Sale and supply MPharm 2

What is EPS and advantages?

Electronic Prescription Service in England

Quick, easy, saves time so more patients can be seen = more money.

Rx can't get lost, reliable, secure, confidential. No more illegible handwriting = less confusion

Pharmacy starts dispensing process before the patient comes in so there is less wait time for the patient so more can be seen = more time spent with them

Can CDs be Rx electronic? What are the requirements?

Yes, schedule 2,3 and 4

must be supplied within 28 days instead of 180

prescribed on a different form to non-CDs

Is EPS used in hosital?

not as much

can’t let pharmacist know urgency

doctor doesn’t know if med in stock

What is regulation for supply of CDs

Misuse of Drugs Regulations 2001

What does the Misuse of Drugs Regulations 2001 include?

Allow for lawful possesion and supply of CDs as medicines under strict legal control

Covers: prescribing, administering, safe custody, dispensing, record keeping, destruction and disposal of CDs to prevent diversion for misuse

Why are CDs prescribed usually?

pain relief

palliative care

epilepsy,

alcohol and drug withdrawal,

methadone substitution scheme

What are the different CD control schedules?

Most Controlled

Schedule 1 : CD Lic - require specific licenses to handle, e.g. illegal substances

Schedule 2: CD POM - morphine

Schedule 3: CD No Register

Schedule 4: CD Benz and CD Anab

Schedule 5: CD Inv

What CDs must be kept in the CD register?

Schedule 2 and above

What CDs have safe custody requirements?

All Sch 2 CDs except quinalbarbitone

Sch 3: temazepam, diethylpropion, buprenorphine and flunitrazepam

How long is a CD Rx valid?

Sch 1-4CDs is valid for 28 days only

How long is a Sch 5 CD Rx valid for?

6 months

Give examples of Sch 5 CDs?

pholcodine, codeine

What CDs can an EMS be made for?

No Sch 1-3CDs except Phenobarbitone for epilepsy

What is a VMP

“Veterinary medicinal product

Any substance presented as having properties for treating/preventing disease in animals

or that may be used with a view to either restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis

What is a POM-V

A POM that can only be prescribed by a veterinary surgeon following clinical assessment of animal

only supplied by veterinary surgeon or pharmacist with written Rx

What is a POM-VPS

POM can be prescribed by any Registered Qualified Person (RQP - a veterinarian, a pharmacist, or other Suitably Qualified Person under DEFRA guidelines) on an oral/written Rx

Written Rx only required if supplier is not prescriber

clinical assessment of animal not requiredw

what responsibilities does a pharmacist prescribing a POM-VPS of making NFA-VPS supply have?

Advise of the safe administration of the product.

Advise of any warnings/contraindications on the label package/leaflet.

Be satisfied that the person administering it is competent, and intends to use it for an authorised use.

Not prescribe/supply more than the minimum amount required for treatment.

What is an NFA-VPS

Medicine for non-food animals that can by supplied by any RQP

No Rx required

What is an AVM-GSL?

Authorised veterinary medicine available for general sale

No legal restrictions

What are the 4 types of veterinary medicines supply?

POM-V

POM-VPS

NFA-VPS

AVM-GSL

Explain the cascade exemption?

Within veterinary medicines regulation: allows for supply of human medicines that are not otherwise licensed for use in animals

It is unlawful to supply a human medicine against a Veterinary Prescription unless it is prescribed by a Vet and specifically states “for administration under the Cascade”

What is the cascade?

1. Supply a licensed VM

2. Consider an existing licensed VM for another species/condition

3. Consider a licensed human medicine or EU licensed VM

4. extemporaneous/specially manufactured medicines considered

What are the 3 types of collection and/or delivery service governed by GPhC standards?

Standard Prescription Collection Service

Managed Prescription Collection Service

Delivery Service

What is the Standard Prescription Collection Service ?

An arrangement whereby a Pharmacy receives a prescription other than directly from the patient or their representative e.g. collected by pharmacy staff or driver

What are the rules for standard and managed prescription collection services?

Obtain consent to receive the patient’s prescriptions.

