Medicines and the Law Flashcards
What tragedy led to stricter regulations around the supply and prescription of drugs?
The thalidomide tragedy
What act was created after the thalidomide tragedy?
Medicines Act 1968
Into what three categories does the medicine act 1968 group drugs?
Prescription only medicines (POM)
Pharmacy medicines (P)
General sales list medicines (GSL)
What are prescription only medicines?
Prescription only medicines cannot be without a prescription from an appropriate prescriber - this includes independent prescribers
Can all prescribers prescribe controlled drugs?
No, controlled drugs such as morphine, pethidine and methadone are regulated more strictly and only prescribed by doctors.
What are pharmacy medicines?
Pharmacy Medicines can only be sold from pharmacies and a pharmacist must make or supervise the sale
Why is it good practice to have a different prescriber and dispenser of the same drug/prescription?
Having the supply of the drug overseen essentially by two people now instead of one reduces the likelihood of error - it is for this reason pharmacists often enquire about the patient’s health conditions before dispensing any drug.
What are general sales list medicines?
General Sales List (GSL) medicines can be sold by a wide range of shops, such as newsagents and supermarkets
How may a general sales list medicine differ to that sold in a pharmacy?
Often, only a small pack size or low strength of the medicine may be sold e.g:
The largest pack size of paracetamol that shops can sell is 16 tablets but pharmacies can sell packs of 32 tablets
The highest strength of ibuprofen tablets that shops can sell is 200mg but pharmacies can sell tablets at 400mg strength
What was the medicines act 1968 surpassed by?
Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation
How does the medicines act 1968 affect optometrists?
Provided it is in the course of their professional practice, registered optometrists may sell or supply the following medicinal products to a patient:
All medicinal products on the General Sale List (GSL)
All P medicines
Which Prescription only medicines (POMs) may optometrists sell or supply?
0.5% chloramphenicol eyedrops or 1% eye ointment
Cyclopentolate hydrochloride
Fusidic Acid
Tropicamide
Independent prescribers have an extended list.
What’s the difference between a signed order and a prescription?
A prescription is for an individual. A signed order is ‘for use in the practice’ or by a certain professional.
What must a signed order for prescription only medicines include?
An order for POMs should include:
Optometrist’s name and address
Date
Name and address of the patient (if applicable)
Name of the drug
Quantity, pharmaceutical form and strength of the POM (e.g. 0.5% eye drops 10ml)
Labelling directions (where applicable)
Original signature of the optometrist
What conditions must a signed order satisfy?
The signed order must be in indelible ink; this includes typewritten and computer-generated orders.
College of Optometrists’ guidance recommends that the optometrist’s GOC number should also be included
What prescription only medicines can be administered by optometrists but not sold or supplied?
Tetracaine hydrochloride 0.5% (Amethocaine)
Lidocaine hydrochloride 4% (Lignocaine)
Oxybuprocaine hydrochloride 0.4% (Benoxinate)
Proxymetacaine hydrochloride 0.5%
Basically the corneal anaesthetics
True or false- the law allows for local arrangements for non-prescribing professionals to supply or administer specific drugs
True - this can be given in two ways:
Patient specific direction
Patient group direction
What is patient specific direction in relation to the supply and administration of drugs?
It is essentially the act of an independent prescriber giving instructions to another professional to administer a drug to a specific person
What is patient group direction in relation to the supply and administration of drugs?
It is a written instruction for the supply or administration of drugs to a specific group of patients, by a named healthcare professional which must be signed and agreed upon by a senior doctor and pharmacist.
How did the crown review affect optometry?
It basically stated that not only doctors should be allowed to prescribe and that other healthcare professionals like optometrists should be able to too within their field.
Thus gave way to independent prescribing and supplementary prescribing
What is independent prescribing?
To be a sole prescriber
What is supplementary prescribing?
3-way partnership between a medical practitioner (independent prescriber) who establishes the diagnosis and initiates treatment, a (supplementary prescriber) who monitors the patient and prescribes further supplies of medication and the patient who agrees to the supplementary prescribing arrangement
What conditions must be satisfied for a prescription to be valid?
A prescription for a medicine should be written legibly in ink or computer generated and should contain the following information:
Date
Name and address of patient
Patents age and DOB (legal requirement in under 12’s)
Name of drug, dose and number of days of treatment required
Prescribers signature
What does the following abbreviation mean?
“ac”
ac- ante cibum (before food)
What does the following abbreviation mean?
“pc”
pc- post cibum (after food)
What does the following abbreviation mean?
“bd”
bd - bis die (twice daily)
What does the following abbreviation mean?
“tds”
tds - ter die sumendum (three times daily)
What does the following abbreviation mean?
“qds”
qds - quater die sumendum (four times daily)
What does the following abbreviation mean in relation to drugs?
“od”
od - omni die (every day)
What does the following abbreviation mean?
“om”
om - omnni mane (every morning)
What does the following abbreviation mean?
“on”
on - omni nocte (every night)
What does the following abbreviation mean?
“prn”
prn - pro re nata (when required)
Who gives out licenses for drugs to be used in the UK?
Medicines and Healthcare products Regulatory Agency (MHRA)
and technically the European Medicines Agency (EMEA) which can grant licences for medicines in the European Union (EU)
What is a medicines license also known as?
The licence is also known as a marketing authorisation
What information does a license for medicines include?
The licence for a medicine includes information such as:
what health condition the medicine should be used to treat
the dose, form and who can use the medicine e.g. age restrictions
how long treatment with the medicine should last
warnings about known safety issues, such as side effects and interactions with other medicines
basically an SPC ( summary product characteristics).
True or False- Specified POMs included in the entry level exemptions list and additional supply medicines can be supplied directly to patients in an emergency and routinely supplied by pharmacists upon presentation of an order signed by optometrists
True
