Prescription Only Medicines (POMs)

• The lecture focuses on the sale and supply of medicines, specifically Prescription Only Medicines (POMs)
• Reference source: Medicines, Ethics and Practice, Edition 47, July 2024

Definition of a POM

• A POM is listed in the POM Order or classified as such in its marketing authorization
• A medicinal product can only be sold or supplied to a patient with a prescription signed by an appropriate practitioner
• Prescriptions are also known as patient specific directions (PSD)
• A PSD is a written instruction from a prescriber to supply or administer medicine to a named patient after assessing their individual needs
• A person may not sell or supply a POM without an appropriate practitioner's prescription (HMR Reg 214), however there are exceptions
• Exceptions to needing a prescription: Patient Group Directions, emergency supplies, and patient specific directions in hospitals
• Dispensing an NHS prescription for a POM is a supply; a private prescription is a sale

Products Always POM

• Parenteral products
• Controlled drugs (CDs), unless the marketing authorization lists it as a P or GSL
• Cyanogenic substances, unless for external use
• Medicinal substances that emit radiation upon administration
• New chemical entities

Legal Requirements for Prescriptions (POMs)

• Must be issued by an appropriate practitioner
• Must be signed in ink by the appropriate practitioner
• Must be written in ink or indelible form. NHS prescriptions (not for CDs in schedule 1, 2, or 3) can be written by carbon paper or similar material
• Must contain certain particulars: address of practitioner, date, indication of practitioner type, name and address of the patient, and age if under 12
• Valid for 6 months from the appropriate date
• The practitioner must be registered in the UK or be an approved health professional in an approved country

Repeatable Prescriptions

• Dispensed for the first time within 6 months of the appropriate date
• Prescriptions without a specified number of repeats can be repeated once, except for oral contraceptives, which can be dispensed up to six times
• Medicines must be supplied within the legally valid period of the prescription from the appropriate date

Definition of 'Appropriate Practitioner'

• Doctor ('registered medical practitioner')
• Dentist
• Community Practitioner Nurse Prescribers
• Supplementary prescribers
• Nurse independent prescribers
• Pharmacist independent prescribers
• Optometrist independent prescribers
• Physiotherapist independent prescriber
• Podiatrist independent prescriber
• Therapeutic radiographer independent prescriber
• Paramedic independent prescriber
• Doctors must be registered with the GMC and have a license to practice

Important Points for Prescriptions

• An indication of the kind of practitioner giving it is required
• Dates, the appropriate date on an NHS prescription, the appropriate date on a private prescription, and post-dated prescriptions
• The name of the practitioner is not needed

Dispensing Requirements

• Name of drug
• Strength
• Form
• Dose
• Frequency
• Quantity

Private Prescriptions

• Follow the same legal requirements as on slides 7 and 8
• Can be written on anything without a template or form
• Can be written by any 'appropriate practitioner'
• The date on private prescriptions is the date when it was signed
• Satisfaction that the prescription is genuine
• No restrictions on what can be prescribed if the prescriber is competent
• Legal prescriptions written by approved health professionals in an approved country
• Can be repeated ('a repeatable prescription)

Repeatable Prescriptions Details

• Definition of a repeatable prescription
• No repeats allowed on FP10 unless part of the NHS Repeat Dispensing scheme
• Number of repeats and 'repeat'
• There is not expiry of a repeat prescription after it has been dispensed for the first time but professional judgement should be used, considering clinical issues
• Patients can retain the prescription between repeats; the pharmacy that dispenses the final repeat must retain the prescription
• Repeatable prescriptions should be marked with the pharmacy's name/address and date of dispensing
• Do not confuse 'repeat prescriptions' with NHS Repeat Dispensing, instalment dispensing for addicts, as well as medicines on a 'repeat' list from a GP vs. 'acute' medicines

Prescribing by Dentists

• FP10(D) (yellow) written by a dentist is valid if the products ordered are in the Dental Practitioners' Formulary (DPF) (found in the BNF)
• Not following dentists' Terms of Service
• DPF includes generic names only; dentists can prescribe a branded version of a generic in the DPF
• A private prescription written by a dentist can legally be for any POM, P, or GSL medicine
• Dentists are required by their registration body (GDC) to restrict prescribing to their competency areas; generally, dentists should prescribe medicines with uses in dentistry

Prescribing by Community Practitioner Nurse Prescribers

• Community nurses (District Nurses and Health Visitors) with extra training
• May prescribe a limited range of medicines on an NHS prescription FP10P (lilac)
• The medicines are listed in the Nurse Prescribers' Formulary for Community Practitioners (NPF) (found in BNF)
• Same Terms of Service issue to dental prescriptions
• Prescribers are recommended to prescribe generically, except where clinically inappropriate or no generic name exists
• Community practitioner nurse prescribers are different from nurse prescribers who are independent or supplementary prescribers

Non-UK Prescriptions

• Written by approved health professionals in an approved countries
• Approved health professionals are doctors and dentists, as well as other prescribing rights for other professionals in their own country.
• Approved countries currently include EEA countries and Switzerland.

