Prescription Only Medicine DOXYCYCLINE 100mg CAPSULES (POM) YOU MUST BE AUTHORISED BY NAME, UNDER THE CURRENT VERSION OF THIS PGD BEFORE YOU ATTEMPT TO WORK ACCORDING TO IT CLINICAL CONDITION OR SITUATION TO WHICH DIRECTION APPLIES For 2nd line treatment of uncomplicated genital Chlamydia Indication Patient Group Direction (PGD) for the Supply of:
Trachomatis infection and sexual contacts of clients with confirmed Chlamydia Trachomatis infection.
To be considered when a client is unable to take 1st line treatment of Azithromycin due to allergy or contra-indication. Informed consent has been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Male and female clients aged 13 years or older who have had a positive genital Chlamydia result and are unable to take Azithromycin. (Clients under 16 may be supplied with Doxycycline only if they fulfil Fraser Competency.) Confirmed contacts of a Chlamydia positive partner, (aged 13 years and over), who are unable to take Azithromycin. (Clients under 16 may be supplied with Doxycycline only if they fulfil Fraser Competency.) Clients who have, since treatment been at risk of re-infection from an untreated sexual partner. Informed consent has NOT been given in accordance with current Locala Community Partnership (LCP) guidelines for the supply of the medicine. Clients under the age of 13 years old. Seek advice as appropriate – refer to action if patient declines or is excluded (below). Clients under the age of 16 years who have not fulfilled Fraser competency. Current acute febrile illness. Seek advice as appropriate – refer to action if patient declines or is excluded (below). A confirmed anaphylactic reaction to a previous dose of doxycycline or to any constituent of the capsule. A known allergy to doxycycline or other tetracycline antibiotitics, or any of the excipients in the capsule. Pregnant or suspected pregnancy. Seek advice as appropriate – refer to action if patient declines or is excluded (below). Breast feeding. Seek advice as appropriate – refer to action if patient declines or is excluded (below). Hepatic impairment or taking hepatotoxic drugs. Renal impairment Clients with Systemic Lupus Erythmatosis (SLE) Clients with porphyria Clients with myasthenia gravis Clients with achlorhydria Clients with alcohol dependence. Client unable to avoid persistent/direct sunlight. Immunocompromised clients PGD No 62 v3 Doxycycline 100mg Capsules 16.2.2012 Review date: 31.3.2014 Page 1
Cautions/Need for Further Advice
Action if Patient Declines or is Excluded
Known HIV infection Male clients with testicular pain/urinary symptoms i.e dysuria, penile discharge, haematuria Female clients with abdominal pain/unusual vaginal discharge and/or bleeding. Clients taking any interacting drug as listed in appendix 1 of the current BNF. Concurrent medication should always be checked for interactions before supply under the PGD. Clients unable to give full details of their current medication. Clients with any medical condition of unknown significance. Please also see Cautions/Need for Further Advice Section 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. See advice to patient. Hormonal combined contraceptives – some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. Refer to chapter 7 of current BNF for further information. If client has reservations/concerns about side effects of the antibiotic. Patients who are excluded from treatment under the contraindications identified above should be referred to an appropriate medical practitioner/prescriber. This should be documented clearly in the patient’s record. Where patients do not wish to receive treatment under this PGD, refusal and action taken should be documented in the patient’s record. Give information about risks of infection and benefits of treatment. Advise to abstain from intercourse until treatment obtained and completed. Give information about how to recognise signs and symptoms of infection (where appropriate). Give information about when the medicine may be given.
DESCRIPTION OF TREATMENT Name, Form & Strength of Medicine Route/Method
Doxycycline Capsules 100mg
Duration of Treatment
Maximum or Minimum Treatment Period Quantity to Supply
Approval Date: 16.2.2012
Oral - Capsules should be swallowed whole with a cup of water
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Licensing Information Side Effects
The product is licensed for the stated indications Side effects include nausea, vomiting, diarrhoea, (antibiotic associated colitis reported occasionally), anorexia, flushing, tinnitus, dysphagia and oesophageal irritation. Rarer side effects include hepatoxicity, pancreatitis, blood disorders, photosensitivity and severe skin reactions (such as Steven-Johnson syndrome, toxic epidermal necrolysis). Refer to the current British National Formulary (BNF) and the current product SPC for a full list of side effects. Report all serious suspected adverse reactions in adults, and all serious and minor reactions in children (under 18 years), to the Medicines and Healthcare products Regulatory Agency (MHRA) using a yellow card (located at the back of the BNF) or on- line via www.yellowcard.gov.uk. Report serious suspected reactions even if they are listed above, in the BNF, or in the product SPC. Serious reactions are those that are fatal, life threatening, disabling, incapacitating or which result in or prolong hospitalisation and/or are medically significant. Yellow cards may be completed by any healthcare professional or the patient.
