Unit 3 Medicine Flashcards
1
Q
Legislation
A
The process of making law. Law is enacted by a legislative body.
2
Q
Act
A
Refers to a piece of legislation. It is a parliamentary act.
3
Q
Statutory Instrument
A
A piece of secondary legislation. Their scope and nature of parliamentary control (if any) is made under the primary legislation.
4
Q
MHRA
A
Medicines and Healthcare products Regulatory Agency
- government agency which is responsible for ensuring that medicines and medical devices work, and are safe
- oversees the licensing of medicines and placing them in different legal categories as well as responding to scientific updates and safety information submitted by healthcare professionals.
- responsibility for medical devices, blood products and biological medicines.
5
Q
GPhC
A
- responsibilities for maintaining the statutory registers of pharmacy professionals and pharmacy premises, as well as setting and monitoring standards of professional practice
- set the standards that must be met by anyone who wants to become a pharmacist including the initial education
6
Q
Responsible Pharmacist
A
- is in charge of the pharmacy and responsible for the staff and procedures on that day
- required in order to legally supply any medicine from a community pharmacy
7
Q
What details are required on a prescription from an approved health professional from an approved country
A
Patient details- full name, DOB
Prescriber details- full name, address, contact details, credentials
Prescribed medicine details- name form strength quantity
Prescriber signature
Date of issue
For prescriptions from these countries the appropriate date is the date on which the prescription was signed.
8
Q
How long is a prescription valid
A
Prescriptions are valid for up to six months from the appropriate date (prescriptions for Schedule 4 CDs 28 days).
9
Q
independent prescribers
A
practitioners responsible and accountable for the assessment of patients with previously undiagnosed or diagnosed conditions and for decisions about the clinical management required, including prescribing
10
Q
Supplementary prescribing
A
partnership between an independent prescriber (either 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
11
Q
Can pharmacist independent prescribers prescribe Schedule 2 to 5 CDs?
A
Yes - but not cocaine, diamorphine or dipipanone for treating addiction
12
Q
Can pharmacist prescribers authorise an emergency supply for items which can be prescribed?
A
Yes - includes phenobarbital for epilepsy but no other Schedule 1, 2 or 3 CDs.
13
Q
Payments to pharmacies are made from the
A
NHS Business Services Authority
14
Q
What areendorsements made by the pharmacist required to do?
A
- Clarify what has been dispensed
- Claim any additional fees
- Prevent the pharmacy from being out of pocket
- Show the number of professional fees and patient charges
15
Q
Where should the appropriate endorsement be added on an NHS prescription?
A
Left hand column
16
Q
What happens after a prescribed item is passed to a patient in the pharmacy?
A
- Confirm the items have been correctly endorsed.
- NHS prescriptions filed away until end of month.
- At the end of the month, NHS forms are sorted into two groups: paid and exempt.
- Then filed by prescriber type and individual prescriber.
- Then sent to Prescription Services of NHS Business Services Authority.
17
Q
What happens when the NHS Business Services Authority receive prescriptions?
A
- Majority scanned electronically.
- Resulting payment calculated and forwarded to each pharmacy
- Material archived.
18
Q
How long are non-repeatable forms filed and kept for in the pharmacy?
A
2 years.
Repeat prescription returned to patient until the last repeat where it is kept in the pharmacy for 2 years.
19
Q
What does the current guidance say about legality of sale of a P medicine?
A
Supervision of sale is only legal if the pharmacist is aware of the sale or supply at the time and is in a position to intervene if necessary
20
Q
What is Pseudoephedrine and ephedrine widely used as?
A
Decongestant but can be used in production of crystal meth (Class A drug)
21
Q
Laws for supply of pseudoephedrine and ephedrine
A
- It is unlawful to supply a product or combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any one time, without a prescription
- It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription
22
Q
three methods of emergency contraception:
A
copper intrauterine device (Cu-IUD)
oral ulipristal acetate
oral levonorgestrel.
