legal requirements for POM's Flashcards
Human medicines regulation 214
(1) a person may not sell or supply a pom except in accordance with a prescription given by a practitioner.
(2) a person may not parenterally administer a pom unless it is given by
(a) an appropriate practitioner other than an EEA health professional ; or
(b) acting in accordance with the directions of such an appropriate practitioner
(3) the following are appropriate practitioners in relation to any POM-
(a) a doctor
(b) a dentist
(C) a supplementary prescriber
(d) a nurse independent prescriber
(e) a pharmacist independent prescriber
(4) a community practitioner nurse prescriber is an appropriate practitioner in relation to a POM specified in schedule 13
(5) an optometrist independent prescriber is an appropriate practitioner in relation to a pom other than
(a) a medicinal product that is a CD
(b) a medicinal product that is for parenteral administration
(6) An EEA health professional is an appropriate practitioner in relation to any POM other than a CD
(7) this regulation is subject to chapter 3 ( exemptions )
Human medicines regulation 217
(1) for the purpose of this chapter , a pom is not sold or supplied in accordance with an appropriate practitioner unless the following conditions are met
(2) condition A is that the prescription is signed in ink by the appropriate practitioner giving it
(3) condition B is that the prescription -
(a) is written in ink or otherwise so as to be indelible
(b) in the case of a health prescription which is not a controlled drug , is written as described in sub paragraph (a) or by means carbon paper or similar
(4) condition C is that the prescription contains the following particulars
(a) the address of the appropriate practitioner giving it
(b) the appropriate date
(c) an indication of the king of appropriate practitioner giving it
(d) the name and address of the person whose the treatment it is giving
(e) if that person is u12 , that persons age
(5) condition D is that the prediction -
(a) is not dispensed after the end of the period of 6 months beginning with the appropriate date; or
(b) in the case of a repeatable prescription -
(i) it is not dispensed for the first time after the end of that period , and
(ii) it is dispensed in accordance with the directions obtained in the prescription
(6) condition E is that , in the case of a repeatable prescription that does not specify the number of times it may be dispensed -
(a) it is not dispensed on more than 2 occasions
(b) in the case of a prescription for an oral contraceptive , it is not dispensed on more than 6 occasions or after 6 months beginning with the appropriate date
(7) in this regulation “appropriate date “ means , subject to para 8 -
(a) in the case of a health prescription , whichever is the later of -
(i) the date on which it was signed by the appropriate practitioner giving it or
(ii) a date indicated by the appropriate practitioner as the date before which it should be dispensed ; and
(b) otherwise, the date on which the prescription was signed by the appropriate practitioner giving it
(8) this regulation
(a) does not apply to a prescription given by an EEA health professional
(b)is subject to regulation 219 ( electronic prescriptions )
what schedule drugs are repeatable/non repeatable
schedule 2+3 are not repeatable
schedule 4+5 are repeatable
Human medicines regulation 253
(1) a person lawfully conducting a retail pharmacy business must , in respect of every sale or supply of a pom , make or cause to be made an entry in a written or computerised record kept for that purpose .
(2) an entry required by paragraph (1)-
(a) must state the particulars specified in schedule 23 and
(b) subject to paragraph 3 must be made -
(i) on the day of the sale or supply , or
(ii) if that is not reasonably practicable , on the day following that
(3) where the sale or supply is made under regulation 224 ( emergency sale) , the particulars specified in paragraph 2(e) and (f) of schedule 23 may be entered on the day that the prescription is received
(4) paragraphs (1) to (3) do not apply if any of the following apply
(a) the sale or supply is in pursuance of a health prescription or a prescription for oral contraceptives
(b) a separate record of the sale or supply is made in accordance with the misuse of drugs regulations 2001 or the misuse of drugs regulations (N.I) 2002
(c) the sale is by way of wholesale dealing and the order or invoice relating to the sale or a copy of the order or invoice is retained by the person lawfully conducting the retail pharmacy business who makes the sale
(d) in scotland , the sale or supply is to a doctor for use in the circumstances referred to in paragraph 45 of schedule 5 to the national health services regulations 2004
(e) in Northern Ireland , the sale or supply is to a doctor for use in the circumstances referred to in paragraph 47 of schedule 5 to the health and person social services regulations 2004
(5) a person lawfully conducting a retail pharmacy business must preserve for a period of 2 years beginning immediately after the relevant date -
(a) the record kept under paragraph 1 to 3
(b) a prescription in pursuance of which a pom has been sold or supplied other than -
(i) a health prescription
(ii) a prescription for a controlled drug
(c) an order or invoice referred to in paragraph 4c or a copy of the order or invoice
(d) orders referred to in column 3 of parts 1 to 3 of schedule 17, except orders referred to in paragraph 3 of part 1 of that Schedule
schedule 23: requirements for a prescription record
date of supply
the name , quantity , the pharmaceutical form and strength of the pom sold or supplied
the name and address of the person giving the prescription
the name and address of the patient
the date on the prescription
in relation to the emergency sale or supply of a pom the date on which the prescription relating to that sale or supply is received
repeat : the date and the reference of the first entry
emergency only : the nature of the emergency
EEA prescribers - prescription must contain
patient full first name , surname , date of birth
prescriber details : prescriber first full name , surname , professional qualifications , direct contact details including email address and telephone or fax number with international prefix and work address including the country they work in
prescribed medication details : name, strength , form and dosage
prescriber signature
date of issue
medications that can be used in an emergency
adrenaline injection
atropine sulphate injection
atropine sulphate and obidoxime chloride injection
atropine sulphate , pralidoxime messmate and avizafone injection
chlorophenamine injection
dicolbat edetate injection
glucagon injection
glucose injection 50%
hydrocortisone injection
naloxone hydrochloride injection
pralidoxime chloride injection
pralidoxime mesilate injection
promethazine hydrochloride injection
snake venom antiserum
sodium nitrate injection
sodium thiosulphate injection
sterile pralidoxime
HMR 226
dealing with pandemic emergency supplies
