2014/15 public health services contract service

2014/15 PUBLIC HEALTH SERVICES CONTRACT

FINAL – PUBLIC HEALTH SERVICES CONTRACT 2015 FINAL V6+6.7REFERENCE: 18533 1

SERVICE SPECIFICATIONS

Tender Reference No. Not applicable

Service Healthy Start Vitamins (Community Pharmacy) – (HSVCP)

Authority Lead

Philip Ray TVPHSS on behalf of Public Health in Hartlepool Borough Council Middlesbrough Borough Council) Redcar and Cleveland Borough Council Stockton on Tees Borough Council

Provider Lead Community Pharmacy

Period 1st

July 2015 to 31st

March 2016

Optional Extensions Period 6 months

Date of Review 31 January 2016

1. Population Needs

1.1 National context and evidence base Healthy Start is a statutory UK-wide government scheme which aims to improve the health of pregnant women and families on benefits or low incomes. One element of this scheme is the availability of vitamin supplements for those eligible. Healthy Start supports low-income families in eating healthily, by providing them with vouchers to spend on cow’s milk, plain fresh or frozen fruit and vegetables, and infant formula milk. Women and children getting Healthy Start food vouchers also get vitamin coupons to exchange for free Healthy Start vitamins. Healthy Start vitamins are specifically designed for pregnant and breastfeeding women and growing children. Pregnant women, breastfeeding women with a child under 12 months and children aged from six months to four years (i.e. up to fifth birthday) who are receiving national Healthy Start vouchers are entitled to free Healthy Start vitamins. Healthy Start vitamins contain the appropriate amount of recommended vitamins A, C and D for children aged from six months to four years, and folic acid and vitamins C and D for pregnant and breastfeeding women. Healthy Start vitamins are important because:

8% of children under five in the UK don’t have enough vitamin A in their diet1

families in lower-income groups tend to have less vitamin C in their diet2

all pregnant and breastfeeding women and young children are at risk of vitamin D deficiency3

(teenagers, younger women and those from ethnic minorities are particularly at risk).

Vitamin A helps with vision in dim light and helps immunity, as well as supporting healthy skin.

Vitamin C protects cells, helps keep them healthy and may assist the body to absorb iron from food. In a

balanced diet most of it can be sourced from fruit and vegetables such as broccoli, oranges and kiwi fruit.

However, a supplement will help ensure that children get enough – particularly as it isn’t stored by the body.

1 Scientific Advisory Committee on Nutrition (2008) The Nutritional Wellbeing of the British Population. London: TSO Cited in

http://www.healthystart.nhs.uk/for-health-professionals/vitamins/ accessed 10.3.14 2 As 1 above

3 Scientific Advisory Committee on Nutrition (2007) Update on Vitamin D. London: TSO. Cited in:

http://www.healthystart.nhs.uk/for-health-professionals/vitamins/ accessed 10.3.14

http://www.healthystart.nhs.uk/for-health-professionals/vitamins/

http://www.healthystart.nhs.uk/for-health-professionals/vitamins/



Vitamin D has a number of important functions. For example, it helps to regulate the amount of calcium and phosphate in the body; needed to help keep bones and teeth healthy. Infants who don’t get enough vitamin D can get softened bones which can lead to rickets. The best source of vitamin D is summer sunlight, but most people in the UK have limited exposure to it.

Two bespoke Healthy Start branded products are available:

Healthy Start children’s vitamin drops (containing vitamins A, C and D)

Healthy Start vitamins (tablets) for women (containing folic acid and vitamins C and D).

1.1.1 Access and distribution As a result of wholesale supply restrictions, the bespoke Healthy Start vitamins have not been made available via the normal supply mechanisms (e.g., pharmacy wholesalers) for similar medicinal-type products i.e. they are not prescribable on FP(10) or routinely available for ‘Over the Counter’ (OTC) sale in a community pharmacy. Between April 2013 and January 2015 it was even illegal for Healthy Start vitamins to be sold by any organisation commissioned to provide them through the national scheme. Consequently, this has severely restricted access points for eligible infants/mothers. 1.2 Local Context Locally, of those estimated to be eligible for the Healthy Start Scheme, around 80-90% of people are estimated to claim and use the food / milk vouchers. However, for many reasons, including those described above, the vitamin supplement element of Healthy Start does not reflect this success. Healthy Start vitamin uptake in the Tees localities in 2012/13 was less than 4% in all four areas. It is acknowledged that as well as low uptake, there seems to have been a failure in the data collection process. The low uptake in recent years (before 2013-14) was despite the fact that some local areas had made significant efforts to raise awareness of the scheme. Nevertheless, there was limited impact on vitamin uptake through the national voucher scheme, which may, at least in part, have reflected the variable/ poor access from the outlets from which they were available. It had been suggested that increasing access points, better awareness and improved multi-agency working could significantly improve uptake. From 1

st April 2014, the four Tees local authorities established a new pilot service for enhanced (so-called

‘universal’) provision of Healthy Start vitamins, which enabled the supply of Healthy Start vitamins across the Borough Council areas of Hartlepool, Middlesbrough, Redcar and Cleveland and Stockton on Tees by community pharmacies; midwives and Health Visitors initiated the supply via a local voucher. The HSVCP service was commissioned by the Public Health teams in the local authorities, facilitated by the Tees Valley Public Health Shared Service. This substantially increased the overall number of vitamins supplied annually via the 43 pharmacies contracted. Benefits to distributing the Healthy Start vitamins via community pharmacy include;

Improved access to the vitamins (location and opening hours)

Pharmacies are best-placed to manage those aspects of ordering, storage and supply that are related to the Safe and Secure Handling of Medicines and client-specific eligibility criteria

Pharmacy are a trusted and well-used resource within communities, particularly in relation to the supply of medicines and associated products

Pharmacy staff are skilled at giving advice and guidance

Potential frequency of opportunity to raise the issue of Healthy Start opportunistically due to other pharmacy attendances/ potential purchases that are baby/child related.

