Self-Care, Over the Counter (OTC) andProducts of Limited Value Prescribing Policy

Version 1

Implementation Date

18th March 2019

Review Date 18th March 2021

Approved BySt Helens CCG Medicines Management Committee

Approval Date 20th February 2019

REVISIONS

Date Section Reason for Change Approved By15/05/2019 Appendice

sNHSE addition to Guidance on conditions for which over the counter items should not routinely be prescribed in primary careImplementation resourcesPeople living in care homes - frequently asked questions.

MMC

15/05/2019 Appendices

Addition of LMC letter to Head Teacher’s MMC

03/06/2019 Appendices

Addition of patient letter MMT

PRESCRIBING COMMISSIONING POLICY: SELF- CARE

NHS St Helens CCG will not fund the prescribing of medicines and treatments for minor, short-term conditions where:

• Self-care is the most appropriate route• Medicines and treatments are available to buy over the counter

NHS St Helens CCG will not fund the prescribing of medicines and treatments forANY medical condition where:

• There is insufficient evidence of clinical benefit• The medical condition has no need of clinical treatment• It is not cost effective to the NHS to prescribe these medications

Medicines for the prevention of malaria, which are not prescription only medicines, can be purchased directly from community pharmacies.

Note: Patients who are not eligible for treatment under this policy may be considered on an individual basis where their GP or consultant believes exceptional clinical circumstances exist that warrant deviation from the rule of this policy.

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ContentsSection Description Page

1 Introduction 4

2 Scope of this Policy 5

3 Medicines available over-the-counter, used for short-term, minor medical conditions

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4 Medicines where there is limited evidence of clinicalbenefit or cost-effectiveness

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5 Medicines that are prescribed to treat conditions where there is no clinical need for treatment

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6 Malaria prophylaxis 8

7 Self-care prescribing reviews 8

8 Prescribing of medication available via the Care at the Chemist scheme

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Appendices

1 Examples of conditions were there are medicinesthat can be purchased over- the-counter for the treatment of minor, short-term conditions

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2Restrictions to supply of some OTC medicines by Community Pharmacies

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3 Care at the Chemist Minor Ailments Service 17

4 Non-prescription (over the counter (OTC)) medications in nurseries and schools

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5 References/resources and associated documents 24

6 NHS England letter 31/1/19- Conditions for which over the counter items should not routinely be prescribed in primary care: letter from Professor Stephen Powis

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7 Implementation resourcesPeople living in care homes - frequently asked questions

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8 LMC letter to Head Teacher’s 31

9 Patient Letter - Treatments/medicines for short-term minor conditions/ailments or where there is insufficient evidence of clinical benefit or cost effectiveness

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SELF-CARE, (OTC) AND PRODUCTS OF LIMITED CLINICAL VALUE PRESCRIBING

POLICY1. INTRODUCTION

1.1. Self-care is widely acknowledged as an important solution to managing demand and keeping the NHS sustainable. Supporting people to self manage common conditions such as coughs and colds could help bring down the 57 million GP consultations each year for minor ailments, which takes up to an hour a day on average for every GP and costs the NHS approximately £2 billion per year.

1.2. Promoting the concept of self-care and increasing the awareness that there are alternatives to making GP appointments, or attendance at OOHs or A&E departments with minor conditions, will encourage patients to explore self-care in the future, so changing the culture of dependency on the NHS.

1.3. St Helens CCG spends over £2million per year on prescribing medicines and products that are available to buy over the counter without a prescription from community pharmacies and retail outlets such as supermarkets. It is recognised that some of this cost is attributable to long-term or complex conditions. However, removing specific medications from routine prescription for minor, short-term conditions and for conditions, such as a common cold, sore throat or minor cough, which would naturally get better themselves in the majority of patients if untreated, would release money to treat more serious conditions such as heart disease and diabetes and would help maintain financial balance in the health economy.

1.4. Some products that are currently prescribed are clinically ineffective or are not cost effective. These treatments will not have undergone rigorous clinical trials to demonstrate that they work, and it is inappropriate to spend the local NHS budget on products that do not have proven efficacy or safety in preference to medicines supported by robust clinical evidence.

1.5. Medicines for malaria prophylaxis are not reimbursable under the NHS. Some medicines for the prevention of malaria are available for the patient to purchase over the counter at a community pharmacy. Prescription only medicines for malaria prophylaxis must be prescribed on a private prescription. Selection of treatment is dependent on destination please see NHS Choices ht t p : / / ww w . n h s . u k / co n d i t i o n s /m a l ari a / p a g es/ p r e v e n t i o n . as p x

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1.6. Since November 2016 the St Helens ‘Self-care’ Prescribing Policy has provided guidance on prescribing in this area for St Helens prescribers.

Nationally there have been several consultations regarding the prescribing of medicines. In December 2017 guidance was released by NHS England regarding 18 products that should not be routinely prescribed in primary care and in March 2018 further guidance has been issued regarding ‘over the counter medicines’.

Please see links below for further details: h t tp s : / / w w w . en g la nd . n h s. u k / pub l i c a t i on /i t em s - w h ic h - s hou l d - n o t - be - ro u ti ne l y p rescr i be d - i n - p r i ma r y - c a re - g u id an ce - f o r - cc g s/

h t tp s : / / w w w . en g la nd . n h s. u k / pub l i c a t i on / c ond i ti on s - f o r - w h ic h - o v e r - t h e - c oun t e r - it em s s h ou l d - n ot - ro u t i n e l y - be - p rescr i be d - i n - p r i ma r y - c a re - g u id an c e - f o r - cc g s/

2. SCOPE OF THIS POLICY

2.1 The NHS St Helens Self-Care Policy has been aligned to national guidance and sets out St Helens Clinical Commissioning Group’s approach to ensure that prescribing of certain products in the following circumstances is stopped and to support prescribers in implementing this decision:• Medicines and treatments available to purchase over-the-counter, used

for the treatment of minor, short-term medical conditions.• Medicines and treatments where there is insufficient evidence of clinical

benefit or cost-effectiveness.• Medicines and treatments that are prescribed to treat conditions where

there is no clinical need for treatment.• Malaria prophylaxis

2.2 This policy will ensure equity of service for all residents of St Helens and will allow the same expectation of what will be provided from the GP Practice or other services.

