5 stage approach

2/3 lectures
mcq
long answers
ethic problem walk through it
mcq- law and ethics sample paper
will pull a lot of questions through there
textbook to law and ethics fastrack to law and ethics
diabetes

MHRA- medicines health and product regulatory agency

Aims: - Protect the public through regulation and ensuring
acceptable risk/benefit ratios of new products
-Promote public health by encouraging understanding of use of
products
-Improve public health by ensuring appropriate products available
MHRA achieves this by system of licensing.
Pharmacist duty to check whether prescription is suitable for the
patient even if it falls within the therapeutic range. Hoxton case in
usa
-

a prescription is a legal document that states what the

prescriber wants supplied, to whom and how much.

Patient Group Directions (PGD)

- allows supply without a prescription
- must be a protocol signed by a doctor, dentist and pharmacist
- specific conditions which they can be supplied
Record Keeping ( mep)
- know the exceptions
- know the particulars to be recorded
Emergency supplyKnow the differences between supply at the request of a
practitioner and at the request of a patient
Wholesale Dealing
- need a license to wholesale
- new rules since july 2012 which state takes place on
occasional basis
- quantity is small to meet the patients need.
- Supply not for profit basis.
Supplying unlicensed medicines
-cannot wholesale unless you have license from mhra
Human Medicines Regulation
- Deal with any illegal activities involving medicines and their
availability, manufacture, import, sale, supply and administration
from sale and supply of
unlicensed products to manufacture and distribution of licensed
products.
HMR part 12
- A person commits an offence if he or she, to the prejudice of the
purchaser, sells any medicinal product, and that product is not of

the nature or quality demanded by the purchaser or specified in the

prescription.
HMR part 13
- A person commits an offense if he or she in the course of a
business sells or supplies a product and the medicinal product is in a
container or package which is labelled or marked in a way which
falsely describes the product; or
is likely to mislead the purchaser or another as to the nature or
quality of the product or as to the uses or effects of medicinal
products of that description.
- The offences are either way, punishable by up to two years'
imprisonment when tried in the Crown Court, or a fine if tried in the
magistrates' courts
cannot sell product with a banned substance.
Misuse of Drugs Act 1971
- An Act to make new provision with respect to dangerous or
otherwise harmful drugs and related matters, and for purposes
connected therewith. 27th May 1971
Offenses under the act include
- Possession of a controlled drug unlawfully
Possession of a controlled drug with intent to supply it
Supplying or offering to supply a controlled drug (even where no
charge is made for the drug)
Allowing premises you occupy or manage to be used unlawfully for
the purpose of producing or supplying controlled drugs
Class A drugs: possession 7+ years , supply- life
Cocaine and crack (a form of cocaine), ecstasy, heroin, LSD,
methadone, magic mushrooms and any Class B drug which is
injected.
Class B drugs:possession 5+ years , supply 14+ fine
Amphetamine, barbiturates, codeine and cannabis.
Class C drugs:Possesion 2 + years supply 14+fine
Mild amphetamines, anabolic steroids and minor tranquillisers.
MDMA now classified as a class b drug
The Misuse of Drugs Regulations 2001
Divided Controlled Drugs (CDs) into five schedules corresponding to
their therapeutic usefulness and misuse potential.
A number of changes affecting the prescribing, record keeping and
destruction of CDs have been introduced as a result of amendments
to the Misuse of Drugs Regulations 2001.