Opportunity to collate routine performance and monitoring data electronically via PharmOutcomes.

One year into the service, some of the processes and pathways were identified for simplification and improvement for this, the new service specification for 2015-16. This includes;

initiation as well as maintenance of the supply is now pharmacy-based

pathway simplification; signposting of eligible persons to community pharmacy without the use of a local voucher system

as a result of a change in the law, the opportunity to incorporate the option of selling the vitamins (in specific circumstances) into the service specification, which was considered valuable

extension of the service to any willing community pharmacy provider to offer even more access points, reduce the potential for confusion or inconvenience and attempt to avoid direction to specific pharmacies.



2. Key Service Outcomes

The HSVCP service covered by this service specification should operate within, and support the execution of, the requirements and recommendations of both Department of Health

4 and relevant NICE

5 guidance in

actively contributing to improving local maternal and infant health outcomes and reduced health inequalities. Given the above, the service should be seen in the context of its contribution to the wider ‘Best Start in Life’ agenda. As health professionals, community pharmacists and their staff can make a significant difference to the health of our local population by making sure those people most at risk are aware of the implications of vitamin D deficiency, and most importantly what they can do to prevent it

6. This is particularly important for our local

population. Service outcomes have been identified and are outlined below: Following on from the successful process in 2014-15 which established provision of Healthy Start Vitamins, free at the point of access, from specified community pharmacies strategically located across the Borough(s), this service will extend the service to

similarly provide (free) Healthy Start vitamins from any willing and contracted community pharmacy across the four localities

facilitate the opportunity for the sale of Healthy Start vitamins, in limited circumstances to clinically eligible pregnant or post-natal women, and parents/ carers of clinically eligible children.

Healthy Start vitamins will be offered for supply free at the point of access via a pharmacy registration process to

all pregnant women

all new mothers with a child under 1 year old

all eligible* children from six months old until their fifth birthday

In particular, the service seeks to provide improved access to, and increased uptake of, Healthy Start vitamins by the following targeted* groups:

o women and children from families eligible for the national ‘Healthy Start’ voucher scheme in accordance with national Healthy Start guidance

o pregnant and breastfeeding women and children (up to their fifth birthday) of families seeking asylum and registered with the specialist practices in Stockton (Arrival) and Middlesbrough (Haven).

Additionally, the new extended service seeks to increase the public awareness of the value and need for these vitamins and the risks of vitamin D deficiency in women and children in all Tees localities. *see section 3.4 for further information on targeted groups

3. Scope

3.1 Aims and objectives of service 3.1.1 Aims The community pharmacy provider will contribute to the delivery of the Health and Wellbeing Strategy of the Borough in which the pharmacy is located.

4 Department of Health (2012). Vitamin D - advice on supplements for at risk groups - letter from UK Chief

Medical Officers 5 Maternal and child nutrition. NICE public health guidance 11 (2008) Guidance for midwives, health visitors,

pharmacists and other primary care services to improve the nutrition of pregnant and breastfeeding mothers and children in low income households. Antenatal care. NICE clinical guideline 62 (2008) Antenatal care: routine care for the healthy pregnant woman. 6 Vitamin D. Information for Health professionals.

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/390393/A5_Vitamin_D_leaflet_HCP_FINAL_19.12.14_.pdf

https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/213703/dh_132508.pdf


http://publications.nice.org.uk/improving-the-nutrition-of-pregnant-and-breastfeeding-mothers-and-children-in-low-income-households-ph11



http://publications.nice.org.uk/antenatal-care-cg62





The aims of commissioning the ‘Healthy Start’ Vitamins (Community Pharmacy) Service are

To remove or reduce barriers to uptake of Healthy Start vitamins in the eligible population of the Borough Councils of Hartlepool, Middlesbrough, Stockton on Tees and Redcar and Cleveland.

To establish clear, auditable pathways which facilitate the supply of Healthy Start vitamins, to the following target groups;

o All those eligible for the vitamins under the existing national government scheme (i.e. in

receipt of centrally issued Healthy Start vouchers which include those for infant formula milk/ vegetables as well as a coupon for the vitamins)

o All those eligible under locally determined criteria

To contribute towards improving the health of pregnant women and infants/ children of families in the Boroughs, particularly those in receipt of state benefits or on low incomes.

3.1.2 Objectives

To substantially increase the number of locations where Healthy Start vitamins are available from across the Borough(s), targeting where possible areas of greatest deprivation, and going beyond that to ensure widest distribution of the messages regarding vitamin D for maternal and child health

To increase the awareness of the Healthy Start vitamins and availability thereof

To actively promote and thereby improve uptake of Healthy Start Vitamins to the targeted groups and record details of proactive interventions and responsive interactions (supplies) made using PharmOutcomes

To display materials promoting Healthy Start vitamins (as sourced by the Provider, via access links or made available by the Public Health teams of the Commissioner)

To manage the process of ordering, receipt, storage and supply of the Healthy Start Vitamins within the pharmacy setting, in a suitably safe and secure manner and in accordance with principles of good pharmaceutical practice and wider clinical and organisational governance i.e.,

o ordering of the Healthy Start vitamins from the locally commissioned wholesale distributor (Lloydspharmacy, Roseberry Park, Middlesbrough, hereafter called the ‘local Distributor’)

o maintaining suitable stock levels to avoid both waste and ‘out-of-stock’ situations

o supplying vitamins (free of charge and on a repeatable basis) in accordance with the appropriate eligibility criteria and protocols for eligible women/ children and in response to (for example)

patient presentation of a national Healthy Start Vitamin voucher (example shown in Appendix 1)

a request as a result of signposting from another health professional or general awareness

a pharmacy-led brief intervention

to enable repeat supplies, registering each eligible individual at first contact, in accordance with suitable standards for confidentiality and consent, using paper documentation where necessary but always later logged onto PharmOutcomes, and maintaining that record in accordance with the Data Protection Act to facilitate the on-going supply of vitamins for as long as the individual remains eligible under the terms of the local scheme

recording details of stock ordering, receipt, supply and associated interventions electronically using



