Medicine /Pharm Y2S2 - Law Exam Part 2

Pharm Y2S2 - Law Exam Part 2

Medicine100 CardsCreated about 2 months ago

Oversight of the production processes for medicinal products. Regulation of how medicines are made available to patients and healthcare providers. Ensuring that imported medicines comply with the required standards.

What are the features of POM-V medicines?

Strcit limitations of use for safety reasons Narrow safety window Require specialist vet knowledge Clinical assessment of animal must occur for prescription to be given Only the minimum amount necessary for treatment should be supplied

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Key Terms

Term
Definition

What are the features of POM-V medicines?

Strcit limitations of use for safety reasons Narrow safety window Require specialist vet knowledge Clinical assessment of animal must occur for pre...

What are the features of POM-VPS medicines?

Used to reduce/prevent effects of endemic disease in herds Use implies risk to target species or user Simple advice should be given along side supp...

What are the overlapping features of POM-V and POM-VPS?

For food producing animals Special precautions taken to avoid unnecessary risk May interfere with future diagnosis Include new VMPs

What are the features of AVM-GSL?

Wide safety margin Treatment for common ailments No specialist advice

What is the exemption for small pet animals?

Permits certain medicines to be placed on the market in any retailer without MA subject to conditions

What animals come under the exemption for small pets?

Aquarium animals Cage birds Homing pigeons Terrarium animals Small rodents Ferrets Rabbits

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TermDefinition

What are the features of POM-V medicines?

Strcit limitations of use for safety reasons Narrow safety window Require specialist vet knowledge Clinical assessment of animal must occur for prescription to be given Only the minimum amount necessary for treatment should be supplied

What are the features of POM-VPS medicines?

Used to reduce/prevent effects of endemic disease in herds Use implies risk to target species or user Simple advice should be given along side supply Professionals may receive adequate training for administration

What are the overlapping features of POM-V and POM-VPS?

For food producing animals Special precautions taken to avoid unnecessary risk May interfere with future diagnosis Include new VMPs

What are the features of AVM-GSL?

Wide safety margin Treatment for common ailments No specialist advice

What is the exemption for small pet animals?

Permits certain medicines to be placed on the market in any retailer without MA subject to conditions

What animals come under the exemption for small pets?

Aquarium animals Cage birds Homing pigeons Terrarium animals Small rodents Ferrets Rabbits

What must be determined by an RQP before the supply of a veterinary prescription/medicine?

Recipient is competent in the use of the product for authorised purpose Advise on safe administration Provide warnings Give minimum quantity necessary for treatment

What are the record requirements for POM-V and POM-VPS?

Name of medicine Date of receipt/supply Batch number Quantity Name and address of Rx-er Name and address of recipient Copy of Rx if possible Retain for 5 years

How long are veterinary prescriptions valid for?

6 months, unless a shorter time is indicated by the prescriber 28 days for schedule 2 and 3

What are the requirements of a veterinary prescription?

Name, address, telephone and qualification of Rx-er Signature Name and address of owner Species, identification and address of animal Date Name and amount of medicine Dosage/administration instructions Warnings/withdrawal periods Number of repeats where necessary

What are the additional prescription requirements for veterinary CD schedule 2 and 3?

RCVS number of prescriber | 'Item prescribed for animal/herd under the care of a veterinarian'

What are the requirements for an EEA veterinarian prescriber?

Must be registered with RCVS | Must have carried out a clinical assessment on the animal

What is the additional requirement for a veterinary prescription under the veterinary cascade?

'Prescribed under the cascade'

What are the requirements for manufacturer labelling of veterinary medicines?

Must be in English UK authorised veterinary medicinal product stamp Name, strength, form Name/proportion of active ingredients and any excipients mentioned in MA Route of administration Batch number Expiry date 'For animal treatment only' 'To be supplied on veterinary Rx' Contents by weight, volume or dosage unites MA number and holder details Labelled space for discard date Target species 'Keep out of reach and sight of children' Distribution category Storage instructions In use shelf life Withdrawal period for food producing species (even if zero) Warnings specified in MA Disposal advice Full indications Dosage instructions Contraindications

What are the label requirements for POM-V?