Standardized forms are required for cd 2 and cd3

Original private CD Rxs must be submitted to the relevant NHS
agency. A copy must be kept in the pharmacy for 2 years from the
date of supply.
Max quantity of schedule 2, 3 or 4 CDs should not exceed 30 days. If
more than 30 days is prescribed, the prescriber should be able to
justify the quantity requested.
Schedule 2, 3 and 4 CD prescriptions are only valid for 28 days. The
28 days will either start from the date the prescription was signed
by the prescriber issuing it
or the date indicated by him / her as being the start date.
Schedule 2, 3 and 4 CDs cannot be supplied more than 28 days after
the appropriate date. If owings are not collected, you need to
endorse the prescription with the amount of CD that you have
supplied and submit it in the normal way.
The first instalment must be dispensed within 28 days of the
appropriate date, after which the prescription can run until all the
instalments are filled
Health and Safety at work act.
- Identify the hazards
- Decide who might be harmed and how
- Evaluate the risks and decide on precaution
- Record findings and implent them
Sale and supply poisons from pharmacy
- A non medicinal poison is a substance included in the Poisons
list
- Sale and supply is controlled by the poisons list order 1982
- Not regarded as relevant day to day practice
The Poisons
Part 1- may only be sold from pharmacies, under the supervision of
the pharmacist.
Part 2- May be sold from pharmacies and listed sellers
Schedule 1 and schedule 4 poisons most important to pharmacy
Schedule 1- Arsenic used as insecticide
Schedule 4 sulphuric acid; can be sold from sellers usally at
specified strengths
Refer to GHPC as unlikely to come across these
Data Protection Act
1.Information to be processed fairly and lawfully
2.Information must be used for specified and lawful purposes

3.Personal data shall be adequate, relevant and not excessive

4.Personal data shall be accurate and, where necessary, kept up
to date
5.Personal data shall not be kept for longer than is necessary
6.Personal data shall be processed in accordance with the rights of
data subjects
7.Appropriate security measures
8.Personal data must stay within the EEA
Caldicott Review
Six Caldicott principles, applying to the handling of patientidentifiable information, are:
1.Justify the purpose(s) of every proposed use or transfer,
2.Dont use it unless it is absolutely necessary, and
3.Use the minimum necessary.
4.Access to it should be on a strict need-to-know basis.
5.Everyone with access to it should be aware of their
responsibilities, and
6.Understand and comply with the law.
The Sale of Goods act 1979
You have a right as a consumer to goods or services:
of satisfactory quality
fit for their purposes,
as described Environment
Must pass waste on to an authorised carrier.
See section 3.5 of July 2012 MEP
Pharmacies dont now need to register an exemption from the
waste regulations but only for temporary storage and up to 5 cubic
metres
Dont take tablets out of blisters
NHS
- created in 1948
- principle was to provide access to care for all on the basis of
need rather than ability to pay.
Health and Social Care act 1998
The Health and Social Care Bill contains significant measures to
modernise and integrate health and social care - four key policy
areas
Care Quality Commission
Professional regulation
Public health protection measures
Health in Pregnancy Grant
Pharmacy in the NHS

Hospital (2ry Care)

Pharmacists employed
Mostly internal prescription procedures
Greater extension of roles (technicians etc.)
Community (1ry Care)
Pharmacist contracted
All scripts come from outside
Less extension of roles
The Health and Social Care Bill 2011
It takes forward Equity and excellence: liberating the NHS (July
2010) and the subsequent Government response Liberating the
NHS: legislative framework and next steps (December 2010), which
require primary legislation. It also includes provision to strengthen
public health services and reform the Departments arms length
bodies.
Essential services of Pharmacist provides
Dispensing
Repeat Dispensing
Supply of Appliances
Waste medication disposal
Healthy Lifestyles service (Public health)
Signposting patients to other healthcare professionals
Support for self-care
Clinical governance
Advanced services
Accreditation requirements
Premises (Consultation area)
Patient & Pharmacist can sit down together
They can talk without being overheard
The area is clearly signed as a private consultation area
Pharmacist
Competency assessment
Advanced services
accreditation requirements
training
facilities
gradual transition to providing the service giving time to
implement changes
Advanced services
Medicines Use Review (MUR)