2.3 This policy applies to all services contracted by or delivered by the NHSacross St Helens CCG including:• GP Practices – GPs and any other Prescribers• Out of hours and extended hours providers• Acute Hospitals• Out-Patient Clinics• NHS Community Providers• Independent providers• Community pharmacies

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2.4 This policy applies to all people (adults and children) who are registered with a GP in St Helens (permanent or temporary resident) or who access a NHS service in St Helens.

3. MEDICINES AVAILABLE OVER-THE-COUNTER, USED FOR SHORT-TERM, MINOR MEDICAL CONDITIONS

3.1 Most minor ailments are generally not serious and can often be managed by the individual. Products aimed at treating the symptoms of many of these ailments may not offer value for money and should not normally be prescribed at NHS expense.

3.2 Patients with short-term, minor ailments and common conditions will be directed to community pharmacies for advice, or other outlets such as supermarkets and local shops, to purchase over-the-counter treatments.

3.3 Community pharmacists have a wealth of experience and training, and are well placed to contribute to the management of minor ailments and common conditions. No appointments are needed and the community pharmacy is often open longer hours than the GP Practice and is also open at weekends. In addition to this, St Helens Clinical Commissioning Group commissions a Community Pharmacy Minor Ailments Service (Care at the Chemist - see Appendix 4).

3.4 Secondary Care will support self-care interventions and refer patients to the community pharmacy if appropriate, particularly where patients have presented inappropriately to A&E, the Urgent Care Centre or Out of Hours Services.

3.5 People will be encouraged to be responsible for their own health and well- being, by all healthcare professionals.

3.6 Patient information leaflets are available for certain conditions, either via sources such as NHS Choices or via the GP Practice prescribing system (EMIS Web), to ensure that people are made aware of warning signs or symptoms that would require them to see their GP.

4. MEDICINES WHERE THERE IS LIMITED EVIDENCE OF CLINICAL BENEFIT OR COST-EFFECTIVENESS

4.1 Some products that are currently prescribed in St Helens have no proven clinical efficacy or are not cost-effective. Many of the products in this category are not licensed drugs under the Medicines Act.

4.2 This means that they have not undergone the rigorous clinical trials as required by the regulatory authorities to confirm their safety, quality and efficacy.

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4.3There is no Summary of Product Characteristics (SPC) for prescribers to consult and therefore pose a risk to the prescriber when unlicensed products are prescribed.

4.4 Many of these products are classed as ‘food substitutes’ and are not covered by Advisory Committee on Borderline Substances (ACBS) regulations (GMS contract) and/or do not appear in the current British National Formulary (BNF) or the Drug Tariff.

4.5 They may not be manufactured to the same high pharmaceutical standards used for licensed medicines; hence there is no guarantee of consistency in formulation and potency.

4.6 It is inappropriate to direct NHS resources towards products that do not have proven efficacy or safety in preference to licensed medicines supported by robust clinical evidence.

4.7 Such judgements should be based purely on clinical factors and should not be influenced by socio-economic aspects such as the patient’s readiness and ability to purchase.

Example medications included in this section are:

4.1.1 Antioxidant supplements for age related macular degeneration.

4.1.2 Lactase enzyme drops (for colic)

4.1.3 Supplements for joints (e.g. glucosamine and chondroitin)

NB: NHS St Helens CCG already has guidance in place to prevent the prescribing of some of these products, (e.g. glucosamine supplements, antioxidant supplements for age related macular degeneration and lactase enzyme drops) and can be accessed via the Pan Mersey Area Prescribing Committee Formulary.

5. MEDICINES THAT ARE PRESCRIBED TO TREAT CONDITIONS WHERE THERE IS NO CLINICAL NEED FOR TREATMENT.

5.1 Conditions such as a common cold, sore throat or minor cough are ones that would naturally get better themselves in the majority of patients if untreated.

5.2 Products to help soothe such conditions (e.g. analgesics, cough mixtures, sore throat lozenges) will no longer be prescribed.

5.3 Such judgements should be based purely on clinical factors and supporting evidence and should not be influenced by socio-economic aspects such as the patient’s readiness and ability to purchase.

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6. MALARIA PROPHYLAXIS

6.1 The British National Formulary (BNF) states that medicines for malaria prophylaxis are not prescribable on the NHS.

6.2 The Department of Health issued guidance in February 1995 (FHSL (95)7) which is still current. This guidance states that private prescription forms should be used to prescribe drugs for malaria prophylaxis.

6.3 The NHS Standard General Medical Services Contract 2014 states that a GP may accept a fee for prescribing or providing drugs or medicines for malaria chemoprophylaxis.

6.4 Some medicines for the prevention of malaria are available for the patient to purchase over the counter at a community pharmacy. If this is the case a GP need not write a prescription. Prescription only medicines for malaria prophylaxis must be prescribed on a private prescription.

7. SELF-CARE PRESCRIBING REVIEWS

7.1 St Helens Clinical Commissioning Group has a duty to ensure that the local NHS budget is spent in an appropriate way.

7.2 The Governing Body is responsible for ensuring that all agreed actions are carried out by healthcare professionals according to this policy.

7.3 Implementation of the policy will be monitored via ePACT data and recorded within the CCG Financial Recovery Plan.

8.PRESCRIBING OF MEDICATION AVAILABLE VIA THE CARE AT THE CHEMIST SCHEME

On occasions when patients present at their surgery with a primary condition warranting a prescription (e.g. antibiotics), the associated prescribing of products for short term symptomatic relief (e.g. paracetamol) can be undertaken by the surgery.

In this instance paracetamol is not being used to treat a minor ailment and should not be available via Care at the Chemist.

Patients may however choose to buy these additional products instead of receiving them on prescription.

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Appendix 1: Examples of conditions where there are medicines that can be purchased over-the-counter (OTC) for the treatment of minor, short-term conditions and therefore should not normally be prescribed in those circumstances.**Note: the list and examples given below is not exhaustive.

1. When referring patients to buy OTC medicine, prescribers need to check if the medicine is licensed for the particular patient and the desired indication (please see appendix 2 for further information on indications). Requests for OTC medicines for unlicensed indications and patients will be refused by the community pharmacy. For example, if a patient has thrush, and they are under 16 or over 60 years old, they will not be able to access this medication over the counter. In this case, the medicine should be prescribed as appropriate.

