12/05/2014

1

Christine Randall

Senior Medicines Information Pharmacist

North West Medicines Information Centre

Part 1

Introduction to NWMIC and information on medicines

Part 2

Medicines, prescribing and the law

Part 3

Drug interactions, risk and local anaesthetics

Part 4

ADRs, Bisphosphonates and the Yellow Card Scheme

Part 5

Corticosteroids, antiplatelets, anticoagulants, pain and analgesia

Part of the national medicines

information pharmacists network

(UKMi)

UKMi specialist advisory centre for

‘Medicines in Dentistry’

[MHRA Yellow Card Centre for

adverse drug reaction reporting]

759 / 3048 dental enquiries in 2012 (25%)

650 (85%) directly from dentists 43% - antibiotic use/choice

42% - interactions/adverse effects

13% - patients on anticoagulants/antiplatelets

10% - availability/prescribing issues

8% - involving local anaesthetics

6% - pregnancy or breast feeding

6% - prophylaxis/endocarditis

6% - bisphosphonates

6% - managing patients on steroids

6% - fluoride/toothpastes

4% - controlled drugs (midazolam)

Steroid cover for primary adrenal insufficiency (Addison’s disease)

Latex status of dental local anaesthetics

Patients with hydrocephalus shunts

Safety of amalgam fillings during breastfeeding

Saliva substitutes

Safety of chronic ingestion of high strength fluoride toothpaste

Local anaesthetic allergy

Can dentists supply medicines?

Endocarditis prophylaxis

LA interactions

CD prescribing regulations

Patients taking antiplatelets

Toothpaste excipients

Miconazole oral gel and statins

PGDs in dental practice

www.ukmi.nhs.uk

Part 2

12/05/2014

2

Medicines Act 1968 (Reviewed and superseded)

Misuse of Drugs Act 1971

The NHS Act 1977/2006

Misuse of Drugs Regulations 2001

PGD legislation – extension 2010

The Human Medicines Regulations 2012 – came

into force August 14th 2012

Licensed medicines

GSL (general sales list)

P (pharmacy only)

PoM (prescription only medicine)

P

PoM

Unlicensed medicines

“Specials” – specially manufactured medicines

e.g. tranexamic acid mouthwash

Imported medicines e.g. some latex free LAs

Unlicensed use of licensed medicines (“off-label

use”) e.g. beclometasone inhaler or Betnesol

dispersible tabs for mouth ulcers

Most herbal and alternative medicines

Prescribing medicines outside the

recommendations of their marketing

authorisation alters (and probably increases) the

prescriber’s professional responsibility and

potential liability. The prescriber should be able

to justify and feel competent in using such

medicines.

Medical Devices

Not governed by the Human Medicines Regulations 2012 BUT in the NHS prescribing restrictions apply

Dentists can prescribe devices

SST Saliva Stimulating Tablets

GMPs restricted to Drug Tariff list

NB. Curasept mouthwash cannot be prescribed on any NHS prescription

Gengigel/Gelclair OK on FP10 but not FP10D

Most dental materials are Medical Devices

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3

For NHS patients

Currently restricted to the drugs on the

Secretaries of State list (see BNF)

For private patients

There is no legal restriction

Ethically restricted to areas in which you are

competent

NHS

If you need to prescribe a medicine not on the

DPF list, the GDS regs allow you to provide a

private prescription to an NHS patient

Dentists must prescribe on WP10D Wales

(FP10D England, GP14 Scot)

Private

A private (not NHS) prescription must be used

Deletions from the DPF list since September 2012

Ampicillin Capsules, BP

Ampicillin Oral Suspension, BP

Chlorhexidine Oromucosal Solution, Alcohol-free, 0.2%, DPF

Additions to the DPF list since September 2012

Licensed alcohol-free versions of mouthwashes in the Dental Practitioners' Formulary, where available, are preferred. (Chlorhexidine mouthwash BP, specify alcohol free)

Artificial Saliva Pastilles, DPF (Salivix)

Artificial Saliva Protective Spray, DPF (Aquoral)

£7.85 per item in England

A ”tax” – not the cost of the drug

Patients can buy P or GSL medicines

Many analgesics and some mouthwashes are

cheaper

E.g. paracetamol, ibuprofen, Glandosane, BioXtra

gel, Corsodyl gel and mouthwash

NOT CHEAPER: Difflam mouthwash, Saliva Orthana

Advise patient

[Private prescriptions – cost + fee]

All prescriptions must

Be written/printed legibly in indelible ink

Be dated

Contain the address of the dentist who writes and signs the prescription

Indicate that the prescriber is a dentist

Include the patient’s name and address

Include the patient’s age, if a child 12 years or under

Be signed in ink by the dentist with their usual signature

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4

Supply of drugs

A prescriber may personally administer to a patient

any drug or medicine required for the treatment of

that patient.

