Regulation of CD- Prescription Requirements 2, blue scripts, destruction.

Question 1

what schedule drugs do CD Prescription Requirements apply too?

Answer 1

For ALL Schedule 2 and 3

Question 2

list the legal requirements for a CD prescription

Answer 2

1) Age and DOB (if appropriate)
2) Patient’s full name
3) Patient’s address.
4) Drug Name
5) Drug strength if more than one exists
6) Form eg tablets or capsules. Even if only one available
7) Dose needs to be specific eg “one as directed” is acceptable, but “as directed” is not
8) Total quantity of the preparation or number of unit doses. In words eg Twenty tablets, as well as figures eg 20 tablets.
9) Signature in prescriber’s own handwriting
10) Prescriber’s Address. Must be within UK
11) Date. Valid for 28 days

Question 3

sometimes CD prescriptions contain Technical errors. when and how can pharmacists amend and continue to dispense as normal if an error is present?

Answer 3

Pharmacists can supply against prescriptions that have:
Minor typographical errors or spelling mistakes
1) The total quantity specified in either words or figures but not both
2) Must amend Rx with indelible ink on main body of script, and clearly show the amendments are made by them (sign, date and GPhC reg. no.).
3) All other amendments or omissions must be corrected by the original prescriber.

Question 4

what quantity should be supplied for a schedule 1-3 drug?

Answer 4

1) Schedule 2, 3 and 4 should be limited to 30 days supply
2) The quantity prescribed should be appropriate for the clinical need of the patient.
3) good practice and not a legal requirement

Question 5

outline the requirements for the Collection of Dispensed CD

Answer 5

1) Pharmacist is legally required to determine who is collecting Sch 2 CD.
2) Ask for proof of identity
3) Pharmacist has the discretion to decide to supply even if ID is not provided.
4) Good practice for the person collecting to sign the back. Instalment Rx only need to be signed once.

Question 6

what are the legal requirements surrounding CD owings?

Answer 6

1) Owings – CD register must only be for the quantity actually supplied. A further entry must be made when the remaining balance is supplied
2) The owing balance for Sch 2, 3 or 4 CDs cannot be dispensed later than 28 days after the appropriate date on the prescription
3) For Sch 5 CDs, the balance of an owing cannot be collected more than 6 months after the appropriate date

Question 7

Are privateRx for Sch 2 & 3 CDs written on a different form?

Answer 7

1) Private Rx for Sch 2 & 3 CDs must be written on designated prescription form: pink private prescription form FP10PCD
2) But not when CDs are issued and dispensed in hospital.

Question 8

outline the CD requisition requirements

Answer 8

1) A requisition in writing must be obtained by the supplier (i.e. the pharmacy) before delivery of any Sch 2 or 3 CD to recipients e.g. GP, hospitals, care homes.
2) In an emergency, a doctor or dentist can be supplied with a Sch 2 or 3 CD if a requisition will be supplied within 24 hours.
3) The requisition must include:
- name, address and Signature of the recipient
- Profession or occupation
- Total quantity of drug
- Purpose of the requisition

Question 9

what are controlled drug instalments and give examples of dugs given in instalments

Answer 9

1) Instalments are when the total quantity is divided and given at specified intervals.
2) Schedule 2 CDs, buprenorphine (Sch 3), buprenorphine with naloxone (Schedule 3) or diazepam (Schedule 4) can be dispensed to substance misusers in instalments for the treatment of drug addiction.

Question 10

what is an FP10(MDA) used for?

Answer 10

1) To supply instalments- must be prescribed using the FP10(MDA) blue form under NHS or privately.
2) FP10(MDA) must not be used for any other purpose.
3) No more than 14 days supply

Question 11

what are the prescription requirements for a FP10(MDA)?

Answer 11

On top of the specific prescription requirements for Sch 2 and 3, FP10MDA must also state:

1) The total quantity in words and figures.
2) The interval between instalments (good practice to specify the dates of the instalments).
3) The number of instalments
4) The quantity to be supplied per instalment
5) The total quantity to be supplied for the period
6) Home office requires the dose and instalment amount to be specified separately.
7) First instalment must be supplied no later than 28 days after the ‘appropriate date’.
8) The remainder of the instalments should be dispensed in accordance with the instructions.
9) The prescription must be marked with the date of supply

Question 12

how would you endorse a methadone script?

