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PBL A3 Presentation

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Nneoma Chigbundu

on 4 February 2014

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Transcript of PBL A3 Presentation

Group members: Irsalan Ahmed, Victor Wai, Angarjan Kalaivannan, Susanna Fasasi, Sophie Henry, Margo Hollamby & Nneoma Chigbundu.

Our Scenario
Group A3 PBL Presentation
The Medicines:
Herbal Medicines
Learning Objectives:
What is it?

Chitosan is a carbohydrate which is obtained from the outer shell of crustaceans such as crabs, lobsters & prawns.
Its chemical name is Poly-D-Glucosamide.
It is produced from the de-acytlation of Chitin[1]
It is classified as a biopolymer, but is not a licenced medicine, rather it is a food supplement which can be found at Holland & Barrets, Boots and a various other retailers.
Method Of Action
What is a herbal medicine?

What are the UK regulations on herbal medicines?

How safe are they?

How effective are they?

Marketing Authorisation (MA)[22]
Weight Management Leaflet
Using the internet
Trustworthy sites for medicine info:
NHS Direct
Electronic Medicines Compendium
nice.org .uk
The Royal Pharmaceutical Pharmacy Society has approved two sites for obtaining POM medicines on the internet;
This is assuming you have a prescription from a registered UK pharmacist

Does It work?
Evidence suggests that it can not reduce cholesterol. It has similar effects to a placebo in most studies due to its low concentration in capsules.
Meta analysis suggests some effect on weight loss but the evidence is poor/unlikely to be of clinical significance.[17]

High cholesterol
Crohn's disease
Dental Cavities.
Applying N-carboxybutyl chitosan directly seems to help donor site tissue rebuild in plastic surgery.
Plant growth regulator[15]

Don't use in pregnancy/breast feeding
Shellfish allergy may/may not be an issue
Chitosan soaks up fat soluble Vitamins A, D, E & K in its action. You must take a multi vitamin product to compensate.[16]
Contraindication: Warfarin
It is a fibrous substance that might block absorption of dietary fat and cholesterol.
In conclusion we would advice the patient to try other proven weight loss methods first before trying supplements.
Advise patient that evidence of weight loss using Chitosan is not fully proven.
We would also ask him to exercise caution when buying medicines online.
We would offer him encouragement to keep applying for jobs, as it is illegal to discriminate against a person due to their weight according to The Equality Act 2010.
The leaflet the pharmacist made would be placed in a visible section in the pharmacy in the hope that it could help people in the future.

A patient comes into your community Pharmacy to collect his regular prescription for Levothyroxine, he also asks for some advice.
He is looking for a leaflet about weight loss and would like to purchase some Chitosan capsules to help him lose weight, he had previously tried methylcellulose and wants to know the difference between the drugs.
The website he looked at claimed that herbal medicines are really safe, and patients can expect to lose 2kg every week they take Chitosan.
The patient weighs 140kg and is 1.7m tall. He goes on to tell you that he hopes to lose weight quickly as he keeps getting rejected from all the jobs he has applied for recently and thinks it is due to his BMI.
Whilst looking around the Pharmacy you notice that you do not have any leaflets about weight loss, so decide that you will design a leaflet for this patient and others that may present to your Pharmacy.

1. What is weight loss and BMI?
2. What is Levothyroxine, Chitosan and Methylcellulose?
3. What is a herbal medicine?
4. What is the role of pharmacists on weight loss?
5. What are the official guidelines to weight loss?
6. Are websites safe to use?
7. How effective are weight loss leaflets?

What is weight loss?[7]
Reduction of the total body mass
->loss of fluid, body fat, adipose tissue…

Two type of weight loss:
1. Unintentional
2. Intentional

Unintentional weight loss[8]
Unexplained weight loss in body weight, when people didn’t try to lose the weight on their own
Reason of unintentional weight loss:
->Feeling depressed, stress or anxiety
->Chronic infection and illness
->Drugs and Drug abuse

Intentional weight loss[8]
Loss of total body mass as a result of efforts to improve fitness and health.
Weight loss guide features:[9]
Promotes safe and sustainable weight loss
Learn to make healthier food choices
Get support from NHS website
A weekly progress chart
Exercise plans to help losing weight
Learn skills to prevent weight regain

Getting started[9]
Work out how much weight need to lose
Learn how to count calories on the plan
Line up some non-food rewards

Eating plan:
Emphasizes fruits, vegetables, whole grains, fat-free/ low-fat milk
Lean meats, fish, bean, eggs, nuts
Low level of fat( unsaturated fat, trans fat, cholesterol)

Lifestyle – Physical activity[10]
Regular physical activity help losing weight
Improve energy level and mood
Lower risk for developing disease

Walking (15mins/ mile or 4 miles/ hour)
Aerobic exercise classes
Energetic house or yard work

Physical activities[9]
Tips on exercising[11]
Pick activities correctly
Work out the best time for exercising
Be active with friends and family
Reduce the amount of time of sit or lie down during the day

BMI and Obesity
Body mass index (BMI) is a measure of body fat based on height and weight.[1]

Patients weight is 140kg and his height is 1.7m
BMI is calculated by dividing his weight by his height squared .

