Pharmacy Stage 1

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 : Matthew Palframan Date : May 2023 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.  No calculators are allowed. Student Number …………………………………………………………………… 1 Part 1 Question 1 Part A You are working as a pharmacist in a community pharmacy when you receive the prescription below for a Schedule 2 controlled drug. It is today’s date. 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 all of the possible steps which could be taken to resolve it, including who is legally able to resolve the issue 9 marks 2 Question 1 Part B The prescription above has now been amended and the item can now be dispensed. Explain what information, if any, needs to be recorded when supplying this controlled drug to the patient. 4 marks Part C What additional actions, if any, need to be taken when handing out this Schedule 2 controlled drug to the patient? 2 marks 3 Question 2 Part A You are the responsible pharmacist on duty in a community pharmacy when a patient walks into the pharmacy. It is today’s date. She wishes to purchase a ‘natural’ remedy to help her sleep. Her GP advised her that you, the pharmacist, may be able to assist her. There is one product on the shelf which is described as ‘homeopathic’ and one which is described as ‘herbal’ but she is unsure what these terms mean and asks for your help. Explain to the patient what the key differences between homeopathic and herbal remedies are? As part of your answer you must include a brief explanation of: a) b) c) d) how the products are made and the principles behind their use any licensing considerations any potential safety issues there may be their likely efficacy 12 marks Part B Before the patient leaves she asks if she can purchase 2 packets of 32 co-codamol 8/500 mg tablets (Pharmacy (P) medicine) for her brother who has hurt his back. He was seen by his GP who advised him to buy this medication over-the counter (OTC). Assuming that the medication itself is clinically appropriate, explain whether or not you would sell this to the customer? a) If you decide NOT to make the sale, explain what advice you would provide the customer with. b) Would your response be any different if the customer had requested effervescent tablets? 3 marks 4 Question 3 You are the responsible pharmacist working in the dispensary of a hospital pharmacy department when a cardiology consultant calls you asking for some advice. It is today’s date. He wishes to prescribe some mexiletine for an adult male patient with ventricular tachycardia (abnormal heart rhythm) but is unsure whether this is available. You look up the drug and discover that it is an unlicensed medicine which the pharmacy stocks. Part A What is meant by an ‘unlicensed medicine’? How does this differ from a medicine prescribed ‘off-label’? Explain your answer. 3 marks Part B What are the prescriber’s responsibilities in relation to the patient if he wishes to prescribe the mexiletine? Explain your answer. As part of your answer you must include: a) what considerations the prescriber must make BEFORE deciding to prescribe this medication b) any information that the prescriber must provide the patient with BEFORE prescribing the medication 7 marks Part C While you are in the dispensary a technician comes up to you to remind you that you have not displayed your responsible pharmacist notice which you are legally required to do. Provide details of the other responsibilities that you have in relation to your role as the responsible pharmacist. 5 marks 5 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 scenarios. 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: record keeping A. B. C. D. E. 1 year 2 years 5 years 7 years a separate record of the supply is not required. Question 1 You are the pharmacist working in a community pharmacy when a patient comes in requesting a Part 3 reportable substance. You are satisfied that the request is genuine and that it is appropriate to make the sale. How long would a record of this supply need to be kept for? Question 2 You are the pharmacist working in a hospital pharmacy when a patient comes in with an outpatient prescription for diazepam 5 mg tablets (Schedule 4 (Part 1) controlled drug). How long would a record of this supply need to be kept for? Question 3 You are the pharmacist working in a community pharmacy when a patient comes in with a veterinary prescription for a dog. How long would a record of this supply need to be kept for? 6 Questions 4 to 6 are based on the SAME list of answer options but describe different Schedules of controlled drugs. 