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Product Design Specification

Meds & Travel


Improving Medication Adherence Whilst Travelling

Produced by Steven Pickett


11 November 2017
Product Design Specification
Project Title: Meds & Travel: Improving Medication Adherence When Travelling.

Amendments
Issue No. Date Description
1 23/10/2017 Product design specification issue 1.
2

1.0 Scope

This specification will outline the requirements needed to design a successful product
solution. The product will address the issues of medication adherence that young adults,
aged between 18 and 24 experience whilst travelling. It aims to achieve this by making
carrying and dispensing of tablet/capsule medication more desirable and user friendly to
encourage better rates of adherence.

2.0 Background (Context)

Taking medication as a young adult can feel like a burden on your life, however the words
keep taking your tablets are probably the best-known mantra in modern medicine. The
failure of patients taking their medication on time has been an issue for years and can be
described as non-adherence, non-compliant and concordance - whichever term you prefer,
all refer to the extent to which patients take their medication as prescribed.1, 2 The three key
elements involve taking a medicine at the right dose, the correct dosing frequency and for
the recommended treatment duration.3 Failing to take medicines as recommended can have
negative consequences; for some this may be related to symptom control or therapeutic
relief but poor adherence can be serious and may manifest itself in disease such as
malaria.1,3,4,5

According to WHO6 (World Health Organisation) up to 50% of people in the UK do not take
their medication as prescribed7 and as a direct result this costs the NHS an estimated 500
million every year8 and even more tragically, across Europe, non-adherence accounts for
over 200,000 deaths9. One issue that has a dramatic influence of a patients adherence to
medication is travelling. Surprisingly, young adults aged between 18 to 24 years are
significantly less likely to take their prescribed drugs with up to 65% of missed prescriptions
blamed solely on their forgetfulness10 followed closely by transportation difficulties.

This is becoming an increasing problem as youth travellers represent an estimated 23% of


all international travellers in one of the fastest growing segments of the international tourism
2
market in 2015.11 More worryingly, with a shift of many millennials choosing to visit more and
more remote destinations with limited access to healthcare, it is proving absolutely vital to
ensure that these individuals have their medications available at times that they are needed
most.

Between the ages of 18 and 24 years it is easy for an individual to neglect their health as
they become more independent. Without the tools to manage and organise themselves and
their medication; the individuals wellbeing can suffer. In an attempt to resolve this issue, the
market for medication storage has boomed and the market is saturated. However, many
existing travel containers are big and bulky, targeting a wide demographic of patients taking
a number of different drugs.

Existing products can cause social anxiety, given many have out-dated and medical
aesthetics, shaming an individuals medical issues.12 For the modern traveller, large
compartments and lots of separated storage spaces are unnecessary as style, size and
functionality are more desirable for medication storage on the move.
Many young individuals that are fit to travel also only require enough of a supply of specific
drugs; such as antimalarial tablets, contraception pills and other medication to see them
through to the end of their trip, rendering these large and out-dated multidrug storage
containers inadequate. For this reason, a user friendly and aesthetic single drug containing
and dispensing unit is needed to fulfil a niche in the travel market that encourages medical
adherence.

3.0 Market

The issue of non-adherence to medication is experienced across the UK, however the risk of
health deterioration is increased dramatically whilst an individual is travelling or backpacking,
as access to healthcare services becomes more distant. For travellers between 18 to 24
years this issue is elevated, as many individuals at this age may be slightly vulnerable
having never experienced such independence before13 and health problems may arise due
to poor adherence to their prescribed medications.

The product solution to this problem has a huge potential market, targeting those out of the
284 million young international travellers14 on single-dose medications such as pills and
tablets, spending on average 2,700 per trip lasting between one to two months (58 days).15

Many existing products on the market are big and bulky, targeting a wide demographic of
patients taking a number of different drugs. As a result the market is saturated with
inexpensive yet poor functioning medication containers that do little to encourage medication
adherence whilst travelling. One brand that successfully markets similar competitive
products is Sabi,16 however their products are not designed for the demands of travellers.

