Week 7 sale and supply of medicine OTC

Question 1

Self-selected medicines

Answer 1

-Over-the-counter (OTC) medicines
-Herbal products
-Vitamins
-Dietary supplements
-Recreational drugs (e.g. alcohol and tobacco)

Question 2

Human Medicines Regulations 2012

Answer 2

Replacing most of the Medicines Act 1968
The result of the Medicines and Healthcare Products Regulatory
Agency’s (MHRA’s) consolidation and review of the UK’s medicines legislation.
Regulation for:
-Authorisation of medicinal products for human use
-Manufacture, import, distribution, sale and supply
-Labelling and advertising
-Pharmacovigilance

Question 3

Licensing

Answer 3

-Marketing authorisation (formerly known as a Product Licence)
-Guarantee of safety, quality and efficacy
Medicines and Healthcare products Regulatory Agency (MHRA)
It must include whether the product is to be available:
-only on prescription
-only from a pharmacy
-on general sale

Question 4

Categories of licencing

Answer 4

-General Sales List (GSL)
-Pharmacy (P)
-Prescription-Only Medicine (POM)

Question 5

General Sales List (GSL)

Answer 5

May be bought from retail stores, such as a newsagent, a supermarket or a vending machine in a shop

Question 6

Pharmacy (P)

Answer 6

An intermediate level of control, can be bought only from pharmacies and under a pharmacist’s supervision

Question 7

Prescription-Only Medicine (POM)

Answer 7

Has to be prescribed by a doctor or other authorised health professional and it has to be dispensed from a pharmacy or from another specifically licensed place

Question 8

OTC

Answer 8

P medicines (needs pharmacist input) and GSL medicines

Question 9

Benefits of the categories

Answer 9

-Quick relief of the disorder
-More autonomy for the individual
-Fast and convenient access to medicines

Question 10

Barriers

Answer 10

-Potentially serious side effects
-Possibility of misdiagnosis and delay in correct treatment, masks symptoms of underlying condition
-Potential for harm / incorrect use

Question 11

Pharmacy staff

Answer 11

-Medicines Counter Assistants (MCAs)
-Dispensing/Pharmacy Assistant
-Pharmacy technicians
-Accuracy Checking Technicians (ACTs)

Question 12

Medicines Counter Assistants (MCAs)

Answer 12

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

Question 13

Dispensing/Pharmacy Assistant

Answer 13

Functions involved in dispensing

Question 14

Pharmacy technicians

Answer 14

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 on symptoms

Question 15

Accuracy Checking Technicians (ACTs)

Answer 15

Check the accuracy of prescriptions dispensed by another staff member before the medicines are given out to patients

Question 16

General Sales List

Answer 16

Medicinal products that are subject to general sale
-Taken for common, easily recognised ailments
-Ailments which usually last around 2–3 days
-These medicines cause few troublesome side effects in normal use

Question 17

General Sales List medicines can be sold…

Answer 17

Always from pharmacies but also can be sold elsewhere, as long as;
-The premises can be closed to the public
-The medicine was packaged elsewhere
-Outer packaging has not been opened

Question 18

Medicinal forms (BNF)

Answer 18

Regardless of whether a drug contains the same active ingredient, they will fall under different categories in the law depending on brand and concentration of API etc…

Question 19

Pharmacy medicines (P)

Answer 19

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
All P meds have a logo, a black square with a capital P in the middle

Question 20

Supervision

Answer 20

If a sale or supply is made by someone who is not a pharmacist, the transaction must be supervised by a pharmacist

Question 21

Supply

Answer 21

WWHAM
Referred if necessary
Reasons for refusing supply is explained if necessary
Verbal advice including specific information e.g., safe storage / expiry dates
All staff trained and aware of when to refer to a pharmacist

Question 22

Cautions

Answer 22

Pharmacist intervention
-Recently become available without prescription
-Subject to abuse or misuse
Alert to requests for large quantities and abnormally frequent requests
Care when supplying products for children, the elderly and other special groups
Sensitive handling of requests for certain medicines

Question 23

Changing the legal classification of a medicine

Answer 23

POM to a P medicine
P medicine to GSL
Can also go the other way

Question 24

Continuing Professional Development

Answer 24

-Information provided is up-to-date, accurate and reliable
-Keep up to date with developments regarding new products and
policies for health promotion

Question 25

Pharmacy medicine (P) to the general sale list (GSL)

Answer 25

“…with reasonable safety…”
More people will have access to the medicine, wider sales
where the hazard to health, the risk of misuse, or the need to take special precautions in handling is small and where wider sale would be a convenience to the purchaser

Question 26

Prescription-only medicine (POM) to pharmacy (P) medicine

Answer 26

A medicine will be non-prescription unless it fulfils certain criteria for prescription control
Prescription only status will apply where:
-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)

Question 26

Signs of Possible Misuse

Answer 26

-Lack of symptoms
-Rehearsed answers
-Opportunistic
-Specific products
-Paraphernalia
-Quantities
-Frequency