3) Human Medicines Regulations, Advertising and Licensing (Part 2) Flashcards
First key aspect of advertising: no person can publish an advertisement for a medicinal product, unless that product has got a…
marketing authorisation or certificate of registration. And all the information within those
advertisements must be consistent with the summary of product characteristics. They can’t make unproven claims.
2) No person can publish an advertisement relating to a business or product,
unless. ..
…that advertisement encourages rational use of that product. So, you present objectively and
without exaggerating its properties, and therefore not be encouraging misuse.
Third aspect of advertising?
No person can publish a misleading advertisement relating to a medicinal product. So again, nothing that can be false or unproven by
the summary of product characteristics.
Part 11 of the Human Medicines Regulations is all about?
Pharmacovigilance
This section on pharmacovigilance stipulate that there are general obligations on the licensing authority, that has to ensure that this takes place. The licensing authority must:
1) Take all appropriate measures to encourage the reporting of any suspected adverse reactions.
2) Facilitate the reporting through provision of
alternative reporting formats, in addition to workplace formats.
3) Take appropriate
measures to measure accurate and verifiable data for scientific evaluation of suspected adverse
reports.
4) Ensure the public has given been important information on
pharmacovigilance concerns relating to the use of the medicine, in a timely manner. Through publication on
the UK web portal and through other means that allows the public to access the information.
5) Ensure all measures are taken to identify any biological medicinal product, dispensed or sold in the UK, which is the subject of a suspected adverse reaction through the methods of collecting data. And when necessary, the follow up of suspected adverse reaction reports.
So really, the regulations are saying that the licensing authority needs to…
1) Ensure that they are measuring the
reporting of adverse reactions, that they are facilitating that report through allowing different
platforms to be available for people to report.
2) Be carrying out some sort of
monitoring, to ensure that the data that’s coming through is accurate and verifiable.
3) Ensure that what’s fed back to the public is accessible, and is done so in a timely manner about
the use of medicines.
4) Ensure that if there are any suspected adverse reactions
reported, that they can identify any medicinal products out there, either recall them, or address any warnings.
The human medicines regulations also have provisions around labelling and containers. Now,
labelling needs to be:
1) legible(?) (Eligible?), comprehensible indelible.
2) In English only, or in English
and one or more other languages providing the same details appear in all of the languages. So, you
can find some products that are coming from Europe may have all of the details in German, for
example, but they will also have additional labels that have all of the details, exactly the same details
in English
Now, the labelling of medicinal products, the outer packaging of those products needs to
be labelled in accordance with the regulations and the stipulations within those. So, the following
information must appear on the medicinal products:
• The name, the form, the strength of the product.
• The active ingredient, the number of dosage units or volume, the list of
excipients, the method of administration, a warning that the medicine should be kept out of the
reach and sight of children, and the other warnings necessary for the product eg. keep out of direct sunlight, and the expiry date. And that should be the month and the year.
• Other special storage requirements needs to be stipulated, and special precautions relating to
disposal.
• There needs to be the name and address of the marketing authorisation holder, the number of the marketing authorisation, the manufacturers batch number, and in the case of nonprescription
medicines, there needs to be the instructions for how to use it.
• Where the medicine is in a blister pack, the blister pack needs to have on it the name, strength and
form of the medicinal product, the expiry date, the name of the holder, and the marketing
authorisation, and the batch number.
• Now, there might be additional labelling that’s required due to the legal classification of the
product. So, in addition to the standard labelling I’ve just described, there may be some additional
labelling for pain medicines, and those that contain paracetamol. So, medicines that contain
paracetamol need to have specifically on the box, that ‘this medicine contains paracetamol’. Also
there needs to be the statements; ‘do not take more medicine than the labels tell you’. ‘If you do not
go get better, talk to the doctor’. An additional label is, ‘do not take anything else containing paracetamol whilst taking this medicine’, and also ‘talk to a doctor at once if you take too much of
this medicine, even if you don’t feel unwell’. All of these labels have been stipulated because of the
awareness of paracetamol toxicity and the risk of overdose. So, because of that, these have been
recognised statements that have to appear on boxes that have medicine, that have paracetamol in
them.
So, for dispensed medical products or something that’s been dispensed against prescription,
standard labelling requirements do not apply. Okay, so all of those details I’ve just listed, do not
apply. Ideally you should dispense medicine in the original package and add the dispensing label to
it. So, if it’s already in its original package, it will have a standard labelling and the dispensing label
will just have the details as required for safe and appropriate usage.