Patients BMI is 140kg /1.7m = 48 kgm

What is Obesity and what are the causes of Obesity ?

Obesity is the abnormal or excessive fat accumulation that may impair health.[3]

Someone who is very overweight and has a high volume of body fat

General causes
High calorie intake
lifestyle choices
lack of physical activity
Genetics (Prader –willi syndrome)
Medical conditions such as hypothyroidism causes weight gain . [4]

What health problems is the patient in our scenario at risk of ?

Complications of Obesity
Obesity can cause serious health problems and shortens life expectancy .
Increased risk of health problems such as :
Hypertension -High blood pressure major risk of developing cardiovascular disease[5]
Coronary Heart Disease

Statistics on Obesity
Estimated that there around 35,000 obesity-related deaths in England each year. This accounts for one in every 16 deaths.[5]
1993 :13% of men and 16% of women were obese [6]
2011 :24% of men and 26% of women were obese.[6]
Used for Hypothyroidism
In general, hypothyroidism can be adequately treated with a constant daily dose of levothyroxine1

For most cases of mild to moderate hypothyroidism, a starting levothyroxine dosage of 50-75 µg/day will suffice.[26]

How does levothyroxine work?
It works by replacing the thyroid hormones which are not being produced naturally, returning the t3 and t4 levels back to normal. It is a levo-isomer.
This increases metabolism in cells, resulting in weight loss.

Methylcellulose is a simple bulking agent which also occurs naturally. It’s indications are:
Constipation or diarrhoea
Control bowel movement
Manage the symptoms of ulcerative collitis
Reduce appetite in the treatment of obesity[12]

What is it?
Use In Weight Loss?
Methylcellulose is used to reduce appetite in obese people who are trying to lose weight.
It is taken half an hour before each meal and when hunger pangs are severe.
As it swells in the gut it gives a feeling of fullness that helps reduce food intake
It is claimed to reduce food intake producing a feeling of satiety, but there is little evidence to support it’s use in the management of obesity.[13]

Thyroid releases hormones, two most important are T3 and T4
Affects how proteins, lipids and carbohydrates are used in the body.
‘Hypothyroidism is a condition characterised by abnormally low thyroid hormone production.[27]

Thyroid hormones stimulate metabolic activities in most tissues, leading to an increase in basal metabolic rate. This increases body heat production.

If there is a thyroid hormone deficiency, metabolism will decrease hence causing a weight gain

Other symptoms of hypothyroidism include fatigue, depression and cold intolerance.

How can hypothyroidism cause weight gain?
Study carried out into hypothyroid treatment and weight
Dr McDermott said "If the increase in resting metabolic rate is not accompanied by increased food consumption, weight loss will occur," he explained. But "If a person eats more calories when treatment of hypothyroidism is started . . . weight loss will not occur.“

Side Effects [28]
Usually only occur if dose is too high
Cardiac abnormalities
Chest pain

What are herbal medicines?

Medicines act definition:

“a medicinal product consisting of a substance produced by subjecting a plant or plants to drying, crushing or any other process, or a mixture whose sole ingredients are two or more substances so produced, or a mixture whose sole ingredients are one or more substances so produced and water or some other inert substance.” [18]

Herbal medicines include herbs, herbal materials, herbal preparations and finished herbal products, that contain as active ingredients parts of plants, or other plant materials, or combinations.[19]
40% people think herbal medicines are safe because they are natural.[20]
What are the regulations?
Before April 2011 -Unlicensed herbal medicines.[21]
No specific standards so large variation.
Did not need to come with safety warnings or other safety information/contraindications.

Companies are no longer able to sell manufactured unlicensed herbal medicines unless they have an appropriate product license, either[20]:

a full marketing authorisation (MA)
a traditional herbal registration (THR)

Same as any other medicine
Different types depending on the active ingredient:
New active substances
Previously evaluated substances

Traditional herbal registration (THR)
Evidence of traditional use:
- 30 years traditional use for the required indication[23]
- bibliographic or expert evidence of traditional use.[23]

Q. Based on the information available, which drugs would be eligible for a MA or a THR? Why?

For a THR do medicines have to show efficacy?

