L3 Module 2 Assignment 1 Questions Oct 2011

Copyright Buttercups Training Ltd – October 2011

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Level 3 Pharmaceutical Science

Module 2 Assignment 1

1. Which one of the following statements is true?

a) An NHS prescription for a GSL medicine doesn’t have to be signed. b) A prescription can be signed in pencil c) A prescription is valid for 6 months after the date of signing unless for certain controlled drugs d) A prescription is valid for 4 months after signing and 13 weeks for controlled drugs 2. A prescription for prednisolone tablets 5mg (30) states “repeat this”. Which one of the following statements is correct? a) If it is NHS it can be repeated once the prescriber has been contacted b) If it is Private it cannot be repeated until the prescriber has been contacted c) If it is a private prescription it can be repeated once within 6 months d) If it is a private prescription it can be repeated once again at any time

Name………………………………………………………………………………………………………………………………….

Module 2 Assignment 1 is composed of 53 questions.

This contributes towards the achievement of the knowledge criteria for Unit 18: Pharmacy Law,

Ethics and Practice in your course syllabus. These are listed below:

To achieve the knowledge criteria please refer to the marking grid provided with the cover sheet for

the Module 2 Assignments. The marking grids outline how many questions you must answer

correctly in each section to achieve the knowledge criteria specified.

P1 – Describe the key principles and requirements of current legislation relating to the use of drugs

and medicines

P3 – Describe the main requirements of current legislation relating to the sale or supply of non-

medicinal poisons

P4 – Outline the current legal requirements for the sale or supply of veterinary medicines

P5 – Summarise the current legal requirement relating to the provision of denatured alcohol

Section 1 (P1)


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3. You are presented with a private prescription for Ovranette which states “repeat”. Which one of the following statements is correct? a) This can be repeated 6 times b) This can be repeated 5 times within 6 months of signing c) This can be repeated once only d) This can be repeated 5 times within 2 years 4. You are asked for an emergency supply of bendroflumethiazide tablets 5mg. The patient takes them once daily. What is the maximum number of tablets you can supply? a) 5 b) 7 c) 28 d) 30 5. When requesting an emergency supply, the prescriber must agree to supply a prescription within how many hours a) 24

b) 48

c) 72

d) 84 6. Which of the following practitioners cannot request an emergency supply for a POM medicine? a) Dentist from Switzerland

b) Doctor from Germany

c) Doctor from America

d) Dentist from Spain 7. You are asked for an emergency supply of Marvelon tablets by a patient who is on holiday in your area. Which of the following does your pharmacist need to validate before they can make a supply? a) The patient’s doctor’s surgery is currently closed b) The patient has brought a repeat prescription slip with them c) The medicine has been previously prescribed by a legitimate prescriber d) The patient can’t afford to purchase condoms


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8. Table 1 (below) provides information on the different categories of medicines that can be sold or supplied by different practitioners to their patients. Each row represents one of the practitioners listed below: 1. Midwife 2. Nurse Independent Prescriber 3. A registered chiropodist (not a supplementary prescriber) 4. A supplementary prescribing optometrist

The word “any” is used if all medicines in that category can be supplied

The word “none” is used if no medicines in that category can be supplied

The words “listed products only” are used if they are allowed to supply some within that category

Use your knowledge on the laws regulating the sale and supply of medicines and the MHRA website to complete the first column of the table below by writing the correct number (1-4) from the list of practitioners provided.

Practitioner/ professional (fill out this column)

Category of medicine that can be sold or supplied to an individual

GSL Sell

GSL Supply

P Sell

P Supply

POM Sell

POM supply

Any Any Listed products only

Listed products only



Any Any Any Any Listed products only


Any Any Any Any Any Any

Any Any Any Any Any POM but only listed CDs

Any POM but only listed CDs

9. Which of the following is legally required for a dispensing label when dispensing a prescription under the ‘The Medicines Act 1968’? a) The pharmacist’s name b) Keep out of the reach of children

c) The batch number

d) Disposal instructions

Table 1


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10. Use Appendix 3 in the British National Formulary (BNF) to identify the correct label number for

each of the recommended cautionary label wordings below.

a) Warning. Do not drink alcohol

b) Do not stop taking this medicine unless your doctor tells you to stop

c) This medicine may colour your urine, this is harmless

d) Warning. This medicine may make you sleepy

e) Protect your skin from sunlight – even on a bright but cloudy day. Do not use sunbeds

f) Do not take more than ... in 24 hours

g) Warning. This medicine may make you sleepy. If this happens do not drive or use tools or machines. Do not drink alcohol

