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The wrong prescription?

Prescribing and the Law

The wrong prescription?

Prescribing and the Law


Safe prescribing

Combining the strengths of UMIST and


The Victoria University of Manchester

The Medicines Act of 1968

Misuse of Drugs Act 1971

The NHS Act 1977

The Misuse of Drugs Regulations 2001

Combining the strengths of UMIST and


The Victoria University of Manchester

THE LEGISLATION
Additional Limitations
GDPs in NHS
NHS contracts
Dentists in community dental service (CDS)

THE MEDICINES ACT OF 1968

Medicinal Product:
any substance that is manufactured, sold, supplied, imported or
exported for specific purposes including the diagnosis, treatment or
prevention of disease and anaesthesia induction

National Health Service Act 1977: Primary Care


Trust Dental Services Directions 2006 [2].

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

THE MEDICINES ACT OF 1968

General sales list medicines (GSL)


licensing

Pharmacy medicines (P)

sale

Prescription-only medicines (PoM)

supply
labelling

Unlicensed medicines

packaging

Medical Devices

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

e.g.

THE MEDICINES ACT OF 1968

THE MEDICINES ACT OF 1968

Unlicensed Medicines

Medical Devices

Licensed medicine but unlicensed use

NHS restrictions
GDPs cannot prescribe under the NHS

Betnesol dispersible tablets used as a mouthwash

GMP prescribing restricted


e.g Gelclair

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

What Can Patients Purchase


General Sales List

THE MEDICINES ACT OF 1968

GSL Medicines
e.g.
Sold or supplied other than under the direction of a
pharmacist.

Ibuprofen (up to 16 tab/cap packs)


Aciclovir cream (2g, not all brands)
Chlorhexidine/Corsodyl mouthwash
Fluoride mouthwashes

Retails outlets including dental practices

Fluoride toothpastes containing no more than 1500ppm fluoride


Paracetamol (up to16 tab/cap packs)

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

What Can Patients Purchase


Pharmacy Medicines

THE MEDICINES ACT OF 1968

P Medicines
e.g.

Aciclovir cream (2g)

Miconazole oral gel (15g tube)

under the direction of a pharmacist *

Corsodyl dental gel

can be sold over the counter without a prescription

Ibuprofen (>16 tab/cap packs)

Paracetamol (up to 32 tab/cap packs)

Fluoride tablets

Fluoride drops

Corlan pellets

only from a pharmacy *

can be prescribed by a dentist, doctor or recognised


non-medical prescriber

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

What DPF Medicines Do Our Patients Need a


Prescription for?
POM

THE MEDICINES ACT OF 1968

POM
e.g.

All oral antibiotics

only from a pharmacy *

Topical and systemic antifungals

under the direction of a pharmacist *

Aciclovir tablets

Duraphat toothpaste

Diclofenac tablets

En-de-Kay Fluorinse

Topical steroids (except Corlan pellets)

NB local anaesthetics, drugs used for the purposes of sedation and emergency drugs
are POMs, dentists can administer POMs to their patients

only supplied against a prescription (patient specific


direction)

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

P Medicines and POM*


NHS Restrictions

P Medicines and POM*

Supply of drugs:

Exemption:
can be sold or supplied by dentists and doctors
but

those required for immediate use before the issue of a prescription e.g.
emergency use

personally administer to a patient any drug or medicine required for the


treatment of that patient

neither dentist or doctors can act as pharmacists - The NHS Act 1977

restrictions as far as NHS practice concerned

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

P Medicines and POM*


NHS Restrictions
Issue of prescription forms:

DENTAL PRESCRIBING

Use form FP10D

A prescriber shall order listed drugs, medicines or appliances as are


needed for the treatment of any patient to whom they are providing
services by issuing to the patient a prescription form.

Only those items listed in the Dental Practitioners


Formulary

The prescription form shall

No limits on the number and variety of substances


which may be administered to patients in the surgery

(a) be signed by the prescriber; and


(b) be issued separately to each patient to whom the
clinic/contractor is providing services.

