MEP 3.7 Additional legal and professional issues Flashcards
what does ‘use by’ or ‘use before’
the product should be used before
the end of the previous month. For example,
‘Use by 06/2023’ means that the product should not be used after 31 May 2022
what does ‘expiry date’ mean
the product should not be used after the end of the month stated. Therefore, an expiry date of 12/2023 means that the product should not be used after 31 December 2023
what is the enforcement body for waste arrangements in england
environment agency
can pharmacies receive waste medicine
Yes.
where should waste medicines be stored
kept in secure waste containers in a designated area preferably away from medicines that are fit for use.
sharps should be stored in sharps container.
how do you deal with confidential information
destroy or obscure any patient identifiable information
how do you dispose tablets or capsules
Blister strips can be removed from their inert outer packaging but tablets and capsules should not be de blistered.
how are sharps disposed
sharps ( syringes / needles) in a sharps container
how are liquids disposed
the whole bottle including empty bottles should be placed into a pharmaceutical waste container
why are liquids disposed like that ?
mixing of medicines could be hazardous
what advice do you give to patients regarding waste products
unused, unwanted medicines should be returned to the pharmacy for safe disposal
how do you dispose of tablets and capsules
Blister strips can be removed from their inert outer packaging but tablets and capsules should not be de- blistered
what is needed to buy dangerous poisons and chemicals
a valid licence issued by the home office
which act is for poisons and chemical regulation
poisons act 1972
which act is for poisons and chemical regulation
poisons act 1972
what does the act require
pharmacies to report
suspicious transactions, significant stock loss
and theft to the local police (dial 101) or the antiterrorism hotline (dial 0800 789321)
what do you check before supply part 1 and part 2 poisons to the pubnlic
- Check the purchaser has a valid Home Office licence
- Check the licence is unaltered and in-date
- Check ID - supplies CANNOT be made to third party
- Check substance requested and total quantity match the details on the licence
- Record the transaction details onto the licence.
which poisons are recorded
part 2 poisons
what details do you keep when recording part 2 poisons
Date of supply
Name & address of purchaser
Purpose of purchase
Signature of purchaser.
what should the pharmacist consider
- if requests are suspicious
- if there are commercial alternative
- if there are commercial retailers are appropriate to refer to.
what things should you consider inorder to post medicines
> Patient consent for delivery or posting
*> Patient confidentiality during the delivery
or posting process
> Whether it is necessary for face-to-face contact
with the patient to ensure that the medicine can
be safely, effectively and appropriately use
d
Whether it is necessary to interview the patient
*>Whether the patient has been assessed or
directly interviewed by the prescriber
> Medicines and medical devices are not ordinary
items of commerce and must be handled and
supplied to the patient safely. An adequate audit
trail must be in place for delivery and receipt
from the point at which the medicine leaves the
pharmacy and is received by the patient/patient
representative or returned to the pharmacy in
the event of delivery failure. Wherever possible
a signature should be obtained to indicate safe
receipt of medicines
*> Storage requirements during transit
When posting – will the postal carrier agree
to transport the medicinal product (check terms
of carriage, prohibited and restricted goods)
- When posting abroad – are there legal
restrictions in the destination country which
would prevent you from posting?
(E.g. guidance produced by the U.S. Food and
Drug Administration (FDA) makes it clear that
it is illegal for a foreign pharmacy to ship
England and Wales Scotland
what are secure environments
prisons
police custody
secure hospital
immigration centres
other places where people detained
are in house pharmacy in prison required to be registered to the GPHC
NO
when should child-resistant packaging should be used
all solid, all oral, all external liquid preparations
when is child-resistant packaging not used
> > specific requests - e.g difficulty opening
> > original pack not child resistant
what is the difference between homeopathic and herbal products
Homeopathy has been defined as a holistic
complementary and alternative therapy involves the administration of dilute and ultradilute products
Herbal preparations contain plant-derived
materials, either as raw or processed ingredients
which may be from one or more plants.
is there evidence for homeopathy
no so it is not endorsed
when can homeopathic products be used
treatment of minor, selflimiting conditions, and must never be used for the
treatment of serious medical conditions, always refer if serious
does the MHRA require homeopathic products to
demonstrate efficacy
NO
does the MHRA does require homeopathic products to demonstrate quality and safety.
YES
what does herbal medicines require for licensing
either have a full marketing
authorisation based upon safety, quality and
efficacy
or
a traditional herbal registration (THR)
based upon safety, quality and evidence of
traditional use.
can children collect and purchase to children on behalf of another person
yes but depends on many factors
which factors are important when dispensing to children
> > knowledge of the child - known to pharmacy
maturity of child - competent
nature of medicine - miuses? cd?
prior arrangement
reason for collection
advice on use of medicine that requires the patient, will the child understand and communicate to person
> > local policies
proof of identity - cd require proof of identity which children may not have
what is a medical device
any instrument, apparatus, appliance, software,
material or other article, whether used alone or in
combination, including the software necessary
for its proper application intended by the
manufacturer to be used on human beings for the
purpose of:
- diagnosis, prevention, monitoring, treatment
or alleviation of disease - diagnosis, monitoring, treatment, or alleviation
of or compensation for an injury or handicap - investigation, replacement or modification
of the anatomy or of a physiological process - control of conception
and which does not achieve its principal
intended action in or on the human body by
pharmacological, immunological or metabolic
means, but which may be assisted in its function
by such means.
give examples of medical devices
dressings, blood pressure monitors, condoms, needles, themometres
who regulates medical devices
MHRA
which mark do all medical devices require
the CE or UKCA
mark denoting compliance with the medical
devices regulations and indicating that the device
performs as intended, is fit for purpose with all
