patient group direction (pgd) for the supply … · may be injected immediately prior to ... supply...

Version 2 Reference Number 14095h

Date of authorisation: 7.8.2014 Expiry date: 30.9.2017

D&T review date: 30.6.2017 of 39

PATIENT GROUP DIRECTION (PGD) FOR THE SUPPLY AND ADMINISTRATION OF

NAMED CORTICOSTEROID AND LOCAL ANAESTHETIC INJECTIONS

BY REGISTERED CLINICAL SPECIALIST PHYSIOTHERAPISTS

VERSION 2

TRUST AUTHORISATION

NAME DATE

Professor Albert Ferro Chair Trust Drugs and Therapeutics Committee

7.8.2014

Tony West Chief Pharmacist

7.8.2014

Change History

Version and Date

Change details

2014 1. Transferred to most recent Trust PGD template.

2. Updated objectives of PGD.

3. Added explanation of how each medicine will be selected

4. Staff characteristics amended

5. Clarification of ‘cautions / need for further advice to be taken’ with addition of some new exclusions

6. Updated to reflect any SPC changes.

7. Clarification of record keeping in light of audit findings

PGD SUPPLY AND ADMINISTRATION OF NAMED CORTICOSTEROID AND LOCAL ANAESTHETIC INJECTIONS BY REGISTERED CLINICAL SPECIALIST PHYSIOTHERAPISTS




CLINICAL CONTENT AUTHORISATION AUTHOR NAME

POSITION

DATE

Lead Author Alison Hyde-Blake

Clinical Specialist Physiotherapist

17.7.2014

Lead Clinical Pharmacist Nazanin Khorshidi

Lead Pharmacist Orthopaedics and Plastics

18.7.2014

Lead Consultant Steven Corbett

Consultant Orthopaedic Surgeon 18.7.2014

Specialist Co-author Dr. Imtiaz Ahmad

GPSI (GP with special interest in Musculoskeletal medicine)

4.8.2014

The lead author (Alison Hyde-Blake) has ensured that the following policies and procedures have been adhered to in the development of this PGD:

• Guys and St Thomas NHS Foundation Trust Medicines Policy and associated Codes of Practice

• Guys and St Thomas NHS Foundation Trust PGD Protocol

• Guys and St Thomas NHS Foundation Trust PGD template guidance notes. CLINICAL DIRECTORATE AUTHORISED SIGNATORIES

NAME DATE Sandra Noonan Therapies Clinical Director and Professional Lead

18.7.2014





CONTENTS PAGE

PAGE NUMBER

Objectives of the PGD 4 Medicines to be administered under the PGD 5 Staff Characteristics

6

Drug Monograph(s)

1. Methylprednisolone acetate aqueous suspension for injection (Depo-Medrone ®) 40mg/mL

7-13

2. Triamcinolone acetonide aqueous suspension for injection (Kenalog ®) 40mg/mL

14-20

3. Hydrocortisone acetate aqueous suspension for injection (Hydrocortistab ®) 25 mg/mL

21-26

4. Methylprednisolone acetate 4% with Lidocaine Hydrochloride 1% (Depo-Medrone with Lidocaine®)

27-33

5. Lidocaine hydrochloride 1% and 2% injection

34-37

Appendix 1 Outine audit plan Appendix 2 Agreement by Registered Practitioner

38

39





OBJECTIVES The objective of this PGD is to authorise registered, clinical specialist physiotherapists, who are trained and fully competent, to administer named corticosteroid and local anaesthetics to patients with local inflammatory joint or soft tissue conditions. All patients are excluded from any treatment under this PGD if they meet any of the following criteria:

• Aged under 18 years.

