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Patient group direction for the supply of doxycycline by nurses working in occupational health and pharmacists working within nhs grampian for the prophylaxis of malaria

Patient Group Direction For The Supply Of Doxycycline For The
Prophylaxis Of Malaria By Nurses Working In Occupational Health
And Pharmacists Working Within NHS Grampian


Co-ordinators:
Consultation Group:
Approver:
Directorate
Signature:
Signature:

Identifier:
Review Date:
Date Approved:
A Patient Group Direction is a specific written instruction for the supply or
administration of named medicines in an identified clinical situation. It is drawn
up locally by Doctors, Pharmacists and other appropriate professionals,
approved by the Employer and advised by the relevant professional advisory
committees. In most cases, appropriate clinical care is provided on an individual
basis by a specific prescriber to a specific individual patient. Patient Group
Directions should only be considered where they offer a benefit to patient care
without compromising patient safety in any way.
Uncontrolled when printed
Version 4.1
Patient Group Direction for the supply of doxycycline for the prophylaxis of malaria by nurses working in Occupational Health and pharmacists Identifier:
Replaces:
This controlled document shall not be copied in part or whole without the express permission
of the author or the author’s representative.
Author:
PGD pharmacist, Pharmacy and Medicines Directorate Key word(s):
PGD patient group direction malaria prophylaxis doxycycline pharmacist occupational health nurse
Policy application:

Purpose:
This Patient Group Direction (PGD) authorises appropriately qualified and trained nurses and pharmacists to supply doxycycline to individuals without the requirement for a patient specific prescription written by a medical practitioner.
Responsibilities for implementation:

Organisational:
Corporate:
Director of Nursing / Director of Pharmacy and Medicines Management Departmental:
Hospital/Interface
services:
Operational

Management Unit:

Policy statement:
It is the responsibility of individual nurses and pharmacists and their line managers to ensure that they work within the terms laid down in this PGD and to ensure that staff are working to the most up to date PGD. By doing so, the quality of the services offered will be maintained, and the chances of staff making erroneous decisions which may affect patient, staff or visitor safety and comfort will be reduced. Supervisory staff at all levels must ensure that staff using this PGD act within their own level of competence. This policy will be reviewed at least every two years or sooner if current treatment recommendations change. PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 This document is also available in large print and
other formats and languages, upon request.
Please call NHS Grampian Corporate
Communications on (01224) 551116 or (01224)
Responsible for review of this document:
PGD pharmacist, Pharmacy and Medicines Directorate Responsible for ensuring registration of
this document on the NHS Grampian
Information/Document Silo:
Physical location of the original of this

document:
Job/group title of those who have control
over this document:
Responsible for disseminating document
as per distribution list:
Revision History:
Date of

Approval
Summary of Changes
date of PGD
that is
being
superseded

Maximum strength of DEET changed to 100%. Removed reference to brown-black microscopic discolouration of thyroid. Removed advise regarding concomitant use of oral contraceptives. Addition of advise that CI in pregnancy. Amendment to identifier number on front page. PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Patient Group Direction for the supply of doxycycline for the prophylaxis of
malaria by nurses working in Occupational Health and pharmacists working
within NHS Grampian.
Contents
Part A –Specific Drug Information

Patients who may be considered for the supply of doxycycline Patients who may receive the supply of doxycycline Action to be taken when a patient is excluded from treatment under Action to be taken when a patient does not wish to receive treatment Description Of Treatment Available Under This PGD
Part B – PGD General Information

Facilities And Supplies To Be Available At Sites For The Supply Of
Part C – PGD Specific Information

Management And Monitoring Of Patient Group Direction Appendix 1 - Health Care Professional Agreement To Supply Appendix 2 - Certificate Of Competence To Supply Medicines Under PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Patient Group Direction For The Supply Of Doxycycline For The
Prophylaxis Of Malaria By Nurses Working In Occupational Health
And Pharmacists Working Within NHS Grampian
1. Introduction

This patient group direction (PGD) will allow nurses working in Occupational Health
and pharmacists to be authorised to supply doxycycline to individuals requiring
malaria prophylaxis for travel purposes.
This PGD should be used in conjunction with the recommendations in the current
British National Formulary and individual Summary of Product Characteristics.
2.
Clinical Decision Making

2.1. Patients who may be considered for the supply of doxycycline
Travellers who are at moderate to high risk of exposure going to malaria endemic
areas of the world where there is doxycycline sensitive P. falciparum malaria. Refer
to Advisory Committee for Malaria Prevention (ACMP).