Combining the strengths of UMIST and


The Victoria University of Manchester

No limits on the number and variety of substances


which may be ordered by private prescription

Combining the strengths of UMIST and


The Victoria University of Manchester

INFORMATION FOR DENTAL PRESCRIBERS

THE MISUSE OF DRUGS Regulations 2001


Controls drugs liable to abuse e.g. morphine,
amphetamines. i.e. controlled drugs

British National Formulary incorporating the Dental


Practitioners Formulary

Class A
Cocaine, diamorphine, lysergide, methadone, opium, pethidine

Other sources of information:


Monthly Index of Medical Specialities (MIMS)

Class B
Oral amphetamines, barbiturates, cannabis, codeine and
pentazocine

Summary of Product Characteristics (SPC)


Patient Information Leaflets (PILS)

Class C
Most benzodiazepines

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

THE MISUSE OF DRUGS REGULATIONS, 2001

5 schedules:
Dentists can possess, supply, prescribe, or administer
controlled drugs in the course of their profession.

Schedule 1 cannabis, lysergide, mescaline.


Schedule 2 diamorphine (heroin), cocaine, morphine, pethidine
Schedule 3 barbiturates, pentazocine, temazepam, midazolam

Record-keeping, custody of drugs and prescription


writing is regulated by this legislation.

Schedule 4 Part 1 all other benzodiazepines Part II anabolic


steroids, somatotrophin
Schedule 5 low strength preparations e.g dihydrocodeine
tartrate 30mg

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

THE MISUSE OF DRUGS REGULATIONS, 2001

Dentists may administer to a patient any drug specified in


Schedule 2, 3 or 4.

Dentists may prescribe on the NHS:

Schedule 3: temazepam tablets, temazepam oral solution

Dentists may direct another person, other than a doctor or a


dentist, to administer such a drug to a patient under their care.

Schedule 4: diazepam tablets, diazepam 2mg/5ml oral solution,


nitrazepam tablets

Any person may administer to another any drug specified under


Schedule 5

Schedule 5: dihydrocodeine 30mg tablets

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Future Developments
Prescribing and DCPs

RECENT CHANGES

Since 1998:

HSC 2000/026 (August 2000)


Patient Group Directions

Community Practitioner Nurse Prescribers (NPF)

Enables nurses, midwives, pharmacists, optometrists, chiropodists,


radiographers (and others) to supply or administer medicines

Since May 2001:


Extended Formulary Nurse Practitioners (NPEF)
From May 2006:

Consultation closed Nov 2009:

Nurse Independent Prescribers

MLX 362: Sale, supply and administration of medicines by Dental


Hygienists and Dental Therapists under a Patient Group Direction
(PGD)

Pharmacist Prescribers
Ongoing:
Recommendations of The Shipman Enquiry
Combining the strengths of UMIST and
The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Patient Group Directions (PGD)

What is a PGD:

Patient Group Directions (PGD)

a written instruction for the supply and/or administration of a


licensed medicine (or medicines) in an identified clinical situation,
signed by a doctor or dentist and a pharmacist. It applies to groups
of patients who may not be individually identified before
presenting for treatment.

What is a PGD:
legal mechanism by which medicines can be supplied and/or
administered to patients by a specified range of healthcare
professionals, without first seeing a doctor or dentist.
by registered, authorised health professionals
to a well-defined group of patients
for the condition described in the PGD

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Future Developments
Prescribing and DCPs
Consultation closed Nov 2009:

The wrong prescription?

MLX 362: Sale, supply and administration of medicines by Dental


Hygienists and Dental Therapists under a Patient Group Direction
(PGD)

February 2010:

Prescribing and the Law


Safe prescribing

Commission on Human Medicines (CHM) recommended amendment of


legislation
CHM recommendations accepted by ministers.
Now awaiting change to legislation will cover LA and fluoride containing
medicines e.g. Duraphat toothpaste
Combining the strengths of UMIST and
The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
The Drug History

Significance:

Prescribing
The Drug History

Significance:
Patient safety
Diagnostic significance
Effective and appropriate treatment
Hidden medical history

Barriers:
Barriers:
Perceived relevance by patient
Non-prescription drugs
Supplements, herbal remedies etc

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Allergic Reactions

Are you allergic to anything?