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4.0 Definitions

4.1 Dispense - To make up and distribute (medicine).

4.2 Medication - A medicinal substance.

4.3 Burden - An entity borne with difficulty.

4.4 Mantra - A often repeated word, formula, or phrase.

4.5 Adherence - The extent to which patients are able to follow the
recommendations for prescribed treatments.

4.6 Non-Adherence - Poor adherence of a patient the taking their


recommended prescription; also see Non-Compliance.

4.7 Concordance - An agreement or consistency for taking medication


between the patient and healthcare professional.

4.8 Therapeutic - The branch of medicine concerned with the treatment


of disease and the action of remedial agents.

4.9 Malaria - A mosquito-borne infectious disease.

4.10 Backpacking - A form of low-cost, independent travel. Includes the use


of a backpack carried for long distances/time period.

4.11 Millennial - The demographic cohort that directly follows


Generation X, consisting of individuals born between
1982 and 2004.

4.12 Wellbeing - The state of being comfortable, healthy, or happy.

4.13 Social anxiety - The fear of social situations that involve


interaction with other people.

4.14 Aesthetics - The philosophy dealing with the nature of beauty.

4.15 Deterioration - The process of becoming progressively worse.

4.16 Single-dose - Medication which requires only one measure if


prescription.

4
5.0 Details

5.1 Performance
5.1.1 The product has to be able to contain adequate supply of
pill/tablet/capsule form medication for an average trip.15
5.1.2 The product should contain a minimum of 30 average sized pills with a
minimum internal volume of 848mm3 or be easily refilled on the move;
see appendix 1.
5.1.3 The product must have the ability to dispense single-dose forms of
medication on demand.
5.1.4 The product must be able to be refilled in less than 2 minutes.
5.1.5 The product should protect its contents from ingress and immersion
up to a depth of 1 meter by conforming to the IP67 standard.17
5.1.6 The product should appeal to the user psychological needs through
aesthetics, usability, functionality and form in order to encourage the
user to adhere to their medication whilst traveling.
5.1.7 The product should have an attachment feature to make it easy to
carry/transport.
5.1.8 The product should be form must make it easy to transport.
5.1.9 The products compartment should be easy to clean with a rinse of
water or wipe.
5.1.10 The product must have a non-medical aesthetic to encourage user
interaction and medical adherence.
5.1.11 The product should use design, materials, colour and psychology to
encourage medical adherence with its users while they travel.
5.1.12 The product should be ambidextrous and operable with one hand.
5.1.13 The product must give an indication or display the amount of
medication left in the device display to ease management of
medication.
5.1.14 The product must have a feature where the medication details are
recorded for emergency purposes, taking into consideration UK
regulations for medical packaging, labelling and patient information
leaflets.18
5.1.15 The product should make access medication easy for the user
however it should take measures to be access tamper resistant; see
standard for reclosable packaging BS EN ISO 8317.19
5.1.16 The product should integrate into the users lifestyle so that they can
be consistently reminded to take their medication whilst travelling.
5.1.17 The product needs to be simple12 yet fun to use to engage with its
user and promote adherence to medications.
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5.2 Ergonomics
5.2.1 The product should be easy and intuitive for the user to operate.
5.2.2 The product will be portable by being able to fit inside a standard
pocket 5 by 6 inches; see appendix 2.
5.2.3 The product should be ambidextrous and fit comfortable into users
hand.
5.2.4 The user product should be designed for the 5th female to 95th male
percentile of its primary user group; see ergonomics and
anthropometrics data.20
5.2.5 The product must not cut or damage the users skin when being
handled.
5.2.6 It is desirable for the secondary market or users aged 18-29
(millennials) also to be able to use the product.

5.3 Environment
5.3.1 The product should be able to protect its contents subject to normal
rainfall and ingress.
5.3.2 The product must operate normally in temperatures ranging from -5 to
50 Celsius, for travelling in a range of climates.
5.3.3 The products casing should be impervious and undamaged by normal
washing liquids, sand, salt and mud and water and water vapour.
5.3.4 The product should consider implications on the environment if the
product was abandoned.
5.3.5 The product should be designed for use in-flight and airport
regulations.

5.4 Aesthetics
5.4.1 The product should have a contemporary but non-medical aesthetic to
appeal to its young user group.
5.4.2 The product must have a feature where the user can insert details of
medication for emergency purposes.
5.4.3 The aesthetics must represent a professional product image through
the use of appropriate colour, material selection and application.
5.4.4 The product should use semiotics to make the product intuitive and
user friendly.
The aesthetic of the product should promote well-being in an attempt
to boost adherence.
5.4.5 The product should appear as premium in comparison to its
competitors.

