Pharmacists, Patients and Medicines Examination

FACULTY OF SCIENCE & ENGINEERING SCHOOL OF PHARMACY EXAMINATION PAPER ________________________________________________________________________ Module Code : 4PY019 Module Title : Pharmacy Stage 1 Assessment title : Pharmacists, Patients and Medicines examination Year lead : Michelle Elston Date : May 2022 Time Allowed : 2 Hours ________________________________________________________________________ INSTRUCTIONS TO CANDIDATES  This is a closed book examination.  Attempt ALL questions.  All answers to Part 2 must be recorded on the separate answer sheet provided. Student Number ……………………………………………………………………… 1 Part 1 Question 1 Part A You are working as a pharmacist on Monday 9th May 2022 in a community pharmacy when you receive the prescription on the following page for a Schedule 3 controlled drug. Consider whether this prescription is legally complete and valid. As part of your answer, you must: a) explain whether there are any legal issues and/or examples of poor practice relating to this prescription b) for each problem identified, explain what steps could be taken to resolve it 8 marks 2 3 Question 1 Part B The prescription above has now been corrected. The patient has collected the first four supplies on 9th, 10th, 11th and 12th May and now presents to the pharmacy on 16th May 2022 to collect that day’s prescription. Assuming that the prescription is clinically appropriate and now legally complete, explain whether you would dispense the medication for him. a) If you would dispense the medication, explain the reason for your answer and any action you would now take. b) If you would not dispense the medication, explain the reason for your answer and any action you would now take. 4 marks 4 Question 1 Part C The patient wants his mother to collect his future prescriptions for Suboxone. Explain what arrangements, if any, would have to be in place to allow this to happen. 3 marks 5 Question 2 You are the community pharmacist on duty on 9th May 2022 when a patient walks into the pharmacy. She is distressed because she has driven 300 miles to help look after her elderly sister, whom she is staying with for the next week, but has left her own prescribed medication at home. She does not have a prescription. She states that she usually takes metformin 500 mg tablets at a dose of ONE tablet TWICE a day and has not had a dose today. She asks whether you can help her? What action would you take? Give a detailed explanation of your answer including: a) what information you need to know to help the patient b) the law relating to this c) what records, if any, you would need to make and where you would make them 15 marks 6 Question 3 Part A You are on your first day of summer work experience in a community pharmacy. You have been assigned to work on the counter where general sale medicines are sold. The pharmacist on duty asks you how you can differentiate between someone displaying a health behaviour, an illness behaviour and a sick role behaviour, when you are serving a customer who is looking for a larger pack of paracetamol tablets or a large pack of co-codamol? a) Define the following terms:    health behaviour illness behaviour sick role behaviour 3 marks 7 b) Based on the definitions you have provided above, give an example of how a person displaying each of these behaviours might ask for a larger pack of paracetamol or a large pack of co-codamol. 3 marks Part B The responsible pharmacist, who is the only pharmacist on duty, is taking a one-hour lunch break today. Nobody will be covering the pharmacy in their absence. The responsible pharmacist notice is on display to the public, but what else must be in place BEFORE the pharmacist can leave for their break? 5 marks 8 Part C While the pharmacist is still on their one-hour lunch break a patient enters the pharmacy to: a) collect their prescription for a prescription only medicine (POM) and b) buy a pack of 16 ibuprofen 200 mg caplets (general sale medicine) Can the accuracy checking technician who is on duty with you carry out these requests for the patient? Explain your answer. 4 marks 9 Part 2 Each question in Part 2 is worth 1 mark Questions 1 to 3 are based on the SAME list of answer options but describe different pieces of legislation. For each numbered question, select the ONE lettered answer that MOST closely corresponds to the description provided. Each lettered option may be used once, more than once or not at all. Theme: legislation A. B. C. D. E. Human Medicines Regulations 2012 Misuse of Drugs Regulations 2001 Pharmacy Order 2010 The Medicines and Medical Devices Act 2021 Misuse of Drugs Act 1971 Question 1 It imposes controls on the import and export, production, possession, safe custody and supply of controlled drugs (CDs), as well as record keeping requirements, the destruction of CDs and their inspection. Which piece of legislation does this description refer to? Question 2 It sets out a comprehensive regime for the authorisation of medicinal products for human use; for the manufacture, import, distribution, sale and supply of those products; for their labelling and advertising; and for pharmacovigilance. Which piece of legislation does this description refer to? Question 3 This