Meeting: Governing Body (Meeting in Public)

Meeting Date 22 May 2019 Action Approve Item No. 6 Confidential No Title Over the Counter for minor short term conditions Presented By Howard Hughes, Clinical Board Member Author Salina Callighan, Head of Medicines Optimisation Clinical Lead Nigget Saleem, Clinical Cabinet Lead-Medicines Optimisation

Executive Summary In March 2018, NHS England issued guidance to CCGs: ‘Conditions for which over the counter items should not routinely be prescribed in primary care’.

In December 2018 the Greater Manchester Medicines Management Group (GMMMG) Clinical Standards Board (CSB) approved a GM commissioning statement (appendix 1) to promote consistent adoption and implementation of the NHS England guidance across Greater Manchester.

In February 2019, the Clinical Cabinet:  Considered the GM commissioning statement and approved the adoption of the GM position which would supersede the local Prescribing for Clinical Need policy.  Approved a local engagement process.

A four week engagement period in relation to conditions for which over the counter items should not routinely be prescribed ran from Friday 15th March until Friday 12th April 2019. This paper summarises the findings of the feedback report ‘Engagement: Conditions for which over the counter items should not routinely be prescribed’ and makes recommendations to the Governing Body, for the full report see appendix 2.

Recommendations It is recommended that the Governing Body:  Consider the local engagement feedback report.  Support Clinical Cabinet’s decision to align Bury’s current Prescribing for Clinical Need policy with the GM commissioning statement and commitment to support local clinicians to implement this policy.

Links to CCG Strategic Objectives To encourage people so that they want to, and do, take responsibility for their own health and well-being. ☒ To drive and support system wide transformation. ☐ To commission joined-up health and social care for people in Bury through a ☐ Single Commissioning Framework.

To achieve financial sustainability for the Bury health and social care economy. ☒ To support the Locality Care Alliance to deliver high quality services in line with ☐ commissioner intentions. To be a high-performing, well-run and respected organisation with an empowered ☐ workforce Does this report seek to address any of the risks included on the Governing Body

Assurance Framework? If yes, state which risk below:

GBAF [Insert Risk Number and Detail Here]

Implications Are there any quality, safeguarding or Yes ☒ No ☐ N/A ☐ patient experience implications? Patients may be reluctant to self-care. It is a longer term strategic objective to change patients’ hearts and minds. Safeguarding and patient experience will be considered following the engagement. Has any engagement (clinical, stakeholder or public/patient) been undertaken in Yes ☒ No ☐ N/A ☐ relation to this report? A four week engagement period ran from Friday 15th March until Friday 12th April 2019. Have any departments/organisations who Yes ☒ No ☐ N/A ☐ will be affected been consulted? Clinical leads (Clinical Director and Clinical Cabinet Lead-Medicines Optimisation). Communications and Engagement Lead. Please note this proposal reflects a policy already in place in Bury since 2015. Are there any conflicts of interest arising from the proposal or decision being Yes ☐ No ☒ N/A ☐ requested? Are there any financial Implications? Yes ☒ No ☐ N/A ☐ Has an Equality, Privacy or Quality Impact Yes ☒ No ☐ N/A ☐ Assessment been completed? Is an Equality, Privacy or Quality Impact Yes ☐ No ☐ N/A ☒ Assessment required? Are there any associated risks including Yes ☒ No ☐ N/A ☐ Conflicts of Interest? Potentially, reputational risk if Bury does not align with the GM position and retains a slightly different policy and exceptions. Are the risks on the CCG’s risk register? Yes ☐ No ☐ N/A ☒

Governance and Reporting Meeting Date Outcome Clinical 06/02/2019 DC/03/06/02/19: Supported the GM commissioning statement in Appendix 1. Cabinet DC/04/06/02/19: Approved that a local engagement process be undertaken and the use of common implementation tools and communication materials. Over the Counter Medications for minor short term conditions

1. Introduction and Background

1.1 On 29th March 2018, NHS England (NHSE) issued guidance to CCGs describing 2 drug groups of limited clinical value and 35 conditions which are considered to be self-limiting and therefore suitable for patient self-care. Key themes are:  encouraging self-care;  stopping prescribing of drugs of limited clinical effectiveness and;  where drugs are available over the counter (OTC) for the treatment of minor conditions, these should not routinely be prescribed. The guidance is condition–based i.e. it is treatment of the conditions listed which may be suitable for self-care.

1.2 In August 2018 the Greater Manchester Medicines Management Group (GMMMG) Clinical Standards Board (CSB) approved a proposal that CCGs implement the NHSE guidance. CCG Medicines Optimisation leads expressed a desire for a GM approach and subsequently a ‘commissioning statement’ (similar to an Effective Use of Resources commissioning statement) was drawn up and approved at the December 2018 CSB. “For equity of patient experience, this is strongly recommended to be adopted across all GM CCGs, with an intention to engage CCG Communications and Engagement Leads and those at the Health and Social Care Partnership in the delivery of a GM-wide approach to implementation”.

