Flashcards in 3. Legislation And Professional Issues Deck (46):
What consolidates most of the legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the medicines act 1968?
The human medicines regulations 2012
Name the three classes of medicinal products for humans under the human medicines regulations 2012
General sale (GSL)
Prescription only (POM)
Why is there restrictions on the quantities of selling pseudoephedrine and ephedrine?
Due to their potential for misuse in the illicit production of methylamphetamine (Crystal meth) - a class A controlled drug
Max quantity of pseudoephedrine that can be sold without a prescription
Max quantity of ephedrine that can be sold without a prescription
True or false: you can sell a pseudoephedrine product at the same time as an ephedrine product
FALSE - this would be unlawful
Licensing for levonorgestrel 1500mcg (EHC)
For women aged 16 years or over for emergency contraception within 72hours of unprotected sexual intercourse or failure of contraception method
Licensing for ulipristal (EHC)
Emergency contraception within 120 hours (five days) of unprotected sex
Legal restrictions of non-effervescent paracetamol tablets OTC?
Not more than 100 - most pack sizes are 16 or 32
Legal restrictions of non effervescent OTC aspirin
Not more than 100 - most are packs of 16 or 32
Pack size of OTC codeine and how many days can it be used for?
Name two antitussives
Name two expectorants
Name 5 nasal decongestants
Name 6 antihistamines
17 yr old wants codeine linctus for dry unproductive cough
No! Has to be 18 or over
7 legal requirements on a prescription
Address of practitioner
Particulars of practitioner
Name of patient
Address if patient
Age of patient (if <12)
Private prescriptions for a POM must be retained for how long from the date of the sale or supply or for repeatable prescriptions from the date of the last sale or supply?
How long should a POM book be retained for?
2years from date of last entry
What five things should be in a POM book
1) supply date
2) prescription date
3) medicine details
4) prescriber details
5) patient details
What medicines are not available on an EEA prescription?
Schedule 1,2 and 3 CDs and medicinal products without a marketing authorisation
Emergency supply at the request of a prescriber: when should the prescriber give the prescription by?
Can you supply CDs in an emergency?
Only schedule 4,5 and phenobarbital for epilepsy
If supplying schedule 4,5 or phenobarbital as emergency supply how many days can you give?
Emergency supply (not including CDs) can be for how long treatment?
30 days- unless insulin, creams, inhalers, COC I.e packs not to be broken
Who can provide a signed order for salbutamol inhalers for a school?
Written order signed by the principal or head teacher at the school
What info should be included in the signed orders for salbutamol for a school
Signed by principal/head teacher
Name of school
Purpose for product
Total quantity required
Do regulated poisons require additional record keeping in a poisons register
When medicines are dispensed from an 'in-house' pharmacy for administration or supply to patients within a prison, the pharmacy does NOT need to be registered with the GPhC - true or false?
MHRA requires homeopathy to demonstrate efficacy, quality and safety
False doesn't need to demonstrate efficacy
What licensing do herbal remedies require
Full marketing authorisation based upon efficacy, quality and safety or a traditional herbal registration (THR) based upon efficacy, quality and safety
All medical devices are regulated by what
Medicines and healthcare products regulatory agency (MHRA)
All medical devices are required to carry what mark denoting compliance with the medical devices regulations
Name the four groups under the new psychoactive substances
What extra details are required on vet CD prescriptions (schedule 2 and 3)
Prescribed for the treatment of an animal or herd under my care and the royal college of veterinary surgeons (RCVS) Reg number
What's the points of the veterinary cascade
To allow the supply of medicines that are not licensed for animals
How long do you keep veterinary documents/records for
At least 5 years
What are the 9 GPhC standards for pharmacy professionals
1) provide person centred care
2) work in partnership with others
3) communicate effectively
4) maintain, develop and use professional knowledge and skills
5) use professional judgement
6) behave in professional manner
7) respect and maintain the persons confidentiality and privacy
8) speak up when they have concerns or when things go wrong
9) demonstrate leadership
Who is the regulator for pharmacists, pharmacy technicians and registered pharmacy premises in England, Scotland and Wales
General pharmaceutical council
What is the pharmacy record
An important legal document that shows who the responsible pharmacist is at any given date and at any time
How should the pharmacy record be kept?
In writing, electronically or in both forms
Who must maintain the pharmacy record
The responsible pharmacist
How long should the pharmacy record be kept for
At least five years
Electronic: 5yrs from day the record created
Written: 5yrs from the last day to which record relates
The responsible pharmacist may be absent for up to how long during the working hours (including if there was two responsible pharmacists)
Max 2 hours
Information that's included on the pharmacy notice
Your registration number
That you are the responsible pharmacist in charge of that registered pharmacy premises