2. The medicines shown below are usually prescribed for minor short-term health problems only and where this is not the case they will continue to be prescribed for example for chronic conditions e.g. analgesics for osteoarthritis (see examples of exceptional circumstances below).

3. Guidance on general exceptions is shown on page 14 of this policy.4. For further information please refer to the NHS guidance at

h t tp s : / / w w w . en g la nd . n h s. u k / pub l i c a t i on / c ond i ti on s - f o r - w h ic h - o v e r - t he c o un t e r - it ems - s h ou l d - no t - ro u t i ne l y - be - p rescr i be d - i n - p r i ma r y - c a re - g u id an c e f o r - cc g s/

Conditions Exceptions

Analgesics (pain killers) forminor aches and pains e.g. mild toothache

No routine exceptions for aches, sprains,headache, period pain, back pain but General exceptions apply

Topical pain relief Anti-inflammatory gels e.g. ibuprofen 5% gel –OTC exemptions include; pregnancy/breastfeeding - 12yrs/14yrs or more (depends on the brand)General exceptions also apply

Mild to moderate hay fever/seasonal rhinitis

• Oral antihistamines (for allergies such as hay fever)

• Steroid nasal sprays for allergies such as hay fever)

• Allergy eye drops (e.g. for hay fever)

• Antihistamine – drowsy e.g. chlorphenamine- OTC exemptions includepregnancy/breastfeeding – 1yr or more

• Antihistamine – non-drowsy e.g. cetirizine/loratadine - OTC exemptions include pregnancy/breastfeeding – cetirizine6yrs or more, Loratadine – 2yrs or more

• Steroid nasal spray e.g. beclometasone nasal spray, fluticasone nasal spray - OTC

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exemptions includepregnancy/breastfeeding – 18yrs or more.

• Sodium cromoglicate eye drops - OTC exemptions include caution in pregnancy – 6yrs or more.

General exceptions also applyDental products for example prevention of dental caries –please refer to Pan Mersey Area Prescribing Committee Guidance for Dental Prescribing in Primary Care

No routine exceptions but general exceptionsapply

Indigestion and Heartburn No routine exceptions but general exceptions apply

Mild dry skin treatment forexample emollients, bath additives and moisturising preparations

No routine exceptions but general exceptionsapply

Sore Throat products Red Flag symptoms (e.g. high temperature, more than 1-week duration)

Decongestant nasal sprays and tablets

Red Flag symptoms (e.g. very high temperature, chest pain, difficulty breathing, swollen glands, rapid unexplained weight loss)

Sunburn due to excessive sun exposure

No routine exceptions but general exceptions apply

Sun protection – unless adiagnosed photosensitive condition.

Exceptions for ACBS approved indication of photodermatoses plus general exceptions

Vaginal moisturisersWart and verrucae treatments No routine exceptions but general exceptions

apply

Topical circulatory products

Cosmetic moisturisers

Ear wax products No routine exceptions but general exceptions apply

Cough and cold treatments Red Flag symptoms (e.g. very hightemperature, chest pain, difficulty breathing, swollen glands, rapid unexplained weight loss, haemoptysis)

Antifungal treatments (e.g. for athletes foot, ringworm and vaginal thrush)

Exceptions for ringworm/athletes foot, lymphedema, or history of lower limb cellulitis plus general exceptions.Exceptions for vaginal thrush – can be treated for patients over 16 years of age and under 61

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years of age only if previously diagnosed by adoctor. See advice in appendix 2 regarding pregnancy and breast feeding.OTC exceptions – e.g. Amorolfine 5% nail lacquer (nail fungal infections) – 18yrs or more only. OTC exclusions include a maximum of 2 nails infected and not sold if pregnant or breastfeeding. Clotrimazole 1% cream (athlete’s foot/ringworm) – OTC exclusions include nail or scalp infections/can be used during pregnancy buy only under the supervision of a physician or midwife. Clotrimazole/Hydrocortisone cream (athlete’s foot for 10 years or more (see exclusions in appendix 2)

Oral thrush No routine exceptions but general exceptions apply.Daktarin OTC oral gel – not for patients on warfarin (unlicensed in under 4 month old children)

Medicated Shampoos for example to treat dandruff (mild scaling to scalp without itching)

No routine exceptions for dandruff but general exceptions apply

Antibacterial Eye Drops (e.g. totreat conjunctivitis although treatment isn’t usually needed for conjunctivitis as the symptoms usually clear within a week)

Red Flag symptoms (e.g. corneal symptoms in contact lens wearers, red, sticky eyes in newborn babies).

Chloramphenicol 0.5% eye drops or chloramphenicol 1% eye ointment bacterial conjunctivitis– OTC exemptions for 2yrs or more and bacterial conjunctivitis only). Patient needs to be seen by the pharmacist – OTC exclusions include pregnancy/breastfeeding.

Antiperspirants for excessivesweating (hyperhidrosis)

No routine exceptions but general exceptions apply

Haemorrhoids treatment Red Flag symptoms (persistent symptoms, pain or bleeding)

Head lice preparations Live head lice can be treated by wet combing; chemical treatment is only recommended in exceptional circumstances and in these cases OTC medicines can be purchased from a pharmacy – see NHS choices for furtherinformation.

Probiotics – limited clinicaleffectiveness

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Vitamins and minerals Exceptions;• all types of medically diagnosed vitamin

or mineral deficiency including for those patients who may have a lifelong condition or have undergone surgery that results in malabsorption – continuing need should be reviewed on a regular basis. This is in line with the current ACBS guidance for prescribers.

• Calcium and vitamin D for osteoporosis.• Malnutrition including alcoholism (see

NICE guidance)• Vitamin D analogues which are

prescription only.Please note that vitamin D maintenance therapy is not included as an exception.

Infrequent cold sores of the lip Exceptions for immunocompromised patientsand Red Flag symptoms (e.g. large and painful, lasting more than 10 days, pregnancy) in addition to general exceptions.

Cradle cap (seborrheicdermatitis – infants)

Exceptions if causing distress to the infant and not improving in addition to generalexceptions.

Infant Colic – please refer to Pan Mersey Black statement for Lactase Enzyme Drops (Colief®)

Exceptions Red Flag symptoms (e.g. weak cry, floppy, green vomit, not feeding) plus general exceptions.

