Human Medicines Regulations Study Pack Flashcards
(152 cards)
1
Q
When did the MHRA begin to codify the medicine legislation to bring it all into one document?
A
in 2009
2
Q
What does MHRA stand for?
A
Medicines and Healthcare Products Regulatory Agency
3
Q
When a review was needed to see if any changes was needed, what regulation was made?
A
result of the enactment of the Human Medicines Regulations 2012
4
Q
What impacted us leaving the UK?
A
EU pharmaceutical law no longer applies to the UK
5
Q
How was the UK’s current law on medicines introduced to us?
A
through the Medicines Directive 2001/83/EC and laws derived from the EU, new powers have been introduced so that Ministers can amend or supplement the laws relating to human medicine, veterinary medicines and medical devices
6
Q
What did the new powers lead to?
A
Medicines and Medical Devices Act 2021 received Royal Assent on 11th February 2021 making it an Act of Parliament
7
Q
What is a medicinal product?
A
some manufacturers would prefer to have their product classified as a food because the food regulations are not as restrictive as they are for a medicine
a term used in HMR is not ‘medicine’ but ‘medicinal product’
8
Q
What do the Human Medicine Regulations 2012 state about medicines being supplied?
A
can only be supplied to the public from pharmacies with the exception of those medicine that can safely be sold without the supervision of a pharmacist
9
Q
What does the HMR cover?
A
labelling of medicine
the containers they are supplied in and how they are advertised
10
Q
Which do NOT apply to medical devices or veterinary medicines?
A
The Medicines Act 1968 and 2012 regulations
11
Q
What is every step of the supply chain include?
A
to regulate, manufacture, import, distribution, sell and supply, labelling, advertising and pharmacovigilance
12
Q
What does General provisions contain?
A
important provisions that apply to much of the rest of the Regulations and these are to include the role of Ministers, including ‘medicinal product’ and ‘advertisement’
13
Q
What does Administration allow?
A
*to continue to function as advisory bodies
*provides the rules for the appointment and role of expert advisory groups
14
Q
What are the advisory bodies in administration?
A
- the Commission on Human Medicines
- the British Pharmacopoeia Commission
15
Q
What does the manufacture & distribution of medicinal products & active substances set out which rules and what does it require?
A
- for manufacturing, importing, and wholesale dealing
- requires that these activities be the subject of a license and establishes what the licensing authority must consider when assessing an application for a license
16
Q
What does manufacture & distribution of medicinal products & active substances also provide?
A
rules around the suspension, revocation and varying of license and sets out requirements for Responsible and Qualified Persons
17
Q
What does the manufacturing & distribution of medicinal products & active substances implement?
A
implements Titles 4 and 7 of DIRECTIVE 2001/83/EC and includes provisions that were in the Medicines Act 1968 and the Medicines for Human Use (Manufacturing, Wholesale Dealing, and Miscellaneous Amendments) Regulations 2005 (SI 2005/2789)
18
Q
What is the Requirement of authorisation?
A
the requirement that medicinal products are the subject of whichever is appropriate of a marketing authorisation, homeopathic certificate of registration, traditional herbal registration or Article 126a authorisation also is a provision for its enforcement
19
Q
What do marketing authorisation contain?
A
detailed requirements
20
Q
What is the importance of marketing authorisations?
A
*to set out the material that is needed to accompany authorisations and make specific provisions for generic medical products, biological medicinal products, products with well-established medicinal use, and new combinations of active substances
* also establishes the criteria that are considered in determining whether a product needs to be subject to the prescription requirement
21
Q
Marketing authorisations imposes which certain obligations on authorisation-holders?
A
such as the requirement to take into account scientific and technical progress and contain rules relating to revocation, variation, suspension, withdrawal of authorisation
22
Q
Marketing Authorisation contains its enforcement provision Medicinal products subject to the Paediatric Regulation to which title?
A
Tile 3, Chapter 1 of Directive 2001/83/EC consolidates material found mostly in the Medicines for Human Use (Marketing Authorisation Etc.) Regulations 1994 (SI 1994/3144)
23
Q
What is a Certificate of homeopathic medicinal products described as?