Prescription Interventions
New Medicine Service NMS
Examples of Enhanced ServicesCare home services
-Minor ailments
-EHC service
-Smoking cessation
-Needle exchange
-Diabetes screening
-Substance use services
-CHD Screening
Patient group directions
Examples of the information that you need to know-A description of those patients excluded from treatment
-A description of the circumstances under which further advice
-Appropriate dosage and maximum total dosage, quantity, etc
Information Governance
Some of the key indicators that must be declared Pharmacy IG Lead
Information Governance Policy
Contractual Confidentiality Clauses
Staff Awareness and Training
Patient Consent
Incident Reporting
What is a Pharmacist?
You can apply to register with the GPhC as a pharmacist if you:
have a UK-recognised pharmacist's qualification
are an European Economic Area (EEA) national with an EEA
pharmacist's qualification
an overseas (non-EEA) qualified pharmacist, or a non-EEA national
with an EEA pharmacy qualification (other than a UK pharmacy
qualification).
What is a Pharmacy Technician?
To register as a pharmacy technician you need a level 3 NVQ
Diploma in Pharmacy Service Skills
Pharmacy technicians with appropriate qualifications can register
with the General Pharmaceutical Council.
Registration is mandatory and only pharmacy technicians with
acceptable qualifications will be able to join. Those not registered,
but practising as a pharmacy technician or referring to themselves
as such, are breaking the law and can be prosecuted.

Accredited underpinning knowledge programme and completion of

work experience in a pharmacy.
GPhC
The General Pharmaceutical Council
Legal obligation to regulate the profession in order to protect the
public
Keeps the register of pharmacists and pharmacy technicians
GPhC functions
The General Pharmaceutical Council (GPhC) is the independent
regulator for pharmacists, pharmacy technicians and pharmacy
premises in Great Britain.
It is their job to protect, promote and maintain the health, safety
and wellbeing of members of the public by upholding standards and
public trust in pharmacy.
Their principal functions include:
approving qualifications for pharmacists and pharmacy technicians
and accrediting education and training providers;
maintaining a register of pharmacists, pharmacy technicians and
pharmacy premises;
setting standards for conduct, ethics, proficiency, education and
training, and continuing professional development (CPD);
establishing and promoting standards for the safe and effective
practice of pharmacy at registered pharmacies;
establishing fitness to practise requirements, monitoring pharmacy
professionals' fitness to practise and dealing fairly and
proportionately with complaints and concerns.
Standards of conduct ethics and performance
Seven Principles
1.Make patients your first concern
2.Use your professional judgement in the interests of patients and
the public
3.Show respect for others
4.Encourage patients and the public to participate in decisions
about their care
5.Develop your professional knowledge and competence
6.Be honest and trustworthy
7.Take responsibility for your working practices
Sanctions available to fitness to practice committee
a) warning to the practitioner, and direct that details of the
warning should be recorded in the practitioners entry in the
Register
give advice to any other person or organisation involved in the
investigation
b) impose conditions on the practitioner for a period not
exceeding three years;

c) suspend the practitioner from the Register, for a period not

exceeding twelve months;
d) remove the practitioners name from the Register of
Pharmacists or Pharmacy Technicians.
Sanctions available under FTP committee (health reasons)
a)issue a warning to the practitioner, and direct that details of the
warning should be recorded in the practitioners entry in the
Register
b) impose conditions on the practitioner for a period not
exceeding three years; and
c) suspend the practitioner from the Register of Pharmacists
(max 12 months)
Changes to requirements of schedule CD 1,2,3
The regulations permit requisitions for CDs to be computer
generated or handwritten.
The signature of the recipient (i.e. the person ordering the CDs)
must be hand written.
The requisition must contain the following fields of information:
the name, address and profession or occupation of the recipient;
the purpose for which the drug is supplied; and
the name, form and strength of the drug and the total quantity to
be supplied
the date on which it was supplied
Use of the pharmacy stamp which includes the full address of the
pharmacy from where the supply is made, should enable this
requirement to be met.

Vet Medicine
lPOM-V may be sold or supplied with a prescription from a vet &
may be supplied by pharmacists & vets.
lPOM-VPS for food producing animals. May be supplied by vet,
pharmacist, suitably qualified person (SQP) in accordance with a
prescription from one of these persons
lNFA-VPS for non food producing animals. May be supplied by a
vet, pharmacist or SQP.
lAVM-GSL authorised vet medicine GSL.
Vet. Surgeon for a POM-V medicine must:
Carry out a clinical assessment on the animal.
The animal must be under the Vet surgeons care.

