Medicine and the Law Flashcards
What is the Medicines Act 1968
- Thalidomide was prescribed in 1950s as sedative and tranquilizer
In 1961 - Congenital deformities associated with use of this drug during pregnancy was reported e.g congenital malformation of limbs
- Prescribed for relieving morning sickness symptom pregnancy
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 who has legal authority to do so - this includes independent prescribers
- E.g optom, nurse, pharmacist, doctor
Can all prescribers prescribe controlled drugs?
- No, controlled drugs such as morphine, pethidine and methadone are regulated more strictly and only prescribed by doctors.
- Stricter legal controls apply to these medicines = cant be used by optoms
What are pharmacy medicines?
Pharmacy Medicines can only be sold from pharmacies and a pharmacist must make or supervise the sale
What may pharmacists ask
Pharmacists may ask patients is they have any medical conditions or take any other medicines, to check that it’s safe to take the medicine
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?
- The Human Medicines Regulations came into force on 14th August 2012
- The regulations were the result of the initiative by the Medicines and Healthcare products Regulatory Agency (MHRA) to consolidate and review UK medicines legislation
- They replace much of the Medicines Act 1968 and around 200 statutory instruments in the process
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
What is now defined within Human Medicines Regulations
Exemptions from the general rules laid down in the Medicines Act for optometrists
Which Prescription only medicines (POMs) may optometrists sell or supply?
- Provided it is in the course of their professional practice and in an emergency, registered optometrists may sell or supply the following POMs
- 0.5% chloramphenicol eyedrops or 1% eye ointment
- Cyclopentolate hydrochloride
- Fusidic Acid
- Tropicamide
- Independent prescribers have an extended list.
What else can optima do
Provided it is in the course of their professional practice and in an emergency, registered optometrists may sell or supply the following POMs
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?
-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
- 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
Study These Flashcards
The law also allows local arrangements to be developed for professionals without prescribing rights to supply or administer medicines to certain types of patients, in certain circumstances.
What is patient specific direction
Instruction given by independent prescriber to another professional to administer medicine to specific rx
What is patient group direction
Written instruction for supply and administration of medicines for certain groups by healthcare professional – instruction must be signed and agreed by a senior dr and pharmacist and include detail info about medicine
What is the Crown Review 1999
- Department of Health. (1999) Review of the prescribing, supply and administration of medicines
- Recommended that certain groups of healthcare professionals should be allowed to prescribe:
Independent prescribing
Supplementary prescribing
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
Format of 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
Latin abbreviations for ax’s
- ac = ante cibum (before food)
- pc = post cibum (after food)
- bd = bis die (twice daily)
- tds = ter die sumendum (three times daily)
- qds = quater die sumendum (four times daily)
- od omni die (every day)
- om omnni mane (every morning)
- on omni nocte (every night)
- prn pro re nata (when required)
What must happen before a medicine can be used in the UK
Must first be granted a licence
What does licensing of medicine include
- A licence indicates all the proper checks have been carried out and the benefits of a medicine are believed to outweigh the risks.
- The licence is also known as a marketing authorisation
In the UK how can licences can be granted
-The MHRA which can grant licences for medicines only in the UK
-The European Medicines Agency (EMEA) which can grant licences for medicines in the European Union (EU)
What information does the licensing of medicine include
-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
