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!Pharmacy Tech year 1 > Pharmacy Law, Ethics and Practice (318) > Flashcards

Pharmacy Law, Ethics and Practice (318) Flashcards

1
Q

What year was the Medicines Act?

A

The Medicines Act (1968)

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2
Q

What does the medicines act (1968) govern?

A

The medicines act (1968) governs the control of medicines for human and vetinary use.

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3
Q

What three classes of medicines does the medicines act (1968) describe?

A
  • Precription only medicines (POM)
  • Pharmacy medicines (P)
  • General sales license (GSL)
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4
Q

Who are the ministers responsible for the medicines act (1968)?

A
  • health minister
  • agriculture minister
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5
Q

What are the eight main parts of the medicines act (1968)?

A
  1. administritive arrangements including establishment and operation of the medicines commission
  2. set up a licensing authority and a licensing scheme relating to clinical trials, manufacturing and wholesale dealing
  3. control sales and supply of medicinal products
  4. conduct and registration of pharmacies
  5. labelling, containers, packaging and identification of medicinal products
  6. advertising and promotion of medicinal products
  7. publication of BP and other compendia including publication of lists of approved names
  8. operation and enforcement of the act
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6
Q

What are the roles of the Commission on Human Medicines (CHM)? ⇒ was the Medicines Commission

A

The CHMs responsibilities include :

  • advising the government on regulation of human medicinal products
  • giving advice in relation to the safety, quality and efficacy of human medicinal products
  • promoting the collection and investigation of information relating to adverse reactions for human medicines.
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7
Q

What does the medicines act (1968) cover?

A
  • licensing
  • retail pharmacy business
  • classification of medicines
  • wholesaler dealing
  • sale and supply of homeopathic medicines
  • herbal medicines
  • vetinary medications and products
  • containers, packaging and identification
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8
Q

What is the main purpose of the Medicines and Healthcare Products Regulatory Agency?

A

The MHRA are responsible for ensuring medicines and medical devices work and are acceptably safe.

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9
Q

What are the main roles of the medicines and healthcare products regulatory agency?

A
  1. post-marketing surveillance, reporting, investigating and monitoring of adverse reactions to drugs and incidents with devices
  2. assessment and authorisation of medicinal products for sale in the UK
  3. Oversee the bodies that ensure medical device manufacturers comply with regulatory requirements
  4. Operate quality surveillance system to sample and test medicines, also monitor the safety and quality of unlicensed products
  5. investigate internal sales and counterfeiting
  6. regulate clinical trials of medicines and devices
  7. monitor and ensure compliance with statuatory obligations relating to medicines and medical devices
  8. promote safe use of medicines and devices
  9. manage the Clinical Practice Research Datalink and the British Pharmacopoeia
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10
Q

What are the Human Medicines Regulations (2012)?

A
  • introduced by the MHRA
  • replaces much of the medicines act (1968)
  • same old same old (check study booklet if need to know more info pg 7)
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11
Q

What is a prescription only medication (POM)?

A

Prescription only medicine is a medicinal product which may only be sold or supplied by retail in accordance with a prescription given by an appropriate practioner.

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12
Q

Which drugs do POMs include?

A
  • those that market authorisation has classed as POMs
  • CDs
  • those for parenteral administration
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13
Q

Who can prescribe POMs?

A
  • doctors
  • nurses (who have completed a prescribing course)
  • dentists
  • optometrist
  • veterinary surgeons
  • rehabilitation clinics
  • pharmacists (who have completed a prescribing course)
  • midwives
  • podiatrists
  • physiotherapists (who have completed a prescribing course)
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14
Q

What us an independent prescriber?

A

An independent prescriber makes a diagnosis and prescribes to treat the condition.

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15
Q

What is a supplementary prescriber?

A

A supplementary prescriber does not make a diagnosis, they continue prescribing on from the independent prescriber.

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16
Q

What are the types of prescriptions?

A
  • Outpatients (prescription to take home)
  • TTOs (discharge meds - also called TTAs)
  • inpatient (cardex/charts)
  • chemo
  • FP10 (community NHS; green slip)
  • FP10D (dental; yellow slip)
  • FP10PN (nurse practitioners; lilac)
  • scripts for high cost drugs or prescribed with caution
  • FPMDA (misuse of drugs; blue script)
  • end of life
  • private - drugs not available on the NHS (blacklisted) or a cost implication
  • repeat
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17
Q

What does a product license state?

A

A product license (PL) lists conditions that medication is allowed to treat. To obtain a product license a drug must undergo clinical trials.

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18
Q

What does a manufacturing license state?