A
- to which it applies and sets out the information that must be supplied with an application for a certificate of registration
- marketing authorisation, impose certain obligations on registration holders, and sets out rules regarding revocation, variation, withdrawal and suspension , implements chapter 2, title 3 of Directive 2001/83/EC and consolidates the Medicines (Homeopathic Medicinal Products for Human Use) Regulations 1994 (SI 1994/105)
24
Q
A
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41
What is needed before a medicinal product can be sold, supplied or imported?
Regulation 46 of the HMR states that it must have a marketing authorisation 9 (MA)
42
What is MA formerly known as?
Product License (PL)
43
What does it mean for conventional medicines and appliance marketed, sold, supplied or imported to the UK need?
need to be approved by a regulatory body which has seen evidence of their safety, quality, and efficacy when used as specified in the MA
44
Who is responsible for issuing the MAs in the UK?
The MHRA - Medicines and Healthcare products Regulator Agency
45
Are Human Medicines int he UK that already had a UK Marketing Authorisation affected by leaving the EU?
No they are unaffected by this
46
How were the Centrally Authorised Products(CAPs) converted into the UK MAs?
All medicines that were approved via the European Medicines Agency (EMA) were to do this after we left the EU and are still authorised unless the CAP holder opted out of this
47
Who has MHRA taken over the role which EU agencies?
the European Commission guidance on Good Pharmacovigilance Practices (GVP) remains in force until the MHRA publishes its own
48
Do pharmacies have to comply with the Falsified Medicines Directive?
No, they do not. End users have been disconnected from the UK National Medicines Verification System, since Jan 1 2021 no longer can verify or authenticate packs of medicine. A UK verification system will be introduced
49
How long is the MA granted for?
a period of 5 years of less and is specified in the MA
50
When is the MA initially granted to the developer?
when there is a new medicine after their application has been met with the relevant agency that the medicine is safe, effective, and of suitable quality
51
What is the agency not allowed to consider?
price, only safety, efficacy and quality
52
What is important for the MHRA to do for medicines and balance them against the benefits?
the risk/benefit ratio as no medicines are completely safe and all medicines do have undesirable effects with other medicines or associated dangers when taken in overdoes
53
What does efficacy mean?
the medicine 'does what it says on the tin' that is to say it has its claimed benefits.
a MA can't refuse just because there is already another product available with greater efficacy
54
When the product is under quality what is the agency to assess?
whether the medicine can be produced with sufficient quality assurance
55
What are the two documents that are produced during the MA?
* the Summary of Product Characteristics (SmPC)
* the Patient Information Leaflet (PIL)
* Both are approved by the licensing agency and both are important documents that are used regularly
56
What does SmPC stand for?
Summary of Product Characteristics
57
Who is SmPC used by?
healthcare professionals - doctors, nurses and pharmacists and they explain on how to use the medicine
58
What is the process of SmPCs?
they are written and updated by pharmaceutical companies and are based on their research and product knowledge, then are checked by the UK or European medicines licensing agency
59
What does PIL stand for?
Patient Information Leaflet
60
What is a PIL?
the leaflet that is included in the pack with a medicine
the PIL is written by the pharmaceutical company and is a patient-friendly version of the Summary of Product Characteristics
61
Whos is the PIL checked and approved by?
the UK or European Medicine licensing agency
62
When is it appropriate in certain circumstances where it is lawful to sell, supply, administer, import, or market a medicine without an MA?
* the MA is intended to control marketing activities and healthcare professionals can use medicine outside of those criteria when it is appropriate.
using an unlicensed medicine or a medicine 'off-label' does not mean that * it is necessarily unsafe but it is to impose extra responsibilities on the prescriber and the supplying pharmacist
63
What is an Unlicensed Medicine?
a medicine which does not have a valid Marketing Authorisation in the UK is referred to as an unlicensed medicine
64
What is an Off-label Medicines?
A medicine that a medicine si being used in a differnet way from described in the MA
65
Given an example of situations where a licensed medication may be used 'off-able?'
* when using a medication for a different indication from that stated in the MA, there could be evidence that supports its use in certain conditions but the manufacturer may not have extended its MA to cover these
* using the medicine in an age group that is not specified in the MA for example when for children it is only licensed for use in adults
* using a medicine at a higher does that it is stated in the MA
66
What is the General Medical's Council, Guide to Good Medical Practice for medical practitioners?
that they should 'usually prescribe licensed medicines by the terms of their license' but they can prescribe unlicensed medicine where, after assessing a patient and they feel that for medical reasons it is necessary in order for them to meet the specific needs of the patient
67
What does the MA for a medicine made up of several conditions include?