Special Considerations Additional information Advice to Client
Approval Date: 16.2.2012
It is the responsibility of the healthcare professional identifying the suspected ADR to report it. To be kept in a lockable cabinet when not in use, in conditions under 25 degrees centigrade. The client must be given an explanation that he/she is agreeing to treatment by the relevant staff member under a Patient Group Direction and that he/she should be offered an appointment to a doctor as an option. Clients should always be signposted appropriately if this is the case, and should be followed up with reference to care pathways. Explain the treatment, why it is needed, and further action where required. Provide the manufacturerâ€™s leaflet and advise the patient to read it. Advise to take at regular intervals and to complete the course (unless otherwise directed). Capsules should be swallowed whole with plenty of fluid during meals while sitting or standing, well before going to bed (to reduce the risk of oesophageal irritation and ulceration). Advise patient not to lie down for at least 30 minutes after taking doxycycline capsules. If gastric irritation occurs, Doxycycline can be given with food or milk. Do not take any indigestion remedies, iron or zinc supplements at the same time. Take them at least two hours before or two hours after a dose of Doxycycline. Give advice on possible side effects and when to seek medical advice.
PGD No 62 v3 Doxycycline 100mg Capsules Review date: 31.3.2014 Page 3
Some people develop thrush after taking a course of antibiotics. Advise patient to speak to their community pharmacist if this happens. The patient should be warned to discontinue treatment and seek medical advice if hypersensitivity reactions occur. If severe drug reaction occurs advise to attend Accident and Emergency. Advise on the potential reduction of the contraceptive effect of combined hormonal contraception. Refer to chapter 7 of the BNF for further information. Clients should be advised to avoid exposure to direct sunlight, sun lamps or ultraviolet light as skin may be more sensitive to sunburn than normal. Clients should be advised not to drink alcohol whilst taking doxycycline. Give advice on Chlamydia Trachomatis infection and discuss treatment. Advise complete abstinence from any sexual contact for 7 whole days after treatment and for 7 days after partner has completed treatment Emphasize the importance and need for sexual partner(s) to be treated. Warn of the risk of re-infection if sexual contact with an untreated partner. Advise about future safer sex and condom use. Advise patient on follow up care arrangements if required. Clients should advise the Chlamydia Screening Office or CaSH if they are unable to complete the course of treatment
Advice to Client continued
Advise patient to seek further medical advice if: The condition worsens, does not improve, or they have not fully complied with treatment. They experience any hypersensitivity reaction There has been a re-infection risk.
Client may need to be followed up to establish compliance. If compliance is poor then re-treatment will be advisable. Explain retreatment process if this is required. Clients who have been treated for Chlamydia should be offered a follow up appointment 3 weeks after completing the treatment.
REFERRAL ARRANGEMENTS AND AUDIT TRAIL Referral Arrangements
Approval Date: 16.2.2012
Referral arrangements (including self-care) to be documented in patients notes. If patient is excluded from this PGD refer to an appropriate medical practitioner/prescriber. Patients should be either referred, as appropriate, to an independent prescriber, the GP, clinic doctor, Local Care Direct, GUM clinic or A&E for further assessment and advice.
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Records/Audit Trail continued
The following information must be documented in records which should be stored appropriately and can be easily retrieved where necessary: Patientâ€™s name, address, date of birth and consent given. If consent is either refused or withdrawn, this decision should also be documented. Contact details of GP if applicable Dose supplied and route Batch number and expiry date Advice given to patient (including side effects) Date supplied Name of staff who supplied the medicine Where applicable, details of any subsequent adverse drug reaction and actions taken including referral arrangements. This MUST be documented in the patientâ€™s medical record. Current medication Known allergies Diagnosis CaSH Services The following additional records should also be taken: Sexual history Menstrual history Contraception used BMI LMP Blood pressure Weight Height Bleeding pattern Any problems Information given (written/verbal) Past medical history Family history Drug treatment Follow up appointment Signature of clinician Chlamydia Screening Service The following additional records should also be taken: Sexual history Menstrual history Contraception used LMP Bleeding pattern Any problems Information given (written/verbal) Past medical history Drug treatment Signature of clinician
Approval Date: 16.2.2012
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STAFF CHARACTERISTICS Qualifications
Specialist Training or Qualifications
Continuing Training & Education
References/Resources and Comments