A dispensing label, so pharmacy dispensing labels, needs to have
• the name of the patient,
• the name and address of the pharmacy,
• the date of dispensing,
• the name of the product,
• directions for use,
• precautions related to the use of the product,
• the statement that says keep out of the reach of children. Ideally keep out of reach and sight of
children.
• The quantity isn’t a legal requirement but it is good practice. • You need to have the active ingredient, the number of dosage units or volume, the list of
excipients, the method of administration, a warning that the medicine should be kept out of the
reach and sight of children, and the other warnings necessary for the product. For example, keep out
of direct sunlight, and the expiry date. And that should be the month and the year.
• Other special storage requirements needs to be stipulated, and special precautions relating to
disposal.
• There needs to be the name and address of the marketing authorization holder, the number of the
marketing authorization, the manufacturers batch number, and in the case of nonprescription
medicines, there needs to be the instructions for how to use it.
• Where the medicine is in a blister pack, the blister pack needs to have on it the name, strength and
form of the medicinal product, the expiry date, the name of the holder, and the marketing
authorization, and the batch number.
• Now, there might be additional labelling that’s required due to the legal classification of the
product. So, in addition to the standard labelling I’ve just described, there may be some additional
labelling for pain medicines, and those that contain paracetamol. So, medicines that contain
paracetamol need to have specifically on the box, that ‘this medicine contains paracetamol’. Also
there needs to be the statements; ‘do not take more medicine than the labels tell you’. ‘If you do not
go get better, talk to the doctor’. An additional label is, ‘do not take anything else containing
paracetamol whilst taking this medicine’, and also ‘talk to a doctor at once if you take too much of
this medicine, even if you don’t feel unwell’. All of these labels have been stipulated because of the
awareness of paracetamol toxicity and the risk of overdose. So, because of that, these have been
recognised statements that have to appear on boxes that have medicine, that have paracetamol in
them.
So, for dispensed medical products or something that’s been dispensed against prescription,
standard labelling requirements do not apply. So pharmacy dispensing labels, needs to have:
- the name of the patient
- the name and address of the pharmacy
- the date of dispensing
- the name of the product
- directions for use
- precautions related to the use of the product
- the statement that says keep out of the reach of children. Ideally keep out of reach and sight of children.
- The quantity isn’t a legal requirement but it is good practice.
Now thinking about the precautions relating to the use of the product, there are two types of warning labels.
Pharmaceutical warnings and BNF warnings.
Pharmaceutical warnings:
They encompass things such as, ‘for external use only’, ‘shake the bottle’ and ‘store in a cool dry place’.
- Because they really relate to stability, and the optimum conditions that would allow that formulation to be in the best states for use.
BNF labels:
they are labelled in such a way that when you look up the medicine in the BNF, you will have additional labels under counselling, and they
will have a list of one to about 26, I think. The back of the BNF you’ve got what those numbers relate to. So, if you get a BNF out and look at the last few pages, you will see a list of BNF warnings.
Some BNF warnings can be incorporated into the directions.
So, for example, there’s take — there’s one
that says take 30 to 60 minutes before food. That can be incorporated directly into directions, rather than being put separately as a warning. Its important that you explain why the warning is on the label. So, it’s important that you don’t just tell a patient, take 30 to 60 minutes before food. But if you explain to them, they’re more likely to adhere to the instructions they understand why that warning is actually suggested.
Patient Information Leaflet
They have been a legal requirement since July the 1st, 1999.
Otherwise known as PIL’s. They must be supplied each time a medicinal product is sold or supplied,
and that includes dispensing
Now, the full details of the legal requirements to
be included on the PIL are contained within the human medicine’s regulations 2012. And what they include is the:
• identification of the physical product,
• the therapeutic indications,
• listed information that’s necessary before taking the medications. So, things such as
contraindications, interactions, for example. So, the similar sub headings that you would find a BNF.
• Also, underneath that you’d find the necessary and usual instructions for proper use, they would
have a description of the undesirable effects that can occur with normal use, and the action that
should be taken in such cases.
• There should be reference to the expiry date on the label, and the date on which the leaflet was
last revised.
So, if you pick up any drug box within the pharmacy, it should have a PIL in there. Or if not, there
may be supplementary PIL’s within the same drawer or shelf. So, once that product is dispensed, you
have a PIL to accompany that dispensed product.
All medicines should be dispensed in child resistant containers, blisters or strip
packs. There are certain exceptions:
where someone has reduced manual dexterity, the child
resistant containers, blister packs and strip packs may be a nightmare for them. They just may not be
able to manipulate them, and there may be an agreement between the pharmacy and the patient,
of a more appropriate form of packaging the medication.