1.3 NHS Bury CCG introduced the Medicines Optimisation Prescribing for Clinical Need policy in September 2015, which was actively implemented during 2016. This policy differs marginally from the GM commissioning statement in the following areas:

Conditions included in the Bury policy Scabies; vaginal thrush but not included in the GM statement

Conditions included in the GM Haemorrhoids; mild cystitis; contact statement but not in the Bury policy dermatitis; hyperhidrosis; infrequent constipation; infrequent migraine; minor burns and scalds; oral thrush; ringworm; travel sickness; fungal nail infection

The GM statement also includes ‘exclusion criteria’ (in line with the NHSE guidance) which will require further definition. The Bury policy does not include exclusions other than those related to the OTC licensing restrictions of certain products.

1.4 A period of engagement ran from Friday 15th March until Friday 12th April 2019, to gather views on the proposed changes i.e. where the commissioning statement differs from our existing Prescribing for Clinical Need policy.

2. Summary of the Feedback report. Engagement: Conditions for which over the counter items should not routinely be prescribed

2.1 Summary of feedback:

 There were 262 responses to the survey, from patients and health professionals.  There was a good amount of support for the approach (current local policy and the current proposal, though feedback that the current policy isn’t consistently applied) to ensure that NHS monies are only spent on medicines that are safe, clinically effective and provide a clear health benefit, to free up resources to be spent elsewhere to improve health in Bury.  Despite not being included in new guidance and some concerns including affordability and the about the risk of scabies spreading, the majority of respondents agreed with the intention to retain scabies and vaginal thrush in our local policy as conditions for which over the counter items should not routinely be prescribed.  In relation to the 11 conditions included in the new guidance that are not currently included in our local policy, there was support for this change to the local policy, however, there were concerns about affordability, eligibility, self-diagnosis/mis-diagnosis and potential complications if conditions aren’t treated appropriately.  There was also concern that vulnerable individuals, people on a low income (affordability), children and those living with a long term condition may be disadvantaged by the approach.

2.2 Through the engagement approach, we tried to provide assurance that whilst our local policy includes a wide range of conditions for which over the counter items for minor conditions are not routinely prescribed by Bury GPs, if it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician.

2.3 Feedback included “Information and education would be needed to support people to make a decision on when to self-care and when to make an appointment”. CCG will utilise the implementation tools and communications materials developed for GM to support consistency of message to patients and other stakeholders.

2.4 There was a suggestion for the changes to made on a trial basis to assess the impact before full roll out. With this approach Bury would not support a GM wide position. This may negatively affect patient experience, adherence to the policy and ability to positively promote self-care.

2.5 A suggestion to re-evaluate the minor ailment scheme was made. Bury commissions a Greater Manchester Minor Ailment Scheme, and will work to ensure it supports decisions made at a local level.

3. Next steps

3.1 Align Bury’s current Prescribing for Clinical Need policy with the GM commissioning statement as outlines in 1.3

3.2 Where appropriate CCG utilises the implementation tools and communications materials developed for GM to support consistency of message to patients and other stakeholders. 4 Recommendations

4.1 Support Clinical Cabinet’s decision to align Bury’s current Prescribing for Clinical Need policy with the GM commissioning statement and commitment to support local clinicians to implement this policy.

5 Actions Required

5.1 The Governing Body is required to:

 Consider the local engagement feedback report.  Support Clinical Cabinet’s decision to align Bury’s current Prescribing for Clinical Need policy with the GM commissioning statement and commitment to support local clinicians to implement this policy.

Salina Callighan Head of Medicines Optimisation [email protected] May, 2019

Appendix 1 Greater Manchester Commissioning Statement on the provision of Over The Counter medicines

In line with NHS England guidance, CCG will not routinely commission at NHS expense medicines that are for conditions that:

 may be considered to be self-limiting, so they do not need treatment as they will get better of their own accord, or  are suitable for self-care, so that the person suffering does not normally need to seek medical advice and can manage the condition by purchasing Over The Counter (OTC) items unless there are clinically exceptional circumstances

This includes provision of NHS funded medicines through all routes of supply e.g. prescriptions, hospitals, Accident and Emergency Departments, Out of Hours services, Walk-in Centres and Minor Ailments Schemes. Medicines and treatments will not be prescribed for new patients and any prescribing for existing patients will be stopped if one of the following criteria is met:

1. The condition for which the or treatment is prescribed is considered to be self-limiting 2. The condition for which the medication or treatment is prescribed is considered suitable for self-care 3. The medication or treatment prescribed has insufficient evidence of benefit