Most herbal medicines do not have sufficient evidence for safety.
Many plants are potent or toxic[25]
Many interact with other medicines.
May cause people to stop taking prescription medication.

Safety of herbal medicines.

The scientific evidence for the use of herbal remedies is often conflicting and although the symptoms of some illnesses improve with some herbal remedies, the best evidence doesn’t prove that herbal remedies cure illnesses.[25]

Effectiveness of herbal medicines.

Role of the pharmacist
Pharmacy White Paper of April 2008 highlighted that more health services should be transferred from GP’s to Pharmacists[29]
Easy access to patient
Saves NHS money[30]
Pharmacist performs health promotion[31].

Why the pharmacist?

BMI of patient is very high
Pharmacist can help him through 2 main ways:

Our Patient

Handing out leaflets and healthy eating guides are effective.
Pharmacist can collaborate with the patient on developing a healthy eating program[31]
May not be suited for our patient


Run in big chains such as Co-Operative and Lloyds[32]
Programmes vary in style, but objective is the same


2) Weight Management Programmes

Initially replaces all meals with shakes or soup
Helps to fulfil all nutritional requirements and reduce calorie intake
Maintenance is done by introducing healthy meals
Prevents gaining of calories

E.g. Lipotrim programme by the Co-Operative

Weight Management schemes prove successful:
Coventry weight management project showed that people lost an average of 0.618 of BMI and 3.37 cm of waist circumference
Central Lancashire Pharmacies showed that over 12 weeks showed that average BMI had fallen by six units
Could be suited for our patient.


What is the main goal of the weight management program?


Decrease calorie intake and increase calorie expenditure

2. On average, how long are weight management programmes for?


2. 12 weeks


The tablets work by absorbing water and increasing in size to make bulk in the stomach or bowels.
It is not absorbed into the blood; stays in GI tract, absorbing water and forming a gel.

How it works

You should aim to drink at least 2 litres of fluid per day
Large quantities can block the intestines
Abdominal discomfort

Before taking methycellulose

What are the indications of methylcellulose?


What is the BMI of the patient in our scenario ?
48 kgm2
20 kgm2
45 kgm2


Which one of these are potential causes of Obesity ?
Heart Disease
Medical conditions such as hypothyroidism causes weight gain .
Eating a balanced diet

Medical conditions such as hypothyroidism causes weight gain .


What are 3 symptoms of hypothyroidism?


Fatigue, weight gain, and intolerance to cold


Why does hypothyroidism cause weight gain?


Because cell metabolism is decreased, therefore fats and carbohydrates are not used for energy as quickly, so more are stored in the body.

Reduction of appetite
Is there extensive proof methylcellulose is effective for weight loss?
What is the site of action for methylcellulose?

The gut/GI tract
Stomach upset
Gastrointestinal Disturbances

Side Effects

A traditional herbal medicinal product is based on traditional use only.[4]

How is Chitosan produced?
The de-acetylation of Chitin
Name a contraindication for Chitosan
1.National Heart , Lung and Blood Institute . Calculate your body mass index. http://www.nhlbi.nih.gov/guidelines/obesity/BMI/bmicalc.htm (accessed 23/01/14).
2. NHS. Health/Weight Chart . http://www.nhs.uk/Livewell/healthy-living/Pages/height-weight-chart.aspx (accessed 23/01/14).
3. WHO. Obesity and Overweight . http://www.who.int/mediacentre/factsheets/fs311/en/ (accessed 23/01/14).
4. NHS. Causes of Obesity. http://www.nhs.uk/conditions/obesity/pages/causes.aspx (accessed 23/01/14).
5. NHS. Complications of Obesity. http://www.nhs.uk/conditions/obesity/pages/complications.aspx (accessed 23/01/14).
6. NHS. Latest obesity stats for England are alarming. http://www.nhs.uk/news/2013/02February/Pages/Latest-obesity-stats-for-England-are-alarming-reading.aspx (accessed 23/01/14).
7. Medical Dictionary. Definition of Weight loss. http://www.medterms.com/script/main/art.asp?articlekey=53393 (accessed 24/1/2014).
8. National institutes of health. Weight loss - unintentional. http://www.nlm.nih.gov/medlineplus/ency/article/003107.htm (accessed 24/1/2014).
9. NHS. Getting started on the NHS weight loss plan. http://www.nhs.uk/Livewell/weight-loss-guide/Pages/losing-weight-getting-started.aspx (accessed 24/1/2014).
10. Kathleen M. Zelman. Lose Weight Fast: How to Do It Safely. http://www.webmd.com/diet/features/lose-weight-fast-how-to-do-it-safely (accessed 25/1/2014).
11. NHS. Get active your way. http://www.nhs.uk/Livewell/fitness/Pages/Activelifestyle.aspx (accessed 24/1/2014).
12. BNF 59. March 2010
13. Electronic Medicines Compendium - Patient Information Leaflet. Electronic Medicines Compendium (eMC), Datapharm Communications Ltd (accessed 28/11/13)
14. British Pharmacopoeia 2013, Volume I & II - Ph. Eur. monograph 1774
15. Final Registration Review Decision, Biopesticides and pollution Prevention Division, EPA-HQ-2007-0566; Chitin Case 6063
16. Pharmacy2U, Pharmacy2U Chitosan capsule dischttp://www.pharmacy2u.co.uk/pharmacy2u-chitosan-capsules-disc-p3388.html (accessed 30/01/14)
17. Mhurchu, C. N., Dunshea-Mooij, C., Bennett, D. and Rodgers, A. Effect of chitosan on weight loss in overweight and obese individuals: a systematic review of randomized controlled trials. Obesity Reviews, 35– 42. 2005
18. Medicines and Healthcare Products Regulatory Agency. Herbal medicines regulation. http://www.mhra.gov.uk/howweregulate/medicines/herbalmedicinesregulation/index.htm (accessed 22 January 1014).
19. Medicines and Healthcare Products Regulatory Agency. Marketing authorisations. http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Marketingauthorisations/index.htm (accessed 23 January 2014).


