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ppm > TBL 4 - SUPPLYING MEDICINES AND POISONS > Flashcards

TBL 4 - SUPPLYING MEDICINES AND POISONS Flashcards

1
Q

What are the role of the GPhC (5 things)?

A

1)Protect public and provide them with assurances that they will receive safe and effective care when using pharmacy services.
2) Set standards for pharmacy professionals and pharmacies to enter and remain on the register.
3) Assurance that pharmacy professionals/pharmacies continue to meet GPhC standards, including by inspecting pharmacies.
4) Protect public/upload public confidence in pharmacy if there are concerns about a pharmacy professional or pharmacy on GPhC’s register.
5)Promote professionalism, support continuous improvement and assure quality and safety of pharmacy.

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2
Q

What are the titles that are an offence to pass yourselves as?

A

Titles are restricted so offence for anyone to use title ‘pharmacists’ or ‘pharmacy tech’ unless registered with GPhC.
Offence to practice as a pharmacist or pharmacy tech without being registered.

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3
Q

What are the requirements to register as a pharmacist (5 things)?

A

1) Successful completion of an accredited Mpharm degree
2) Successful completion of 1 years training after degree
3) Successful completion of GPhC’s registration exam
4) Meeting fitness to practice requirements

5) All registrants, pharmacists and pharmacy tech, must renew their registration each year.
- Revalidation: process which helps show that the trust members of the public have in pharmacy professionals is well placed.

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4
Q

What does Part IV of the Medicines Act 1968 looks at (4 things)?

A

1) Who can lawfully conduct a retail pharmacy business
2) Registration of pharmacies
3) Use certain titles, descriptions and emblems
4) Disqualification and removal of premises from the register

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5
Q

What are 2 titles used for pharmacists?

A

2 titles: superintendent pharmacist/responsible pharmacist

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6
Q

HMR 2012 state that its unlawful to sell or supply a medicinal product and that is not subject to GSL unless certain conditions are complied with. Include:

A

1) The person who sells or supplies is lawfully conducting a retail pharmacy business
2) The sale or supply of the medicinal product is made on premises that it is registered as a pharmacy by the GPhC

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7
Q

What is a retail pharmacy business?

A

1) A business which consisted of or includes the retail sale of medicinal products that are not subject to general sale’
2) Pharmacies in different locations - shops, supermarkets, GP surgeries - known as community pharmacist

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8
Q

Lawfully conducting a retail pharmacy business defined as:

A

A person who carried on a retail pharmacy business is the owner or person who employs the pharmacist working there NOT the employee e.g. locum pharmacist
Found in case of R v Lee (Elizabeth) [2010]

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9
Q

Who can own or conduct a retail pharmacy business (5 things)?

A

1) A registered pharmacist

2) A partnership of pharmacists in England or Wales where EVERY PARTNER is a pharmacist (Scottish law is different)

3) A body corporate such as public limited company. Examples: boots, Lloyds, co-operative
A body corporate must appoint a superintendent pharmacist

4) Representatives of decreased or bankrupt pharmacist or pharmacist that has lost mental capacity. GPhC must be notified of this and there are time limits.

5) In Scotland, a partnership where one or more partners is a pharmacist.

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10
Q

Who can appoint a responsible pharmacist (RP) and what type of requirements are needed?

A

Owner of retail pharmacy business must appoint RP who is a registered pharmacist, to be in charge of registered pharmacy. Every pharmacy when its open must have one RP.

Pharmacy owner must ensure that arrangements in place for an RP to be appointed

No additional requirements needed to be RP but they need to be competent to take on responsibility before they agree to do so.

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11
Q

What are the duties of RP (6 things)?

A

1)RP role is to secure the safe and effective running of the registered pharmacy whenever its open and operating as a pharmacy.
2) A pharmacist can currently be the RP for only one pharmacy at only one time.
3) If there’s more than one pharmacist working in a pharmacy at the same time, one of them takes on the role of RP. Normally decided in agreement with employer.
4) RP responsible for establishing and maintaining SOPs
5) RP must make a record of who is the RP is on the premises at any given day and time. Known as RP log which must be available on the premises.
6) RP expected to be present during pharmacy’s opening hrs.

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12
Q

Why is a Responsible pharmacist notice used?

A

Need to ensure that members of the public know how the RP is in the pharmacy.
RP required to display a notice stating they are the RP at the time

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13
Q

What should be included on a RP notice (6 things)?