Answer 12

1) Endorse with the volumes dispensed at each ‘pick-up’
2) For each ‘pick up’, receive a professional fee, CD fee, consumables allowance, container allowance (if appropriate) and volume fees paid automatically.
3) Plus an “item level fee” of £2.50 per script automatically.
4) Plus “packaged dose fee” of 55p can be claimed per additional bottle of oral liquid methadone supplied – must endorse PD and the no of additional packaged doses supplied.
- packaged dose endorsement goes on the endorsements section as normal. PD fees = total number of separately packed doses supplied- total number of interactions)
- in the number of prescription forms down the bottom: dispenser documents the total number of interactions ( number of collections) - any missed instalments. ( not used to calculate NHS payment)

Question 13

explain the legal requirements surrounding the collection of FP10MDA

Answer 13

1) The prescription must be dispensed on the date specified.
2) If not collected on the date due, that supply is no longer valid.
3) More than one day’s supply can be prescribed to be collected.
4) if several days’ instalments are to be collected on one day and the client does not come in on the specified day, then he/she loses the complete instalment. Endorse ‘NOT DISPENSED’.
5) The Home Office has approved the use of specific wording on the FP10MDA to allow pharmacist to supply the remaining balance if the person failed to collect on date specified. If missed the instalment minus the amount prescribed for the days missed may be supplied

Question 14

what happens if a FP10 MDA collection has been missed >3 days in a row?

Answer 14

1) If patient missed >3 days, there is a risk that they will lose tolerance and the usual dose may cause overdose.
2) Need to consider contacting the prescriber for appropriate next steps
3) 3 day rule is strictly adhered to: Often, a telephone authorisation to supply will suffice

Question 15

who can collect an FP10 MDA?

Answer 15

1) The client should collect the prescribed CD in person.
2) If unable to collect personally, client may arrange for a representative to collect.
3) Representative must bring a suitable note on each occasion to show they have authority to collect.

Question 16

outline the requirements for the CD register

Answer 16

1) For all Sch 2 CD received or supplied by a pharmacy.
2) No fixed format of CDR but certain headings must appear in the CDR and certain fields of information must be completed.
3) A separate page must be used for each strength and form of that drug.
4) Must be kept at the premises to which it related and be available for inspection at any time.
- Not to be used for any other purpose

Question 17

In the CD register entries should be made when drugs are obtained from the supplier and also when a CD supply has been made to the patient. what information must be recorded when a CD is obtained from a supplier?

Answer 17

1) Date the CD supply obtained
2) Name and address from whom obtained (e.g. wholesaler)
3) Quantity obtained

Question 18

Outline what must be entered in the CD register when supplying a CD to the public

Answer 18

1) Date supplied
2) Name and address of person (or firm) supplied
3) Details of authority to possess – prescriber or licence holder’s detail
4) Quantity and form supplied
5) Details of person collecting Sch 2 CD
6) Whether proof of identity was requested
7) Whether proof of identity was provided
8) As good practice, pharmacists should maintain a running balance of stock in the CDR and enter prescriber identification no. and name and registration no. of the pharmacist supplying the CD.

Question 19

how long should a CD register be kept for? and can mistakes be crossed out?

Answer 19

1) Be kept for 2 years from the date of last entry.
2) Entries and corrections must be indelible.
3) Entries must not be cancelled, obliterated or altered. Corrections must be made by dated marginal notes or footnotes.
4) Entries must be made on the day of the transaction or on the next following day.

Question 20

outline the requirements for electronic CD registers

Answer 20

1) The Regulations require that every computerised entry must be attributable and capable of being audited.
2) It must be accessible from the premises and capable of being printed.
3) Must ensure safeguards are incorporated into the software to ensure author of each entry is identifiable; entries cannot be altered at a later date

Question 21

Explain how CD’s are destroyed

Answer 21

1) Pharmacy contractors must have appropriate arrangements in place for safe CD destruction/disposal.
2) The Home Office advises all Sch 2, 3 and 4 (Part 1) CDs should be denatured (irretrievable) before placed into waste containers.
3) Where practicable pharmacists should use CD denaturing kits in order to denature CDs.
4) For expired Sch 2 stock, the destruction requires to be witnessed by an authorised person and make an entry in CDR.

Question 22

how are patient returns of CD’s dealt with ?

Answer 22

1) Community pharmacies can accept CDs returned by patients from their own homes and from care homes.
2) In England and Wales, cannot accept waste medicines from care homes which provide nursing care.
3) A record should be made (but not in the CDR) for patient returned Sch 2 CD.
4) No legal requirement to destroy in presence of an authorised witness, but it is good practice to be witnessed by another staff and this is recommended.

Question 23

how is expired CD stock dealt with?

Answer 23

1) Legal requirement to destroy expired and unwanted Sch 2 CDs in presence of an authorised witness
2) Accountable Officers can authorise people or groups of people to witness the destruction. Previously only by the police chemist inspection officers, the RPS inspectors, and the Home Office inspectors.
3) A record must be made in the CDR and include:
- Drug name, Form, Strength and quantity, Destroyed date, Signature of the authorised witness, Signature of the professional destroying it.

Question 24

explain how tablets and capsules and liquids are destroyed

Answer 24

1) tablets and capsules: remove from outer shells using gloves, grind or crush and place into CD denaturing kit. or grind and crush and place in small amount of hot soapy water. empty the mixture in the waste disposal container
2) liquids: pour into CD denaturing kit and then place into a pharmaceutical disposal container. or pour onto cat litter then destroy by incineration via usual waste disposal methods