11. Which of the following is legally required on a prescription for a POM medicine?

a) Patient’s address including postcode

b) Patient’s age if under 12

c) Patient’s date of birth

d) Dose of prescribed item

12. Nurse Independent Prescribers can write a handwritten prescription on which of the following forms? a) FP10SP

b) FP10MDA

c) FP10SS

d) FP10D 13. Which of the following applies to prescriptions written by a dentist? a) Medicines on an NHS FP10D prescription must be found in the ‘Dental Practitioners Formulary’

b) Dentists cannot write prescriptions for controlled drugs

c) Dentist prescriptions are written on the form FP10MDA

d) Ethically dentists can write a private prescription for any clinical purpose 14. Which of the following prescription forms cannot be used by a pharmacist supplementary prescriber? a) FP10SS

b) FP10NC

c) FP10MDA

d) FP10SP

a)

b)

c)

d)

e)

f)

g)

answer here by writing the correct

cautionary label number into the

appropriate boxes below:


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15. What do the directions 1 bd ac mean? a) Take one three times a day after food b) Take one twice a day before food c) Take one three times a day before food d) Take one twice a day after food 16. A prescription calls for 21 days supply requiring 1 tablet QDS for 2 days, then 1 tablet TDS for 7 days, then 1 tablet BD for 7 days and finally 1 tablet OD for 5 days. How many tablets do you supply? a) 32 b) 56 c) 21 d) 48 17. If a prescription asks for 7 days supply of a liquid “10ml QDS” what is the minimum quantity you should supply? a) 150ml b) 200ml c) 280ml d) 300ml 18. In which one of the following circumstances does a record of the supply of a POM not need to be made in the prescription only register? a) Emergency supply at the doctor’s request

b) An NHS prescription from a dentist

c) A private prescription from a doctor

d) A wholesale transaction to a chiropodist

19. Identify which of the following statements is true

a) PGD’s are classed as an emergency supply

b) PGD’s must always be signed by a doctor

c) During a pandemic the treatment of a particular disease may be supplied using a protocol from

designated collection points

d) During a pandemic, the pharmacist does not have to be satisfied that the patient has previously

been prescribed the medicine when making an emergency supply

20. Which of the following is the initial action you would take if you suspect a forged prescription?

a) Speak to the patient and ask them if they have altered the prescription

b) Ring the GP and ask what was prescribed

c) Call the police

d) Discreetly alert your pharmacist


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Questions 21-25 concern the private prescription below:

21. What information, that is required, is missing from this prescription?

a) The quantity written in words

b) The patient’s date of birth

c) The date the prescription expires

d) The prescriber’s qualification

22. How many times (in total) can this prescription be dispensed? a) Two b) Three c) Four d) There is no limit 23. State the date before which the prescription must be dispensed for the first time. a) 1st July 2011 b) 1st Jan 2010 c) 1st October 2010

d) 1st August 2010

Tel 0115-96357 Andrew Smith

The Field Surgery

Redmile Road

Ainsdale Village

PT56 7GH

1st July 2009 Mr David Jones 1 Mossgiel Avenue Ainsdale PT56 7GI

Viagra 50mg tablets One to be taken as directed 8 tablets

Repeat three times

A Smith


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24. How long does a private prescription need to be kept after the last dispensing? a) For as long as necessary b) 1year c) 2 years d) 6 years 25. Which of the following would you need to record in the prescription-only register after dispensing this prescription? (select all that apply) a) Prescriber details (name and address) b) Date on prescription c) Patient’s date of birth d) Name of the pharmacist who dispensed the medication e) Date of dispensing f) Relationship of the person collecting medication to the patient g) Patient name and address h) Prescription drug details: (name, form, strength and dosage) i) Was proof of identity requested? (yes/no) 26. Which one of the following statements is true? a) A company needs a manufacturer’s licence and wholesaler’s licence to manufacture and sell a product b) A company needs a manufacturer’s license and marketing authorisation to manufacture and sell a product c) A wholesaler needs a wholesaler’s license and marketing authorisation to manufacture and sell a product d) A wholesaler needs a manufacturing licence and wholesalers licence to sell a product

27. Which one of the following types of medicine is not licensed by the MHRA? a) POMs b) Herbal Medicines c) Veterinary Medicines d) Homeopathic medicines

