Legal Aspects Ocular Pharmacology Flashcards
Define the term ‘Medicine’
A preparation given for the treatment or prevention of a disease
What does a medicine include?
Excipients- inactive ingredient - no therapeutic effect
Drug - active ingredient
Name some example of excipients within a medicine
preservatives
flavouring agents
Stabilisers
Lubricants
Define the term ‘ drug’
A chemical substance which will produce a specific physiological response within the body
What does INN stand for ?
International non-propriety name
What is the term used for a drug which has a brand name ?
Propriety name
What is the INN?
Common name for the drugs
General - not specific to any manufacturer
When was the opticians act first published ?
1958
When were the most recent changes made to the optician act?
2005
State what the original form of the Optician Act stated about optometrists
Refer all patients with an injury or disease of the eye to a medical practitioner for tx
Optometrists role was more of detection rather than diagnosis which meant lx access to meds
Who has powers to amend legislation ?
GOC
What changes and when were they made to the optician act
1999
The rules relating to injury or disease of the eye
Optoms may now choose to not refer patients with an eye disease/injury if no justification to do so
Optoms may now diagnose and manage
This means we need more access to medicines
When was the medicines act published ?
1968
What is the medicines act?
Regulates medication for both human and veterinary use including the manufacturing and supply of medicines .
The regulation of medicines within the UK is seen by who ?
MHRA
medicines and healthcare products regulatory agency .
The medicines act define three categories of medicines . What are they ?
General sales list
Pharmacy medicines
Prescription only medicines
Briefly explain what the GSL medicines is ?
- Avail to pts without medical supervision
- Don’t need rx , or approval from healthcare professional
Can be sold by any retailers with secure locked premises - Can be bought of shelf of pharmacy , news agents and supermarkets
- Don’t have a specific label
- Ingredients , volume , concentration is deemed to be sufficiently safe for Public use without medical supervision
Pts responsibility to read the information leaflet in the box and follow guidance on how to use meds safely and prevent ADR
What is ‘ Sales list’
eyedrops/ointment medication which are available for patients to purchase in same way as GSL meds.
Give some examples of products which fall within the Sales List group .
Artificial tears and ocular lubricants to alleviate sx of dry eyes
Contact lens rewetting drops to lubricate the CL
Eye baths /cleansers to soothe or cleanse an irritated eye
Give two clinical examples in which you would provide a GSL medicine to a patient .
- Corneal Abrasion
Sx - red , sensitive to light and painful right eye
VA - reduced
EE - large deep corneal abrasion seen with FS
Management - paracetamol 500mg, 2tabs 4h apart for four days - seasonal allergic conjunctivitis - HAYFEVER
Sx - 2/52 itchy watery and red eyes
EE - lacrimation, oedema , conjunctival hyperaemia
Management - Certrizine 10mg , I tab per day
Briefly explain what the P meds group is
- Can only be supplied to patient under supervision of pharmacist
- No rx required
- Can’t be bought of shelf
- Can’t be sold by retailers or supermarkets without pharmacy
- Pharmacist supervision is a control step for reasons - 1. Medication is sUITABLE for pt to use in terms of pts condition and other meds
2. Warnings are highlighted ADR
Give an example of a drug which falls into the GSL and P meds group
Paracetamol 500mg , 16 tabs GSL
Paracetamol 500mg , 32 tabs P
Larger quantities require more supervision
MHRA advise retailers to allow 2 packs per customer only
What rights to optoms have in relation to P meds ?
Optoms can sell or supply only if
- Case of emergency
- It’s within their course if professional practise
2005 1. Dropped
What is an diagnostic drug ?
Used within an eye exam to investigate cause of patients sx and signs
What classification do diagnostic drugs fall within ?
P Meds
Give TWO examples example of a diagnostic P med ?
Flourescein sodium -
examine tear film
Examine cornea and conjunctiva
Assess CL patients
Production of this stopped in 2013 - now rely on imported products from Europe
Phenylephrine hydrochloride (2.5/10%)
mydriatic drug , high myopes , pts with sx of vision loss
Gives detailed assessment of vitreous And retina
What is a therapeutic drug ?