PharmOutcomes to ensure collation of data required for return to the Department of Health and additional local data requirements; submitting data via PharmOutcomes either to the Commissioner, to the ‘local Distributor’ of the vitamins or the TVPHSS as requested, and in a timely manner

in specific circumstances, making sales of HSV to eligible individuals who either do not wish to register for the free scheme or are not resident in one of the four Borough(s), at prices defined by the Commissioner (included at section 3.2.1.3) and in accordance with the Legislation

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communicating appropriately with general practice where necessary e.g., to inform about the general operation of the service or to support update of patient records related to any prescription interventions related to Healthy Start vitamins

To retain in the pharmacy for six months, and thereafter destroy, any national Healthy Start vitamin coupons handed in by users of the service, to support validation of reimbursement to the Borough Council, from the DH, of Healthy Start vitamin product costs - and for audit purposes.

3.2 Service description/pathway 3.2.1 Service Description Pharmacies commissioned by the Local Authority will supply (or in specific circumstances sell) Healthy Start vitamins to the appropriate client groups as described in this specification, with or without the presentation of a national Healthy Start voucher. 3.2.1.1 Stock Ordering, Receipt and Management of Healthy Start Vitamins Using the process and /or documentation specified, pharmacies providing the service will

Receive a start-up supply of initial Healthy Start vitamin stock from the ‘local Distributor’ (Lloydspharmacy, Roseberry Park, Middlesbrough)

on receipt of the vitamins, store in a suitable place in accordance with good pharmacy practice and in such a way that sales or supplies will only be made in accordance with the terms of this commissioned service

efficiently manage stock levels in accordance with demand and expiry dates of the vitamins

keep good records (using PharmOutcomes) of supplies received, made, and any ‘out-of-date’ stock (including safe disposal thereof). Some transactions may be recorded using paper documentation supplied by the Commissioner to facilitate patient supply in a time-efficient manner, then entered onto PharmOutcomes with reasonable promptness at a time convenient to the pharmacy

re-order Healthy Start vitamins from the ‘local Distributor’ in a similar way, to replace issued or date-expired stock, ideally on a ‘top-up’ basis – stock will be delivered according to a pre-specified delivery frequency and will be provided at no direct cost to the pharmacy

record an exception report via PharmOutcomes where a pharmacy is ‘out of stock’ at any time when a client presents.

All data entries relating to interventions, stock management and supply will be recorded accurately and promptly in PharmOutcomes to facilitate real-time audit and pharmacy payment.

3.2.1.2 Vitamin Supply, free to clinically eligible individuals via client registration All free supplies will be made to eligible women, or the parents/carers of eligible children, using a client registration system. An individual in a pharmacy may be identified as eligible for the service via several routes which might include:

presentation of a national Healthy Start vitamin coupon or voucher (example shown in Appendix 1,

7 The Healthy Start Vitamins Charging (England) Regulations 2014



Figure 1)

presentation in the pharmacy of the local Healthy Start leaflet for women and children of asylum-seeking families – issued by the specialist Health Visitor - to aid communication of service request and eligibility between client and pharmacy for this specific group

patient/carer request as a result of signposting from another health professional or general awareness

brief intervention made by the pharmacy with potentially eligible persons attending the pharmacy. Clinically eligible women or parents/carers for clinically eligible children, will be offered registration for free vitamin supply. Examples of the national and local leaflets, and national Healthy Start vitamin coupons/ vouchers will be provided to pharmacies for reference purposes. Since the supply of Healthy Start vitamins is intended to last for a minimum of several months, often several years, a registration process has been adopted by the Commissioners which supports maintenance of a relationship with the pharmacy to encourage compliance with vitamin-taking and improved data on uptake of the vitamins within the eligible population. Women or parents/carers for eligible children will register with a pharmacy, giving consent for their data to be held in the pharmacy in accordance with the Data Protection Act. In return, a client-held Healthy Start Vitamin Supply reminder Card will be issued to record up to six supplies (once every two months) made under the terms of the service (example of patient-held supply card included as Appendix 1, Figure 2). A unique Vitamin Supply Card number will be generated and recorded on the card comprising both the ‘Public Health Code’ assigned to that pharmacy (see Appendix 2) and a sequential number generated by the pharmacy. Clients will be advised to return to the same pharmacy, with their Supply Card, every 8 weeks to collect their vitamins. Normally, one of these Supply Cards will suffice for all supplies required for a pregnant women. A new card will be offered to mum when the baby is born which will then last for all eligible post-natal supplies (the same Vitamin Supply Number will be retained). Children, whose eligibility may last beyond 12 months (depending on their age when they first encounter the scheme, e.g., if the first supply is at around six months of age), will be re-issued with a new supply card when each one is full, under the same registration number, to continue their vitamin supply until their 5

th birthday. If

a client wishes to move pharmacy, each pharmacy will be able annotate the client’s registration on PharmOutcomes, to track on-going supplies. 3.2.1.4 Sales of Healthy Start Vitamins Pharmacies offering the service are no longer prohibited by law from selling the Healthy Start vitamins. No eligible person will be required to make a payment to the pharmacy for a supply of Healthy Start vitamin made under this scheme, provided they agree to the register with a pharmacy to obtain their supplies. All the clinically eligible groups would be exempt from prescription charges were the vitamins available by that route (which they are not). Where an eligible individual does not give consent to register for a free supply, pharmacies will be permitted to sell the vitamins at cost price only rounded to the nearest 5p as notified by the Commissioner and updated on PharmOutcomes. At June 2015, ‘retail’ prices for Healthy Start Vitamins sold as part of this service will be:

Women’s vitamin tablets - £0.75

Children’s vitamin drops - £1.40

Vitamins are supplied free to the pharmacy, hence the payment collected/ received by pharmacies will be automatically deducted at source from the service payment fees made to pharmacies on a monthly basis. 3.2.2 Care Pathways 3.2.2.1 Pregnant women (and thereafter, new mums) Pregnant women will usually receive an early intervention from a midwife regarding the importance of taking suitable vitamins throughout pregnancy. All pregnant women will now be signposted to go to any pharmacy to register for their free vitamin supply.



