2- Legal classification Flashcards
Which governing body regulates medicinal products in the UK
The Human Medicines Regulation 2023 (Statutory Instrument 2012: No.1916)
When did the Human medicines regulation come in to force
14.8.2012
What are the three main categories of drugs
General Sales List (GSL),
Pharmacy medicine (P)
Prescription Only Medicines (POM).
Why is the access to drugs controlled
If the drug has more chances of drug doing harm then there is more control on access it.
Its important to control who can access the drugs and under what circumstances.
What has cocaine been used for in the past
Differentially diagnose a pupil defect.
What is an OTC medicine
over the counter medicine
(not a legal classsificaton but it is commonly referred to)
Who is a prescriber
medical doctors, dentists and certain professions which allow for the creation of Independent Prescriber (IP) status such as nursing and optometry among others.
Can orthoptists prescribe
Consultation has begun to see if orthoptists should also become a profession which has recognised IP status.
What is the law around the act of prescribing drugs
In law, the act of prescribing a medicinal product is a restricted one.
The majority of medicinal products are supplied by a Patient
What is a PSD
Specific Direction (PSD) which is the traditional written instruction from a certified prescriber, such as a doctor.
What to avoid and is there a difference between prescribing and supplying
Avoid term prescribing as it is legally protected protected
There is a difference between prescribing and supplying
What are non prescribers
If a group of patients can be identified that need a POM in course of diagnosis or treatment then a hospital may create a Patient Group Directive (PGD) to facilitate access to a POM.
These will name certain practitioners who are able to work within the remit of the PGD.
Finally, there is scope within legislation to define health care professionals as being exempt from the legislation restricting the supply and administration of P and POM class products.
What do PGDs allow for
Administration of drugs in clinic to a patient group by a named clinician
Exemptions operates outside of PGD
Anaesthetising the cornea can make installing drops easier
Allied Health professionals (AHPs) 2009 project
- In 2009, an Allied Health Professions (AHPs) Prescribing and Medicines Supply Mechanisms Scoping Project was conducted “to establish whether there was evidence of service and patient need to support extending access to medicines for AHPs” (NHS England, 2015, p15).
- The Commission on Human Medicines agreed in principle to the proposal that orthoptists be named as certain persons exempt for the sale, supply or administration of the named POMs and P medicines (Summary of the Commission on Human Medicines Meeting, 2015)
Legalese on Statutory Instrument 2016
Started on On 1 April 2016, (Statutory Instrument 2016 No.186) came into force and may be cited as the Human Medicines (Amendment) Regulations 2016.
There is amendment of schedule 17 (exemption for sale, supply or administration by certain persons) which adds for the first time orthoptists to those persons exempt from legislation.
It also lists those POMs and P medicines which orthoptists may sell, supply or administer and stipulates that this should “be only in course of their professional practice” (p5).