Treatments for the following conditions are included in this policy: (Adults are defined to be 18 and over) 1. Acute Sore Throat 2. Infrequent Cold Sores of the lip. 3. Conjunctivitis 4. Coughs and colds and nasal congestion 5. Cradle Cap (Seborrhoeic dermatitis – infants) 6. Haemorrhoids 7. Infant Colic 8. Mild Cystitis 9. Mild Irritant Dermatitis 10. Dandruff 11. Diarrhoea (Adults) 12. Dry Eyes/Sore (tired) Eyes 13. Earwax 14. Excessive sweating (Hyperhidrosis) 15. Head Lice 16. Indigestion and Heartburn 17. Infrequent Constipation 18. Infrequent Migraine 19. Insect bites and stings 20. Mild 21. Mild Dry Skin 22. 23. Sun Protection 24. Mild to Moderate Hay fever/Seasonal Rhinitis 25. Minor burns and scalds 26. Minor conditions associated with pain, discomfort and/fever. (e.g. aches and sprains, headache, period pain, back pain) 27. Mouth ulcers 28. Nappy Rash 29. Oral Thrush 30. Prevention of dental caries 31. Ringworm/Athletes foot 32. Teething/Mild Toothache 33. Threadworms 34. Travel Sickness 35. Warts and Verrucae 36. Fungal nail infections

This policy also applies to the following items of limited clinical effectiveness

37. Probiotics 38. Vitamins and minerals

In all cases of first presentation of any of the above conditions, a pharmacist should be consulted for advice on treatment and the purchase of suitable products. The pharmacist should provide suitable guidance on product use and any subsequent actions that may be needed. For some conditions – see the table – advice should be sought if the condition does not improve within 2-3 days.

Note that age or other contraindications have only been included as exceptions when there is no OTC treatment.

Potential general exceptions to the policy:  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 where OTC products would not be suitable.  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 (e.g. Dry eyes due to Sjögren's syndrome).

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

 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.  The British Medical Association has highlighted that the guidance does not alter contractual obligations for GPs, nor remove the clinical discretion of the prescriber in accordance with their professional duties and that they remain obliged to prescribe what they believe their patients require. Therefore, prescribers should: • Continue to make the care of the patient first concern • Advise patients if that treatment for their condition is available over the counter • Offer an FP10 if concerned that not doing so would make it likely the advice would not be followed • Issue an FP10 if requested for a treatment that the prescriber has advised is necessary.

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. Examples of potential exceptional circumstances may include the following:

₋ Affordability can be considered an exemption where the prescriber believes it prohibits the individual’s ability to self-care e.g. homelessness, asylum seekers and those without recourse to public funds ₋ A patient goes to see their GP with indigestion problems. As this is the first occasion they should be advised to buy an indigestion remedy over the counter. However, if the problem persists the issue will be investigated further and medication can be prescribed. Patients with long-term indigestion problems will not be affected. ₋ A cancer patient has flu and is given the option to purchase remedies themselves but the GP doesn’t believe they will and not having the medication will affect their general health and wellbeing; ₋ If the GP believes that their patient who has a learning disability needs some vitamins but that they don’t fully understand the option of going to purchase medication themselves then they can prescribe this for them.

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Condition Example products (not Specific Exceptions (for Comments / further exhaustive) general exceptions see information above) 1. Acute (short duration) Sore throat lozenges and sprays, sore throat analgesics 2. Infrequent cold sores Aciclovir cream Immunocompromised patients of the lip Zovirax cold sore cream 3. Conjunctivitis a) (Bacterial) Bacterial: Children under 2 years Note there is no need to exclude a) Bacterial Chloramphenicol eye of age, pregnancy, lactation children from nursery unless they b) Viral drops or ointment Viral: no exceptions are feeling very unwell.1 (also see hayfever below) b) (Viral) hypromellose eye drops 4. Coughs, colds and Simple linctus,codeine nasal congestion linctus, pholcodine linctus Pseudoephedrine nasal sprays and oral preparations Xylometazoline and ephedrine nasal sprays and drops 5. Cradle cap Almond oil, olive oil, cradle cap Consult a HealthCare shampoos professional if the cradle cap:  itches  swells  bleeds  spreads to the face or body1 6. Haemorrhoids Anusol cream, ointment or Patient less than 18 years of age suppositories Patients with chronic bowel Anusol HC cream, conditions ointment, suppositories 7. Infant colic Simeticone liquid Advise to purchase OTC Dimeticone Liquid “Lactose free” formula for 6-8 Colief Drops weeks to allow symptoms to Lactose-free Formulas resolve then slowly reintroduce standard formula. Direct to HV for feeding advice

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and breastfeeding support (see RED book for contact & clinic details) 8. Mild cystitis (2-3 days) Potassium citrate mixture or Males. The condition does not improve sachets Children. within 2-3 days of self-treatment. Cranberry products 9. Mild irritant dermatitis Emollient creams and lotions Mild Exceptions for The condition has not improved corticosteroid creams (e.g. hydrocortisone cream: after a week of self-care after hydrocortisone)  Children under 10 years removal of the irritant.  Pregnant women When required for use on the face, anogenital region, broken or infected skin (including cold sores, acne, and athlete’s foot). 10. Dandruff (mild scaling Shampoos including , of the scalp without antiseptic, selenium and coal tar itching) 11. Diarrhoea (adults) Loperamide Diarrhoea resulting from a chronic A suitable healthcare Oral rehydration sachets medical condition e.g. professional should be consulted Kaolin-containing preparations inflammatory bowel disease if the condition does not improve within 2-3 days of self-care. 12. Dry eyes/sore tired eyes Hypromellose eye drops, Chronic moderate or severe dry carbomer 980 gel eyes Hyaluronate eye drops 13. Earwax Olive Oil, sodium bicarbonate This includes prior to syringing. ear drops 14. Excessive Aluminium chloride 20% sweating solutions (e.g. Driclor, Anhydrol (hyperhidrosis) Forte) 15. Head lice Dimeticone, malathion, Children under 6 months of age First line treatment is wet- cyclomethicone, permethrin combing and must be tried first.1 shampoos and liquids Head lice may be resistant to “Bug buster” kits insecticidal lotions and therefore Nit combs use of these should be minimised. 16. Indigestion and heartburn Peptac, Gaviscon A healthcare professional should be consulted if the condition does