Healthy Start women’s vitamin tablets

The daily dose is one tablet, which contains:

70 milligrams of vitamin C

10 micrograms of vitamin D

400 micrograms of folic acid.

They are suitable for vegetarians and free from milk, egg, gluten, soya and

peanut residues. The shelf life is two years from manufacture. Beneficiaries are

entitled to one bottle of 56 tablets every eight weeks.

For those families/ pregnant women that are eligible (see Appendix 3) for the wider national Healthy Start scheme (i.e. for the free vegetables and milk as well as vitamins), midwives will continue to give them the information leaflet which enables them to register with the Department of Health, with relevant authorisation completed. Women eligible for the national Healthy Start voucher scheme will then complete their relevant parts of the leaflet/ form and send to the Department of Health to register their eligibility. It is vital that these forms continue to be returned to the DH so that uptake of the other parts of the scheme are maintained. Pharmacies may encourage/ support individuals to do this.

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It is not the intention that midwives will give women specific names and locations of pharmacies in the Borough in which they are resident who are providing this commissioned service as it is anticipated that the majority of pharmacies will participate in the 2015-16 service. However, all pregnant women will be advised:

that only participating pharmacies will be able to provide the vitamins free of charge

of the requirement to register with a particular pharmacy and remain registered with them, usually for the duration of their eligibility for the vitamins.

Pregnant women will present at a pharmacy who will re-inforce the importance of the vitamins, carefully explain the service and, with written consent

9, register them.

Pharmacy will make the first vitamin supply and issue women with a client-held Healthy Start Vitamin Supply reminder Card to record dates and locations that supplies are made / received - every two months (vitamins last 56 days); this will also help to indicate when the next supply is due.

Women will return to that pharmacy, with their Vitamin Supply reminder Card, to continue registration and receive vitamin supplies until their due date and thereafter, as a new mother, until they are no longer eligible (i.e., when their child is one year old).

Pharmacies will record all supplies made, either directly onto PharmOutcomes or using paper documentation retained until promptly entered onto PharmOutcomes at a convenient time.

Pharmacies will issue a new reminder card when, after her baby is born, the woman moves from an ante-natal to a post-natal supply (even if the ante-natal supply card is not full) and continue to record supplies made as before.

Pharmacies will ensure that women understand the daily dose and that they will not need to take another supply of the same vitamins at the same time. They will therefore remind individuals to inform their GP or check with the pharmacist before taking any other prescribed or purchased vitamins whilst they are pregnant or breastfeeding.

8 If they wish to, pharmacies can provide advice to pregnant women and families, advising that they can check their eligibility

online at https://www.healthystart.nhs.uk/healthy-start-vouchers/do-i-qualify/ and / or apply on-line at https://www.healthystart.nhs.uk/healthy-start-vouchers/how-to-apply/online-application-form/ 9 Space for signature re consent is included on paper Registration forms provided by TVPHSS which should be retained for a

minimum of two years.

https://www.healthystart.nhs.uk/healthy-start-vouchers/do-i-qualify/



3.2.2.1.1 Pregnant women (and thereafter, new mums) from asylum-seeking families Pregnant women from asylum-seeking families who may have late presentation and miss the opportunity for a midwife intervention, may instead be issued with information about the local Healthy Start vitamin service by a specialist Health Visitor that supports asylum-seeking families. A local leaflet will be completed by the Health Visitor and given to the client to present to a named pharmacy to aid communication about the vitamin supply required.

The circumstances of these women/ families mean that they are unlikely to be eligible for the national Healthy Start scheme, yet they may be a group most in need for the vitamins, hence the value of the local free vitamin service. Based on need and location, just one or two pharmacies in each of Middlesbrough and Stockton-on-Tees borough council areas are identified as those pharmacies who will be permitted to register pregnant or post-natal women and clinically eligible children for the local Healthy Start vitamin service. The specialist Health Visitors will signpost these families to these specific pharmacies, who will have additional PharmOutcomes modules to be able to record these particular vitamin supplies. These pharmacies will be annotated on the full list of all provider pharmacies that will be issued of PharmOutcomes and kept up to date on the Tees Valley Public health shared Service website.

3.2.2.2 Children

Babies and young children will usually receive an early intervention from a health visitor regarding the importance of taking suitable vitamins in early childhood. The health visitor will signpost parents /carers to go to any pharmacy to register for free vitamin supply when their children are aged between 6 months old and their fifth birthday. For those families that are eligible for the wider national Healthy Start scheme (i.e. for the free vegetables and milk as well as vitamins), Health Visitors will continue to give them the information leaflet which enables them to register with the Department of Health, with the relevant authorisation completed. Parents /carers of children eligible for the national Healthy Start voucher scheme will complete the relevant parts of the leaflet/ form and send to the Department of Health to register their eligibility. Those requiring help to complete the form may be supported by the pharmacy to complete it

10. It is vital that these forms are

returned to the DH so that uptake of the other parts of the scheme are maintained.