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5.5 User
5.5.1 The primary user of the product will be male or female and aged
between 18 to 24 years old.
5.5.2 The secondary user of the product will be millennial travellers, aged
18 to 29 years old.
5.5.3 The users will also be participating in a form of independent travel or
are in the process of planning.
5.5.4 The user of this product will be taking a pill/tablet form of single-dose
medication such as antimalarials, contraception etc.
5.5.5 The primary user will reside within the UK, however an appreciation to
international markets and culture should be considered.

5.6 Materials
5.6.1 The surface of the product must not be damaged by dust and water
ingress.21
5.6.2 The product should be made of a shatter resistant material as a
precaution for if it gets knocked from a raised surface.
5.6.3 The materials used will be non-hazardous and safe to be in contact
with the users medication; see food safe materials.22
5.6.4 Materials should have the ability to be sterilized; see serializable
plastics.23
5.6.5 All materials will be UV stable as the product may be exposed to
sunlight.
5.6.6 There must be global availability and access to materials for
manufacturing.
5.6.7 The product and its packaging will be made from recycled materials
where possible (subsequent to quality control and availability).

5.7 Packaging
5.7.1 The packaging for the product should be designed for point of sale.
5.7.2 The packaging must contain and protect the product from damage.
5.7.3 The packaging should be recyclable and/or reusable to so that the
product has a sustainable appeal and achieves CE accreditation.
5.7.4 The packaging must be durable enough to be reused and sent back
for returning goods.
5.7.5 The products packaging will tessellate or stack efficiently to reduce
storage space needed and shipping/transportation costs.
5.7.6 The packaging must advertise the packaging contents.
5.7.7 The packaging will be clear to understand, appealing to the target
market demands.
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5.7.8 The packaging must use images of the product and context.
5.7.9 The packaging must adhere to the products color scheme.
5.7.10 The packaging will contain or illustrate instructions for use.
5.7.11 The products packaging should be designed to be sold both online
and instore.
5.7.12 The product must be designed with consideration for shipping

container sizes.

5.7.13 The packaging should label disposable components.

5.8 Size
5.8.1 The product must be small enough to operate and hold with one hand.
5.8.2 The product will be portable by being able to fit inside a standard
pocket that is 5 by 6 inches in size; see appendix 2.
5.8.3 The product should fit easily into the average bag, backpack or
handbag.
5.8.4 The packaged product should be smaller than 353mm by 250mm by
25mm to fit into so it can be sold online and posted as a large letter,
saving postage costs.24
5.8.5 The product should have a minimum internal capacity for 14 average
sized tablets and a maximum capacity for 58 to 60 average sized
medical tablets.

5.9 Safety
5.9.1 The product will have no small or loose components as they can be
choking hazards. This relates to European Standard EN71.21
5.9.2 The materials used will be non-hazardous and safe to be in contact
with the users medication; see BS5577 for food safe materials.22
5.9.3 The product should have no sharp edges so that the user cannot
injure or cut themselves whilst holding the product.
5.9.4 There must be a feature on the product for the user to label their
medication it contains. Consider the UK government legislation for
Medicines: packaging, labelling and patient information.18
5.9.5 Misuse of the product should be considered in the products design.

5.10 Manufacture
5.10.1 Manufacture drawings will be completed to BSI/ ISO standards; see
BS 8888:2017, Technical product documentation and specification.25
5.10.2 The product should be manufactured using mass production
techniques.
5.10.3 The manufacture process should allow the product to be sterile.
5.10.4 All polymer components will be designed to be injection moulded and
family mouldings should be considered in an attempt to save costs,
control quality and assemble kitted parts.
5.10.5 The product design must allow for efficient and cost-effective

manufacturing of parts.

5.10.6 The manufacturing processes must allow for a range of coloured


options.
5.10.7 It is desired that manufacture and assembly of the product will take
place across the least number of manufacturers in order to reduce the
productions carbon footprint.
5.10.8 The manufacture of the product should follow TQM (Total Quality
Management) procedures.