28. Which of the following statements is true regarding the roles of the MHRA?

a) The MHRA sample medicines on the UK market to check for safety, ensure they are of good

quality and not counterfeit

b) The MHRA conduct clinical trials on new medicines

c) The MHRA allow parallel imports to be sold in the UK with a foreign PIL

d) The MHRA have no role in the storage and transportation of medicines in the UK


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29. Which of the following statements is true?

a) The advertising code for medicines in known as ‘The Green Guide’

b) POM medicines can be advertised directly to the public

c) ‘3 for 2’ promotions on OTC hayfever medicines are acceptable

d) Prescribers can be given expensive incentives by manufacturers to prescribe medicines

30. The Medicines Act does not legislate for which one of the following? a) The labelling of human medicines b) The advertising of cosmetics c) The administration of injections d) The classification of human medicines 31. Match up each stage of the MHRA enforcement approach for ensuring compliance with ‘The Medicines Act 1968’ with its corresponding explanation by filling out the boxes below

Explanation

iii. Enforcement officers will take samples and documentation to test

ii. Providing information and guidance on how to stay within the regulations

iv. Scheduled or unscheduled inspections will occur and the internet is also monitored

i. The manufacturer could have their licence revoked or they could be asked to improve procedures

Stage

a) Prevention of non-

compliance

b) Identification of

non-compliance

c) Investigation of

non-compliance

d) Sanctions for non-

compliance

a) b) c) d)


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32. Which of the following is not an outcome of ‘The Medicines Act 1968’ being enforced?

a) The police prosecuting a company for selling a medicine without a marketing authorisation b) The MHRA ordering the destruction of stock which has been incorrectly stored by a manufacturer c) The Royal Pharmaceutical Society deregister a pharmacy for promoting paracetamol tablets on a ‘buy one get one free’ offer d) The GPhC reprimanding a pharmacist for authorising P medicines to be supplied whilst they are not in the pharmacy

33. What type of legislation is the Medicines Act 1968?

a) Pharmacy Law

b) Civil Law

c) Statute Law

d) Administrative Law

34. Which of the following is not legally required on the label/packaging of a manufactured

medicine under ‘The Medicines Act 1968’?

a) Batch number

b) Daily dosage

c) Expiry date

d) Name of product

35. This question concerns the safety of medicines under ‘The Medicines Act 1968’. Which of the

following statements is false?

a) A 100ml bottle of podophyllum resin must be dispensed in a fluted bottle

b) Every pack of a manufactured product must contain a PIL

c) Every pack of a manufactured product must have a security seal

d) CRC’s are not required on every pack of manufactured medicine, but are required for aspirin and

paracetamol


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36. Match each of the following classifications with the appropriate description of each by filling

out the boxes below

37. Which of the following are the correct abbreviations used in relation to denatured alcohols a) IDA stands for ‘Independent Denatured Alcohol’ b) TSDA stands for ‘Trades Specific Denatured Alcohol’ c) CDA stands for ‘Controlled Denatured Alcohol’ d) IDA stands for ‘Illegal Denatured Alcohol’ 38. Which one of the following statements is false? a) CDA has no restrictions on the quantity that can be obtained from a wholesaler b) CDA can only be supplied in quantities less than 20L c) IDA can be supplied on receipt of a prescription by a GP d) IDA and TSDA can only be obtained by an authorised user from a wholesaler

Description

iii. These medicines use the principle of “like cures like” and are

registered under The Simplified Scheme or The National Rules

Scheme

ii. These medicines can be sold from any retail outlet providing they can be closed to the public

iv. These medicines are usually only supplied on a prescription written by an appropriate prescriber

i. Products can be given a licence starting ‘THR’ followed by nine numbers. This means the product is of good quality but has no evidence of efficacy

v. These medicines are not specifically listed under ‘The Medicines Act 1968’, but mean they can only be sold from a pharmacy

Classification

a) GSL

b) POM

c) P

d) Herbal

d) Homeopathic

a) b) c) d) e)

Section 2 (P3 and P5)