A prescriber shall order listed (DPF list) drugs,

medicines or appliances as are required for the

treatment of any patient to whom they are providing

services under the contract by issuing to the patient

a prescription form.

A prescriber may supply to a patient listed drugs,

medicines or appliances (DPF list) as are required for

immediate use before the issue of a prescription

NHS patients (The National Health Service Regulations 2005)

Only medications required for immediate use

Cannot supply PoM or P medicines

Private patients

Can sell all PoM and P medicines

Must comply with labelling regs for dispensed

medicinal products

Must comply with packaging regs

Prescription Only Medicine

Patients must provide informed consent to

this otherwise the NHS contract will be

breached.

Patients must sign form FP17DC to consent to

private treatment being carried out alongside

an NHS course of treatment.

The consent process must include a discussion

about the patient’s entitlement to receive

Duraphat® toothpaste via an NHS prescription

and relative costs.

One NHS prescription charge is currently £7.85.

Patients entitled to free NHS prescriptions will not benefit

An approximate dental trade price for one 75ml tube Duraphat® 2800 is ~ £3.50 and one 51g tube Duraphat® 5000 is ~ £4.90

More than one tube of Duraphat® toothpaste may be prescribed on a single NHS prescription.

The NHS prescription charge is £7.85 regardless of the number of tubes prescribed.

It is good practice to limit prescribing to three months supply.

Compare three tubes of Duraphat® toothpaste on an NHS prescription (£7.85) with three tubes of Duraphat® 2800 direct from the dentist (3 x £3.50 = £10.50 (at least)).

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5

The following information MUST appear on the outer

packaging when a manufacturers original pack is dispensed

to a patient:

The name of the patient.

The name and address of the person (dentist) who sells or supplies

the product.

The date on which the product is sold or supplied.

PLUS any of the following if the container is not a

manufacturers original pack/details are not already on the

packaging:

the name of the product or its common name

directions for use of the product

precautions relating to the use of the product.

When working under a PGD named hygienists

and therapists are able to

Independently choose and administer

medicines e.g. local anaesthetics

Issue named medicines directly to patients

e.g. fluoride preparations including Duraphat

toothpaste

All PoM supplies must be labelled as

dispensed medicines

NB – working under a PGD is NOT prescribing

UKMi medicines Q&A

Patient Group Directions in dental practice

NHS Evidence Search

National PGD website

NICE

Good Practice Guidance Patient Group Directions

National Prescribing Centre (NPC)

A practical guide and framework of competencies for

all professionals using patient group directions

Misuse of Drugs Act 1971

Manufacture, supply, possession

Penalties for offences

Class A e.g. most opiates, cocaine, ‘ecstasy’

Class B e.g. amphetamines, barbiturates

Class C e.g. cannabis, anabolic steroids

Classification for supply and possession

Schedule 1 – drugs not used medicinally e.g cannabis

Schedule 2 e.g. diamorphine, pethidine

Schedule 3 e.g. temazepam, midazolam, barbiturates

Schedule 4 e.g. most benzodiazepines, anabolic steroids

Schedule 5 – very low strengths e.g. codeine linctus

NHS –

temazepam (schedule 3),

diazepam (schedule 4)

Private – any CD as long as used to manage a dental

condition

NB private CD prescriptions require official private

prescription forms – obtain from local primary care

organisation

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Schedule 3 from Jan 2008

Prescriptions or requisitions for midazolam must comply with the full CD regulations.

Invoices for midazolam need to be retained for 2 years.

Records of midazolam usage do not need to be kept in a CD register.

Midazolam is exempt from the safe custody requirements and does not legally require storage in a CD cabinet.