A

A manufacturing license states what drugs a drug company is allowed to make.

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19
Q

What exception to prescriptions does not have to be individually named?

A

Veterinary prescriptions do not have to be individually named if they are for eg. a herd of 100 cows.

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20
Q

Which prescriptions might you expect to see in a hospital setting?

A
  • end of life
  • private
  • outpatients
  • TTO
  • inpatient
  • chemotherapy
  • scripts for high cost drugs or prescribed with caution
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21
Q

Which prescriptions might you expect to see in a community pharmacy setting?

A
  • private
  • repeat prescriptions
  • FP10
  • FP10D
  • FP10PN
  • scripts for high cost drugs
  • FPMDA
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22
Q

What is a private prescription?

A

A private prescription could be written on a scrap of paper. It is a drug that is not available on the NHS usually due to a cost implication.

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23
Q

What does it mean if a drug is blacklisted?

A

If a drug is blacklisted thet it is not available on the NHS.

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24
Q

What does the FP in FP10 mean?

A

The FP in FP10 means that the prescription was created in England.

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25
Q

What colour is an FP10D?

A

An FP10D is yellow.

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26
Q

What colour is an FP10PN?

A

An FP10PN is lilac.

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27
Q

What colour is an FP10MDA?

A

An FP10MDA is blue.

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28
Q

What is an FP10MDA?

A

An FP10MDA is prescribed due to misuse of drugs. It is specifically for addicts. eg. methadone prescription.

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29
Q

What code is used on Scottish community pharmacy prescriptions?

A

GP(10)

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30
Q

What is the code used on Welsh community pharmacy prescriptions?

A

WP(10)

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31
Q

How many legal requirements on a prescription?

A

There are eight legal requirements that must be fulfilled on a prescription.

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32
Q

What are the legal requirements on a prescription?

A
  1. name of the patient
  2. address of the patient
  3. age of the patient (DOB if under 12)
  4. date of the prescription
  5. prescribers signature
  6. adress of prescriber
  7. prescriber’s registration (eg GMC or GPhC no.)
  8. written in indelible ink
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33
Q

How long is a standard prescription valid for?

A

A prescription is valid for 6 months.

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34
Q

How long is a CD prescription valid for?

A

A prescription for CDs is valid for 28 days.

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35
Q

What might be indications that a prescription is a forgery?

A
  • if the prescriber’s signature is unknown
    • new prescriber?
  • if the patient has not visited the pharmacy before
  • if the patient is not suffering from a condition for which the prescription has been written
  • unusually large dose
  • doctor written before or after the prescriber’s signature
  • incorrect spelling
  • an incorrect dose
  • no GMC no. or it is incorrect
  • a change in ink
    • a possible ammendment
  • missing legal requirements
  • photocopy
  • terminology used
  • signature inconsistensies
  • changes in handwriting
    • possible ammendment
  • patient behaviour
  • not written in indelible ink
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36
Q

Which prescribers can write a prescription for an emergency supply of medicines?

A
  • an EEA or Swiss doctor or dentist
  • all other legal UK prescribers
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37
Q

How long after an emergency prescription is obtained must the prescriber write the pharmacy a prescription?

A

The pharmacy must receive a prescription within 72 hours from the prescriber.

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38
Q

Which drugs cannot be supplied on an emergency prescription?

A

Control drug schedule 1, 2 or 3 cannot be supplied on an emergency prescription.

39
Q

Which control drugs are the exception and can be supplied on an emergency prescription?

A

Phenobarbitone or phenobarbitone sodium for epilepsy can be prescribed on an emergency prescription.

40
Q

What records need to be kept after the issuing of an emergency prescription at the request of a prescriber?

A
  • the date the POM was supplied
  • the name, strength, form and quantity of medicine
  • name and address of patient
  • date of prescription (when received)
  • date on which the prescription is received
41
Q

When can a patient request to be prescribed a POM?

A
  • if they have previously been prescribed the drug
  • if they have been interviewed and it is deemed that they have an immediate need for the POM
42
Q

If a schedule 4 or 5 control drug is prescribed on an emergency prescription, how many days supply may be dispensed?

A

A patient may be issued with up to 5 days of treatment with a control drug on an emergency prescription.

43
Q

How many days worth of POMs can be prescribed on an emergency prescription?

A

Cannot supply more than 30 days of POMs on an emergency prescription, except for exceptions.

44
Q

What are the exceptions to the ‘no more than 30 days for POMs’ rule for emergency prescriptions?

A
  • insulin
  • ointments
  • creams
  • inhalers
  • oral contraceptive
  • antibiotic
45
Q

What records need to be kept when issuing an emergency prescription at the request of the patient?