2.2. Patients who may receive the supply of doxycycline
Patients for whom after risk assessment and evaluation of travel plans, doxycycline is
deemed to be the most appropriate chemoprophylactic agent.
Malaria prophylaxis with doxycycline is particularly recommended for travellers to
malarious areas in which multiple resistant P. falciparum strains occur.
All patients in 2.1 above, where they, their parent, guardian or person with parental
responsibility does not want specifically to consult with a doctor and are happy for the
supply to be given by the nurse or pharmacist.

2.3. Contraindications
Patients may NOT be supplied with doxycycline under this PGD if they:

(i)
have shown hypersensitivity to doxycycline, any of the capsule ingredients or are suffering from systemic lupus erythematosus or porphyria. PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 2.4. Precautions
Doxycycline should be administered with caution in patients with hepatic impairment
or those receiving potentially hepatotoxic drugs.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed
in some individuals taking tetracyclines, including doxycycline. Patients likely to be
exposed to direct sunlight or ultraviolet light should be advised that this reaction can
occur and told that treatment should be discontinued at the first signs of skin
discomfort or erythema. Alternative anti-malarial prophylaxis may be required.
The use of antibiotics may occasionally result in over-growth of nonsusceptible
organisms including Candida albicans. If this occurs, doxycycline should be
discontinued and the patient referred to a doctor for treatment. Alternative anti-
malarial prophylaxis may be required.
Care should be taken in the administration of doxycycline to patients with Myasthenia
gravis as they may experience increased muscle weakness.

2.5. Action to be taken when a patient is excluded from treatment under this
PGD
If a patient is excluded from treatment under this PGD, medical advice should be
sought – refer to a doctor.

2.6. Action to be taken when a patient does not wish to receive treatment
under this PGD
The patient should be advised of the risks of malaria in the region being visited and
given advice on bite avoidance and the signs and symptoms of malaria infection.

3.

Description Of Treatment Available Under This Direction

3.1. Doxycycline 50mg or 100mg
(i)
Doxycycline (non-proprietary) capsules for oral use are available in either 50mg or 100mg strengths. Colour of capsules and excipients will vary by manufacturer. Refer to
SPC.
(ii) Vibramycin®-D Dispersible Tablets. Light yellow, round tablets scored on one face
and coded 'VN' on the other containing 100mg doxycycline.

Doxycycline is a Prescription-only Medicine (PoM).
3.2. Dose, route and frequency
Prophylaxis of malaria.
100mg daily in adults and children over the age of 12 years. Prophylaxis can begin 1-2
days before travel to malarial areas. It should be continued daily during travel in the
malarial areas and for 4 weeks after the traveller leaves the malarial area.
PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 3.3. Concurrent medication
The absorption of doxycycline may be impaired by concurrently administered antacids
containing aluminium, calcium, magnesium or other drugs containing these cations; oral
zinc, iron salts or bismuth preparations. Dosages should be maximally separated.
Since bacteriostatic drugs may interfere with the bactericidal action of penicillins, it is
advisable to avoid giving doxycycline in conjunction with penicillins.
There have been reports of prolonged prothrombin time in patients taking warfarin and
doxycycline. Tetracyclines depress plasma prothrombin activity and reduced doses of
concomitant anticoagulants may be necessary.
The serum half-life of doxycycline may be shortened when patients are concurrently
receiving barbiturates, carbamazepine or phenytoin. An increase in the daily dosage of
doxycycline should be considered.
Alcohol may decrease the half-life of doxycycline.
Doxycycline may increase the plasma concentration of cyclosporin. Co-administration
should only be undertaken with appropriate monitoring.

Refer to current BNF, SPC or Travax for up to date information.

3.4. Adverse effects
Gastro-intestinal symptoms diarrhoea, nausea, vomiting, anorexia, dysphagia and
dyspepsia are usually mild and rarely lead to discontinuation of treatment. Oesophagitis
and oesophageal ulceration have been reported.
Oral candidiasis, vulvovaginitis, pruritus ani and inflammatory lesions in the anogenital
region may occur due to overgrowth of Candida albicans. Overgrowth of resistant
organisms may cause glossitis, stomatitis or staphlococcal enterocolits.
Pseudomembranous colitis has occasionally been reported due to overgrowth of
Clostridium difficile.
There have been rare reports of hepatotoxicity with transient increases in liver function
tests, hepatitis, jaundice hepatic failure and pancreatitis.
Flushing and tinnitus, arthralgia and myalgia have been reported.
Rashes including maculopapular and erythematous rashes, exfoliative dermatitis,
erythema multiforme, Steven-Johnson syndrome, toxic epidermal necrolysis,
photosensitivity skin reactions and photo-oncholysis have been reported.
Photosensitivity see section 2.4.
Anaphylaxis, anaphylactoid purpura, angioneurotic oedema, urticaria, pericarditis, serum
sickness hypotension, dyspnoea, tachycardia and exacerbation of systemic lupus
erythematosus have been reported.
PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Headache. Bulging fontanelles in infants and benign intracranial hypertension in
juveniles and adults have been reported. In relation to benign intracranial hypertension,
symptoms included blurred vision scotomata and diplopia. Permanent visual loss has
been reported.
Haemolytic anaemia, thrombocytopaenia, neutropenia, porphyria and eosinophilia have
been reported.

