Legislation & Professional Issues Flashcards
What does the Human Medicines Regulations 2012 cover?
• Legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the Medicines Act 1968
True or False
The Medicines Act of 1968 has been replaced fully
• False
What does the Veterinary Medicines Regulations cover? 2005 updated 2013
• The prescribing and supply for animals
What is the responsibility of the Programme Board for Rebalancing Medicines Legislation and Pharmacy Regulation?
• Reviews relevant pharmacy legislation and regulation to ensure it provides safety for users of pharmacy services
How many classes of medicinal products for humans do pharmacist deal with under the Human Medicines Regulations 2012?
• Three
True or False
Medicines should be considered normal items of commerce
• False
Where can general sale medicines (GSL) be sold?
- In registered pharmacies
- In retail outlets
That can close so as to exclude the public
How are medicines classified as GSL medicines?
- Through EU or UK marketing authorisation (product license)
- Traditional herbal registration
- Certificate of registration as a GSL medicine homeopathic product
What does (PO) medicine refer to? What is an example?
- A product that is licensed as a GSL medicine for which the manufacturer wishes to restrict sales or supplies through pharmacies ONLY
- 30-sachet packs of Fybogel
When can GSL medicines be sold, within pharmacy?
• When a pharmacist has assumed the role of a RP, even if physically absent for a limited period whilst still the RP
Where can P meds be sold?
• From a registered pharmacy premises by a pharmacist/representative
Which classifications of medicines are considered OTC (non-prescription)?
- P meds
* GSL meds
True or False
Pharmacy medicines must be accessible to the public by self-selection
• False
True or False
POMs require a prescription written by an appropriate practitioner before it can be sold or supplied
• True
What does medicine classification depend upon?
- Formulation
- Strength
- Quantity
- Indication
- Marketing authorisation
What are pseudoephedrine and ephedrine?
• Decongestant P meds – potential for misuse
Which drug are they a used in the illicit production of?
- Methylampehtamine (crystal meth)
* Class A Controlled Drug
What is the max strength of pseudoephedrine that can be supplied without a prescription?
• 720mg
What is the max strength of ephedrine that can be supplied without a prescription?
• 180mg
What are signs of possible pseudoephedrine and ephedrine misuse?
- Lack of symptoms: cough, cold or flu symptoms
- Rehearsed answers
- Impatient or Aggressive
- Opportunistic: waiting for busy periods
- Specific products: brands containing only pseudoephedrine or ephedrine
- Paraphernalia: lithium batteries/acetone
- Large quantities
- Frequent requests
What are red flag products, if bought with pseudoephedrine/ephedrine products?
- Lithium batteries
* Acetone
True or False
It is lawful to sell or supply any pseudoephedrine product at the same time as an ephedrine
• False
If misuse of ephedrine/pseudoephedrine products suspected, who can you report to?
- Local GPhC inspector
- Local Controlled Drugs liaison police officer
- Accountable officer
Which are licensed as pharmacy medicines for emergency hormonal contraception: EHC?
- Levonorgestrel 1500mcg tablet
* Ulipristal acetate 30mg tablet
Levonorgestrel is licensed for women aged______or over for emergency contraception within________of unprotected sexual intercourse or failure of a contraceptive method.
- 16 years
2. 72 hours
Ulipristal acetate is licensed for emergency contraception within _______ of unprotected sexual intercourse or failure of a contraceptive method.
- 120 hours (5 days)
Supply is not contraindicated <16 years; however, pharmacist may wish to consider additional factors e.g. consent, Gillick competency
True or False If true, why? If false, why not?
Pharmacist can provide an advanced supply of oral emergency contraception
• True – assess competency & intent to use appropriately and clinical appropriateness
Prior to unprotected sexual intercourse or in case of failure of a contraceptive method
Are children under 13 years legally able to consent to any sexual activity? Where should cases be reported?
- No
* Report cases to social services
Is sexual activity under the age of 16 an offence? Can it be consensual?
- Yes
* Yes
Can pharmacist provide contraception/sexual health advice to a child under the age of 16?
- Yes and patient confidentiality applies
* Decision to share information, consent should be sought – child’s best interest (prevent harm & protect welfare)
Where can patients be referred if sale of EHC inappropriate (sale outside of MA)?
- Family planning clinics
- General practice clinics
- Providers of PGDs for EHC
- Genitourinary medicine clinics (GUM)
What is the OTC legal restrictions for paracetamol?
• Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time
There are no legal limits on the quantity of OTC
effervescent tablets, powders, granules or liquids that can be sold to a person at any one time.
What is the OTC legal restrictions for aspirin?
• Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time
There are no legal limits on the quantity of OTC effervescent tablets, powders, granules or liquids that can be sold to a person at any one time.
Why are there tighter controls and new warnings on packaging of OTC solid dose medicines (tablets/capsules) containing codeine/dihydrocodeine?
• To minimise risk of overuse and addiction
What are the indications for OTC solid dose codeine/dihydrocodeine?
• Short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone
All other previous indications – flu, cold, sore throats and minor pain – have been removed
What is the maximum pack size of OTC codeine/dihydrocodeine?
• 32 dose units (>32 requires MA as a POM)
This includes effervescent formulations
What warning must now be positioned in a prominent clear position on the front of the pack of OTC codeine/dihydrocodeine?
• ‘Can cause addiction. For three days use only’
What does the PIL and packaging of OTC codeine/dihydrocodeine need to state?
- The indication
- The medicine can cause addiction/overuse headache if used for more that 3 days
- Warning signs of addiction
How many packs of codeine/dihydrocodeine should be sold OTC?
• 1
True or False
Many cough and cold medicines are no longer used in children under six years of age.
• True
What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Antitussives
- Dextromethorphan
- Pholcodine
Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days
What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Expectorants
- Guafenesin
- Ipecacuanha
Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days
What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Nasal Decongestants
- Ephedrine
- Oxymetazoline
- Phenylephrine
- Pseudoephedrine
- Xylometazoline
Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days
What OTC medicines are deemed unsuitable for children under six? What are the recommendations for these in the 6-12 age group?
Antihistamines
- Brompheniramine
- Chlorphenamine
- Diphenhydramine
- Doxylamine
- Promethazine
- Triprolidine
Use these medicines as second line to best practice supplied in a child-resistant container and should not be used for more than 5 days
What is best practice (1st line) for treating children with cough &/cold?
- Drink plenty of fluids
- Treat fever and pain with paracetamol/ibuprofen if child doesn’t respond to paracetamol. Using paracetamol & ibuprofen together is not recommended for <5 year olds
- Treat nasal congestion with saline nasal drops, vapour rub or decongestant or steam inhalation
- Treat cough with warm clear fluids or warm lemon and honey drinks (if >1 years old), simple cough mixtures: glycerol/simple linctus
Most colds will resolve within_______days
• 5 to 7
What age can OTC liquid preparations containing codeine be used?
• 18 years
What are some newly classified P medicines?
- Amorolfine nail lacquer
- Chloramphenicol eye drops and eye ointment
- Levonorgestrel and ulipristal acetate
- Omeprazole and pantoprazole
- Orlistat
- Sumatriptan
- Sildenafil
- Tamsulosin
- Tranexamic acid
