Legislation 6 - advertising of sales of MP

Question 1

What are the nuances to the HMR 2012?

Answer 1

• 18th July Human medicines regulation 2014
• allow supply of salbutamol inhalers to schools
• allows schools to hold asthma inhalers with salbutamol for use

Question 2

what does the supplier need to request?

Answer 2

• by principal/head teacher
• name of school where required
• purpose for which product required
• total quantity required

Question 3

What is expanding access to naloxone like?

Answer 3

• 2nd Dec 2024
• for future use to those who need it, without prescription

Question 4

who did exemption of naloxone expand to?

Answer 4

• med services of armed forces
• police forces - drug treatment workers in these settings
• prison staff, probation officers
• registered midwives, nurses, pharmacy professionals, paramedics

Question 5

what are prescription types and prescriber restrictions?

Answer 5

• table in MEP - amended to reflect new prescribers in HMR 2012 including
• physiotherapist, podiatrist, therapeutics radiographer independent prescriber
• therapeutic radiographers
• dietitians as supplementary prescribers
• orthoptists - certain supply and admin exemptions

Question 6

what are amendments to HMR 2012 - october 2017?

Answer 6

• adrenaline auto-injectors administered in schools (emergency)
• corrects omission - sell/supply certain POM
• inc clarity of certain provisions
• change definition of external use

Question 7

What is an advertisement relation to MPs?

Answer 7

• promote prescription, supply, sale or use that product
• door-to-door canvassing
• visits by med sales reps
• supply of samples
• provision of inducements to prescribe/supply MP by gift/offer/promise benefit/bonus
• sponsorship of promotional meetings
• sponsorship of scientific congresses

Question 8

when is advertising acceptable?

Answer 8

• high standards
• responsible
• not misleading
• not cause offence

Question 9

what is not an advert?

Answer 9

• reference material
• info relating to human health, disease
• answer specific query about MP
• journal article
• labelling, package leaflet of MP

Question 10

what are the regulation of advertisment?

Answer 10

• human medicines regulations 2012
• trade descriptions act 1968
• consumer protection from unfair trading regulation 2008
• business protection from misleading regulation 2008
• broadcasting act 1990 and 1996
• communications act 2003
• bribery act - serious fraud office

Question 11

what is advertising of meds controlled by?

Answer 11

• statuatory measures - MHRA
• self regulation through codes of practice - PMCPA, PAGB, health food manufacturers association (HFMA), OFCOM, ASA

Question 12

who is responsible for the advert?

Answer 12

• licence holder
• advertiser
• publisher
• offence to anyone breaching regs

Question 13

what does the MHRA do?

Answer 13

• protect public health by promoting sae use of medicines
• checks advertising for compliance with law prior to publication
• monitors published ad mats
• handles complaints about ads
• enforces regulations when mats dont comply

Question 14

what are adverts not allowed to suggest?

Answer 14

• superiority of product
• guaranteed effects
• recovery claims
• medical consultation not necessary
• offering a diagnosis
• health enhancing/ health affect by not taking
• not directed at children

Question 15

what info is needed on an advert?

Answer 15

• clear message that is an advert and medicine
• name of med + common name
• correct use of med
• read PIL/ label if no leaflet

Question 16

what are cautions to take with adverts of meds?

Answer 16

• vulnerable patient groups
• comparative claims
• no SE
• not endorsed/linked to celeb
• no claims that it’s special because it has a MA or DoH approval

Question 17

When is sponsorship allowd?

Answer 17

• OTC product - not individual celebs
• manufacturer acceptable - galpharm stadium, not to promote POM

Question 18

what is digital communication like?

Answer 18

• website providers have responsibility
• blogs, discussion forums
• POM’s prohibited

Question 19

what are 3 for offers like?

Answer 19

• discourages volume based promotion
• no more than 2 packs in one transaction
• discourages retailers from promoting offers

Question 20

what must full advertisements include?

Answer 20

• essential info compatible with SPC
• comprehensive info to form opinion
• 1 or more licensed indication
• dosage and method of use from SPC
• side-effects/C.I/ cautions/route
• product name/ API/ PL no/ legal status/ name and addy of licence holder

Question 21

what are advertisement for registered homeopathic medicines like?

Answer 21

• name of stock and dilution
• certificate num
• admin details
• form, expiry, storage details
• warnings
• batch no
• content of sales presentation
• consult doctor if symptoms persist
• “homeopathic medicinal product without approved therapeutic indication”