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: controlled drugs A. B. C. D. E. Schedule 1 Schedule 2 Schedule 3 Schedule 4 (Part 1) Schedule 5 Question 4 This Schedule of controlled drug must comply with controlled drug prescription requirements and prescriptions are valid for 28 days from the appropriate date. For the majority of drugs in this Schedule emergency supplies cannot be made. Which Schedule does this controlled drug belong to? Question 5 Supplies of this Schedule of controlled drug do not need to be recorded in the controlled drugs register. Private prescriptions for this controlled drug are not repeatable. Which Schedule does this controlled drug belong to? Question 6 Supplies of this Schedule of controlled drug do not need to be recorded in the controlled drugs register and prescriptions are valid for 6 months. Which Schedule does this controlled drug belong to? 7 Questions 7 to 9 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. Data Protection Act 2018 Pharmacy Order 2010 Public Interest Disclosure Act (PIDA) 1998 The Medicines and Medical Devices Act 2021 The Pharmacy (Preparation and Dispensing Errors – Hospital and Other Pharmacy Services) Order 2022 Question 7 This legislation makes provision for the establishment of the General Pharmaceutical Council (GPhC) and gives the GPhC powers to make orders and rules in relevant areas, including the discipline of pharmacists, subject to approval. Question 8 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? Question 9 It extends existing defences to other healthcare professionals and introduces a new statutory role of the “Chief Pharmacist” giving the GPhC additional powers regarding describing chief pharmacists’ responsibilities Which piece of legislation does this refer to? 8 Question 10 Which ONE of the following is NOT a legal requirement for a veterinary prescription for a UK-wide licensed human prescription only medicine? A. The telephone number of the prescriber. B. The address of the owner. C. A statement highlighting that the medicine has been prescribed ‘under the cascade’. D. If the prescription is repeatable, the number of times it can be repeated. E. The date (valid for 28 days). Question 11 Which ONE of the following statements is NOT one of the nine GPhC Standards for Pharmacy Professionals? A. Pharmacy professionals must be a member of the Royal Pharmaceutical Society B. Pharmacy professionals must provide person-centred care. C. Pharmacy professionals must work in partnership with others. D. Pharmacy professionals must speak up when they have concerns or when things go wrong. E. Pharmacy professionals must demonstrate leadership. Question 12 Which ONE of the following is NOT an example of an NHS Advanced Service? A. B. C. D. E. Smoking cessation service NHS Community Pharmacy Consultation Service (CPCS) COVID-19 Vaccination Service New Medicine Service (NMS) Hypertension case-finding service 9 Question 13 When considered in the context of a patient’s treatment, which ONE of the following statements BEST describes the ethical principle of autonomy? A. This is about avoiding harm to the patient; any harm caused should not be disproportionate to the benefits of treatment. B. This ensures the fair distribution of benefits, risks and costs. C. This considers the balancing of the benefits of treatment versus its risks and costs; the ultimate aim is to benefit the patient. D. This is about respecting the decision-making abilities of individuals, allowing them to make informed choices. E. This describes the provision of 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. Common law is a body of law that has been built up over many years, it is based on the principle of judicial precedent. C. Professional law gives regulatory bodies, such as the General Pharmaceutical Council, powers to register and discipline relevant health professionals. D. The purpose of civil law is to restore the claimant to the position that they would have been in had the incident not occurred. E. Secondary legislation is a term used to describe the main laws passed by the legislative bodies of the UK, including the UK parliament. Question 15 Which ONE of the following statements concerning the structure of the NHS and its key organisations is FALSE? A. The Care Quality Commission (CQC) is the independent regulator of health and social care in England which ensures that health and social care services provide people with safe, effective, compassionate, high-quality care. B. Integrated care boards (ICBs) allocate the NHS budget and commission services and produce a five-year system plan for health services. C. Provider collaboratives cover a population of 1-2 million people; they consist of NHS trusts and can include voluntary, community and social enterprise organisations and the independent sector. D. Primary care refers to care which is usually provided by a hospital and can either be planned (elective), emergency or urgent care. E. NHS England leads the National Health Service (NHS) in England. It supports NHS organisations to work in partnership to deliver better outcomes for patients and communities and provide value for taxpayers. 