Name, address of owner and supplier Date of supply Name, strength and quantity Dosage and directions for use 'For animal use only' 'For external use only'

What are the stages of the veterinary cascade?

1- VMP authorised in the UK for another animal species OR another condition in the same species 2- UK medicinal product for human use OR VMP authorised in another EU country for use with any animal species 3- medicine prepared extemporaneously as prescribed

What is the veterinary cascade?

Used to find an alternative where there is no suitable authorised VMP in the UK

Which persons can supply under the veterinary cascade?

Veterinarians and pharmacists may supply any medicine supplied under the cascade SQPs may dispense any authorised VMPs prescribed

What is a schedule 1 controlled drug?

Licensed POM

What are the requirements of CD schedule 1 drugs?

No therapeutic use, limited to research etc | License required from the home office to produce/possess/supply

Under what circumstances may a pharmacist possess a schedule 1 CD?

For destruction or police handover

Give examples of schedule 1 CDs?

LSD Ecstasy Raw opium Cannabis

What is a schedule 2 controlled drug?

Register POM

What are the requirements of CD schedule 2 drugs?

License required for import/export Pharmacy controls over destruction, container marking, record keeping and safe custody including expired and returned meds Private prescriptions written on a standard form

What is the exception for safety custody of CD schedule 2?

Quinalbarbitone

Give examples of schedule 2 CDs?

Cocaine Methadone Morphine Ketamine Opiates

What is a schedule 3 controlled drug?

No register POM

What are the requirements for schedule 3 controlled drugs?

No register or destruction requirements | Invoice must be retained for two years

Which schedule 3 drugs to safe custody rules apply to?

Diethylpropion Temazepam Buprenorphine Flunitrazepam

Give examples of schedule 3 CDs?

Barbituates Midazolam Tramadol

What are schedule 4 part I CDs?

Benz POM

What are schedule 4 part II CDs?

Anab POM

What are the requirements for schedule 4 controlled drugs?

No register, safe custody or destruction requirements Home office license for import/export Emergency supplies permitted No restriction on possession of part II

Give examples of schedule 4 CDs?

Part I- benzodiazepines, cannbinoids | Part II- anabolic/androgenic steroids, growth hormones

What are schedule 5 CDs?

Invoice POM/P

What are the requirements for schedule 5 controlled drugs?

Negligible potential to supply or for misuse Invoices retained for 2 years Exempt from other controls

Give examples of schedule 5 CDs?

Codeine Pholcodeine Morphine present at low strengths

Are legal highs banned?

Yes for import, manufacture, distribute and supply

What is Sativex?

Schedule 4 CD derived from whole plant extracts of cannabis | Destruction requirements apply to importers, exporters and manufacturers

When is it lawful to possess/supply CDs?

Prescribed for person (or animal) Have appropriate Home Office license Person specified in regulations as acting in their capacity (constable, postal worker, customs officer)

Who is specified in law to possess CDs?

Doctors, dentists, pharmacists, independent prescribers Senior registered nurse on a ward Person in charge of laboratory Public analyst, sampling officer Master of a ship with no doctor on board Ambulance trusts

What are the requirements for taking CDs abroad?

No personal license required by the home office for less than 3 months supply Patient advised to obtain covering letter from prescriber, check with embassy and travel operators before travel

When do CD requisitons/prescriptions not need to be sent to the NHSBSA? What is their fate?

Veterinary prescriptions- retained for 5 years Hospital/care home- retain for 2 years Manufacturer/wholesale Prison pharmacy to prison wings Midwife supply order- retain for 2 years

What CDs can a midwife obtain on a supply order?

Diamorphine Morphine Pethidine

How many days treatment can be given on a CD instalment?

14 days

What drugs are given on a CD instalment?

Schedule 2 drugs Buprenorphine Diazepam

When must the first instalment be dispensed on an FP10MDA prescription?

Within 28 days of date on Rx or date expressly specified

What is contained within an instalment direction?

Amount per instalment Interval between instalments Dose and instalment amount must be specified separately

What exemptions may be included in an instalment direction?

Dispense instalments due on pharmacy closed days on prior suitable days If a day is missed, dispense the amount due for remaining days Contact Rx-er if 3 or more consecutive days are missed

Who may prescribe treatment for addicts? What treatment does this include?