Treatment of overdose
Patient should be referred for medical attention immediately.

3.5. Advice to patient
(i)
Advise that women of childbearing potential should take reliable contraceptive precautions for the entire duration of therapy and for one week after the last dose of doxycycline. (ii) Advise patients to avoid drinking alcohol. (iii) Advise patients of interacting medications. (iv) The patient should be advised not to take indigestion remedies or medicines containing zinc or iron at the same time of day as the anti malarial. (v) Advice should be given on what to expect and what to do for major and minor reactions. Patient should be advised of the possible side effects, including risk of photosensitivity. If they are concerned about any unwanted effects they need to seek medical advice as soon as possible and before taking their next tablet. (vi) Advise patient to take with adequate amounts of fluid in the sitting or standing position, well before retiring at night, to reduce the risk of oesophageal irritation and ulceration. If gastric irritation does occur, advise to take with food or milk. (vii) The patient information leaflet contained in the medicine(s) should be made accessible to the patient/parent /guardian in a language that they can understand. (viii) The patient should be made aware that any illness that occurs within 1 year and especially within 3 months of return might be malaria even if all recommended precautions against malaria were taken. Travellers should be warned of this and told that if they develop any illness particularly within 3 months of their return they should go immediately to a doctor and specifically mention their exposure to malaria. (ix) The patient should be reminded of the need to take the anti-malarial on a regular basis (x) Personal protection against being bitten is very important. Mosquito nets impregnated with permethrin provide the most effective barrier protection against insects; mats and vaporised insecticides are also useful. Diethyltoluamide (DEET) 20–100% in lotions, sprays, or roll-on formulations is safe and effective when applied to the skin of adults and children over 2 months of age. It can also be used during pregnancy PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 and breastfeeding. The duration of protection varies according to the centration of
DEET and is longest for DEET 100%. Long sleeves and trousers worn after dusk also
provide protection.
3.6. Follow up treatment
Not applicable.
PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Designated Staff Authorised To Supply Under This PGD

The following staff are authorised to supply the drug specified in this PGD without an
individual medical prescription providing the patient falls into one of the categories listed
in 2.2 of this PGD. Staff must be employed either directly by NHS Grampian, or
contracted to provide NHS services, or providing services in partnership with NHS
Grampian under the direction of this authorised PGD.

(i)
Nurses, as recognised by the NMC, working in Occupational Health. (ii) Pharmacists registered as Practising Pharmacists as recognised by the General Pharmaceutical Council. In addition the following requirements are necessary. Staff must: (i) agree to be professionally accountable for their work (Appendix 1). (ii) be competent to assess the patient’s capacity to understand the nature and purpose of the supply in order for the patient to give or refuse consent. (iii) be aware of and have access to current malaria recommendations and be competent to discuss issues about the drug with the patient. (iv) have been trained and assessed as being competent in aspects of travel medicine risk assessment an in the supply of the drug. All staff will have access to the current PGD. (v) maintain their skills, knowledge and their own professional level of competence in this area according to their individual Code of Professional Conduct. (vi) agree to work within the terms of the NHS Grampian PGD. The Director of Pharmacy and Medicines Management /Nurse Managers in Occupational Health will be responsible for: (i) Ensuring that the current PGD is available to staff providing care under this direction. (ii) Ensuring that the staff have access to all relevant Scottish Government Health Directorate advice, including any relevant CMO letter(s). (iii) Ensuring that staff have received adequate training in all areas relevant to this PGD and meet the requirements above. (iv) Maintaining a current record of all staff authorised to supply the drug specified in this PGD. PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 5. Documentation

5.1. Authorisation of supply

Nurses working within Occupational Health can be authorised to supply the drug
specified in this PGD by the Consultant in Occupational Health Medicine, NHS
Grampian.
Pharmacists working within NHS Grampian can be authorised to supply the drug
specified in this PGD by The Director of Pharmacy and Medicines Management.
A certificate of competence (Appendix 2) signed by the authorising doctor/manager
should be supplied. This should be held in the individual staff records or as agreed
locally.
5.2. Record of supply