A
  • Must include the RP’s name
  • Must include their GPhC number
  • With a statement that they are the RP at this time
  • Must be displayed for as long as that pharmacist remains the RP
  • Must be visible to the public
  • There’s no required design or layout for this notice but should be clearly printed and have a professional appearance
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14
Q

What does RP records need to contain (3 things)?

A

Records need to contain:
1)Name of RP
2)GPhC registration number
3)RP is in charge of pharmacy at that moment of time.

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15
Q

RP must complete the pharmacy record to show (4 things):

A

1) Their name and registration number
2) Date and time they become the RP
3) Date and time they stop being the RP
4) Date and time of any absences from the pharmacy (so the time that they left and the

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16
Q

How long can an RP be absent for?

A

RP can be absent for max 2 hrs

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17
Q

RP can’t be absent from the premises unless, whether it is reasonably practicable (3 things):

A

1) Arrangements are in place to ensure that medicinal products are ordered, stored, prepared, sold, supplied, delivered and disposed of in a safe and effective manner
2) Procedures that deal with circumstances when a pharmacy member of staff who is not a pharmacist may give advice about medicinal products.
3) Procedures in place for identifying which members of staff the RP feels competent to perform certain tasks in the pharmacy

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18
Q

What happens when an RP is absent for more than 2 hrs?

A

A RP may be absent from pharmacy for up to 2 hours during business hours whilst remaining the RP. If they are absent for more than 2 hrs another RP must be appointed
Total absence allowed for RP at one pharmacy during 2hr period must not exceed 2 hrs.

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19
Q

1) Only leave pharmacy if they judge that pharmacy can……
2) Record the…. of the absence, their leaving …. and…….
3) Remain…… by other pharmacy staff.
4) If not possible to remain…..they may arrange for…….. to be contactable to provide advice. This pharmacist does not become the …….
5) Return……. if they feel it becomes necessary.

A

1) continue to operate safely and effectively in their absence
2) time of the absence, leaving time and time of return
3) contactable
4) contactable, another pharmacist, RP
5) reasonably promptly

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20
Q

What are standing operating procedures?

A

SOPs is a set of step by step instruction for preforming a particular task - e.g. in pharmacy there will be SOPs to cover dispensing process.

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21
Q

What does SOP states?

A

An SOP states what must be done, when, where, how and by whom. They can be written on paper, be electronic or both, however they must be available for inspection when required.

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22
Q

What is an SOP’s aim?

A

SOPs are compulsory in pharmacy. They are a risk management and harm minimisation strategy and contribute to clinical governance

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23
Q

What are the advantages of the SOPs (7 things)?

A

1) help to ensure that the principles of good practice are followed at all times
2) provide an opportunity to fully utilise the expertise of all members of the pharmacy team
3) enable pharmacists to delegate tasks appropriately and may free up time for other activities
4) help to avoid confusion over who does what (role clarification)
5) provide advice and guidance to locums and part-time staff
6) Contribute to the audit process
7) provide assurances that procedures comply with the law and professional standards

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24
Q

What are the disadvantages of SOPs (4 things)?

A

1) voluminous and complex
2) a substitute for professionalism
3) a replacement for thinking
4) an excuse for not doing something extra that is required

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25
Q

Who establishes and maintains the SOPs?

A

the regulations place a duty on the responsible pharmacist to establish , maintain and review procedures for safe working in the pharmacy.

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26
Q

When is SOPs reviewed?

A

All SOPs must be reviewed at least every two years to ensure that they remain relevant and workable.

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27
Q

If a situation has come up what can the RP do in regards to the SOPs?

A

The responsible pharmacist can make a temporary change to SOPs e.g. if someone is off sick or some other temporary circumstance applies.
The SOPs must revert back to normal once the situation has been resolved.

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28
Q

What is a superintendent pharmacits role?

A

When a company owns a pharmacy or a number of pharmacies it must appoint a superintendent pharmacist who is responsible for managing the business so far as it concerns the keeping, preparing and dispensing of P or POM meds. e.g. boots, Lloyds have a SP

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29
Q

Who should be notified about being an SP?

A

Name and registration number of the SP must be notified to the GPhC
SP don’t have any legal duties or responsibilities

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30
Q

What are serious shortage protocols an exemption of?

A

SSPs are an exemption to the HMR requirement that POMS can only be sold or supplied in accordance with a valid prescription and are intended to be used in the event of a serious shortage of a meds to allow community pharmacies to manage shortages without needing to refer patients back to prescribers.

