Law Records & Prescription Requirements PDF

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Record-Keeping Requirements 1. POM Register – Kept for 2 years in the pharmacy from LAST DATE OF ENTRY,

electronic OR bound book acceptable. Hospital pharmacies only need POM register when registered with the GPhC!! Used in 6 cases      

Private POM (LEGAL) Private CD (GOOD PRACTICE) Private POM – With Repeat (LEGAL) Emergency Supply at the request of a PATIENT (LEGAL) Emergency Supply at the request of a PRESCRIBER (LEGAL) Veterinary Prescription (LEGAL) – Vet prescriptions are private prescriptions, hence need to go in POM register as well!! VMP records are ONLY FOR RECORDING TRANSACTIONS INVOLVING VETERINARY MEDICINAL PRODUCTS!! DO NOT CONFUSE!!

Requirements For private POM, private CD, & Vet prescriptions (SAME REQUIREMENTS)  Date of sale  Date of Rx  Name & address of prescriber  Name & address of patient  Drug name, quantity. Form & strength ONLY REQUIRED WHEN CANNOT TELL FROM NAME. E.g. paracetamol TABLETS 500MG. No need form & strength in record. BUT if drug name is insulin. Need to put “injection, 30 mg/ml”.  Reference number. For private POM with repeats  Date of sale  Date of Rx  Date of FIRST SUPPLY  Name & address of prescriber  Name & address of patient  Drug name, quantity. Form & strength ONLY REQUIRED WHEN CANNOT TELL FROM NAME. E.g. paracetamol TABLETS 500MG. No need form & strength in record. BUT if drug name is insulin. Need to put “injection, 30 mg/ml”.  Reference number.  Reference number of FIRST SUPPLY For emergency supplies (at the request of a patient)  Date of sale  Name & address of patient  Drug name, quantity, (form & strength where appropriate).  Nature of the emergency

For emergency supplies (at the request of a prescriber)  Date of sale  Date on prescription  Date when prescription IS RECEIVED (Must be within 72 hours – this is the responsibility of the prescriber, NOT the pharmacist)  Name & Address of patient  Name & Address of practitioner  Name, quantity, (form & strength where appropriate) -Nature of the emergency IS NOT REQUIRED.

Confusing differences     

Private POMs & private CDs 2x date & 2x name+address. However, emergency supply at request of patient only 1x date & 1x name+address. (There is no prescriber) Emergency supply at the request of a prescriber 3x dates & 2x name&address. Emergency supply also no reference number – there is no prescription to write the reference number on. Private POM with repeat - 3x dates!

2. CD Register - Kept for 2 years in the pharmacy from LAST DATE OF ENTRY.

Book ONLY! NO electronic records!!! Used in 2 cases  

Schedule 2 CD – NHS (LEGAL) Schedule 2 CD – Private (INCLUDING VET) (This goes into the POM register as well) (LEGAL)

Requirements For NHS CD & private CD (SAME REQUIREMENTS) – For buying AND selling CDs  Date of sale/supply ONLY – DATE ON THE RX NOT REQUIRED!  Name & address of prescriber  Name & address of patient  Drug class*, strength & form (At the top/head of the register)  Drug quantity Other general CD register requirements (NONE OF THESE REQUIRED IN POM REGISTER!):  Chronological  Each class of drugs written is a separate SECTION in the register.  Each form & strength of the same drug class is in a separate PAGE in the register.

Confusing differences with POM REGISTER    

Date of Rx is NOT required in CD register (1 date only!!) CD register includes stock IN AND OUT. The POM register is only for selling (stock OUT). Drug CLASS is required in CD register; in POM register the drug NAME is required. STRENGTH & FORM IS ALWAYS REQUIRED..NOT ALWAYS IN THE POM REGISTER No reference number required in CD.

1x date

3. VMP Record – Kept for 5 years from the last entry! Electronic/book both

acceptable Used in 1 case 

When there is a transaction involving A LICENSED VMP ONLY! DOES NOT APPLY FOR HUMAN MEDICINES PRESCRIBED FOR ANIMALS! (Prescribing under the cascade)

Requirements For VMPs – For VETERINARY MEDICINAL PRODUCTS ONLY  Date of sale/transaction ONLY – DATE ON THE RX NOT REQUIRED!  Name & address of prescriber (if applicable)  Name & address of patient/supplier  Drug name – NO NEED FORM & STRENGTH!!  Drug quantity Other unique vet requirements (NONE OF THESE REQUIRED IN POM REGISTER/CD REGISTER!):  Batch number for FPA

Confusing differences/similarities with POM REGISTER/CD REGISTER   

Date of Rx is NOT required in VMP register (1 date only!!) (SAME AS CD REGISTER) Vet register includes stock IN AND OUT. The POM register is only for selling (stock OUT). (SAME AS CD REGISTER) NO NEED DRUG FORM & STRENGTH!!