An electronic or paper record for recording the screening of patients and the subsequent
supply of the drug specified in this PGD must be completed in order to allow audit of
practice. This should include:
(i)
Name and address of patient/parent/guardian/person with parental responsibility, Unit No/CHI No
(ii) Date of birth
(iii) Consultant/General Practitioner details
(iv) Risk assessment details
(v) Exclusion criteria, record why drug not supplied
(vi) Reason for giving
(vii) Consent to the supply (if not obtained elsewhere)
(viii) Drug manufacturer, batch number, expiry date
(ix) Dose and quantity supplied
(x) Signature and name in capital letters of practitioner who supplied the drug
(xi) Date drug given
(xii) Record of adverse effects (advise patient’s doctor).
These records should be retained:
For children and young people, retain until the patient's 25th birthday or 26th if the
young person was 17 at the conclusion of treatment.
For 17 years and over retain for 6 years after last date of entry.
Or for 3 years after death, or in accordance with local policy, where this is greater than
above.
5.3. Consent

In this situation where the patient is seeking treatment, consent to receive the supply of
the antimalarial is implied. However, the following should be noted: Prior to the supply
of the drug, consent must be obtained, preferably written, either from the patient, parent,
guardian or person with parental responsibility and documented either in the patient’s
PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 medical records/notes or on a supply form (see section 5.2). Consent must be in line
with current NHSG “Staff Policy for Obtaining Consent for Clinical Procedures and
Healthcare Interventions”. See link below.

6.
Further Points

For current advice on geographical resistance patterns and appropriate
chemoprophylaxis, current guidelines or the Malaria Reference Laboratory should be
consulted, details of which can be found in the British National Formulary (BNF).
Patients should be advised of the importance of the ABCD of malaria prophylaxis.
The manufacturer leaflets inside boxes of drug should be read and advice from them
taken into consideration.

7.

Facilities And Supplies To Be Available At Sites For The Supply Of The
Drug Specified In The PGD
The following should be available at sites where the drug is to be supplied:
(i)
Access to medical support (this may be via telephone). (ii) Access to Travax.
(iii) Safe storage areas for medicines and equipment.
(iv) Approved equipment for the disposal of used materials.
(v) Clean and tidy work areas.
(vi) Copies of the current PGD for the drug specified in the PGD.
8. Audit


All records of supply of the drug specified in this PGD will be filed with the normal
records of medicines administration in each practice/service. A designated person
within each CHP/practice/service will be responsible for auditing completion of drug
forms and collation of data.

PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Management And Monitoring Of Patient Group Direction

9.1. Consultative group
Fiona Browning
General Practitioner, Skene Medical Group
9.2. Professional advisory group approving PGD
Medicine Guidelines and Policies Group

9.3. Authorising managers


Dr Roelf Dijkhuizen
Medical Director, NHS Grampian

Mr David Pfleger
Director of Pharmacy and Medicines Management, NHS Grampian

Ms Elinor Smith
Nursing Director, NHS Grampian
10. References

Doxycyline 100mg caps, Kent Pharmaceuticals - Date of revision of text 05.03.12, accessed 02.10.12 Vibramycin® D tabs - Date of revision of text December 2008, accessed 02.10.12 2.
British National Formulary, 64 September 2012 –The Pharmaceutical Press. Document: Drafted: May PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Review: At least every 2 years or sooner if current treatment recommendations change. Appendix 1
Health Care Professional Agreement To Supply Medicines Under Patient Group
Direction
Agree to supply medicines under the direction contained within the following Patient Group Direction Patient Group Direction for the supply of doxycycline for the
prophylaxis of malaria by nurses working in Occupational Health
and pharmacists working within NHS Grampian.

I have completed the appropriate training to my professional standards enabling me to
supply medicines under the above Patient Group Direction. I agree not to act beyond
my professional competence nor outwith the recommendations of the Patient Group
Direction.



Print Name:

PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1 Appendix 2
Certificate Of Competence To Supply Medicines Under Patient Group Direction
To supply medicines under the following Patient Group Direction Patient Group Direction for the supply of doxycycline for the
prophylaxis of malaria by nurses working in Occupational Health
and pharmacists working within NHS Grampian.
The above named person has satisfied the training requirements and is competent to supply medicines under the above Patient Group Direction. The above named person has agreed not to act beyond their professional competence nor outwith the recommendations of the Patient Group Direction PGD for the supply of doxycycline by nurses and pharmacists – Version 4.1

Source: http://www.nhsgrampian.com/grampianfoi/files/doxy_mal_537_1212.pdf

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