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not respond to dietary adjustment and / or self-care. 17. Infrequent constipation Senna, lactulose, macrogol Children where dietary and A healthcare professional should (duration less than 2 sachets lifestyle changes have not be consulted if the condition weeks) been sufficient. persists for longer than 2 weeks. Condition does not respond to self-care. 18. Infrequent migraine Analgesics, Migraleve Migraines unresponsive to over-the-counter pain relief. 19. Insect bites and stings Antihistamine oral and topical preparations, calamine lotion Topical corticosteroids 20. Mild Acne Benzoyl peroxide creams and gels 21. Mild dry skin Emollient creams and lotions 22. Sunburn due to Emollients, oral and topical excessive sun exposure antihistamines, analgesics 23. Sun protection Sun creams such as Uvistat, ACBS approved indication of After a melanoma has occurred, Sunsense, etc. protection from UV radiation patients should manage their own in abnormal cutaneous skin protection by covering up photosensitivity. (i.e. where and use of high-factor skin protection should be sunscreens. prescribed) 24. Mild to moderate Antihistamines, nasal sprays, Children under 1 year. Patients are expected to use all hayfever/seasonal eye drops If the condition does not respond types of product appropriate to rhinitis to maximal over the counter their hayfever symptoms before therapy. consulting a GP. 25. Minor burns and scalds Antiseptic creams, analgesics, More serious burns always A suitable healthcare dressings require professional medical professional should be consulted attention. Burns requiring if a burn is not getting better hospital A&E treatment include within 2-3 days. but are not limited to:  all chemical and electrical burns;  large or deep burns;  burns that cause white or charred skin;

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 burns on the face, hands, arms, feet, legs or genitals that cause blisters.1 26. Minor conditions Analgesics, NSAIDs, topical associated with pain, anti-inflammatory preparations, discomfort and/or fever heat rubs (rubefacients) and (e.g. aches and cooling products sprains, headache, period pain, back pain) 27. Mouth ulcers Local anaesthetic gels, Immunocompromised persons A suitable healthcare hydrocortisone buccal tablets Taking medication that pre- professional should be consulted disposes to mouth ulcers if the condition is not getting better within 2-3 days. 28. Nappy rash Barrier preparations such as Sudocrem, metanium 29. Oral thrush Miconazole oral gel, nystatin Infants less than 4 months old A suitable healthcare oral suspension Patients taking warfarin professional should be consulted if the condition is unresponsive to appropriate treatment. 30. Prevention of dental caries Fluoride mouthwashes Dentists may prescribe for Toothpaste treatment of caries when indicated. 31. Ringworm/athlete’s foot Topical preparations containing Lymphoedema or history of miconazole, clotrimazole etc. lower limb cellulitis Pregnancy Lactation 32. Teething/mild toothache Teething gels, paracetamol, Babies under 2 months ibuprofen 33. Threadworms Mebendazole Children under 2 years of age because not licensed for OTC sale. 34. Travel sickness Cinnarizine, hyoscine, promethazine 35. Warts and verrucae Salicylic acid containing Treatment of anogenital warts. Patients with diabetes MUST products, glutaraldehyde consult a healthcare professional. 36. Fungal nail infections Nail lacquers, paints and softening children products

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Items of limited clinical value Example products (not Specific Exceptions (for general exhaustive) exceptions see above) 37. Probiotics lactobacillus, acidophilus 38. Vitamins and minerals Individual vitamin,  Vitamins for proven multivitamin, multivitamin deficiency. and mineral preparations  Calcium and vitamin D for osteoporosis or osteopenia. Vitamin D for patients with hyperparathyroidism, hypercalcaemia and patients receiving parenteral osteoporosis treatment. NB maintenance or preventative treatment is not an exception.  Thiamine for alcohol related conditions & neurological complications.  Vitamin supplements will be prescribed following bariatric surgery which has been carried out on the NHS.  Vitamin supplements for premature and low birth weight babies as advised by hospital.  When 5mg folic acid is required during pregnancy  Certain vitamin preparations in cystic fibrosis  Refeeding syndrome

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(short term) Patients suitable to receive Healthy start vitamins for pregnancy or children between the ages 6 months to their fourth birthday. (NB this is not on prescription but commissioned separately) Even if patients are not entitled to receive Healthy Start vitamins at no charge, these may be purchased for a small sum and should be used by all pregnant women and their babies.