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31
Q

SSPs may provide authority to sell or supply under the supervision of a pharmacist (5 things):

A

1) an alternative quantity
2) an alternative strength
3) an alternative formulation o
4) a generic equivalent.
5) a therapeutic equivalent

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32
Q

Supply of an SSP is subject to following conditions (4 things):

A
  • Must be in accordance in the SSP
  • Sale or supply is by or under the supervision of a pharmacist
  • Pharmacist in exercising their skill and judgement believes that the substitution is reasonable and appropriate.
  • Patient would also agree to the alternative supply for that dispensing month.
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33
Q

Emergency supply at the request of a prescriber includes (6 things):

A

1) Relevant prescriber
2) Emergency
3) Prescription within 72 hours
4) Directions - t
5) Controlled drugs and emergency supply
6)A record

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34
Q

POM register entry for an emergency supply of a POM at the request of a prescriber includes (6 things):

A

1) Date of supply
2) The name and address of the prescriber who made the request
3) The name and quantity of medicine supplied (including strength and form where appropriate)
4) The name and address of the patient for whom it was supplied
5) The date on which the prescription is received (may be added when this is received)
6) The date on the prescription (may be added when this is received)

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35
Q

When a patient request an emergency of a POM the pharmacist must first interview the patient and satisfy themselves that (4 things):

A

1) There is an intermediate need for the medicine
2) Not practical for patient to obtain a prescription
3) Patient has previously been prescribed the medicine by a relevant prescriber
4) The dose is appropriate for the patients need

36
Q

When is an interview not possible for an emergency supply?

A

Interview may not be possible e.g. if the patient is a child or being cared for. RPS advises pharmacist to use their professional judgement and consider the best interest of the patient.

37
Q

What is the max quantity of POM that….
a) Prep of insulin, or an inhaler for relief of asthma, an ointment or cream
b)Made up for sale in package elsewhere

A

Smallest available pack should be supplied

38
Q

What is the max quantity of an oral contraceptive?

A

Full treatment cycle should be supplied

39
Q

What is the max quantity of an antibiotic for oral administration in liquid form?

A

Smallest quantity that provides full course of treatment should be supplied.

40
Q

What is the max quantity of an controlled drug with schedule 4 or 5 of the misuse of drugs regulations 2001?

A

Phenobarbital can be supplied to patients of UK-registered prescribers for the purpose of treating epilepsy. Medicinal products can’t be supplied if they consist of or contain any other schedule 1,2 or 3 CDs or the substance.

41
Q

What is the max quantity of any other POM?

A

30 days treatment

42
Q

POM register entry for an emergency supply of POM at the request of a patient includes (3 things):

A
  • Date of supply
  • The name and quantity of meds supplied (including strength and form where appropriate)
  • Info about nature of emergency, why the need the POM and why it is impracticable for them to get a prescription
43
Q

What should be labelled on a container for an emergency supply?

A

emergency supply

44
Q

What is the payment method for the emergency supply?

A

An emergency supply in not a supply against an NHS prescription, the NHS wont reimburse pharmacy for the cost of the medicine supplied.
Up to pharmacist or their employer to decide whether to charge a patient for their emergency supply of so how much.

45
Q

What is a summary care record (SCR) and where can it be found?

A

SCR is an electronic record which contains key clinical information about a patient.
Sourced from GP records and can be seen and used via NHS spine.
Patients can opt out of SCR, can ask or add info to their SCR by visiting their GP

46
Q

What kind of info does a SCR contain (7 things)?

A

1) Allergies
2) Pervious ADRs experienced by the patient
3) Acute meds (12 month history with newer GP system)
4) Current repeats (18 months with newer GP systems)
5) Discontinued repeats (6 months with newer GP systems)
6) Patients name, address, date of birth and NHS number.
7) Additional info included from the patient. Can include diagnoses, immunization and personal preferences.

47
Q

What are the advantages of using a SCR (6 things)?

A

1) Reduce need to call GP to resolve prescription queries
2) Improve response to patient quires
3) Make better informed patient consultations and reviews
4) Help to identify prescribing errors
5) Reduce patient waiting times
6) Improve healthcare for patients

48
Q

If a healthcare professional wants to access a patients SCR must satisfy the following conditions which include?

A

1) access a patients SCR should gain explicit consent
2) Must not pressure on patients or coerce them, if they don’t want to allow you to access their records you must respect their wishes
3) In order to access an SCR must have a legitimate relationship with the patient. Currently involved in patients care.

49
Q

When would it be appropriate to access a patients SCR without their permission (3 things)?