• Have known hypersensitivity to any ingredient of the medicine. (See SPC for further information)

• Are Pregnant or breast feeding

• Have untreated known or suspected systemic infection

• Have infection at the injection site

• Need an injection in a previously infected joint

• Need injection into an unstable joint

• Need injections into a prosthetic joint

• Need injections into tendon bodies and other avascular areas

• Need injection into weight bearing joint that is due to undergo surgery within three months of the injection

• Need injection within one week of planned surgical procedure

If patients are excluded, alternative appropriate treatment or referral will be offered according to the reason for exclusion above. The practitioner must refer to individual monographs for further information because additional exclusion criteria may apply. This PGD should be used in conjunction with local policies and guidelines relating to clinical practice within this service. Additional facilities and supplies must include access to a resuscitation trolley and presence of an anaphylaxis kit.





MEDICINES TO BE SUPPLIED UNDER THE PGD This PGD includes the following medicine(s): Medicine Subject to no other reasons for exclusion:

Methylprednisolone acetate aqueous suspension for injection (Depo-Medrone ®) 40mg/mL

First-line corticosteroid of choice when the therapeutic effects of a larger volume injection are indicated and a single syringe technique is not favoured.

Triamcinolone acetonide aqueous suspension for injection (Kenalog ®) 40mg/mL

Second - line corticosteroid of choice when the therapeutic effects of a larger volume injection are indicated and a single syringe technique is not favoured.

Hydrocortisone acetate aqueous suspension for injection (Hydrocortistab ®) 25mg/mL

First line corticosteroid of choice in patients with dark skin. Third-line for all other patients when the therapeutic effects of a larger volume injection are indicated and a single syringe technique is not favoured.

Methylprednisolone acetate 4% with Lidocaine Hydrochloride 1% (Depo-Medrone with Lidocaine®)

To be supplied first line when the therapeutic effects of a smaller volume injection is indicated and a single syringe technique is favoured.

Lidocaine hydrochloride 1% and 2% injection

May be injected immediately prior to the Corticosteroid injection when indicated (excluding Depo-Medrone with Lidocaine®), to reduce steroid induced tissue irritation and widen the field of steroid effect.

Medicines must be administered separately and not mixed in a syringe prior to administration. The decision to supply and/or administer any medication rests with the individual registered practitioner who must abide by the PGD and Trust policies.





STAFF CHARACTERISTICS The named health professional authorised to supply and/or administer medications under the PGD must meet the following criteria:

Qualifications

• Registered Clinical Specialist Physiotherapist employed by the Trust

Specialist qualifications

Successful completion of :

• Chartered Society of Physiotherapy recognised diploma (or equivalent) in injection therapy.

Specialist competencies

• Provides evidence of successful completion of Trust Medicines Management test. (COMPULSORY).

• Provides evidence of successful completion of Medicines Management Competencies for Physiotherapists (COMPULSORY)

• Provides evidence of successful completion of mandatory training in Cardiopulmonary Resuscitation (CPR) and recognition of anaphylaxis (COMPULSORY).

• Actively partaking in CPD and annual Individual Performance Review (COMPULSORY)

• Evidence of maintenance of continuing professional development (CPD), to be assessed through a minimum of 10 injections per year.

An up to date list and signatures of registered practitioners who are authorised to practice under this PGD is kept in the Physiotherapy Department St Thomas’ Hospital by the Clinical director of Therapies. Practitioners not listed are not authorised to practice under this PGD.





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DRUG NAME /STRENGTH/FORM Methylprednisolone acetate aqueous suspension for injection (Depo-Medrone ®) 40mg/mL QUANTITY 4mg-80mg

POM

CLINICAL CONDITION TO WHICH THIS DIRECTION APPLIES

Localised inflammatory conditions in adults as specified under inclusions below

INCLUSION CRITERIA

Patients who are aged 18 years and over and who have one or more of the following conditions:

• Localised inflammatory joint conditions.