Parents /carers will not be specifically advised of names and locations of pharmacies in the Borough in which they are resident who are providing this commissioned service as it is anticipated that the majority of pharmacies will participate in the 2015-16 service. However, they will be advised

o that only participating pharmacies will be able to provide the vitamins free of charge

10

If they wish to, pharmacies can provide advice to pregnant women and families, advising that they can check their eligibility

online at https://www.healthystart.nhs.uk/healthy-start-vouchers/do-i-qualify/ and / or apply on-line at https://www.healthystart.nhs.uk/healthy-start-vouchers/how-to-apply/online-application-form/

Healthy Start children’s vitamin drops

Children receiving Healthy Start vouchers qualify for free vitamin supplements

from six months old until their fourth birthday. The daily dose of five drops

contains:

233 micrograms of vitamin A

20 milligrams of vitamin C

7.5 micrograms of vitamin D3.

Children who are having 500ml or more of formula a day do not need Healthy

Start vitamins.

The vitamins are suitable for vegetarians and free from milk, egg, gluten, soya and

peanut residues, and have a shelf life of 10 months from manufacture. They come in

10ml bottles, each of which contains just over 56 daily doses. Beneficiaries are

entitled to one bottle every eight weeks.

https://www.healthystart.nhs.uk/healthy-start-vouchers/do-i-qualify/

https://www.healthystart.nhs.uk/healthy-start-vouchers/how-to-apply/online-application-form/



o of the requirement to register with a particular pharmacy and remain registered with them, usually for the duration of their eligibility for the vitamins

Parents /carers will present at their chosen pharmacy, who will re-inforce the importance of the vitamins, carefully explain the service, establish clinical / age- eligibility and with the written consent of the parent/ carer, register the child.

Pharmacy will make the first vitamin supply, ensuring understanding of dose, frequency and need in relation to formula milk (see section 3.4.1), and issue the parent / carer with a client-held Healthy Start Vitamin Supply reminder Card to record dates that supplies are made / received - every two months (vitamins last 56 days); this will also help indicate when next supply is due.

Parents /carers will return to that same pharmacy, with the Vitamin Supply reminder Card, to continue registration and receive vitamin supplies until their child is no longer eligible (up to their fifth birthday).

3.2.2.2.1 Children of asylum-seeking families

Parents/carers of children from asylum-seeking families will be issued with information about the local Healthy Start vitamin service by the specialist Health Visitor that supports asylum-seeking families. A local leaflet will be completed by the Health Visitor and given to the client to present to the pharmacy to aid communication about the vitamin supply required. The circumstances of these families mean that they, and their children, are unlikely to be eligible for the national Healthy Start scheme, yet they may be a group most in need of the vitamins, hence the value of the local free vitamin service.

Based on need and location, just one or two pharmacies in each of Middlesbrough and Stockton-on-Tees borough council areas are identified as those pharmacies who will be permitted to register pregnant or post-natal women and clinically eligible children for the local Healthy Start vitamin service. The specialist Health Visitors will signpost these families to these specific pharmacies, who will have specific PharmOutcomes modules to be able to record their vitamin supplies. These pharmacies will be annotated on the full list of all provider pharmacies that will be issued of PharmOutcomes and kept up to date on the Tees Valley Public Health Shared Service website.

3.3 Population covered There are three specific population groups covered by this service specification:

pregnant women

women with a child under one year of age

children aged 6 months to four years old. 3.4 Any acceptance and exclusion criteria and thresholds 3.4.1 Acceptance criteria For this service specification, there is no distinction in eligibility based on whether a woman or child is eligible for the national Healthy Start scheme or not. It is the aim of the service to increase access to these vitamins for those clinically eligible and in doing so, to particularly meet the needs of those who may be in most need; including those vulnerable groups not covered by the largely income/ benefit-based national eligibility criteria.

Women/ families who are eligible for the national scheme should be encouraged to obtain the vitamins, as well as the vegetables/ milk, and to bring their green national vitamin coupons/ vouchers to the pharmacy if they are able.

To be considered for eligibility for free vitamins under the local scheme, pregnant women, new mums and children aged between 6 months and the date of their fifth birthday, must be resident in one of the Borough Council areas of Middlesbrough, Stockton-on-Tees, Hartlepool and Redcar and Cleveland ONLY

11.

Resident women and children must register with a pharmacy to be able to access free vitamins via the local Healthy Start Vitamins scheme, whether they are eligible for the national Healthy Start scheme or not and with or without a green national Healthy Start vitamin coupon/voucher or not.

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Healthy Start vitamins may be SOLD under the terms of this specification to clinically eligible individuals who are not resident in one of these four local council areas.



Registration information will be provided by women or parents/ carers for children at the time of their providing their written consent for the pharmacy to hold their information to allow free vitamins supplies to be given and all data recorded electronically on PharmOutcomes.

Women will provide their own date of birth and their baby’s estimated due date (and thereafter date of birth) to allow the last eligible date to be calculated.

Parents/ carers will provide a child’s date of birth to ensure clinical and protocol eligibility for the free supply of vitamins under the local scheme. Eligibility is for children over the age of 6 months and until their fifth birthday who meet the criteria specified by the Healthy Start children’s vitamin drops decision tree; i.e., who are having less than 500ml (about a pint) of infant formula a day. Children having 500ml or more of standard formula milk a day do not need Healthy Start Vitamins. Pharmacies should check/ remind parents/carers that children are not given prescribed vitamins, or other self-purchased vitamins, at the same time.

Asylum-seeker families will be directed to, and accepted at, specific pharmacies in Stockton and Middlesbrough only.

Ideally, clients will attend the same pharmacy every time for the vitamins, and bring along their Healthy Start Vitamin supply reminder card.