A

May be permissible to access a patients SCR even when they are unable to provide permission. In emergency situation cus patients is unconscious in community pharmacy likely reasons for using emergency access could include:
1) Patients who are unable to speak English and SCR access is needed to provide appropriate care
2) Patients who are confused and are unable to understand the question and access is required to address a safety issue
3) Access for patients in care home settings

50
Q

What are the 3 main scenarios where you can use a patients SCR’s in a community pharmacy?

A

1) Emergency supply
- Patient visits pharmacy asking for emergency supply of their med check their SCR to confirm what to prescribe, the dosage and frequency.

2) Adverse reactions
- If patient can't remember what they are allergic to, can check SCR to make sure to give safe medication.

3) Self-care providing vaccination and other series Patient asks for a free flu vaccination and check their SCR to see if they are eligible.
51
Q

What is the aim of the Community pharmacy consultation service (CPCS)?

A

The CPCS aims to relieve pressure on the wider NHS by connecting patients with community pharmacy, which should be their first port of call and can deliver a swift, convenient and effective service to meet their needs.

52
Q

How is a label set out to assist blind or partially sighted patient?

A

In order to assist blind or partially sighted patients, the product name must appear in Braille format on the outer packaging and the MA holder must ensure that they are able to provide the patient information leaflet for the product in suitable formats for these patients.

53
Q

When labelling dispensed medicines what should be added (7 things)?

A

1) Patients name
2) name and address of pharmacy supplying medicine
3) Date the medicine was dispensed
4) product name as specified by prescriber
5) Direction for use specified by prescriber
6) Precautions relating to items
7) Other particulars specified by prescriber

54
Q

Where should labels be placed on medicinal products?

A

Labels should be placed on inside and outside of each packaging

55
Q

Why is it essential for a pharmacist to supply a PIL?

A

It is compulsory to supply a PIL with every medicine as it includes information which could be essential to the patient (unless all the required information is stated on the packaging of the product).

56
Q

Where is the information for the PIL taken from?

A

The information in the PIL is taken from the SmPC and is specific to a particular medicinal product

57
Q

What conditions does the PIL need to be in according in HMR?

A

The HMR says that a PIL must be legible, clear and easy to use.

58
Q

For medical products for children what type of containers should they been?

A

Regulated medicinal products must be supplied only in containers which are opaque or dark-tinted and child resistant.

59
Q

When a containers are child resistant what does that mean?

A

Child resistant could mean a blister pack or a re-closable container which requires dexterity on the part of the user. e.g. ‘line up the arrows and push off’.

60
Q

When dispensing, a pharmacist can decide not to supply child resistant packaging in two situations:

A

1) where it is not reasonably practical or
2) where a patient, over 16, requests their medicine in a non-child resistant container, perhaps because they have difficulty opening them.

61
Q

Who governs the sale of non-medicinal poisons?

A

The sale of non-medicinal Poisons and Chemicals through pharmacies is governed by the Poisons Act 1972.

62
Q

What is the pharmacist’s duty in regards to suspensions when purchasing poisons?

A
  • Required to report suspicious transactions , significant stock loss and theft to the local police or anti-terrorism hotline.
63
Q

Before purchasing poisons what should the purchaser have?

A
  • Must have a valid home office license (an explosive precursors and poisons (EPP) license) before buying poisons.
64
Q

When the license is required for the purpose of purchasing poisons what should a pharmacist check?

A

Pharmacist must check that it is valid, unaltered and matches the request.

65
Q

When a license is not required for the purpose of purchasing poisons what should a pharmacist check?

A

Pharmacist must think about whether the request is suspicious and whether the customer should be referred to a commercial retailer

66
Q

What are regulated substances?

A

Regulated substances are chemicals that may be used to cause harm.
They may also have legitimate everyday uses in the home or for use in hobbies.

67
Q

Sale of regulated substances to the public is restricted what should be shown to purchase regulated substances?

A

Sale of these chemicals to the general public is restricted. If a member of the general public wants to buy any of the regulated substances, they have to apply to the Home Office for a licence to acquire, possess and use that substance (EPP licence). They must produce the licence when they purchase regulated substances.

68
Q

What is Part 1 of regulated substances called?

A

Part 1 – Regulated explosives precursors includes hydrogen peroxide at concentrations greater than 12%.

69
Q

What is Part 2 of regulated substances called?

A

Part 2 – Regulated non-medicinal poisons includes arsenic and its compounds, hydrogen cyanide, mercury and its compounds.