Mild Cystitis Exceptions Red Flag symptoms (pregnant, male, child, prolonged severe symptoms, fever) plus general exceptions.

Mild Irritant Dermatitis OTC exemptions for steroid creams and ointments e.g. hydrocortisone 1%cream/ointment – OTC exclusions do not use on face, anogenital region, broken or infected skin, don’t use in pregnancy, duration of usenot more than 7 days – for 10 yrs. or more only.General exceptions apply

Acute diarrhoea treatment No routine exceptions for acute diarrhoea (adults) but general exceptions apply, fever blood in the stools, recent foreign travel.

Dry eyes/sore tired eyes No routine exceptions but general exceptions apply

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Infrequent constipation – pharmacists can help suggest on OTC laxative if diet and lifestyle changes aren’t helping. Most laxatives work within 3 days. They should be used for a short time only. Laxatives are not recommended in children unless prescribed by a GP.

No routine exceptions but general exceptionsapply

Infrequent migraine No routine exceptions but general exceptions apply

Insect stings and bites No routine exceptions but general exceptions apply

Mild acne No routine exceptions but general exceptions apply

Minor burns and scalds Exceptions for more serious burns always require professional medical attention. Burns requiring hospital A&E treatment include but are not limited to: all chemical and electrical burns, large or deep burns, burns that causewhite or charred skin, burns on the face, hands, arms, feet, legs or genitals that cause blisters – plus general exceptions.

Nappy rash – this conditionusually clears up after about three to seven days if recommended hygiene tips are followed.

No routine exceptions but general exceptions apply

Teething No routine exceptions for teething/mild toothache but general exceptions apply

Threadworms – follow strict hygiene measures

OTC exemptions e.g. mebendazole tablets/suspension – exclusions include pregnancy/breastfeeding – only sold for 2 years or moreGeneral exceptions apply

Travel sickness No routine exceptions but general exceptions apply

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General Exceptions to the Guidance:There are certain scenarios where patients should continue to have their treatments prescribed and these are outlined below:

• Patients prescribed an OTC treatment for a long-term condition (e.g. regular pain relief for chronic arthritis or treatments for inflammatory bowel disease).

• For the treatment of more complex forms of minor illnesses (e.g. severe migraines that are unresponsive to over the counter medicines).

• For those patients that have symptoms that suggest the condition is not minor (i.e. those with red flag symptoms for example indigestion with very bad pain.)

• Treatment for complex patients (e.g. immunosuppressed patients).

• Patients prescribed OTC products to treat an adverse effector symptom of a more complex illness and/or prescription only medications should continue to have these products pre- scribed on the NHS.

• Circumstances where the product licence doesn’t allow the product to be sold over the counter to certain groups of patients. This may vary by medicine, but could include babies, children and/or women who are pregnant or breast-feeding. Community Pharmacists will be aware of what these are and can advise accordingly.

• Patients with a minor condition suitable for self-care that has not responded sufficiently to treatment with an OTC product.

• Patients where the clinician considers that the presenting symptom is due to a condition that would not be considered a minor condition.

• Circumstances where the prescriber believes that in their clinical judgement, exceptional circumstances exist that warrant deviation from the recommendation to self-care.

• Individual patients where the clinician considers that their ability to self-manage is compromised as a consequence of medical, mental health or significant social vulnerability to the extent that their health and/or wellbeing could be adversely affected, if reliant on self-care. To note that being exempt from paying a prescription charge does not automatically warrant an exception to the guidance. Consideration should also be given to safeguarding issues.

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Appendix 2: Restrictions to supply of some OTC medicines by Community Pharmacies

When referring patients to buy OTC medicine, check it is licensed for the particular patient and the desired indication. Requests forOTC medicines for unlicensed indications and patients will be refused by the community pharmacy.

RestrictedMedicine Common Examples OTC Indication(s) Note: may vary by brand Common OTC Exclusions Age allowing

OTC Supply

Antihistamine –Drowsy

Chlorphenamine Allergic conditions including hay fever, vasomotor rhinitis, urticaria, reactions to food or medicines, serum reactions and insect bites

Pregnancy and/or breastfeeding 1yr or more

Antihistamine - Non-drowsy

Cetirizine, loratadine Symptomatic treatment of hay fever and other allergies, urticarial

Pregnancy and/or breastfeeding Cetirizine – 6 yrs. or moreLoratadine - 2yrs ormore

Steroid nasal spray

Beclometasone nasal spray, fluticasone nasal spray

Prevention and treatment of allergic rhinitis, including hay fever

Pregnancy and/or breastfeeding 18yrs or more

Steroid creams and Ointments

Hydrocortisone 1%cream/ointment

Treatment of allergic contact dermatitis, irritant dermatitis, insect bite reactions and mild to moderate eczema

Use on the face, anogenital region, broken or infected skin.Duration of use > 1week. Pregnancy.

10yrs or more

Pain relief cream/ointment for short-term use

Antiinflammatory gels

Ibuprofen 5% gel Topical analgesic and anti-inflammatory Pregnancy and/or breastfeeding 12yrs/14yrs or more(depends on brand)

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[Type text]

Antibacterial eye drops

Eye drops/ointments

Chloramphenicol 0.5% eye drops,chloramphenicol 1%Ointment

Treatment of acute bacterial conjunctivitis

Patient needs to be seen by the pharmacist – face to face.

Indications other than bacterial conjunctivitisPregnancy and/or breastfeeding

2yrs or more

Sodium cromoglicate eye drops

Relief and treatment of the eye symptoms of hay fever Caution in pregnancy 6yrs or more

Treatments for fungal infections including athletes’ foot, fungal nail infections and vaginal thrush

TopicalAntifungals

Amorolfine 5% nail lacquer Fungal infections of the nails affecting the upper half or sides of the nails in up to 2 nails

Maximum 2 nails affected Pregnancy/breastfeeding 18yrs or more

Clotrimazole 1% cream Treatment of fungal infections including athlete’s foot,fungal sweat rash, ringworm, candidal nappy rash, vulvitis

Nail or scalp infectionsCan be used during pregnancy, but only under the supervision of a physician or midwife

-Clotrimazole 500mg pessary Vaginal thrush (Candidal vaginitis) only if previously

diagnosed by a doctorCan be used during pregnancy, but only under the supervision of a physician or midwife (insert without the applicator) Seekadvice if breast feeding

