POMs, GSLs, Ps And POs Flashcards
What does P stand for?
Pharmacy Medicine
What does GSL stand for?
General Sale List
What does PO stand for?
Pharmacy only medicine
What is a GSL?
A medicinal product that is not a prescription only medicine or a pharmacy medicine (P) but has an authorisation which states that it is to be available on general sale
This authorisation may be:
UK marketing authorisation/ THR/ article 126a
These are MPs that with reasonable safety, can be sold or supplied without supervision of the pharmacist, they are obtainable from any lockable premises eg. A supermarket
Examples of things that aren’t usually GSLs?
Eye ointments
parenterals
Anthelmintics
Enemas
Aspirin containing products for children
Vitamin A and D containing products over a certain amount
paracetamol/aspirin if sold over certain pack sizes get classified as P
Limits get imposed on the pack sizes of certain GSL products when they’re sold from non pharmacy businesses (eg supermarkets) eg?
Paracetamol-16 tablets
Aspirin 75mg- 28 tablets
Ibuprofen- 16 tablets
What is a PO?
A substance which contains GSL ingredients but is licensed for sale through pharmacies only. Examples: Fybogel sachets Gaviscon Advance Cystemme cystitis sachets
Note: PO is not an official class of medicinal product under the HMR (Human medicines regulations)
What is a P medicine?
A product that is not a POM product or a medicinal product subject to general sale but it covered by an authorisation which states it should only be available from a pharmacy
These MPs require more control than GSLs
Examples;
Larger quantities, higher concs and higher doses of GSLs
Mix of two GSLs= P
Made up in pharmacy and it’s ingredients aren’t POM
They’re obtainable only from registered pharmacies with a responsible pharmacist present
Where / by who can P medicines be supplied?
A person lawfully running a retail pharmacy
From premises that are a registered pharmacy
Acts under supervision of a pharmacist
What are retail sales?
Any sales that don’t fall into the meaning of wholesale dealing
What does supervision mean?
The pharmacist must be aware of what is going on and must be in a position to intervene in a transaction
What 7 types of MPs are POM?
MPs with a marketing authorisation which classifies it as a POM
MPs that are controlled Drugs
MPs for parenteral administration.
Radioactive MPs
Aloxiprin, aspirin and paracetamol products
Pesuedoephedrine and ephedrine products
Cyanogenetic substances
A person may not parenterally administer (unless to himself) a POM unless the person is?
An appropriate practitioner
Acting in accordance with the direction of such an appropriate practitioner
Who are classed as appropriate prescribers of medicines for human use?
Doctor, dentist, nurse independent prescriber, supplementary prescriber, pharmacist IP, optometrist IP, community practitioner nurse prescriber (but only certain POMs)
Ephedrine and pseudoephidrine are exemptions from POM classification under certain circumstances.
Although it is unlawful to supply the following without a Rx:
Product containing more than 720 mg pseudoephidrine or 180 mg ephedrine
A product containing ephedrine with a product containing pseudoephidrine together in one transaction.
All controlled drugs are POMs but __ CDs may be P medicines under certain conditions….
6 CDs
How long are new medicinal products a POM for after first
Iicensing unless there is existing evidence of safety?
For 5 years after first licensing
When can a MP switch from POM to P?
When MP is safe to be supplied without a prescription and not likely to be dangerous without prescriber supervision, or normally prescribed for parenteral admin. usually takes around 5 years
P-> POM if new risks are identified which need a prescriber to be involved eg a bad drug interaction.
Example: terfendinine (antihistamine)
When can an MP switch from P to GSL?
When an MP is safe to be supplied without the supervision of a pharmacist….
GSL-> P when MP is not longer safe to be supplied without supervision of a pharmacist
What are codeine and dihydrocodeine indications?
Short term treatment of acute moderate pain that is not relived by paracetamol, aspirin or ibuprofen alone
What is the maximum pack size of codeine and dihydrocodeine?
Max 32 doses
What labels and PIL info need to be present with codeine and dihydrocodeine?
“can cause addiction. For 3 day use only”
Can cause headache if use for over 3 days
PIL should give info on warning signs of addiction
Indication must be stated
Medicines containing antitussives, expectorants, nasal decongestants and antihistamines should NOT be used for _____
Children
Cough and cold medicines usually contain these
what's the legal class of: Common salt
OSodium Chloride BP
OSalt (Sodium Chloride) Tablets BP
OSodium Chloride Mouthwash BP (made up in the Pharmacy)
OSodium Chloride Injection
OCommon Salt. NOT a MP. (just salt-food!)
OSodium Chloride BP= GSL
OSalt (Sodium Chloride) Tablets BP= GSL
OSodium Chloride Mouthwash BP (made up in the Pharmacy)= P
OSodium Chloride Injection= POM (parenteral!)
