Patient Group Directions for the supply of medication by Community Pharmacists under the Common Ailments Service PGD Drug Indication Page No. 129 Miconazole 2% cream (30g) Athletes foot and 2 Intertrigo/Ringworm 130 Chloramphenicol 0.5% eye drops Conjunctivitis 7 (10ml) 131 Chloramphenicol 1% ointment (4g) Conjunctivitis 13 227 Hydrocortisone 1% cream (30g) Dermatitis 18 228 Hydrocortisone 1% ointment Dermatitis 22 229 Hydrocortisone 2.5% cream Dermatitis 26 230 Hydrocortisone 2.5% ointment Dermatitis 30 133 Scheriproct ointment (30g) Haemorrhoids 34 134 Scheriproct suppository (12) Haemorrhoids 38 135 Sodium cromoglicate 2% eye drops Hay fever 42 (13.5ml) 136 Beclometasone 50mcg nasal spray (200 Hay fever 46 dose) 137 Omeprazole 20mg capsules (28) Indigestion and reflux 51 231 Lansoprazole 30mg capsules (28) Indigestion and reflux 56 140 Miconazole 20mg/g oral gel (80g) Oral thrush 61 141 Nystan 100 000u/ml oral suspension Oral thrush 67 (30ml) 142 Mebendazole 100mg tablets (6) Threadworm 72 232 Mebendazole 100mg/5ml suspension Threadworm 75 143 Clotrimazole 10% cream (5g) Vaginal thrush 79 144 Clotrimazole 500mg pessary and Vaginal thrush 84 2%cream (1 & 20g) PGD Pharmacist Authorisation Form 89 References AWMSG – Common Ailments Scheme Formulary – http://howis.wales.nhs.uk/doclib/WHC(2000)116.pdf The National Assembly for Wales WHC (2000) 116 Patient Group Directions - Review Of Prescribing Supply And Administration Of Medicines. http://howis.wales.nhs.uk/doclib/WHC(2000)116.pdf Accessed August 2015 Version 2.0 September 2015 Page 1 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. Version 2.0 September 2015 Page 2 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. PATIENT GROUP DIRECTION- NUMBER 129 Miconazole 2% Cream 1. Clinical condition Situation Patients with athletes foot or intertrigo/Ringworm Inclusion criteria Athletes foot - patients with an itchy, scaly, dry rash on the bottom and sides of feet and between the toes. Intertrigo – Itchy rash commonly affecting occluded skin creases such as groin, under breasts and axillae Ringworm – typically circular patch of skin, mild redness with a well demarcated outer edge Exclusion criteria  Patients with poorly controlled diabetes who have not been reviewed by their GP in the last 3 months  Patients with severe inflammation, signs of bacterial infection, unresponsive rash or recurrent episodes  Previous sensitivity or irritation to miconazole cream or any of its ingredients  Patients taking a contra-indicated medicine  Patients who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment Special warnings and  Miconazole Cream must not come into contact with the precautions for use eyes  If a reaction suggesting sensitivity or irritation should If in doubt seek occur, the treatment should be discontinued medical advice  Benzoic acid (E210) is mildly irritant to the skin, eyes and mucous membranes  Butylated hydroxyanisole (E320) may cause local skin reactions (e.g. contact dermatitis), or irritation to the eyes and mucous membranes  Pregnancy - In animals miconazole nitrate has shown no teratogenic effects but is foetotoxic at high oral doses. Only small amounts of miconazole nitrate are absorbed following topical administration. However, as with other imidazoles, miconazole nitrate should be used with caution during pregnancy  Lactation - Topically applied miconazole is minimally absorbed into the systemic circulation, and it is not known whether miconazole is excreted in human breast milk. Caution should be exercised when using topically applied miconazole products during lactation Action if patient is Refer to GP excluded Action if patient General self management advice as per Common Ailment declines the Formulary medication Seek further advice Refer to SPC, BNF & the All Wales Common Ailments Service Formulary Version 2.0 September 2015 Page 3 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. 2. Treatment Name of Medicine Miconazole nitrate Legal Status POM Route/Method Topical - Cutaneous use Dosage 2% Cream Form/Strength Licensed or off licensed Licensed use Frequency Apply twice daily to affected skin. Duration of treatment Treatment should be continued for:  at least one week after all lesions have disappeared to prevent relapse (athletes foot)  7-14 days after all lesions have disappeared to prevent relapse (intertrigo/ringworm) Maximum or minimum Supply 1 x 30g tube of cream per episode. treatment period Maximum of 2 episodes per year, plus for intertrigo/ringworm, 2nd episode must be at least 6 months after the first. Adverse reactions Hypersensitivity can occur including urticaria, rash, pruritis and application site reactions. This list is not exhaustive. Please refer to the Summary of Product Characteristics (SPC) for further information. Significant drug Miconazole administered systemically is known to inhibit interactions CYP3A4/2C9. Due to the limited systemic availability after topical application, clinically relevant interactions are rare. However, in patients on oral anticoagulants, such as warfarin, caution should be exercised and anticoagulant effect should be monitored. This list is not exhaustive. Please refer to the current edition of the BNF & Summary of Product Characteristics (SPC) for further information. Storage and Handling Do not store above 25ºC Version 2.0 September 2015 Page 4 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. 