Professional and legal issues: prescription only medicines

What are the sale, supply and administration of POMs restricted by?

Human Medicines Regulations 2012

What are the requirements of POMs?

must have a prescription or valid exemption, only certain practitioners can supply, prescribing regulations, information that is required on prescriptions

What are CDs?

controlled drugs

What are the general prescription requirements?

1. signature of the prescriber - either ink or advanced electronic

2. address of prescribed

3. date - private - the date it was signed, NHS - later of either the date it was signed or another date indicated by the prescriber

4. particulars - indicate the type of prescriber

5. name of patient

6. address of patient

7. age of patient if under 12

How long are POM and Sch 5 CDs prescriptions valid for after the appropriate date?

6 months

How long are prescriptions for Sch 2,3, and 4 CDs valid for after the appropriate date?

28 days

What must the prescribers signature be in?

indelible ink, computer generated or typed

Are carbo copies of prescriptions allowed?

yes, as long as signed in ink

What are the rules around language on a prescription?

not specified but the pharmacist must be able to understand the prescription and put safety first

If a prescription says ‘as directed’ what do you need to do?

check with the patient that they understand how to use the medicine

What are the different types of prescriptions?

FP10 - primary care prescription, prescription for substance misuse, nurses, dentists

What is an owing?

when the pharmacy doesn’t have any stock or only part of the medicines prescribed, the pharmacist can issue what they do have and provide an owing slip for the patient to collect the remainder at a later date, within the time frame of the prescription.

What are the requirements around repeat private prescriptions?

POMs - first dispensing within 6 months of the appropriate date then no legal time limit. Sch 4 CDs - first dispensing in 28 days but then no legal time limit use professional judgement. Sch 2 and 3 prescriptions are not repeatable. The patient can choose to retain the prescription and have repeats dispensed from different pharmacies or the pharmacy can retain the prescription. The prescription should be annotated with the name and address of the first pharmacy where the supply was made and the date.

What are repeatable prescriptions?

private prescriptions that can be dispensed more than once

What are the record requirements for private prescriptions of POMs?

they must be retained for 2 years from the last date of the sale or supply

What are the record requirements for private prescriptions of Sch 2 and 3 CDs?

they must be submitted to the relevant NHS agency

Where must records be made?

in the POM register which should be retained for two years from the date of the last entry in the register

What must records contain?

the supply date; prescription date; medicine details: name, quantity, formulation and strength; prescriber details: name and address; patient details: name and address.

When should records be made?

on the day or day following the supply or sale

What special requirements of records are there for a Sch 2 CDs?

a separate record should be made in the CD register

What is the electronic repeat dispensing service?

a prescriber can authorise a batch of prescriptions for up to 12 months with one signature for repeat prescriptions for those with long term health problems that are being managed effectively, this is potentially more efficient, the prescriptions are available for dispensing at specified intervals.

What are the requirements for a repeat prescription on the electronic repeat dispensing service?

intended time interval, how many times the repeatable prescription can be issued, staff must be trained to monitor patient in absence of GP review and look for any other changes that may effect the suitability of the prescription

What happens after the prescription is generated on the electronic repeat dispensing service?

it is sent to the NHS spine where it ca be a downloaded by a nominated dispenser (this is a requirement)

What is the repeat authorisation token?

this is the master copy of the prescriptions

What must the repeat authorisation token have?

the usual information, items, number of issues, interval and end date

what is the repeat dispensing service?

the paper version of the electronic dispensing service, batch of paper prescriptions

How does the repeat authorisation work for the repeat dispensing process?

needs to have information about how many repeats can be made, if electronically issued, it is not used as a prescription so is not signed, if the RA is not electronic then the prescriber signs the RA instead of the RDs

What is the repeat dispensing form?

prescriptions which are dispensed against, has a digital signature

For NHS repeat prescriptions what do you need to confirm with the patient before suppling the drug?