Prescribing
Allergic Reactions

Are you allergic to anything?


Tell me what happened?
Was the reaction investigated, did you have any tests for it?

Knowledge:

Knowledge:
Types of hypersensitivity (I immediate and IV delayed)
Investigations (prick testing, patch testing, direct challenge, RAST)

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Prescribing
Safe Prescribing

Know your patient

Know your patient

Know your drugs

Medical history

Know your limitations

Drug history

Know what to do when things go wrong

Allergy
Do you require additional information from GMP?

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Prescribing
Safe Prescribing

Know your limitations:

Know your drugs:


Use BNF
Check indications, cautions, contra-indications, side-effects
Check interactions Appendix 1
Check dose
Give appropriate warnings

Combining the strengths of UMIST and


The Victoria University of Manchester

use drugs you are familiar with


if in doubt consult patients GMP
seek advice
local Max Fac or Oral Med consultant
UK Medicines Information
http://www.ukmi.nhs.uk
North West Medicines Information Centre
Medicines in Dentistry Specialist Advisory Service
http://www.ukmi.nhs.uk/activities/specialistservices

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Adverse Reactions

Prescribing
Resources
British National Formulary http://bnf.org
Wray,D and Wagle SMS. A dentists guide to using the BNF: part I. British Dental Journal, 2008;
204: 437-439,

If things go wrong

Wray,D and Wagle SMS. A dentists guide to using the BNF: part I. British Dental Journal, 2008;
204: 487-491
Scottish Dental Clinical Effectiveness Programme. Drug Prescribing For Dentistry

good record keeping

(published April 2008, latest update November 2009)

good history

http://www.sdcep.org.uk/index.aspx?o=2334

explain to patient

Can dentists supply medicines? Prepared by UK Medicines Information (UKMi) pharmacists for

let GMP know


report the adverse reaction

NHS healthcare professionals Expiry: April 2010 National Electronic Library for Medicines
http://www.nelm.nhs.uk
The above references are essential reading

Medicine and Healthcare Regulatory Agency MHRA


www.mhra.gov.uk
referral for further investigation if appropriate

Other useful sources of information include:


UK Medicines Information http://www.ukmi.nhs.uk
North West Medicines Information Centre, Medicines in Dentistry Specialist Advisory Service
http://www.ukmi.nhs.uk/activities/specialistservices
Medicine and Healthcare Regulatory Agency MHRA www.mhra.gov.uk

Combining the strengths of UMIST and


The Victoria University of Manchester

Combining the strengths of UMIST and


The Victoria University of Manchester

The wrong prescription?

Prescribing and the Law


Safe prescribing

Combining the strengths of UMIST and


The Victoria University of Manchester

The wrong prescription?


Prescribing and the Law

The Medicines Act of 1968

Misuse of Drugs Act 1971

The NHS Act 1977

The Misuse of Drugs Regulations 2001

Combining the strengths of UMIST and


The Victoria University of Manchester

THE LEGISLATION
Additional Limitations
GDPs in NHS
NHS contracts
Dentists in community dental service (CDS)
National Health Service Act 1977: Primary Care
Trust Dental Services Directions 2006 [2].

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

Medicinal Product:
any substance that is manufactured, sold, supplied, imported or
exported for specific purposes including the diagnosis, treatment or
prevention of disease and anaesthesia induction

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

licensing
sale
supply
labelling
packaging

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

General sales list medicines (GSL)


Pharmacy medicines (P)
Prescription-only medicines (PoM)
Unlicensed medicines
Medical Devices

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

Unlicensed Medicines

e.g.

Licensed medicine but unlicensed use

Betnesol dispersible tablets used as a mouthwash

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

Medical Devices

NHS restrictions
GDPs cannot prescribe under the NHS
GMP prescribing restricted
e.g Gelclair

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

GSL Medicines

Sold or supplied other than under the direction of a


pharmacist.
Retails outlets including dental practices

Combining the strengths of UMIST and


The Victoria University of Manchester

What Can Patients Purchase


General Sales List
e.g.

