W4 Sale and Supply of Medicines Flashcards
Inc lectures OTC, POM, Packaging Labelling and Leaflets
Examples of self selected medicines: (5)
OTC medicines (GSL & P)
Herbal products
Vitamins
Dietary supplements
Recreational drugs (alcohol and tobacco)
What is the Human medicines regulations 2012? (4)
The regulation for…
Regulation for:
- Authorisation of medicinal products for human use
- Manufacture, import, distribution, sale and supply
- Labelling and advertising
- Pharmacovigilance
What does licensing tell us?
Marketing authorisation (formerly known as a Product Licence)
* Safety, quality and efficacy
Includes whether the product is to be available:
* only on prescription
* only from a pharmacy
* on general sale.
Where can GSL medicines be sold?
What are the conditions?
- Can always be sold from pharmacies
- But, can be sold from other places e.g. Retail, newsagents, supermarket vending machine provided;
- The premises can be closed to the public
- The medicine was packaged elsewhere
- Outer packaging has not been opened
What is a GSL medicine?
Used for?
A general sales list medicine.
Taken for common, easily recognised ailments
* Ailments which usually last around 2–3 days
* These medicines cause few troublesome side effects in normal use.
Examples of GSL medicines?
Ibuprofen 200,400,600mg
Paracetamol
Flu medication
Examples of P medicines?
Co-codamol
Lunox
Hydrocortisone cream 1% w/w
What is a P medicine?
Where are they obtained from? (condition)
What are they used for?
A ‘Pharmacy medicine’
- Can only be bought from pharmacies and under a pharmacists supervision (an intermediate level of control)
- Not accessible to the public by self-selection
- Sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist
- For short term treatment of medical conditions
- For management of some long-term conditions
What is a POM?
A prescription-only medication.
- Has to be prescribed by a doctor or authorised HCP and has to be dispensed from a pharmacy or another specifically licensed place.
What are OTC?
- Over the counter medicines (informal term)
-Referred to as this but includes GSL and P medicines (not POM) - No prescription needed
Why are there categories for medicines:
What are the benefits and barriers to buying them from off-license/otc?
Benefits?
- Quick relief of the disorder
- Individual can exercise more autonomy and choice
- Rapid and convenient access to medicines
Barriers?
- Potentially troublesome or serious side effects
- Possibility of misdiagnosis and delay in correct treatment
- Potential harm for incorrect use
Which 4 pharmacy staff (in comm) can supply these medicines?
- MCAs (Medicine Counter Assistants)
- Dispensing/Pharmacy assistant
- Pharmacy technicians
- ACTS (Accuracy Checking Technicians)
What is a MCA and what do they do?
Medicine Counter Assistant
- Sale of non-prescription medicines, receipt of
prescriptions, handing out of completed dispensed items and giving advice on health matters.
What does a Pharmacy assistant do? (in a nutshell)
Functions involved in dispensing.
What does a pharmacy technician do?
Technical functions involved in the preparation and supply and dispensing of medicines. They are also qualified to sell OTC medicines and provide information to customers
What do ACTs do?
Accuracy Checking Technicians (ACTs) check the accuracy of prescriptions dispensed by another
staff member before the medicines are given out to patients.
What are the legal issues surrounding pseudoephedrine and ephedrine?
- They are decongestant medicines.
- Used in the production of methylamphetamine (crystal meth)
- legal restrictions on the quantities that can be sold
“It is unlawful to supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any one time, without a prescription”
(Human Medicines Regulations 2012)
“It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription”
(Human Medicines Regulations 2012).
What are the signs of possible misuse of medication? (7)
(Abusing services)
- Lack of symptoms
- Rehearsed answers
- Being Opportunistic
- Asking for Specific products
- Paraphernalia- Asking for drugs that can be used to make illicit drugs
- Asking for Quantities
- Frequency (High)
What are the professional and legal issues surrounding paracetamol and aspirin?
Paracetamol and Aspirin
- POM, P and general sale medicines depending upon pack size and formulation
- Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time.
- Since most OTC pack sizes are for 16 or 32-dose units, this means that, in practice, 96 is the maximum number that can be sold. Paracetamol and Aspirin
- 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. *=Paracetamol only
- Use professional judgement to decide the appropriate quantity to supply and what limits to impose.
What are the professional and legal issues surrounding codeine and dihydrocodeine?
(2)
Codeine and dihydrocodeine
* Short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone
* No more than 32 unit doses
* Warning label: “Can cause addiction. For three days use only”
What are the professional and legal issues surrounding EHC (emergency hormonal contraception)? (2)
Ethical dilemmas
Woman’s health
It is unlawful to supply products that contain more than ?? mg of pseudoephedrine OR ?? mg of ephedrine
720mg of pseudoephedrine
180mg of epehedrine
What are the criteria for a drug to be considered prescription control? (POM)
- A direct or indirect danger exists to human health, even when used correctly, if used without medical supervision
- There is frequently incorrect use which could lead to direct or indirect danger to human health
- Further investigation of activity and/or side-effects is required
- The product is normally prescribed for parenteral administration (injectable)
Which of the following best describes the
categories of medicines available from a
pharmacy?
1. GSL, POM, RP
2. GSL, HMR, P
3. GSL, P, POM
4. OTC, P, POM
=3
What Act does the Humans Medicines Regulations 2012 replace most of?
