Pharmacy law and ethics 4b: medication advertising, labelling and packaging requirements

What is advertising covered under?

HMR 2012 section 14

Advertisement

anything designed to promote the prescription, supply, sale or use of that medicinal product

Advertising is.........

tightly restricted to ensure patient safety

Adverts for what type of drugs to the public are banned?

POMs and CDs except approved vaccine campaigns

General principles of advertising:

> NO person can publish an advert for a medicinal product unless there is a MA, certificate of registration or traditional herbal registration in place

> Must comply with particulars in SPC

> Must encourage rational use of the product- objectively and without exaggerating properties

> Should not be misleading

Rules regarding hospitality held by companies for healthcare professionals

> Given to healthcare professionals only (persons qualified to prescribe or supply)

> Must be reasonable to main objective of meetings held solely for scientific or professional purposes

> No person may supply/ promise gifts, pecuniary (financial) advantage or benefit in kind unless it is inexpensive and relevant to the practice or medicine or pharmacy

Who monitors advertising?

self regulatory bodies, UK ASA (advertising standards authorities), health ministers involved

Misleading drug advert example

Kim Ks morning sickness drug ig post, US regulators demanded it be took down, was misleading, efficacy presented without risks, suggested safer than has been demonstrated

Adverts must:

> be clear that it is an advert

> product clearly identified as medicinal product

What information should an advert contain about a medicinal product?

• Name of the medicinal product

• Common name of active ingredient (when only one active ingredient is contained in the product)

• Information necessary for the correct use of the product

• Express and clear invitation to carefully read package or leaflet instructions

What has MHRA produced to give guidance on advertising medicines?

Blue guide

Where are regulations for labelling, packaging and leaflets stated?

HMR 2012 part 13

Immediate packaging=

container/packaging in contact with the medicinal product e.g iprofen

Package

A package refers to any container (box, packet, etc.) used to enclose one or more product containers, including situations where one box is enclosed within another.

Medicines on prescription

A medication that has been dispensed against a prescription

General labelling regulations

Name, strength and form of medicinal product

– If appropriate whether product intended for babies, children or adults

– Where the product contains up to three active substances the common name of each active substance

– Expiry date (month and year)

– Manufacturer’s batch number

– Administration method and if necessary route of administration (small cont)

– Statement of the active substances e.g., volume/ weight/ dosage unit

– Pharmaceutical form and contents by weight, volume or number of doses of the product (small cont)

– List of all excipients (for injectables, topical or eye preparations) or for other routes all excipients knows to have a recognised action or effect and included in guidance in HMR

– Where appropriate, space for prescribed dose to be indicated

– Warning to store out of the reach and sight of children

– Any special warnings applicable to the product e.g., take with or after food

– Special storage precautions e.g., keep out of direct sunlight

– Precautions relating to disposal

– Name and address of MA holder (blister)

– MA number

– If not a POM, instructions for use

– Information showing the classification - e.g., POM or P

– Specific information about certain products e.g., paracetamol e.g., do not take anything else containing paracetamol while taking this medicine

All containers and packages must be

Legal, comprehensible and indelible, Given in English, unless an orphan medicinal product

Legal requirement for following information to appear on dispensed medicinal products

Name of the patient

- Name and address of the supplying pharmacy

- Date of dispensing

- Name of the medicine

- Directions for use (e.g. take ONE tablet THREE times a day'

- Precautions relating to the use of the medicine (e.g., for external use only)

- The RPS recommends the following also appears on the dispensing label:

• 'Keep out of the reach and sight of children'• 'Use this medicine only on your skin' where applicable.

In a prison what should be on label

prisoner number to identify pt

Can pharmacist add extra info to label?

yes, maybe extra advisory or cautionary labels found in BNF

1 multiple choice option

Is quantity on label legal?

no but good practice

What should pharmacist do with BNF advisory and cautionary labels?

recommended to add to dispensing label and provide to pt during consultation

Where should you put label if packaging is likely to be disregarded?

straight onto immediate packaging

Can pharmacist change prescribers directions for use, name or precautions on label without asking?

yes if not appropriate but keep a record

What do u need to do assembly and pre-packaging of medicines to give to another trust?

appropriate MHRA licence

What must be included with a dispensed medicinal product?

PIL (package leaflet)

• medince details about identy,strength and formualtion

• how to take medcines safely and cirrectly

• information on side effects

• full lsit of ingreidents

• precautions

• therpautic group of the product and indications

Requirements for child safety

Suitable child-resistant packaging should be used for supplying all solid, all oral and external dose preparations unless good reasons provided

What can you do if patient requests non child proof packaging?

supply in non child proof container

Why would original packaging not be child proof?

might be reason it is in this container for key reasons, not appropriate to change container

Regulated medicinal products that contain aspirin, paracetamol or >24mg elemental iron should be sold in...

opaque or dark-tinted child resistant packaging unless

- Sale/ supply under supervision of pharmacist, in registered pharmacy premises