Must only prescribe minimum amount of veterinary medicine

required for treatment.
Pharmacists should check with the Vet Surgeon if they are
concerned about the quantities prescribed on a prescription.
POM-VPS
lVeterinary Surgeon, Pharmacist and SQP can prescribe.
Does not have criteria for clinical assessment
Prescription can be oral or written if being elsewhere for supply
Must only prescribe minimum amount of medicine required for
treatment
AVM-GSL
- authorized pet medicine
available on general supply
no restrictions
can be sold anywhere
Prescribing CascadePrescribed by bet and supplied by vet or pharmacist
Must supply product named on the prescription
If generic must supply product named on the prescription
If no authorized vet meidicne a vet can treat in this order
medicines authorised for different species or different condition in
same species
medicines authorised for human use in UK
Vet medicine not licensed in U.K but licensed in another E.U
member state
medicine extemporaneously prepared made to vet surgeons
specifications
Prescribin casecade for food producing animals
Only authorized products may be administered
Withdrawal of milk and eggs for 7 days
28 days for meat
500 degree days for fish
advice on supply
if a pharmacist provides vet medicine they must
provide advice on how to safely administer
advise on any warnings or contra-indications on the label or
package leaflet
be satisfied that the person is competent to use it safely & intends
to use it for a use which it authorised
RX requirements
Name and address of prescriber
Qualifications of prescriber
Name and address of owner

Species
Date of prescription
Signature
CD prescription
lA declaration written on it to say that the CD is prescribed for an
animal or herd under his care
PSNC ( Pharmaceutical services Negotiating Committee)
LPC local pharmaceutical committee

Clinical Governance and patient safety

- CG is the cornerstone around which NHS organisations

demonstrate continuous quality improvement. There are seven
components to Clinical Governance
1.Patient and Public Involvement
2.Clinical Audit
3.Risk Management
4.Clinical Effectiveness
5.Staffing and Staff Management
6.Education, Training and Continuing Professional and Personal
Development 7.Using Information
The outcomes of strong Clinical Governance Framework are:
Improved patient care
Effective use of resources
Engaged and informed staff
Improved customer service
Reduced risk of litigation
The pharmacy contract requires that every pharmacy has a Clinical
Governance Lead.
This person does not need to be a pharmacist.
Negligence and Law of Tort
Part of civil law
tort is an act or omission that causes harm to someone, whether
intentionally or not.
Breach of a duty under a contract.
Most common in healthcare is negligence or battery
NegligenceThree things need to be proved
A duty of care between health professional and service user
A breach of this duty of care
This breach caused harm to the service user.
Burden of proof is proved on balance of probabilities unlike
criminal law.

Intro to ethics

Values - are concepts or ideals that give meaning to an individuals

life and provide a framework for decisions and actions. They can
include religious beliefs, family relationships, prejudices, and roles.
Morals - can be defined as the standards of right and wrong
associated with individuals, groups, and society in general.
Ethics - can be defined as declarations of what is right or wrong and
what ought to be.
Ethical dilemma - ethical dilemmas arise when moral claims
conflict with each other and represent a difficult problem
seemingly incapable of a satisfactory solution, or a situation
involving choice between equally unsatisfactory alternatives

Consent, Confidentiality and Child Protection

Purpose of Consent to treatment
-moral purpose, clinical purpose, legal purpose
Consent: LAW
- valid consent
- capacity to decide, sufficient information, acts voluntarily
Capacity- understand information provided
-retain and believe it
weight it in the balance to make a choice
Sufficient Information- tort of negligence
-material or significant risks must be disclosed. Patients questions
answered truthfully.
Voluntary
-no pressure or undue influence either to accept or refuse
treatment or care
sources of pressure
partners; family members; health or social care professionals.
Re T (Adult: Refusal of Treatment) (1992)
Best Interests
- no one can consent to treatment on behalf of an incompetent
adult
- doctrine of necessity can be invoked for emergency
treatment
- treatment can be given on basis of best interests
Childs right to consent
S8 family Law Reform Act 1969:
16-17 years of age
Gillick Competent