Explain to patients/carers what the service involves including when to collect the medication.

Prescriptions must be collected by individuals acting in accordance with the Pharmacist’s directions.

Have procedures in place to safeguard confidentiality and security.

Any request for an ONGOING service must come directly from patient/carer – ideally written request.

On receipt of any prescriptions the Pharmacist must ensure that they are authorised to receive and dispense them.

Any prescription received without consent should be returned to the surgery.

What is the Managed Prescription Service Collection?

Collecting Rx from surgery without patient prompting the pharmacy to order their repeat Rx

The pharmacy will prompt the patient to establish what medications are needed and will inform the patient when the medication will be ready to collect.

What are some advantaged of the managed prescription collection service?

Began to manage increasing workloads: allows the Pharmacy 7 days to order and dispense the Rx.

Reduces wastage, increases compliance, and secures the patient’s repeat custom

What is the prescription delivery service

Medicines handed to patient/carer someplace other than in the registered pharmacy premise - e.g. their home

What are the rules for the prescription delviery service?

Pharmacist still has a professional responsibility to ensure patient knows how to use the medication safely, and are not experiencing S/Es or compliance issues.

Must obtain consent – preferably written.

Appropriate records must be kept for the purpose of audit.

It is the responsibility of the Pharmacist to ensure that the delivery mechanisms:

• Are safe.

• Ensure prompt delivery with instructions for use.

• Medicines are handed to the patient/carer unless alternative arrangements have been made.

• Confirm the correct name and address of recipient.

• Cater for special storage requirements e.g. refrigerated lines.

• Have a clear audit trail and safeguards confidentiality.

• Obtain a signature to verify safe delivery (good practice)

Why must rules be put in place for delivery and collection services?

To ensure confidentiality and safety of patients and their medicines information

What is Batch Repeat Dispensing?

Patient’s pharmacy of choice receives batch of Rx after consenting and up to date with medication reviews

Subsequent medications are supplied to patient at the intervals set by the prescriber

No need for patient to contact prescriber to request a repeat

Until final issue in which patient is referred back to prescriber to attend a review

What requirement of batch repeat dispensing helps avoid medicine wastage?

At point of supply the dispenser must ask patient if they require all items on prescription before every issue

esp. useful for prn meds

What patients would be most suitable for batch repeat dispensing?

Patients with stable, chronic conditions identified by their GP

How many batches of repeat meds can be given on BRD?

6 months initially

Then up to 12 months

What are some benefits of batch repeat dispensing?

Improve workload management from GP

Improve access to GP surgeries for those that need it.

Patient-centred approach to repeat medication, increasing convenience and ownership of their medication

Reduce medicine wastage

Are faxed prescriptions legal?

No

risk that rx is not legal/genuine, og rx might not be given, sent to multiple pharmacies, system is not secure

What is a wholesale dealer’s license?

MHRA requires most medicines wholesalers to obtains a Wholesale Dealer’s License unless specific exemptions are met by community/hospital pharmacies

What do pharmacies not need a Wholesale Dealer’s license for?

supply medicines to the public in the UK and to others authorised to receive medicines.

obtain small quantities of a medicine from another pharmacist in order to meet the needs of individual patients.

supply medicines to other HCP in the UK who need to hold medicines for treatment/supply to patients.

In the last 2 circumstances, the exemption holds true providing that the supply to other HC Professionals:

• takes place only on an occasional basis.

• the quantity of medicines supplied is small.

• the supply is made on a not for profit basis.

• the supply is not for onward wholesale distribution

as the MHRA will not deem such transactions as commercial dealing and pharmacies will not be required to hold a WDA(H)

What is a signed order?

A document that is needed to allow a registered pharmacy to supply POMs to healthcare professionals.

An entry must be made in the POM register OR the signed order/invoice needs to be retained for 2 years from the date of supply

What does a signed order POM register need to include?

Date the POM was supplied

Name, quantity and (where it is not apparent) formulation and strength of the POM supplied

Name and address, trade, business or profession of the person to whom the medicine was supplied

The purpose for which it was sold or supplied

What does a signed order need to include?

