Patient Group Directions for the supply of medication by Community Pharmacists under the Common Ailments Service

Transcription

1 Patient Group Directions for the supply of medication by Community Pharmacists under the Common Ailments Service PGD No. Drug Indication Page 130 Chloramphenicol 0.5% eye drops Conjunctivitis (Bacterial) 2 (10ml) 131 Chloramphenicol 1% ointment (4g) Conjunctivitis (Bacterial) Hydrocortisone 0.5% cream Nappy rash Hydrocortisone 1% cream (15g & 30g) Athlete s Foot 20 Dry skin/dermatitis Intertrigo Ringworm 228 Hydrocortisone 1% ointment Dry skin/dermatitis Hydrocortisone 2.5% cream Dry skin/dermatitis Hydrocortisone 2.5% ointment Dry skin/dermatitis Scheriproct ointment (30g) Haemorrhoids Scheriproct suppository (12) Haemorrhoids Sodium cromoglicate 2% eye drops (13.5ml) 136 Beclometasone 50mcg nasal spray (200 dose) Allergic conjunctivitis 56 associated with hayfever Hay fever Omeprazole 20mg capsules (28) Indigestion and reflux Lansoprazole 30mg capsules (28) Indigestion and reflux Miconazole 20mg/g oral gel (80g) Oral thrush Nystatin u/ml oral suspension Oral thrush 91 (30ml) 142 Mebendazole 100mg tablets (6) Threadworm Mebendazole 100mg/5ml suspension Threadworm Clotrimazole 10% cream (5g) Vaginal thrush Clotrimazole 500mg pessary and Vaginal thrush 113 2%cream (1 & 20g) PGD Pharmacist Authorisation Form 121 Pharmacy Record of PGD Authorisation 122 References AWMSG Common Ailments Scheme Formulary The National Assembly for Wales WHC (2000) 116 Patient Group Directions - Review Of Prescribing Supply And Administration Of Medicines. Accessed August 2015 Version 3.0 April 2018 Page 1 of 122

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3 PATIENT GROUP DIRECTION- NUMBER 130 Chloramphenicol 0 5% Eye Drops 1. Clinical condition Situation Inclusion criteria Exclusion criteria Special warnings and precautions for use If in doubt seek medical advice For patients with conjunctivitis (bacterial) without visual disturbance. 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 is severe or likely to become severe, providing serious causes of a red eye can be confidently excluded Children under 2 years of age; Pregnant or breastfeeding women; Patients whose vision is reduced or in any way impaired Patients with significant photophobia; Patients with restricted or painful eye movements Patients with red eye and no discharge; Patients whose eye is painful; Patients with redness and swelling around the eye; Patients with a history of trauma or foreign body; Patients who wear contact lenses and are unwilling to stop using them during treatment; Where there has been no improvement in the patient s signs or symptoms despite treatment; Patients with a history of recent eye surgery; 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. Personal or family history of bone marrow problems; Prolonged use of chloramphenicol eye drops should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new 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. Version 3.0 April 2018 Page 3 of 122

4 Action if patient excluded Action if patient declines the medication Seek further advice 2. Treatment Name of Medicine Legal Status 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. Consider referral to optometrist. Consider referring patients with multiple episodes of infection to optometrist (or GP, if optometry service unavailable). Patients can be referred or self refer to the Wales Eye Care service at an accredited optometrist; Referral to GP; Refer to A&E if reduced vision, significant photophobia, recent eye surgery, restricted or painful eye movements. General self management advice as per Common Ailment Formulary (February 2018). Refer to SPC, BNF & the All Wales Common Ailments Service Formulary (February 2018). Chloramphenicol 0 5% eye drops POM Route/Method Dosage Form/Strength Licensed or off licensed use Frequency Duration of treatment Maximum or minimum treatment period Topical - eye 0 5% Eye Drops Licensed use 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. Continue treatment for 48 hours after healing Supply one 10ml bottle for each affected eye per episode 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. Version 3.0 April 2018 Page 4 of 122