Schedule 3 drugs should be denatured (rendered irretrievable) before being placed in waste containers.

SOPs required

Must cover the following

ordering and receipt of CDs

assigning responsibilities

where the controlled drugs are stored

who has access to the controlled drugs

record keeping

who should be alerted if complications

arise.

July 2008 ‘Security of prescription forms guidance’

Using NHS prescription forms

As a matter of best practice, prescribers should keep a record of the

serial numbers of prescription forms issued to them. The first and last

serial numbers of pads should be recorded. It is also good practice to

record the number of the first remaining prescription form in an in-use

pad at the end of the working day. This will help to identify any

prescriptions lost or stolen overnight.

To reduce the risk of misuse, blank prescriptions should never be pre-

signed. Where possible, all unused forms should be returned to stock

at the end of the session or day; they should not, for example, be left

in patients’ notes. Prescription forms are less likely to be stolen from

(locked) secure stationery cupboards.

http://www.hscic.gov.uk/catalogue/PUB10751

Antibacterial Drugs

3,924,400 items prescribed by

dentists

43,274,000 items prescribed by

all other prescribers

9.1% of all antibiotic

prescriptions written by dentists

Dental prescriptions account for

about 0.6% of all items dispensed

GDPs account for just under 10% of

all primary care antibiotic prescribing

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7

“The danger posed by

growing resistance to

antibiotics should be

ranked along with

terrorism on a list of

threats to the nation”

Prof Dame Sally Davies

CMO England

March 2013 The use of antimicrobials favours resistant organisms,

allowing them to proliferate while sensitive ones are

killed. Over time, resistant bacteria come to dominate

and treatments are lost.

We control this antibiotic-driven selection

it reflects the extent of antibiotic use, the ‘quality’ of

use, and the effectiveness of infection control.

It is critical that existing antimicrobials are preserved

and targeted appropriately.

An organisational or healthcare-system-wide

approach to promoting and monitoring judicious

use of antimicrobials to preserve their future

effectiveness. It has 3 major goals:

Optimise therapy for individual patients

Prevent overuse, misuse and abuse

Minimise development of resistance at patient

and community levels.

Indiscriminate use of broad-spectrum antimicrobials is

undesirable for two reasons:

Firstly, prescribing these agents where narrow-spectrum

drugs are effective creates a selective advantage for

bacteria resistant even to these ‘last-line’ broad-spectrum

agents, allowing such strains to proliferate and spread.

Secondly, disruption of normal flora can leave patients

susceptible to antibiotic-resistant harmful bacteria such as

C. difficile.

Prescribe in accordance with local policies and guidelines, avoiding broad-spectrum agents.

Document in the clinical notes the indication(s) for antibiotic prescription.

Drain pus and remove foreign bodies if indicated.

Prescribe the shortest antibiotic course likely to be effective.

Our understanding of the optimum and shortest safest duration of antibiotic therapy is very limited.

Always select agents that minimise collateral damage (i.e. selection of multi-resistant bacteria/C. difficile).

Consult your local infection experts.

Send appropriate specimens to the microbiology lab.

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Antimicrobial prescribing in primary care is only

indicated:

As an ADJUNCT to the management of acute or chronic

infection - where there is an elevated temperature, evidence

of systemic spread and local lymph gland involvement.

For the definitive management of active infective disease, eg.

necrotising ulcerative gingivitis.

Where definitive treatment has to be delayed due to referral to

specialist services. E.g.

inability to establish drainage in an uncooperative patient who requires

sedation or general anaesthesia for treatment or

a patient who needs to be treated in a hospital environment due to

comorbidities.

AMOXICILLIN

Dose

• By mouth, 500 mg every 8 hours, dose doubled in severe infection;

• child 1 month–1 year, 62.5 mg every 8 hours, dose doubled in severe infection;

• 1–5 years, 125 mg every 8 hours, dose doubled in severe infection;

• 5–18 years, 250 mg every 8 hours, dose doubled in severe infection

[BNF 65 – dose adult and child over 5 years, 250mg every 8 hours, dose doubled in severe infections]

Part 3

+ +

?