Ibuprofen (up to 16 tab/cap packs)

Aciclovir cream (2g, not all brands)

Chlorhexidine/Corsodyl mouthwash

Fluoride mouthwashes

Fluoride toothpastes containing no more than 1500ppm fluoride

Paracetamol (up to16 tab/cap packs)

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

P Medicines

only from a pharmacy *


under the direction of a pharmacist *
can be sold over the counter without a prescription
can be prescribed by a dentist, doctor or recognised
non-medical prescriber

Combining the strengths of UMIST and


The Victoria University of Manchester

What Can Patients Purchase


Pharmacy Medicines
e.g.

Aciclovir cream (2g)

Miconazole oral gel (15g tube)

Corsodyl dental gel

Ibuprofen (>16 tab/cap packs)

Paracetamol (up to 32 tab/cap packs)

Fluoride tablets

Fluoride drops

Corlan pellets

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

POM

only from a pharmacy *


under the direction of a pharmacist *
only supplied against a prescription (patient specific
direction)

Combining the strengths of UMIST and


The Victoria University of Manchester

What DPF Medicines Do Our Patients Need a


Prescription for?
POM
e.g.

All oral antibiotics

Topical and systemic antifungals

Aciclovir tablets

Duraphat toothpaste

Diclofenac tablets

En-de-Kay Fluorinse

Topical steroids (except Corlan pellets)

NB local anaesthetics, drugs used for the purposes of sedation and emergency drugs
are POMs, dentists can administer POMs to their patients

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

P Medicines and POM*

Exemption:
can be sold or supplied by dentists and doctors
but
restrictions as far as NHS practice concerned

Combining the strengths of UMIST and


The Victoria University of Manchester

P Medicines and POM*


NHS Restrictions
Supply of drugs:

those required for immediate use before the issue of a prescription e.g.
emergency use

personally administer to a patient any drug or medicine required for the


treatment of that patient

neither dentist or doctors can act as pharmacists - The NHS Act 1977

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MEDICINES ACT OF 1968

P Medicines and POM*


NHS Restrictions
Issue of prescription forms:

A prescriber shall order listed drugs, medicines or appliances as are


needed for the treatment of any patient to whom they are providing
services by issuing to the patient a prescription form.

The prescription form shall


(a) be signed by the prescriber; and
(b) be issued separately to each patient to whom the
clinic/contractor is providing services.

Combining the strengths of UMIST and


The Victoria University of Manchester

DENTAL PRESCRIBING

Use form FP10D


Only those items listed in the Dental Practitioners
Formulary
No limits on the number and variety of substances
which may be administered to patients in the surgery
No limits on the number and variety of substances
which may be ordered by private prescription

Combining the strengths of UMIST and


The Victoria University of Manchester

INFORMATION FOR DENTAL PRESCRIBERS

British National Formulary incorporating the Dental


Practitioners Formulary
Other sources of information:
Monthly Index of Medical Specialities (MIMS)
Summary of Product Characteristics (SPC)
Patient Information Leaflets (PILS)

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS Regulations 2001


Controls drugs liable to abuse e.g. morphine,
amphetamines. i.e. controlled drugs

Class A
Cocaine, diamorphine, lysergide, methadone, opium, pethidine

Class B
Oral amphetamines, barbiturates, cannabis, codeine and
pentazocine

Class C
Most benzodiazepines

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

Dentists can possess, supply, prescribe, or administer


controlled drugs in the course of their profession.
Record-keeping, custody of drugs and prescription
writing is regulated by this legislation.

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

5 schedules:

Schedule 1 cannabis, lysergide, mescaline.

Schedule 2 diamorphine (heroin), cocaine, morphine, pethidine

Schedule 3 barbiturates, pentazocine, temazpam, midazolam

Schedule 4 Part 1 all other benzodiazepines Part II anabolic


steroids, somatotrophin

Schedule 5 low strength preparations e.g dihydrocodeine


tartrate 30mg

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

Dentists may administer to a patient any drug specified in


Schedule 2, 3 or 4.

Dentists may direct another person, other than a doctor or a


dentist, to administer such a drug to a patient under their care.