* the indication for the medicine (what it is intended to treat)
* the dosage of medicine that is effective and acceptably safe
* the patient population in which the medicine has been authorised (gender, age group, medical status)
* the route of administration
68
When is a prescriber allowed to prescribe a medicinal product 'off-label' in which situations?
* the MA does not reflect new knowledge i.e. information discovered since the original approval
* the MA does not include well-proven uses
69
Examples of a generic medicinal product which means a medicinal product?
* the same qualitative and quantitative composition in active substance as the reference medicinal product (RMP), that is to say the product it is being compared to
* that is to have the same pharmaceutical form as the RMP
* whose bioequivalence with the RMP has been demonstrated in appropriate studies
70
What is a proprietary product also reffered as?
a branded product which tends to be more expensive than the generic product and so the prescribers are encouraged to prescribe these instead of proprietary alternative
71
What are Borderline Products?
these are products where the status of the product is queried: is it a medicinal product, a food supplement, a medicinal device, or a cosmetic product?
72
What is the committee called for nutritional and dermatological products?
the Advisory Committee on Borderline Substance (ACBS) which advises on their use in the NHS primary care
after a decision is made about the status of a product has been made by the MHRA can serve a notice in writing
73
What does ML stand for?
Manufacturer's License
74
When is an ML required?
if you want to manufacture, assemble or import human medicines other than from an approved country for import
75
What can you NOT do without a manufacturer's; license?
you are not able to apply for marketing authorisation for a specific product
76
When applying for a Manufacturer's License what must you do?
make sure it is in line with Good Manufacturing Practice 9GMP) which is the minimum standard that must be met with respect to production processes
77
What is stated in the Wholesale Dealer's License, Regulation 18 of the HMR?
A person may not except in accordance with a license (a wholesaler dealer license)
* distribute a medicinal product by way of wholesale dealing
* possess a medicinal product for the purpose of such distribution
78
What is Wholesale Dealing, Regulation 18 of the HMR?
* the selling, supplying, procuring, holding, and exporting of a medicinal product for sale and supply
* to a person who receives it to sell or supply the product or administering it causing it to be administered to one or more human beings
* in the course of a business by that person
*wholesale dealing refers to the sale or supply of a medicinal product to a person who is not the person who will actually use that medicinal product
79
Is it possible for you to distribute a medicinal product by wholesale dealing?
NO, you can't, unless you have a marketing authorisation, certificate of registration, or traditional herbal registration for that particular product
80
What is Pharmacovigilance?
* also known as drug safety - is a broad term that describes the collection, analysis, monitoring, and prevention of adverse effects in drugs and therapies
* it is a completely scientific process-driven area within pharma
81
How do we monitor the safety of licensed medicines?
there are information sources including:
* spontaneous adverse drug (ADR) reporting schemes, for example, the Yellow Card Scheme
* clinical and epidemiological studies
* worldwide published medical literature
* pharmaceutical companies
* worldwide regulatory authorities
* morbidity and mortality database
82
What is Yellow Card Scheme?
It collects information about the side effects of different drugs
83
Who is the Yellow Card Scheme run by?
the Medicines and Healthcare products Regulatory Agency (MHRA)
84
What do Herbal remedies need to have?
either a full marketing authorisation based upon safety, quality and efficacy or a traditional herbal registration (THR)
85
What is Homeopathy?
a system created by Samuel Hahnemann in the 18th Century with no real evidence of efficacy
86
What are the two main principles of homeopathy?
* 'like cures like'
* diluting a substance makes it more potent
87
Are Homeopathic remedies diluted?
yes highly diluted
88
Does MHRA need to require applicants to prove that the remedy is effective?
No they do NOT however, they DO need to demonstrate product quality and safety
89
Do homeopathic remedies contain any quality of active substance?