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39. Which of the following statements is true with regard to the supply of denatured alcohol? a) IDA and TSDA can only be supplied by the pharmacy to users authorised by HM Revenue and Customs b) The pharmacist must obtain a copy of the purchaser’s authorisation for denatured alcohol prior to a sale of IDA or TSDA c) Medical practitioners can be supplied TSDA on receipt of a signed order d) CDA must be sold under the supervision of a pharmacist 40. Which of the following statements is true with regard to the supply and storage of denatured alcohol? a) CDA must be kept under lock and key under the pharmacist’s control b) Records of supply are required for CDA c) All pharmacies can stock IDA and TSDA without an “entry of premises” d) Records of supply are required for IDA or TSDA 41. Which of the following statements is true with regard to legislation on poisons? a) A substance included in The Poisons List is controlled under The Poisons Act 1972, unless it is being used as a medicine b) The Poisons List is divided into eight parts c) The Poisons Rules divide poisons into six schedules relating to their storage conditions for sale records d) The GPhC inspectorate enforce the sale of Part II Poisons from listed sellers 42. Which one of the following statements is false? a) Part I Poisons may be sold by grocers b) Part II Poisons can be sold by pharmacies and other authorised sellers c) All Poisons are covered by CHIP4 regulations d) Part II Poisons are widely available 43. Which one of the following is the correct procedure when selling a schedule I poison? a) A person known to the pharmacist buys a schedule I poison and a record is made in the poisons book but is not signed by the purchaser b) A person not known to the pharmacist produces a certificate to say he is a householder signed by someone unknown to the pharmacist and a record is made in the poisons book with the purchaser’s signature c) A person known to the pharmacist can buy a schedule I poison on the receipt of a signed order and a record is made in the poisons book, but not signed by the purchaser d) A person not known to the pharmacist presents a householder’s certificate signed by a police officer in charge of a station and a record is made in the poisons book, but not signed by the purchaser


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44. Which of the following statements will validate your answer to the previous question? a) The person must be known to the pharmacist; otherwise a sale may not go ahead b) The householder’s certificate must be signed by a second person known to the pharmacist c) Sales of all schedule I poisons must be recorded in the poisons book and signed by the purchaser d) The entry in the poisons book must be signed by the purchaser unless a signed order has been received by the pharmacy 45. Which one of the following statements is true? a) Schedule I Poisons need to be isolated from other stock b) Schedule I poisons need to be kept in a locked cupboard c) Schedule I Poisons do not need to be kept separately from other stock d) Schedule I Poisons can only be ordered specially; they may not be stored in a pharmacy 46. Which one of the following details is NOT required to be included on a signed order for poisons? a) Name and address of purchaser b) Address of premises where poison is to be used c) Name and quantity of poison d) Signature of purchaser

47. How long are prescriptions issued by veterinary surgeons which are not for Controlled Drugs

valid?

a) Up to 4 weeks

b) Up to 13 weeks

c) Up to 20 weeks

d) Up to 26 weeks

48. Identify the abbreviation which does not relate to a class of veterinary medicinal products:

a) POM b) POM-VPS c) POM-V d) AVM-GSL

Section 3 (P4)


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49. Identify the false statement relating to the treatment of animals under the prescribing cascade:

a) The cascade can only be used when no authorised VMP exists in the UK b) Pharmacy (P) medicines can be sold for the treatment of an animal without a valid prescription from a veterinary surgeon c) The prescription issued by the vet should indicate that they are prescribing under the cascade d) Prescribing an extemporaneously prepared VMP is the last option on the cascade 50. Identify the piece of information which is not legally required on a prescription for a VMP:

a) The prescriber's name and address b) If for a controlled drug - total quantity must be written in words and figures c) The owner's telephone number d) Identification of the animal being treated 51. Records of the receipt and supply of POM-V and POM-VPS products must be kept for at least: a) One year b) Two years c) Five years d) Seven years 52. Identify the false statement in relation to the supply of a POM-V product: a) A valid, written prescription must be provided before a pharmacist can supply a POM-V to the owner/keeper of the animal(s) being treated b) Appropriate records must be kept relating to the supply of the POM-V c) The pharmacist does not need to counsel the owner/keeper of the animal(s) being treated on the correct use of the product d) The pharmacist can authorise a competent person to supply a POM-V; the pharmacist's authorisation must be given in advance of the supply and on each occasion a supply is made

53. Which of the following is not a requirement on the dispensing label of a VMP supplied under

the cascade?

a) The name of the veterinary prescriber

b) The name and quantity of the active ingredient

c) ‘Keep out of reach of children’

d) ‘Prescribed under the cascade’


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L3 Module 2 Assignment 1 Questions Oct 2011

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