Any person may administer to another any drug specified under


Schedule 5

Combining the strengths of UMIST and


The Victoria University of Manchester

THE MISUSE OF DRUGS REGULATIONS, 2001

Dentists may prescribe on the NHS:

Schedule 3: temazepam tablets, temazepam oral solution

Schedule 4: diazepam tablets, diazepam 2mg/5ml oral solution,


nitrazepam tablets

Schedule 5: dihydrocodeine 30mg tablets

Combining the strengths of UMIST and


The Victoria University of Manchester

RECENT CHANGES

Since 1998:
Community Practitioner Nurse Prescribers (NPF)

Since May 2001:


Extended Formulary Nurse Practitioners (NPEF)

From May 2006:


Nurse Independent Prescribers
Pharmacist Prescribers

Ongoing:
Recommendations of The Shipman Enquiry

Combining the strengths of UMIST and


The Victoria University of Manchester

Future Developments
Prescribing and DCPs

Consultation closed Nov 2009:


MLX 362: Sale, supply and administration of medicines by Dental
Hygienists and Dental Therapists under a Patient Group Direction
(PGD)

February 2010:
Commission on Human Medicines (CHM) reommended amendment of
legislation
CHM recommendations accepted by ministers.
Now awaiting change to legislation

Combining the strengths of UMIST and


The Victoria University of Manchester

The wrong prescription?

Prescribing and the Law


Safe prescribing

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
The Drug History

Significance:

Barriers:

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
The Drug History

Significance:
Patient safety
Diagnostic significance
Effective and appropriate treatment
Hidden medical history
Barriers:
Perceived relevance by patient
Non-prescription drugs
Supplements, herbal remedies etc

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Allergic Reactions

Are you allergic to anything?

Knowledge:

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Allergic Reactions

Are you allergic to anything?


Tell me what happened?
Was the reaction investigated, did you have any tests for it?
Knowledge:
Types of hypersensitivity (I immediate and IV delayed)
Investigations (prick testing, patch testing, direct challenge, RAST)

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Know your patient

Know your drugs

Know your limitations

Know what to do when things go wrong

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Know your patient


Medical history
Drug history
Allergy
Do you require additional information from GMP?

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Know your drugs:


Use BNF
Check indications, cautions, contra-indications, side-effects
Check interactions Appendix 1
Check dose
Give appropriate warnings

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Safe Prescribing

Know your limitations:


use drugs you are familiar with
if in doubt consult patients GMP
seek advice
local Max Fac or Oral Med consultant
UK Medicines Information
http://www.ukmi.nhs.uk
North West Medicines Information Centre
Medicines in Dentistry Specialist Advisory Service
http://www.ukmi.nhs.uk/activities/specialistservices

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Adverse Reactions

If things go wrong
good record keeping
good history
explain to patient
let GMP know
report the adverse reaction
Medicine and Healthcare Regulatory Agency MHRA
www.mhra.gov.uk
referral for further investigation if appropriate

Combining the strengths of UMIST and


The Victoria University of Manchester

Prescribing
Resources
British National Formulary http://bnf.org
Wray,D and Wagle SMS. A dentists guide to using the BNF: part I. British Dental Journal, 2008;
204: 437-439,
Wray,D and Wagle SMS. A dentists guide to using the BNF: part I. British Dental Journal, 2008;
204: 487-491
Scottish Dental Clinical Effectiveness Programme. Drug Prescribing For Dentistry
(published April 2008, latest update November 2009)
http://www.sdcep.org.uk/index.aspx?o=2334
Can dentists supply medicines? Prepared by UK Medicines Information (UKMi) pharmacists for
NHS healthcare professionals Expiry: April 2010 National Electronic Library for Medicines
http://www.nelm.nhs.uk
The above references are essential reading

Other useful sources of information include:


UK Medicines Information http://www.ukmi.nhs.uk
North West Medicines Information Centre, Medicines in Dentistry Specialist Advisory Service
http://www.ukmi.nhs.uk/activities/specialistservices
Medicine and Healthcare Regulatory Agency MHRA www.mhra.gov.uk

Combining the strengths of UMIST and


The Victoria University of Manchester

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