Over 16 and under61 years old

Clotrimazole cream 2% Adjunct to treatment of vaginal thrush (candidal vaginitis)only if previously diagnosed by a doctor, Candidal vulvitis

Can be used during pregnancy, but only under the supervision of a physician or midwife Seek advice if breast feeding

Over 16 and under61 years old

Clotrimazole 10%intravaginal cream

Vaginal thrush (Candidal vaginitis) only if previously diagnosed by a doctor

Pregnancy (use alternative product that does not use an applicator)Seek advice if breast feeding

Over 16 and under61 years old

Clotrimazole /hydrocortisone cream

Athlete's foot, Fungal sweat rash (Candidal intertrigo) Use on the face, eyes, mouth mucous membranes, anogenital area, broken or infected skin.Duration of use > 1wk Pregnancy and/orbreastfeeding under the supervision of a physician or midwife

10yrs or more

OralAntifungal

Fluconazole 150mg capsule Vaginal thrush (Candidal vaginitis) only if previously diagnosed by a doctor

Pregnancy and/or breastfeeding Over 16 and under61 years old

Treatments for threadworms

Threadworms Mebendazole tablets/suspension

Treatment of threadworms (pinworms) Pregnancy and/or breastfeeding 2yrs or more

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Appendix 3 Care at the Chemist Minor Ailments Service

Indication Treatment Notes

Acute bacterial conjunctivitis Chloramphenicol 0.5% eye drops (10ml) For ages 2 years and over.

Chloramphenicol 1% eye oint. (4g) For ages 2 years and over.

Allergy Loratadine 10mg tablets (30) For ages 12 years and over.

Sodium cromoglycate 2% eye drops (10ml) For adults and children 2 years and over.

Beclometasone 50mcg/metered dose nasal spray(100 dose)

For ages 18 years and over.

Loratadine 5mg/5ml syrup (100ml) For ages 2 years and over.

Chlorphenamine tabs 4 mg (28) For ages 12 years and over.

Chlorphenamine syrup 2mg/5ml (150ml) For ages 2 year and over.

Hydrocortisone cream 1% (15g) For ages 10 years and over.

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Indication Treatment Notes

Athletes footClotrimazole 1% cream ( 20g) For ages 1 year and above

Cough Simple linctus paediatric sugar free (200ml) For ages 1 to 12 years.

Simple linctus sugar free (200ml) For ages 12 years and over.

Pholcodine linctus sugar free (200ml) For ages 12 years and over.

Cold sores Aciclovir 5% cream (2g) For ages 1 year and over.Should not be recommended if the blisters are already present.

Constipation Ispaghula husk 3.5g sachets (10) For ages 12 years and over.

Lactulose liquid (500ml) For ages 1 to 12 years

Senna 7.5mg tablets (20) For ages 12 years and over.

Contact Dermatitis Hydrocortisone 1% cream (15g) For ages 10 years and over.

Cystitis Potassium Citrate mixture (200ml) For females aged 16 -70 years.

Diarrhoea Dioralyte relief (6 sachets) For ages 1 year and over

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Indication Treatment Notes

Loperamide 2mg caps (6) For ages 12 years and over.

Ear Wax Olive Oil (10ml) For ages 12 years and over

Haemorrhoids Anusol oint (23g) For ages 12 years and over.

Anusol suppositories (12) For ages 12 years and over.

Paracetamol 500mg tablets (32) For ages 12 years and over.

Headache , pain and temperature

Paracetamol 120mg/5ml susp. sugar free 100ml For use in line with OTC product licence

Paracetamol 250mg/5ml susp. sugar free 100ml For use in line with OTC product licence

Ibuprofen 200mg tablets (24) For ages 12 years and over.

Ibuprofen 100mg/5ml susp. sugar free 100ml For use in line with OTC product licence

Give special consideration to the signs and symptomsof meningitis.

Head lice Malathion 0.5% aqueous liquid- Derbac M (2 x 50ml)

For ages 1 year and over.

Dimeticone 4% lotion- Hedrin (2 x 50ml) For ages 1 year and over.

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Indication Treatment Notes

Supply two applications.

Indigestion and heartburn Acidex advance (250ml) For ages 12 years and over.

Gaviscon advance (150ml) For ages 12 years and over.

Ranitidine 75mg (12) For ages 16 years and over.

Mucogel suspension (500ml) For ages 12 years and over.

Infant Colic Simeticone 40mg/ml Oral Suspension SF (50ml) For use from birth onwards

The most useful intervention is advice and support for parents, and reassurance that infantile colic will resolve. Only consider trying medical treatment if parents feel unable to cope despite advice and reassurance.

Mouth ulcers Anbesol liquid (6.5ml) For ages 1 year and over.

Give special consideration to the signs and symptomsof oral cancer.

Nappy Rash Zinc and Castor Oil Ointment BP (100g) Contains peanut oilFor use from birth onwards

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Indication Treatment Notes

Metanium Nappy Rash Ointment (30g) For use from birth onwards

Nasal congestion Menthol and eucalyptus inhalation BP (100ml) For ages 6 years and over. Caution in children.

Sodium chloride 0.9% nasal drops (10ml) For ages 1 year and over.

Pseudoephedrine 60mg tablets (12) For ages 12 years and over.

Pseudoephedrine 30mg/5ml elixir (100ml) For ages 6 years to 12 years.

Oral thrush Miconazole 20mg/g oral gel (15g) For ages 4 months and over.

Sore Throats Paracetamol 500mg tablets (32) For ages 12 years and over.

Paracetamol 120mg/5ml susp sugar free 100ml For ages 1 year to 6 years.

Paracetamol 250mg/5ml susp sugar free 100ml For ages 6 year to 12 years.

Ibuprofen 200mg tablets (24) For ages 12 years and over.

Ibuprofen 100mg/5ml susp. sugar free 100ml For ages 1 year to 12 years.

Teething Anbesol liquid (6.5ml) For ages 2 months and over

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Indication Treatment Notes

Threadworm Mebendazole 100mg chewable tablets (2) For ages 2 years and over.

Genital thrush Canesten Combi (op) For ages 16 year to 60 years.

Clotrimazole 1% cream 20g For ages 16 year to 60 years.

Fluconazole 150mg capsule (1) For ages 16 year to 60 years.

