Unit 1 - sale and supply lesson 1&2 Flashcards

1
Q

what are the general requirements for a prescription ?

A
Prescription Requirements
Signature of Prescriber
Prescriber’s Address
Date
Particulars of the Prescriber
Name and Address of Patient
Age of Patient

Indelible – Prescriptions need to be written in indelible ink; they may be computer generated or typed.

Private prescriptions – This diagram bears the image of an NHS prescription; however, the same requirements apply to private prescriptions.

Carbon copies – It is permissible to issue carbon copies of NHS prescriptions as long as they are signed in ink.

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2
Q

what are the key parts required for the prescribers address ?

A

Prescriptions must include the address of the appropriate practitioner

This is usually the practice address for a GP or dentist and it is already printed on the FP10

For a nurse employed by a Primary Care Trust, the trust’s address is printed on the form and the nurse has to add a code that identifies the patient’s GP practice

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3
Q

What is key to remember about the date of a prescription ?

A

Prescriptions need to include the date they were signed

Valid for six months from the appropriate date

For NHS scripts this is either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed, whichever is later

For private prescriptions, this will always be the date on which it was signed

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4
Q

What information is required on a prescription for the particulars of a prescriber ?

A

Prescriptions require particulars that indicate the type of appropriate practitioner i.e. whether the prescriber is a doctor, dentist, nurse or pharmacist.

This does not have to be the prescriber’s qualifications

FP10s contain a number to identify the prescriber

If this is missing, it can be added by the Pharmacist. Particulars can be confirmed by searching GMC/GDC/GNC/GPhC databases, or by speaking with the patient.

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5
Q

Can you edit a prescription if it has the name or address missing ?

A

Yes
Name and address must be given but the format for this information is not specified

It’s not essential to give the patient’s title but it can be helpful

If missing, the Pharmacist can add these details after confirming with the Patient (using professional judgement e.g. by confirming Date of Birth)

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6
Q

is the age of a patient always a legal requirement for a prescription?

A

Only a legal requirement if under 12

However, having the age of the patient is always useful

GP computer systems should print the age or date of birth on the script for all patients and this information is very useful for the pharmacist.

Again, can be added by the Pharmacist if enough additional detail is present to confirm that the Patient is the correct one!

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7
Q

what are the different colours and types of prescription in England ?

A

Green
FP10SS
FP10NC
FP10HNC

Blue - prescriptions for addiction (eg. methadone)
FP10MDA-SS	
FP10MDA-S	
FP10MDA-SP	
FP10HMDA

yellow - FP10D - Dentist

Lilac - FP10PN
Community Practitioner Nurse Prescriber
Nurse Independent/Supplementary Prescriber

FP10P-REC are used by OOH providers to record items supplied directly to a patient and not dispensed through a community pharmacy. These forms, are submitted to Pricing Authority directly by the OOH provider through their own account.

FP10SP
FP10P-REC (Non-FP10 supply form)

pink
FP10PCDSS Prescribers of Schedule 2 and 3 controlled drugs prescribed in the private sector where prescriptions are dispensed by community pharmacy
Prescriptions must be annotated with the type of prescriber issuing it.

FP10PCDNC

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8
Q

what colour are welsh prescriptions ?

A

All Green
therefore it is important to know the form types in order to distinguish the type of prescriber or prescription.

WP10
WP10SS
WP10SP
WP10HP
WP10HSP	
GPs
Hospitals
Supplementary prescribers.

WP10D
Dentists in primary care
Only items listed in the dental formulary can be prescribed on this prescription.

WP10CN
WP10PN	
Nurse prescribers
Only items listed in the relevant formularies can be prescribed on this prescription.
Green

WP10MDA
WP10HP(AD) Instalment dispensing prescription form.

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9
Q

what is a POM ?

A

A prescription-only medicine (POM) is a medicine that requires a prescription written by an appropriate practitioner before it can be sold or supplied

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10
Q

what are dentists able to prescribe ?

A

Unlike Doctors, dentists are restricted to a specific list of products that they can prescribe on WP/FP10D (NHS forms).

The NHS Prescription Services will only reimburse the dispensing contractor (i.e. pharmacy) if the products are in the formulary.

You can find the list of preparations which may be prescribed on form WP/FP10D as Part XVIIA of the Drug Tariff or in BNF.

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11
Q

What can Community Practitioner Nurses prescribe?

A

Dressings
Appliances
Licensed medicines

The medicines are listed in the Nurse Prescribers’ Formulary for Community Practitioners

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12
Q

What can Independent Prescribers prescribe?

A

For any clinical condition, but must be within their professional and clinical competence

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13
Q

What is an Independent Prescriber responsible for?