- Medicines Act 1968
What Act does the Humans Medicines Regulations 2012 replace most of?
- Medicines Act 1968
What is the HMR2012 law regarding POM?
Humans Medicines Regulation 2012
“A person may not sell or supply a Prescription Only Medicine except in accordance with a prescription given by an appropriate practitioner.”
What are POM used to treat?
Conditions that are best diagnosed and managed by health professionals.
-If a medicine is prescribed by brand name…
- Only a product bearing that brand name may be supplied and NOT a therapeutically equivalent generic product.
Who can prescribe?
Doctors
Dentists
Community Practitioner nurse prescribers
Independent Prescribers
What are the different codes for prescription type? (Wales) for info
WP10- GP
WP10D- Dentist
WP10CN- Nurse Prescriber
WP10IP- Independent Prescriber
What can be prescribed? (info)
- Licensed drugs (POMs, Ps, GSLs, foods, toiletries or cosmetics)
- Off label and off licence medicines
- Unlicensed medicines
- Controlled Drugs (CDs) – Year 2
- Some appliances or chemical reagents
- Selected List Scheme medicines (SLS)
- Borderline Substances (ACBS)
Who pays for NHS medication?
- Drug Tariff is a tariff of drug prices
- Price is paid to a pharmacy
- Prescription becomes an invoice
- Sent away to NHS for payment
How to assess a prescription:
- Nature of product – is the drug permitted on the NHS or is the appliance listed in the Drug Tariff?
- Prescriber type – does the prescriber hold relevant registration(s) to issue prescriptions for the requested items?
- Dental or Nurse Prescribers’ formulary – are the prescribed items listed in the relevant prescriber’s formulary?
- Form type – is the product prescribed on a valid NHS prescription?
- Prescriber endorsements – has the prescriber annotated the prescription with the correct endorsements for e.g. ‘SLS’ for items that
may only be ordered in certain circumstances?
What is The Blacklist?
- Items not permitted on NHS prescriptions
- Found in chapter XVIIIA of the drug tariff
- Key information is given in the BNF
Can prescribers prescribe the same things?
(doctors, nurses, dentists)
No.
*Doctors can prescribe any licensed drug
* Dentists can only prescribe within the Dental Practitioners’ Formulary
* Community Practitioners Nurses prescribers can only prescribe within
the Nurse Prescribers’ Formulary
What can Independent prescribers and supplementary prescribers prescribe?
Any licenced drug
* However,Independent Prescribers must work within their own level of professional competence and expertise
* Supplementary prescribers must work in a partnership with an independent prescriber (a doctor or a dentist) to implement an agreed Clinical Management Plan for an individual patient with that patient’s agreement.
What are the approved countries in which doctors and dentists can prescribe and are legally acceptable in the UK?
EEA/EU countries and Switzerland
What is the Selected List Scheme (SLS)?
- Drugs that may be prescribed in certain circumstances
- The ‘selected list’ is found in Part XVIIIB of the Drug Tariff
- The Prescriber must endorse the prescription with the term ‘SLS’ (selected list scheme)
What is The Advisory Committee on Borderline Substances (ACBS)?
Borderline substances include certain foods and toilet preparations.
* Part XV of the Drug Tariff.
* The prescriber should endorse the prescription specifically with the term ‘ACBS’.
Electronic Transfer of Prescriptions
‘2DRx’ stands for 2-Dimensional Barcoded (2D) Prescriptions (Rx)
* In England, information is connected from GPs and community pharmacies to a central store of English patients’ information, known as ‘the Spine’.
Can a prescription be written in pencil?
No.
A prescription must be…
* Signed in ink
* Written in ink or indelible
* Dispensed within six months (beginning with the appropriate date)
What are the Legal Requirements of a prescription?
- Name of the patient
- Address of the patient
- Age of the patient (if under 12)
- Prescribers Signature
- Date
- Prescriber Address
- Particulars of prescriber
What are clues of a forged prescription?
- Unknown prescriber
- New patient
- Excessive quantities
- Uncharacteristic prescribing or method of writing prescription by a known doctor
- “Dr” before or after prescriber’s signature
Which items of information are deemed critical for the safe use of the medicine? (5)
- Name of the medicine
- Expression of strength
- Route of administration
- Dosage
- Warnings
In law, which part of a medicine is a container and which is the package?
Container= Inner receptacle- containing the medicine
Package= Outer receptacle
What is the ‘name of the medicine’? (3)
Name, strength and pharmaceutical form
Child safety (for info)
Suitable, child-resistant packaging should be used for supplying aII solid, all oral and external liquid dose preparations.
* Unless there is a good reason for not doing so:
* Specific request if difficulty opening
* Original pack may not be child-resistant
* No child-resistant packaging exists for a particular liquid medicine
Labelling:
What are the legal requirements for labels on dispensed medicinal products? (6)
- Name of the patient
- Name and address of the supplying pharmacy
- Date of dispensing
- Name of the medicine
- Directions for use
- Precautions relating to the use of the medicine
What is included in the PIL? (6)
- Identification of the medicine
- Therapeutic indications
- Information necessary before taking the medicine
- Dosage
- Description of side effects
- Additional information
