labelling and leaflets

Question 1

Provisions covering packaging and leaflets for medicinal products are in Part 13 of HMRs: what regulations?

Answer 1

(Regs. 257-276, and Sch.24-29)

Question 2

(Sch. 24)

Answer 2

labelling of packaging

Question 3

(Reg. 257 and Sch.24)

Answer 3

packaging requirements

Question 4

(Reg. 262, Meds Act s.88 (1))

Answer 4

• Display and nature of distinctive marks on packs

– Colour or shape (Meds Act s.88 (1))

Question 5

(Sch.27)

Answer 5

– Leaflets

Question 6

what did Schedule 25 of the HMRs extended provisions to allow pharmacists to do?

Answer 6

use their discretion when labelling dispensed medicines

• A pharmacist can include particulars they think are appropriate
• Remove those that they believe are inappropriate

Question 7

examples where optimisation of med use and labelling could be considered

Answer 7

https://www.notion.so/law-ethics-1cb00bb3982d809b9d9bd2c9750213d5?pvs=4#1de00bb3982d8051af1ef4a1e6851c71

Question 8

examples of limitations of the legislation changes for optimising med labels

Answer 8

https://www.notion.so/law-ethics-1cb00bb3982d809b9d9bd2c9750213d5?pvs=4#1de00bb3982d80e8aa02ffbeebe36a01

Question 9

labels should contain the following

Answer 9

• individual name
• product name
• name and addy of person supplying
• date if supply
• precautions relating to product
• directions for use

Question 10

where/ how should a label be applied

Answer 10

label needs to be applied fully (no folding it over two sides etc), and shouldn’t cover any of the back warnings, or front which shows strength, name and amount.) Should be straight too, esp on bottles, and not wrapped around on topicals.

Question 11

General requirements: All POM medicines when sold or supplied by retail must bear what capital letters

Answer 11

“P” or “POM” within a rectangle containing no other matter

Question 12

Standard requirements: Dispensed medicines must contain the following: (4)

Answer 12

1. The name of the individual
2. Name and address of person supplying product
3. Date of supply
4. Particulars of the medication
   * Name of the product
   * Directions for use
   * Precautions relating to the product

Question 13

Requirements for paracetamol containing products (4)

Answer 13

must include
1. ‘contains…’
2. do not take more medicine than the label tells you to
3. adults - do not take anything else
4. children do not give anything else
(containing paracetamol with this medicine)

Question 14

requirements for small containers

Answer 14

• name of product
• strength and form
• batch number
• experience date
• common name of active ingredients

Question 15

when do these requirements to small containers apply

Answer 15

when the container is not a blister pack but too small to require the standard ones e.g.
- containers with a nominal volume of 10ml or less
- where appropriate, the label should say whether the product is for babies, children for adults

Question 16

requirements of blister packs

Answer 16

1. expiry and batch
2. product name and active ingredient
3. MA holder
4. strength and form
   (Calendar pack only appropriate if daily dosing etc)
5. whether it is for babies or adults

Question 17

all labels of containers and packages must be

Answer 17

• english only (may include other languages as long as the info is the same)
• comprehensive
• legal

Question 18

are literacy levels high or low

Answer 18

emc’s considered ‘too scary’ by some
literacy levels in adults much lower than expected: <11 year olds

• therefore changed e.g may cause drowsiness → makes you sleepy / do not stop taking this medicine except on your doctors advice → do not stop unless your doctor tells you to stop.

Question 19

what is the regulation to do with patient leaflets

Answer 19

HMRs Reg.269

Question 20

what does HMRs Reg.269 say

Answer 20

• It is an offence for any person in the course of business to supply a product that
  
  1. Has a package leaflet that does not comply with the marketing authorisation
  2. Is not accompanied by a package leaflet when one is required

Question 21

Any person contravening this regulation 269 for pil’s is liable for a

Answer 21

imprisonment or a fine

Question 22

pils must contain:

Answer 22

• identification of the medicine (name, active substance, pharmaceutical form, strength)
• therapeutic indications (conditions for which it’s authorised)
• information necessary before taking the medicine (where it shouldn’t be used, interactions with other meds/foods, warnings, precautions, any effects on driving ability, info for special groups e.g. pregnant women)
• dosage: route, method, how often, what to do in case of overdose
• description of side effects which would be under normal use
• additional info e.g. excipients, conditions, name and address of MAH and manufacturer, registered pack sizes

Question 23

side effects in pils: categories

Answer 23

Very common greater than 1 in 10

Common 1 in 100 to 1 in 10

Uncommon [‘less commonly’ in BNF] 1 in 1000 to 1 in 100

Rare 1 in 10 000 to 1 in 1000

Very rare less than 1 in 10 000

Question 24

The legal requirements of a dispensing label

Answer 24

• Name of the patient
• Name and address of the supplying pharmacy
• Date of dispensing
• Name of the medicine
• Directions for use
• Precautions relating to the use of the medicine
• ‘’For external use only’’ external liquid preparations
• ‘’keep out of reach of children’’ all dispensed medicines

Question 25

Additional information can be added to the dispensing label if the pharmacist considers it to be necessary, e.g

Answer 25

Shake the bottle/Store in a cool place/Do not use after…../Discard …… days after opening

Question 26

good practice for labelling

Answer 26

- All of the **legal requirements** of a dispensing label are met - The **patient’s name is spelt correctly and visible** - The **pharmacy name and contact details are clearly visible** - The **dose and frequency** are written in **block capitals**, i.e. ‘Take TWO tablets TWICE daily’

Question 27

what to be careful of when selecting medicines

Answer 27

- NEVER dispense from the labels, always from the prescription - Ensure that the pharmacy is laid out alphabetically with the drugs stored under their generic name - Beware of look-alike& sound-alike drugs! these are medicines for which the packaging or name is incredibly similar, but in reality the medicines have very different indications.

Question 28

examples of LASA errors - the most common cause of dispensing errors

Answer 28

*Impact on patient health and can be fatal * Medicines with similar names propranolol & prednisolone; atenolol & allopurinol; gabapentin & pregabalin * Medicines with similar structural appearance of letters: Carbamazepine & Carbimazole

Question 29

some LASA drugs found commonly in community pharmacy

Answer 29

1. Gabapentin / Ganciclovir 2. Lisinopril / Lithium 3. Sertraline / Sildenafil 4. Fentanyl / Loperamide 5. Hydrochlorothiazide / Hydrocodone

Question 30

examples of some cautionary and advisory labels

Answer 30

1. **Caution: Do not drive or operate machinery** Used for medications that may cause drowsiness or impair motor skills. 2. **Take with food** Indicates that a medication should be taken with food to enhance absorption or reduce gastrointestinal irritation. 3. **Avoid alcohol** Advises patients to refrain from consuming alcohol while taking certain medications, which may cause adverse effects or interactions. 4. **Store in a cool, dry place** Provides guidance on how to properly store the medication to maintain its effectiveness. 5. **Discontinue if rash develops** Alerts patients to stop taking the medication if they experience a rash, indicating a potential allergic reaction.