• Bursitis

• Epicondylitis

• Capsulitis

• Tendonitis

• Tenosynovitis

• Entrapment neuropathy

• Plantar fasciitis

EXCLUSION CRITERIA (I.E. SITUATIONS NOT COVERED BY THE PGD)

• Patients who are aged under 18 years

Patients who have:

• Known hypersensitivity to methylprednisolone or any other ingredient of the medicine. (See SPC for further information)

• Pregnant or breast feeding

• Known or suspected systemic infection unless specific anti-infective therapy is employed

• Infection at the injection site



• Need an injection into a prosthetic joint

• Need an injection into tendon bodies and other avascular areas

• Need an injection into weight bearing joint that is due to undergo surgery within three months of the injection.

• Already received one injection in the last 12 weeks for the treatment of a weight bearing joint


• Diabetes with Hba1c greater than 10% or taken more than 3 months previously

• Diet or tablet controlled diabetes which is poorly controlled (see info under cautions)

• Epilepsy

• Uncontrolled hypertension (see info under cautions).

• Abscess

• Haemarthrosis See next page






POM

EXCLUSION CRITERIA (I.E. SITUATIONS NOT COVERED BY THE PGD) continued

• Unstable Heart Failure

• Unstable Liver failure or cirrhosis

• Active tuberculosis

• Unstable Renal insufficiency

• Osteoporosis where pain to be treated is due to the disease

• Patients with or history of intestinal anastomoses, diverticulitis, history of GI ulceration

• Patients with or history of ulcerative colitis

• Patients with or history of thrombophlebitis

• Existing or previous history of severe affective disorders (especially previous steroid induced psychosis)

• Myasthenia Gravis

• Unstable Glaucoma

• Previous steroid induced myopathy Patients who are:

• Immunosuppressed due to disease or treatment

• Taking Levothyroxine and have altered their dose within 2-3/12 or if TSH level is outside the reference range (typically 0.4–4.5 mU/L)

• taking any medicine which will either interact with the steroid injection or indicates a risk factor for the patient which requires referral to a Doctor (see appendix 1 BNF)

• taking Warfarin (or any other Vitamin K antagonist) with an INR result either less than 2 or greater than 3

• taking Warfarin (or any other Vitamin K antagonist) where the last INR result was more than 48 hours ago.

• taking novel oral direct anticoagulants: e.g. rivaroxaban, apixaban and dabigatran who received a dose less than 12 hours ago

• taking cardioactive drugs such as digoxin due to the risk of steroid induced electrolyte disturbances

ACTION IF EXCLUDED

• Consider if there is alternative appropriate treatment under this PGD.

• If no appropriate alternative treatment, refer to medical colleague and document action in the patient record.

• Inform GP in writing if patient is excluded from injection therapy.






POM

CAUTIONS/NEED FOR FURTHER ADVICE/ACTION TO BE TAKEN

• Due to the dosing interval stipulated in this PGD, it is not necessary to issue a steroid card.

• For diet or tablet controlled diabetic patients, physiotherapist to discuss control with the patient with respect to stability of symptoms and medication and refer to Dr if concerned. Advice to patient - explain steroids may reduce the effect of antidiabetic medicines and they may need to closely monitor their blood sugars for a few days after treatment, as per Trust PIL.

• Hypertension: Physiotherapist to discuss blood pressure control with the patient with respect to stability of symptoms and medication and exclude patient if concerned.

ACTION IF PATIENT DECLINES

• Document refusal/action taken in patient records.

• Discuss alternative appropriate treatment.

• If no appropriate alternative treatment, refer to medical colleague and document action in the medical notes






POM

DRUG DETAILS

NAME, FORM & STRENGTH OF MEDICINE

Methylprednisolone acetate aqueous suspension for injection (Depo-Medrone ®) 40mg/mL

USE OUTSIDE THE TERMS OF THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC)

Use of this medicine for capsulitis, tendonitis and entrapment neuropathy are not licensed, but are commonly treated with this drug. This use is approved by the Joint Formulary Committee.

ROUTE/METHOD Intra-articular Injection for inflammatory joint conditions or peri-articular for soft tissue injections with no-touch technique.

