human medication regulation and types

Question 1

what is a parallel import

Answer 1

(PI) is a legitimately produced medicinal product which is imported into one member state from another. Prices can vary, and shortages can occur.

Question 2

Explain the term ‘pharmacovigilance; and describe pharmacists responsibilities in relation to it

Answer 2

Pharmacovigilance is the continued surveillance of a medicinal product once it is on the market

Question 3

what is the yellow cards scheme for

Answer 3

• Yellow cards for reporting adverse events
• Reporting suspected adverse reactions after authorisation of the medicinal product is important.
• It allows continued monitoring of the benefit/risk balance of the medicinal product.

Question 4

what are black triangle medicines

Answer 4

-Medicines that are being monitored particularly closely by regulatory authorities in the European Union (EU) are described as being under ‘additional monitoring’.

Question 5

what is GSL

Answer 5

general sale list: can with reasonable safety be sold or supplied other than under the supervision of a pharmacist

Question 6

what are the human medication regulations that are key

Answer 6

HMR (Reg. 5), and HMR reg 222

Question 7

what does HMR (Reg. 5) sets out:

Answer 7

that it must have an appropriate marketing authorisation to be sold in this way

Question 8

What conditions apply to HMR reg 5 (3)

Answer 8

(a) Premises able to exclude the public
(b) Products manufactured elsewhere & sold in unopened containers
(c) Business must be carried out in accordance with prescribed conditions

Question 9

what does HMR reg 222 say

Answer 9

Medicinal products which are subject to the General Sales list can be sold from automatic machines

Question 10

what conditions apply to regulation 222

Answer 10

• Machines must be located in a premises which the occupier is able to
  close to exclude the public

Limits are imposed on the pack sizes and strengths of certain GSL products when sold from non pharmacy businesses.

e.g. 16 tablets of paracetamol only

Question 11

products not to be on general sale are decided by what act/regulation?

Answer 11

Human Medicines Regulations (2012) specify certain classes of medicine which are only to be available from a pharmacy – i.e. they are not general sale

Question 12

What products are not to be on general sale (3)

Answer 12

– Eye ointment

– Products containing Vitamin A with MDD of 7500 iu or 2250 mcg of retinol

– Vitamin D with MDD of more than 400 units

Question 13

The Human Medicines Regulations (2012) does what?

Answer 13

divides medicinal Products into 3 Classes
– General Sale List GSL
– Pharmacy Medicines P
– Prescription Only Medicines POM

Question 14

why is the sale of medicinal products restricted?

Answer 14

to ensure that there is:
– Safe use
– Appropriate use

Question 15

what is a P medicine

Answer 15

A ‘pharmacy medicine’ or ‘P Medicine’ is a medicinal product that can be sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.

• Medicinal Products requiring more stringent control than GSL

Question 16

There is no definitive list of P medicines Medicinal Products are
classified as P under the 4 following conditions

Answer 16

1. Is in GSL but
   * Sold in larger quantities than allowed by GSL
   * At higher concentration than specified by GSL
   * At higher dose than in GSL
2. Is POM but exempt on the grounds of
   * Dose Concentration (Strength)
   * Route of administration Use
3. Is not included in either GSL or POM list
4. Is made up in a Pharmacy and is not a POM

Question 17

Explain the regulations in respect to Pharmacy supply of P medicines

Answer 17

• P medicines may not be sold or supplied by retail sale in the course of a business carried on by any person unless:

– (a) That person is a “Person Lawfully Conducting a Retail Pharmacy Business”

– (b) The sale is from a Registered Pharmacy

– (c) that person, or, if the transaction is carried out on their behalf by another person, that other person is, or acts under the supervision of a pharmacist

Question 18

what do we mean by supervision by the pharmacist

Answer 18

Supervision generally means that the Pharmacist must be aware of what is going on and is in a position to intervene in the transaction

Question 19

reclassification of medicines from POM-P includes changes to what

Answer 19

• new packaging and PIL
• reduced packs size e.g. 15g instead of 30g of cream
• altered licensing e.g. age, conditions, duration

Question 20

describe what constitutes a POM

Answer 20

A prescription-only medicine (POM) is a medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner before it can be sold or supplied.
- There are exemptions to requiring a prescription in some circumstances
- Some medicines can be classified under more than one category and this can depend upon formulation, strength, quantity, indication or marketingauthorisation

Question 21

what regulation defines a POM

Answer 21

HMR reg 5

Question 22

legal definition of a POM by HMR reg 5

Answer 22

1. a medicinal product covered by authorisation of which is a term that product is to be available only on prescription
2. a med product covered by EU marketing authorisation as available only on prescription
3. a med product that is a prescription only medicine by virtue of part 1 of schedule 1 of HMR
4. a medicinal product that is the result of the assembly or reformulation of a medicinal product that is a POM

Question 23

New MPs are POM for how long after first licensing?

Answer 23

5 years after first licensing unless there is existing evidence of safety

Question 24

Normally the POM Order will be updated to include the product when?