A drug interaction occurs when

The effects of one drug are changed

by the presence of another drug (or

food, drink or other agent)

Many drugs will interact in the body

Clinical significance depends on

The therapeutic range – wider range – fewer problems

The enzymes involved in activation/metabolism – the more

involved, the less likely that changes involving one enzyme

will be significant

Genetic polymorphisms and population variability – some

individuals are susceptible due to their genetic make up

Many listed interactions are theoretical extrapolations

12/05/2014

9

Some cytochrome P450 isoenzymes

subject to ‘genetic polymorphism’

Slow metabolisers

vs. normal metabolisers

vs. rapid metabolisers

vs. ultrarapid metbolisers

Codeine is biologically activated (to morphine)

by CYP2D6

CYP2D6 – slow metabolisers [poor response]

5-10% Caucasians

0-2% black and Asians

CYP2D6 – ultra-rapid metabolisers [excellent

response]

3% Northern European (White)

5-10% Southern European

10-30% Arabian/NE African

X

X

X

X

?

X = No analgesic effect

= analgesic effect

50-70%

10-15% 0-15%

Morphine 200x greater affinity for the µ-receptor

than codeine

Codeine CONTRAINDICATED in

children 0-18 years old who undergo tonsillectomy and/or adenoidectomy for obstructive sleep apnoea syndrome due to an increased risk of developing serious and life-threatening adverse reactions

all children under 12 years

patients known to be CYP2D6 ultra-rapid metabolisers

women during breastfeeding.

Codeine can be used for acute moderate pain in children over 12 years only if it cannot be relieved by other

painkillers such as paracetamol or ibuprofen.

UK Faculty of Family Planning and

Reproductive Health Care (FFPRHC)

recommendations – changed in Jan 2011

Current recommendations are that NO

additional contraceptive precautions are

required when combined oral contraceptives

are used with antibacterials that do not

induce liver enzymes, unless diarrhoea or

vomiting occur.

Altered (usually enhanced) response to anticoagulation

with warfarin has been reported with virtually every

class of antibacterial

Some result from a pharmacokinetic interaction but for

others there is no clear explanation

Theoretical mechanisms include

reduced intestinal bacterial production of vitamin K

substances,

reduced enterohepatic recycling

a reduction in dietary vitamin K intake because of illness

the effect of fever or infection on coagulation or drug

metabolism.

Difficult to produce an interaction in healthy

volunteers

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10

Penicillins

no clinically relevant interaction

Erythromycin/ azithromycin/ clarithromycin

controlled studies suggest that macrolides do not cause clinically relevant changes in anticoagulant effects of warfarin

Tetracyclines

of little clinical relevance

Cephalosporins

Cefradine and cefalexin do not interact

Metronidazole

interaction established and clinically important

Fluconazole and miconazole inhibit

metabolism of warfarin in the liver (via

CYP2C9)

An established and clinically important

interaction leading to increased

anticoagulant effect of warfarin.

Monitor the INR if the combination is

essential.

Erythromycin + simvastatin is CONTRAINDICATED

Simvastatin must be temporarily withdrawn if erythromycin

is required

Erythromycin + atorvastatin

Use only if the benefits outweigh the risks, lower doses of

atorvastatin may be considered

Erythromycin + other statins

not contraindicated but warnings apply

Interactions least likely with pravastatin and rosuvastatin

Clarithromycin – as for erythromycin

Azithromycin – unlikely to interact – different

metabolic fate

Simvastatin + miconazole

CONTRAINDICATED

No reports of interaction

Combinations with other statins not contraindicated

but warnings apply

Atorvastatin should only be used with

fluconazole/miconazole if the benefits outweigh the

risks

Pravastatin does NOT interact

[See UKMi Q&A - Can miconazole oral gel be used by patients taking a statin? for further detail]

Methotrexate + penicillin antibiotics

? methotrexate toxicity, combination not

contraindicated but close monitoring is

advisable

Methotrexate and NSAIDs / paracetamol

Reduced renal perfusion due to reduced PGE2

synthesis

toxicity may be dose related and lowest risk in

those taking low-dose methotrexate for

psoriasis or rheumatoid arthritis with normal

renal function.