DOSAGE/FREQUENCY Range 4mg-80mg

• Smaller joints 4mg-10mg (0.1mL-0.25mL)

• Medium joints 10mg-40mg (0.25mL-1.0mL

• Larger joints 20mg-80mg (0.5mL-2.0mL)

• Soft tissue 4mg-30mg (0.1mL-0.75mL) Undesirable effects may be minimised by using the lowest effective dose for the minimum period. The drug may be administered alone (if excluded from the use of local anaesthetic), or following local anaesthetic. See Lidocaine hydrochloride 1% or 2% PGD pxx.

MAXIMUM OR MINIMUM TREATMENT PERIOD

Injections to be administered not less than 4 weeks apart.






POM

SIDE EFFECTS

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction.

The following are potential adverse effects of corticosteroids:

• Facial flushing

• Post injection flare

• Skin hyper/hypopigmentation

• Cutaneous / subcutaneous atrophy

• Alteration in glycaemic control (relevant to diabetics)

• Joint sepsis

• Soft tissue infections

• Tendon rupture

• Steroid arthropathy.

• Charcot-like arthropathy

• Anaphylactic reactions or allergic reaction

• Gastrointestinal effects including dyspepsia and ulceration

• Psychiatric reactions including affective disorders This list may not represent all reported side effects of this medicine. Refer to the most current SPC for more information. Adverse drug reactions should be reported following the Trust Untoward Incident Policy Any suspected adverse drug reaction, whether to a drug supplied or administered to the patient by the practitioner or to a drug already taken by the patient must be reported to a doctor immediately or as appropriate. Report all serious suspected adverse reactions to the MHRA via the yellow card scheme. Contact the clinical pharmacist to ensure any retrospective reports are carried out. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. Yellow Cards may be offered to each patient receiving medicines under this PGD. These can be obtained from the Pharmacy Department as well as pharmacies and GP surgeries. Yellow cards can also be obtained via Freephone 0808 100 3352 or online at Yellow Card Scheme - MHRA






POM

ADVICE TO PATIENT/CARER

• Provide Manufacturer’s Patient Information Leaflet

• Provide Trust Patient Information Leaflet - Corticosteroid injections PPG 2574

• Explain mode of action, side effects and benefits of having a

corticosteroid injection.

• Advise about the risks of the medication including treatment

failure , serious side effects and the actions to be taken

• Advise about relative rest following the injection and avoidance of over-use of the area in which symptomatic benefit has been obtained

FOLLOW UP

• Clinical observation after injection.

• Clinic review 4 weeks post injection if further intervention or investigation likely.

• Letter to GP stating drugs administered and outcome






POM

RECORDS The GSTFT ‘injection checklist under PGD’ must be completed. The following must all be recorded :

• reasons for inclusion or exclusion

• patient consent to treatment

• date and time of supply and/or administration

• patient details, such as name, date of birth, allergies, previous adverse events and how the patient met the criteria of the PGD

• details of medicine, such as name, strength, dose, frequency, quantity, route and site of administration

• batch number and expiry date

• a statement that supply or administration is by using a PGD

• name and signature (which may be an electronic signature) of the health professional supplying or administering the medicine

• relevant information that was provided to the patient or their carer

• analysis of outcome measures e.g. changes in visual analogue scale or objective measures

• any adverse reaction to the medicine (See side effects section)

REFERENCES Manufacturer’s Summary of Product Characteristics (SPC)

Depo-medrone ® 07/03/1989 Date of revision of text 08/03/2013

www.medicines.org.uk/emc/medicine/3549/SPC

British National Formulary Number 66. British Medical Association and Royal Pharmaceutical Society of Great Britain; London: September 2013 Section 10.1.2.2

Guy’s and St Thomas’ NHS Foundation Trust

• PGD Protocol 2013

• Medicines Policy and associated Codes of Practice

• Infection Prevention and Control Policy National Institute for Health and Care Excellence (2013). Patient Group Directions. http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp





DRUG NAME /STRENGTH/FORM Triamcinolone Acetonide (Kenalog® ) 40 mg/mL Injection Quantity 5mg- 40mg

Legal category POM



INCLUSION CRITERIA



• Bursitis

• Epicondylitis

• Capsulitis

• Tendonitis

• Tenosynovitis





Patients who have:

• Known hypersensitivity to Triamcinolone or any other ingredient of the medicine. (See SPC for further information)








• Need an injection into weight bearing joint that id due to undergo surgery within three months of the injection.