A

The clinical assessment of a patient’s condition, formulating or reviewing diagnosis and devising an appropriate treatment plan

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14
Q

How can a pharmacist become an Independent Prescriber?

A

They need to successfully completed an education and training program accredited by the GPhC for Independent prescribing after they have been a pharmacist for at least 2 years. It needs to be supervised by a doctor

The name is held on the membership register of the General Pharmaceutical Council with an annotation signifying further accreditation

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15
Q

What can a Pharmacist Independent Prescriber prescribe?

A

Similar to doctors both on NHS and private

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16
Q

How can a nurse become an Independent Prescriber?

A

1st level Registered Nurse or Midwife, or a Registered Specialist Community Public Health Nurse who has completed a specific program

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17
Q

What can a Nurse Independent Prescriber prescribe?

A

Similar to doctors both on NHS and private

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18
Q

How can an optometrist become an Independent Prescriber?

A

Practitioners will need to register their independent prescribing speciality with the General Optical Council before prescribing

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19
Q

What can an Optometrist Independent Prescriber prescribe?

A

Cannot prescribe CDs or unlicensed medicines

Can prescribe any ophthalmic medication for eye conditions but must work within their professional competence

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20
Q

What is Supplementary Prescribing?

A

A partnership between a medical practitioner who establishes diagnosis and initiates treatment, a pharmacist (or other health professional) who monitors the patient and prescribes further supplies of medication and the patient who agrees to the treatment

Supplementary prescribing is a partnership between an independent prescriber (a doctor or a dentist) and a supplementary prescriber to implement an agreed Clinical Management Plan for an individual patient with that patient’s agreement. - From BNF

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21
Q

What is the role of Supplementary Prescribing?

A

Supplementary prescribers can make decisions after diagnosis (independent prescribers can also diagnose)

Decisions are around:
dose
frequency
formulation
choice of drug from a class within the scope of a Clinical Management Plan (CMP)

The medical practitioner/independent prescriber must review the patient at pre-determined intervals

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22
Q

What did the Health Act 2006 place a requirement of?

A

Each registered pharmacy is to have a Responsible Pharmacist in charge of the business where this relates to the sale or supply of medicines

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23
Q

What does Section 72A of the Medicines Act state?

A

That the Responsible Pharmacist must secure the safe and effective running of the pharmacy business in question so far as it concerns the sale or supply of medicinal products

24
Q

Who should the Responsible Pharmacist clarify things with?

A

Pharmacy owner
Superintendent pharmacist
Other delegated person

25
Q

What should the Responsible Pharmacist do if they believe the pharmacy is not safe or patients are at risk?

A

Steps should be taken to secure the safe and effective running of the pharmacy

If this is not possible then the pharmacy may need to be closed

26
Q

What are the Responsible Pharmacist requirements?

A

The Responsible Pharmacist must sign in and out of the pharmacy record to show when they have taken charge of the pharmacy
A notice must be displayed conspicuously in the registered pharmacy and must include:
the pharmacist’s name
the pharmacist’s registration number
declaration that they are the Responsible Pharmacist in charge of that Registered Pharmacy premises

A Responsible Pharmacist must establish, maintain and review the pharmacy procedures in the pharmacy they are working in

27
Q

What are pharmacy staff limited to carrying out in the absence of the Responsible Pharmacist?

A
Answering the phone
Receiving prescriptions
Stocking medicines
Accessing the Patient Medical Record (PMR)
Date checking
28
Q

Who must be informed if a pharmacy fails to open?

A

The Local Health Board or Primary Care organisation as they have a contract to dispense NHS prescriptions

Failure to inform would be a breach of NHS contract, which is a big no-no! Costs lots of money

29
Q

How long may a Responsible Pharmacist be absent for?

A

A maximum period of two hours during the business hours between midnight and midnight

30
Q

What are the conditions that a Responsible Pharmacist may be away?

A

They must remain contactable by staff and be able to return within reasonable promptness
They must arrange for another pharmacist to be available and contactable where this is not possible

31
Q

What is the Supply Chain for drugs?

A

Manufacturer -> Wholesaler -> Pharmacy -> Patient

32
Q

What is the manufacturer responsible for?

A

production of the medication

33
Q

What is the wholesaler responsible for?

A

Purchasing products from the manufacturer and acting as suppliers to pharmacies

34
Q

How does a pharmacy obtain their stock?

A

They order medication from wholesalers based on the stock they sell over the counter and prescriptions they dispense to patients

35
Q

Do all pharmacies use the same wholesalers?