5 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. Significant drug interactions This list is not exhaustive. Please refer to the product SPC for further information The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be 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 at 2 8 o C. Shelf life: 28 days once opened. 3. Advice to patient Adverse Drug Reaction Reporting For established medicines, report all serious suspected adverse drug reactions, even if it is well recognised. Reports can be submitted by post or online: o via the Yellow Card reporting website at o The link within the Choose Pharmacy application; o Yellow Card forms can be found in the back of the BNF, downloaded from the MHRA website, by writing to FREEPOST YELLOW CARD or by ing yellowcard@mhra.gsi.gov.uk The adverse reaction to the drug should be documented in the medical records and the GP should be informed Explain patients can self-report any suspected adverse reactions directly to the MHRA. Version 3.0 April 2018 Page 5 of 122

6 Written/additional advice to patient/carer 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 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 their lenses again after successful treatment. Soft contact lenses should not be replaced for 24 hours after completing the treatment. There is no recommended exclusion period from school, nursery or childminders for isolated cases but many nursery and primary schools may nevertheless have an exclusion policy check with school policy. General safe care advice (see Common Ailments Formulary monograph Conjunctivitis, February 2018). Follow up advice If symptoms do not improve within 5 days refer to accredited optometrist or GP. 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. Version 3.0 April 2018 Page 6 of 122

7 5. Staff Group Professionals to which PGD applies Specialist competencies or qualifications Continued training and education requirements Pharmacists registered with the General Pharmaceutical Council (GPhC); Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme; All professionals must act within their appropriate Code of Professional Conduct. Additional requirements access to: British National Formulary (BNF) and BNF for Children latest edition. AWMSG Common ailments scheme formulary (February 2018). All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence. 6. References Summary of Product Characteristics Chloramphenicol 0.5% eye drops emc (accessed 27/3/18). Wales Eye Care Service British National Formulary: Joint Formulary Committee, BMJ Group & Pharmaceutical Press (online): Chloramphenicol chloramphenicol.htm (accessed 27/3/18). AWMSG Common ailments Scheme Formulary nts%20formulary.pdf (accessed 27/3/18). Aneurin Bevan University Health Board Common Ailments Service Patient Group Directions Version 1 February Version 3.0 April 2018 Page 7 of 122

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9 PATIENT GROUP DIRECTION- NUMBER 131 Chloramphenicol 1% Eye Ointment 1. Clinical condition Situation Inclusion criteria Exclusion criteria Special warnings and precautions for use If in doubt seek medical advice For patients with conjunctivitis (bacterial) without visual disturbance. 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 is severe or likely to become severe, providing serious causes of a red eye can be confidently excluded. Children under 2 years of age; Pregnant or breastfeeding women; Patients whose vision is reduced or in any way impaired Patients with significant photophobia; Patients with restricted or painful eye movements; Patients with red eye and no discharge; Patients whose eye is painful; Patients with redness and swelling around the eye; Patients with a history of trauma or foreign body; Patients who wear contact lenses and are unwilling to stop using them during treatment; Where there has been no improvement in the patient s signs or symptoms despite treatment; Patients with a history of recent eye surgery; 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. Personal or family history of bone marrow problems. 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. Consider referral to optometrist. Consider referring patients with multiple episodes of infection to optometrist (or GP, if optometry service unavailable). Version 3.0 April 2018 Page 9 of 122