23
Q
Oral emergency contraceptives doses
A
Levonorgestrel 1500 microgram tablet and ulipristal acetate 30mg tablet are licensed as pharmacy medicines for emergency hormonal contraception (EHC).
24
Q
Levonorgestrel
A
Levonorgestrel is licensed for women aged 16 years or over for emergency contraception within 72 hours of unprotected sexual intercourse or failure of a contraceptive method.
25
Ulipristal acetate
Ulipristal acetate is licensed for emergency contraception within 120 hours (five days) of unprotected sexual intercourse or failure of a contraceptive method.
26
Paracetamol and aspirin OTC legal restrictions
Not more than 100 non effervescent tablets or capsules can be sold to a person at any one time. Since most OTC pack sizes are for 16 or 32 dose units, this means that, in practice, 96 is the maximum number that can be sold.
27
Indications for solid dose OTC codeine and dihydrocodeine products
restricted to the short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone
28
POM pack size for codeine and dihydrocodeine
containing more than 32 dose units
29
The Human Medicines Regulations 2012
All medicines intended for human use must meet requirements under UK and EU law.
All licensed medicines available for human use are classified, either by the regulations or by their marketing authorisation (MA), as being POM, P or GSL with differing conditions placed on the sale or supply of each category
30
Misuse of Drugs Act 1971
consolidated previous legislation including the Dangerous Drugs Act and controls the possession, supply, manufacture and import/export of the controlled substances specified in the legislation.
Possession and supply of Controlled Drugs is illegal unless specifically allowed by regulations.
31
Misuse of Drugs Regulations 2001 (as amended)
provides detailed information on use of Controlled Drugs and covers information such as prescribing requirements, storage and destruction, classification of schedules, and other information
32
Health Act 2006
Part 3 relates to pharmacies and medicines and creates the concepts of Responsible Pharmacist and the Accountable Officer.
Each designated body must appoint a fit and proper person to ensure safe and effective management of controlled drugs in the organisation for which they have oversight responsibility. This individual has a range of accountabilities under the law.
33
Role of Advisory Council of Misuse Drugs (ACMD)
advising the UK government on drug-related issues
- Provides advice
- Drug classification
- Recommendations to government
34
Purpose of designating drugs into classes
to provide a framework for regulating their production, supply, and possession, with the aim of minimizing harm to individuals and society.
classification system helps inform law enforcement priorities, drug education and prevention efforts, and healthcare interventions aimed at reducing drug-related harm
35
Examples of control drugs
Morphine
Methadone
Diazepam
36
What did amendments to the Misuse of Drugs Regulations 2001 do for control drug possession?
made the use of an approved form for the requisitioning of Schedule 2 and 3 CDs in the community mandatory
Hospices and prisons are exempt from the requirement to use the approved form.
37
LEGAL REQUIREMENTS FOR A CONTROLLED DRUG REQUISITION
1 Signature of the recipient
2 Name of the recipient
3 Address of the recipient
4 Profession or occupation
5 Total quantity of drug
6 Purpose of the requisition
38
Is it legal or good practice to retain a copy of the requisition for two years from the date of supply
Good practice
39
SCHEDULE 1
CD LIC POM
Have no therapeutic use and a licence is generally required for their production, possession or supply
e.g. hallucinogenic drugs (e.g. ‘LSD’), ecstasy-type substances and raw opium.
40
SCHEDULE 2
CD POM
includes opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine.
41
SCHEDULE 3
CD NO REGISTER POM
include minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam, phenobarbital, gabapentin and pregabalin) that are less likely to be misused (and less harmful if misused) than those in Schedule 2.
42
SCHEDULE 4 part 1
CD Benz POM
Contains most of the benzodiazepines (such as diazepam), non-benzodiazepine hypnotics (such as zopiclone), and Sativex (a cannabinoid oromucosal mouth spray)
43
SCHEDULE 4 part 2
CD Anab POM
Contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones.