Prescribers specifically authorised by the secretary of state Cocaine, diamorphine, dipipanone

What is the protocol for collection of CDs?

Supply to patient or representative and request of ID is at the pharmacist's discretion HCP collecting on behalf of patient must provide ID, name and address

What is the protocol for collection of drug misuse CDs?

Representative must have a letter of authorisation from the patient for each time they collect Rx-er must be contacted if this is a supervised dose

What CDs may a nurse or pharmacist supply against a PGD?

For necessary immediate treatment of a sick patient they may supply diamorphine or morphine

What CDs may a nurse or pharmacist supply in addiction?

Schedule 5 or 4 part I Midazolam Not parenteral

What are the requirements of emergency supplies of CDs?

Phenobarbitone or schedule 4/5 are permitted at the request of a prescriber Up to 5 days treatment with schedule 4/5 at patient request

Where does safe custody apply to CDs?

Retail dealers Care homes Private hospitals

What are the requirements of CD containers?

Should be plainly marked with the amount of drug | With preparations, with the amount per dosage unit and number of dosage units

How long should a CD register be kept for?

2 years from its last entry

What are the requirements for destruction of schedule 2 CDs?

Must have an authorised witness present, not necessary for patient returns

What is a CD accountable officer?

Some appointed by a designated body who does not routinely supply/handle CDs

Who may act as an authorised witness?

Constable GPhC inspector Senior staff Suitably trained employees Controlled drug liaison officer

What legislation accounts for patient returned CDs?

Hazardous Waste Regulations 2005

What are P medicines?

Available in registered pharmacies without prescription under the supervision of a pharmacist Listed in HMR 2012 Schedule 1 part 2

What products are included in the P medicine category?

Anthelmintics Parenterals Enemas and irrigation Aspirin in under 16s POM under certain conditions of marketing authorisation GSL above certain quantities Covered by exemptions from licensing from pharmacists

What medicines are included in HMR 2012 schedule 1 part 1?

Parenterals CDs Cyanogenics Those that emit radiation Restrictions of aloxiprin, aspirin, paracetamol, pseudoephedrine salts

Which controlled drugs are exempt from POM status?

Those containing one of the following substances in a specified form and at a max strength Dihydrocodeine Ethylmorphine Pholcodeine Codeine Morphine Any of their salts

What are counter prescribed medicines?

Can be made up by a pharmacist if deemed appropriate consisting of either GSL or P medicines

What are the restrictions on pseudoephedrine and ephedrine products?

Unlawful to sell these products together where they contain more than 720mg of pseudoephedrine salt or 180mg of ephedrine

What are the main professional problems presenting with sale of P medicines?

Emergency oral contraception Codeine/dihydrocodeine should not be used for more than 3 days, max supply of 32 Cough medicines unsuitable for children contains pholcodine, dextromethorpran, guaifenesin, ephedrine OTC codeine liquid not for use in under 18s

What are GSL medicines?

Not classified as P or POM but have marketing authorisation. May be sold with reasonable safety without supervision of a pharmacist

Give an example of a medicine available as POM, P and GSL?

Quinine P with a max daily dose of 300mg GSL in its base form with a max daily dose of 35mg

When can retail shops sell GSL?

Where they can be closed to exclude the public The product was made elsewhere and remains in its original packaging Follow schedule 15 requirements

What are the exemptions for general conditions of sale/supply of GSL?

Doctor/dentist to a patient under their care Registered midwife in the course of their practice Hospitals/healthcare centres

What are the common pack size limits in GSL medicines?

Paracetamol and aspirin up to 500mg in packs of 16 Aspirin, aloxiprin and paracetamol effervescent up to 30 EC aspirin 75mg in packs of 28 Ibuprofen in packs of 16 or 12 granules/powder sachets

What are the requirements for a product to be moved from a POM to a P classification?

No longer presents danger to health Not frequently used incorrectly Activity/side effects require no further investigation Not usually prescribed by doctor as a parenteral

What are PO medicines?

Not a legal classification in HMR 2012 | GSL products whose sale is restricted to pharmacies, RP does not need to be present

What are the requirements for an emergency supply at the request of a prescriber?