No, they DO NOT and a normally to not have direct safety issues
90
What was found in the 2012 review that was published in the International Journal of Clinical Practice?
they found 38 reports of adverse effects affecting 1159 patients, including 4 fatalities
30 reports were direct adverse effects caused by homeopathic remedies
8 were indirect (harm caused by substituting homeopathy for conventional medicines)
91
What are Homeopathic remedies made from?
often plants but may be from mineral, animal or even synthetic material
92
What are Herbal remedies made from?
naturally occurring plants, parts of plants or extract of plants
93
Does the dose affect the efficacy of the product (Homeopathic remedies)?
homeopaths believe that the greater the dilution and succussion of a product, the more potent and efficacious it becomes
94
Does the dose affect the efficacy of the product (Herbal remedies)?
increasing the dose will increase the effect and/or increase the risk of adverse effects
95
Does Homeopathic remedies contain active ingredients?
the starting material is diluted so that a few or no molecules of the starting material remain in the product
NB: some homeopathic products are not ultra-dilute and may contain noticeable amounts of the starting material
some products are administered orally and topically that do contain measurable amounts of the starting material
96
Does Herbal products contain active ingredients?
they often contain mixtures of many chemical compounds obtained from the plant, although precise compositions can be variable due to the natural source
NB: active substances in many prescription medicines is obtained or derived from plant sources
97
How is the product made? (Homeopathic remedies)
homeopaths believe that serial dilution and shaking steps are critical in ensuring the efficacy of the product
98
How is the product made? (Herbal remedies)
herbal products are prepared using either extracts of the herbal material or through use of the crude drug itself
99
Are the products safe? (Herbal remedies)
generally considered by homeopaths to be non-toxic and safe for administration to adults and children, particularly at high dilution
100
Are the products safe? (Herbal products)
even though they are obtained from natural sources, there's still a chance of side effect and can't be regarded as safe
101
Are they safe in
pregnancy and breast-
feeding? (Homeopathic remedies)
suitable for use during pregnancy and while breastfeeding, but ideally under the guidance of a suitably qualified homeopath
however, important that they are to inform healthcare professionals if they are taking a homeopathic product during pregnancy and breastfeeding, even if it is a highly diluted product
102
Are they safe in
pregnancy and breast-
feeding? (Herbal remedies)
certain herbal ingredients should be avoided or used with caution in pregnancy
103
Do they interact with other
medication? (Homeopathic remedies)
no evidence of interaction between high dilution products and conventional medicines
104
Do they interact with other
medication? (Herbal remedies)
it can interact with prescription and other conventional medicines
105
Is it known how
they work? Homeopathic remedies
there is no sound scientific basis to explain the activity of homeopathic products claimed by homeopaths
106
Is it known how
they work? Herbal remedies
the effects of active ingredients in a herbal product can be shown to have pharmacological actions
107
What's the
evidence to
support the
efficacy of
these products? Homeopathic remedies
there is no scientific or clinical evidence to support the efficacy of homeopathic products, although anecdotal reports of their effectiveness have been published when used as part of individualised homeopathic treatments by a homeopathic practitioner
108
What's the
evidence to
support the
efficacy of
these products? Herbal remedies
there is scientific evidence to support the efficacy of a limited number of herbal products in specific conditions
however, for many herbal products efficacy has not been formally evaluated
109
What does the Regualtion 62 of the HMR state?
that a UK must include a term to indicate whether the product is available
* only on prescription or
* only from a pharmacy or
* only on general sale
110
What is the supply for medicines?
a retail supply is a supply which is not a wholesale supply
111
What does a retail supply normally involve?
supplying to the end user of the product
112
Can medicines be moved from one legal class to another?
restricted class and can demonstrate its safety or even because new information makes the classification of a drug inappropriate
113
When did diclofenac stop being a retail sale OTC from a pharmacy?
until January 2015 and now is only available against a prescription, this change was made because evidence became available demonstrating an increased risk of cardiovascular side effects (mainly heart attacks)
114
Give an example of a changing legal classification?
the reclassification of Maloff Protect, an anti-malarial medication
this was only available on prescription but it is now available as a P medicine and is available to purchase OTC from pharmacies
115
What does GSL stand for?
General Sales List
116
What is the rationale of GSL?
* considered to be safe enough to be sold or supplied without the supervision of a pharmacist
* they are available as 'self-selection' items for sale in registered pharmacies and retail outlets that can 'close to exclude the public'
* there are still some restrictions, even on these products
117
What does P stand for?
Pharmacy only medicine
118
What is the rationale for Pharmacy (P)?