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Risk of GI bleeding increased by

Age over 65 years

Male > female

History of GI bleeding

Alcohol intake

Smoking

Helicobacter pylori infection

Serious comorbidity, such as cardiovascular disease,

hepatic or renal impairment diabetes, or hypertension

Concomitant use of medicines that increase GI bleeding

risks (aspirin, NSAIDs, SSRIs, corticosteroids, warfarin,

nicorandil)

Relative risk (odds ratio) = 2 (100% increase in risk) e.g.

4/10 8/10

2/100 4/100

1/10,000 2/10,000

Absolute risk = actual increase in risk

4/10 8/10 = 4/10

2/100 4/100 = 2/100

1/10,000 2/10,000 = 1/10,000

Absolute risk - 1 bleed per 1,000 persons per year at

55 years

Compared with people aged 25 to 49 years who take a

NSAID:

People aged 50 to 59 years were at 1.8 times the risk.

People aged 60 to 69 years were at 2.4 times the risk.

People aged 70 to 80 years were at 4.5 times the risk.

People aged over 80 years were at 9.2 times the risk

Of developing a GI bleed

NSAIDs inhibit synthesis of prostaglandins

Prostaglandin inhibition causes decreased

Mucus production

Bicarbonate secretion

Mucosal blood flow

Mucosal resistance to injury

And increased risk of injury from

Stomach acid, bile salts, pepsin, endogenous and exogenous toxins

GI risk due to systemic rather than topical effect

Aspirin irreversibly inhibits platelet activity

Platelet aggregation leads to clot formation

Use of low dose aspirin doubles GI bleeding risk

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Serotonin has an important role in the

haemostatic response by promoting platelet

aggregation

SSRIs inhibit serotonin uptake into platelets

Platelets cannot make serotonin

SSRI use leads to increased risk abnormal bleeding

The relative risk of experiencing an upper GI

haemorrhage is doubled in people who take an

SSRI.

Odds ratios (relative risk) of upper GI haemorrhage:

OR (95% CI) P value

SSRIs alone 2.36 (1.44 to 3.85) 0.0006

NSAIDs alone 3.16 (2.40 to 4.18) <0.00001

SSRIs & NSAIDs 6.33 (3.40 to 11.82) <0.00001

For patients on an SSRI or aspirin needing a NSAID

consider

Using a NSAID with a lower risk i.e. ibuprofen vs.

diclofenac

Co-prescription of a Proton Pump Inhibitor (PPI)

e.g. omeprazole, lansoprazole.

Ibuprofen and diclofenac do not alter INR

Reasons for care with concomitant use include

Topical erosive effect of NSAIDs in GI tract

NSAID antiplatelet effect

No clinically significant interactions occur with plain

local anaesthetics at the small and localised doses

used in dentistry

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‘Potential interactions with

vasoconstrictors are of the most concern

to general dental practitioners’

Considering the amount of LA + adrenaline used in

dental practice reports of serious drug interactions

occurring following dental procedures are

exceedingly rare.

Most adverse events reported with adrenaline

administration in dental practice probably involve

excessive dosing and/or poor aspirating technique in

cardiovascularly compromised patients

*NOT DRUG INTERACTIONS*

Adrenaline

1:80,000 (1ml = 12.5mcg)

1:100,000 (1ml = 10mcg)

1:200,000 (1ml = 5mcg)

Epipen 1:1000 (1ml = 1000mcg)

[dose in anaphylaxis is 500mcg]

Tricyclic antidepressants

‘A well documented, well established and

potentially serious interaction.’

BUT – in LA for infiltration anaesthesia, or nerve

block the case is less clear.

Cases cited are all from the 1960s or 1970s

Concentrations of adrenaline several times greater

than those used currently

The interaction is rarely significant

*LIMIT DOSE TO RECOMMENDED MAX*

Beta-blockers

Interaction between propranolol and adrenaline is

established. It may be serious and potentially life-

threatening, depending on the dosage of adrenaline.

Marked and serious blood pressure rises and severe

bradycardia have occurred in patients given

300 micrograms of adrenaline

LA used in dental surgery usually contain very low

concentrations of adrenaline (so dose is 5 to 20 mcg/mL)

and only small volumes are given - undesirable

interactions are unlikely.

*The minimum amount of local anaesthetic containing the lowest

concentration of adrenaline should be used*

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? Diuretics

K+ may be low due to diuretic action

leading to possible increase in

cardiotoxicity.