Prescriber is appropriate There is a genuine emergency Rx to be provided within 72 hours Supply made in accordance with instructions CD 4 and phenobarbital are permitted from UK prescriber Record may on the day or day following

What are the record requirements for an emergency supply?

Medicine supplied, all details including quantity Name/address of Rxer Name/address of patient Date on which POM is sold Date on Rx Date Rx received by pharmacy Reason for supply Reference number

What are the requirements for an emergency supply at the request of a patient?

Immediate need Treatment has previously been received on Rx Dose appropriated Patient has been interviewed Treatment does not exceed 30 days (5 days for phenobarbital and Sch 4/5)

What POMs cannot be given in an emergency supply at patient's request?

Bromide salts Hexobarbitone Methohexitone Strychnine Thiopentone

What may be given in emergency supply at patient's request where treatment exceeds 30 days?

Inhalers Creams Insulin Where smallest pack size exceeds 30 days

Which POMs may be administered by anyone for the purpose of life saving?

Adrenaline 1mg/ml Atropine sulphate Chlorphenamine Dicobalt edetate Glucagon Glucose 50% Hydrocortisone Naloxone Pralidoxime Antiserum (venom) Sodium nitrite

What are the requirements of a PGD?

Doctor/dentists signature Pharmacist signature Name of business that owns it Description of medicines Start/end dates Health professionals able to administer Signature by appropriate organisation Clinical situation where it applies Details of dosage, form, quantity and regimen Warnings Follow up actions Records

What medication requires guidance or is not permitted on a PGD?

Antimicrobials to be used with caution Black triangle drugs included in exceptional circumstances Unlicensed drugs not permitted No anabolic steroids No midazolam from schedule 3 Schedule 2 morphine and diamorphine excluded for addiction

Under what circumstances is it permissible to supply others with 'wholesale' medicines without a wholesale license?

Supply to HCPs to hold for local provision or to other pharmacies to meet the needs of individuals where this happens only on occasion and in small quantities on a non-profit basis where the medicines are not for onward wholesale distribution

Where can you find the list of persons eligible to receive wholesale medicines?

Listed in HMR 2012, schedules 17 and 22

What medicines may a midwife sell/supply in their capacity?

GSL and P medicines | POM medicines containing diclofenac, hydrocortisone, miconazole, nystatin or phytomenadione

What medicines may a midwife administer parenterally in their capacity?

Adrenaline, anti-D immunoglobulin, cyclizine, diamorphine, ergometrine, hep B vaccine, lignocaine, naloxone, oxytocin, pethidine, prochlorperazine, NaCl

What POM medicines may optometrists supply in their capacity?

Chloramphenicol eye drops <0.5% Chloramphenicol eye ointment <1% Cyclopentate Fusidic acid Tropicamide

What POM medicines may optometrists obtain in their capacity for clinical use?

Amethocaine Lignocaine Oxybuprocaine

What POM medicines may additional supply optometrists supply in emergencies?

Diclofenac | Polymixin B

What P medicines may chiropodists supply in their capacity?

Potassium permanganate crystals Ibuprofen Heparinoid ointments Clotrimazole 1% Crobamiton 10% Griseofulvin 1% Miconazole 2% Salicylic acid 70% Terbinafine 1%

What medicines may POM chiropodists supply in their capacity?

Amoxicillin Erythromycin Flucloxacillin Co-codamol Co-dydramol Codeine Amorolfine Hydrocortisone 1%

What medicines may local anaesthetic chiropodists give parenterally in their capacity?

Adrenaline Lignocaine Prilocaine Methylprednisolone

What medicines may paramedics administer to patients requiring immediate treatment?

Diazepam 5mg/ml Succinylated gelatin 4% infusion Adrenaline Amiodarone Anhydrous glucose Ergometrine Furosemide Heparin (cannula flushing) <20mg morphine Metoclopramide Naloxone Streptokinase NaCl

Define criminal law.

Relationship between an individual and the state, regulating human behaviour

Define civil law.

Relationship between individuals relating to the conduct of human relations Compensation may be awarded to the victim

What is penal law?

Conditions of bodies of rules with potential for severe punishment, actions considered harmful to society as a whole

What is primary legislation?

An act of parliament laying down general principles

What is secondary legislation?

An act delegates power to other bodies by making detailed rules