Legal Requirements

• Prescription should include patients first name(s), surname, date of birth, and Prescriber's information including name(s), surname, professional qualifications, contact details, and address, medicine(s) (brand name), pharmaceutical details
• Controlled drugs are prohibited, as well as products without UK marketing authorisation

Electronic Prescriptions

• Apply to all legal requirements of POMs
• Must be signed by an advanced signature
• NHS prescriptions sent to pharmacy from via the NHS spine
• Printed out prescriptions are known as 'dispensing tokens'
• Pharmacies print on stationary supplied by NHS (FP10DT)
• Rejected prescriptions are sent back to the GP for cancellation

Practical Considerations

• Prescribed medicines using brands names can only be dispensed as that brand
• Prescriptions need to be supplied exactly as requested, which can be altered with a serious shortage protocol
• Remaining quantity of the prescription or 'owing slip' should be given to the patient with validity of prescription

Original Pack Dispensing (OPD)

• Future law change as of January 1st, 2025
• Drug in its outer packaging can be dispensed, even with a different quantity
• The prescription quantity dispensed should be within 10%
• Only applied to NHS and private. Excludes prescriptions with specific supplies and non-prescription
• Excludes CD's
• The patients medication needs to appropriate and reasonable, with no failure to the prescriber
• Avoids and saves time in 'blister cutting'

Valproate-Containing Medicines Guidelines:

• Valproate medicines include sodium valproate, valproic acid, and valproate semisodium
• Valproate exposure during pregnancy is highly linked with congenital malformations
• Law changes require full packs to be dispensed
• Applies to NHS and private
• Ensures warnings are seen relating to risks in women and babies
• Label should not be covered by manufacture prints
• See pharmacy poster for poster: https://mhra-gov.filecamp.com/s/i/dr66W7LuRQ3pY7u5

Prescription Records

• A record should be made, unless it is a, health prescription or for oral contraceptive
• Kept for at least 2 years
• Either in electronic or bound book (POM register or 'prescription book') with adequate backups
• Including any legal requirements, as well as any good practice to be recorded
• Hospital pharmacies are not registered with GPhC

Details for Prescription Records

• Date of supply or sale
• Name, strength and quantity
• Date of Prescription
• The patients and prescribing practitioners address
• Reference number

Fate of a Dispensed Prescription

• NHS prescriptions should be sent to NHS Business Services Authority (NHSBSA)
• Not repeatable prescriptions kept for 2 years
• Repeatable prescriptions should be given back for outstanding repeats
• For final repeated prescriptions, keep for 2 years from the date of final dispensing

Hub and Spoke Dispensing:

• Involves different step through processes to label and check and generation
• Model of the process and accuracy check can be undertaken in just one pharmacy
• Pharmacy will only supply/dispense to the patients with the same retail business
• Requires chain pharmacies
• Two popular models, both involving prescription handed into hub
• Must be registered with the GPhC
• Not from a distance selling (internet) pharmacy, where the prescription receives directly

New Dispensing Advantages

• More efficient
• Lower operating costs
• Saves time by pharmacists
• Automation e.g. robots
• Reduces errors and safe

Disadvantages

• concerns regarding accountability
• Can effect patient security, more complected and confusing
• Not suitable

Current Dispensing situation

• Medicine devices act 2021 introduced hub and spoke dispensing
• Wider usage of prescribing that allows pharmacies through one or more sites
• A level playing field can be made for independent companies
• Not considered wholesale dealing
• A volentury arrangement

Internet (Online) Pharmacies

• Also know was distance selling pharmacies
• 400 in 2023 alone
• Only 5% were involved with items dispensed with internet pharmacies
• Bound by the same rules of a normal physical pharmacy
• Can only dispense from a traditional pharmacy- increased risks
• Fail regulatory standards
• Investigations involve the sale of OTC medicine with no safeguard or check