What is the legal class of: OIbuprofen Tablets 400mg for headache
OInjection of Hydrocortisone 100mg/ml
OParacetamol Tablets 500mg 16
OChloramphenicol 0.5% Eye Drops 10ml
OWater for injection 10ml
OIbuprofen Tablets 400mg for headache = P
OInjection of Hydrocortisone 100mg/ml = POM
OParacetamol Tablets 500mg 16 = GSL
OChloramphenicol 0.5% Eye Drops 10ml = POM or P
OWater for injection 10ml = POM
What is a POM?
They’re obtainable by wholesale dealing, they can only be supplied when a prescription is present.
Eg a practitioner may obtain a POM by wholesale from a pharmacy or wholesaler
What 4 ways is a member of the public able to obtain a POM?
Against a valid prescription from a practitioner
Emergency supply at request of doctor/ patient
By a Patient Group Direction
Who are Private POM prescriptions funded by?
The patient
So you don’t send it to NHS BSA
Are repeat prescriptions allowed on private prescriptions?
Yes
What colour are NHS private prescriptions?
PINK
Can be FP10CDSS and FP10CDNC
Are veterinary prescriptions private or NHS?
PRIVATE
You can’t get vetinary NHS prescriptions- No NHS for animals!!
Who pays for NHS prescriptions?
Usually NHS- SEND to NHS PPD
But some patients may pay £7.65 per item!
What colour are prescriptions supplied to primary/ secondary care patients and what different forms are there?
Green
FP10NC
FP10HNC
FP10SS
What are Blue FP10 prescriptions for?
Drug misuse instalment prescribing
FP10MDS-S are the ones give by GPs
FP10MDA-SP given by supplementary prescribers
FP10HMDA given by hospital doctors
What are Yellow FP10 forms used for?
Dentist prescriptions
Called FP10D
What are Lilac FP10s?
nurses prescriptions
FP10PN-practice nurses
FP10CN- community nurses
FP10SP- supplementary prescribers
How is a pharmacist paid for NHS prescriptions?
By REIMBURSEMENT Payment for costs incurred (Drugs) And by REMUNERATION Ie payment for their work Prescriptions get sent to the Prescription pricing division every month
A POM prescription must not be dispensed more than 6 months after the appropriate date on the prescription unless?
Unless its a repeatable prescription
Unless its a CD (28 days)
A repeatable Rx not specifying the number of repeats may be dispensed no more than ____ unless it’s an Oral contraceptive which may be dispensed ___ times within 6 months of the appropriate date on the Rx..?
No More than twice
Oral contraceptive may be dispensed SIX times within 6 months
When are repeats NOT allowed?
Not allowed on FP10 NHS prescriptions, or any prescription for a controlled drug!
Remember they must be dispensed for the first time within 6 months of the appropriate date
All supplies of POMs must be recorded in a POM book except when?
It’s an NHS prescription, only private POM book entries need to be made.
Any prescriptions for an Oral contraceptive do not need to be written in a POM book.
A Seperate record is done for a CD (CD register)
Don’t need to do if sale/ supply is by wholesale dealing, as long as the invoice is kept for 2 years
Don’t need to do one if the supply is made in connection with the NHS drug testing scheme
What are Signed orders all about?
They’re classed as a Wholesale transaction
They enable organisations and Health care professional to obtain POMs from a pharmacy for their PROFESSIONAL USE
What needs to be done with Signed orders?
Signed order should state “for use in my practice”
Pharmacist needs to make a POM entry that gives details of the supply, or keep the signed order or copy of the order
Done for good practice/ VAT records
Person that requests the Medication Pays for them
For signed orders, what must the packs supplied be?
Must be complete packs
Must not be labelled
What EEA health professionals can request an emergency supply?
Must be engaged in medical/ dentist practice in EEA state or Switzerland,
Can be a doctor or a Dentist
What’s the only CD that can be given as an emergency supply apart from Schedule 4 and 5 CDs?
Phenobarbital for treatment of Epilepsy
When given an emergency supply, a POM book record must be made within _____
24 hours
With an emergency supply at the request of a patient, who pays for the drug?
The patient
They aren’t funded by the NHS
What’s the maximum length of time you can supply a CD for on an emergency supply? (must be Sch 4 or 5 CD or phenobarbital)
What about for POMs?
CD: Maximum 5 days
For POM maximum is 30 days
Insulin, ointments, cream or aerosols: supply smallest available
Oral contraceptive: supply a COMPLETE cycle
Liquid antibiotics: supply smallest complete course
What needs to go in POM book with emergency supply’s at request of a PATIENT?
Date of supply
Quantity, name, form, strength
Patients name and address
NATURE of emergency
(don’t need date on Rx as you won’t be getting one!)