• Epilepsy


• Abscess

• Haemarthrosis

• Unstable Heart Failure See next page






Legal category POM












• Previous steroid induced myopathy Exclusions particular to this drug monograph:

• Acute Glomerulonephritis

• Exanthematous disease

• Metastatic Carcinoma Patients who are:


• taking Levothyroxine and have altered their dose within 2-3/12 or if TSH level is outside the reference range (typically 0.4–4.5 mU/L)






ACTION IF EXCLUDED









Legal category POM














Legal category POM

DRUG DETAILS


Triamcinolone Acetonide 40mg/mL – Kenalog® Sterile aqueous suspension for injection.


Use of this medicine for capsulitis, tendonitis, entrapment neuropathy and plantar fasciitis are not licensed, but are commonly treated with this drug. This use is approved by the Joint Formulary Committee.




• Larger joints 10mg-40 mg (0.25mL-1.0mL)

• Soft tissue 10mg-40mg (0.25mL-1.0mL) Single injections into several sites can be administered for multiple joint involvement up to a total maximum dose of 80 mg. Undesirable effects may be minimised by using the lowest effective dose for the minimum period. The drug may be administered alone (if excluded from the use of local anaesthetic), or following local anaesthetic. See Lidocaine hydrochloride 1% or 2% PGD pxx


Injections to be administered not less than 4 weeks apart






Legal category POM

SIDE EFFECTS

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction.


• Facial flushing





• Joint sepsis


• Tendon rupture











Legal category POM









FOLLOW UP



• Letter to GP stating drugs administered and outcome RECORDS The GSTFT ‘injection checklist under PGD’ must be completed.

The following must all be recorded :

















Legal category POM

REFERENCES Manufacturer’s Summary of Product Characteristics (SPC) for Kenalog® 10/07/1986. Date of revision of text 25/06/2012


British National Formulary Number 66. British Medical

Association and Royal Pharmaceutical Society of Great Britain; London: September 2013 Section 10.1.2.2




• Infection Prevention and Control Policy National Institute for Health and Care Excellence (2013). Patient

Group Directions. http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp





DRUG NAME /STRENGTH/FORM Hydrocortisone acetate aqueous suspension for injection (Hydrocortistab ®) 25 mg/mL Quantity 5mg-50mg

Legal category POM



INCLUSION CRITERIA



• Bursitis

• Epicondylitis

• Capsulitis

• Tendonitis

• Tenosynovitis


• Plantar fasciitis EXCLUSION CRITERIA (I.E. SITUATIONS NOT COVERED BY THE PGD)


Patients who have:

• Known hypersensitivity to Hydrocortisone or any other ingredient of the medicine. (See SPC for further information)













• Epilepsy








Legal category POM












• Previous steroid induced myopathy Exclusion particular to this Monograph:

• Recent Myocardial infarction Patients who are:







ACTION IF EXCLUDED









Legal category POM





• ACTION IF PATIENT DECLINES









Legal category POM

DRUG DETAILS


Hydrocortisone acetate aqueous suspension for injection (Hydrocortistab ®) 25 mg/mL


Use of this medicine for capsulitis, tendonitis, entrapment neuropathy and plantar fasciitis are not licensed, but are commonly treated with this drug. This use is approved by the Joint Formulary Committee.