Answer 24

before the expiry of the 5 year period

Question 25

What does HMR reg 2.36 say about products being exempt from POM control

Answer 25

Products containing aloxiprin, aspirin and paracetamol are exempt from POM control if the quantity sold or supplied to a person at any one time does not exceed 100 tablets or capsules (HMR Reg 2.36)

Question 26

- who can supply POMS and in what scenarios

Answer 26

- Professional person – By wholesale from a pharmacy or wholesaler - Member of the public – Against a valid prescription from a practitioner – As Emergency Supply at request of a doctor or designated prescriber – As Emergency Supply at request of patient – By means of a Patient Group Direction (PGD)

Question 27

what does HMR reg 2.14 say about the main route a pharmacist can supply a POM

Answer 27

The main route by which a pharmacist is able to sell or supply a POM is under the authority of a prescription from an appropriate practitioner (or via an exemption)(HMR Reg 2.14)

Question 28

criteria to define something as a POM laid down by the MHRA/MHR

Answer 28

- a direct or indirect danger exists to human health, even when used correctly if without medical supervision - there is frequently incorrect use, which could lead to direct or indirect danger to human health - further investigation of activity / side effects is required - the product is normally prescribed for parenteral administration

Question 29

are details of the medicinal product a legal requirement for prescriptions for POM

Answer 29

no, apart from controlled drugs

Question 30

who are private prescriptions written by

Answer 30

written by doctors or dentists who work outside of the NHS e.g private hospitals like BUPA, medicentres etc

Question 31

who pays for private prescriptions

Answer 31

patients pay for initial consultation, any tests, for prescription to be written and medicines to be dispensed

Question 32

can private prescriptions be repeated

Answer 32

if indicated by prescriber→ private prescriptions can be repeated

Question 33

which prescriptions are not repeatable

Answer 33

NHS prescriptions and prescriptions for schedule 2 or 3 controlled drugs are not repeatable

Question 34

what is the only exception to a repeat

Answer 34

a prescription for an oral contraceptive, which can be dispensed six times within six months of the appropriate date

Question 35

for other repeatable prescriptions, the first dispensing must be made within how long?

Answer 35

the First = within six months of the appropriate date, following which there is no legal time limit for the remaining repeats

Question 36

all supplies of a POM must be recorded except when (3 things)

Answer 36

1. supply is on NHS script or any script for an oral contraceptive 2. a separate record is made in the controlled drugs register 3. sale or supply is by wholesale dealing and the order or invoice relating to the sale is retained for 2 years

Question 37

**private prescription records:** - are these paper of electronic

Answer 37

this register can be paper or electronic

Question 38

when do we have to make the entry / record of a private prescription

Answer 38

this entry must be made at the time of the supply within 24 hours

Question 39

how long do we retain private prescriptions for a POM

Answer 39

must be retained for two years from the date of the last sale or supply: records must be made in the POM register

Question 40

things that have to be on private records:

Answer 40

1. date of supply 2. prescription date 3. medicine, prescriber and patient details

Question 41

which orders need to be signed in the pharmacy

Answer 41

for POM - record in POM book (unless is wholesale transaction where no required but signed order must be retained for 2 years)

Question 42

which med classes don't legally require records

Answer 42

gsl and p

Question 43

what records do POM need

Answer 43

record in POM book legally required

Question 44

what records do CD (Sch2) need

Answer 44

CD Register entry legally required: POM book record made for good practice

Question 45

where are NHS prescriptions sent for payment and how often

Answer 45

the NHS business service authority, every month

Question 46

what does the the NHS Business Service Authority do

Answer 46

they check electronically and manually every prescription in order to pay the pharmacy

Question 47

PRIVATE prescriptions fate - GSL / P

Answer 47

endorse and return to patient

Question 48

PRIVATE prescriptions fate - POM

Answer 48

retain in pharmacy for 2 years unless from the date of the last sale or supply: if repeatable, return to the patient until final supply made, then retain for 2 years.

Question 49

PRIVATE prescriptions fate - CD

Answer 49

retain in pharmacy for 2 years = ‘repeats’ not allowed *Except Private prescriptions for CDs schedule 2 &3 Send to NHSBSA.*

Question 50

what is parenteral drug administration?

Answer 50

Parenteral drug administration refers to drugs given by routes other than the digestive tract. The term parenteral is usually used for drugs given by injection or infusion. 

Question 51

can anyone administer POM’s parenterally?

Answer 51

No person shall parenterally administer a POM unless they are an appropriate practitioner or acting in accordance with an appropriate practitioner

Question 52

what are the exemptions? to parenteral administration

Answer 52

- emergency (anyone can administer certain meds) - smallpox/exposure - certain HCP’s (e.g. midwives/paramedics, for specific parenteral POMS under certain conditions)

Question 53

can anyone administer non-parenteral POMs

Answer 53

Medicines legislation does not restrict who can administer a non-parenteral POMs (i.e. oral, inhaled, topical or rectal dosage forms, etc)

Question 54

But generally in healthcare, the person administering the medicine should only do so with:

Answer 54

1. A prescription; 2. A patient specific direction (PSD); 3. A patient group direction (PGD); and should be appropriately trained - Have knowledge of the regulations pertaining to containers for medicines and labelling of medicines for human use. - Have knowledge of the regulations in relation to Patient information leaflets. (which we find on the emc)