confers the power to amend or supplement the existing law relating to human medicines, veterinary medicines and medical devices. It established a new Patient Safety Commissioner in England. Which piece of legislation does this refer to? 10 Questions 4 to 6 are based on the SAME list of answer options, but different scenarios. For each numbered question, select the ONE lettered answer that MOST closely corresponds to the scenario. Each lettered option may be used once, more than once or not at all. Theme: prescription validity & record keeping A. B. C. D. E. 28 days 30 days 6 months 2 years 5 years Question 4 You are the pharmacist working in a community pharmacy when a patient comes in with a private prescription written by a dentist. Assuming that the dentist has not specified a shorter time period, how long is this prescription valid for from the appropriate date on the prescription? Question 5 You are the pharmacist working in a community pharmacy when a patient comes in with a prescription for a Schedule 3 controlled drug. Assuming that the prescriber has not specified a shorter time period, how long is this prescription valid for from the appropriate date on the prescription? Question 6 You are the responsible pharmacist on duty in a community pharmacy supervising a foundation year pharmacist. She has been asking you some questions about controlled drugs (CDs) and wants to know how long records of the supply of Schedule 2 CDs, prescribed on an FP10SS, must be kept for? 11 Questions 7 to 9 are based on the SAME list of answer options, but different scenarios. For each numbered question, select the ONE lettered answer that MOST closely corresponds to the scenario. Each lettered option may be used once, more than once or not at all. Theme: legal restrictions on over-the-counter sales A. 12 B. 16 C. 32 D. 100 E. There are no legal limits on the quantity that can be supplied. Question 7 A patient comes into their local community pharmacy and requests the largest amount of paracetamol soluble tablets that he can buy. Assuming that the medication is clinically appropriate, how many tablets can you legally supply? Question 8 You are the pharmacist on duty in a community pharmacy. A patient comes into the pharmacy and asks if she can have 100 co-codamol 8/500 mg effervescent tablets. She is going away on holiday for 3 months and doesn’t want to run out. Assuming that the medication is clinically appropriate, how many tablets can you legally supply to meet her request most closely? Question 9 A patient comes into their local community pharmacy for some pseudoephedrine 60 mg tablets as she is suffering from a cold and is very congested. Assuming that the medication is clinically appropriate, how many tablets can you legally supply her with? 12 Question 10 Which ONE of the following statements does NOT describe one of the usual responsibilities of a hospital pharmacist? A. Carrying out a medicines reconciliation. B. Advising healthcare professionals on how to select, prescribe and administer appropriate treatments for patients, including the correct formulation and dose. C. Ordering stock medication. D. Educating and training colleagues. E. Putting together medication formularies. Question 11 Which ONE of the following statements is NOT one of the nine GPhC Standards for Pharmacy Professionals? A. Pharmacy professionals must provide person-centred care. B. Pharmacy professionals must work in partnership with others. C. Pharmacy professionals must speak up when they have concerns or when things go wrong. D. Pharmacy professionals must demonstrate leadership. E. Pharmacy professionals must always let the patient decide. Question 12 Which ONE of the following statements concerning ‘duty of candour’ is TRUE? A. The pharmacist must never openly admit to the patient that something has gone wrong. B. The pharmacist must only offer an appropriate remedy or support to put matters right if the patient requests it. C. The pharmacist must only explain the short-term effects of what has happened to the patient (or, where appropriate, the patient’s advocate, carer or family) D. The requirement to be open and honest also applies to being open and honest with colleagues, employers and relevant organisations. E. The pharmacist must never apologise to the patient (or, where appropriate, the patient’s advocate, carer or family). 13 Question 13 When considered in the context of a patient’s treatment, which of the following statements BEST describes the ethical principle of autonomy? A. This considers the balancing of the benefits of treatment versus its risks and costs; the ultimate aim is to benefit the patient. B. This is about respecting the decision-making abilities of individuals, allowing them to make informed choices. C. This is about avoiding harm to the patient; any harm caused should not be disproportionate to the benefits of treatment. D. This ensures the fair distribution of benefits, risks and costs. E. This describes the provision of informed patient consent. Question 14 Which ONE of the following statements about the law in England is FALSE? A. Administrative law is part of civil law; it creates and regulates public bodies such as NHS Authorities, Hospital Trusts and Clinical Commissioning Groups. B. Professional law gives regulatory bodies, such as the General Pharmaceutical Council, powers to register and discipline relevant health professionals. C. The purpose of civil law is to restore the claimant to the position that they would have been in had the incident not occurred. D. Secondary legislation is a term used to describe the main laws passed by the legislative bodies of the UK, including the UK parliament. E. Common law is a body of law that has been built up over many years, it is based on the principle of judicial precedent. 