, GSL and P

• must be licensed

what is classed as an advert?

• digital

• magazines

• sales reps

• meetings

what is classed as not an advert?

• reference materials (catalogues and price lists)

• information relating to human health or disease(asking questions and getting answer back)

• journal article

• package leaflet

who regulates advertising medicines?

MHRA

• self regulating but overseen by MHRA

whos responsible for adverts?

• license holder

• advertiser

• publisher

• copies of samples and adverts are kept for 3 years

• MHRA keeps copies of complaints for 7 years

what does the MHRA do if a breach is identified?

• send a letter

• might ask to ammend, remove or issue a corrective statement

• any other adverts released after they might want to see it first

what does the MHRA do to a breach?

• fine

• or prison

adverts for self medication( P or GSL)

• prohibits cancer remedies

• prohibits abortion and narcotic products

what can you not suggest in an advert?

• superiority of a product

• effect are guaranteed

• claims of recovery

• medical consultation not necessary

• offering a diagnosis

• health can be enhanced by taking…

• health can be affected by not taking…

• advertising should not be directed at children

what is needed or found on an advert?

• clear message that it is an advert and also a medicine

• name of medicine + common name

• correct use of medicine

• read PIL/Label if no leaflet

• cant advertise no side effects

• dont put pregnant people at risk

• cant suggest its natural so no SE

• cant be endorsed or linked to a celebrity

• cant claim its special because it has a MA

some sponsors allowed but not individual celebrities

• stadiums

• not to promote POMs

3 for 2 is discourages

• no more than 2 per packs sold in one transaction, discourages retailers from promoting offers

POMs can be online advertised but locked to Healthcare professionals only

advertising to prescribers:

• needs side effects

• what it does

• names

• adverse reactions etc

abreviated adertisements:

• doesnt exceed 420 sq cm

• must have at least one spc indication

• unacceptable to imply that product is safe

• placebo-like, unacceptable

• to mislead prescribers, unacceptable

promotional aids:

• must be less than 6 pounds

• pens, notepad, mugs, post-its

• consist solely of name of product

medical sales reps should be trained, must have an SPC, no loyalty schemes