• Larger joints 10mg-50 mg (0.4-2.0mL)

• Soft tissue 10mg-50mg (0.4-2.0mL) Single injection into several sites up to a total of 50 mg for multiple joint involvement; no more than three joints should be treated on any one day. Undesirable effects may be minimised by using the lowest effective dose for the minimum period. The drug may be administered alone (if excluded from the use of local anaesthetic), or following local anaesthetic. See Lidocaine hydrochloride 1% or 2% PGD pxx








Legal category POM

SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines adverse reactions or to medicines used in the treatment of children.


• Facial flushing





• Joint sepsis


• Tendon rupture





• Psychiatric reactions including affective disorders

This list may not represent all reported side effects of this medicine. Refer to the most current SPC for more information.

Adverse drug reactions should be reported following the Trust Untoward Incident Policy

Any suspected adverse drug reaction, whether to a drug supplied or administered to the patient by the practitioner or to a drug already taken by the patient must be reported to a doctor immediately or as appropriate.

Report all serious suspected adverse reactions to the MHRA via the yellow card scheme.

Contact the clinical pharmacist to ensure any retrospective reports are carried out.

The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so.

Yellow Cards may be offered to each patient receiving medicines under this PGD. These can be obtained from the Pharmacy Department as well as pharmacies and GP surgeries. Yellow cards can also be obtained via Freephone 0808 100 3352 or online at Yellow Card Scheme - MHRA














Legal category POM

FOLLOW UP
















REFERENCES Manufacturer’s Summary of Product Characteristics (SPC) for Hydrocortistab ® 11/01/1999 Date of revision of text May 2013


British National Formulary Number 66. British Medical Association and Royal Pharmaceutical Society of Great Britain; London: September 2013 Section 10.1.2.2




• Infection Prevention and Control Policy

National Institute for Health and Care Excellence (2013). Patient Group Directions.

http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp





DRUG NAME /STRENGTH/FORM Methylprednisolone acetate 4% with Lidocaine Hydrochloride 1% (Depo-Medrone ® with Lidocaine) QUANTITY 4mg - 80mg

Legal category POM



INCLUSION CRITERIA



• Bursitis

• Epicondylitis

• Capsulitis

• Tendonitis

• Tenosynovitis





Patients who have:

• Known hypersensitivity to methylprednisolone or any other ingredient of the medicine. (See SPC for further information)













• Epilepsy


• Abscess







Legal category POM













• Previous steroid induced myopathy Patients who are:


• taking Levothyroxine and have altered their dose within 2-3/12 or if TSH level is outside the reference range (typically 0.4–4.5 mU/L)






ACTION IF EXCLUDED









Legal category POM














Legal category POM

DRUG DETAILS


Methylprednisolone acetate 4% with Lidocaine Hydrochloride 1% (Depo-Medrone ® with Lidocaine)


Use of this medicine for capsulitis, tendonitis and entrapment neuropathy are not licensed, but are commonly treated with this drug. This use is approved by the Joint Formulary Committee.

ROUTE/METHOD Intra-articular Injection for inflammatory joint conditions or peri-articular for soft tissue injections with no-touch technique



• Medium joints 10mg-40mg (0.25mL-1.0mL)

• Larger joints 20mg-80 mg (0.25-2.0mL)

• Soft tissue 4mg-30mg (0.1mL-0.75mL) Undesirable effects may be minimised by using the lowest effective dose for the minimum period.








Legal category POM

SIDE EFFECTS Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines adverse reactions or to medicines used in the treatment of children.