It is an offence to supply a member of the public any of these regulated substances unless they hold a valid EPP licence issued by the Home Office

70
Q

Before supplying a regulated substance to a member of the public you must (5 things):

A

1) Check they have an EPP licence
2) Check it is valid, in date and unaltered
3) Check the photo ID specified in the license, you can only make supplies to the individual named on the license.
4) Check the substance and the quantity requested match the license
5) Record the transaction on the license.

71
Q

Which part of the regulated substances would you need to record in the poisons register before making the supply?

A

You must make a record of supplies of Part 2 substances (regulated non-medicinal poisons) in the poisons register. This record must be made before the supply is made.

72
Q

If the supply is to a private individual the record must include (4 things):

A
  1. date of supply
  2. name and address of the purchaser
  3. name and quantity of the regulated poison supplied
  4. the purpose for which it is required
    the signature of the purchaser
73
Q

If the supply is for use in a trade, business or profession, the record must include (4 things):

A

1) date of supply
2) name and address of the trade, business or profession
3) name and quantity of the regulated poison supplied
4) the purpose for which it is stated by the trade, business or profession to be required
the signature of the person authorised on behalf of the trade, business or profession

74
Q

What regulations would help to identify suspicious requests (4 things)?

A
  1. The purchaser appears unclear or unfamiliar with the intended use or cannot explain it plausibly.
  2. They try to buy substances in quantities, combinations or concentrations which are uncommon for private use.
  3. They are unwilling to provide proof of identity or address.
  4. They insist on unusual methods of payment including large amounts of cash.
75
Q

What is the main requirement for storing poisons?

A

The main requirement is that poisons must be stored separately from other items; in particular they must be kept away from food and drink.

76
Q

What phase should be labelled on the regulated substances?

A

regulated substances, the packaging must also be labelled with the phrase ‘Acquisition, possession or use by the general public is restricted’ or similar

77
Q

What are 4 examples of Part 1 - regulated explosive persecutors?

A

1) Hydrogen peroxide over 12% w/v
2) Nitromethane over 30% w/w
3) Nitric acid 3% w/w
4) Potassium chlorate over 40% w/w

78
Q

What are 4 examples of Part 2 - regulated non-medicinal poisons ?

A

1) Hydrogen cyanide
2) Lead acetates
3) Oxalic acid over 10% w/w
4) Barium salts

79
Q

What are 4 example of part 3 - reportable explosive precursors?

A
  • Acetone
  • Aluminum powders
  • Ammonium nitrate
  • Hexamine
80
Q

What are 4 example of part 4- reportable non-medicinal poisons?

A
  • Aldicarb
  • Alpha-chloralose
  • Ammonia
  • Hydrochloric acid
81
Q

The Registered Qualified Persons (RQP) can do what with vet meds?

A

Under the Veterinary Medicines Regulations (VMR) vets, pharmacists and suitably qualified persons (SQP), collectively known as RQPs, can prescribe or supply certain categories of authorised veterinary medicines that they are qualified and registered to supply.

82
Q

What is prescription only medicine - veterinarian (POM-V)?

A
  • POM-V may be only prescribed by a vet
  • supplied by prescribing vet or in accordance with written prescription by another vet or a pharmacist
  • Vet prescribing the med must first carry out a clinical assessment of the animals and the animal/herd must be under their care.
83
Q

What is prescription only medicine - veterinarian, pharmacist, SQP (POM-VPS)?

A
  • POM-VPS meds may be prescribed by any RQP
  • May be supplied by prescriber, or in accordance with a written prescription by another RQP?
  • A clinical assessment of animal doesn’t have to be carried out when prescribing POM-VPS meds and animal doesn’t have to be under the RQP’s care.
84
Q

What is non-food animal - vet, pharmacist, SQP (NFA-VPS)?

A
  • NFA-VPS meds doesn’t have to be prescribed but only supplied by an RQP
85
Q

What is authorised veterinary medicine - general sale lists (AVM-GSL)?

A
  • no legal restirctions on the retail sale supply of vet meds
86
Q

What is exempt meds under schedule 6 of the vet meds regulations - exemptions for small pet animals (SAEs)?

A

An unlicensed med that doesn’t require a marketing authorisation cus it meets the requirements of schedule 6 of vet meds regulations - exemption for small pet animals

87
Q

What is unauthorised vet meds?

A
  • An unlicensed med that doesn’t require a marketing authorisation and is not eligible through the SAE
  • only prescribed by vet under cascade.

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