3. Advice to patient Adverse Drug Reaction  Any adverse reaction to the medication must be Reporting documented in the patients medical records  Doctor/ GP should be informed  Use the yellow card system to report adverse drug reactions directly to the Commission on Human Medicines (CHM). Guidance on the use of the yellow card system is available in the current BNF or can be accessed via o the MHRA website https://yellowcard.mhra.gov.uk/ o The link within the Choose Pharmacy application o or contact Medicines Information Written or verbal Athlete’s Foot advice to patients  Wear footwear that keeps feet cool and dry and/or carers  Wear cotton socks  Change to a different pair of shoes every 2-3 days  After washing, dry feet thoroughly, especially between toes  Do not share towels and wash them frequently Intertrigo/Ringworm  Wash the affected skin daily and dry thoroughly, particularly in the skin folds  Wash clothes and bed linen frequently to eradicate the fungus  Do not share towels and wash them frequently  Wear loose-fitting clothes made of cotton or material designed to move moisture away from the skin Follow up advice Cream should be used for 7-14 days after disappearance of all signs and symptoms. 4. Documentation and Audit Trail Records A record must be made in the pharmacy patient medication record (PMR) at the time of supply, detailing  Patient name, address, date of birth  Registered GP  Name of medicine  Strength and form supplied  Dose / Quantity of medicine supplied 5. Staff Group  Pharmacists registered with the General Professionals to which Pharmaceutical Council (GPhC) PGD applies  Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme  All professionals must act within their appropriate Code of Professional Conduct Version 2.0 September 2015 Page 5 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. Additional requirements – access to: Specialist  British National Formulary (BNF) and BNF for Children competencies or – latest edition qualifications  AWMSG Common ailments scheme formulary – latest update All registered professionals are personally responsible for Continued training and their practice and in the exercise of professional education accountability there is a requirement to maintain and requirements improve their professional knowledge and competence 6. References  Summary of product characteristics Daktarin 2% cream – eMC https://www.medicines.org.uk/emc/medicine/6713 (accessed 25/8/15)  BNF Online August 2015, Chapter 13 Skin, Section 13.10.2 Antifungal preparations https://www.medicinescomplete.com/mc/bnf/current/PHP8030-miconazole- nitrate.htm (accessed 25/8/15)  AWMSG – Common ailments Scheme Formulary – http://www.awmsg.org/docs/awmsg/medman/All%20Wales%20Choose%20Pharma cy%20Formulary.pdf (accessed 25/8/15) Version 2.0 September 2015 Page 6 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. Version 2.0 September 2015 Page 7 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. PATIENT GROUP DIRECTION- NUMBER 130 Chloramphenicol 0·5% Eye Drops 1. Clinical condition Situation For patients with conjunctivitis (bacterial) without visual disturbance Inclusion criteria Patients presenting with purulent discharge or mild severity of red eye and one of the following:  symptoms have been present for at least three days and are not improving or  condition has deteriorated over recent days or  condition is severe or likely to become severe, providing serious causes of a red eye can be confidently excluded Exclusion criteria  Children under 2 years of age  Pregnant or breastfeeding women  Patients who wear contact lenses  Patients complaining of visual disturbances  Patients with significant photophobia  Patients with a history of recent eye surgery  Patients with restricted or painful eye movements  Patients with redness and swelling around the eye  Patients with a history of trauma or foreign body  Where there has been no improvement in the person’s signs or symptoms despite treatment  Patients hypersensitive to chloramphenicol or any other component of the drops.  