5.11 Market
5.11.1 The product will primarily target young international travellers 18 to 24
years residing in the UK, with a secondary market made up of 284
million millennial travellers across the world, aged 15 to 29 years.14
5.11.2 The user will be planning to take a variant of tablet form, single-dose
medication on their travels such as antimalarial, contraception
hypothyroidism drugs etc.
5.11.3 The products primary market will be in the UK, however international
markets should be considered for future ventures.
5.11.4 The average user will be travelling/backpacking with an average stay
of 58 days.15
5.11.5 The product aims to target the estimated 3 million young individuals
from the primary market alone year residing in the UK alone; see
appendix 3.
5.11.6 There is a secondary market for general pill/tablet storage to
encourage adherence at work, whilst commuting or within individuals
homes.

5.12 Competition
5.12.1 The product should differentiate itself, in terms of design and
branding, from its completion as the market is already saturated; see
an example of market competition in appendix 4.
5.12.2 Competitive products range in prices from 1 to 20.
5.12.3 Competitive products tend to be for storage of multiple medications
and are large and unsuitable for travelling.
5.12.4 Products in original packaging can cause embarrassment and poor
medical adherence whilst travelling.12
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5.13 Quantity
5.13.1 The product should achieve sales of in year 1 to be 15,000 units
(0.5% of primary market), year 2 to be 25,000 units (0.83% of primary
market), year 3 to be 40,000 units (1.33% of primary market).
5.13.2 The product should be marketed internationally between years 2 to 4
to help increase the demand and sales of the product.
The product sales will reach maturity between years 5 to 7 with
volumes expected of 60,000 units (2% of primary market).

5.14 Cost
5.14.1 The user expects to pay 5 to 20 for this product depending on its
quality and functionality.
The products aims to be priced close to 10 with a minimum of 70%
profit margin.
5.14.2 Material cost per product should be no more than 30% of the RRP
(Recommended Retail Price).
5.14.3 Packaging cost should be under 20% of unit cost as it is a disposable
item.

5.15 Quality & Reliability


5.15.1 The product should be premium quality in to build a to ensure the
product is reliable and differentiate itself on the market, appealing to
the primary user group. This reliability or confidence with the user
should encourage adherence according to Amy Bucher a psychologist
from Johnson & Johnson Company.12
5.15.2 The products quality should be appropriate for its price and intended
life span.
5.15.3 Quality control during manufacturing should guarantee a maximum of
2% faulty products.

5.16 Weight
5.16.1 The product must weigh less than 25kg to comply with European
Directive 76/211/EEC.
5.16.2 The product must weigh less than 0.5kg so that it can be transported
and carried with ease at a low packaging cost; see Royal Mail cost for
large letters.24
5.16.3 The product should have an even weight distribution so that it can be
carried with balance and rattling of medication is reduced.

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5.17 Life in Service
5.17.1 The product is expected to withstand forces and elements exerted
upon it during the users travels in a range of conditions.
5.17.2 The product will be designed so that it can be wiped or rinsed clean
during its life span.
5.17.3 Features such as living hinges should be designed to withstand
normal use over the products lifespan.

5.18 Disposal
5.18.1 The design should consider ease of the dismantling of the product so
that different parts may be recycled.
5.18.2 The product should be able to be safely disposed of across the world
as the user travels.
5.18.3 The packaging should be designed to be fully recyclable.
5.18.4 It is desirable that packaging has disposal information on it.

5.19 Product Life Span


5.19.1 The product is expected to last for a minimum of 5 average trips (240
days of travelling); see appendix 3.
5.19.2 The users of the product anticipate it will last between 2 to 5 years of
normal use.

5.20 Standards
5.20.1 The product should comply to relevant standards for the nature of the
product and its use; see examples below.
5.20.2 The product should comply to BS EN 60529:1992+A2:2013 with an
IP67 protection rating to protect its contents from dust and water up to
1m depths.17
5.20.3 The product should comply to British Standard BS EN 71 small parts
and choking hazards.21
5.20.4 The product should comply to British Standard BS EN ISO 8317 for
reclosable packaging.19
5.20.5 The product should comply to British Standard BS 5577:1999 for
Specification for table cutlery to guarantee materials are food safe as
they are in contact with users medications.
5.20.6 The product should comply to British Standard BS 8888:2017,
Technical product documentation and specification for all technical
drawings produced. This will ease manufacture and ensure the design
is communicated accurately.