A
  • the date the drug was supplied
  • name, strength, form and quantity
  • name and address of patient
  • nature of prescription - why can’t one be obtained?
46
Q

What additional information should appear on the label of an emergency prescription?

A

The words “emergency supply” will appear on the label of an emergency prescription.

47
Q

What information needs to be recorded after a private prescription is issued?

A
  • drug name
  • prescribers name
  • quantity
  • strength
  • form
  • date dispensed
  • name and address of patient
  • date of prescription
48
Q

What does PGD stand for?

A

The Patient Group Direction

49
Q

What is the patient group direction?

A

The patient group direction (PGD) are documents which make it legal for POMs to be given to groups of patients without individual prescriptions having to be issued.

50
Q

When is PGD used?

A
  • mass imunisation during pandemics
  • travel clinics
  • flu jabs
  • childhood vaccination programme
  • emergency hormonal contraception
  • mass casualty situations
51
Q

What does a first category PGD allow?

A

First category allows authorised healthcare professionals to supply medicines on behalf of the NHS.

52
Q

What does a second category PGD allow?

A

A second category PGDs are to assist a doctor or dentist providing primary care NHS services.

53
Q

What is a third category PGD?

A

Third category is where an NHS body authorises a PGD for the supply and administration of a POM by a person lawfully conducting a retail pharmacy business.

54
Q

What is another term for a ‘pharmacy’ medicine?

A

Pharmacy medicines are also known as ‘over the counter’.

55
Q

Who has to be on the premises for a pharmacy medication to be sold?

A

The pharmacist has to be on the premesis for a pharmacy medicine to be sold.

56
Q

Which medicines are deemed safe enough to be sold without the supervision of a pharmacist?

A

General sales list medicines are deemed safe enough to be sold without any direct supervision of a pharmacist.

57
Q

What conditions apply to the retail supply of GSL medicines?

A
  1. the business must be closed to the public at some point or the product must not be readily available.
  2. the medicine must be sold in its original packaging.
58
Q

What license states what category (POM/P/GSL) a medicine falls into?

A

The product license will state what category a medicine is.

59
Q

What pack size can analgesics be sold in to deem them GSL?

A

Analgesics can be sold in pack sizes of 16 for them to class as GSL.

60
Q

What pack size are analgesics sold in for them to be categorised as P?

A

Analgesics need to be sold in pack sizes of 17-32 for them to be classed as P.

61
Q

What pack sizes are analgesics sold in for them to be classed as POM medicines?

A

Analgesics sold in pack sizes greater than 32 are POMs.

62
Q

What has to occur for a POM-V to be prescribed?

A

For a POM-V to be prescribed a clinical assessment of the animal must take place.

63
Q

What is a POM-V?

A

This is a medicine that can only be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written prescription.

64
Q

What is a POM-VPS?

A

This is a medicine that can be prescribed by a veterinary surgeon, a pharmacist or a suitably qualified person either via an oral or written prescription. A written prescription is only required if the supplier is not the prescriber.

65
Q

What is an NFA-VPS?

A

This is a category of medicines for non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person. A written prescription is not required.

66
Q

Give an example of a NFA-VPS.

A

Front-line is an example of an NFA-VPS.

67
Q

What is an AVM-GSL?

A

This is an authorised veterinary medicine that is on the general sales list.

68
Q

Give an example of an AVM-GSL.

A

Worming tablets are an example of an AVM-GSL.

69
Q

What are exempt medicines under the small animal exemption scheme (SAES)?

A

This type of medicine is now called ESPA - exemption from authorisation for medicines for small pet animals. This product does not need a market authorisation (product license) (eg fish food).

70
Q

What is an unauthorised veterinary medicine?

A

This is an unlicensed medicine that can only be prescribed by a veterinary surgeon under the veterinary cascade.

71
Q

What is the veterinary cascade?

A

The veterinary cascade is the system that veterinary surgeons use to prescribe. - only links to POM-V and POM-VPS.

72
Q

What is the first port of call to consider when prescribing under the veterinary cascade?

A

When prescribing under the veterinary cascade, the first thing to consider is:

Is there a licensed medicine to treat the disorder they have diagnosed for the animal?

73
Q

When prescribing under the veterinary cascade, if there isn’t a licensed medicine for that particular animal for that particular condition, what must you consider next?

A

When prescribing under the veterinary cascase, if there is not a licensed medicine for that particular animal for that particular condition, the next thing you must consider is:

Is there a licensed medicine that will treat a similar disorder? or in a similar animal?