3.4.2 Exclusion criteria The following criteria exclude the described individual(s)/groups from free vitamin supply under the local Healthy Start vitamin service: Non-residents: Pregnant women, breastfeeding women or children aged 6 months to 4 years old who live outside one of the four Borough Council areas are excluded from free vitamin supply. Vitamins may be sold to clinically eligible women or to parents/carers for clinically eligible children (aged 6 months to five years) who are not resident in one of these four areas; these sales must be recorded on PharmOutcomes as ‘Out of Area Sales’. Not eligible by virtue of a child’s age:

Women whose youngest child is over one year old

Children five years old or over

Children under 1 month old are clinically ineligible for these vitamins

Children presenting for first registration after 1.7.15 and aged between 1 month and 6 months old are not eligible for free vitamins under the 2015-16 scheme

Clinical note in respect of infants under 6 months old:

Most infants under 6 months old will not need Healthy Start Vitamins.

Note that if mothers did not take Vitamin D in pregnancy, it is advised that vitamin drops containing vitamins A, C and D should be given to exclusively breastfed babies from one month of age. However, as the local community pharmacy Healthy Start Vitamin scheme has now been operating for over a year, many women will have accessed the Healthy Start vitamins whilst they were pregnant. It is for this reason that this 2015-16 service specification applies only to children from 6 months of age

12.

Should a pharmacy now encounter one of the small number of women who may present for the first time for registration at the pharmacy from July 2015, and who

DID NOT take Vitamin D in pregnancy (either Healthy Start or in another form) and

whose infants, aged over one month of age and under 6 months of age, are exclusively breast-fed

they may be directed to their general practice for vitamin prescription to be considered.

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There is therefore no facility on PharmOutcomes to record the supply of Healthy Start vitamins to a child aged under 6 months of age.



Once the child is 6 months old, and having less than 500ml of formula milk a day, they may be advised to go to a the pharmacy, to be registered for free Healthy Start vitamins which will REPLACE any prescribed supply (i.e. taking care to ensure that any prescribed vitamins are now stopped).

3.5 Interdependencies with other services

The community pharmacy service provider will be required to use the commissioned wholesale distributor (Lloydspharmacy, Roseberry Park, Middlesbrough) for ordering and receiving of stock and Vitamin Supply Cards.

The community pharmacy service provider will be required to use PharmOutcomes to enter transaction data returning information on vouchers for validation and monitoring purposes.

Midwifery and Health Visiting services in particular will continue to fulfil their duty to advise women and families about the importance of vitamins in pregnancy and the early years, signposting to pharmacies to access the service.

GPs will pick up and prescribe where necessary for any child from one month to six months old that they consider may benefit from vitamins of this type. GPs will also signpost their patients to the pharmacy-led Healthy Start vitamin service.

In exceptional circumstances, where a Healthy Start vitamin product is unavailable on a given day

when the pharmacy is approached to obtain a supply, the pharmacy must use the information provided by the commissioner to signpost the client to the nearest available alternative provider UNLESS the individual prefers, after having been given the option, to wait until such time as their first choice pharmacy (with whom they should be registered) is able to supply, e.g., where there is a widespread low availability of children’s vitamins.

The specified pharmacies in Stockton or Middlesbrough who will supply vitamins to asylum-seeker families may benefit from additional preparedness to support families for whom English is not their first language. Healthy Start leaflets are available in other languages. 3.6 Remuneration Pharmacies will be provided with stock vitamins free of charge (paid for by local authority public health) and must manage stock levels cost-effectively. Stock issues supplied from the wholesaler and issued to clients via a voucher will be balanced and auditable via PharmOutcomes data-entry. All pharmacies will be paid a single one-off and fully inclusive fee of £100 for 2015-16 at commencement of the service; this will be claimable after satisfactory submission of the Self-Validation service implementation template on PharmOutcomes, which will include declaration of attendance at the training event. After a set-up supply, the Commissioned vitamin distribution provider will only continue to supply pharmacies that the TVPHSS have notified them as having agreed to sign/ signed the PH contractual agreement / Contract Variationand completed the Self-Validation template to provide the service. If a pharmacy makes no data-entry related to supplies made within the first 6 months of the stsrt of this service, 50% of this fee may be reclaimed. Pharmacies will be paid a further £1 (plus VAT) per complete PharmOutcomes transaction/ supply record made for supplies made free under the local scheme. Vitamins SOLD will also be recorded and will also attract a £1 (plus VAT) fee per completed transaction record; pharmacies are reminded that this not the preferred route of supply. Since vitamins are supplied free to the pharmacy, the payment collected/ received by pharmacies for any vitamins sold and not supplied free, will be automatically deducted at source (via PharmOutcomes) from the service payment fees made to pharmacies on a monthly basis. Activity through the various pharmacies will be reviewed in real time via PharmOutcomes and pharmacies will be expected to enter their sales/ supplies data promptly to facilitate this. After 6 months of the 2015-16 scheme, vitamin supply/sales activity across the Tees area will be reviewed to establish patterns of uptake across the large number of pharmacies offering the service, check data quality and monitor on-going affordability. There is a set-up cost to the commissioner, including the cost of ‘dead stock’ of vitamins, which



may also incur ongoing costs via ‘out-of-date’ vitamins13

(both ‘direct financial cost’ and the ‘opportunity cost’ of vitamins sitting in one pharmacy whilst another has no stock to issue). Pharmacies recording the lowest levels of activity may need to be de-commissioned to ensure that the cost-benefit of such a service is in balance, seeking best value for the commissioner and the public purse. The LPC will be openly included in determining, and adjusting, the criteria for this review with respect to vitamin uptake, pharmacy activity and performance, and the needs of the commissioner to demonstrate cost-effectiveness and/ or make any service savings.

