Year 1 MPharm Law

Medicinal product

A substance which has properties of preventing or treating a disease in humans by modifying physiological function.

Authorizied medicinal product

Has a marketing authorization.

Relevant medicinal product

Not including homeopathic or traditional herbal substances.

Administer definition

Introduce to the body internally or externally.

What is an “appropriate practitioner”?

Under the Human Medicines Regulation, a qualified healthcare professional who is legally authorized to diagnose patients and prescribe POMs.

What legally defines a POM?

A medicine requiring a prescription from an appropriate prescriber as it:

• can be misused

• new active substance

• parenteral administration

• requires supervision to prevent damage to health.

Legal requirements for POMs

• Signed in indelible ink (or advanced electronic signature)

• Name, address, and particulars of prescriber → GPhC no, type of Rxer.

• Prescriber signature

• Patient name, address, and age if < 12

• Date

Rx validity length

6 months for a regular POM, 28 days for a CD Schedule 2-4 from appropriate date

Repeatable Rx validity length

Dispensed for the first time within 6 months, then valid indefinitely unless stated otherwise.

• if number of times it may be dispensed not specified → one other time.

• if oral contraceptive → dispense 6 times within 6 months.

Pharmacist prescribing restrictions

• Schedule 2-5 CDs except cocaine, diamorphone, or dipipanone

• Can prescribe unlicensed medicines and off-label medicines

• Can authorize an emergency supply of CD 4-5 + phenobarbital for epilepsy (Schedule 3)

How are POMs prescribed and supplied in hospital?

Via Patient Specific Directions (e.g. Kardex) which gives nurses administration instructions.

PSDs requirements

Oral or written (best practice)

Patient identifiable - name and hospital No.

Appropriate practitioner.

Dentist prescribing restrictions

Anything from the BNF, but NHS will only reimburse Rx from the Dental Practitioner’s Formulary.

POM records duration and requirements

NHS prescriptions, wholesale dealing, and S2 CDs are exempt.

Must be made on supply date or the next day, register should be retained for two years.

Inlcude supply date, prescription date, info on medicine, prescriber + patient details.

POM prescriptions

Must be retained for two years from date of supply or date of last supply (for repeatable), including oral contraceptives.

NHS Rx sent to BSA for reimbursement, private Rx for S2+3 CDs are sent off,

Labeling of dispensed medicinal products, what is required and where?

Should be placed on outer container, legal requirements include pharmacy name, medicine details, patient name, date, directions for use, and precautions.

Breaking down from bulk labeling requirements

Must include medicine name, quantity in each container, expiry date, batch reference number, handling and storage requirements.

Would then need to be labelled with usual labeling requirements upon dispensing.

Oral contraceptives records + prescription retaining

On private prescriptions → no record but retain prescription for two years

What legally defines a P medicine?

Covered by an authorization which says it is to be available only in a pharmacy, with a pharmacist present to intervene.

Examples of P medicines

Used for treatment of worms, parenterals, enemas, irrigation for bladder/vagina, aspirin for patients under 16.

If a pharmacist “makes up” a medicine → considered as P even if all contents are GSL.

Pseudoephedrine and ephedrine legal requirements

Can be used to synthesize crystal meth.

• 720 mg of pseudo and 180 of ephedrine per sale without Rx.

• Cannot sell together without Rx.

• Pharmacist can deny if suspicious.

Oral emergency contraceptives legal requirements

• Levonorgestrel 1.5mg licensed for above 16 years within 72 hours of unprotected sex.

• Ulipristal acetate 30mg licensed within 120 hours of unprotected sex.

Keep in mind that requests can be linked to abuse, children under 13 are too young to consent and duty of confidentiality is not absolute.

Paracetamol and aspirin legal requirements

Not more than 100 effervescent tablets can be sold at a time.

Up to 16 = GSL

17-32 = P

Codeine and dihydrocodeine

Maximum OTC pack size is 24 units for a P medicine.

If GSL is on a prescription

Treat as P medicine

P medicines can be on an NHS prescription.

GSL medicines

Can be sold/supplied with reasonable safety without the supervision of a pharmacist.

Pharmacy-only medicines

GSL that can only be sold in a retail pharmacy - customer self-selection is allowed.

Schedule 2 CDs

Pharmacists have the authority to prescribe and possess. Must be recorded in the CD register.

→ no other class of CDs must be recorded.

CD prescriptions

Must be clear on quantity in the doses; vague instructions not accepted.

Can be on both types of Rx. Non-CD medicines should not be included on the same private Rx.