* can be sold or supplied from a pharmacy under the supervision of a pharmacist
119
What does POM stand for?
Prescription Only Medicine
120
What is the rationale of POM?
supplied against a valid prescription under the direct supervision of a pharmacist
this class of medicines consist of:
* products where the risks are not yet clear (new meds)
* products where significant risk exists
* most products intended for parenteral administration
121
Who is responsible for setting the legal class of medicine?
the MHRA and this is specified in the Marketing Authorisation for the medicine
122
What is Regulation 221 and Schedule 15? GSL
* the place where the medicine is sold must be on the premises capable of being closed to exclude the public (no market stalls, car boot sales, and sales from the back of the van)
* the medicine must have been packed elsewhere
* the packaging must not have been opened (no split packs)
123
Before the HMR came into force where was the medicinal products listed?
in the Medicines (Products Other Than Veterinary Drugs) (General Sales List) Order 1984 (the GSL Order) - still in force but nothing has been added to the list since 2001
124
Does the HMR use a GSL?
no, they do not as the MA of the medicinal product which is to dictate how it is classified and the conditions of its sale and supply
125
What does 30 Effervescent tablets for GSL should NOT contain?
* aspirin
* more than 325 milligrams of aspirin per tablet
126
What do 20 Effervescent tablets for GSL contain?
* more than 325 milligrams of aspirin per tablet
127
What do 20 Effervescent tablets for GSL NOT contain?
* more than 500 milligrams per tablet
128
What are/do contain Non-effervescent 28 tablets?
* are enteric-coated
* contain aspiring only
129
What do Non-effervescent 28 tablets do NOT contain?
* more than 75 milligrams per tablet
130
How many tablets are given for GSL that are other non-effervescent?
16 tablets
131
How many sachets are given for power or granules for GSL?
* 10 sachets
132
How many capsules are given for GSL?
16 capsules
133
How many liquid preparations of paracetamol are intended for persons AGED 12 years and OVER for GSL?
160 millilitres
134
How many liquid preparations of paracetamol intended for persons aged LESS THAN 12 YEARS for GSL?
individual unit doses of not more than 5 millilitres each, to a maximum of 20 unit doses
135
A medicinal product that contains Ibuprofen in the form of tablets, can be given the maximum amount of tablets for GSL?
16 tablets
136
A medical product that is to contain Ibuprofen can be given the maximum amount of how many capsules for GSL?
16 capsules
137
A medicinal product that is to contain Ibuprofen in powder or granules for GSL?
12 sachets
138
A medicinal product that is for liquid preparations of Ibuprofen for GSL can be given what maximum amount?
individual unit dose of not more than 5 millilitres each, to a maximum of 20 unit doses
139
What is a Pharmacy medicine defined as in the HMR regulation 5?
(5) In these Regulations references to a pharmacy medicine are to a medicinal product that
is not a prescription only medicinal product or a medicinal product subject to general
sale but is—
(a) covered by an authorisation of which it is a term that the product is to be available only
from a pharmacy;
(b) a product that—
(i) is covered by an EU marketing authorisation, and
(ii) is not classified in the authorisation as a prescription only medicine
other than a product to which paragraph (1)(b)(iii) applies;
(c) available only from a pharmacy by virtue of Part 2 of Schedule 1; or
(d) the result of—
(i) the assembly, or
(ii) the reformulation (including the combining with other substances),
of a medicinal product that is a pharmacy medicine by virtue of sub-paragraph (a) or (b)
140
Does Supervision have a definiton?
No, but several legal cases have debated this term it remains a controversial subject and further classification on this is required
141
Where can some important points be taken from?
the current case law and the HMR wording
a comprehensive list of these are in Chapter 8 of Dale and Appelbe's Pharmacy Law and Ethics 12th edition
142
Give some key points of Chapter 8 of Dale and Appelbe’s Pharmacy Law &
Ethics 12th edition?
** a sale or supply of a P medicine by someone other than a pharmacist is allowed but if
this sale or supply is made it must be supervised by the pharmacist.
* a sale or supply not made by a pharmacist should be no less safe and effective than if
the pharmacist had been conducting the sale or supply in person.
* adequate supervision has occurred if the pharmacist, who is physically present, is aware
of what is being sold or supplied by another individual and is in a position to intervene to
prevent an inappropriate sale or supply.