Main Internet (Online) Concerns

• High rate of prescribing medicines liable to overuse and abuse
• High-risk medicines

Key Internet (Online) guidlines

• Governance helps safety of the public
• Safegaurding staff empowers public safety
• Safe environment
• Safeguard services
• Safety and wellbeing of equipment

GPhC have concerns regarding high-risk and low-quality checks

• No real time GP assessment
• Commercial focus
• No face-to face contact
• Not checking and monitoring repeats
• Histories not taken into account

Logo check assurances:

• There have been counterfeit website, selling illegal medicines
• Voluntary logo checks can be approved by the GPhC
• MHRA approve retailers
• Patients should check before purchasing
• Registered pharmacy will present a logo and serial code

Serious Shortage Protocols

• Introduced into legislature in 2019
• Allows pharmacist to supply with an alternative medicine based on a prescription
• Allowed in accordance with serious shortage protocols issues by DHSC, along with any actions to take
• Can dispense a smaller quantity, different strength or formulation and a generic equivalent
• A patient GP should be informs of switch in medicine
• Supply is a responsibility under supervision of a pharmacist
• Need professional judgement

Shortages protocol 2

• Protocols apply to legitimately valid prescriptions
• Must have received medicine under a protocol
• Doctor must clearly understand any alternate drugs
• Dispensing label should indicate any protocol
• Patients do not get charged when receiving under protocols

Shortages protocol 3

• Protocol is important to read, specify checks prior to action
• Each SSP is expiry date- limited
• Certain drugs are not eligible for certain protocols
• Fluoxetine, HRT, are examples of issued drugs in certain presentations
• Every contractors will be sent an email to their email
• Website: https://www.nhsbsa.nhs.uk/pharmacies-gp-practices-and-appliance-contractors/serious-shortage-protocols-ssps

Prescription Collection Units:

• Prescription collection Units (PCUs) are locker that are accessed through automated machines
• Collection is allowed 24 hours, even when business if closed
• Can be a text, email, of code to acess
• Patient opt in is required for the collections
• Not all prescriptions are good for, fridges, bulky itmes
• Should be a clear audit trail
• Storage limited

Current Dispensing Errors Definition

• Not well defined
• Error during the process of dispensing
• Received medication in errors of that not designed by the patient
• Criminal prosecutions have occurred in the past

Types of Dispensing Errors

• Incomplete labeling
• For incorrect patients
• Expired
• Wrong medication

Medicines Act 1968, Section 64 states:

• "No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser"
• Still Applies
• Dispensing is a criminal offence

Possible Reasons Why Dispensing Is 'Criminalised'

• Criminalising pharmacist with errors
• Does Not improve patient safety
• Drafts can not guarantee safety
• But errors should not come at a mistake
• Can't allow intent to harm, needs to be recognised

Pharmacy Legal Order 2018

• Applied 2018 in April
• To community and hospitals, registered
• Section 64 has been retained
• Statutory legal defence could be used

Legal Defences

• Cannot be an offence, if medicines is under supervision is prepared by a pharmacy
• Medicine is supplied
• Registration is acting in course of profession
• Under a direction of the prescriber
• If are aware, give a prompt error
• All listed above apply
• If intention was deliberate must still apply
• Accountably is important - If the FtP committee is present referral most likely does not happen

Fax Prescriptions

• Discourages by the NHS
• April 2020 has no confidential information should
• Not a legal prescription
• If dispensed, pharmacist must provide short term
• Criminal offence if involves schedulding 2 to 3

Email Prescriptions

• Can come with service of GP's
• Shows through app as a photo email
• Used for health care for all purposes
  • However are not used for legal purposes
  • Is like printing a printed fax- a document
  • Cannot be shown as a legal document

Forgery

• Should always be alert to any forged prescription
• Pharmacist has to exercise for diligence when a prescription is issued
• The RPS has provided information factors
• Signature should be carefully check and contact prescriber- but avoid old data

Prescribing POMs in Hospitals

• Should be Specific Patient Direction, written with chart doctor
  • The law does not specify what should be included on a PSD
• Authorisation can be taken to supply form in discharge
• A pharmacist most prescribe under a original direction

Administration of POMs

• Unlawful to administer a paternal, practitioner or other than you
• Can't give is directions
• Small vaccine and classes should be exempt
• A group direction needs to be in place if non-parternal

Self Checking Prescriptions

• Checks and preforms the same accuracy, maximises safety, can cause error if not careful and assembled
• Short mental break is always necessary
• Can find information under RPS self checking