20. Medicines and Healthcare Products Regulatory Agency. End of transitional arrangements for traditional herbal medicinal products. http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/TraditionalHerbalMedicinesRegistrationSchemelatestnewsandapplicationnumbers/CON341200 (accessed 23 January 1014).
21.Medicines and Healthcare Products Regulatory Agency. How to register your product under the Traditional Herbal Medicines Registration Scheme: Traditional use. http://www.mhra.gov.uk/Howweregulate/Medicines/Herbalmedicinesregulation/RegisteredTraditionalHerbalMedicines/HowtoregisteryourproductundertheTraditionalHerbalMedicinesRegistrationScheme/Traditionaluse/index.htm (accessed 23 January 1014).
22. World Health Organization. Traditional Medicine: Definitions. http://www.who.int/medicines/areas/traditional/definitions/en/ (accessed 25 January 2014).
23. Medicines and Healthcare Products Regulatory Agency. Reforms of s12(1) of the Medicines Act 1968: Possible extension to non herbal ingredients. http://www.mhra.gov.uk/home/groups/es-cb/documents/websiteresources/con2025651.pdf (accessed 25 January 2014).
24.Medicines and Healthcare Products Regulatory Agency. Public health risk with herbal medicines: An overview. http://www.mhra.gov.uk/home/groups/es-herbal/documents/websiteresources/con023163.pdf (accessed 25 January 2014).
25.Bupa. Herbal remedies. http://www.bupa.co.uk/individuals/health-information/directory/h/herbal-medicine (accessed 25 January 2014).
26.Philip R Orlander, MD. Hypothyroidism Treatment accessed 19/01/14
27.Nancy A. Melville. American Thyroid Association (ATA) 83rd Annual Meeting. Weight Loss Not a Certainty With Hypothyroidism Treatment. http://www.medscape.com/viewarticle/812877 ; accessed 19/01/14
28. Ruchi Mathur, MD, FRCP(C). Hypothyroidism. http://www.medicinenet.com/hypothyroidism/article.htm#what_is_hypothyroidism; accessed 19/1/14
29. DoH: Pharmacy in England - Building on Strengths & Delivering the Future,http://www.official-documents.gov.uk/document/cm73/7341/7341.pdf (Accessed: 25/01/2014).
30.NHS: Ask your Pharmacist for advice and support - Live Well, http://www.nhs.uk/Livewell/Pharmacy/Pages/Yourpharmacy.aspx (Accessed: 25/01/2014).
31. J.ennie Naidoo, Jane Willis: Health Promotion, 3rd edition, Elsevier Ltd, 2009
32. Co-operative:Expert Weight Loss Advice & Supplements, http://www.co-operativepharmacy.co.uk/Pharmacy/Content/health-advice-and-services/Expert-weight-loss-from-the-Co-operative-Pharmacy-and-Lipotrim/ (Accessed: 25/01/2014).
33.DoH: Pharmacy in England - Building on Strengths & Delivering the Future,http://www.official-documents.gov.uk/document/cm73/7341/7341.pdf (Accessed: 25/01/2014).
34.PSNC: Community Pharmacy: At the Heart of Public Health, http://psnc.org.uk/wp-content/uploads/2013/08/Public-health-Diet_and_Exercise.pdf (Accessed: 25/01/2014).
35. R.Kiley, E. Graham. The patient's Internet Handbook Royal Society of Medicine Press, 2002.


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