Coursework Assessment Brief 
Module Title: Preparation for Professional Practice: System Based Patient Care 2                    Module Code:Level 6
  Practical 2: BioequivalenceThis assessment is worth 15% of the overall module mark
  The brief / instructions   This assessment has 2 activities. In activity 1 you are asked to write a report for the  Medicines & Healthcare Products Regulatory Agency (MHRA) considering the clinical implications of some bio equivalence data and in activity 2 you are asked to design a patient information leaflet for an appropriate dosage form for the formulation.   Consider the information provided in each section and use appropriate scientific resources to answer the questions and/or address the tasks.  Make sure you clearly indicate which section(s) you are answering. Each question is assigned a mark, use this as a guide for the amount of detail you should provide.     This is an individual piece of work that involves you analysing and graphing data to reach a valid scientific conclusion, you will then use that knowledge to choose an appropriate dosage form on which you will produce a patient information leaflet. You will be expected to apply your scientific and practice knowledge and understanding to address the questions and tasks in this assessment.  This assessment is worth 15% of your module mark.      As with all of your assessments, the learning outcomes and links to the GPhC standards and UCLan attributes are mapped onto different parts of the assessment.  Please read through these aspects to help you understand what you are expected to achieve from this assessment.     At level 6, it is expected that you are able to discuss each section in appropriate detail – this means drawing upon your taught material (including workshops, lectures, learning packs and associated directed reading). A very good answer would include accurate interpretation of the data and appropriate use of primary sources of information from PubMed, Medline etc as well as NICE guidance and the BNF to help you with synthesising your answers.  The standard University marking criteria has been included for your ease of reference.      The assessment word limit for ALL sections is 1000 words (+/- 10%). We have provided more guidance in the submission details section regarding word limits and use of information in tables, etc.      The assessment learning outcomes are:   1 Explain, compare and differentiate how advanced dosage forms are formulated and contribute to medicines optimisation.   2 Develop and demonstrate the ability to combine component communication skills tasks to form working partnerships with patients in the management of their own conditions     Practical 2 linked to the GPhC Standards   GPhC standards  Indicate the key elements to be included that will allow the GPhC standard and the attributes to be assessed.  Attribute  10.2.1.a  Shows how: Promote healthy lifestyles by facilitating access to and understanding of health promotion information  The generation of the information leaflet to give patients understanding of how the drug works and how to administer the drug in relation to other factors. Pharmacy Expert 5  Pharm Collaborator 3  Pharm Communicator 4  Health Advocate 2  Health Advocate 3  10.2.1.f  Knows how: Play an active role with public and professional groups to promote improved health outcomes   The generation of the information leaflet for public and professional groups to understand. Pharmacy Expert 5  Pharm Communicator 4  Pharm Collaborator 4  Health Advocate 2 (Shows how)  Health Advocate 3 (Shows how)  Scholar 2  Scholar 4  Professional 5  10.2.2.b  Shows how: Identify inappropriate health behaviours and recommend suitable approaches to interventions  The information leaflet will provide advice on e.g. side effects, situations where the medication is not appropriate or should be taken with caution, conditions where medical advice should be sought. Pharmacy Expert 5  Pharmacy Expert 4  Pharmacy Expert 6  Pharm Collaborator 3  Pharm Communicator 4  Pharm Communicator 5  Health Advocate 2  10.2.3.b  Shows how: Apply pharmaceutical principles to the formulation, preparation and packaging of products   Part 1 of the practical considers pharmaceutical principles. Professional 5      The scenario and the data:   Pfi-Pharma, a major pharmaceutical company holds the recently expired patent for “Brand X”, a modified-release drug used in the treatment of ADHD (attention deficit hyperactivity disorder). Brand X is delivered orally at a dose of 200mg once daily.   