44
SCHEDULE 5
CD INV POM OR CD INV P
contains preparations of certain CDs (such as codeine, pholcodine and morphine) that are exempt from full control when present in medicinal products of specifically low strengths.
45
How long is a prescription of Sch2-4 drugs available for?
28 days
46
How long is a prescription of Sch5 drugs available for?
6 months
47
3 drugs where a special license is required to prescribe
Diamorphine/heroin- treatment of addiction
Methadone- opioid substitution therpay
Cocaine- local anaesthesia
48
Controlled Drug prescription requirements for Schedule 2 or 3 CDs
Signature of prescriber
Date
Address of prescriber
Name of CD, form, dose, strength, quantity supplied, total quantity
Patient name
Patient address
Dental wording where appropriate
Installment wording where appropriate
49
How long do CD veterinary prescription forms be retained
Forms must be retained for five years.
50
Technical error CD
contains a minor typographical error or spelling mistake, or where either the words or figures (but not both) of the total quantity has been omitted
51
Who can solve technical error CD
pharmacist can amend the prescription indelibly so that it becomes compliant with legislation.
52
What must be included on standardised private prescriptions
should be on a standardised form
prescriber identification number
number issued by the relevant NHS agency and the prescriber can obtain it from their local primary care organisation. In Scotland, a valid NHS prescriber code is used where available or new ones issued where necessary.
53
How does the Safe Custody Regulations say CD S2/3 drugs should be stored
keep relevant CDs in a ‘locked safe, cabinet or room which is constructed as to prevent unauthorised access to the drugs’.
54
Which control drugs must be kept under safe custody?
Schedule 1 drugs
Schedule 2 drugs except some liquid preparations and quinalbarbitone
Schedule 3 CDs which require safe custody include temazepam and buprenorphine
55
In prisons and hospitals, what is the recommended CD cabinet?
Sold secure silver standard
56
COLLECTION BY A REPRESENTATIVE OF A DRUG MISUSE PATIENT
1. Obtain a letter from the drug misuser that authorises and names the representative
2. Separate letter should be obtained each time the drug misuser sends a representative to collect and the representative should bring identification
3. If directions on the prescription state that the dose must be supervised, the pharmacist should contact the prescriber before the medicine is supplied to the representative – since supervision will not be possible.
57
Which schedules of CDs require records to be kept?
Any Schedule 1 and Schedule 2 CDs received or supplied by a pharmacy
And Sativex which is S4 Part 1 drug
58
For Controlled Drugs received, the following must be recorded
Date supply received
Name and address from whom received
Quantity received.
59
For Controlled Drugs supplied, the following must be recorded
Date supplied
Name and address of recipient
Details of authority to possess – prescriber or licence holder’s details
Quantity supplied
Details of person collecting Schedule 2 CD – patient, patient’s representative or healthcare representative (if the latter, also record their name and address)
Whether proof of identity was requested of the person collecting
Whether proof of identity was provided.
60
All entries made in CD registers should be
Entered chronologically
Entered promptly
In ink or indelible
Unaltered
61
How can corrections in CD register be made
Corrections must be made by dated marginal notes or footnotes. The register should be marked to show who the amendments made are attributable to
62
Structure of CD register
the class, strength and form be specified at the head of each page of the CD register
a bound book register
different classes are kept in a separate part of the register and, within each class, a separate page is used for different strengths and formulations of each drug.
63
CONTROLLED DRUGS THAT NEED TO BE DENATURED BEFORE DISPOSAL
all CDs in Schedules 2, 3 and 4 (Part 1) should be denatured and, therefore, rendered irretrievable before disposal.
64
When is an authorised witness required in pharmacy?
Where there is a requirement to make a CD register entry, legislation also requires to have their destruction witnessed. Typically, the destruction of pharmacy stock of Schedule 2 CDs needs to be witnessed.
65
Which activities can pharmacists carry out without the need for an authorised witness?
The destruction of patient-returned CDs, whether they require denaturing or not, does not require witnessing by an authorised person.