10 Question 16 Which ONE of the following statements regarding prescription only medicines (POMs) is TRUE? A. A record of the supply of POMs prescribed on FP10 SS prescriptions must be made in the POM register. B. Private prescriptions for oral contraceptives do not have to be recorded in the POM register. C. Records of the sale or supply of private POMs must be written; computerised records cannot be used. D. If it is not practical to make a record on the day a supply of a POM on a private prescription is made, it can be done any time that week. E. Records of the supply of POMs on private prescriptions must be retained in the pharmacy for 5 years from the date of sale or supply. Question 17 A 40-year-old patient presents to a community pharmacy requesting an emergency supply of tramadol 50 mg capsules (Schedule 3 controlled drug). Assuming that the usual requirements for an emergency supply at the request of a patient are met, how many days’ supply can you provide the patient with? A. A maximum of 5 days’ supply can be issued as an emergency supply provided that appropriate records are made. B. A maximum of 7 days’ supply can be issued as an emergency supply provided that appropriate records are made. C. A maximum of 5 days’ supply can be issued as an emergency supply, provided that it is at the request of a prescriber. D. A maximum of 30 days’ can be issued as an emergency supply, provided that it is at the request of a prescriber. E. None. It is illegal to supply Schedule 3 controlled drugs as an emergency supply. 11 Question 18 Which ONE of the following statements concerning protected titles is FALSE? A. The titles ‘pharmacist’ and ‘chemist’ and even the title ‘druggist’ which has fallen out of common use are all protected under the Medicines Act 1968. B. Under the Pharmacy Order 2010 it is illegal to represent yourself as a pharmacy technician if you are not on the GPhC register. C. Under the Pharmacy Order 2010 the offence of falsely representing yourself or practising as a registered ‘pharmacist’ when not registered can be punished with an unlimited fine. D. It is illegal to falsely use several protected titles including ‘doctor of medicine’ and ‘general practitioner’ (GP). E. Dentists and veterinarians cannot call themselves ‘Dr’ as this may mislead the general public. 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. 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. D. Legislation requires that suspicious transactions, significant disappearances and thefts of chemicals and poisons are reported. E. For Part 2 regulated poisons you must make an entry in the poisons register. 12 Question 20 Which ONE of the following statements concerning actions which can take place without a responsible pharmacist in charge of the pharmacy is FALSE? A. Suitably trained staff can order stock from pharmaceutical wholesalers in line with standard operating procedures.. B. Suitably trained staff can respond to enquiries about medicine issues in line with standard operating procedures. C. Processing patient-returned medicines can be undertaken by suitably trained staff in line with standard operating procedures. D. Stock can be received from pharmaceutical wholesalers by suitably trained staff in line with standard operating procedures. E. Accuracy checking can be undertaken by suitably trained staff in line with standard operating procedures. Question 21 A 55-year-old patient comes into a community pharmacy with an FP10 SS for the following Schedule 3 controlled drug, which the prescriber has signed and dated with today’s date. The prescription includes the patient’s and prescriber’s names and addresses: Temazepam 5 mg tablets Take ONE tablet at NIGHT when required Supply 7 (SEVEN) 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 a record must legally be made in the controlled drugs register. C. The prescription cannot be dispensed unless the pharmacist amends the prescription and signs and dates the amendment so that it is attributable to them. D. The prescription can be dispensed and no separate records of the supply legally need to be made. 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. 13 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. Question 23 You are the pharmacist on duty in a community pharmacist. You receive a requisition which you have been expecting from the local hospital for some Matrifen (fentanyl) 12 microgram/hour patches (Schedule 2 controlled drug). Before it is supplied you need to check that it meets all the legal requirements for a requisition. Which ONE of the following pieces of information is NOT required on a controlled drugs requisition form? A. B. C. D. E. The signature of the recipient. The name of the recipient. The address of the recipient. The purpose of the requisition. The strength of the drug in words and figures. 14 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. 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 (GSL), 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 statements concerning private prescriptions for Schedule 2 and 3 controlled drugs is FALSE? A. B. C. D. The prescriber identification number must be present. The medication must be prescribed on a standardised form. The quantity of the medication must be written in words and figures. The original prescription does not need to be submitted to the NHS Business Services Authority. E. The prescriptions are valid for 28 days from the date of the appropriate date. 15 Question 27 Which ONE of the following statements concerning an emergency supply at the request of a prescriber is FALSE? A. The prescriber must agree to provide a written prescription within 72 hours. B. The words ‘emergency supply’ do not need to be added to the dispensing label. C. The medicine must be supplied in accordance with the directions given by the prescriber. D. The pharmacist must be satisfied that the request is from a ‘relevant prescriber’. E. The patient must be interviewed in person to ensure that there is an immediate need for the medication. 