no specific age depends on individual child

child capable of understanding and who has the intelligence to
understand fully what is proposed
Lord Scarman
parent can act for a child who is not Gillick Competent but cannot
override a Gillick Competent childs consent
Consent treated differently to refusal
parents, guardian or court able to over-rule refusal by a Gillick
competent adolescent to receive treatment which is in her best
interests
Re R (A minor) (1992); Re W (A Minor) (Medical Treatment:
Courts Jurisdiction) (1992)
Gillick competence depends on seriousness of the decision taken
as well as cognitive powers and maturity
Re L(Medical Treatment: Gillick Competence) (1998)
Confidentiality
-Professional obligation moral duty
Hippocratic oath
Whatever I see or hear, professionally or privately, which ought not
to be divulged, I will keep secret and tell no one.
Geneva Declaration
I WILL RESPECT the secrets which are confided in me, even after
the patient has died
Professional guidelines
Codes of Ethics; GMC & BMA guidelines
Ethical aspects
Deontological treat others as you would be treated yourself
Utilitarian
Keeping confidences maximises happiness (utility)
Virtue ethics
faithfulness, maintain trust
Tort
Tort of Negligence need to prove breach confidentiality caused
damage
No general privacy tort however....
Wainwright v Home Office [2003]
But implications of the ECHR- privacy is an issue to be taken into
account
Campbell v MGN [2004]
Special cases
children
with capacity obligation of confidence

without capacity law requires best interests approach

incompetent adults
law requires best interests approach
deceased persons
When to breach confidentiality
-Danger to self, third party or public W v Egdell (1990)
Freedom of the Press Public Concern- Graham Pink Case
With consent kept to minimum Caldicott
When in best interests of person without capacity
Confidentiality in the NHS
The 6 Caldicott Principals
1.Justify the purpose for using confidential information
2.Only use when absolutely necessary
3.Use the minimum that is required
4.Access should be on a strict need-to-know basis
5.Everyone must understand his/her responsibilities
6.Understand & comply with law
Statutory Requirements
Certain Infectious Diseases
Road Traffic Act must provide to police on request any
information requested (not medical records for criminal investigation
needs a judges order)
Prevention of Terrorism Act
Misuse of Drugs Act
Abortion Act 1967
Health and Safety at Work Act (1974)
Child Protection
Childrens Act 2004
All organisations with responsibility for services to children,
including healthcare organisations, must make arrangements to
ensure that in discharging their functions they safeguard and
promote the welfare of children
Every local authority has to establish a Local Safeguarding Children
Board (LSCB)
key principals
-be alert to the possibility of child abus and neglect
be able to recognize and act upon indications that a childs safety/
welfare may be at risk.
Indicators of abuse in child
-unexplained/unusual injuries1
evidence of poor overall care
eveidence of std, self harm
evidence of inapproopratiate sexual activity
behavioural problems

Indicators of abuse in parent / carer

Provides inconsistent explanation of injuries
Delays seeking treatment/advice
Shows detachment
Is reluctant to give information
Exhibits aggressive behaviour towards child
what to do if you suspect abuse
- talk to senior collegues, childs gp, or pct
- If after discussion, contact named professional for child
protection at local council or the police, if an emergency.
- If report is phoned, confirm in writing within 3 days
- Make a record of all concerns and discussions
Reporing sexual activity in children
Under 13 considered too young in law and is likely to result
in some action
13-16 is an offence but less so if consensual
Information Sharing
Information sharing among practitioners and other agencies
is essential when a child is at risk.
Attempt to gain consent
If there is no consent, the childs best interests come first
May not need to give all personal details on discussion

Emergency Supply

-Verbal orders- can be given in hospitals but usually reserved for

emergency situations
- written directions to supply ( prescription chart)
Patient Group Directions- Written direction relating to supply and administration of POM
- Signed by dr, dentist or pharmacist
- Must specify inclusion and exclusion criteria
Supplementary prescribing form (april 2003)
Clinical management plan
Agreement among patient, independent prescriber (doctor/dentist)
and supplementary prescriber.
Medicines legislation has been amended to enable podiatrists,
radiographers, physiotherapists and optometrists to become
supplementary prescribers (Original status to nurses, pharmacists
and midwives)
Independent Prescribing