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Appendix 2

Feedback report. Engagement: Conditions for which over the counter items should not routinely be prescribed

FINAL OTC feedback report May 19.doc

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Feedback report Engagement: Conditions for which over the counter items should not routinely be prescribed

Executive summary

A four week engagement period in relation to conditions for which over the counter items should not routinely be prescribed ran from Friday 15th March until Friday 12th April 2019.

The Governing Body will consider this engagement feedback report at its meeting on 22nd May 2019.

An important part of the period of engagement was to offer the opportunity for people to highlight if they felt the CCG had failed to consider something significant, before coming to a decision.

The key points from the feedback received are summarised below:

 262 individuals responded to our survey.  62% said that they are registered with a GP practice in Bury.  14% said they were a healthcare professional.  Around half (48%) of respondents said they were aware that the CCG introduced a local policy in September 2015 which includes a wide range of conditions for which over the counter items are not routinely prescribed by Bury GPs. The remaining respondents said they didn’t know about the policy or weren’t sure if they had heard about it.  In relation to the two conditions already included in our local policy that are not included in the new guidance, we intend to retain these in our local policy as conditions for which over the counter items should not routinely be prescribed. Respondents were asked whether they agreed with this intention. Despite some concerns: o In relation to scabies 62% said yes they agreed with the intention, 27% said no and 11% said they didn’t know. o In relation to vaginal thrush 64% said yes they agreed with the intention, 30% said no and 6% said they didn’t know.  In relation to the 11 conditions included in the new guidance that are not currently included in our local policy, we intend to include these as additional conditions for which over the counter items should not routinely be prescribed. Respondents were asked to highlight the conditions that they believed would have an impact on local people if they were no longer routinely prescribed: o Ringworm, contact dermatitis (a type of eczema), haemorrhoids (piles) and oral thrush scored the highest in terms of respondents’ belief that not prescribing them would have an impact.

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Written feedback included:  A good amount of support for the approach to free up GP time to deal with more complex cases and use resources wisely.  There were concerns that: o Vulnerable individuals, people on a low income (affordability), children and those living with a long term condition may be disadvantaged by the approach. The changes relate to minor, short term health conditions. If it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. o The policy could create a two tier system of those that can and those that cannot afford over the counter medicines. o Individuals may wrongly self-diagnose their condition. o The potential complications if conditions are not treated. o Conditions that are contagious are difficult to diagnose and could easily spread without treatment in i.e. schools or care homes. o Some over the counter items are expensive, hard to obtain or don’t work very well.  A suggestion that patient information should be made available to support the changes.

About NHS Bury Clinical Commissioning Group (CCG)

NHS Bury CCG commissions (buys) health services for the local area with doctors and other health care professionals making decisions about local services.

The CCG has a budget to plan and purchase a range of health services including those provided in hospitals and in the community, including GP services.

The Governing Body (Board) of the CCG oversees the work of the organisation and sets its priorities and direction. The Board is made up of doctors and other health care professionals and members represent the interests of patients, carers and local people.

Background

Each year nationally the NHS spends over £550 million on prescriptions for medicines that could be purchased over the counter from a pharmacy or other outlet such as a supermarket. Nationally it is estimated that around 57 million GP appointments relating to minor conditions such as constipation, conjunctivitis and heartburn are booked each year.

For many of the medicines used to help manage the symptoms of minor conditions there is little evidence that they work. In addition many of the short term (self-limiting) conditions the medicines aim to treat will get better on their own without any intervention.

In December 2017 NHS England launched a national public consultation on reducing prescribing of over the counter medicines for a range of minor, short term health conditions. The aim of the consultation was to develop a consistent approach.

Following the national consultation, in March 2018 guidance was issued to CCGs on how to implement the recommendations or amend existing guidance at a local level in relation to conditions for which over the counter items should not routinely be prescribed.

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Following this, in December 2018 the Greater Manchester Medicines Management Group Clinical Standards Board approved new Greater Manchester guidance (see Appendix 1 for the full list) to promote consistent adoption and implementation of the NHS England guidance across Greater Manchester.

Purpose of the period of engagement

The purpose of the period of engagement was to:

 Inform patients registered with a Bury GP practice, Bury health care professionals and other local interested parties about new Greater Manchester guidance in relation to conditions for which over the counter items should not routinely be prescribed.  Inform people about how the new Greater Manchester guidance differs from our local policy.  Advise people of and seek views on our intention to update and align our local policy to the new Greater Manchester guidance by including an additional 11 conditions for which over the counter items should not be routinely prescribed.  Advise people of and seek views on our intention to retain the two conditions that are currently included in our local policy but are not included in the new Greater Manchester guidance as conditions for which over the counter items should not be routinely prescribed.  Ensure that local issues are understood and considered before a decision is made.

The case for change

 Many of the short term (self-limiting) conditions the medicines aim to treat will get better on their own without any intervention.  Conditions suitable for self-care can be treated with items that can easily be purchased over the counter from a pharmacy or other outlet.  For some medicines used to help manage the symptoms of minor conditions there is little evidence that they work.  New Greater Manchester guidance is now available to promote consistent adoption and implementation of the NHS England guidance across Greater Manchester.

