Legislation & Professional Issues Flashcards
Covering Chapter 3 of MEP.
What are the 3 classes of medicinal products for humans?
1 - General Sales List (GSL)
2 - Pharmacy (P)
3 - Prescription Only Medicines (POM)
Where can GSL products be sold?
In pharmacies and other retail outlets.
Where can P products be sold?
Only from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist.
True or False - POM products can be sold OTC.
False.
When can POM’s be supplied?
When a prescription written by an appropriate practitioner has been supplied.
Who is an appropriate practitioner available to request POM’s?
- Doctor
- Dentist
- Supplementary Prescriber
- Nurse Independent Prescriber
- Pharmacist Independent Prescriber
- EEA and Swiss Doctors and Dentists (but not for all CD’s)
- EEA and Swiss Prescribing Pharmacist and
Prescribing Nurse (where they exist) - Community Practitioner Nurses (for a limited selection of POM’s)
- Optometrist Independent Prescribers (not for CD’s, or parenteral medicines)
- Podiatrist
- Physiotherapist
- Therapeutic Radiographer Independent Prescribers (for certain medicines see section 3.3.15)
What are pseudoephedrine and ephedrine used for in pharmacy?
Decongestants.
What are the signs of misuse of pseudoephedrine and ephedrine OTC products?
- Lack of symptoms - not suffering from cough, cold or flu symptoms, or unable to describe these in the patient
if buying for someone else. - Rehearsed answers - gives answers that appear to be rehearsed or scripted.
- Impatient / Aggressive - in a rush or hurrying to complete the transaction.
- Opportunistic - waiting for busy periods in the shop or until less experienced staff are available.
- Specific products - wants certain brands that contain only pseudoephedrine or ephedrine.
- Paraphernalia - wishes also to purchase other items which can be used to manufacture methylamphetamine (e.g. lithium batteries, chemicals such as acetone).
- Quantities - requests large quantities.
- Frequency - makes frequent requests.
Why is the sale of OTC pseudoephedrine and ephedrine products restricted?
They can be used to produce methylamphetamine.
What is the maximum amount of pseudoephedrine and ephedrine that can be sold in 1 transaction OTC?
A product or combination of products that contain more than:
- 720mg of pseudoephedrine
OR
- 180mg of ephedrine.
True or False - A pseudoephedrine product can be sold at the same time as an ephedrine product.
False - it is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription.
When can the sale or supply of pseudoephedrine or ephedrine be refused?
If there’s reasonable grounds for suspecting misuse.
Who can suspicions of pseudoephedrine and ephedrine misuse be reported to?
- Local GPhC inspector
- Local CD liaison police officer / accountable officer
What 2 drugs are available for use OTC as EHC?
- Levonorgestrel 1500 microgram tablet (Levonelle)
- Ulipristal acetate 30mg tablet (EllaOne)
What is the licensing for each drug available for EHC?
- Levonorgestrel is licensed for women aged 16 years or over for emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.
- Ulipristal acetate is licensed for emergency contraception within 120 hours (five days) of unprotected sexual intercourse or failure of a contraceptive method.
True or False - Advanced supply of EHC can not be given.
Why?
False - it can be given if the patient has been assessed to ensure that they are competent, they intend to use the medicine appropriately and it is clinically appropriate.
An example may include patients who are going on holiday.
True or False - The supply of ulipristal acetate to patients under the age of 16 years is not CI by the
manufacturer.
True. However, consider the following:
• Children under the age of 13 are legally too young
to consent to any sexual activity. Instances should
be treated seriously with a presumption that the
case should be reported to social services, unless
there are exceptional circumstances backed by
documented reasons for not sharing information.
• Sexual activity with children under the age of 16 is
also an offence but may be consensual. The law is
not intended to prosecute mutually agreed sexual
activity between young people of a similar age,
unless it involves abuse or exploitation.
• Pharmacists can provide contraception or sexual
health advice to a child under the age of 16 and
the general duty of patient confidentiality applies,
so where there is a decision to share information,
consent should be sought whenever possible prior
to disclosing patient information. This duty is not
absolute and information may be shared if you
judge on a case-by-case basis that sharing is in
the child’s best interest (e.g. to prevent harm to
the child or where the child’s welfare overrides the
need to keep information confidential). It is possible to seek advice from experts without disclosing identifiable details of a child and breaking patient confidentiality – and that where there is a decision to share information, this should be proportionate.
What is the maximum quantity of paracetamol and aspirin tablets that can be sold OTC?
No more than 100 non-effervescent tablets / capsules. Theoretically, based on pack sizes, it would be 96.
Why is there restrictions around the sale of codeine and dihydrocodeine containing products?
Risk of addiction.
For what indications can codeine and dihydrocodeine be sold OTC?
Short-term treatment of acute, moderate pain not relieved by paracetamol, ibuprofen or aspirin alone.
Codeine can also be sold OTC in liquid formulation for cough suppression - MUST believe the request is genuine.
What is the maximum quantity of codeine and dihydrocodeine tablets that can be sold OTC?
32.
What warning must be prominently displayed on the packaging of a product containing codeine or dihydrocodeine?
Can cause addiction. For 3 days use only.
Additionally, both the PIL and packaging must state the indication and that the medicine can cause addiction or headache if used continuously for more than 3 days. The PIL must also contain information about the warning signs of addiction.
What are the legal requirements of a prescription?
1 - Patient’s name & address
2 - Patient’s DOB and age (if under 12)
3 - Appropriate date - within 6 months of dispensing for regular POM’s and 28 days for CD’s. For NHS prescriptions, the appropriate date is the date on which the prescriber has indicated the patient can collect the prescription from (if different to the date on which the prescription was signed). For private prescriptions, the appropriate date is the date on which the prescription was signed.
4 - Prescriber’s particular’s and address
5 - Signature of the prescriber
The prescription must be written in indelible ink.
True or False - Private prescriptions are subject to further prescription requirements in order for them to be legal.
False - private prescriptions are subject to the same prescription requirements.
What are repeatable prescriptions?
They are private prescriptions that contain a direction that they can be dispensed more than once, e.g. ‘repeat x5’.
If a repeatable prescription does not specifically state the number of times it can be repeated, how many times can the dispensing be repeated?
Once (i.e. dispensed twice) unless the prescription is
for an oral contraceptive in which case it can be
repeated 5 times (i.e. dispensed 6 times).
True or False - Prescriptions for all CD’s are repeatable.
False - prescriptions for schedule 2 & 3 CD’s are not repeatable, but for schedule 4 & 5 CD’s, they are repeatable.
When must repeatable prescriptions be dispensed?
A repeatable prescription must be dispensed for the 1st time within 6 months of the appropriate date on the prescription (28 days for a schedule 4 CD). There is no legal time limit to dispense the remaining repeats.
How long should private prescriptions be retained in pharmacy for?
2 years.