What needs to go on the LABEL of an emergency supply at request of a patient?
Date of supply Quantity, name, form, strength Directions The words "emergency supply" Ref number Name and address of pharmacy
Can you obtain GSLs from vending machines?
Yes!! MHRA says you can as long as they’re in lockable premises
GSLs can be supplied as long as theyre in lockable premises, unopened packaging, and they’ve been made elsewhere.
When is an emergency supply at request of a patient NOT permitted?
If the POM is a controlled drug, specified in schedules 1,2,or 3 of misuse of Drugs Regulations EXCEPT for phenobarbital/ phenobarbital sodium used to treat EPILEPSY, this applies to both emergency supply for a patient at request of a patient and at request of a doctor
Or if The POM is included in a prescribed list
When can Sch 2 and 3 CDs be supplied emergency supply?
Only directly to a DOCTOR (Not a patient) by means of WHOLESALE DEALING
But the doctor must undertake a supply Requisition within 24 hours!!
Plus appropriate records must be made into the CD register
What is a patient Group Direction?
A written set of directions which relates to the supply and/ or administration of a POM to persons generally (a group of people) and is signed by a doctor or dentist AND by a pharmacist.
These are used to assist a doctor or dentist in the provision of NHS primary medical/ dental services
Note: NO prescriptions are needed, this is NOT a form of prescribing!!
Usually done for POMs, but can be done for P,GSL and CDs in certain circumstances
Who do Patient Group Directions (PGDs) need to be signed by?
By a doctor or dentist AND by the pharmacist
And by any other person who may be required to sign it
Some examples of patient group directions?
Flu vaccinations in a pharmacy
Weight loss clinics in pharmacy
Chlamydia treatment
What people are permitted to supply or administer drugs under Patient group directions (PGD)?
Pharmacists Registered nurses Registered midwives Chiropodists Radiographers
What need to be detailed/ included in the PDG?
Clinical condition
Description of the treatment
Characteristics of the pharmacist / other health care professional
Management of the PGD
The availability of Levonelle One Step (morning after pill) as a P medicine (ie doesn’t need a prescription)
Can get it from a registered pharmacy, sold under supervision of a pharmacist
Pharmacist must deal with supply personally (not anyone else)
Patient needs necessary advice and info
Handle request sensitively
What about Levonelle 1500?
It’s a POM
Can supply against a valid prescription
As an emergency supply at request of a Doctor
As an emergency supply at request of a patient POSSIBLY
Can supply in accordance with Patient Group Direction
What happens with signed order Records?
For POM signed orders: record in POM book, retain for 5 years
If its a wholesale transaction: no record legally required, but the signed order form must be retained for 2 years
NHS prescriptions. Are Records needed for P, GSLs? What about POMs?
No records needed for any as they’re NHS
Are any records needed for NHS prescriptions for CD Schedule 2 drugs?
Yes
CD register entry legal requirement
What records are needed for Private prescriptions for GSL & Ps? What about POM?
GSL and P: POM book entry is GOOD PRACTICE
POM: record in POM book is a LEGAL requirement
What records are needed for Private prescriptions for CD Sch 2 drugs?
CD register entry is legally required
POM book entry can be made for good practice
FP10PCD send to NHS PPD, and a photocopy kept in the pharmacy for 2 years
What should you do with the following Prescriptions after they've been dispensed: FP10 Private GSL/ POM Private POM FP10CD
FP10: retain these until the end of the calendar month and then send to the Prescription Pricing Division (PPD)
Private GSL/ POM: Endorse these and Return to Patient
Private POM: retain in pharmacy for two years, (unless repeatable then return to patient until the final supply is made, then keep for 2 years)
FP10CD: send to PPD, and Retain a PHOTOCOPY in the pharmacy for 2 years. Remember Repeats of CDs aren’t allowed!!
When can a person Parenterally administer a POM medicine?
The only person that can administer it is the patient themself, an appropriate practitioner, or someone acting in accordance with the directions of the appropriate practitioner
Certain injections may be administered objecting to this rule of I’m an emergency for the purpose of life saving
What POM injections may be given without advice of a practitioner In order to save a life?
Adrenaline injection, BP
Chloramphenamine injection
Hydrocortisone injection BP
Snake Venom Antiserum
How long has the doctor got to get a prescription to you I’m the case of an emergency supply at doctors request?
72 hours
What is now needed for wholesale dealing to take place?
A wholesale dealers license!
How long should private Rxs be kept for?
2 years
How long should CD registers be kept for?
2 years minimum after last recorded entry!!
How long should POM books be kept for?
2 years
How long should signed orders be kept for?
2 years if wholesale
5 years if POM entry made
What colour should paracetamol or aspirin sold or supplied be?
Must be white
How long should invoices be kept?
2 years
