MEP 3.7 Additional legal and professional issues

Question 1

what does ‘use by’ or ‘use before’

Answer 1

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

Question 2

what does ‘expiry date’ mean

Answer 2

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

Question 3

what is the enforcement body for waste arrangements in england

Answer 3

environment agency

Question 4

can pharmacies receive waste medicine

Answer 4

Yes.

Question 5

where should waste medicines be stored

Answer 5

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.

Question 6

how do you deal with confidential information

Answer 6

destroy or obscure any patient identifiable information

Question 7

how do you dispose tablets or capsules

Answer 7

Blister strips can be removed from their inert outer packaging but tablets and capsules should not be de blistered.

Question 8

how are sharps disposed

Answer 8

sharps ( syringes / needles) in a sharps container

Question 9

how are liquids disposed

Answer 9

the whole bottle including empty bottles should be placed into a pharmaceutical waste container

Question 10

why are liquids disposed like that ?

Answer 10

mixing of medicines could be hazardous

Question 11

what advice do you give to patients regarding waste products

Answer 11

unused, unwanted medicines should be returned to the pharmacy for safe disposal

Question 12

how do you dispose of tablets and capsules

Answer 12

Blister strips can be removed from their inert outer packaging but tablets and capsules should not be de- blistered

Question 13

what is needed to buy dangerous poisons and chemicals

Answer 13

a valid licence issued by the home office

Question 14

which act is for poisons and chemical regulation

Answer 14

poisons act 1972

Question 14

which act is for poisons and chemical regulation

Answer 14

poisons act 1972

Question 15

what does the act require

Answer 15

pharmacies to report
suspicious transactions, significant stock loss
and theft to the local police (dial 101) or the antiterrorism hotline (dial 0800 789321)

Question 16

what do you check before supply part 1 and part 2 poisons to the pubnlic

Answer 16

1. Check the purchaser has a valid Home Office licence
2. Check the licence is unaltered and in-date
3. Check ID - supplies CANNOT be made to third party
4. Check substance requested and total quantity match the details on the licence
5. Record the transaction details onto the licence.

Question 17

which poisons are recorded

Answer 17

part 2 poisons

Question 18

what details do you keep when recording part 2 poisons

Answer 18

Date of supply
Name & address of purchaser
Purpose of purchase
Signature of purchaser.

Question 19

what should the pharmacist consider

Answer 19

• if requests are suspicious
• if there are commercial alternative
• if there are commercial retailers are appropriate to refer to.

Question 20

what things should you consider inorder to post medicines

Answer 20

> 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

Question 21

what are secure environments

Answer 21

prisons
police custody
secure hospital
immigration centres
other places where people detained

Question 22

are in house pharmacy in prison required to be registered to the GPHC

Answer 22

NO

Question 23

when should child-resistant packaging should be used

Answer 23

all solid, all oral, all external liquid preparations

Question 24

when is child-resistant packaging not used

Answer 24

> > specific requests - e.g difficulty opening

> > original pack not child resistant

Question 25

what is the difference between homeopathic and herbal products

Answer 25

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.

Question 26

is there evidence for homeopathy

Answer 26

no so it is not endorsed

Question 27

when can homeopathic products be used

Answer 27

treatment of minor, selflimiting conditions, and must never be used for the
treatment of serious medical conditions, always refer if serious

Question 28

does the MHRA require homeopathic products to
demonstrate efficacy

Answer 28

NO

Question 29

does the MHRA does require homeopathic products to demonstrate quality and safety.

Answer 29

YES

Question 30

what does herbal medicines require for licensing

Answer 30

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.

Question 31

can children collect and purchase to children on behalf of another person

Answer 31

yes but depends on many factors

Question 32

which factors are important when dispensing to children

Answer 32

> > 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

Question 33

what is a medical device

Answer 33

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.

Question 34

give examples of medical devices

Answer 34

dressings, blood pressure monitors, condoms, needles, themometres

Question 35

who regulates medical devices

Answer 35

MHRA

Question 36

which mark do all medical devices require

Answer 36

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