74
Q

When prescribing under the veterinary cascade, if there is no licensed medicine available for that particular animal for that particular condition, or for similar animals with similar conditions, what is the next prescribing step?

A

If prescribing under the veterinary cascade and there is no licensed medicine for that animal for that condition or for similar animals with similar conditions then:

Is there a licensed human medicine to treat the disorder?

75
Q

If prescribing under the veterinary cascade and there are no licensed medicines available for that animal, similar or licensed human medicines available, what is the next prescribing step?

A

If prescribing under the veterinary cascade and there are no licensed medications available:

Are there unlicensed medicines available to treat that condition?

76
Q

If prescribing under the veterinary cascade and there are no licensed or unlicenced medicines available, what is the next course of action?

A

If prescribing under the veterinary cascade and there are no licensed or unlicensed medicines available for animal or human use for that condition, The next course of action is to make up an extemporaneous medicine.

77
Q

What are the legal requirements for a veterinary prescription?

A

* name of prescriber * Qualification of prescriber * Address of prescriber * Name and species of recipient * Name of owner * Address of owner * Name of drug * Quantity of drug * Directions * Any applicable warnings * If the prescription can be repeated, must be stated * State prescribed under the veterinary cascade * Signature of prescriber * Date of prescription * Written in indelible ink

78
Q

If a CD schedule 2 or 3 is prescribed for veterinary use, what needs to be stated on the prescription?

A

If a schedule 2 or 3 control drug is prescribed for veterinary use the prescription must state that the drug is for veterinary use only.

79
Q

What is an additional legal requirement on prescriptions for livestock animals?

A

Prescriptions for livestock must state the withdrawal period. The length of time between finishing the medication and being clear of the medication to enter the food chain.

80
Q

What is a wholesaler license required for?

A

To sell or supply medicines to anyone other than the patient using the medicine, you need a wholesaler licence – also known as a wholesale dealer licence or wholesale distribution authorisation.

81
Q

What does GMP stand for?

A

GMP is good manufacturing practice.

82
Q

What is GMP?

A

Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product.

83
Q

Which class of CDs are illegal drugs?

A

Schedule 1 are illegal drugs.

84
Q

What is the drug tariff?

A

The drug tariff is a pharmacy reference source compiled on behalf of the department of health in England and Wales. It is published monthly and available in different formats. It outlines what will be paid to pharmacy contractors for the NHS services provided.

85
Q

What does the drug tariff tell you?

A

* what can be prescribed on a prescription (NHS) * Prices for calculation of payments - what you’ll get paid for dispensing certain generic medications (medication + dispensing fee) * Dispensing fees payable - paid more for unlicensed and CDs

86
Q

What is broken bulk?

A

Broken bulk is medications specifically ordered in for a patient. Say pack size is 100 but the patient only needs 28. Can claim the rest of money back via broken bulk after 6 months non-use.

87
Q

What is the PPA

A

The prescription pricing authority

88
Q

What is an FP34A?

A

An FP34A is an end of month form which is sent off to the PPA.

89
Q

What information goes on an FP34A?

A

* prescriber * Type of prescription * No. Of items * Whether patient paid or is exempt

90
Q

What are the six main areas of the drug tariff used in a pharmacy setting?

A
  1. Rules for NHS dispensing and endorsing 2. Fees and allowance - extra money for unlicensed or CDs 3. Disallowed products - blacklisted products 4. Allowable, on an NHS prescription, appliances and reagents - glucose + protein sticks, stoma products, hosiery, dressings 5. Prices for commonly used generic medicines - average of 2 wholesalers and 2 generics - only affects NHS prescriptions not OTC 6. Specifications and prices for appliances - size and shape available for NHS prescription
91
Q

What acts and regulations relate to poisons?

A

* The deregulations act (2015) * Regulated substances (I & II)

92
Q

What does a pharmacy need to supply a non-medicinal poison?

A

* need a license from the home office to state they may be in possession of that poison * If supplying part II poisons must be supplied from a registered pharmacy business under the supervision of a pharmacist

93
Q

What does a pharmacy need to supply a reportable substance?

A

To supply a reportable substance: * Do not need a home office license * Person supplying it has to be sure request is genuine

94
Q

What needs to be on a veterinary medicines label?

A

* name of the prescribing vet * Name and address of the owner * Name and address of the pharmacy that supplied the medicine * Name and species of animal * Date medicine supplied * Expiry date of medicine * Name of the drug (strength, form & quantity) *directions and dosage instructions * Storage instructions (eg refrigerate) * Any warnings - if applicable (eg with or after food) * Withdrawal period - if applicable * For veterinary use only * Keep out of the reach of children

!Pharmacy Tech year 1 (22 decks)

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