10 Action if patient is excluded Action if patient declines treatment Seek further advice: Prolonged use of chloramphenicol eye ointment should be avoided as it may increase the likelihood of sensitisation and emergence of resistant organisms. If any new 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 ointment and patients should be warned not to drive or operate machinery unless their vision is clear. Patients can be referred or self refer to the Wales Eye Care Service at an accredited optometrist. Referral to GP. Refer to A&E if reduced vision, significant photophobia, recent eye surgery, restricted or painful eye movements. General self management advice as per Common ailment formulary (February 2018). Refer to BNF, SPC or the All Wales Common Ailments Service formulary (February 2018). 2. Treatment Name of Medicine Legal Status Route/Method Dosage Form/Strength Licensed or off licensed use Frequency Duration of treatment Maximum or minimum treatment period Chloramphenicol 1% Eye Ointment POM Eye Ointment Topical-eye 1% Eye Ointment Licensed use The BNF recommended dosage for adults and children (aged 2 years and over) is: Apply a thin line of ointment applied along the inside of the lower lid of the affected eye(s) 3-4 times a day. Treatment should be continued for 48 hours after the eye appears normal. One 4 gram tube for each affected eye to be supplied per episode. Adverse reactions Transient stinging, burning or irritation. Blurring may occur. Patients should be warned not to drive or operate machinery unless vision is clear. Itching and skin inflammation. BNF states that chloramphenicol eye ointment is well tolerated, however Chloramphenicol is absorbed systemically from the eye and toxicity has been reported Version 3.0 April 2018 Page 10 of 122

11 (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. Significant drug interactions This list is not exhaustive. Please refer to the Summary of Product Characteristics (SPC) for further information. The concomitant administration of chloramphenicol with other drugs liable to depress bone marrow function should be 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 below 25ºC Shelf life: 28 days once opened 3. Advice to patient Adverse Drug Reaction Reporting Written/additional advice to patient/carer For established medicines, report all serious suspected adverse drug reactions, even if it is well recognised. Reports can be submitted by post or online: o via the Yellow Card reporting website at o The link within the Choose Pharmacy application o Yellow Card forms can be found in the back of the BNF, downloaded from the MHRA website, by writing to FREEPOST YELLOW CARD or by ing yellowcard@mhra.gsi.gov.uk The adverse reaction to the drug should be documented in the medical records and the GP should be informed o Explain patients can self-report any suspected adverse reactions directly to the MHRA The patient should be instructed not to touch the eye or eye lashes with the tube or nozzle as this may contaminate the medicine. Explain how to apply the ointment and also that the ointment melts rapidly and blinking helps to spread it. Version 3.0 April 2018 Page 11 of 122

12 Follow up advice 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 tube(s) of ointment should be discarded If symptoms worsen despite treatment, seek medical advice. If chloramphenicol is used 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 their lenses again after successful treatment. Soft contact lenses should not be replaced for 24 hours after completing the treatment. There is no recommended exclusion period from school, nursery or childminders for isolated cases but many nursery and primary schools may nevertheless have an exclusion policy check with school policy. General safe care advice (see Common Ailments Formulary monograph Conjunctivitis (Bacterial), February 2018). If symptoms do not improve within 5 days refer to accredited optometrist or GP. 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 Version 3.0 April 2018 Page 12 of 122

13 5. Staff Group Professionals to which PGD applies Specialist competencies or qualifications Continued training and education requirements Pharmacists registered with the General Pharmaceutical Council (GPhC) Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme All professionals must act within their appropriate Code of Professional Conduct Additional requirements access to: British National Formulary (BNF) and BNF for Children latest edition AWMSG Common ailments scheme formulary (February 2018) All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence 6. References Summary of Product Characteristics Chloramphenicol 1% eye ointment, emc (accessed 27/3/18). Wales Eye Care Service - British National Formulary: Joint Formulary Committee, BMJ Group & Pharmaceutical Press (online): Chloramphenicol chloramphenicol.htm (accessed 27/3/18). AWMSG Common ailments Scheme Formulary nts%20formulary.pdf (accessed 27/3/18). Aneurin Bevan University Health Board Common Ailments Service Patient Group Directions Version 1 February Version 3.0 April 2018 Page 13 of 122