14 Question 15 Which ONE of the following statements concerning the sale and supply of the different classes of medicines is FALSE? A. General sale medicines can be sold from almost any outlet without the supervision of a pharmacist; the outlet must be able to close so as to exclude the general public. B. If a pharmacy (P) medicine is sold by a member of the pharmacy team other than the pharmacist, there is an expectation that the standard of advice will be lower than if the product was sold by a pharmacist. C. When pharmacy (P) medicines are sold a responsible pharmacist, who is physically present on the premises, must be in charge of the pharmacy at the time of the sale. D. Prescription only medicines (POMs) can only be sold or supplied in accordance with a prescription given by an appropriate practitioner. E. Classes of medication that can only be supplied on prescription include parenteral medicines, medicines which emit radiation and controlled drugs which are not P medicines. Question 16 Which ONE of the following statements regarding prescription only medicines (POMs) is TRUE? A. If it is not practical to make the record on the day the POM supply is made it can be done any time that week. B. Private prescriptions for POMs must be retained in the pharmacy for 2 years from the date of sale or supply. C. For NHS prescriptions for Schedule 2 Controlled Drugs (CDs) a record of the supply must be made in the POM register and the CD register. D. Private prescriptions for Schedule 2 controlled drugs are repeatable. E. Records of the sale or supply of POMs must be written; computerised records cannot be used. Question 17 Which ONE of the following statements regarding herbal remedies is TRUE? A. Other than a placebo effect, there is no evidence that herbal products are effective treatment options for any condition. B. Herbal remedies are based on the concept of ‘like to treat like’. C. Herbal remedies are normally highly diluted. D. All herbal products must have a marketing authorisation. E. For the purposes of licensing, the MHRA requires herbal products to demonstrate quality, safety and efficacy. 15 Question 18 Which ONE of the following statements concerning ‘off-label’ and unlicensed medicines is TRUE? A. Off-label medicines are unlicensed medicines which are used for a range of licensed indications. B. Off-label medicines are unlicensed medicines which are used for unlicensed indications. C. Off-label medicines are licensed medicines which are used in a different way from that described in the marketing authorisation. D. Unlicensed medicines are medicines that do not have a marketing authorisation but can be used for a range of licensed indications. E. Unlicensed medicines are only classed as unlicensed in certain situations. Question 19 Which ONE of the following statements concerning selling chemicals and poisons from a pharmacy is FALSE? A. If a member of the public wants to buy any of the regulated substances, they must apply to the Home Office for an explosives, precursors and poisons (EPP) licence to acquire, possess and use it. B. Reportable substances can be classified as ‘reportable explosives precursors’ and ‘reportable non-medicinal poisons.’ C. Legislation requires that suspicious transactions, significant disappearances and thefts of chemicals and poisons are reported. D. For Part 2 regulated poisons you must make an entry in the poisons register. E. Before selling a reportable substance, you must check the purchaser’s ID, that they have a Home Office licence and that the substance and quantity matches the licence’s details. Question 20 Which ONE of the following statements regarding the responsible pharmacist’s notice is FALSE? A. It must include the pharmacist’s General Pharmaceutical Council (GPhC) registration number. B. It must include a statement stating that they are the responsible pharmacist at this time. C. It must be displayed for as long as that pharmacist remains the responsible pharmacist. D. It must be visible to the public. E. The responsible pharmacist must use the GPhC’s template for the notice which can be downloaded from the GPhC’s website 16 Question 21 A 55-year-old patient comes into a community pharmacy with an FP10SS for the following Schedule 4 (Part I) controlled drug, which the prescriber has signed and dated with today’s date. The prescription includes the patient’s name and the addresses of the patient and the prescriber: Diazepam 5 mg tablets Take ONE tablet TWICE a day when required Supply 28 tablets Assuming that the prescription is clinically appropriate, which ONE of the following statements represents the MOST appropriate course of action? A. The prescription cannot legally be dispensed. The