Originally formulated as an immediate release formulation, Brand X was quickly identified as being rapidly absorbed through the gastrointestinal mucosa, requiring multiple daily dosing. Consequently, it was re-formulated as a modified-release formulation. Brand X is weakly basic with a molecular weight of 68.82 g/mol and a solubility of 1.56g/L in water.   Brand X is believed to be pharmacologically akin to methylphenidate. Two thirds of a given dose are metabolized by CYP3A4, CYP3A5, CYP2J2 and CYP-independent mechanisms. The drug is also observed to have a narrow therapeutic index.   Three separate smaller companies, 220-Pharma, Fakli-Pharmaceuticals and Doda-Ceuticals, have recently started pilot studies in a bid to manufacture three separate generic formulations Generic A, Generic B and Generic C respectively, which are all modified release. You are provided with the data from the clinical trial which measured the plasma concentration of each of the  formulations at 30-minute intervals over a 36- hour period  from volunteers who have taken each brand (please see table 1 below, the raw data is also available as an excel file in blackboard PJ3300> assessments > practical 2 > raw data)     Activity 1 You are asked to write a report for the Medicines & Healthcare Products Regulatory Agency (MHRA) of 500 words + 10% words, which should consider the following the points, please note that the potential clinical implication of this data should be explored in detail:   In table 1 you have been provided with the data from the pilot study discussed above: Plot this data on an appropriate graph (5 marks). From your graph, identify what type of modified release formulation is shown (ie what type of modified formulation is Brand X, Generic A, Generic B and Generic C?) (3 marks)   Interpret the data shown in your graph and discuss the bioequivalence of each of the generics compared to brand X. Comment on the clinical impact of this bioequivalence on the patient. In your answer please consider side effect exposure, and how the management of a patient’s condition might be affected (12 marks).   Discuss the influence of excipients upon drug release, comparing the modified-release formulation (i.e. brand X) with immediate release formulations (15 marks)   Looking at the data, which of the generic formulations is expected to produce the closest clinical effect to brand X? You should justify your response with reference to the biopharmaceutical classifications system (i.e. which formulation would you recommend and why?) (5 marks)   Table 1: Plasma concentrations of each of the generic formulations and brand X at 30-minute intervals over a 36- hour period from volunteers who have taken each brand     Plasma concentration (mcg/ml)   Time (Hrs) Brand X Generic A Generic B Generic C 0 0 0 0 0 0.5 4.07 8.07 0 30.07 1 22.44 26.44 3.44 39.92 1.5 33.98 37.98 14.98 49.98 2 43.22 47.22 24.22 71.88 2.5 51.21 55.21 32.21 79.94 3 58.98 62.98 39.98 80.21 3.5 62.89 66.89 43.89 80.23 4 64.99 68.99 45.99 78.33 4.5 65.89 69.89 46.89 77.22 5 67.22 71.22 48.22 75.45 5.5 68.22 72.22 49.22 72.01 6 69.5 73.5 50.5 70.99 6.5 69.54 73.54 50.54 67.33 7 67.33 71.33 48.33 66.78 7.5 33.98 37.98 25.88 49.98 8 43.22 47.22 27.66 71.88 8.5 51.21 55.21 32.21 79.94 9 65.33 62.98 39.98 80.21 9.5 74.55 66.89 43.89 80.23 10 72.21 68.99 45.99 78.33 10.5 69.22 59.05 39.05 57.21 11 54.33 58.33 38.33 55.22 11.5 53.78 57.78 37.78 54.01 12 53.06 57.06 37.06 52.77 12.5 52.22 56.22 36.22 51.01 13 51.55 55.55 35.55 49.99 13.5 49.22 53.22 33.22 48.23 14 48.22 52.22 32.22 46.21 14.5 46.12 50.12 30.12 44.97 15 44.21 48.21 28.21 42.98 15.5 42.22 46.22 26.22 39.01 16 41.01 45.01 25.01 37.88 16.5 39.77 43.77 23.77 36.32 17 38.01 42.01 22.01 35.99 17.5 36.99 40.99 20.99 35.22 18 35.23 39.23 19.23 34.22 18.5 33.21 37.21 17.21 33.5 19 31.97 35.97 15.97 31.22 19.5 29.98 33.98 15.66 29.23 20 27.88 31.88 15.3 28.01 20.5 26.77 30.77 14.97 26.59 21 24.01 28.01 14.97 25.01 21.5 22.01 26.01 14.97 23.77 22 20.33 24.33 14.97 21.51 22.5 19.22 23.22 14.97 19.86 23 18.5 22.5 14.97 17.77 23.5 18.21 22.21 14.97 14.98 24 18.21 22.21 14.97 13.28 24.5 18.21 22.21 14.97 12.21 25 18.21 22.21 14.97 10 25.5 18.21 22.21 14.97 10 26 18.21 22.21 14.97 10 26.5 18.21 22.21 14.97 10 27 18.21 22.21 14.97 10 27.5 18.21 22.21 14.97 10 28 18.21 22.21 14.97 10 28.5 18.21 22.21 14.97 10 29 18.21 22.21 14.97 10 29.5 18.21 22.21 14.97 10 30 18.21 22.21 14.97 10 30.5 18.21 22.21 14.97 10 31 18.21 22.21 14.97 10 31.5 18.21 22.21 14.97 10 32 18.21 22.21 14.97 10 32.5 18.21 22.21 14.97 10 33 18.21 22.21 14.97 10 33.5 18.21 22.21 14.97 10 34 18.21 