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5.21 Patents
5.21.1 The product should not conflict with current UK or US patents unless a
licensing agreement is arranged; some examples are below.
5.21.2 The product should not infringe with the patent: GB 1318450A;
Dispensing device for pills and the like.
5.21.3 The product should not infringe with the patent: US 20070138049A1;
Medicament dispenser and associated methods.
5.21.4 The product should not infringe with the patent: US 6758338B2;
Accessible medicinal dosage carrier.
5.21.5 The product should not infringe with the patent: US 1974332A; Pill
dispenser.
5.21.6 The product should not infringe with the patent: US 5791515A; One at
a time pill/medication dispenser.
5.21.7 The product should not infringe with the patent: US 4653668A;
Medicament dispensing container.
5.21.8 The product should not infringe with the patent: US 3004566A; Pill
Dispenser.
5.21.9 The product should not infringe with the patent: US
20040094567A1; Tablet dispenser for dispensing individual tablets or
US 20050051454A1; Case with pill receiving sleeves for storing and
dispensing pills.

Continue to next page.

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6.0 Appendices

Appendices 1

Average round tablet26


T = 2mm, D = 6mm, R = 3mm
Tablet volume = R2 = 32 = 28.27mm3
Min Volume for 30 tablets = 30 * 28.27 = 848.23mm3

r
Appendices 2

Average pocket size = 5 by 6 inches.27

Appendices 3

70.8 million visits overseas by UK residents in 2016.28


19 - 29 make up 23% of travellers.11
Minimum of 20% of travellers take some sort of medication.
Estimate of target market capacity = 70.8*0.23*0.2 = 3.25 million

Appendices 4

The average travelling trip for the user group is between 1 to 2 months
(58 days).15 58 days * 5 = 290
The product should last a minimum of 290 days of continual use without
deteriorating in quality.

Appendices 5

Examples of competitive products.

Continue to next page.

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7.0 References

1 Aronson J. Compliance, concordance, adherence. Br J Clin Pharma- col 2007; 63(4):


383-384.

2 Van den Bemt B, Zwikker H, Van den Ende C. Medication Adherence in Patients
With Rheumatoid Arthritis: A Critical Appraisal of the Exist- ing Literature: Adherence
Terminology: Adherence, Compliance and Concordance. Expert Rev Clin Immunol
2012; 8(4): 337-351.

3 Bruxvoort K, et al. How Patients Take Malaria Treatment: A System- atic Review of
the Literature on Adherence to Antimalarial Drugs. PLOS One 2014; 9(1).

4 Siddiqui M & Ruby, et al. Adherence to Artemisinin Combination Therapy for the
treatment of uncomplicated malaria in the Demo- cratic Republic of the Congo.
F1000 Research 2015; 4(51).

5 Adherence to antimalarial treatments in the real world does it really matter?.


(2017). 1st ed. [ebook] Medicines for Malaria Venture, p.p1. Available at:
https://www.mmv.org/sites/default/files/uploads/docs/publications/Articles/Adherence
_to_antimalarial_treatments_in_the_real_world.pdf [Accessed 23 Oct. 2017].

6 Adherence to Long-Term Therapies - Evidence for action. (2003). [ebook] Geneva,


Switzerland: World Health Organisation, p.Full Text. Available at:
http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf [Accessed
23 Oct. 2017].

7 Sabat E, editor, ed. Adherence to Long-Term Therapies: Evidence for Action.


Geneva, Switzerland: World Health Organization; 2003.

8 The True Cost of Medication Non-Adherence. (2017). 1st ed. [ebook] UK: Omnicell,
Full Text. Available at: http://www.letstakecareofit.com/wp-
content/uploads/2015/10/The-True-Cost-of-Medication-Non-Adherence-Report.pdf
[Accessed 23 Oct. 2017].

9 The True Cost of Medication Non-Adherence. (2017). 1st ed. [ebook] UK: Omnicell,
p4. Available at: http://www.letstakecareofit.com/wp-content/uploads/2015/10/The-
True-Cost-of-Medication-Non-Adherence-Report.pdf [Accessed 23 Oct. 2017].