Registered nurse with current registration working within Locala Community Partnerships LCP. Registered nurses working in CaSH must also hold a recognised post registration qualification in Contraception and Sexual Health. Has undertaken appropriate training and is competent to undertake the clinical assessment of patients according to the indications listed in this PGD. Has undertaken appropriate training and is competent in working under PGDs for the supply and administration of medicines Has undertaken training and is competent in the recognition and treatment of anaphylaxis. Has undertaken training and is competent in resuscitation skills. Has undertaken training appropriate to this PGD such as updates in contraception and sexual health at recommended intervals and understanding the clinical aspects of sexually transmitted infection screening and treatment. Accepts personal responsibility for working within the PGD, understands the legal implications of doing so and works within the scope of the PGD. Keep updated via departmental meetings and updates Has undertaken training appropriate to this PGD The practitioner should be aware of any change to the recommendations for the medicine listed. It is the responsibility of the individual to keep up-to-date with continued professional development and to work within the limitations of their scope of practice. Practitioner should have access to current BNF, Faculty of Contraception and Sexual Health Guidance, and updated DOH advice where appropriate. Annual training at the LOCALA update on resuscitation skills and management of anaphylaxis within the community. In service training/awareness in the treatment of Chlamydia Trachomatis. SPC from Electronic Medicines Compendium http://www.medicines.org.uk/ BNF 62 September 2011 http://www.bnf.org/bnf/ DH http://www.doh.gov.uk/ MHRA http://www.mhra.gov.uk/ BASHH http://wwwbashh.org/committees/cgc/ 2006 UK National Guidelines for the Management of Genital Tract Infection with Chlamydia Trachomatis. http://www.guidelines.gov/summary.aspx?ss=15&docid=3029&nbr=2255
Notes: SPC – Summary of Product Characteristics BNF – British National Formulary DOH – Department of Health MHRA –Medicines and Healthcare Products Regulatory Agency
Approval Date: 16.2.2012
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This PGD is an amended version of PGD No 62 v2 ‘Doxycycline 100mg Capsules’, which was produced in November 2009. It was updated for use within Locala Community Partnerships by the authors as listed below Name
Head of Medicines Management
Community Services Manager
Specialist Pharmacy Technician, Community Services
Clinical Lead – Locala CaSH
Clinical Nurse Manager
February 2012 February 2012
Advice contained in the individual Summary of Product Characteristics (SPC) may have been overridden in accordance with guidance issued by the relevant Dept of Health (if this is applicable) This will result in an unlicensed use of a licensed product following current DH guidance.
REVISION PROFORMA The following amendments have been made to PATIENT GROUP DIRECTION: No 62 v2 SECTION
Cautions / Special Advice
The following statement has been removed Hormonal combined contraceptives – some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. The patient should be advised to use additional contraceptive precautions whilst taking doxycycline and for a further 7 days after stopping. If these 7 days run beyond the end of a packet the next packet should be started immediately without a break. In the case of ED tablets the inactive ones should be omitted. Refer to chapter 7 of the BNF for further information. And replaced with Hormonal combined contraceptives – some antibacterials may reduce the efficacy of combined oral contraceptives and contraceptive patches. Refer to chapter 7 of current BNF for further information.
Removed “Pharmacist” – This service was never developed for this professional group.
Approval Date: 16.2.2012
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Individual Authorisation for the supply of: Doxycycline 100mg capsules by: Nurses working in Locala CaSH Service Nurses working for Locala Chlamydia Screening Programme LOCALA DOES NOT ACCEPT LIABILITY IN RESPECT OF INDEPENDENTLY EMPLOYED STAFF PGDs DO NOT REMOVE INHERENT PROFESSIONAL OBLIGATIONS OR ACCOUNTABILITY. It is the responsibility of each professional to practice only within the bounds of their own competence and in accordance with their own Code of Professional Conduct I have read and understood the Patient Group Direction and agree to administer this medicine only in accordance with this PGD. In signing this declaration the registered health care professional is willing to be professionally accountable for this work as defined in their Code of Professional Conduct. Name of Professional
Authorising Manager and
Staff who are no longer required to administer under this PGD should be removed from it. This can be done by crossing through the relevant name, adding date and initials. Authorising Managers For Locala staff this will be the team leader, or relevant clinical manager. Note to Authorising Managers: Authorised staff working at a fixed base should have access to the signed PGD held at the base. Authorised staff who may supply/administer medicines away from the base should have an individual copy of the relevant signed PGD with them when supplying/administering the medicine.
Approval Date: 16.2.2012
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Organisational Approval This patient group direction must be agreed to and signed by all health care professionals involved in its use. Locala Community Partnerships will hold the original signed copy. The PGD must be easily accessible in the clinical setting.
ORGANISATION Director of Clinical and Operational Services
Locala Community Partnership Name : Christina Quinn
Signature: Head of Medicines Management
Name: Lucianne Ricketts
Signature: Medical Lead
Name: Dr Stephen Warner
PCT Authorisation ORGANISATION Director of Patient Care & Professions
NHS Kirklees Name : Sheila Dilks
Signature: Senior Medicines Management Adviser
Name: Eric power
Signature: Medical Director
Name: Jim Lee
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