prescriber must be contacted for a new prescription. B. The prescription can be dispensed and no separate records legally need to be made. C. The prescription can be dispensed and a record must legally be made in the controlled drugs register. D. The prescription cannot be dispensed unless the pharmacist amends the prescription and signs and dates the amendment so that it is attributable to them. E. The prescription can be dispensed provided that the prescriber is contacted to confirm it is appropriate to dispense it and a record of the conversation is made. Question 22 Which ONE of the following statements regarding serious shortage protocols (SSPs) is FALSE? A. SSPs are an exemption to the requirement that prescription only medicines (POMs) can only be sold or supplied in accordance with a valid prescription. B. SSPs may be used where there is a serious shortage of a medicine so that community pharmacies can manage shortages without referring patients back to prescribers. C. The supply of an SSP can be made without the supervision of a pharmacist in emergency situations. D. SSPs may provide authority to sell or supply an alternative formulation of a POM, if for example a tablet formulation is in serious shortage, but capsules are still available. E. SSPs may provide authority to sell or supply an alternative strength of a POM if one strength of a product is in serious shortage and other strengths are still available. 17 Question 23 Which ONE of the following statements regarding pharmacy standard operating procedures (SOPs) is TRUE? A. In a community pharmacy, SOPs are only required to provide step-by-step instructions for the dispensing process. B. SOPs must only be written on paper and be available for inspection when required. C. If an SOP is in place, pharmacists can delegate the responsibility of tasks, normally completed under their supervision, to other members of the pharmacy team when they are absent. D. All SOPs must be reviewed at least every five years to ensure that they remain relevant and workable. E. SOPs are a risk management and harm minimisation strategy and contribute to clinical governance. Question 24 Which ONE of the following statements concerning the burden and standard of proof in legal cases in the UK is FALSE? A. In a civil case the burden of proof is on the claimant. B. In a civil case the claimant must prove on the balance of probabilities that the defendant is responsible for the problem. C. On the balance of probabilities means that no other logical explanation can be deduced from the facts and evidence presented in court except that the defendant committed the crime. D. In a criminal case the burden of proof is on the prosecution to prove their case. E. Beyond reasonable doubt is the standard of proof required in a criminal court. 18 Question 25 Which ONE of the following statements regarding the registration of pharmacy premises is FALSE? A. It is unlawful to sell a medicinal product, except general sale medicines, unless the sale or supply is made on premises that are registered as a pharmacy by the General Pharmaceutical Council (GPhC). B. The title ‘pharmacy’ may only be used in respect of a registered pharmacy or the pharmaceutical department of a hospital or health centre. C. The superintendent pharmacist has the sole responsibility for a pharmacy’s registration and for renewing the registration each year. D. It is an offence to use the title ‘pharmacy’ in connection with any other business that involves the retail sale of goods. E. The owner and the superintendent pharmacist are jointly responsible for ensuring that the pharmacy meets the GPhC standards for registered pharmacies. Question 26 Which ONE of the following does NOT represent one of the legal requirements of an FP10SS prescription? A. B. C. D. E. Address of the appropriate practitioner Type of appropriate practitioner The telephone number of the appropriate practitioner Patient name and address Written in indelible ink Question 27 Emergency supplies at the request of a prescriber can only be made by a ‘relevant prescriber’. Which ONE of the following healthcare professionals would NOT be classed as a relevant prescriber for the purposes of requesting an emergency supply of a prescription only medicine for their patient? A. B. C. D. E. Physician’s associate Physiotherapist Dentist Paramedic A supplementary prescriber 19 Question 28 Which ONE of the following statements concerning the sale or supply of regulated medicinal products for use in children is FALSE? A. Medicinal product containers must be opaque or dark tinted. B. Medicinal product containers must be child resistant. C. Paracetamol suppositories can only be sold for use in children aged 12 or under if they are white in colour. D. Paracetamol suspension may be sold for use in children aged 12 or under in a colour other than white. E. Paracetamol tablets can only be sold for use in children aged 12 or under if they are pink in colour. Question 29 Which ONE of the following statements concerning veterinary medicines is FALSE? A. A POM-V medicine may only be prescribed by a veterinary surgeon after first carrying out a clinical assessment of the animal under their care. B. A POM-V medicine can only be supplied by the prescribing