Warts and verrucae Salactol wart paint 10ml For ages 1 year and over.

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Appendix 4: Non-prescription (over the counter (OTC)) medications in nurseries and schools

December 2017

Non-prescription (over the counter (OTC)) medications in nurseries and schools

The relevant Department of Education guidelines supporting this are detailed below:

Nurseries

The Statutory Framework for the Early Years Foundation Stage1 governs the standards of institutions looking after and educating children from birth to 5 years

Section 3.45 and Section 3.46 relate to medications and state the following:

“3.45. Prescription medicines must not be administered unless they have been prescribed for a child by a doctor, dentist, nurse or pharmacist (medicines containing aspirin should only be given if prescribed by a doctor).”

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GPs in St Helens will no longer accept requests for prescriptions for non-prescription (over the counter (OTC)) medicines solely for the purposes of allowing administration within a nursery or school setting.

The MHRA licenses all medications and classifies them as over-the counter when it considers them safe and appropriate to be used without prescription.

Medicine purchased OTC to treat minor self-limiting conditions contain dosage instructions and patient information leaflets with information relating to the medicine.

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“3.46. Medicine (both prescription and non-prescription) must only be administered to a child where written permission for that particular medicine has been obtained from the child’s parent and/or carer. Providers must keep a written record each time a medicine is administered to a child, and inform the child’s parents and/or carers on the same day, or as soon as reasonably practicable.”

There is a clear distinction made between prescription and non-prescription medications. Therefore a non-prescription (over the counter) medication can be administered by a member of staff in a nursery or school as long as written permission has been obtained from a child’s parent or carer and a written record of administration is kept.

A prescription is only necessary for administration of a prescription only medication.

Schools

Department of Education guidance for governing bodies of maintained schools & proprietors of academies in England “Supporting Pupils at School with Medical Conditions - December 2015”2states

“Wherever possible, children should be allowed to carry their own medicines and relevant devices or should be able to access their medicines for self-medication quickly and easily. Children who can take their medicines themselves or manage procedures may require an appropriate level of supervision. If it is not appropriate for a child to self-manage, relevant staff should help to administer medicines and manage procedures for them.”

Children should therefore be allowed to self-medicate where appropriate

“No child under 16 should be given prescription or non-prescription medicines without their parent’s written consent – except in exceptional circumstances where the medicine has been prescribed to the child without the knowledge of the parents. In such cases, every effort should be made to encourage the child or young person to involve their parents while respecting their right to confidentiality. Schools should set out the circumstances in which non-prescription medicines may be administered”

“A child under 16 should never be given medicine containing aspirin unless prescribed by a doctor. Medication, e.g. for pain relief, should never be administered without first checking maximum dosages and when the previous dose was taken. Parents should be informed”

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This makes clear that non-prescription medicines can be administered with written permission from the child’s parent. There is no requirement for a prescriber to provide consent for the administration of a non-prescription medication.

Schools should only accept prescribed medicines if these are in-date, labelled, provided in the original container as dispensed by a pharmacist and include instructions for administration, dosage and storage. The exception to this is insulin, which must still be in date, but will generally be available to schools inside an insulin pen or a pump, rather than in its original container

This makes clear that the requirements for labelling of medications with instructions for administration only applies to prescribed medications.

Department for Education. Statutory framework for the early years foundation stage. Effective 3rd April 2017.https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/596629/EYFS_STATUTORY_FRAMEWORK_2017.pdf

2Department for Education Supporting pupils at school with medical conditions. December 2015. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/638267/supporting-pupils-at-school-with-medical-conditions.pdf

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Appendix 5: References/resources and associated documents

• Self-care for minor ailments. T8 January 2015 V 2.0. PrescQIPP. Available at; h t tp s : / / w w w . p resc q ip p .i n f o /res o u rces/s e nd / 1 4 1 - s e l f - c a re - w eb kit/ 17 4 8 - t 8 - s e l f c a r e - f o r - m in o r - a i lm en ts

• Putting the self into self-care. Annual review 2014. Proprietary Association of GreatBritain. Available at: h t tp : / / w w w . pa g b .c o . u k / pub l i c a ti o n s/ pd f s / an nu a l r e v i e w 2014 . pd f . Ac c e ss e d 30 t h M a rch 2 0 1 6

• The NHS Plan. A plan for investment. A plan for reform. July 2000. Department of Health. Accessed 31st March 2016 - available at: h t tp : / / w eba rchi v e . na ti o na larchi v e s. g o v . u k/+/ h t tp : / / w w w . dh . g o v . u k/ en / Pub l i c a t i o n s and s t a tistics/ P ub l i c a t i on s/ P ub l i c a ti o n sP o l i c y A nd G u id a n c e /DH_ 4 0 0 29 6 0

• Putting patients first – The NHS business plan 2014/15-2016/17. NHS England.Accessed 31st March 2016 - available at: h t t p s: / /ww w . en g la nd . nh s . u k/ w p - c on t e n t / up lo a d s/ 2 0 1 5 / 11 / n h s e - b u s - p la n - 1 4 1 5 1 6 17 . pd f

• Five Year Forward View. NHS England. October 2014. Accessed 22nd

April 2016 - available at: h t tp s : / / w w w . en g la nd . n h s. u k/ w p c on t en t / up l o a d s/ 2 0 14 / 10 / 5 y f v - w eb . pd f

• Joint Formulary Committee, September 2016 (70). British National Formulary(BNF). London: Pharmaceutical Press.

• NHS England, the NHS Standard General Medical Services Contract 2014.Gateway reference: 01538

• NHS Executive. FHSL (95) 7. Malaria Prophylaxis: Regulation permitting GPs to charge for prescribing or providing anti-malarial drugs. February 1995.

• NHS England Guidance, Items which should not be routinely prescribed in primary care, Dec 2017. h t tp s : / /ww w . en g la nd . nh s. u k/ pub l i c a ti o n /it e m s - w h ic h s h o u l d - not - b e - ro u ti ne l y - p rescr i be d - i n - p r i ma r y - c a r e - g u id an c e - f o r - cc g s/

• NHS England Guidance on conditions for which over the counter items should not routinely be prescribed in primary care, March 2018. h t tp s : / / w w w . en g la nd . n h s. u k / pub l i c a t i on / c ond i ti on s - f o r - w h ic h - o v e r - t h e - c oun t e r it em s - s hou l d - n ot - ro u ti n e l y - be - p rescr ibe d - i n - p r im a r y - c a re - g u id an c e - f o r - cc g s/

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Appendix 6: NHS letter 31/01/2019.