• Facial flushing





• Joint sepsis


• Tendon rupture











Legal category POM









FOLLOW UP



• Letter to GP stating drugs administered and outcome






Legal category POM

RECORDS The GSTFT ‘injection checklist under PGD’ must be completed. The following must all be recorded :












REFERENCES Manufacturer’s Summary of Product Characteristics (SPC) for

Depo-Medrone ® with Lidocaine 03/03/1981 Date of revision of text 20.05.2013

www.medicines.org.uk/emc/medicine/1502/SPC/Depo-Medrone+with+Lidocaine/

British National Formulary Number 66. British Medical Association and Royal Pharmaceutical Society of Great Britain; London: September 2013 Section 10.1.2.2 Guy’s and St Thomas’ NHS Foundation Trust



• Infection Prevention and Control Policy National Institute for Health and Care Excellence (2013). Patient Group Directions. http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp





DRUG NAME /STRENGTH/FORM Lidocaine hydrochloride 1% and 2% injection Quantity 2mL- 10mL 1% (10mg/mL) and 0.5mL-2mL 2% (20mg/mL)

Legal category POM


Local anaesthesia

INCLUSION CRITERIA

Patients who are aged 18 years and over and who have been assessed as suitable for inclusion to receive a named corticosteroid under this PGD only and who also require local anaesthesia prior to injection of the corticosteroid, where this has been stated in the corticosteroid PGD monograph.


• Known hypersensitivity to Lidocaine, amide local anaesthetics or any other ingredient of the medicine. (See SPC for further information)

• Patient has already been excluded from administration of any named corticosteroid within this PGD.

• Any medication which interacts with Lidocaine (see appendix 1 BNF)

• Suspicion of hereditary tendency to malignant hyperthermia

• History of porphyria

• Hypovolaemia, shock/hypotension

• History of cardiac disease, impaired cardiac conduction, heart block, liver disease, respiratory disease or renal impairment.

• Bradycardia (<50bpm)

• Adam-stokes or Wolff Parkinson-White syndrome

ACTION IF EXCLUDED

• Consider if it is appropriate to administer corticosteroid treatment in isolation under this PGD. Explain to patient and document decision.

• If not appropriate, refer to medical colleague and document action in the patient record.

• Inform GP in writing if patient is excluded from administration of lidocaine.










Legal category POM

DRUG DETAILS


Lidocaine hydrochloride 1% and 2% injection


The use of Lidocaine is not licenced for joint of soft tissue injections. The injection of Lidocaine immediately prior to a corticosteroid injection is common practice. As well as providing anaesthetic pain relief, it is also suggested to reduce steroid induced tissue irritation and widen the field of steroid effect where larger volumes are required for a therapeutic effect. This use is approved by the Joint Formulary Committee.



• 2% for volumes of 0.5mL- 2 mL (10mg – 40mg)

• 1% for volumes of 2mL-10 mL (20mg – 100mg) Undesirable effects may be minimised by using the lowest effective dose for the minimum period.


Refer to associated corticosteroid injection schedule i.e. Injections to be administered not less than 4 weeks apart.

SIDE EFFECTS

Any drug may produce unwanted or unexpected adverse reactions. Detection and recording of these is of vital importance. Patients should be actively encouraged to report any suspected adverse reaction, particularly to black triangle medicines adverse reactions or to medicines used in the treatment of children.

• CNS effects including drowsiness, confusion,

• dizziness, blurred or double vision, nervousness and

• tremor

• GI effects including nausea and vomiting

• Allergic reactions including anaphylaxis This list may not represent all reported side effects of this medicine. Refer to the most current SPC for more information. Adverse drug reactions should be reported following the Trust Untoward Incident Policy Any suspected adverse drug reaction, whether to a drug supplied or administered to the patient by the practitioner or to a drug already taken by the patient must be reported to a doctor immediately or as appropriate. Report all serious suspected adverse reactions to the MHRA via the yellow card scheme. Contact the clinical pharmacist to ensure any retrospective reports are carried out. The public can report adverse effects directly to the MHRA via the yellow card scheme and should be encouraged to do so. Yellow Cards may be offered to each patient receiving medicines under this PGD. These can be obtained from the Pharmacy Department as well as pharmacies and GP surgeries. Yellow cards can also be obtained via Freephone 0808 100 3352 or online at Yellow Card Scheme - MHRA