4. Applicable Service Standards

4.1 Applicable national standards e.g. NICE 4.1.1 National standards for pharmacy premises and clinical governance The pharmacy provider will be operating to appropriate standards of clinical governance as detailed in the Essential Service Specification section of the national Community Pharmacy Assurance Framework (CPAF). A self-declaration will be made on the Healthy Start Vitamin Community Pharmacy Service Self-Validation documentation (via PharmOutcomes) submitted prior to service commencement. The commissioner reserves the right to request that the pharmacy provides confirmation from NHS England of satisfactory assessment performance in the most recent CPAF exercise. Pharmacies should be aware of GPhC premises standards and be operating to those standards. Pharmacies should be mindful of the need to protect patient confidentiality and handle sensitive information within the constraints of the usual Caldecott principles, and the Law including the Data Protection Act. NHS and GPhC principles of good practice in relation to confidentiality and consent Staff should be aware of, and operate within, policies and processes which support Safeguarding. 4.1.2 NICE Guidance PH 11 Maternal and Child Nutrition http://publications.nice.org.uk/maternal-and-child-nutrition-ph11 Antenatal care. NICE clinical guideline 62 (2008) Antenatal care: routine care for the healthy pregnant woman. http://www.nice.org.uk/nicemedia/pdf/CG062NICEguideline.pdf Implementing Vitamin D Guidance – update in progress, expected November 2014 (NICE) 4.1.3 Other Guidance Annual Report of the Chief Medical Officer 2012: Our children deserve better: prevention pays https://www.gov.uk/government/publications/chief-medical-officers-annual-report-2012-our-children-deserve-better-prevention-pays Department of Health (2012). Vitamin D - advice on supplements for at risk groups - letter from UK Chief Medical Officers Healthy Start http://www.healthystart.nhs.uk/ See professional Guidance

Vitamin D. Information for Health professionals. https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/390393/A5_Vitamin_D_leaflet_HCP_FINAL_19.12.14_.pdf

4.2 Applicable local standards One pharmacist and one member of counter or dispensary staff from each pharmacy must be identified as the Service Governance Leads for the HSVCP service. The lead pharmacist will be responsible for establishing the systems and processes in the pharmacy within the constraints of the commissioned service. Suitable SOPs should be in place to support this and ongoing service delivery to suitable standards. The

13

This is particularly common for the children’s vitamins which only have a ten-month shelf-life from the date of manufacture.

http://publications.nice.org.uk/maternal-and-child-nutrition-ph11



http://www.nice.org.uk/nicemedia/pdf/CG062NICEguideline.pdf

https://www.gov.uk/government/publications/chief-medical-officers-annual-report-2012-our-children-deserve-better-prevention-pays

https://www.gov.uk/government/publications/chief-medical-officers-annual-report-2012-our-children-deserve-better-prevention-pays



http://www.healthystart.nhs.uk/




identified Service Governance Lead staff will support the cascade of training and documentation protocols to the remaining pharmacy staff. In accordance with good pharmacy practice and accepted principles and standards of clinical governance, staff delivering the HSVCP service must be suitably trained, having appropriate qualifications, knowledge and skills to undertake their own specific tasks, roles and responsibilities in relation to this service. All frontline staff should be competent / developing competencies in using behaviour change techniques/strategies and interventions towards ‘Making every Contact Count’. This supports the proactive and not just responsive approach required of this service. A consultation room to national standards should be available; however the need to use the consultation room should be assessed at each client visit and take the individual’s needs and preference into account. Pharmacies should be mindful of the need for suitable chaperones to be available; this may be particularly relevant to the asylum-seeking client group. Where a consultation does not take place in a confidential space, the provider should ensure that suitable levels of privacy are maintained in accordance with the supply of the HSV. This may be of particular relevance during the registration process when personal information is collected and written consent to hold that data is obtained. Pharmacies should complete and submit (via PharmOutcomes) a Self-Validation / assessment document for the service before the service commences. This will include reference to suitable declaration on the above and on policies and processes in place for managing risks, incident reporting and the handling of complaints. Complaints and incidents related to the service should be resolved locally within the pharmacy or any wider parent organisation where possible. It is intended that a generic complaints/incidents section will be available on PharmOutcomes to support summary-reporting to the Commissioner for all public health services. Until such time as this is available, it is helpful if the Commissioner is kept informed of any incidents to be able to understand and manage any risks/ share any learning with other providers. 4.3 Training standards Initial training will be organised and provided on behalf of the commissioner. A minimum of one, ideally two, individuals will be trained via the initial face to face training session; both the pharmacist and pharmacy staff lead identified above. As many places as possible will be made available such that the pharmacy may send as many staff as they wish/ to provide resilience in case of staff movement / absence. Staff will be required to undertake one session of initial face to face training which will be locally delivered in conjunction with the LPC. Pre- and post- (initial training) knowledge-based learning may also be required to support safe and effective operation of the service. Training will need to be cascaded throughout the staff of the pharmacy to ensure all members of the team understand their roles and responsibilities in delivering this service. Training/ learning updates / contract changes will be shared with pharmacies via PharmOutcomes. Pharmacies should include the need to regularly read and act upon PharmOutcomes messages as well as enter service data accurately and promptly.

5. Location of Provider Premises

Pharmacies across each Borough Council area will be commissioned to provide this service. An up to date list of providers will be maintained on PharmOutcomes for signposting reference purposes and/ or via the TVPHSS website.

6. Required Insurances

See main Public Health Contract



7. Service Quality Outcomes

7.1 Service Quality Principles Pharmacies will complete a self-validation assessment / self-declaration via PharmOutcomes before starting the service. Pharmacies will meet the required training and accreditation requirements. Pharmacies will deliver the service to a standard commensurate with good pharmaceutical professional practice, and the law, including reasonable promptness of vitamin supply and treatment of clients with a suitable level of dignity and respect, and adequate security of patient information. Promptness and accuracy of data handling is a key quality requirement; interventions and supplies should be logged on PharmOutcomes within 1 month of the date that they took place to ensure prompt payment. However, it would be good practice for vitamin sales/ supplies to be entered onto PO within one week. Pharmacies must log the client eligibility (in respect of the national Healthy Start scheme) correctly on PharmOutcomes to ensure the local authority is able to make suitable claims for DH reimbursement to Public Health. Pharmacies will maintain an incident record in the pharmacy, as they would for any other service or activity in line with good clinical practice/governance. Pharmacies will log stock receipts and issues and undertake to complete an exception report log (e.g., to report any ‘out-of-stock’ situations via PharmOutcomes where templates are available. Pharmacies will agree to participate in patient satisfaction surveys and any reasonable review or audit without additional fees, which will, where possible, be managed through PharmOutcomes. Pharmacies will act upon any reasonable improvement notices advised.