10 The True Cost of Medication Non-Adherence. (2017). 1st ed. [ebook] UK: Omnicell,
p20. Available at: http://www.letstakecareofit.com/wp-content/uploads/2015/10/The-
True-Cost-of-Medication-Non-Adherence-Report.pdf [Accessed 23 Oct. 2017].

11 World Tourism Organisation (2016), Affiliate Members Global Reports, Volume


Thirteen - The Power of Youth Travel, UNWOTO, Madrid

12 BLOG: 6 guidelines for medication adherence. (2017). [Blog] Managed Healthcare


Executive. Available at:
http://managedhealthcareexecutive.modernmedicine.com/managed-healthcare-
executive/content/tags/medication-adherence/blog-6-guidelines-medication-
adherenc?page=full [Accessed 23 Oct. 2017].

13 Bynner,J. 2017. Young People's Changing Routes to Independence. Full Text.


Joseph Rowntree Foundation/YPS.

14 Wysetc.org. (2017). Facts and Stats | WYSE Travel Confederation. [Online] Available
at: https://www.wysetc.org/facts-and-stats/ [Accessed 24 Oct. 2017].

14
15 Reynolds, J. (2017). Travel Trends by Age Demographic. [Online] Groupstoday.com.
Available at: http://groupstoday.com/business/404-travel-trends-by-age-demographic
[Accessed 24 Oct. 2017].

16 designed2enable. (2017). Pill Boxes and Organisers. [Online] Available at:


http://www.designed2enable.co.uk/category/pill-boxes-and-organisers?page=1
[Accessed 24 Oct. 2017].

17 BRITISH STANDARDS INSTITUTE, 2013. BS EN 60529:1992+A2:2013, Degrees of


protection provided by enclosures (IP code). London: British Standards Institute.

18 Gov.uk. (2017). Medicines: packaging, labelling and patient information leaflets -


GOV.UK. [online] Available at: https://www.gov.uk/guidance/medicines-packaging-
labelling-and-patient-information-leaflets#uk-and-european-regulation [Accessed 28
Oct. 2017].

19 BRITISH STANDARDS INSTITUTE, 2015. BS EN ISO 8317;2015, Child-resistant


packaging. Requirements and testing procedures for reclosable packages. London:
British Standards Institute.

20 Pheasant, S. and Haslegrave, C. (2005). [book] Bodyspace. 2nd ed. London: CRC
Press, p.83-92.

21 British Standards Institute. (2017). EN 71. [online] Available at:


https://www.bsigroup.com/en-GB/ [Accessed 27 Oct. 2017].

22 British Standards Institution, 1999, BS5577:1999 Specification for table cutlery.


European Parliament and Council, 2004, Regulation (EC) No 1935/2004 on Materials
and Articles intended to come into contact with food. Accessed on 29th October 2017
at http://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:02004R1935-
20090807

23 Industrialspec.com. (2017). Plastics Compatability with Sterilization Methods. [online]


Available at: https://www.industrialspec.com/resources/plastics-sterilization-
compatibility/ [Accessed 29 Oct. 2017].

24 Postoffice.co.uk. (2017). UK Standard Delivery | Post Office. [online] Available at:


https://www.postoffice.co.uk/mail/uk-standard [Accessed 29 Oct. 2017].

25 British Standards Institution, 2017, BS 8888:2017, Technical product documentation


and specification. Available at:
https://shop.bsigroup.com/ProductDetail/?pid=000000000030334593 [Accessed on
29th October 2017].

26 Pill Sizes image. Digital Image. Puritans Pride. Web. Available at:
https://images.vitaminimages.com/pp/images/pillsizes_chart.png [Accessed 24 Oct.
2017].

27 Inseam Studios. 2017. How to sew a patch pocket. [Online]. Available at:
http://inseamstudios.com/sew-patch-pocket/. [Accessed 27 October 2017].

28 Travel trends: 2016. (2017). People, population and community; Leisure and tourism,
[online] (1), p.2. Available at:
https://www.ons.gov.uk/peoplepopulationandcommunity/leisureandtourism/articles/tr
aveltrends/2016 [Accessed 28 Oct. 2017].
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