Legal category POM




• Explain potential side effects of Lidocaine


FOLLOW UP





















Legal category POM

REFERENCES Manufacturer’s Summary of Product Characteristics (SPC)for Lidocaine ®1% 05/11/2002 (date of revision of text 05/11/2009) and Lidocaine ® 2% 17/09/1997 (date of revision of text 08/07/2013)

http://www.medicines.org.uk/emc/medicine/20887/SPC

http://www.medicines.org.uk/emc/medicine/26501/SPC British National Formulary Number 66. British Medical Association and Royal Pharmaceutical Society of Great Britain; London: September 2013 Section 10.1.2.2 Guy’s and St Thomas’ NHS Foundation Trust



• Infection Prevention and Control Policy National Institute for Health and Care Excellence (2013). Patient

Group Directions. http://www.nice.org.uk/mpc/goodpracticeguidance/GPG2.jsp





APPENDIX 1 : Outline audit plan with timeframes 10 notes per clinician will be randomly audited by the PGD lead author on an annual basis. The following will be assessed:

1. Completion of injection checklist, including inclusion and exclusion criteria outlined in

PGD, history of allergies documented, and receipt of information leaflet by patient. 2. Date and time of administration, signature and name of staff who administered

medication, batch numbers and expiry dates 3. Documentation of reasons for exclusion from injection therapy (where appropriate) 4. Adequate clinical reasoning in clinical notes to support the use of injection therapy

evidenced during patient assessment 5. Side effects and adverse drug reactions documented and reported 6. Analysis of outcome measures Refer to the Trust PGD Protocol and Trust Clinical Audit Protocol for further information.





APPENDIX 2 AGREEMENT BY REGISTERED PRACTITIONER I have received, read and fully understand the following:

• The Drug Monographs included in the PGD

• Methylprednisolone acetate aqueous suspension for injection (Depo-Medrone ®) 40mg/mL

• Triamcinolone acetonide aqueous suspension for injection (Kenalog ®) 40mg/mL

• Hydrocortisone acetate aqueous suspension for injection (Hydrocortistab ®) 25 mg/mL

• Methylprednisolone acetate 4% with Lidocaine Hydrochloride 1% (Depo-Medrone with Lidocaine®)

• Lidocaine hydrochloride 1% and 2% injection

• Local policies and guidelines relating to clinical practice within this service.

• Guy’s and St Thomas’ NHS Foundation Trust Medicines Policy and associated Codes of Practice.

• Guy’s and St Thomas’ NHS Foundation Trust PGD Protocol I have received the training set out in the PGD which practitioners must undertake before being authorised to supply and/or administer any medicinal product under the PGD. I have provided evidence to the assessor that I fulfil the specialist competencies required to practice under the PGD. I agree to act as a practitioner within the terms of the PGD and to supply and/or administer medicinal products in accordance with the PGD. In return, the Trust accepts vicarious liability for the practitioner acting under the terms of the PGD where the practitioner has been deemed competent to practice under the PGD. I understand that by agreeing to act as a practitioner under the PGD, I am extending my role and job description. I understand that my acceptance of this extension of my role and job description has not been a compulsory requirement of Guy’s and St. Thomas’ NHS Foundation Trust. I agree to inform the Trust of any changes in my circumstances that would affect my ability to act as a practitioner under the PGD e.g. registration status.

PRACTITIONER NAME (BLOCK CAPITALS)

PRACTITIONER SIGNATURE DATE

FOR COMPLETION BY DESIGNATED MANAGER: Authorisation of Registered Practitioner by:

DESIGNATED MANAGER NAME

(BLOCK CAPITALS) DESIGNATED MANAGER

SIGNATURE DATE

(TO CONFIRM THAT TRAINING HAS BEEN ATTAINED TO A SATISFACTORY STANDARD) Original signed copy with PGD to be kept by practitioner and a copy of this agreement to be kept by designated manager

DATE COMMENT

Added to list of registered practitioners

Removed from list of registered practitioners (add reason)

patient group direction (pgd) for the supply … · may be injected immediately prior to ... supply...

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