Nurses, midwives and heath visitors have been Independent

prescribers (working to a formulary) for some time.
Extended to pharmacists (May 2006).
In August 2013 physiotherapists/podiatrists were added to the list
of who can be independent prescribers
All should be working to the single competency framework
Emergency Supplies
POMs can be supplied without script in some circumstances
1.At the request of the patient
2.At the request of a doctor, a supplementary prescriber, a
community practitioner nurse prescriber, a nurse independent
prescriber or a pharmacist independent prescriber, dentist but not a
vet
VETS CANNOT request emergency supply
At request of patient
Interview person requesting the medication
Must be impractical to obtain a script
Immediate need
Previously supplied by doctor registered in UK, EEA or Switzerland
Dose
30 days supply maximum.(5 days for CD schedule 4 or 5 or
phenobarbitone for epilepsy)
Emergency supply on label.
Records must be kept
NOT CD schedule 2 or 3(Except phenobarbitone for epilepsy) or
certain other products
Must consider consequences of not supplying (You can supply when
the surgery is open!)
Emergency supply at request of patient
Make an entry in POM book, stating:
Date POM was sold/supplied
Name, quantity, form and strength
Name and address of patient
Nature of emergency i.e. why?
ES at request of prescriber
Any length of supply
Pharmacist must be satisfied that request is by an appropriate
prescriber who by some reason of an emergency cannot supply a Rx
POM supplied in accordance with prescribers directions
Not CD schedule 2 or 3 (except phenobarbitone for epilepsy)
Must have script within 72 hours
Records for ES at request of practitioner

Entry is made in the POM register on that day (or if impracticable

the next day) with the following:
Date which medicine sold/supplied
Name, quantity, form and strength
Name and address of practitioner
Name and address of patient
Date on Rx
When receive Rx, amend entry to include date on which the Rx
received
Pandemic arrangements
Emergency supply
Dont need to interview patient
Just check theyve had it before and dose is appropriate
Supply of POMs
Protocols will be issued by NHS England
Records of who supplies and who receives
Supply of POMs and Ps from pharmacies
May be relaxed
up to 30 days emergecncy supply can be given.

5 STAGE PROCESS
Gather relevant facts
Prioritise and ascribe values
Generate options
Choose an option
Record the situation
1)gather relevant facts
-criminal law, nhs law, civil law, standards of coduct ethics and
behaviour, professional and other knowledge
2) prioritize and ascribe values- what are interest of people
affected
-patient/customer, the public, carers/relatives, other
healthcare professionals, your employer, yourself
requires you to consider carefully and, probably more
importantly, put your own feelings to the background to
consider the greater good
3)
-

Generate Options
What could you do
Consequences of each option
How likely are the consequences

4) choosing an option

-what should you do and can u justify the choice

5)
-

record your actions

date and time of incidence
names of all involved
exact details of all events that occurred
include all relevant information

Mrs Fraser comes in to your pharmacy on Saturday afternoon and

says that her mother, who has diabetes and is frail, is at Mrs Frasers
home in quite a state. Her mother has come to stay for the
weekend and forgot to pack her metformin 500mg tablets. Mrs
Fraser has tried ringing her own surgery but could get no reply.
What can you do?
1) gather relevant information
- needs emergency supply
- criminal law- POM medication, however allowed to give
emergency supply
- NHS law- allowed to give emergency supply
- Civil- consider consequences of supplying vs not supplying
2) Prioritze and ascribe values
-the patient/ customer
the public
pharmacy profession
employers
yourself
3) generate options
-Do not make the supply
Dont make the supply and suggest further action
Make the supply in accordance with the emergency supply
regulations
Contact a doctor and make an emergency supply on his
instruction
Delay to seek advice
Refer to A&E or walk in centre
4) choose an option
- make the supply in accordance with the emergency supply
regulations
5)
-

record your actions

date and time of event
names of people who were involved
factors affecting your decision
An entry needs to be made in the POM register with the
following information on the day of supply

the date the POM was supplied

the name (including strength and form where appropriate) and
quantity of medicine
the name and address of the patient requesting the
mediaction
why patient is unable to provide a prescription
labeling should have emergency supply written on it.

