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m103 > W4 Sale and Supply of Medicines > Flashcards

W4 Sale and Supply of Medicines Flashcards

Inc lectures OTC, POM, Packaging Labelling and Leaflets

1
Q

Examples of self selected medicines: (5)

A

OTC medicines (GSL & P)
Herbal products
Vitamins
Dietary supplements
Recreational drugs (alcohol and tobacco)

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2
Q

What is the Human medicines regulations 2012? (4)
The regulation for…

A

Regulation for:
- Authorisation of medicinal products for human use
- Manufacture, import, distribution, sale and supply
- Labelling and advertising
- Pharmacovigilance

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3
Q

What does licensing tell us?

A

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.

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4
Q

Where can GSL medicines be sold?
What are the conditions?

A
  • 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
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5
Q

What is a GSL medicine?
Used for?

A

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.

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6
Q

Examples of GSL medicines?

A

Ibuprofen 200,400,600mg
Paracetamol
Flu medication

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7
Q

Examples of P medicines?

A

Co-codamol
Lunox
Hydrocortisone cream 1% w/w

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8
Q

What is a P medicine?
Where are they obtained from? (condition)
What are they used for?

A

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
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9
Q

What is a POM?

A

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.

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10
Q

What are OTC?

A
  • Over the counter medicines (informal term)
    -Referred to as this but includes GSL and P medicines (not POM)
  • No prescription needed
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11
Q

Why are there categories for medicines:

What are the benefits and barriers to buying them from off-license/otc?

A

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

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12
Q

Which 4 pharmacy staff (in comm) can supply these medicines?

A
  1. MCAs (Medicine Counter Assistants)
  2. Dispensing/Pharmacy assistant
  3. Pharmacy technicians
  4. ACTS (Accuracy Checking Technicians)
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13
Q

What is a MCA and what do they do?

A

Medicine Counter Assistant
- Sale of non-prescription medicines, receipt of
prescriptions, handing out of completed dispensed items and giving advice on health matters.

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14
Q

What does a Pharmacy assistant do? (in a nutshell)

A

Functions involved in dispensing.

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15
Q

What does a pharmacy technician do?

A

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

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16
Q

What do ACTs do?

A

Accuracy Checking Technicians (ACTs) check the accuracy of prescriptions dispensed by another
staff member before the medicines are given out to patients.

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17
Q

What are the legal issues surrounding pseudoephedrine and ephedrine?

A
  • 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).
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18
Q

What are the signs of possible misuse of medication? (7)
(Abusing services)

A
  • 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)
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19
Q

What are the professional and legal issues surrounding paracetamol and aspirin?

A

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.
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20
Q

What are the professional and legal issues surrounding codeine and dihydrocodeine?
(2)

A

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”

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21
Q

What are the professional and legal issues surrounding EHC (emergency hormonal contraception)? (2)

A

Ethical dilemmas
Woman’s health

22
Q

It is unlawful to supply products that contain more than ?? mg of pseudoephedrine OR ?? mg of ephedrine

A

720mg of pseudoephedrine
180mg of epehedrine

23
Q

What are the criteria for a drug to be considered prescription control? (POM)

A
  • 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)
24
Q

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

A

=3

25
Q

What Act does the Humans Medicines Regulations 2012 replace most of?

A
  • Medicines Act 1968
26
Q

What Act does the Humans Medicines Regulations 2012 replace most of?

A
  • Medicines Act 1968
27
Q

What is the HMR2012 law regarding POM?

A

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.”

28
Q

What are POM used to treat?

A

Conditions that are best diagnosed and managed by health professionals.

29
Q

-If a medicine is prescribed by brand name…

A
  • Only a product bearing that brand name may be supplied and NOT a therapeutically equivalent generic product.
30
Q

Who can prescribe?

A

Doctors
Dentists
Community Practitioner nurse prescribers
Independent Prescribers

31
Q

What are the different codes for prescription type? (Wales) for info

A

WP10- GP
WP10D- Dentist
WP10CN- Nurse Prescriber
WP10IP- Independent Prescriber

32
Q

What can be prescribed? (info)

A
  • 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)
33
Q

Who pays for NHS medication?

A
  • Drug Tariff is a tariff of drug prices
  • Price is paid to a pharmacy
  • Prescription becomes an invoice
  • Sent away to NHS for payment
34
Q

How to assess a prescription:

A
  1. Nature of product – is the drug permitted on the NHS or is the appliance listed in the Drug Tariff?
  2. Prescriber type – does the prescriber hold relevant registration(s) to issue prescriptions for the requested items?
  3. Dental or Nurse Prescribers’ formulary – are the prescribed items listed in the relevant prescriber’s formulary?
  4. Form type – is the product prescribed on a valid NHS prescription?
  5. 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?
35
Q

What is The Blacklist?

A
  • Items not permitted on NHS prescriptions
  • Found in chapter XVIIIA of the drug tariff
  • Key information is given in the BNF
36
Q

Can prescribers prescribe the same things?
(doctors, nurses, dentists)

A

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

37
Q

What can Independent prescribers and supplementary prescribers prescribe?

A

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.

38
Q

What are the approved countries in which doctors and dentists can prescribe and are legally acceptable in the UK?

A

EEA/EU countries and Switzerland

39
Q

What is the Selected List Scheme (SLS)?

A
  • 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)
40
Q

What is The Advisory Committee on Borderline Substances (ACBS)?

A

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’.

41
Q

Electronic Transfer of Prescriptions

A

‘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’.

42
Q

Can a prescription be written in pencil?

A

No.
A prescription must be…
* Signed in ink
* Written in ink or indelible
* Dispensed within six months (beginning with the appropriate date)

43
Q

What are the Legal Requirements of a prescription?

A
  • Name of the patient
  • Address of the patient
  • Age of the patient (if under 12)
  • Prescribers Signature
  • Date
  • Prescriber Address
  • Particulars of prescriber
44
Q

What are clues of a forged prescription?

A
  • Unknown prescriber
  • New patient
  • Excessive quantities
  • Uncharacteristic prescribing or method of writing prescription by a known doctor
  • “Dr” before or after prescriber’s signature
45
Q

Which items of information are deemed critical for the safe use of the medicine? (5)

A
  • Name of the medicine
  • Expression of strength
  • Route of administration
  • Dosage
  • Warnings
46
Q

In law, which part of a medicine is a container and which is the package?

A

Container= Inner receptacle- containing the medicine
Package= Outer receptacle

47
Q

What is the ‘name of the medicine’? (3)

A

Name, strength and pharmaceutical form

48
Q

Child safety (for info)

A

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

49
Q

Labelling:

What are the legal requirements for labels on dispensed medicinal products? (6)

A
  • 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
50
Q

What is included in the PIL? (6)

A
  • Identification of the medicine
  • Therapeutic indications
  • Information necessary before taking the medicine
  • Dosage
  • Description of side effects
  • Additional information

m103 (46 decks)

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