Legislation & Professional Issues Flashcards by Stia Pre-reg

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

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True or False

The Medicines Act of 1968 has been replaced fully

• False

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What does the Veterinary Medicines Regulations cover? 2005 updated 2013

• The prescribing and supply for animals

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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

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How many classes of medicinal products for humans do pharmacist deal with under the Human Medicines Regulations 2012?

• Three

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True or False

Medicines should be considered normal items of commerce

• False

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Where can general sale medicines (GSL) be sold?

In registered pharmacies
In retail outlets

That can close so as to exclude the public

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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

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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

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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

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Where can P meds be sold?

• From a registered pharmacy premises by a pharmacist/representative

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Which classifications of medicines are considered OTC (non-prescription)?

P meds

* GSL meds

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True or False

Pharmacy medicines must be accessible to the public by self-selection

• False

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True or False

POMs require a prescription written by an appropriate practitioner before it can be sold or supplied

• True

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What does medicine classification depend upon?

Formulation
Strength
Quantity
Indication
Marketing authorisation

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What are pseudoephedrine and ephedrine?

• Decongestant P meds – potential for misuse

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Which drug are they a used in the illicit production of?

Methylampehtamine (crystal meth)

* Class A Controlled Drug

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What is the max strength of pseudoephedrine that can be supplied without a prescription?

• 720mg

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What is the max strength of ephedrine that can be supplied without a prescription?

• 180mg

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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.

1. 16 years | 2. 72 hours

Ulipristal acetate is licensed for emergency contraception within _______ of unprotected sexual intercourse or failure of a contraceptive method.

1. 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?

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