Our local policy

A Prescribing for Clinical Need policy (local policy) was introduced in Bury in September 2015 and includes a wide range of conditions for which over the counter items for minor conditions are not routinely prescribed by Bury GPs.

The majority of the conditions included within the new Greater Manchester guidance are already included in our local policy. Our local policy does, however, differ slightly from the new Greater Manchester guidance in the following areas:

Position Condition Our proposal Conditions included in our  Scabies To retain these two local policy that are not  Vaginal thrush conditions within our local

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Having previously included these conditions in our local policy as conditions not routinely prescribed for by Bury GPs, we consider them to be suitable for self-care.

If it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. Conditions included in the  Haemorrhoids (piles) To update our local policy to new Greater Manchester  Mild cystitis include these 11 conditions guidance that are not  Contact dermatitis (a for which over the counter included in our local policy type of eczema) items should not routinely be  Hyperhidrosis prescribed. (excessive sweating)  Infrequent constipation  Infrequent migraine  Minor burns and scalds  Oral thrush  Ringworm  Travel sickness  Fungal nail infection

Our proposal

 To retain the conditions currently included in our local policy that are in line with the new Greater Manchester guidance  To retain the two conditions that are currently included in our local policy but are not included in the new Greater Manchester guidance:  Scabies  Vaginal thrush  To update our local policy to align to the new Greater Manchester guidance in relation to an additional 11 conditions:  Haemorrhoids (piles)  Mild cystitis  Contact dermatitis (a type of eczema)  Hyperhidrosis (excessive sweating)  Infrequent constipation

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 Infrequent migraine  Minor burns and scalds  Oral thrush  Ringworm  Travel sickness  Fungal nail infection

Approaches and mechanisms used to promote the period of engagement

 An online survey was made available, which was also available in paper format on request (see Appendix 2).  Views could be sent to the CCG by letter or by e-mail. The opportunity to take part in the period of engagement was promoted through the following mechanisms and networks:

 A press release was issued to promote the launch of the period of engagement.  CCG website content including on the home page.  Promotion through social media platforms including pinned posts.  Content on GP practice information screens.  Advertisement on the Bury Directory.  Health Matters E-News issued.  Promotion through all existing networks including through Voluntary, Community and Faith Sector organisations, Healthwatch Bury and seeking support from local groups and organisations i.e. via Six Town Housing, Children’s Centres and GP practices.

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Feedback received from our survey

QUESTION 1: You are mainly responding as: A patient registered with a Bury GP practice A carer A healthcare professional An interested party responding on behalf of an organisation Other Answer Choices Responses A patient registered with a Bury GP practice 56.70% 148 A carer 2.30% 6 A healthcare professional 13.79% 36 An interested party responding on behalf of an organisation 2.68% 7 Other 24.52% 64 Answered 261 Skipped 1

QUESTION 2: Are you registered with a GP practice in one of the areas of Bury?

Answer Choices Responses Yes 61.78% 160 No 38.22% 99 Answered 259 Skipped 3

QUESTION 3: Are you aware that NHS Bury CCG introduced a local policy (known as the Prescribing for Clinical Need policy) in September 2015 which includes a wide range of conditions for which over the counter items are not routinely prescribed by Bury GPs? Answer Choices Responses Yes 47.89% 125 No 42.91% 112 I don’t know 9.20% 24 Answered 261 Skipped 1

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QUESTION 4: If you have any comments on our existing local policy, please use the space below to share your thoughts. Comments were considered and collated under the following themes:

Support o There was good support for the existing local policy, with respondents highlighting it being a sensible approach to not fund items that can be purchased at a low cost and over the counter. o Highlighting that the policy will free up GP time to treat more urgent or serious issues whilst promoting self-care.

Policing of the policy o There was feedback that the policy needs to be policed more closely to ensure a consistent approach to prescribing amongst all GP practices and services.

Self-care o Some concern that patients choosing to self-care for what they think is something minor when it might be more serious. o A need to make better use of the Care Navigator service in practices to signpost patients to the most appropriate option to meet their needs. o Patient information would be helpful to inform and educate local people about the changes and self-care.

Exclusions o A suggestion that where a condition could be contagious that prescribed treatment should be considered. o Concern that people living with a long term condition and requiring treatment should not be excluded. The changes relate to minor, short term health conditions. If it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. o Some concern that where a minor condition may become something more serious, this should be prescribed for, also where it would cost the patient more than the cost of a prescription examples given included: hayfever, some emollients and medicines to treat reflux. Affordability o Concerns around affordability of over the counter items for individuals on a low income i.e. head lice treatment. Seeing a GP o Feedback that a patient may still feel the benefit of seeing their GP even if they aren’t prescribed anything and instead receive advice/signposting for self-care.

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QUESTION 5: The majority of the conditions included within the new Greater Manchester guidance are already included within our local policy and therefore are not routinely prescribed by Bury GPs. Our local policy does, however, differ slightly from the new Greater Manchester guidance as follows. There are two conditions included in our local policy that are not included in the new Greater Manchester guidance. We intend to retain these two conditions in our local policy as conditions for which over the counter items should not routinely be prescribed as we consider them to be suitable for self-care.

