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 can be dispensed six times (i.e. repeated five times) or 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

What is the pharmacy contract why is it beneficial?

Pharmacies from 2005 in England and Wales are now rewarded by quality rather than quantity as there were no specific funds allocated for services

Less money for dispensing but more for services

How did the pharmacy contract change in 2016?

Changed in 2016

Reduction in the amount of money paid for Dispensing

Introduction of the Community Pharmacy Contractual Framework

Introduction of Quality Schemes

What is Global sum, how has it changed?

Total sum of money allocated to pharmacy, in past it was all for dispensing

After 2005, pharmacy services were introduced and some of the sum was spent on services, global sum increased from £1.7bn to £2.8bn

Funding freeze of 5 years £2.59bn (2019-2024) but more of global sum spent on services and quality and safety, less of sum spent on dispensing

What are the 4 types of services in the Community Pharmacy Contractual Framework?

Essential

Advanced

Enhanced

Quality schemes

What are the essential services in England?

Discharge Medicines Service

Dispensing Medicines

Disposal of Unwanted Medicines

Healthy Living Pharmacies

Public Health

Repeat Dispensing

3xD-HPR

What is Discharge Medicines Service?

New England Essential service from Feb 2021 (years after Welsh DMR):

Medication reconciliation after hospital discharge (often changes to medication)

Medication optimisation ensuring the patient understands new regimen

Solving any issues that arise

What are dispensing services?

Essential service

England: EPS, required to maintain record of all medicines dispensed and any significant interventions

Wales: dispense drugs and appliances, supply in accordance with an SSP (serious shortage protocol), urgent supply without a prescription, refusal to provide drugs/appliances ordered

What is Disposal of Unwanted Medicines vs Disposal Services in respect of Unwanted Drugs?

Disposal Services in respect of Unwanted Drugs = Wales

Both essential services

Pharmacies are obliged to accept bac unwanted medicines from patients. Additional segregation is required under Hazardous Waste Regulations

What is Healthy living pharmacies?

Essential service England

Achieving consistent provision of a broad range of health promotion interventions to meet local need, help reduce health inequalities. Previously in quality schemes

Signposting, support for self care

What is Public Health?

Essential service England

Promoting healthy lifestyle

What type of service is Repeat dispensing/repeat batch dispensing?

Repeat dispensing = England essential service

Repeat batch dispensing = Wales essential service

What are the Wales Essential Pharmacy Services?

Dispensing Services

Batch Repeat Dispensing

Disposal Services in respect of Unwanted Drugs

Clinical Governance

Pharmacy information management and technology (IM&T)

Promotion of Healthy Lifestyles

Prescription Linked Intervention

Public Health Campaigns

Signposting

Support for self-care

DB-DC-4xP-SS

What are England Advanced Services?

1. Pharmacy first

2. Flu Vaccination Service

3. Pharmacy Contraception Service (PCS)

4. Hypertension case-finding service

5. New Medicines Service (NMS)

6. Smoking Cessation Service

7. Lateral flow test supply

What is Pharmacy first?

England Advanced service

Sinusitis (12yrs+)

Sore throat (5yrs+)

Earache (children),

infected Insect Bites,

Impetigo (1yr+),

Shingles (adults),

UTIs in women (16-64yrs)

3 Components: 7 conditions, referred in for minor illness from GP, referral from NHS 111 service if deemed pharmacy is most appropriate place for signposting

Can also provide emergency medication under pharmacy first if referred by 111

WHar is New Medicnes Service?

Advanced Service in England Only

Gives a follow-up too, call up in 3 weeks after being given new medicine for first time and being counselled on how to take it

What are Enhanced Services England?

Not as many national services in England - mainly covid vaccine service

Usually: Locally Commissioned Services - designed with local health needs in mind, particular health inequalities in the community

What are pharmacy quality schemes in England?

Greatly reduced in England for current year due to large workload in pharmacy. Entry criteria are reduced.

Gateway criteria is to provide at least 15 NMS consultations

Services include in 2023/24 as delayed contract for this year:

• Medicines Safety and Optimisation: high risk medicines (anticoagulant audit), palliative and end of life care (PEoLC)

• Respiratory: inhaler technique checks, inhaler waste management, referrals for patients using 3 or more bronchodilators in 6 months, use of a spacer in ages 5-15yrs, personalised asthma action plan (PAAP)

• Prevention: antimicrobial stewardship and inflection prevention and control

What are Wales Advanced Services?

Only 1: Discharge Medicines Review

Looks at medicines optimisation and patient adherence after changed care settings - usually leaving hospitals as that is high risk situation

What are some pros of DMR? When was it introduced? How much money are pharmacies given?