66
Patient returned controlled drug
Is denaturing required?
Yes, if Schedule 2, 3 or 4 (Part 1).
67
Patient returned controlled drug
Is an authorised witness required?
No. However, it is preferable for denaturing to be witnessed by another staff member familiar with CDs (preferably a registered health professional).
68
Patient returned controlled drug
Record keeping
record should not be made in the CD register but records of patient-returned Schedule 2 CDs and their subsequent destruction should be recorded in a separate record for this purpose
69
Expired/obsolete/unwanted stock
Is denaturing required?
Yes, if Schedule 2, 3 or 4 (Part 1).
70
Expired/obsolete/unwanted stock
Is an authorised witness required?
Yes, if Schedule 2. For Schedule 3 medicines it would be good practice to have another member of staff witness the denaturing.
71
Accountable Officer
individual has a range of accountabilities including appointing persons who are authorised to witness the destruction of controlled drugs. The CDAO (CD Accountable Officer) may not act as an authorised witness
72
Examples of doses that are not legally acceptable
As directed
When required
PRN
As per chart
Titration dose
Weekly (this is just a frequency and not a dose)
Decrease dose by 3.5ml every four days
Twice a day.
73
Examples of doses that are legally acceptable
One as directed
Two when required
One PRN
Three ampoules to be given as directed (better still – three ampoules to be given over 24 hours as directed)
One to two when required.
74
only the following can be supplied in instalments against form FP10MDA
Schedule 2 Controlled Drugs;
Buprenorphine;
Buprenorphine/naloxone (Suboxone); and
Diazepam
75
If a patient misses an installment what should be recorded
NOT DISPENSED
76
How to endorse liquid oral methadone prescriptions correctly
Pharmacists will endorse the prescription with the volumes dispensed at each “pick-up” episode
The required endorsement is PD and the number of additional packaged doses supplied, e.g. PD 8
PD n (where n = Total number of separately packaged doses supplied minus Total number of patient interactions)
77
Which prescribers can request you to make an emergency supply?
A doctor
A dentist
A supplementary prescriber
A nurse independent prescriber
A pharmacist independent prescriber
A community practitioner nurse prescriber
A physiotherapist independent prescriber
A podiatrist independent prescriber
A therapeutic radiographer independent prescriber
An optometrist independent prescriber
An EEA or Swiss health professional (see section 3.3.5)
A paramedic independent prescriber
78
conditions for an emergency supply at the request of a prescriber
Relevant prescriber
pharmacist is satisfied that a prescription cannot be provided immediately due to an emergency
prescriber agrees to provide a written prescription within 72 hours
medicine is supplied in accordance with the direction given by the prescriber
Not for CDs, except phenobarbital
An entry must be made into the POM register on the day of the supply
usual labelling requirements
79
conditions for an emergency supply at the request of a patient
requires a pharmacist to interview the patient
pharmacist must be satisfied that there is an immediate need for the POM and that it is not practical for the patient to obtain a prescription without undue delay
POM requested must previously have been used as a treatment and prescribed by a UK, EEA or Swiss health professional listed above
Not for CDs, except phenobarbital
If the emergency supply is for a CD, the maximum quantity that can be supplied is for five days’ treatment. For any other POM, no more than 30 days
entry must be made in the POM register on the day of the supply
words ‘Emergency supply’ need to be added to the dispensing label.
80
exceptions to 30 day treatment for emergency supply
the POM is an insulin, an ointment, a cream, or an inhaler for asthma (i.e. the packs cannot be broken), the smallest pack available in the pharmacy should be supplied
If the POM is an oral contraceptive, a full treatment cycle should be supplied
If the POM is an antibiotic in liquid form for oral administration, the smallest quantity that will provide a full course of treatment should be supplied
81
Patient group directions
allow healthcare professionals to supply and administer specified medicines to pre-defined groups of patients, without a prescription
82
criteria that must apply for pharmacies to supply medicines without the need for a wholesale dealers licence
The transaction takes place on an occasional basis
The quantity of medicines supplied is small
The supply is made on a not for profit basis
The supply is not for onward wholesale distribution.
