PGDs

Question 1

Herd immunity

Answer 1

vaccination of a significant proportion of a population results in less risk to individuals who have not developed immunity. Chain of infection is disrupted. Greater the proportion of individuals who are resistant the smaller the probability that a susceptible individual will come into contact with an infectious individual. Depending on disease herd immunity threshold 80-95%

Question 2

active immunisation

Answer 2

stimulating the immune system like an infection

Question 3

passive immunisation

Answer 3

introducing antibodies, protection until lost from circulation

Question 4

natural passive immunity

Answer 4

eg trans-placental spread, breast feeding

Question 5

acquired passive immunity

Answer 5

eg serum from individuals, pooled antibody fraction eg immunoglobulin

Question 6

“live” attenuated vaccines

Answer 6

the vaccine is live but weakened eg MMR

Question 7

“killed” vaccines

Answer 7

inactivated and non-infectious eg typhoid and influenza

Question 8

subunit vaccines

Answer 8

subunit vaccines contain fragments of protein and/or polysaccharide from the pathogen eg mono-component hepatitis B

Question 9

Toxoid

Answer 9

bacterial toxin that is no longer active but retains the property of combining with or stimulating the formation of antibodies eg tetanus, diphtheria

Question 10

adjuvants

Answer 10

added to help immunogen generate an adequate and protective response

Question 11

how do adjuvants increase immune response

Answer 11

prolonging retention of immunogen at site, increasing effective size of immunogen, stimulating local influx or immune cells

Question 12

where do adjuvants come from

Answer 12

derived from bacteria eg HPV, immune cell signals or stimulating T helper cells, from inert material eg alum salts

Question 13

Definition of PGD

Answer 13

“PGDs provide a legal framework that allows some registered health professionals to supply and/ or administer a specified medicine to a pre-defined group of patients, without them having to see a prescriber” Nice

Question 14

when are PGDs administered

Answer 14

“supplying or administering medicines under PGDs should be reserved for situations in which this offers an advantage for patient care, without compromising patient safety. For example, a PGD may be appropriate for supplying a medicine to a patient seeking treatment for a minor ailment in a community pharmacy or walk in centre”

Question 15

is a PGD a form of prescribing

Answer 15

no

Question 16

do patients need to fit every bit of criteria in the PGD

Answer 16

yes

Question 17

can supply or administration of the medicine be delegated when working under PGD

Answer 17

no

Question 18

intention of PGD use

Answer 18

should be provided on an individual, patient-specific basis, use must be consistent with appropriate professional relationships and accountability

Question 19

the MHRA states…

Answer 19

PGDs are an important mechanism in delivering the required capacity and enabling the effective service delivery in the NHS

Question 20

what are the 3 classes of drugs

Answer 20

GSL, P and POM

Question 21

what is the medicines act 1968

Answer 21

“authorisation of medicinal products for human use”

Question 22

what do they oversee

Answer 22

manufacture, import, distribution, sale supply and administration, labelling and advertising, pharmacovigilance

Question 23

which of those groups do PGDs come under

Answer 23

sale and administration

Question 24

PGD definition

Answer 24

a specific written instruction for the supply and administration or administration of a named medicine in an identified clinical situation. it applies to groups of patients who may not be individually identified before presenting for treatment

Question 25

in what situations are PGDs a good fit

Answer 25

when medicine use follows a predictable pattern and is less individualised, used mainly to manage specific episodes where supply or administration is necessary. they are best used in first contact services eg A and E, ambulance service, occupational health

Question 26

how a PGD is implemented

Answer 26

identify need for PGD, prepare template for organisation eg Health Board, Training and competency assessment, review timelines (usually 2 years)

Question 27

what information must a PGD contain

Answer 27

clinical, medicine specific, organisation, named staff

Question 28

authorising a PGD

Answer 28

produced by a multidisciplinary group: senior doctor (or dentist), senior pharmacist, a representative of any professional group expected to operate under the PGD. Must be authorised by the organisation, signatures

Question 29

organisational requirements

Answer 29

a senior person in each profession should be designated with the responsibility to ensure only fully competent, qualified and trained professionals operate within direction. NHS organisations should maintain a record of the designated senior person for each professional group. All professions must act within their appropriate code of professional conduct. a direction should be reviewed every 2 years

Question 30

training required for PGD

Answer 30

individuals operating under a PGD should receive appropriate training relevant to the clinical condition and the medicines used, a competency assessment should be completed

Question 31

PGD records

Answer 31

healthcare may only operate under PGF as named individuals, a record of the named individual must be maintained, all PGDs documentation must be kept for 8 years (for children until child is 25 years)

Question 32

medicines that can be included in a PGD

Answer 32

medicine must have a UK marketing authorisation, black triangle drugs can be included, medicines can be included for off-label use, antimicrobials (use should be supported by evidence of best practice), certain controlled drugs can be included

Question 33

PGD in practice

Answer 33

sexual health- EHC, antibiotics. Vaccines- childhood immunisation. Minor ailments- sore throat test and treat. emergency planning- potassium iodide