Version Control – 2015-16 Draft v1 - 2015-16 updated specification to LPC 27.5.14 PW Draft v2 – 28.5.14 PW Draft v2.1 LPC feedback on version 2 Draft v5 full markup revision after LPC Draft v6 markup revision after LPC comments left Final draft Final issued version (this version) July 2015



APPENDIX 1 Figure 1. Example of coupon for Healthy Start vitamins that might be presented by those individuals eligible for the national Healthy Start scheme (which also includes vouchers for milk and vegetables)

Figure 2. Example of both sides of the client-held Healthy Start Vitamin Supply reminder Card



APPENDIX 2

Example of the unique Pharmacy ‘Public Health’ codes for pharmacies in Tees:

Unique Code Name Identifier Local Authority Area

H01 Asda Pharmacy Marina Way Hartlepool

H02 Boots UK Limited Marina Way Hartlepool

M07 Eston Pharmacy Norchem, Eston Middlesbrough

M08 F I Maguire Marton Pharmacy Middlesbrough

R14 Lloyds Pharmacy Loftus Redcar and Cleveland

R15 Lloyds Pharmacy Dormanstown Redcar and Cleveland

S24 Rowlands Pharmacy Tennant St Stockton on Tees

S25 Rowlands Pharmacy Yarm Lane Stockton on Tees

The full list will be available to access via PharmOutcomes and the TVPHSS website.

APPENDIX 3

From the Healthy Start website, an individual will qualify for the national Healthy Start vouchers and vitamin coupons in the following circumstances:

Women at least 10 weeks pregnant or have a child under four years old

and they or their family get:

Income Support, or Income-based Jobseeker’s Allowance, or Income-related Employment and Support Allowance, or Child Tax Credit (but not Working Tax Credit unless your family is receiving Working

Tax Credit run-on only*) and has an annual family income of £16,190 or less (2014/15).

Women also qualify if they are under 18 and pregnant when they apply, even if they don’t get any of the above benefits or tax credits.

*Working Tax Credit run-on is the Working Tax Credit you receive in the 4 weeks immediately after you have stopped working for 16 hours or more per week (single adults) or 24 hours per week (couples).

We know that the benefits system is changing and that Universal Credit is being expanded to families. This means that, due to a change in circumstances, you may be assessed for entitlement to Universal Credit instead of the benefits you or your partner were claiming previously. Alternatively you may be new to the benefits system and may be assessed for entitlement to Universal Credit from the start of your claim. Whatever your circumstances, if you are claiming Universal Credit and are pregnant, or have a child under four years old, make sure you call the Healthy Start helpline on 0345 607 6823 or email on [email protected] for information about any discretionary support that may be available.

Families can apply on-line at https://www.healthystart.nhs.uk/healthy-start-vouchers/how-to-apply/online-application-form/

mailto:[email protected]





APPENDIX 4

List of paper documentation and associated PharmOutcomes templates used for this service: NB. Service specification: Healthy Start Vitamins (Community Pharmacy) – (HSVCP) is primary service reference Document ref

Document Name Purpose PharmOutcomes module What to do with it

HSV15/01

Healthy Start Vitamins Service Sequential Vitamin Supply Card numbers.pdf

List of sequential numbers for clients/patients registered for the Healthy Start Vitamins Service.

Not applicable Retain list on paper or in accessible word/ excel doc for as long as any of the individuals on the list are still registered for the service.

HSV15/02

HSV WOMAN Registration Form A4.pdf. Healthy Start Vitamins Service Registration and Consent Form: Women

Form to register women for HSV service and obtain written consent

Womens Healthy Start Vitamins Registration 2015/16

Retain signed paper copy for minimum two years

HSV15/03

HSV CHILD Registration Form A4.pdf Healthy Start Vitamins Service Registration and Consent Form: Child

Form to register child for HSV service Register child and obtain written consent

Child Healthy Start Vitamins Registration 2015/16

Retain signed paper copy for minimum two years

HSV15/04 Pharmacy Public Health Code List.pdf To find the Public Health Code for your pharmacy (used for Vitamin Supply Card number) and any other pharmacy that your HSV clients may attend as shown on their Vitamin Supply Card

Not applicable Accessible version of list, either paper or electronic, needed for reference in the pharmacy

HSV15/05 free SUPPLY RECORD HSV final.pdf Healthy Start Vitamins Scheme – Record of FREE Vitamin SUPPLIES Only

Two pages - Record of free supply of Healthy Start Vitamins for eligible women and children

Womens Healthy Start Vitamins Provision 2015/16 OR Child’s Healthy Start Vitamins Provision 2015/16

Once logged onto PharmOutcomes, retain for 6 months for audit /validation purposes then paper copy may be destroyed

HSV15/06 SALES Healthy Start Vitamin Supply record.pdf

Two pages - Record of SALES of Healthy Start Vitamins for clinically eligible women and children

SALES only Healthy Start Vitamins 2015/16

Once logged onto PharmOutcomes, retain for 6 months for audit /validation purposes then paper copy may be destroyed

HSV15/07 Issuing a new Vitamin Supply reminder Card

Info sheet for issuing / completing the card and creating Vitamin Supply Card Number

Not applicable Reference doc only. Keep in service file

HSV15/08 Process notes for the Healthy Start Vitamin Service 2015

Guidance to support HSV service implementation

Not applicable Reference doc only. Keep in service file

2014/15 public health services contract service

Documents