83
entry in the POM register must include the
Date the POM was supplied
Name, quantity and, where it is not apparent, formulation and strength of the POM supplied
Name and address, trade, business or profession of the person to whom the medicine was supplied
Purpose for which it was sold or supplied.
84
Veterinary Cascade order
Supply vet medicine with a UK wide/GB marking authorisation for the species and condition
OR A vet medicine with NI marking authorisation for species and condition
OR GB/UK wide/NI marking authorisation for another species or condition
OR GB/UK wide/NI licensed human medicine
OR vet medicine authorised by another country
OR a specially manufactured medicine can be considered
85
Categories of veterinary medicines
NFA-VPS
POM-V
POM-VPS
AVM-GSL
Exempt medicines under Schedule 6 of the veterinary medicines regulations – exemptions for small pet animals (SAES)
Unauthorised veterinary medicine
86
NFA-VPS
Category of medicine for non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person.
87
POM-V
Prescription-only medicines that can only be prescribed by a veterinary surgeon and supplied by a veterinary surgeon or a pharmacist with a written prescription.
88
POM-VPS
Prescription-only medicines that can be prescribed and supplied by a veterinary surgeon, a pharmacist or a suitably qualified person on an oral or written prescription
89
AVM-GSL
An authorised veterinary medicine that is available on general sale.
90
Requirements for a veterinary medicine prescription
1 Name, address, telephone number, qualification and signature of the prescriber.
2 Name and address of the owner.
3 Identification and species of the animal and its address (if different from the owner’s address).
4 Date.
5 Name, quantity, dose and administration instructions of the required medicine
6 Any necessary warnings and if relevant the withdrawal period
7 Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary Cascade
8 If the prescription is repeatable, the number of times it can be repeated.
91
differences between veterinary and human Controlled Drug prescriptions
Standardised forms are not required for veterinary prescriptions; however, a statement that the medicines are ‘prescribed for the treatment of an animal or herd under my care’ is required for Schedule 2 and 3 CDs.
Veterinary prescriptions should be retained for five years and not submitted to the relevant NHS agency.
For all CDs, it is considered good practice for only 28 days’ worth of treatment to be prescribed on veterinary prescriptions unless in situations of long term ongoing medication (e.g. when treating epilepsy in dogs).
Veterinary prescriptions for Schedule 2 and 3 CDs must include the Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber.
92
Categories of veterinary medicines that require a prescription
POM-V
POM-VPS- only required if prescriber is not supplier
Unauthorised veterinary medicine- only prescribed by a veterinary surgeon under the Cascade
93
Categories of veterinary medicines that do not require a prescription
NFA-VPS
AVM-GSL
94
What must you not supply without a prescription for animals?
you must not sell or supply any human medicines for animal use without a prescription even where verbal instruction has been given by a veterinary practitioner
95
Specific information that appears on the label of a medicine supplied under the cascade
Name of the prescribing veterinary surgeon
Name and address of the animal owner
Name and address of the pharmacy
Identification and species of the animal
Date of supply
Expiry date of the product
The name or description of the product or its active ingredients and content quantity
Dosage and administration instructions
If appropriate, special storage instructions
Any necessary warnings for the user (e.g. relating to administration, disposal, target species, etc)
Any applicable withdrawal period (i.e. the time between when an animal receives a medicine and when it can safely be used for food)
The words: ‘For animal treatment only’
The words: ‘Keep out of reach of children’.
96
Additional things on vet medicine label
Name of the prescribing veterinary surgeon
Name and address of the animal owner
Identification and species of the animal
Expiry date of the product
The name or description of the product or its active ingredients and content quantity
Any applicable withdrawal period (i.e. the time between when an animal receives a medicine and when it can safely be used for food)
The words: ‘For animal treatment only’
