Human Medicines Regulations 2012 B

Medicines Legislations 3

What legislation governs the sale, supply and administration of medicines in the UK?

Human Medicines Regulations 2012

Anyone selling medicines by wholesale requires…

a license

Are pharmacists exempt from wholesale dealing licenses under HMR 2012?

No, they are no longer exempt

What is a requisition?

A formal request by a practitioner for a service to be provided

What is a signed order?

A formal request by a practitioner for a service to be provided in writing

A written requisition

What is the purpose of signed orders?

To allow practitioners to purchase medicines by wholesale for professional use

What information must a signed order include?

• Name and address of supplier

• Name, address and signature of practitioner

• Medicine name, strength, quantity

• Date

Name professionals who may purchase medicines by signed order.

• Midwives

• Chiropodists

• Optometrists

• Drug treatment service personnel

• Masters of ships

• RNLI first aiders

• First Aid organisations

• Occupational health schemes

• Oil & gas rig first aiders

• Ministers of the Crown and Government departments

Can optometrists and podiatrists prescribe medicines?

Yes, if qualified as independent or supplementary prescriber

Can optometrists or podiatrists write a signed order?

Yes, to supply medicines directly to a patient

What must pharmacists do when supplying medicines under these signed orders?

• Label the medicines

• Provide a PIL

• Advise the patient on the use of the drug

• Keep adequate records

What medicines can midwives request?

• All GSL medicines

• All P medicines

• Some POMs for professional use

• Some parenteral POMs (POMs that have to be administered by injections)

Can student midwives administer parenteral medicines?

Apart from controlled drugs, yes, under the supervision of a qualified midwife

What is a Patient Group Direction (PGD)?

A written instruction for the sale and/or administration of medicines to groups of patients without individual prescriptions

Who must sign a PGD?

1. A doctor or dentist

2. A pharmacist

Who can supply or administer medicines under a PGD?

Specific healthcare professionals (e.g nurses, pharmacists)

Exemption for supply by national health service bodies.

Regulation 229

Exemption for supply etc under a PGD to assist doctors or dentists

Regulation 230

Exemption for supply etc under a PGD by independent hospitals

Regulation 231

Exemption for supply etc under a PGD by dental practices and clinics: England and Wales

Regulation 232

Exemption for supply etc under a PGD in retail pharmacies

Regulation 233

Exemption for supply etc of products under a PGD to assist the police

Regulation 234

Information required in a PGD

• Who developed it

• Who authorised it

• Where it can be used

• Training required

• Clinical conditions

• Inclusion and exclusion criteria for patients

• Cautions and relevant action

• Medical referrals

• What to do if patient declines treatment

• Details of the medicine

• Records to be kept

Who must be involved in developing a PGD?

A multidisciplinary group involving:

• A doctor or dentist

• A pharmacist

• A representative of the profession(s) who will use the PGD

Who authorises PGDs?

An appropriate NHS body, or equivalent for private providers

When should PGDs be only administered?

If there is an advantage for the patient without compromising their safety

Which medicines can be supplied under PGDs?

• POM

• P

• GSL

• Some controlled drugs

Which medicines cannot be supplied by PGD?

• unlicensed medicines

• dressings, appliances and devices

• radiopharmaceuticals

• abortifacients such as mifepristone

Can PGD services be delegated to support staff?

No

Who was added as authorised PGD users in 2024?

Registered Pharmacy Technicians

What is the legal term for a prescriber?

An “Appropriate Prescriber”

Which regulation defines prescribers?

Regulation 214 of The HMR 2012

Who were the original groups of practitioners who were authorised to prescribe?

• Doctors

• Dentists

• Vets

What can doctors prescribe?

Any:

• POM

• P

• GSL

and most controlled drugs

What prescription forms do doctors use?

• FP10SS

• FP10NC

• FP10HNC

  • FP10MDA

What medicines can dentists prescribe privately?

Any:

• POM

• P

• GSL

most controlled drugs

What can dentists prescribe on the NHS?

Only medicines listed in the Dental Practitioners’ Formulary

What NHS Prescription form do dentists use?

FP10D

What can Community Practitioner Nurse Prescribers prescribe?

Only medicines listed in the Nurse Prescribers’ Formulary

Which NHS prescription forms do CPNPs use?

FP10SS or FP10P which have ‘Community Practitioner Nurse Prescriber’ written on them

Who can be a non-medical prescriber?

• Nurses and Midwives

• Pharmacists

• Optometrists

• Chiropodists and Podiatrists

• Radiographers

• Physiotherapists

• Paramedics

What is supplementary prescribing?

A partnership between an Independent Prescriber and a Supplementary Prescriber.

What are supplementary prescribers?

Specially trained healthcare professional who prescribes specific medications within a Clinical Management Plan (CNP)

What are Clinical Management Plans?

Voluntary agreements between a supplementary prescriber and an independent prescriber

What must a CNP include?

• Patient details

• Patient condition

• Treatment with medicines

• When the patient should be referred back to the independent prescriber

• Details of independent prescriber

• Details of supplementary prescriber

Which medicines can supplementary prescribers prescribe?

Any POM, P, GSLs as long as they are included in the CMP

Why become a prescribing pharmacist?

• Increased autonomy - greater involvement in decisions about patients

• Better patient care

• Professional development

• Career satisfaction