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15 PATIENT GROUP DIRECTION- NUMBER 294 Hydrocortisone 0.5% Cream 1. Clinical condition Situation Treatment of inflamed nappy rash Inclusion criteria Patient presenting with nappy rash Inflammation present Exclusion criteria Patients less than one month old; Patients with severe inflammation; Patients who are systemically unwell or have a fever; Patients taking a contra-indicated medicine; Hypersensitivity to hydrocortisone or to any of the other excipients; Patients diagnosed with psoriasis; Symptoms indicative of bacterial (e.g. impetigo), viral (e.g. Herpes simplex) infections of the skin, scabetic infections, Rosacea, Perioral dermatitis; Untreated fungal infections of the skin; Symptoms failing to respond to appropriate treatment. Person with parental responsibility presenting on behalf of the patient who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment. Special warnings and precautions for use If in doubt seek medical advice Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy including nappy rash. In infants and children, courses of treatment should therefore not exceed 7 days. Seek further advice if signs or symptoms of infection develop or rash fails to respond to therapy. Product may contain cetomacrogol emulsifying wax with cetostearyl alcohol and chlorocresol which may cause local skin reactions (e.g. contact dermatitis). Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings may suppress adrenocortical function. Avoid prolonged use - risk of systemic absorption. Pregnancy and lactation Version 3.0 April 2018 Page 15 of 122

16 There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area. Action if patient is excluded Action if patient declines treatment Seek further advice: NPSA Fire Hazard Alert Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product. Refer to GP General self management advice as per Common Ailment Formulary (February 2018) Refer to BNF, SPC or the All Wales Common Ailments Service Formulary (February 2018) 2. Treatment Name of Medicine Legal Status Hydrocortisone 0.5% cream POM Route/Method Topical cutaneous Dosage 0.5% Cream Form/Strength Licensed or off licensed Licensed use use Frequency Apply once a day Duration of treatment Discontinue treatment as soon as inflammation subsides Maximum treatment period 7 days. Maximum or minimum treatment period Supply 1x15g tube per episode Adverse reactions Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Version 3.0 April 2018 Page 16 of 122

17 Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Following prolonged topical use, systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated. Eye disorders-frequency Not known: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist. Significant drug interactions Storage and Handling This list is not exhaustive. Please refer to the current edition of the Summary of Product Characteristics (SPC) for further information None Known. Please refer to the current edition of the BNF & Summary of Product Characteristics (SPC) for further information. Store below 25 C. Do not freeze. Version 3.0 April 2018 Page 17 of 122

18 3. Advice to patient Adverse Drug Reaction Reporting Written/additional advice to patient/carer Follow up advice For established medicines, report all serious suspected adverse drug reactions, even if it is well recognised. Reports can be submitted by post or online: o via the Yellow Card reporting website at o The link within the Choose Pharmacy application o Yellow Card forms can be found in the back of the BNF, downloaded from the MHRA website, by writing to FREEPOST YELLOW CARD or by ing yellowcard@mhra.gsi.gov.uk The adverse reaction to the drug should be documented in the medical records and the GP should be informed Explain patients can self-report any suspected adverse reactions directly to the MHRA Apply thinly to inflamed area. Patients or carers should be given advice on how to administer corticosteroid cream. Patients and their carers should be reassured that side effects such as skin thinning and systemic effects rarely occur when topical corticosteroids are used appropriately. Patients should be warned of risk of clothing/bedding/fabric igniting when using the product and should be given appropriate advice to keep away from fire when using this product. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations. Discontinue treatment with hydrocortisone as soon as inflammation subsides or after a maximum of 7 days. Advise to use adequate quantities of barrier cream daily. General safe care advice (see Common Ailments Formulary monograph Nappy Rash, February 2018). General Advise patients to seek medical advice if condition worsens or there are signs of infection erythema, inflammation, weeping, pustules, crusts, rapidly worsening rash, fever and malaise. Seek advice if rash is not responding to therapy. Version 3.0 April 2018 Page 18 of 122