To: Directors of Commissioning Regional heads of Primary Care Heads of Primary CareCCG Clinical Leads and Accountable Officers

31st January 2019Publications clearance: 00095

Dear colleagues

C ondi t ion s f o r w hi c h o ve r t h e c oun t e r i t e m s s houl d no t r ou t in e l y b e p r e sc r ib e d in pr imar y car e

Between December 2017 and February 2018 NHS England consulted on

proposals to restrict routine prescribing in primary care of items which are available

over the counter (OTC) for the treatment of conditions which are self-limiting or

which lend themselves to self-care. The consultation led to the publication of

guidance for CCGs on the treatment of conditions for which OTC items should no

longer be routinely prescribed: h tt p s :// www . eng l and . nh s . u k / p ub l i c a t i o n / c on d i t i o n s -

f o r - w h i c h - o v e r - t h e - c oun t e r - i t e ms - s hou l d - no t -r o u t i n e l y - be - p r e sc r i be d - in - p r i m a r y -

c a r e - gu i dan c e -

for -cc gs /

NHS England expects CCGs to have regard to this guidance in taking local prescribing decisions. However, we understand that GP practices are unclear about whether they should follow this guidance, and some practices have raised concerns about whether they would be in breach of the terms of their contract if they follow it.

Regulation 94 of The National Health Service (General Medical Services Contracts) Regulations 2015 and Regulation 86 of The National Health Service (Personal Medical Services Agreements) Regulations 2015 and Paragraph 7 (v)

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Appendix 6: NHS letter 31/01/2019.

of The Alternative Provider Medical Services Directions 2016 state that contractors must

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have regard to all relevant guidance issued by NHS England. These Regulations do not state that the guidance needs to be directed to GP practices, but simply be relevant.

The OTC guidance includes specific reference to prescribers, and requires prescribers to reflect local policies in prescribing practice. In NHS England’s view, this guidance is “relevant guidance” under Regulation 94 and other relevant regulatory references. Contractors are therefore required to have regard to this guidance and are able to follow the guidance and exercise judgement about when it

is (and is not) appropriate to prescribe OTC items, without any risk that they will be in breach of their contract.

GPs are also able to inform patients they must have regard to this guidance when communicating any decision not to prescribe an OTC item for treatment of one of the conditions identified.

Implementation resources, including a patient leaflet and a GP handout, are

available to GP practices and can be accessed at:

h tt p s :// www . eng l and . nh s . u k / m ed i c i n e s / c ond i t i on s - f o r-w h i c h - o v e r - t h e - c oun t e r - i t e ms -

s hou l d - no t -r o u t i ne l y - be - p r e sc r i be d / c ond i t i o n s - f o r- w h i c h - o v e r - t h e - c o u n t e r - i t e m s -

s hould-not-routinely-be- presc ribed- in-pr im ary- c are- im plem ent ati on- res o urc es /

Yours sincerely,

Professor Stephen Powis National Medical Director NHS England

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Appendix 7: Implementation Resources, FAQ

People Living in Care Homes – Frequently Asked Questions

These frequently asked questions have been developed to support Clinical Commissioning Groups (CCGs) to implement the NHS England guidance for people living in care homes.

Why has the CCG guidance been developed?

In the year up to June 2017, the NHS spent approximately £569 million on prescriptions for medicines which could otherwise be purchased over the counter (OTC) from a pharmacy and/or other outlets such as petrol stations or supermarkets, sometimes at a lower cost than that which would be incurred by the NHS.

These prescriptions include items for a minor condition:

That is considered to be self-limiting and so does not need treatment as it will heal or be cured of its own accord (although a patient a may still want to obtain symptomatic relief with an over the counter (OTC) medicine until the condition has resolved);

Which lends itself to self-care, i.e. that the person suffering does not normally need to seek medical advice but may decide to seek help from a local pharmacy for symptom relief and use an OTC medicine.

Or items:

For which there is limited evidence of clinical effectiveness.

By reducing spend on treating minor conditions that are self-limiting or which lend themselves to self-care, these resources can be used for other higher priority areas that have a greater impact for patients, support improvements in services and help deliver the long-term sustainability of the NHS.

Therefore, the guidance was developed to direct CCGs when formulating their local polices, and for prescribers to reflect local policies in their prescribing practice.

Where can I find more information about the use of OTC medicines in care homes?

The National Institute for Health and Care Excellence (NICE) published Managing medicines in care homes which advises on processes for prescribing, handling and administering medicines in care homes. It also recommends how care and services relating to medicines should be provided to people living in care homes including advice on provision of OTC medicines for care home residents. Recommendation 1.16 details a homely remedies process which should be considered when treating care home residents for minor ailments.

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The Care Quality Commission (CQC) also published Treating minor ailments and promoting self-care in adult social care which explains homely remedies and provides information on supporting residents in care homes to self-care where appropriate. It also covers how the administration of the OTC medicines to residents should be documented.

The implementation of the CCG guidance has been identified as a priority for the Regional Medicines Optimisation Committees (RMOCs). RMOCs are committees within England that make recommendations, pursue actions, and co-ordinate activities related to any aspect of Medicines Optimisation (MO). There are four committees, one for each NHS England region; however they produce national recommendations and resources to support and guide Area Prescribing Committees (APCs) and CCGs on a range of MO topic areas. In August 2018 the Midlands & East RMOC reviewed issues pertaining to homely remedies in care homes. The RMOC programme has now issued guidance on this subject, which includes a template policy which can be adapted for local use.

Should prescriptions for items that can be purchased over the counter be stopped for care home residents?

Stopping prescribing for the conditions in the CCG guidance should be considered for care home residents on an individual basis. The CCG guidance has identified certain scenarios where patients should continue to have their treatments prescribed (general exceptions) and these are outlined below:

Patients prescribed an OTC treatment for a long term condition (e.g. regular pain relief for chronic arthritis or treatments for inflammatory bowel disease).

For the treatment of more complex forms of minor illnesses (e.g. severe migraines that are unresponsive to over the counter medicines).