veterinary surgeon. C. An NFA-VPS medicine does not have to be prescribed but it may only be supplied by a registered qualified person (RQP), provided that the requirements for supply are followed. D. A POM-VPS medicine may be prescribed by any RQP. It may be supplied by the prescriber, or in accordance with a written prescription, by another RQP. E. A clinical assessment of the animal does not have to be carried out when prescribing POM-VPS medicines and the animal does not have to be under the RQP’s care. 20 Question 30 A 50-year-old patient comes into a community pharmacy to collect the following FP10SS prescription for a prescription only medicine (POM) which the prescriber has signed and dated with today’s date. The prescription includes the patient’s name and the addresses of the patient and the prescriber: Metformin 500 mg tablets 1 bd Supply 56 tablets Assuming that the prescription is clinically appropriate, which ONE of the following statements represents the MOST appropriate course of action? A. Label the item ‘Take ONE tablet TWICE a day’ and supply 56 tablets. A separate record of the supply is not required. B. Label the item ‘Take ONE tablet ONCE a day’ and supply 56 tablets. Make a record of the supply in the POM register. C. Label the item ‘Take ONE tablet TWICE a day’ and supply 56 tablets. Make a record of the supply in the POM register. D. Label the item ‘Take ONE tablet ONCE a day’ and supply 56 tablets. A separate record of the supply is not required. E. It is NOT appropriate to make a supply. Question 31 Which ONE of the following statements concerning private prescriptions for controlled drugs is FALSE? A. They must be written on a standardised form. B. The prescription must include the prescriber’s unique identification number. C. The original prescription must be submitted to the NHS Business Services Authority, which is done on a monthly basis. D. Items other than controlled drugs (CDs) may be written on an FP10PCD, provided that there is also a CD prescribed on it. E. Private veterinary prescriptions for CDs do not need to be written on standardised forms or submitted to the relevant NHS agency. 21 Question 32 A 45-year-old patient comes into a community pharmacy with a private prescription written on the clinic’s headed note paper for the following, which the prescriber has signed and dated with today’s date. The prescription includes the patient’s name and the addresses of the patient and the prescriber: Fentanyl 25 micrograms/hour patches Apply ONE patch every 72 hours Supply 5 patches Assuming that the prescription is clinically appropriate, which ONE of the following statements represents the MOST appropriate course of action? A. B. C. D. E. The prescription cannot legally be dispensed. The prescriber must be contacted for a new prescription. The prescription can be dispensed in accordance with the prescriber’s directions and no separate records need to be made. The prescription can be dispensed in accordance with the prescriber’s directions and a record must be made in the controlled drugs register. The prescription can legally be dispensed if the pharmacist amends the prescription and signs and dates the amendment so that it is attributable to them. A record of the supply must be made in the controlled drugs register. The prescription can be dispensed if the prescriber is contacted to confirm it is appropriate to dispense it and a record of the conversation is made. Question 33 Which ONE of the following statements concerning the General Pharmaceutical Council’s guidance on raising concerns is FALSE? A. Before raising a concern, it is important for pharmacy professionals to find out their employer’s policy on this. B. Pharmacy professionals should report their concerns to either their immediate supervisor or another suitable person in authority or an outside body. C. If a patient is at risk, it is important not to report your concerns immediately; you need to take the time to speak to all parties involved first. D. Pharmacy professionals must keep a record of their concerns, who they have raised them with and the action that has been taken as a result. E. The Public Interest Disclosure Act protects employees from unfair treatment from their employer if they have made a certain disclosure of information in the public interest. 22 Question 34 Which ONE of the following does NOT describe one of the principles of the General Data Protection Regulation (GDPR) 2018? A. B. C. D. E. Data minimisation Appropriate content Purpose limitation Storage limitation Accuracy Question 35 Which ONE of the following statements concerning the biopsychosocial model of health is FALSE? A. It looks at the idea that the adaptation and maintenance of new behaviours may dramatically affect health outcomes. B. It takes into account subjective feelings and emotional states. C. It takes into account thoughts, beliefs, and attitudes which are often formed by early life experiences. D. It concerns the idea that people move between good health and illness continuously regardless of the illness type (physical or mental). E. It takes into account characteristic ways of thinking and feeling which are thought to be shaped both by temperament and by early experiences. End of examination 23