19 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 Professionals to which PGD applies Specialist competencies or qualifications Continued training and education requirements Pharmacists registered with the General Pharmaceutical Council (GPhC); Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme; All professionals must act within their appropriate Code of Professional Conduct. Additional requirements access to: British National Formulary (BNF) and BNF for Children latest edition. AWMSG Common ailments scheme formulary (February 2018). All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence. 6. References Summary of Product Characteristics Hydrocortisone 0.5% cream TEVA UK (accessed 28/03/18). British National Formulary: Joint Formulary Committee, BMJ Group & Pharmaceutical Press (online): Hydrocortisone, (accessed 28/03/18). AWMSG Common ailments Scheme Formulary nts%20formulary.pdf (accessed 27/3/18). Aneurin Bevan University Health Board Common Ailments Service Patient Group Directions Version 1 February Version 3.0 April 2018 Page 19 of 122

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21 PATIENT GROUP DIRECTION- NUMBER 227 Hydrocortisone 1% Cream 1. Clinical condition Situation Treatment of Athlete s Foot where there is co-existing dermatitis (inflamed and/or itchy skin), in combination with antifungal cream. Acute exacerbation of Dry skin/mild atopic dermatitis (red, itchy skin) Treatment of inflammatory Intertrigo where there is particularly inflamed or itchy skin in combination with antifungal cream. Treatment of inflammatory Ringworm where there is particularly inflamed or itchy skin in combination with antifungal cream. Inclusion criteria Athlete s Foot Dermatitis present; Concurrent treatment with antifungal cream. Dry skin/dermatitis Acute exacerbation of dermatitis; Patients who are using adequate quantities of emollients. Exclusion criteria Ringworm/Intertrigo inflammation present; concurrent treatment with antifungal cream. Athlete s Foot Patients with severe or extensive disease, or recurrent episodes; Patients with signs of bacterial infection; If there has been no improvement after 1 week of treatment or if there is pain and discomfort; Patients who are immunocompromised; Patients who have poorly controlled diabetes and have not been reviewed by their GP in the last 3 months; Patients not using antifungal cream. Dry Skin/Dermatitis Infected eczema (signs suggestive of infection erythema, inflammation, weeping, rapidly worsening rash, fever and malaise); Rash failing to respond to therapy; Patients not using adequate quantities of emollient. Version 3.0 April 2018 Page 21 of 122

22 Ringworm/Intertrigo Patients with severe or extensive disease, or recurrent episodes; Patients with ringworm on the scalp; If there has been no improvement after 2 week of treatment or if there is pain and discomfort; Patients who are immunocompromised; Patients who have poorly controlled diabetes and have not been reviewed by their GP in the last 3 months; Patients not using antifungal cream. Special warnings and precautions for use If in doubt seek medical advice All patients Patients taking a contra-indicated medicine; Hypersensitivity to hydrocortisone or to any of the other excipients; Patients diagnosed with psoriasis; Symptoms indicative of bacterial (e.g. impetigo), viral (e.g. Herpes simplex) infections of the skin, scabetic infections, Rosacea, Perioral dermatitis; Untreated fungal infections of the skin; Symptoms failing to respond to appropriate treatment; Patients who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment. Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy. In infants and children, courses of treatment should therefore not normally exceed 7 days. Seek further advice if signs or symptoms of infection develop or rash fails to respond to therapy. Product may contain cetomacrogol emulsifying wax with cetostearyl alcohol and chlorocresol which may cause local skin reactions (e.g. contact dermatitis). Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings may suppress adrenocortical function. Avoid prolonged use (particularly on the face)- risk of systemic absorption. Version 3.0 April 2018 Page 22 of 122

23 Pregnancy and lactation There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone Cream is administered to nursing mothers. In this event, the product should not be applied to the chest area. Action if patient is excluded Action if patient declines treatment Seek further advice: NPSA Fire Hazard Alert Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product. Refer to GP General self management advice as per Common Ailment Formulary (February 2018). Refer to BNF, SPC or the All Wales Common Ailments Service Formulary (February 2018). 2. Treatment Name of Medicine Legal Status Hydrocortisone 1% cream POM Route/Method Dosage Form/Strength Licensed or off licensed use Frequency Topical cutaneous 1% Cream Licensed use Athlete s Foot apply thinly once or twice daily Dry skin/dermatitis - Apply thinly once or twice daily Intertrigo/ringworm - Apply thinly once or twice daily, or once daily to groin area. Version 3.0 April 2018 Page 23 of 122