For those patients that have symptoms that suggest the condition is not minor (i.e. those with red flag symptoms for example indigestion with very bad pain.)

Treatment for complex patients (e.g. immunosuppressed patients). Patients on prescription only treatments. Patients prescribed OTC products to treat an adverse effect or symptom of a more

complex illness and/or prescription only medications should continue to have these products prescribed on the NHS.

Circumstances where the product licence doesn’t allow the product to be sold over the counter to certain groups of patients. This may vary by medicine, but could include babies, children and/or women who are pregnant or breast-feeding. Community Pharmacists will be aware of what these are and can advise accordingly.

Patients with a minor condition suitable for self-care that has not responded sufficiently to treatment with an OTC product.

Patients where the clinician considers that the presenting symptom is due to a condition that would not be considered a minor condition.

Circumstances where the prescriber believes that in their clinical judgement, exceptional circumstances exist that warrant deviation from the recommendation to self-care.

Individual patients where the clinician considers that their ability to self-manage is compromised as a consequence of medical, mental health or significant social vulnerability to the extent that their health and/or wellbeing could be adversely

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affected, if reliant on self-care. To note that being exempt from paying a prescription charge does not automatically warrant an exception to the guidance. Consideration should also be given to safeguarding issues.

Where can I find out more about management of self-limiting conditions and self-care?

A wide range of information is available to the public on the subjects of health promotion and the management of minor self- treatable illnesses. Advice from organisations such as the Self Care Forum and NHS Choices is readily available on the internet. Many community pharmacies are also open extended hours including weekends and are ideally placed to offer advice on the management of minor ailments and lifestyle interventions. The Royal Pharmaceutical Society offers advice on over the counter products that should be kept in a medicine cabinet at home to help patients treat a range of self-treatable illnesses.

If a GP does not prescribe would they be in breach of the terms of their contract?

The GP contracts state that GP practices must have due regard to relevant guidance issued by NHS England. The CCG guidance includes specific reference to prescribers, and requires prescribers to reflect local policies in prescribing practice. GP practices are therefore able to follow the CCG guidance and exercise judgement about when it is (and is not) appropriate to prescribe OTC items, without any risk that they will be in breach of their contract. It does not remove the clinical discretion of the prescriber, in accordance with their professional duties. GPs are also able to inform patients they must have due regard for the CCG guidance when communicating any decision not to prescribe an OTC item for treatment of one of the conditions identified.

The intention of the CCG guidance is to produce a consistent, national framework for CCGs to use, while taking account of local circumstances and their own impact assessment and legal duties to advance equality and have regard to reduce health inequalities.

Who is clinically accountable for the treatment of the person?

If the resident is able to self-care then they are clinically accountable as is the case for people living in their own home. However, if the condition is not responding to treatment or the condition is getting worse then a referral to the GP or pharmacist is required. If a GP or pharmacist is prescribing a medication then they would be clinically accountable.

Who should be making the assessment of the individual as to whether they are able to self-care?

It is up to the individual care home; some care homes will already have infrastructure in place to do those assessments. The care home may seek advice from a GP or pharmacist should they have concerns or need further advice. We encourage that residents and their families should be involved in decisions about self-medication and what medicines they take.

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How does the CCG guidance relate to people in care homes that cannot self-care as they may lack capacity?

People who are not able to self-care fall under the general exceptions in the CCG guidance (see Question 4). The ability to self-care should be assessed by a healthcare professional on an individual basis.

What about residents who have learning disabilities?

An assessment would need to take place to determine whether a resident has the ability to self-care and they should be supported to do so. If they do lack capacity then a best interest’s judgement can be made by consulting with their family or GP about what to do. The general exceptions in the CCG guidance may apply in some circumstances.

An Easy Read ‘over the counter’ leaflet has also been developed to support conversations with people with learning disabilities.

How does the care home demonstrate they have taken the appropriate advice from a healthcare professional?

All medicines taken by a resident including those they self-administer should be documented by the care home.  In cases where care homes have received advice from a health professional (e.g. GP or pharmacist) they should document the advice in the resident’s care plan or similar document.

What is the role of the pharmacist in supporting care home residents with OTC medicines?

Local pharmacies provide NHS services in the same way as GP practices. Pharmacists and pharmacy staff are trained to identify red flags for OTC medicine and assure that all medicines being prescribed are patient-appropriate. If care homes are struggling with the CCG guidance, pharmacists will be there to advise them, in a medicine advisory and optimisation capacity.

What is being done nationally with care homes which have policies in place which may prevent their residents buying their own OTC medicines?

NHS England’s Medicines Optimisation in Care Homes (MOCH) programme works closely with care homes and pharmacy teams. There is ongoing work to reduce the variation in implementing the CCG guidance across all care homes.

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Appendix 8: LMC Letter to Head Teacher’s

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Appendix 9 Patient Letter

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Dear Sir /Madam,

Treatments and medicines for short-term minor conditions/ ailments or where there is insufficient evidence of clinical benefit or cost effectiveness

NHS St Helens Clinical Commissioning Group has recently issued updated guidance to GPs regarding self-care prescribing in St Helens. It advises that patients buy medication for short-term minor conditions/ailments or where there is insufficient evidence of clinical benefit or cost effectiveness themselves, rather than being prescribed by their GP. This is in line with national guidance released in December 2017 and March 2018 by NHS England.The Clinical Commissioning Group has directed GPs to stop prescribing these treatments and medicines. Patients will be expected to buy the treatments and medicines themselves over-the-counter at a local pharmacy (or supermarket).

Your prescription for ………………………… has been reviewed and your doctor now feels that it is appropriate to stop prescribing this (amend as appropriate)

………………………………………………… is available to buy over-the-counter at your local pharmacy (or supermarket) (amend as appropriate).

If you would like to discuss this further or you have any concerns please contact the Clinical Commissioning Group’s Patient Advice and Liaison Service (PALS) Tel: 0800 218 2333.

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Acknowledgements:

Wirral Health & Care Commissioning

MLCSU Medicines Management and Optimisation Team – West Cheshire CCG

Medicines Management Team, Midlands and Lancashire Commissioning Support Unit (Warrington) Communications Team, Warrington Clinical Commissioning Group

Medicines Management Team, Heywood, Middleton and Rochdale ClinicalCommissioning Group.

Hayley Venables, MLCSU Medicines Management Administrator.

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