CPD (AERP)
Is continued professional development
As a pharmacist/techncian it is your duty to keep up with the quality
of development of the profession. The way to do this is filling out a
CPD
-CPD can be recorded online at the website, on another computer or
even a hard copy document
-more than 9 cpd entries should be recorded every year
- record of CPD should be kept in complainace with good practice
critieria
-record how cpd has contributed to development of your profession
-submit CPD
Action- is where the learning takes place. CPD cycle may start here,
if unplanned learning has occurred. Record in CPD
Evaluation- end stage of CPD cycle where you asses if you have
reached your learning goals, and how it will benefit your practice
Reflection- thinking about your pharmacy practice as a professional
Planning- deciding how and when you are going to learn what you
want to learn to do.
Oppurtunities for CPD1) work based learning- for example, when a new product or technique is
introduced, when undertaking work shadowing, when asked to review a
protocol
2) Self Directed learning-e-learning. Journals from pharmaceutical
journal
3) Formal Learning- attending courses or study days to increase
knowledge (yields cpd entry)
4) Professional Activity- participating in specialist groups, giving
lectures and presentations

How long are Controlled Drugs prescriptions valid for?

28 days
Which of the following answers best describes the legal categories
of medicines that require an indication of legal status on the box?
Answer

Pom and p

The MHRA can only enforce UK law, the European Medicines

Agency have to enforce European Legislation
Answer false

HowfrequentlymustaUKpharmacyrenewitsregistrationwiththeGeneral
PharmaceuticalCouncil?
Answeryearly

Schedule 5 CD's are the most heavily regulated

False

Under the Health and Safety at Work Act, employers must

make sure there are no risks to employees as a result of
their employment.
false

All schedule 1, 2 and 3 drugs must be recorded in the CD

register
False

Any person manufacturing a medicinal product must have a

marketing authorisation for that product.
Answer false

If a person brings a claim for negligence seeking to sue a pharmacist

for not supplying a medicine on emergency supply, under which
branch of law is it likely to be heard?
civil

If a mistake is made in the Controlled Drugs register which is

the ONE MOST acceptable way to correct it?
Asterisk, cross then write at bottom and sign and date it

Which of the following best describes a medicinal product?

Answer treats diseases

Only a person registered with the General Pharmaceutical

Council may use the title 'Pharmacy Consultant'.
-

False

It is illegal to make an emergency supply if there is an

open GPs surgery close to the pharmacy

Answer false

Which of the following is TRUE with regards to the Caldicott

Review 1997?
Access to it should be on a strict need-to-know basis

Chloropicrin is described in the alphabetical list of nonmedicinal poisons as 'P1; S1'. Which ONE of the following
statements best describes the meaning of this under the
poisons act? (You can check this in the MEP)
It is a product which appears in the Poisons List and 'S1'
means it can only be sold from a registered pharmacy under
the supervision of a pharmacist.
A:

A patient asks if he can return a box of MST Continus

(modified release morphine sulphate) 10 mg tablets which
are no longer needed. The box is unopened and the tablets
do not expire for a further two years. What should you do?
A: accept the tablets and arrange for their disposal without entering receipt
in the Controlled Drug register

Vets can become supplementary prescribers

False

If a doctor prescribes an unlicensed product which of the

following options is most appropriate for the pharmacist to
do?
Agree to dispense the prescription assuming responsibility for its
clinical validity.
Which of the following is true regarding the advertising of medicinal
products to health professionals compared to advertising to the
general public?

Adverts for prescribers need to mention side effects

whereas those for the public don't
Which of the following answers best describes the legal categories
of medicines that require an indication of legal status on the box?
Pom only

What is the maximum length of time a manufacturing licence

is valid for?
5 years

Part 2 poisons may only be sold from pharmacies under the

supervision of a pharmacist
True

Any person manufacturing a medicinal product must have a

marketing authorisation for that product.
True

Which of the following best describes the legal situation

regarding poisons?
Poisons are governed by 'schedules' which can be amended
by 'parts' of the Poisons rules
Which of the following is true regarding the advertising of medicinal
products to health professionals compared to advertising to the
general public?

Under the Health and Safety at Work Act, employers must

make sure there are no risks to employees as a result of
their employment.
false

Employers have to take out insurance against risk to their

employees
True

Which of the following statements is true regarding Private

CD prescriptions?
Cd2 and 3