Prescribing and the law

What are the legal requirements for an FP10

1. Patient Name

2. Patient Address

3. Age (if under 12)

4. Prescriber Signature

5. Prescriber Address

6. Type of Prescriber (usually indicated within address)

7. Appropriate date (within 6 months)

What are good practice to include on an FP10

NHS number

DOB/age if over 12 yrs

Patient weight if it was used in dose calculation

Cancellation of empty space

Details of medicine required on an FP10

1. Name of medicine (generic or brand)

2. Form (oral tablets, suspension etc.)

3. Strength

4. Direction for use

   • Should include quantity and frequency

5. Quantity to be supplied (e.g. 56 tablets)

What are legal requirements on a dispensing label

1. Name of patient

2. Name and address of supplying pharmacy

3. Date of dispensing

4. Name of medicine

5. Directions for use

6. CALs or precautionary warning (e.g. external use only)

What is good practice on a dispensing label

1. Keep out of sight and reach of children

2. “Use this medicine only on skin” where applicable

3. Dispenser and checker boxes

9 Pharmacist standards

Requirements for an inpatient drug chart (Don’t necessarily have to be on there, but they should have room for them)

1. Patient identifiable information (name , NHS number)

2. Allergy status

3. Patient calculation information (height, weight BSA)

4. Drug information

   1. What drug

   2. Indication

   3. Date and time of administration

   4. Route

   5. Frequency

   6. Until when

Labelling requirements for drug packaging

1. Name of medicinal product (In text and braille)

2. Strength and pharmaceutical form

3. If intended for children/babies (if appropriate)

4. Active substance common name

5. Qualitative and quantitative expression of active substance per dosage unit/per given volume/weight

6. Pharmaceutical form and contents by weight, volume or number of doses

7. Keep out of sight and reach of children

8. Any CALs if present

9. Any storage precautions

10. Space for dispensing label (POMs only)

11. Method of administration

12. Expiry date

13. Manufacturer batch number

14. Name and address of MA holder

15. Marketing authorisation number

16. Legal category

17. Instruction for use (except POMs)

18. Special disposal precautions (if any)

19. All excipients with a recognised action or effect

    1. Except for injectable, topical or eye products, which need ALL excipients listed

20. “UK only”

Good practice for medicinal packaging

1. Strengths expressed in similar units (not interchanging between 1g and 500mg)

2. No trailing zeros (e.g. 2.50)

3. Micrograms unabbreviated

4. Positive administration instructions only

   1. (e.g. For intrathecal use only, rather than not for intravenous use)

5. Tallman letttering