24 Duration of treatment Athlete s Foot maximum of 7 days treatment. Dry skin/dermatitis - Continue for 48 hours after the flare is controlled. Maximum treatment period 7-14 days. Children maximum treatment period of 7 days Intertrigo maximum of 14 days treatment. Ringworm - Use combined treatment in the first few days only in significantly inflamed ringworm. Maximum or minimum treatment period Athlete s Foot Supply 1x15g tube per episode. Dry skin/dermatitis -Supply 1 x 15g or 1x30g tube per episode. Intertrigo/Ringworm Supply 1 x 15g tube per episode. Adverse reactions Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated. Eye disorders-frequency Not known: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist. This list is not exhaustive. Please refer to the current edition of the Summary of Product Characteristics (SPC) for further information. Version 3.0 April 2018 Page 24 of 122

25 Significant drug interactions Storage and Handling None Known. Please refer to the current edition of the BNF & Summary of Product Characteristics (SPC) for further information. Do not store above 25 C. 3. Advice to patient Adverse Drug Reaction Reporting Written/additional advice to patient/carer For established medicines, report all serious suspected adverse drug reactions, even if it is well recognised. Reports can be submitted by post or online: o via the Yellow Card reporting website at o The link within the Choose Pharmacy application. o Yellow Card forms can be found in the back of the BNF, downloaded from the MHRA website, by writing to FREEPOST YELLOW CARD or by ing yellowcard@mhra.gsi.gov.uk The adverse reaction to the drug should be documented in the medical records and the GP should be informed o Explain patients can self-report any suspected adverse reactions directly to the MHRA. Apply thinly to inflamed area. Patients or carers should be given advice on how to administer corticosteroid cream. Patients and their carers should be reassured that side effects such as skin thinning and systemic effects rarely occur when topical corticosteroids are used appropriately. Patients should be warned of risk of clothing/bedding/ fabric igniting when using the product and should be given appropriate advice to keep away from fire when using this product. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations. Athlete s Foot Only use in combination with antifungal cream. Discontinue treatment with hydrocortisone after 7 days. General safe care advice (see Common Ailments Formulary monograph Athlete s Foot, February 2018). Version 3.0 April 2018 Page 25 of 122

26 Dry skin/dermatitis Apply thinly to inflamed area. Should only be used if also using adequate quantities of emollients daily. Do not apply within half hour of applying emollient to the inflamed skin. Advise that once exacerbation settles, continue for 48 hours after the flare is controlled and continue with the emollient. General safe care advice (see Common Ailments Formulary monograph Dry skin/dermatitis, February 2018). Intertrigo Only use in combination with antifungal cream. Discontinue treatment with hydrocortisone after 14 days. General safe care advice (see Common Ailments Formulary monograph Intertrigo, February 2018). Ringworm Only use in combination with antifungal cream. Discontinue treatment with hydrocortisone after 3-4 days. General safe care advice (see Common Ailments Formulary monograph Ringworm, February 2018). Follow up advice General Advise patients to seek medical advice if condition worsens or there are signs of infection erythema, inflammation, weeping, pustules, crusts, rapidly worsening rash, fever and malaise. Seek advice if rash is not responding to therapy Version 3.0 April 2018 Page 26 of 122