22.21 14.97 10 34.5 18.21 22.21 14.97 10 35 18.21 22.21 14.97 10 35.5 18.21 22.21 14.97 10 36 18.21 22.21 14.97 10     Activity 2   You must design a patient information leaflet of 500 words + 10% words for an appropriate dosage form for the formulation that you have chosen in the previous question. You are expected to provide a rational explanation on the science underpinning the information included in the patient information leaflet. Considerations should include the effect of food, interaction with co-administered drugs, interchangeability of brand, storage conditions, packaging etc. The weightings for activity 2 will be allocated as follows: 50% Patient relevant information (e.g. how and when to take, considerations for specific patient groups, warnings and precautions etc.)50% Interpretation of formulation and drug specific characteristics (e.g. side-effects, storage conditions, considerations relating to administration etc.)10% Overall presentation   Design instructions   You are given creative freedom in terms of design of the leaflet and number of pages, however, please ensure that the design is professional and that you address all of the key areas. Also, please ensure that you do not exceed the word count of 500 words and use a minimum font size of 10   Your patient information leaflet should contain all relevant information pertaining to the medicine, including but not limited to:   What the medication is and what it is used for (e.g. what classification of drugs compound (BCS) belongs to and potential therapeutic indications) (5 marks)   What do the patient need to know before taking the medication (e.g. contraindications, interaction (food and drug), cautions, warnings, precautions and any associated monitoring) (15 marks)   How to take the medication (e.g. in line with prescriber advice, route and method of administration, what to do in instance of missed doses, duration of therapy, what to do in the event of overdose and also withdrawal) (15 marks)   Description of possible side effects. All the effects which may occur under normal use of the medicine and what action the patient should take if any of these occur, information should include frequency and severity (15 marks)   How to store the medicine, specific advice. i.e. store in original packaging, temperature, moisture etc.  (5 marks)   Clear and effective presentation of the information (5 marks)                     Marking Criteria for practical 2     First (74; 80; 87; 94; 100) Upper second (62; 65; 68) Lower second (52; 55; 58) Third (42; 45; 48)   Fail (0;10; 25;30;35)   Comprehension Clear understanding of all subject / topic / concept / theory material. Clear development of own ideas Good understanding of most of subject / topic / concept / theory. Some development of ideas Adequate understanding of a fair range of subject / topic / concept / theory. Some limitations apparent Limited understanding of some of subject / topic / concept / theory No evidence of understanding of subject / topic / concept / theory   Application Successful application of theory / knowledge to new situations.  General application of theory / knowledge.  Limited application of theory / knowledge. Little evidence of application No application evident   Analysis Excellent analysis, with clear, independently derived conclusions Good analysis, clear and orderly, with some logical conclusions More descriptive than analytical; conclusions very limited Largely descriptive; few or no conclusions Descriptive, with some inaccuracies.   Evaluation   Distinctive work, showing independent thought. Arguments logical and structured Evidence for independent thinking  and / or logical argument. Development of some independent thinking;. Limited evaluation Standard view rather than independent position presented No independent evaluation. Paraphrasing of others’ statements   Presentation   Excellent: almost no errors of spelling. Appropriate choice of words. Good sentence / paragraph construction; very clearly presented. Correct scientific conventions used Very good: almost no errors of spelling. Good structure / construction, neatly presented. Readable style. Acceptable                        bibliography Acceptable: some errors in spelling and syntax. Correct structure, style difficult to follow in places. Limited bibliography Poor: many errors in spelling and syntax. Poor structure, difficult to follow. Limited bibliography Poor spelling and syntax. Poor structure; untidy presentation. Inappropriate bibliography Fulfils all requirements: 100, 94–all aspects of guidance are fulfilled to extremely  high standard: no errors. 87, 80 – all aspects of guidance are fulfilled to a very high standard: few errors 74 – all key aspects of guidance are fulfilled to a high standard still at a good level     All key  aspects of guidance are fulfilled to a good level: May not be at quite the same level, but are still at an acceptable level.   All key aspects of guidance completed to an acceptable level All key aspects of Proposal & accompanying docs completed to a lower pass level All aspects poor, or some aspects not approached                    