Patients with a known personal or family history of blood dyscrasias including aplastic anaemia  Patients taking a contra-indicated medicine  Patients who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment Special warnings and  Personal or family history of bone marrow problems precautions for use  Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation If in doubt seek and emergence of resistant organisms. If any new medical advice infection appears during treatment, the antibiotic should be discontinued and appropriate measures taken Chloramphenicol should be reserved for use only in infections for which it is specifically indicated  Blurring of vision can occur with the drops and patients should be warned not to drive or operate machinery unless their vision is clear  Contact lens wearers - Advise patient to avoid wearing contact lenses whilst eye infection is present and during the course of treatment and to thoroughly cleanse contact lenses before re-using them Action if patient  Patients can be referred or self refer to the Wales Eye Care Version 2.0 September 2015 Page 8 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. excluded service at an accredited optometrist, referral should be recommended for all contact lens wearers  Referral to GP  Refer to A&E if reduced vision, significant photophobia, recent eye surgery, restricted or painful eye movements Action if patient  General self management advice as per Common Ailment declines the Formulary medication Seek further advice Refer to SPC, BNF & the All Wales Common Ailments Service Formulary 2. Treatment Name of Medicine Chloramphenicol 0·5% eye drops Legal Status POM Route/Method Topical - eye Dosage 0·5% Eye Drops Form/Strength Licensed or off licensed Licensed use use Frequency The BNF recommended dosage for adults and children (aged 2 years and over) is one drop to be applied to the affected eye at least every 2 hours then reduce frequency as infection is controlled Duration of treatment Continue treatment for 48 hours after healing Maximum or minimum Supply one 10ml bottle for each affected eye per episode treatment period Maximum of 2 episodes per year (second at least 6 months after first) Adverse reactions  Transient stinging, burning or irritation may occur on application  Blurring may occur. Patients should be warned not to drive or operate machinery unless vision is clear  BNF states that chloramphenicol eye drops are well tolerated, however Chloramphenicol is absorbed systemically from the eye and toxicity has been reported (rarely) following chronic exposure. Bone marrow hypoplasia, including aplastic anaemia and death, has been reported following topical use of chloramphenicol. Whilst the hazard is rare, it should be borne in mind when assessing the benefits expected from the use of the compound hypersensitivity reactions that may present as angioneurotic oedema, urticaria, anaphylaxis, fever, and vesicular and maculopapular dermatitis. In such instances treatment should be discontinued immediately. This list is not exhaustive. Please refer to the product SPC for further information Significant drug The concomitant administration of chloramphenicol with other interactions drugs liable to depress bone marrow function should be Version 2.0 September 2015 Page 9 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent. avoided This list is not exhaustive. Please refer to the current edition of the BNF & Summary of Product Characteristics (SPC) for further information Storage and Handling Store in a fridge (stock) but can be stored at room temperature once opened. 3. Advice to patient Adverse Drug Reaction  Any adverse reaction to the medication must be Reporting documented in the patients medical records  Doctor/ GP should be informed  Use the yellow card system to report adverse drug reactions directly to the Commission on Human Medicines (CHM). Guidance on the use of the yellow card system is available in the current BNF or can be accessed via o the MHRA website https://yellowcard.mhra.gov.uk/ o The link within the Choose Pharmacy application o or contact Medicines Information Written/additional  Advise patient that conjunctivitis is very contagious and to advice to patient/carer exercise care with hand washing, using separate towels, particularly before and after applying the drops  Good eye hygiene is essential. Wipe with cooled boiled water  The patient should be instructed not to touch the eye or eye lashes with the nozzle as this may contaminate the medicine  Advise patient that they may experience transient irritation, burning, stinging or itching  Advise patient that if blurring of vision occurs not to drive or operate machinery until vision is clear  On rare occasions hypersensitivity may occur (wheeziness, fever, swelling of face, lips and tongue) in which case treatment must be stopped immediately and medical advice sought  Advise patient not to wear eye make up as infection can re-occur  Once the treatment is completed the bottle(s) of eye drops should be discarded  If symptoms worsen despite treatment, seek medical advice  If chloramphenicol is used following the advice of a doctor/optometrist in patients that normally wear contact lenses – patients’ should be advised that lenses should not be worn during the period of treatment. Hard contact lens users and disposable contact lens users can start using Version 2.0 September 2015 Page 10 of 89 Paper copies of this document should be kept to a minimum and checks made with the electronic version to ensure the version to hand is the most recent.