CD REGISTER & VMP REGISTER BOTH ONLY 1 DATE REQUIRED!!! BOTH are for STOCK IN AND STOCK OUT!!! 1x date

4. Pharmacy Record – Kept for 5 years. Electronic/book both acceptable Used in pharmacy – not for recording prescriptions Legal Requirements     

Pharmacist name Registration number Date & time when started becoming Responsible Pharmacist Date & time when stopped becoming Responsible Pharmacist Date & time of absence

Good Practice Requirements    

Completed by pharmacist personally Amendments should identify who made them Complete in real time Back up electronic records

3x dates Poisons Record Only for S1 poisons. All S1 poisons sale must be supervised by pharmacist EVEN if the poison is classified as a part 2 poison. Requirements  Date  Name & address of purchaser  Name & address of householder (if there is householder certificate)  Name & quantity of poison sold  Purpose  Occupation of purchaser  SIGNATURE OF PURCHASER!

Labelling Requirements All dispensed products (Including CDs – CDs no special labelling requirements) From MEP: When a medicinal product is dispensed there is a legal requirement for the following to appear on the dispensing label:  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 The RPS recommends the following also appears on the dispensing label (Good practice):  “Keep out of the sight and reach of children”  “Use this medicine only on your skin” where applicable.

Emergency supplies From MEP: Labelling – in addition to standard labelling requirements, the words “Emergency supply” needs to be added to the dispensing label. (ONLY FOR EMERGENCY SUPPLY AT THE REQUEST OF A PATIENT – AT REQUEST OF PRESCRIBER NO NEED)

Veterinary medicines SPECIAL LABELLING REQUIREMENTS ONLY FOR MEDICINES PRESCRIBED UNDER THE CASCADE! IF THE PRODUCT IS A VMP, A LABEL IS NOT LEGALLY REQUIRED! (Unlike normal human medicines, where a label is always required) From MEP: When a medicine is supplied by a pharmacy for use under the cascade, the following details must appear on the dispensing label unless they already appear on the packaging and are not obscured by the dispensing label:  Name of the prescribing veterinary surgeon (ADDRESS & TELEPHONE NOT REQUIRED! ONLY REQUIRED IN PRESCRIPTION!)  Name and address of the animal owner = Name of patient  Name and address of the pharmacy = Name and address of the supplying pharmacy  Identification and species of the animal  Date of supply = date of dispensing  Expiry date of the product  The name or description of the product or its active ingredients and content quantity = Name of medicine  Dosage and administration instructions = Directions for use  If appropriate, special storage instructions  Any necessary warnings for the user (e.g. relating to administration, disposal, target species, etc) = Precautions related to the use of the medicine  Any applicable withdrawal period (i.e. The time between when an animal receives a medicine and when it can safely be used for food)  The words: “For animal treatment only”  The words: “Keep out of reach of children” – This is a legal requirement in vet label, good practice in normal labels.

Restrictions on days of supply Good practice restrictions      

Normal POMS – No restrictions. Normal CDs (Schedules 2,3,4) – 30 days Normal CDs (Schedule 5) – No restrictions Veterinary CDs – 28 days Emergency supply at the request of a PRACTITIONER (CD – Phenobarbital for epilepsy + Sch 4) – 30 days (Treat as normal CD) Emergency supply at the request of a PRACTITIONER (CD Schedules 5) – No limits

Legal restrictions   

Emergency supply at the request of PATIENT (POM) – 30 days Emergency supply at the request of PATIENT (CD – All schedules that can be supplied) – 5 days Emergency supply at the request of a PRACTITIONER (POM) – No restrictions

Other Points   

Repeat prescriptions ≠ NHS Repeat dispensing ‘Personal control’ ≠ ‘Supervision’(Supervision = sale of P medicines, still in use now) The responsible pharmacist must remain contactable by mobile phone/other means, OR arrange for another pharmacist to be contactable. Doesn’t mean that sale of P medicines can continue when the pharmacist is absent. Supervision can’t be done through mobile phone. (Have to be in a position to intervene when necessary....