27 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 Professionals to which PGD applies Specialist competencies or qualifications Continued training and education requirements Pharmacists registered with the General Pharmaceutical Council (GPhC). Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme. All professionals must act within their appropriate Code of Professional Conduct. Additional requirements access to: British National Formulary (BNF) and BNF for Children latest edition. AWMSG Common ailments scheme formulary (February 2018). All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence. 6. References Summary of Product Characteristics Hydrocortisone 1% cream (accessed 28/03/18). Summary of Product Characteristics Hydrocortisone 1% cream TEVA (accessed 28/03/18). British National Formulary: Joint Formulary Committee, BMJ Group & Pharmaceutical Press (online):hydrocortisone, (accessed 28/03/18). AWMSG Common ailments Scheme Formulary nts%20formulary.pdf (accessed 27/3/18) Aneurin Bevan University Health Board Common Ailments Service Patient Group Directions Version 1 February Version 3.0 April 2018 Page 27 of 122

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29 PATIENT GROUP DIRECTION- NUMBER 228 Hydrocortisone 1% Ointment 1. Clinical condition Situation Acute exacerbation of mild atopic dermatitis (red, itchy skin). Inclusion criteria Acute exacerbation of dermatitis; Patients who are using adequate quantities of emollients. Exclusion criteria Infected eczema (signs suggestive of infection erythema, inflammation, weeping, rapidly worsening rash, fever and malaise) Symptoms failing to respond to appropriate treatment. Patients not using adequate quantities of emollient Patients taking a contra-indicated medicine Hypersensitivity to hydrocortisone or to any of the other excipients Patients diagnosed with psoriasis Symptoms indicative of bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin, scabetic infections, Rosacea, Perioral dermatitis Patients who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment Special warnings and precautions for use If in doubt seek medical advice Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy. In infants and children, courses of treatment should therefore not normally exceed 7 days. Seek further advice if signs or symptoms of infection develop or rash fails to respond to therapy Prolonged use of uninterrupted occlusion or use with extensive occlusive dressings may suppress adrenocortical function Avoid prolonged use (particularly on the face)- risk of systemic absorption. Pregnancy and lactation There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus. Version 3.0 April 2018 Page 29 of 122

30 There is no evidence against use in lactating women. However, caution should be exercised when Hydrocortisone ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area. Action if patient is excluded Action if patient declines treatment Seek further advice: NPSA Fire Hazard Alert Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product. Refer to GP General self management advice as per Common Ailment Formulary (February 2018) Refer to BNF, SPC or the All Wales Common Ailments Service Formulary (February 2018) 2. Treatment Name of Medicine Legal Status Hydrocortisone 1% ointment POM Route/Method Dosage Form/Strength Licensed or off licensed use Frequency Duration of treatment Maximum or minimum treatment period Topical cutaneous 1% ointment Licensed use Apply thinly once or twice daily Continue for 48 hours after the flare is controlled. Maximum treatment period 7-14 days. Children maximum treatment period of 7 days Supply 1 x 30g tube per episode Adverse reactions Hydrocortisone preparations are usually well tolerated, but if any signs of hypersensitivity appear, application should stop immediately. Epidermal thinning, telangectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption. Version 3.0 April 2018 Page 30 of 122

31 Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated. Eye disorders-frequency Not known: Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist Significant drug interactions This list is not exhaustive. Please refer to the current edition of the Summary of Product Characteristics (SPC) for further information None Known Please refer to the current edition of the BNF & Summary of Product Characteristics (SPC) for further information Storage and Handling Do not store above 25 C 3. Advice to patient Adverse Drug Reaction Reporting Written/additional advice to patient/carer For established medicines, report all serious suspected adverse drug reactions, even if it is well recognised. Reports can be submitted by post or online: o via the Yellow Card reporting website at o The link within the Choose Pharmacy application o Yellow Card forms can be found in the back of the BNF, downloaded from the MHRA website, by writing to FREEPOST YELLOW CARD or by ing yellowcard@mhra.gsi.gov.uk The adverse reaction to the drug should be documented in the medical records and the GP should be informed o Explain patients can self-report any suspected adverse reactions directly to the MHRA Should only be used if also using adequate quantities of emollients daily; Do not apply within half hour of applying emollient to the inflamed skin; Advise that once exacerbation settles, continue for 48 hours after the flare is controlled and continue with the emollient. Version 3.0 April 2018 Page 31 of 122