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. 16 Question 29 Which ONE of the following statements concerning prescriptions for 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 registered qualified person (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. Question 30 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 concerns the idea that people move between good health and illness continuously regardless of the illness type (physical or mental). C. It takes into account characteristic ways of thinking and feeling which are thought to be shaped both by temperament and by early experiences. D. It takes into account subjective feelings and emotional states. E. It takes into account thoughts, beliefs, and attitudes which are often formed by early life experiences. 17 Question 31 A 60-year-old patient comes into a community pharmacy to collect the following FP10 SS prescription for a prescription only medicine (POM) which the prescriber has signed and dated with today’s date. The prescription includes the patient’s and prescriber’s names and addresses: Betahistine 8 mg tablets 1 tds 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 THREE times a day’ and supply 56 tablets. A separate record of the supply is not required. B. Label the item ‘Take ONE tablet THREE times 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 when required’ and supply 56 tablets. A separate record of the supply is not required. E. It is NOT appropriate to make a supply. Question 32 Which ONE of the following statements concerning pharmacovigilance is FALSE? A. It may be described as “the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other possible drug-related problems.” B. Only healthcare professionals can use the MHRA Yellow Card Scheme to report adverse reactions; reports can be made via the Yellow Card Scheme website, the App or via freephone. C. The holder of a marketing authorisation must operate a pharmacovigilance system. D. If pharmacovigilance is carried out well it will help to identify any risks and risk factors promptly so that harm can be avoided or minimised. E. It involves the collection and appropriate communication of information about adverse events in order to prevent their occurrence. 18 Question 33 A 65-year-old patient comes into a community pharmacy with a private prescription written on the clinic’s headed note paper for the following prescription only medicine (POM), which the prescriber has signed and dated with today’s date. The prescription includes the patient’s and prescriber’s names and addresses: Risperidone 500 microgram tablets Take ONE tablet at NIGHT Supply 28 tablets 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 of the supply need to be made. The prescription can be dispensed in accordance with the prescriber’s directions and a record of the supply must be made in the POM register. The prescription can legally be dispensed if the pharmacist amends the prescription. A record of the supply must be made in the POM 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 must be made. Question 34 Which ONE of the following statements concerning the General Pharmaceutical Council’s guidance on raising concerns is FALSE? A. Pharmacy professionals should find out their employer’s policy on raising concerns or ‘whistle blowing’ and follow this whenever possible. 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. Examples of concerns that pharmacy professionals must raise are concerns about the behaviour or competence of a colleague or healthcare professional, as well as concerns about the working environment. 19 Question 35 Which ONE of the following statements concerning confidentiality and disclosures made in the public interest is FALSE? A. A pharmacy professional may disclose confidential information if it is in the public interest e.g. where the information is required to prevent a serious crime. B. When deciding to disclose confidential information a pharmacist must weigh up the competing interests of maintaining confidentiality versus the public interest benefit in disclosing it. C. Examples of disclosures protected under the Public Interest Disclosure Act (1998) include disclosures involving or likely to involve a breach of a legal obligation, damage to the environment and a miscarriage of justice. D. Pharmacists do not need to comply with data protection law if the disclosure made is in the public interest. E. Pharmacy professionals can disclose confidential information if they have the consent of the person under their care to which it relates or they are required by law to disclose it. End of examination 20