A

No as many are owned by the same overall business

Lloyds use AAH
Boots use Alliance Healthcare
Well use Bestway Medhub

Independents and hospital pharmacies use a variety

Some specialise in certain types of medications or unusual products from overseas

36
Q

What is the problem with the supply chain?

A

Today’s distribution network for medicinal products is increasingly complex and involves many players. It is becoming easier for Falsified Medicines to enter the supply chain

37
Q

What is a Falsified Medicine?

A

A fake medicine that passes themselves off as a real, authorised medicine

38
Q

How can medicines be Falsified?

A

Contain ingredients of low quality or in the wrong doses
Be deliberately and fraudulently mislabelled with respect to their identity or source
Have fake packaging, the wrong ingredients or low levels of the active doses

39
Q

Why are Falsified Medicines a health threat?

A

They do not pass through the usual evaluation of quality, safety and efficacy that is required for EU authorisation procedure

40
Q

What is a counterfeit medicine?

A

Medicines that do not comply with intellectual-property rights or infringe trademark law

A medicine made by someone other than the genuine manufacturer, by copying or imitating an original product without authority or rights.

41
Q

Where are the vulnerabilities in the supply chain?

A
False labelling of pharmaceutical ingredients
Counterfeits sold to wholesalers
Adulterated raw materials
Adulteration by pharmacists
Toxic ingredients
42
Q

What does the EU Directive from 2011 aim to do?

A

Prevent falsified medicines entering the legal supply chain and reaching patients

It introduced harmonised safety and strengthened control measures across Europe by applying new measures

43
Q

What are the Safety Measures that were brought in by the EU in July 2011?

A

Safety features of medicines (two safety features to be placed on the packaging of most human medicines - a unique identifier (2-dimensional barcode) and an anti-tampering device)

Supply Chain and good distribution practice- new responsibilities for wholesalers

Active substances and ingredients (from July 2013 all active substances manufactured outside the EU and imported into the EU had to be accompanied by written confirmation from the regulatory authority of the exporting country)

Internet Sales (obligatory logo on websites of legally operating online pharmacies and approved retailers in the EU)

44
Q

What are the sale, supply and administration of POMs restricted by?

A

The Human Medicines Regulation 2012 (HMR)

45
Q

What are the three legal classes of medicines?

A

General Sales List (GSL) (includes Pharmacy Only (PO) medicines)
Pharmacy medicines (P medicines)
Prescription-Only medicines (POM)

46
Q

What is a General Sales List medicine?

A

A medicine that can be sold in any retail outlet that can be ‘closed so as to exclude the public’

47
Q

What is the definition of a GSL medicine?

A

A product that is not a POM or a P medicine but is a product that:
is covered by an authorisation of which it is a term that the product is to be available on general sale, or
is covered by an EU marketing authorisation and is not classified as a POM and the licencing authority has determined should be available on general sale

48
Q

What is a Pharmacy Only (PO) medicine?

A

A medicine that is licensed as a GSL but for which the manufacturer wishes to restrict sales or supplies through pharmacies only

49
Q

When can GSL medicines be sold?

A

They can only be sold once a pharmacist has assumed the role of RP but the pharmacist may be physically absent for a period of time while remaining responsible

50
Q

What is a Pharmacy medicine (P medicine)?

A

Any medicinal product which is not a POM or classified as a GSL

51
Q

When can P medicines be sold?

A

They can only be sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist

52
Q

What are GSL medicines and P medicines collectively known as?

A

Over the Counter medicines (OTC)

Non-prescription medicines

53
Q

What is a Prescription Only Medicine (POM)?

A

A medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner

54
Q

Pharmacists must ensure competent staff who can:

A

Obtain sufficient information to make supply
Give appropriate advice about medicine
Know when to refer to the pharmacist
Ensure safe and effective sales
Be alert to abused products
Understand that confidentiality is essential

55
Q

What are the requirements for a POM book entry?

A

PRESCRIBER DETAILS – the name and address of the practitioner

PATIENT DETAILS – the name and address of the patient

SUPPLY DATE – the date on which the medicine was sold or supplied

PRESCRIPTION DATE – the date on the prescription

MEDICINE DETAILS – the name, quantity, formulation and strength of medicine supplied (where not apparent from the name)

Make a record of the price paid, no VAT is added (for PoP: Cost minus VAT)

Stamp the script with branch stamp

Add a reference number to correlate the entry to the prescription. – In Register and on Prescription (good practice only, not legal requirement)

Record should be made on day of sale or supply or if not practical, on the next day

Prescriptions for oral contraceptives are exempt from record keeping

Prescriptions for Schedule 2 Controlled Drugs are also exempt, only where a separate Controlled Drug register record has been made (see 3rd year PH3113)