• whether they are taking and using the medicine and that the actual appliance/formulation is appropriate

• is not experiencing any side effects and check whether a review is needed

• has not had any change to the therapy

• has not experienced any other health changes that need to be reviewed

What colour is a private prescription?

white

What colour is an acute prescription?

white

What colour is a NHS repeat prescription?

green

What colour is a dental prescription?

yellow

What are the rules about prescribing for dentists?

they can legally write a prescription for any POM, if prescribing on a NHS prescription must be from the Dental prescribers formulary, the general dental council advises dentists to restrict prescribing to competency and used in dentistry

What do you need to have legally on the label of a dispensed product?

name of the patient, name and address of the supplying pharmacy, date of dispensing, name of the medicine, directions for use, precautions relating to the use of the medicine

What are the suggested things for a label of a dispensed product?

‘keep out of the reach and sight of children’, and ‘use this medicine only on your skin’ where applicable, where the most appropriate place for label

What is a broken down supply?

breaking down the original quantity of a medicine to supply a smaller amount to satisfy a prescription

What must the label of a box containing a broken down supply contain in addition of the normal requirements?

name of the medicine, quantity of the medicine in the container, quantitative particulars of the medicines e.g. ingredients, handling and storage requirements, expiry date, batch reference number

What defines who can administer medicines or the appropriate delegation of the administration of medicines?

the organisational polices in that setting

What are the laws around registered healthcare professionals administering medicines?

they are accountable for their own actions, non-actions and omissions, they must exercise professionalism and professional judgement at all times, they are expected to meet their own professional and regulatory standards and guidance

What are the laws around non registered healthcare professionals administering medicines e.g. parental guardian or carer of patient or patient in hospital?

they must be appropriately trained, assessed as competent and meet relevant organisational guidance on medicines administration

What needs to be done before the administration of a medicine?

the person administrating the medicine must have an understanding of the medicine being administered and seeks advice if necessary from a prescriber or a pharmacy professional

When possible the actions of prescribing, dispensing/supply and administration are performed by separate healthcare professionals. why?

Reduces errors

When can a healthcare professional be safely responsible for the prescribing and dispensing/supply/administration of medicines?

in certain circumstances when it is in the best interests of the patient, they should have a risk assessment and keep a robust audit trail of decisions made and actions taken

What does a PPP stand for?

pregnancy prevention programme

When is a PPP involved?

when the patient is prescribed certain medicines with high risk of foetal malformations and/or increase risk of spontaneous abortion

What is the role of Pharmacists in the PPP?

they ensure medicines are not dispensed for women or girls who might be pregnant or are considering pregnancy

What is the aim of the PPP?

to protect females of childbearing potential by minimising risk of pregnancy

What are biosimilars?

a biological medicine that is similar to a biological medicine that is already licenced

What is a biologic?

a medicine made from natural sources either human, animal or microbiological

Are biologic and biosimilar medicines identical? And why?

no, they are large biological molecules do you can’t make an identical copy

What must happen for a patient to switch between brands of a biologic?

the decision must be made by a prescriber and a patient

What is the recommendations by the MHRA around prescribing biologics?

that they be prescribed by brand to prevent automatic switching

What does ATMP stand for?

advanced therapy medicinal products

What are ATMPs?

a biological medicinal product based on genes, tissues or cells which is either: a gene therapy medicinal product, a somatic cell therapy medicinal product or a tissue engineered product

What are the requirements around ATMPs and why?

different requirements around how they are stored, prescribed and monitoring, due to their complex nature, treat with a high degree of caution

What are the requirements around prescriptions from the EEA or Switzerland?

• Prescriptions and repeatable prescriptions issues by an approved heath professional in an approved country are legally recognised the UK

• Emergency supplies for patients of these healthcare professionals are permitted

• Not allowed for Sch 2 or 3

• requires prescribers professional qualifications and direct contact details

• Exercise professional judgement to confirm prescriber and registration status, patient safety as a key priority

• Must adhere to any local laws and to laws in country of origin