*The minimum amount of local

anaesthetic containing the lowest

concentration of adrenaline should be

used*

Light physical work 4mcg/ml adrenaline

(plasma)

Continuous IV infusion of 10mcg/ml adrenaline

solution 4mcg/ml adrenaline (plasma)

2mls lidocaine with 1:80,000 adrenaline = 25mcg

adrenaline

IV admin 25mcg adrenaline <4mcg/ml (plasma)

Anxiety and pain adrenaline

Most commonly used LA by UK

dentists

2.2ml cartridge contains

Lidocaine 44mg

Adrenaline 27.5micrograms

Manufactured & licensed by Dentsply

Xylocaine 2% with adrenaline 1:80,000

Maximum = 500mg

Manufactured & licensed by Septodont

Lignospan Special with adrenaline 1:80,000

Lignokent with adrenaline 1:80,000

Rexocaine with adrenaline 1:80,000

Eurocaine 2% with adrenaline 1:80,000

Utilycaine with adrenaline 1:80,000

Maximum = 3 x 2.2ml cartridges (132mg lidocaine)

Different doses and ways to express:

BNF = 500mg

Martindale – The extra pharmacopoeia =

500mg

Oxford Handbook = 500mg (Paed 4.4mg/kg)

Churchill's = 4.4mg/kg (~ 300mg for 70kg)

Med Probs Dentistry = 7mg/kg or 500mg

US prescribing info = 7mg/kg or 500mg

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Doses lower if no adrenaline

BNF – 200mg

Martindale – 200mg

US – 300mg

Med problems in Dentistry – 4.4mg/kg or 300mg

In the Irish Republic (Eire)

Maximum dose licensed by Septodont is

300mg lidocaine

(UK max = 3 x 2.2ml = 132mg)

Part 4

“an unwanted or harmful reaction

experienced following the

administration of a drug or

combination of drugs under normal

conditions of use and suspected to

be related to the drug”

During

treatment

After treatment

discontinued

Potassium channel activator used for

Chronic stable angina

Prophylaxis acute coronary syndrome previous MI or CABG

Ulceration appears to be dose related

Superficial and non-specific ulceration but can be very severe

Does not always respond to standard treatment for oral ulceration

Usually resolves only when nicorandil is reduced or stopped.

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Recognised problem with all ACEIs

Incidence of 0.1-0.5%

Affects tongue, lips, eyelids, genitalia, may affect airway

Usually (60%) in first weeks of treatment but may not appear for months/years

Can have intermittent presentation

ACEIs MUST be stopped if angioedema has occurred

Defined as

“exposed bone in the maxillofacial region for more

than 8 weeks in the absence of radiotherapy but in

the presence of bisphosphonate use.”

Mechanism for the reaction not fully understood

Bone supplies blood to some areas of

gingival mucosa and pulp.

As bone dies, gingival mucosa/pulp lose

their blood supply

More of a problem in areas where mucosa

very thin

Pain associated with ONJ – ischaemic

pain? Due to the overlying mucosa or pulp

dying?

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The underlying condition

cancer vs. osteoporosis

The drug

higher incidence with more potent bishosphonates:

Zoledronate > pamidronate > alendronate ibandronate risedronate > etidronate

A higher cumulative dose

higher doses for cancer ~ 10 fold

The duration of therapy

for oral therapy negligible risk before 3 years

NO evidence based national or

international strategies for the

prevention and treatment of BONJ

NO prospective data

Guidance based on expert opinion and

anecdotal evidence

Scottish Dental Effectiveness

Programme

(www.scottishdental.org/cep)

‘Oral Health Management of

Patients Prescribed

Bisphosphonates, Dental

Clinical Guidance’

Published April 2011

Routine prophylactic and/or postoperative

antibiotics NOT recommended

There is NO evidence that antibiotic

prophylaxis reduces the incidence of

osteonecrosis of the jaw following extractions

or dental surgical procedures

N.B. If the bone has no blood supply –

antibiotics will not reach the site

Only anecdotal data to suggest stopping helps

Canadian consensus guidance (2008) advise

IV - Stop for 3-6 months before and until the extraction

site has healed – only if medical condition permits

Oral – stop for ‘several months’