Rules on pharmacists ammending

Can ammend minor errors like typos, missing words/figures in total quantity, marking amendments with name, date, and signature.

Cannot amend missing dose, strength, form or date → contact prescriber.

Emergency supply - request of prescriber

• Prescription must be provided within 72 hours

• Record patient details, medicine details, prescriber details, date of supply and date the Rx was provided.

• Quantity as prescribed, ensuring to cover the emergency period.

Emergency supply - request of patient

• Must interview patient and be satisfied that Rx cannot be obtained and medicine has been given before.

• Record patient details, medicine details, and circumstances of emergency.

• Max 30 day supply except:

  • 5 days for S4 + 5 + Pheno CDs

  • Full course of antibiotics + oral contraceptives

  • Smallest pack of insulin/inhaler.

• Standard labeling + emergency supply.

National Care Records Services

National digital service that supports the direct care of patients. Includes SCR, reasonable adjustments, personal demographic services etc.

Summary Care Records

Key clinical information including allergies, medications (and discontinued ones), significant diagnoses, care plan info → patient must consent.

Administration of parenteral POMs

Normally no one may administer except appropriate practitioners or in accordance with their directions.

Some POMs may be administered in a life-threatening emergency, e.g. adrenaline 1 in 1000 (EpiPen).

Patient group directions meaning

Written instructions for the supply of medicines to groups of patients who may not be individually identified.

PGD requirements

Period of time, medicine details, valid clinical situations, clinical criteria under which a patient is eligible, how to seek further advice, and relevant warnings.

PGD storage and handling

Should be supplied as pre-packs. Stock and usage records must be kept.

Specific medicines that can/cannot be used in PGD

Antimicrobials can be, but unnecessary.

Black triangle drugs and off-label drugs.

Unlicensed medicines cannot be used.

PGD - controlled drugs

All schedule 5, all schedule 4 except anabolic steroids, midazolan S3 and morphine/diamorphine S2.

NHS England Pharmacy First

Pharmacists are allowed to supply medicines to treat 7 common conditions → example of PGD.

• acute otitis media

• sinusitis

• sore throat

etc…

Specific criteria must apply like age range.

Who can supply PGDs

Qualified non-prescribing healthcare professionals such as pharmacists and nurses.

Who should sign PGDs

A senior doctor/dentist and a senior pharmacist

Wholesale dealing definition

The business of purchasing and distributing medicines in bulk to entities like pharmacies and hospitals rather than individual patients.

Requirements for wholesale dealers

• Must sell to other dealers, pharmacies, or a person entitled to supply medicines to the public NOT patients.

• Must have a whoelsale dealer’s license

• Must apply GDP standards

• Must have an experienced “Responsible Person”

Record keeping for wholesale dealing

Signed order or invoice (kept for 2 years) OR POM register → good practice to do both.

Schools and wholesale dealing

May keep salbutamol inhalers and adrenaline auto-injectors for emergencies. Supply can be made against a written order signed by a principal or head teacher.

Which combination of factors allows wholesale supply without a wholesale dealer’s licence?

• Occasional basis

• Small quantity

• Not for profit

• Not for further distribution

• Patient specific (emergencies)

Which professionals are legally required to issue signed orders?

Optometrists and podiatrists

Health Act 2006

Introduced the role of a responsible pharmacist, enabling ministers to make regulations covering their ability to be absent from the pharmacy.

Pharmacy Order 2022

Shifts power to create pharmacy governance from government ministers to bodies like GPhC.

Responsible pharmacist

Manages safe daily operation of a pharmacy while signed in.

Must display a notice:

• RP name, GPhC number, and that they are in charge of the pharmacy at the time.

Superintended pharmacist

Oversees governance and regulatory compliance across all company-owned pharmacies, 24/7.

• Must be senior managers with decision-making authorities.

• Can oversee multiple business.

• No longer need a statutory inspector on the board.

The Pharmacy Record

• RP name and GPhC number

• Date and time at which RP became and ceased to be RP → start and end of shift

• Date and time of absence, good practice to right reason → max 2 hours in operating hours.

Paper or electronic, must be kept for 5 years, changes made must be identified.

SOPs

Must be reviewed every 2 years at least, only responsible when pharmacy is in operation.

What can happen when the RP is absent?

If < 2h + another pharmacist present:

• GSL, P, POM dispensing

If < 2h + no other pharmacist:

• GSL sale and taking in RX

If > 2h + no other pharmacist:

• Only taking in Rx

No RP in charge = no medicine sale at all.