32 Apply thinly to inflamed area; Patients or carers should be given advice on how to administer corticosteroid cream. Patients and their carers should be reassured that side effects such as skin thinning and systemic effects rarely occur when topical corticosteroids are used appropriately. Patients should be warned of risk of clothing/bedding/fabric igniting when using the product and should be given appropriate advice to keep away from fire when using this product. Mixing topical preparations on the skin should be avoided where possible; several minutes should elapse between application of different preparations. General safe care advice (see Common Ailments Formulary monograph Dry Skin/dermatitis, February 2018). Follow up advice Advise patients to seek medical advice if condition worsens or there are signs of infection erythema, inflammation, weeping, pustules, crusts, rapidly worsening rash, fever and malaise. Seek advice if rash is not responding to therapy. 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 Professionals to which PGD applies Pharmacists registered with the General Pharmaceutical Council (GPhC) Pharmacist registered to provide the Community Pharmacy Common Ailments Scheme All professionals must act within their appropriate Code of Professional Conduct Version 3.0 April 2018 Page 32 of 122

33 Specialist competencies or qualifications Continued training and education requirements Additional requirements access to: British National Formulary (BNF) and BNF for Children latest edition AWMSG Common ailments scheme formulary (February 2018) All registered professionals are personally responsible for their practice and in the exercise of professional accountability there is a requirement to maintain and improve their professional knowledge and competence 6. References Summary of Product Characteristics hydrocortisone 1% ointment, emc (accessed 28/03/18) Summary of Product Characteristics hydrocortisone 1% ointment TEVA (accessed 28/03/18) British National Formulary: Joint Formulary Committee, BMJ Group & Pharmaceutical Press (online):hydrocortisone, (accessed 28/03/18) AWMSG Common ailments Scheme Formulary nts%20formulary.pdf (accessed 27/3/18) Aneurin Bevan University Health Board Common Ailments Service Patient Group Directions Version 1 February 2017 Version 3.0 April 2018 Page 33 of 122

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35 PATIENT GROUP DIRECTION- NUMBER 229 Hydrocortisone 2.5% Cream 1. Clinical condition Situation Acute exacerbation of mild atopic dermatitis (red, itchy skin) that has not responded adequately to treatment with hydrocortisone 1%. Inclusion criteria Acute exacerbation of dermatitis not adequately controlled by using hydrocortisone 1%; Patients who are using adequate quantities of emollients. Exclusion criteria Infected eczema (signs suggestive of infection erythema, inflammation, weeping, rapidly worsening rash, fever and malaise); Patients who have not used hydrocortisone 1% to treat current episode; Symptoms failing to respond to appropriate treatment; Patients not using adequate quantities of emollient; Patients taking a contra-indicated medicine; Hypersensitivity to hydrocortisone or to any of the other excipients; Patients diagnosed with psoriasis; Symptoms indicative of bacterial (e.g. impetigo), viral (e.g. Herpes simplex) or fungal (e.g. candidal or dermatophyte) infections of the skin, scabetic infections, Rosacea, Perioral dermatitis; Patients who the pharmacist has assessed as not having capacity to understand the nature and purpose of treatment. Special warnings and precautions for use If in doubt seek medical advice Although generally regarded as safe, even for long-term administration in adults, there is potential for overdosage in infants and children. Extreme caution is required in dermatoses of infancy. In infants and children, courses of treatment should therefore not normally exceed 7 days. In infants and children particularly, care should be taken that the lowest strength of hydrocortisone cream that is clinically effective is used. The 2.5% strength is normally only necessary in the more severe cases and is better avoided in infants. Seek further advice if signs or symptoms of infection develop or rash fails to respond to therapy. Product contains cetomacrogol emulsifying wax with cetostearyl alcohol and chlorocresol which may cause local skin reactions (e.g. contact dermatitis). Version 3.0 April 2018 Page 35 of 122