Legally details are not specifed, same as POM register entry:

Date the POM was supplied

Name, quantity and (where it is not apparent) the formulation and strength of the POM supplied

Name and address, trade/business/profession of the person to whom the medicine was supplied

The purpose for which it was sold or supplied

Are there different laws surrounding signed orders for CDs?

Yes

Can you supply POM to HCPs?

Yes, as long you make a signed order/POM book entry

Some HC providers are limited in what POMs they can obtain

What are the exeptions of sale/supply of POMs without a prescription?

EMS and PGDs

Wholesale dealing to give to HCPs

Injections in an emergency e.g. epi pen

Pandemic exemptions

Optometrist/podiatrist signed orders for patients

Supply of salbutamol inhalers and adrenaline autoinjectors to schools

Supply of naloxone by individuals providing recognised drug treatment services

Is there a difference between NHS repeat Rxs and private repeatable Rxs?

Yes, private Rx can be suppled more than once against same form

NHS Rxs need a separate form for each supply made

What CDs are repeatable on a private Rx?

Sch 2-3 CDs are not repeatable

Sch 4-5 CDs are repeatable

When must repeatable private Rxs be first dispensed by? what about subsequent repeats?

28 days for Sch 4 CDs

6 months for all other meds (inc. Sch 5 CDs)

No legal time limit for remaining repeats

How many Rx repeats can be given on a private Rx is not stated

Only 1 repeat

Except oral contraceptives (one month supply), can be dispensed six times (i.e. repeated five times) within six months of the appropriate date

Who keeps private repeatable Rxs?

Patient or pharmacist - they can go to a different pharmacy

What audit details must be written for each repeatable private Rx supply on the actually Rx?

Date, name and address of the pharmacy from where supply has been made and which dispensing/repeat was made on that date.

How long should pharmacy keep private rx?

2 years

If repeat, 2 years after last dispensing

How long should pharmacy keep POM book?

2 years after last entry

What must a POM book registry include? Any exemptions?

• Prescriber details - name and address of practitioner

• Patient details - name and address

• Supply date

• Prescription date

• Medicine details - name, quantity, formulation and strength

• Make record of price paid - no VAT added

• Stamp script with branch stamp

• Add a reference number to correlate the entry to the prescription (good practice, not legally required)

• Record should be made on day of sale/supply or next day

Prescriptions for oral contraceptives are exempt from record keeping

Prescriptions for Sch 2 CDs are also exempt when a separate CD register record has been made

What is AWTTC?

All Wales Therapeutics and Toxicology Centre based at UH Llandough

NHS organisation delivering range of services:

Yellow Card Centre (YCC) Wales

The Welsh National Poisons Unit

Publish NHS Wales Primary Care Antimicrobial Guidelines

What is AWMSG?

The All Wales Medicines Strategy Group (AWMSG) advises Welsh Government about the use, management and prescribing of medicines in Wales

AWTTC supports AWMSG and they work collaboratively with NICE to develop Wales-specific guidelines

• Develop timely, independent and authoritative advice on new medicines.

• Advise Welsh Government about future developments in healthcare.

• Help Welsh Government to develop a medicines prescribing strategy for Wales.

What is NICE? Who follows their guidelines?

National Institute for Health and Care Excellence

England, Wales, and (more loosely) N. Ireland

Who publish Scottish HC guidelines?

Scottish Intercollegiate Guidelines Network (SIGN)

What HC guidelines do Ireland follow?

Endorsement of NICE guidelines (can adopt/modify)

What is the BRAG list?

Guidelines coving where/in what setting certain drugs should be prescribed for each LHB

Black = no one

Red = hospital specialist use only

Amber = initiated by specialist, shared care later

Green = any

Where can you get info for a clinical check from?

The prescription

The patient, patient’s representative or carer

The patient's GP

The patient's medication record (PMR) system

Other medical records where available (e.g., in Scotland – access to the Emergency Care Summary; in a prison – access to medical records)

Other HCPs involved in the person's care (e.g., dieticians, microbiologists, and physiotherapists)

Medical and nursing care notes

Additional ward charts

Laboratory results