Dispensing, Records, Emergence Supply and Signed Orders

what legislation governs a dispensing label?

HMR 2012 Regulation and Schedule 25 set out the dispensing-labelling requirements

what legislation governs a manufacturer’s packaging label?

Regulation 257 and Schedule 24

what information must appear on a dispensing labeL

under HMR 2012 Schedule 25

• name of medicine

• directions for use

• precautions or warnings relating to use

• patient’s name

• date of dispensing/supply

• name and address of pharmacy

• keep out of reach of children

what information can pharmacists add/change on a dispensing label?

• name of medicine

• directions

• precautions relating to use

when are pharmacy dispensing records required and which legislation governs them?

• HMR 2012 Regulation 253 = requires pharmacy records for the sale/supply of POMs in specific circumstances

• Schedule 23 = states what information must be recorded

• mainly relevant to private prescriptions and emergency supplies. NHS ones processed through NHS systems

what information must be included in a private prescription dispensing record?

• date the medicine was supplied

• medicines name, quantity, form and strength

• prescriber’s name and address

• date written on the prescription

when should a dispensing record be made and what is the exemption?

• on the day of sale/supply. next day if this is not possible

• Regulation 224 = for practitioner emergency supply request, the dates can be added later when the pharmacy get the prescription

how long must private prescription records be kept?

2 years

when is a Regulation 253 pharmacy-record entry not required?

• when the supply is recorded in the CD register

• for health prescriptions (ordinary NHS prescriptions) convered by the exemption

• for oral contraceptive prescriptions covered by exemption

what order should information be entered into the private prescription register for the dispensing exam?

1. patient name and address

2. medicine name, quantity, form and strength

3. prescriber name and address

4. date on the prescription

5. date supplied to the patient

6. left margin = audit reference number

7. right margin = price charged

dont forget the 2 different dates (prescription and supply date)

what is an emergency supply of a POM and what are the 2 routes?

allows pharmacy to supply a POM without having a legal prescription

1. Regulation 224 = emergency supply at the request of a prescriber

2. Regulation 225 = emergency supply at the request of a patient

both routes require a pharmacy record under Regulation 253 and Schedule 23

what are the legal requirements for the emergency supply at a practitioner’s request?

Regulation 224

• pharmacist must be satisfied that it is an emergency

• prescriber can’t give a prescription immediately

• prescriber must give the prescription within 72 hours

• medicine must be supplied to the prescriber’s directions

• CDs excluded (apart from phenobarbital)

• pharmacy record required (Regulation 253, Schedule 23, paragraph 2)

what are the legal requirements for emergency supply at a patient’s request?

Regulation 225

• pharmacist must interview patient

• there must be an immediate need for the POM

• it must be impractical to get a prescription

• the medicine must have been previously prescribed

• pharmacist must be satisfied that the dose is appropriate

• pharmacy record required (Regulation 253, Schedule 23, paragraph 4)

what CDs are excluded from emergency supply?

• Schedule 2 and 3 CDs cannot be supplied apart from phenobarbital/sodium for epilepsy

• Schedule 4 and 5 CDs can be supplied when relevant conditions are met = max 5 days treatment

maximum quantities allowed for emergency supply at a patient’s request

Regulation 225

• insulin = smallest available pack

• asthma aerosol = smallest available pack

• ointment/cream = smallest available pack

• oral contraceptive = one full treatment cycle

• oral liquid antibiotic = smallest quantity for a full course

• Schedule 4 or 5 CD = 5 days treatment

• other POMs = 30 days treatment

what must be recorded for emergency supply at a practitioners request?

Regulation 253 and Schedule 23

• date of supply

• medicine details

• prescriber’s name and address

• patient’s name and address

• prescription date and the date the prescription was received

what must be recorded for emergency supply at a patients request?

Regulation 253, Schedule 23

• date of supply

• medicine details

• name and address of the person requesting the medicine

• nature of the emergency

what are the labelling requirements for the emergency supply at a patient’s request?

Regulation 225, paragraph 6

• “Emergency Supply”

• date of supply

• medicine details

• name of patient

• pharmacy name and address

what must the pharmacist consider when deciding how much medicine to supply in an emergency?

• follow relevant legal quantity limits

• use professional judgement

• record emergency supply as legally required

what is a requisition?

a formal request for a medicine or supply, needed for professional use. it is not a prescription for a named patient

what is a signed order?

a written requisition signed by an entitled person

what must the pharmacist check before supplying medicines against a signed order?

• who is requesting it. are they legally entitled?

• what medicine is being requested

• quantity requested

• intended professional use

• whether the relevant legal exemption permits the supply

• which records must be kept

what information should be included in a professional-use signed order?

• name and address of the supplying pharmacy

• statement requesting the medicine for professional use

• medicine name, strength and formulation

• quantity requested

• requester’s name and professional status

• practice details

• requester’s signature

• date

which legislation permits certain professional-use supplies under a signed order?

• HMR 2012, Regulation 235, Schedule 17

• medicine must be permitted for that particular profession

• pharmacist must check relevant exemption before supplying

• required order and supply records must be kept

what is a Midwife Supply Order?

a separate mechanism for certain CD supplies under the Misuse of Drugs Regulations 2001, Regulation 11