General Information

Question 1

MHRA guidance on what should appear on a Patient Information Leaflet (PIL)

6 main sections

General Information OTC

Answer 1

1. identification of the medicine
2. Therpaeutic Indications (what it is used for)
3. Information necessary before taking the medicine
4. Dosage
5. Description of side effects
6. Additional information (e.g. storage information, excipient details…)

Question 2

What is a herbal medicine?

Answer 2

Herbal products and some vitamins and minerals may be referred to as ‘alternative’ medicines or food supplements because they have not undergone the rigorous testing that conventional licensed medicines go through.

Question 3

What must a herbal medicine for sale to the public making any medicinal claimes need to have in order to be sold to the public?

Answer 3

Needs to either be registered as a conventional medicine(GSL/P/POM) or be registeted under the Traditional Herbal Medicines Registration Scheme (THR) to be sold to the public.

Question 4

What must a herbal medicine/product show to register under the Traditional Herbal Medicines Registration Scheme (THR)?

Answer 4

The quality & saftey of the herbal product needs to be shown.
- The manufacturer does not need to prove or have proof it will work for the condition it claims to ease or treat however.

Question 5

What is the aim of the Traditional Herbal Medicines Registration Scheme (THR)?

Answer 5

To standardise the herbal market.
- prior to this regulation anyone could market a herbal product of any standard and sell it without a speciifc license.

Question 6

What Is General Data Protection Regulation (GDPR)?

Answer 6

GDPR + The data protection act 2018 make up the UK data protection legislation.

GDPR is the legislation that covers any personal information you hold on a patient.
- As a pharmacy you are a data controller and must be compliant with the GDPR.

Question 7

What Comes Under GDPR?

Answer 7

Any personal data you have on a patient must comply with GDPR

Question 8

What Are The Data Protection Principles Of The GDPR?

6 of them

Answer 8

There are 6 data protection principles of the GDPR which require that personal data must be:
1. Processed lawfully, fairly & in a transparent manner
2. Collected for specified, explicit & legitimate purposes
3. Adequate, relevant & limited to what is necessary in relation to the purpose of processing
4. Accurate & where necessary kept upto date
5. Kept in a form whuch allows the identification of an individual for no longer than necessary
6. Processed in a manner that ensures appropriate security.