Currently stopping NOT advised by LUDH

Stopping not advised in Scottish guidance

Patients with suspected ONJ should be

REFERRED IMMEDIATLELY

to the local maxillofacial/oral surgery

department for specialist assessment and

management

Please report ALL cases of suspected ONJ to the

MHRA via the Yellow Card Scheme

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http://www.fgdp.org.uk/_assets/pdf/research/final%20report-27.11.12.pdf

80/155 BAOMS units submitted case

5/155 BAOMS units had no cases

59/155 BAOMS units did not participate

378 cases registered

378 cases registered

369 analysed (9 had too few data for analysis)

256 women

111men

2 unknown

Mean age was 68.5 years

Route of administration

Oral = 207

IV = 125

IV and oral = 27

Name of bisphosphonate received Number of cases

Alendronic acid 166

Zoledronic acid 93

Ibandronic acid 37

Disodium pamidronate 34

Risedronate sodium 27

Sodium Clodronate 9

Disodium Etidronate 5

Tiludronic acid -

Not known 36

N.B. some patients received more than one bisphosphonate

Diagnosis for which patient taking bisphosphonate

Cancer Osteoporosis Both Other

Ibandronic acid 18 11 - 1

Sodium Clodronate 7 - - -

Alendronic acid 10 110 4 -

Disodium Etidronate 2 2 - 1

Risedronate sodium 2 18 1 1

Tiludronic acid - - - -

Disodium pamidronate

22 2 3

Zoledronic acid 65 4 2

Not known 26 4 1

Total 152 151 7 7

0

50

100

150

200

250

Jan-0

5

May-0

5

Sep-0

5

Jan-0

6

May-0

6

Sep-0

6

Jan-0

7

May-0

7

Sep-0

7

Jan-0

8

May-0

8

Sep-0

8

Jan-0

9

May-0

9

Sep-0

9

Jan-1

0

May-1

0

Sep-1

0

Jan-1

1

May-1

1

Sep-1

1

Jan-1

2

May-1

2

Sep-1

2

Jan-1

3

Zoledronate

Pamidronate

Alendronate

Ibandronate

Clodronate

Risedronate

Etidronate

Tiludronate

N.B. 378 cases registered in the 2 year study

12/05/2014

19

Collecting, collating and investigating

reports of suspected ADRs

All suspected reactions for

herbal medicines

medicines used in children

black triangle drugs

All serious suspected reactions for

established drugs, vaccines and contrast

media

drug interactions

A reaction that is

fatal

life-threatening

disabling or incapacitating

result in or prolong hospitalisation

congenital abnormalities or

medically significant.

ONJ – bisphosphonates

Oral ulceration – nicorandil

Angioedema – ACE inhibitors

Gingival hyperplasia – nifedipine

Cleft lip – phenytoin

Prolonged paresthesia - LAs

www.mhra.gov.uk/yellowcard

You don’t have to be 100% certain to report

12/05/2014

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Part 5

Patients taking corticosteroids as an

immunosuppressant are unlikely to need

additional steroid cover for dental

procedures

Patients who have primary adrenal

insufficency e.g. Addison’s disease will

need additional steroid cover

BNF Section 6.3

‘A suitable regimen for corticosteroid

replacement, in patients who have taken

more than 10 mg prednisolone daily (or

equivalent) within 3 months of surgery, is:

Minor surgery under general anaesthesia — usual

oral corticosteroid dose on the morning of surgery

OR hydrocortisone 25–50 mg (usually the sodium

succinate) IV at induction; the usual oral

corticosteroid dose is recommenced after surgery

What is minor surgery?

Surgery undertaken under local

anaesthetic and lasting under 1 hour

The general anaesthetic is the biggest

stress in minor surgery under GA

Below 10mg prednisolone suppression of

HPA unlikely/limited stress response

will occur

Above 10mg prednisolone there will be

enough steroid ‘on board’ to protect the

patient

Carry out procedures first thing in the

morning.

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www.addisons.org.uk

Antiplatelet meds increase the

bleeding time (clopidogrel > aspirin)

Apply local measure to stop bleeding

Aspirin + clopidogrel bleeding

time (anecdotally could be 45 -60

mins)

Ask patient what happens when they

cut themselves

BNF

Prescribing in dental practice

Medical problems in dentistry

Thromboembolic disease

Stable INR - should be assessed 72 hours before the dental procedure.