Used to treat pt sx and clinical signs of disease /injury
Only supply after examination
Give two examples of an therapeutic p med used by optoms ?
Chloramphenicol , antibx
Used it treat bacterial conjunctivitis
Sx - mucopurulent discharge pus, conjunctival hyperaemia
Management - chloramphenicol 0.5% eye drops , every two hours for two days then Every 4h for four days
Otrivine antistin , for tx of seasonal drug allergic conjunctivitis
Contains antazoline which is an topical antihistamine
Why isn’t chloramphenicol a GSL medicine ?
Need expert opinion
May need review appt
Risk of incorrect self diagnosis
Why isn’t otrivine antistin a GSL meds ?
Contains a decongestant
Stimulates the SNS - leads to increase blood pressure and heart rate
Needs to be used in caution in patients with cardiovascular disease , systemic hypertension and diabetes
Briefly example what the PoM group is ?
Highest level of medical supervision needed
Require rx to take to pharmacy for dispenstion
To protect pts safety for example due to nature of drug
Example warfarin - blood thinner , reduce blood clots
Puts pts at risk of stroke so needs close supervision
Give some examples of PoM
Salbutamol - asthma Amoxicillin - antibx Citalopram- antidepressant Atorvastatin- cholesterol Ramipril- Systemic Hypertenstion
Give an example of drug that falls into the P and PoM group
Co-codomol codeine+paracetamol
Codeine 8mg P
Codeine 30mg PoM
Higher dose needs higher supervision
What exemptions to optoms have in relation to PoM
Exempted PoM - Use only
Exempted PoM - Use and Supply
Discuss the exempted PoM - Use only group
Topical anaesthetics - used to numb front of eye either for foreign body removal , measure of ocular pressure and stopping of blinking reflex
Proxymetacainehydrochloride
Oxybuprocaine hydrochloride
Tetracaine hydrochloride
Lidocaine hydrochloride
Why are drugs in exempted PoMs use only ?
Risk of overdose >4drops in one house
Toxic to cornea high doses
Masks pain without addressing root cause
In what situation would optoms use topical anesthetics
Contact tonometry , IOP
Probe needs to be in contact with patients cornea
Discuss the exempted PoM - Use and Supply
- Mydriatics/cycloplegics
Tropicamide and cyclopentolate (0.5/1%)
2 . Antibacterial
Chloramphenicol eye drops 0.5%
Chloramphenicol 1% eye ointment
Fusidic acid 1%
What are each of the drugs used for in exempted PoM use and supply
Tropicamide - mydriasis , dilate pupil
Cyclopentolate - susp acc , relaxed ciliary muscle
Chloramphenicol - tx of bacterial conjunctivitis
Fusicdic - tx of blepharitis
Blepharitis …
Inflammatory condition which often includes bacterial infection of the eyelid margin
The bacteria colonise eye lid particularly meibomian glands
what is the ruling with regards to GSL meds and optoms
can use as long as within course of practise
may sell or supply if considered to be effective tx for minor eye injuries or diseases
What should a signed order from an optom include
Date
optoms details ( name , goc number, practise address)
pt deatils - name , DOB, address
medication details - name , drug , quantity , form , conc and optoms signature
In what situation may an optom provide a pt with a signed order
outside of an emergency for meds in the use and supply group
Why is tropicamide preferred over phenylephrine
more rapid and stable
tropicamide comes in two conc , what are they and how would you decide which conc to use for each pt
0.5 and 1%
conc is decided based on pts age and iris colour
state a therapeutic use of cyclopentolate
anterior uvietis
chloramphenicol l comes in two forms , drops and ointment , how is it decided which the patients receives
decided between practitioner and pt.
ointments instilled - 2/4x per day , half freq of drops
reduced dosing regimen found more convenient
ointment may cause smeary effect on pts vision - certain near tasks difficult
P Med formulation of Chloramphenicol used for tx of what
bacterial conjunctivitis only. if optom wants to use foer other infections POM form must be used
fusidic acid is effective against which type of bacteria
staphylococal aureus