PREPARATION FOR THE ASSESSMENT   Use of quotation statements are discouraged in scientific writing. The point you want to make must be written in your own words  Feed forward/feedback from practical 1 should be used to inform this assignment.Guidance and support for this assignment is provided on blackboard (how to cite appropriately, drawing graphs using excell) In line with the School policy, your feedback will inform you ‘what you did well’, ‘what to improve’ on your summative submission.  This may be specific details, or more generic feedback e.g. more primary sources of information required.  Generic feedback is for you to apply to the whole assessment.
RELEASE DATES AND HAND IN DEADLINE   Assessment Release date:                    Assessment Deadline Date and time:   Please note that this is the final time you can submit – not the time to submit!   Your generic feedback and/or mark for this assessment will be provided by  
  SUBMISSION DETAILS   The assessment word limit for ALL sections is 1000 words. We have provided more guidance below regarding word limits and use of information in tables etc.   The School follows the University regulations for word counts which we want you to remember prior to any submission you would make   Unless specifically stated otherwise, the word count is a limit with a tolerance of 10 % extra permitted as an absolute maximum. Students MUST supply the word count on the front cover of their work. This number should not include references. In text citations ARE included in the word count. Figures and Table titles and legends ARE NOT included in the word count for this assignment. Table contents are NOT included in the word count, BUT tables should be used appropriately for the nature of the work and should NEVER be used just to avoid words counting within the word count.  If it is judged that tables have been used inappropriately then the content of the table(s) will be ignored when determining the mark for the work. The reference section is NOT included in the word count. Any information in the appendices will NOT be considered if word count has been exceeded. The absolute maximum i.e. word count + 10 % will be regarded as a cut-off point and nothing beyond this count will be considered.
HELP AND SUPPORT   Academic support for this assessment is provided in the seminars/tutorials and the drop-in sessions    For support with using library resources, please contact ***   or *** You will find links to lots of useful resources in the My Library tab on Blackboard.If you have not yet made the university aware of any disability, specific learning difficulty, long-term health or mental health condition, please complete a Disclosure Form.  The Inclusive Support team will then contact to discuss reasonable adjustments and support relating to any disability.  For more information, visit the Inclusive Support site.   To access mental health and wellbeing support, please complete our online referral form. Alternatively, you can email ***, call *** or visit our UCLan Wellbeing Service pages for more information.   If you have any other query or require further support you can contact The <i>, The Student Information and Support Centre.  Speak with us for advice on accessing all the University services as well as the Library services. Whatever your query, our expert staff will be able to help and support you. For more information`, how to contact us and our opening hours visit Student Information and Support Centre.   If you have any valid mitigating circumstances that mean you cannot meet an assessment submission deadline and you wish to request an extension, you will need to apply online prior to the deadline.
Disclaimer: The information provided in this assessment brief is correct at time of publication. In the unlikely event that any changes are deemed necessary, they will be communicated clearly via e-mail and a new version of this assessment brief will be circulated.Version: 1

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