Question 5: Do you agree with our intention to retain the following two conditions in our local policy as conditions for which over the counter items should not routinely be prescribed? Yes No I don't know Total Scabies 61.87% 159 27.24% 70 10.89% 28 257 Vaginal thrush 64.45% 165 29.69% 76 5.86% 15 256 Answered 258 Skipped 4

QUESTION 6: If you have ticked no for either of the conditions at question 5, please use the space below to tell us why. Comments were considered and collated under the following themes:

Affordability o The approach could disadvantage low income families and other vulnerable individuals. o A healthcare professional references not wanting to penalise those on a low income.

Scabies o Scabies is difficult to diagnose correctly, is contagious and could easily spread if the correct treatment/advice isn’t provided i.e. in schools or care homes. o People may be too embarrassed to speak to their pharmacy and may prefer to see their GP. o The self-care route is positive as this saves the embarrassment of a GP appointment.

Vaginal thrush o Easy to treat with over the counter items. o Vaginal thrush could be indicative of underlying health issues or lead to further complications. o Over the counter items are expensive. o Unfairly disadvantages females. o A suggestion that nurse appointments should be available to help with diagnosis and advise on treatment, even if this is an over the counter item.

Other o Support that these conditions could be managed through self-care / without a trip to the GP.

8 | P a g e o Suggestion that pharmacists should have the option to refer a patient back to the GP should a self-care treatment not be effective.

QUESTION 7: There are 11 conditions included in the new Greater Manchester guidance that are not currently included in our local policy. We intend to update our local policy to include these additional conditions as conditions for which over the counter items should not routinely be prescribed.

Question 7: Please have a look at the list of the 11 additional conditions below and tick those conditions that you believe would have an impact on local people if they were no longer routinely prescribed. Answer Choices Responses Haemorrhoids (piles) 48.09% 63 Mild cystitis 40.46% 53 Contact dermatitis (a type of eczema) 48.85% 64 Hyperhidrosis (excessive sweating) 39.69% 52 Infrequent constipation 20.61% 27 Infrequent migraine 29.01% 38 Minor burns and scalds 27.48% 36 Oral thrush 46.56% 61 Ringworm 51.15% 67 Travel sickness 15.27% 20 Fungal nail infection 41.22% 54 Answered 131 Skipped 131

QUESTION 8: If you have ticked any of the 11 conditions at question 7, please use the space below to tell us why. Comments were considered and collated under the following themes:

Support o Support that the treatment for these conditions should be paid for by the individual, saving GP time and NHS resources.

Affordability and eligibility o Concern that cost might make purchasing items over the counter prohibitive for some individuals i.e. on a low income or vulnerable individuals. o Feedback that items should still be prescribed for children, people on a low income, those living with a long term condition. The changes relate to minor, short term health conditions. If it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. o Concern that some over the counter items can be expensive i.e. fungal nail, or be difficult to obtain.

Self-diagnosis and complications o Self-diagnosis leading to a mis-diagnosis. o Individuals might under estimate the severity of a burn or scald. o Conditions such as haemorrhoids can lead to further complications.

9 | P a g e o Cystitis requires a sample to make a diagnosis and recurring cystitis can lead to complications. o Concern that ring worm is contagious and if this is not treated it could easily spread in some groups i.e. young children.

Over the counter o If you need antibiotics, you cannot buy them over the counter. o Concern that some over the counter items are not strong enough i.e. migraine treatment, or doesn’t work well i.e. eczema.

Education o Information and education would be needed to support people to make a decision on when to self-care and when to make an appointment.

QUESTION 9: If any of the conditions at question 7 were conditions for which over the counter items were not routinely prescribed in the future, who do you think this decision would impact most? Feedback received included: o People living with long term conditions i.e. diabetes and eczema. The changes relate to minor, short term health conditions. If it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. o Patients who do not pay for prescriptions or are on a low income. o Children and older people including those living in a care home. o Individuals: suffering from neglect or abuse / with a learning disability / with a mental health condition / that are homeless. o It shouldn’t impact anyone if the item can be bought over the counter. The illness must be diagnosable by a pharmacist and the medication should be affordable for all. o Positively impacting health care professionals and patients who genuinely do need an appointment/prescription.

QUESTION 10: How do you self-care for you and your family at present? Feedback received included: o Good hygiene. o Healthy lifestyle, not smoking and drinking in moderation. o Keeping a medicine cabinet and first aid kit at home. o Seeking pharmacy advice, also dentist, optometrist etc. o Using the walk-in Centre instead of A&E. o Minor ailments scheme, NHS111 service or NHS website advice. o Natural and alternative remedies. o Purchasing a pre-payment certificate for prescriptions.

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QUESTION 11: If you feel we have missed anything, if you have any other comments about our local policy or these proposals, please use the space below to tell us: Feedback received included: o The policy could create a two tier system of those that can and those that cannot afford over the counter medicines. o GPs are in the best position to assess a patient’s needs and should have the discretion to prescribe for conditions that have failed to respond to over the counter items. o Patients should still be able to make an appointment with their GP if they want some advice or reassurance, even if they have to buy items over the counter in the end. o Suggestion to make the change on a trial basis to assess the impact before full roll out. o Suggestion to re-evaluate the minor ailment scheme.