* there is no professional guidance on whether supervision can be done remotely.
* note that supervision is distinct from direct supervision which is discussed later.
143
What was introduced in August 2020?
the MHRA introduced new restrictions on the sale of stimuland laxatives containing Bisacodyl, Sodium picosulfate and senna and sennosides
144
What are the restrictions on the stimulant laxatives that contain bisacodyl, sodium picosulfonate, and senna and sennosides?
the changes made in August 2020 meant that the large packs are NOT available from general sale outlets such as supermarkets
145
What are the sale of stimulant laxatives that contain biscodyl, sodium picosulfate and senna and sennosides allow Pharmacies to do?
to let them sell, under the supervision of a pharmacist, packs of up to 100 tablets for children aged 12 years and older.
146
What does Regulation 62 of the HMR state?
that an MA must include a term that the medicinal product in question is to be available only on prescription, only from a pharmacy or on general sale
147
What are the factors when deciding whether a product should be made available only on prescription?
* the maximum single dose
*the maximum daily dose
*the strength of the product
*its pharmaceutical form
*its packaging
*such as other circumstances relating to its use as the licensing authority considers relevant
148
How is a UK marketing authorisation granted?
granted subject to a condition that the product to which the
authorisation relates is to be available only on prescription if the licensing authority considers that the
product—
(a) is likely to present a direct or indirect danger to human health, even when used correctly, if used without
the supervision of a doctor or dentist;
This means that risks can be properly monitored and adverse effects dealt with appropriately.
(b) is frequently and to a very wide extent used incorrectly, and as a result is likely to present a direct or
indirect danger to human health;
This allows healthcare professionals to ensure that the product is used correctly.(c) contains substances, or preparations of substances, of which the activity requires, or the side effects
require, further investigation; or
New substances present unknown potential risks which mean that their use must be monitored and
adverse effects reported.
(d) is normally prescribed by a doctor or dentist for parenteral administration.
Look up what parenteral means and add this definition to your glossary at the end of the pack.
(4) In deciding whether paragraph (3) applies to a product, the licensing authority must take into account
whether the product—
(a) contains a substance listed in any of Schedules I, II or IV to the Narcotics Drugs Convention (where the
product is not a preparation listed in Schedule III to that Convention);
What is a narcotic? Look this up and add the definition to your glossary at the end of the pack. These
substances are tightly controlled because of their potential for abuse.
(b) contains a substance listed in any of Schedules I to IV of the Psychotropic Substances Convention
(where the product is not a preparation which may be exempted from measures of control in accordance
with paragraphs 2 and 3 of article 3 of that Convention);
What does psychotropic mean? Look this up and add the definition to your glossary at the end of the pack.
Again these substances are tightly controlled because of their potential for abuse.
(c) is likely, if incorrectly used—
(i) to present a substantial risk of medicinal abuse,
(ii) to lead to addiction, or
(iii) to be used for illegal purposes;
(d) contains a substance that, by reason of its novelty or properties, might fall within paragraph (c), but as
to which there is insufficient information available to determine whether it does so fall;
(e) by reason of its pharmaceutical characteristics or novelty, or in the interests of public health, is reserved
for treatments that can only be followed in a hospital;
(f) is used in the treatment of conditions that must be diagnosed in a hospital or in an institution with special
diagnostic facilities (although administration and subsequent supervision may be carried out elsewhere); or
These conditions are not suitable for self-diagnosis or self-treatment.
(g) is intended for outpatients but may produce very serious side effects which would require a prescription
drawn up as required by a specialist and special supervision throughout the treatment.’
Patients taking these medicines need continuous monitoring throughout their treatment
149
What do the regulation 214 do?
specify who is an appropriate practitioner and who is legally permitted to write a prescription
150
Who can write prescriptions for any POM?
Under the HMR doctors, supplementary prescriber, nurse independent prescriber and a pharmacist independent prescriber
151
Who can write POMS but are subject to some restrictions?
Community practitioner nurse prescribers, optometrist independent prescribers,
physiotherapist independent prescribers, podiatrist independent prescribers, therapeutic
radiographer independent prescribers, paramedic independent prescribers and EEA health
professionals
152
How is a prescription for a POM legally valid?
it must meet the conditions in Regulations 217