Unstable INR - should be assessed within 24 hours of the dental procedure.

For minor dental procedures e.g. extractions, who have an INR <4.0 may continue warfarin without dose adjustment.

There is no need to check the INR for a patient requiring a non-invasive dental procedure.

Use local haemostatic measures

Dabigatran, Rivaroxaban, Apixaban

Is there a need to stop or alter the oral anticoagulant?

We have no trial data and little hands on practical

experience to guide practice yet.

Advice? 3 options

stop - use SPC to guide, consult prescriber

Dabigatran – need to know renal function

Rivaroxaban – stop for 24 hours

Apixaban – stop for 24 hours

Continue –

Maximise time since last dose

Use all local haemostatic measures as per warfarin

Refer to local oral surgery unit

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Most mild to moderate dental pain and

inflammation is effectively relieved by NSAIDs

(BNF section 4.7)

NSAIDs prescribable for NHS patients

Ibuprofen

Diclofenac

Aspirin

Paracetamol has analgesic and antipyretic

action but no anti-inflammatory effect

[Dihydrocodeine – the only opioid analgesic on

the DPF list.]

Dose

GSL/ P packs

200mg - 400mg up to three times daily.

Maximum 1200mg daily

PoM

1200mg – 1800mg daily in 3-4 divided doses

Maximum 2400mg daily for acute conditions

Take with or after food

N.B. available as a P medicine with codeine or paracetamol ibuprofen 200mg + codeine 12.8mg

Ibuprofen 200mg + paracetamol 500mg

Dose

P

12.5mg – 25mg every 4 -6 hour

Maximum 75mg daily

PoM

75mg – 150mg daily in 2 or 3 divided doses

Maximum 150mg daily

Take with or after food

Dose – GSL/ P/ PoM

500mg – 1000mg every 4-6 hours,

Maximum 4000mg (8 tablets) in 24

hours

N.B. available (GSL/ P) in combination

preparations with ibuprofen,

dihydrocodeine (7.46mg), codeine

(12.5mg), aspirin

Dihydrocodeine acts on opioid receptors in the brain and is

traditionally used for moderate to severe pain.

It reduces the patient's perception of pain and improves the

psychological reaction to pain by reducing the associated

anxiety

However, studies show that opioid analgesics are relatively

ineffective in dental pain and their side-effects can be

unpleasant.

Combining a non-opioid with an opioid analgesic can provide

greater relief of pain than either analgesic given alone.

However, this applies only when adequate doses of each

analgesic are used.

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Dose

P – only as Co-dydramol - dihydrocodeine 7.46 mg + paracetamol 500 mg

1- 2 tablets every 4 -6 hours

Maximum 8 tablets in 24 hours

PoM

30mg every 4-6 hours (or at the discretion of the prescriber)

Maximum recommended 180mg

[NB PoM co-dydramol can be 10/500, 20/500 or 30/500]

Ensure full doses of paracetamol plus

ibuprofen/diclofenac are being taken

Add dihydrocodeine to paracetamol plus NSAID –

the combination is effective for some people

Topical fluoride important for caries prevention

Daily use of a less concentrated rinse is better than weekly use of a more concentrated rinse

Available topical fluoride preparations for prescription:

Duraphat toothpaste 2800 and 5000 PoM

En-De-Kay fluorinse – 2% - currently unavailable

Duraphat weekly rinse – 0.2% - discontinued

Duraphat daily mouthwash 0.11% -not prescribable, device

FluoriGard daily rinse – 0.05%

En-De-Kay daily rinse – 0.05%

En-De-Kay fluodrops 0.25mg fluoride/0.15ml – currently unavailable

http://www.bnf.org/bnf/index.htm Prescribing and Medicines Management (BDA Advice Sheet)

BNF pages 1-9

12/05/2014

24

http://www.medicines.org.uk/emc/

www.evidence.nhs.ukContact us:

Telephone: 0151 794 8206

Email: nwmedinfo@nhs.net

Online resources:

www.ukmi.nhs.uk/activities/speci

alistServices/

The End