Conclusion

o A four week period of engagement ran from Friday 15th March until Friday 12th April 2019. o There were 262 responses to the survey. o Through the engagement approach, we tried to provide assurance that whilst our local policy includes a wide range of conditions for which over the counter items for minor conditions are not routinely prescribed by Bury GPs, if it is felt there are exceptional circumstances, the decision will always remain with the prescribing clinician. o There was a good amount of support for the approach (current local policy and the current proposal, though feedback that the current policy isn’t consistently applied) to ensure that NHS monies are only spent on medicines that are safe, clinically effective and provide a clear health benefit, to free up resources to be spent elsewhere to improve health in Bury. o Despite not being included in new guidance and some concerns including affordability and the about the risk of scabies spreading, the majority of respondents agreed with the intention to retain scabies and vaginal thrush in our local policy as conditions for which over the counter items should not routinely be prescribed. o In relation to the 11 conditions included in the new guidance that are not currently included in our local policy, there was support for this change to the local policy, however, there were concerns about affordability, eligibility, self-diagnosis/mis- diagnosis and potential complications if conditions aren’t treated appropriately. o There was also concern that vulnerable individuals, people on a low income (affordability), children and those living with a long term condition may be disadvantaged by the approach.

Next steps

o An important part of the period of engagement was to offer the opportunity for people to highlight if they felt the CCG had failed to consider something significant, before coming to a decision. o The Governing Body will consider this engagement feedback report at its meeting on 22nd May 2019.

11 | P a g e o After a decision has been made by the Governing Body, feedback will be provided on the decision to stakeholders through all existing mechanisms, including the press and media, social media and the internet, through local third sector organisation networks and other networks.

NHS Bury CCG Communications Team [email protected] May 2019

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Appendix 1 Conditions contained within new Greater Manchester guidance for which over the counter items should not routinely be prescribed:

 Acute Sore Throat  Infrequent Cold Sores of the lip.  Conjunctivitis  Coughs and colds and nasal congestion  Cradle Cap (Seborrhoeic dermatitis – infants)  Haemorrhoids  Infant Colic  Mild Cystitis  Mild Irritant Dermatitis  Dandruff  Diarrhoea (Adults)  Dry Eyes/Sore (tired) Eyes  Earwax  Excessive sweating (Hyperhidrosis)  Head Lice  Indigestion and Heartburn  Infrequent Constipation  Infrequent Migraine  Insect bites and stings  Mild Acne  Mild Dry Skin  Sunburn  Sun Protection  Mild to Moderate Hay fever/Seasonal Rhinitis  Minor burns and scalds  Minor conditions associated with pain, discomfort and/fever. (e.g. aches and sprains, headache, period pain, back pain)  Mouth ulcers  Nappy Rash  Oral Thrush  Prevention of dental caries  Ringworm/Athletes foot  Teething/Mild Toothache  Threadworms  Travel Sickness  Warts and Verrucae  Fungal nail infections

In addition the following items of limited clinical effectiveness:

 Probiotics  Vitamins and minerals

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Appendix 2

Survey

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Appendix 3

Equality monitoring information

What is your gender?

Answer Choices Responses Male 18.39% 48 Female 75.86% 198 Trans 0.77% 2 Prefer not to say 4.60% 12 Other (please specify) 0.38% 1 Answered 261 Skipped 1

What is your age? Answer Choices Responses 18 to 30 12.31% 32 31 to 40 18.08% 47 41 to 50 21.15% 55 51 to 60 21.54% 56 61 to 70 13.85% 36 Over 70 8.08% 21 Prefer not to say 5.00% 13 Answered 260 Skipped 2

What is your sexual orientation?

Answer Choices Responses Heterosexual 77.87% 197 Gay 1.98% 5 Lesbian 2.37% 6 Bi-sexual 1.98% 5 Prefer not to say 15.81% 40 Answered 253 Skipped 9

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Please tell us what you consider your ethnicity to be Answer Choices Responses White: British 82.95% 214 White: Irish 3.88% 10 White: East European 0.00% 0 White: Gypsy/Roma/Traveller 0.78% 2 White: Other background 1.16% 3 Mixed: White and Black Caribbean 0.00% 0 Mixed: White and Black African 0.39% 1 Mixed: White and Asian 0.39% 1 Mixed: Other background 0.00% 0 Asian or Asian British: Indian 0.78% 2 Asian or Asian British: Pakistani 1.16% 3 Asian or Asian British: Bangladeshi 0.00% 0 Asian or Asian British: Other background 0.00% 0 Black or Black British: Caribbean 0.39% 1 Black or Black British: African 0.39% 1 Black or Black British: Other background 0.00% 0 Chinese or other ethnic group: Chinese 0.00% 0 Chinese or other ethnic group: Any other 0.00% 0 Prefer not to say 6.20% 16 Other (please specify) 2.71% 7 Answered 258 Skipped 4

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