Decrease problems after discharge = decreased readmission to hospital - 1/3 of patients readmitted withing 2 weeks

Introduced by Welsh gov in 2011 DMR service

Pharmacies can do a max of 140 DMR in 12 months - NO LONGER A MAX after 2022

Pharmacies are paid £37 per DMR

Cost saving: as reduced readmission, reduced A&E attendances and reduced drug wastage

What patients are eligible for DMR?

Patients who have been discharged from a “care” setting AND where any of the following apply:

• Medications have been changed during their stay

• is taking 4 or more medications

• Needs medications dispensed into a multi-compartment compliance aid

• The pharmacist believes in their professional judgement that the patient will benefit from the service

What are the 2 parts of a DMR?

1. Medicines Reconciliation

   within 4 weeks of discharge

   does the medication on the 1st RX after discharge match the advice from the Hospital?

2. Adherence Support

   4 weeks after part MR

   a compliance check, explore problems

What are Enhanced Services Wales?

Common Ailments Scheme

Contraception services

Emergency Medicines Supply

What are the core Wales Clinical Community Pharmacy Service (CCPS)?

Continuity

Seasonal flu vaccine

Contraception services

Common ailments scheme

Emergency medicines supply

What is CAS?

Enhanced Service Wales and core CCPS

26 conditions to supply medicine, advice or signpost

What is contraception services?

Wales enhanced service (England have PCS as advanced) and core CCPS

Used to be emergency contraception but now bridging to have access to ongoing contraception through pharmacy if previously didn't have access

What is Emergency Medicines Supply?

Enhanced Service Wales and core CCPS

What are some Additional Clinical Services Wales?

not core, happen in some HBs rather than national level:

Sore throat test and treat

Blood borne virus testing 2021

Care home support national enhanced service 2022

Inhaler review service September 2022

Locally commissioned services

MAR chart service 2023 - medicines administration record provided to care workers

National just in case pack service - provide palliative care emergency medicines pack to patients foe which its anticipated their medical condition may deteriorate into the terminal phase of illness

National stop smoking service 2020

Needle and syringe supply 2022 - harm reduction by providing sterile injecting equipment and related including foil as an alternative, harm reduction information, advice, referral to specialist treatment services, sharps disposal equipment, acceptance of returned sharps waste, referral for testing of blood-borne viruses, providing naloxone and advice/training on its use

Patient sharps service 2020 - provide patients with safe and convenient mean of disposing of sharps

Supervised administration national enhanced service 2020

Training and accreditation

Urgent medicines service 2022

Waste reduction service 2023

Coronavirus information and updates, Lateral flow test and supply service 2024, Covid antivirals treatment service national specification, Primary care Covid-19 immunisation service 2021

What are Wales Quality and Safety Schemes?

1. Wales national workforce reporting system - up to date record of staff and skills in pharmacy

2. Climate change carbon literacy training in line with net zero Wales

3. All Wales pharmacy database validation - keeping online database up to date with available services pharmacy can provide so NHS 111 can refer and signpost to suitable pharmacies

What are Collaborative working schemes Wales?

7 main HBs in Wales, split further into primary care clusters (each has a lead)

Community Pharmacy Collaborative Lead: brings together other pharmacy representatives to talk about collaborating with each other and other allied HCPs. Working with local GP to improve repeat dispensing process, with local sexual health clinic to improve referrals between them, memory team for dementia referral

For 2024/25 meetings with other HCPs such as GPs can claim bonus for £277 per meeting for up to 6 meetings, bonus if attending at least 5 meetings

What is Clinical Governance?

Wales Essential Service

Framework through which NHS organisations are accountable for continually improving the quality of care

What is near miss log?

An error that is made, but been identified and corrected before final sign off to supply to the patient

What is incident managment?

Mistake after final sign off to supply to patient

Incorrect advice when selling OTC meds

Failure to supply medication - e.g. forgot insulin from fridge

CD discrepancies

Adverse reactions involving a pharmacy service (e.g. flu jab).

Should record incident as soon as possible. Need to demonstrate change. Review errors.

Barriers: blame culture

Pros and cons of OTC/CAS/PIPs supply

OTC:
Can be sold by any pharmacy staff
Quick and easy
No need to be registered with pharmacy/GP

Patient must pay

CAS:
Provided by any registered pharmacist
Free

Must have face-to-face consultation with pharmacist and wait for product to be labelled
Patient must register for service AND be registered with a Welsh GP

PIPs:
More items can be prescribed by an IP qualified pharmacist working within their scope of practice
Free

Must have face-to-face consultation with pharmacist and wait for product to be dispensed
Patient must live in Wales OR be registered with a Welsh GP

What are the different PIPs scopes?

Ear

Skin

Upper respiratory tract

Urinary tract

Contraception

Other: viral infection, pyrexia, gout exacerbations, all CAS

Can opticians supply eye preparations under a signed order?

Yes providing the Optometrist in question is accredited by the General Optical Council as an Additional Supply Optometrist