MEP Flashcards

(89 cards)

1
Q

What is a profession?

A

• Is recognised by the public as a profession
• Has a recognised representative professional body
• Benefits from professional standards and codes of conduct
• Is regulated to ensure the maintenance of
standards and codes of conduct

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2
Q

What is a professional?

A

• A member of a profession
• A member of a professional body
• An individual who:
– Behaves and acts professionally
– Exercises professionalism and professional judgement
– Undertakes continuing professional development

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3
Q

What is Pharmacy professionalism?

A

Pharmacy professionalism can be defined as a
set of values, behaviours and relationships that
underpin the trust the public has in pharmacists.
Examples of these are:
• Altruism
• Appropriate accountability
• Compassion
• Duty
• Excellence and continuous improvement
• Honour and integrity
• Professional judgement
• Respect for other patients, colleagues and other
healthcare professionals (including listening to
and acting on feedback when needed)
• Working in partnership with patients, doctors
and the wider healthcare team in the patient’s/
public’s best interest
• Work within competence
• Ensure patient is placed at the centre of all
decision making
• Being honest about scope of practice
• Knowing when to seek support.

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4
Q

Examples of conflicts of interest.

A

• Having another job or receiving consultancy fees (i.e. having an outside employment) which impacts upon another role
• Receiving or being offered gifts from patients or suppliers to the NHS or your employer
• Receiving or being offered hospitality such as travel, accommodation, meals or refreshments e.g. in relation to attending a meeting, conference or training event
• Receiving or being offered sponsorship for
events, research grants or posts
• Owning shares in a company whose value could be influenced by your role
• Having an indirect interest or non-financial
interest e.g. if a spouse, close relative, business partner or close friend has an interest
• Receiving any other payments or ‘transfers of value’.

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5
Q

Rules for dispensing for family?

A

• Is the situation an emergency - where not
advising or dispensing a prescription could put the person at risk of serious harm?
• Could the person be easily signposted to an alternative appropriate healthcare provider?
Would it be more appropriate to do so?
• Are you able to maintain objectivity and exercise professional judgement?
• Is maintaining confidentiality an issue?
• Does the person who is asking the question have a right to know the answer?
• Are you fully aware of all of the care currently being provided?
• Do you have all of the necessary information to professionally and confidentially provide
the pharmacy service/information - can you
advise accurately and appropriately with the
information that you have?
• Is what you are being asked for within the
bounds of your professional competence?
• Can you demonstrate transparency – personal and professional boundaries should be maintained to prevent any conflict of interest arising?
• Do you have access to Summary Care Records (or equivalent, as appropriate)?
• Are you able to make appropriate records
(where required)?
• Will providing the service/advice affect the
person’s relationship with their usual healthcare provider(s), and if so, how?
• Do you need to inform anyone else of what you have done/advised?
• What is in the best interests of the patient, all factors considered?
• Remember, even if you a providing pharmacy services (such as advice) outside the work environment, you are still expected to provide it to the same standard as you would at work, and your liability if anything should go wrong is likely to be the same.
• Ensure that you know what your employer’s policies are regarding providing services to friends and family.

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6
Q

What is required for validation?

A

To revalidate, pharmacy professionals must submit
the following records each year:
• Four continuing professional development (CPD)
records (at least two planned)
• A peer discussion
• A reflective account.

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7
Q

What is person centered care?

A

Common themes are:
• Treating patients as people and as equal
partners in decisions about their care
• Putting people at the centre of all decisions
• Respect for patient preferences
• Compassion, dignity and empathy
• Support for self-care, enablement, autonomy
and independence
• Patient choice, control and influence
• Good communication.

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8
Q

Examples of person centered care?

A

• Introducing yourself (e.g. the ‘Hello, my name is’ campaign) and explaining your role clearly and explicitly
• Asking, rather than telling, people to do
something
• Helping people to make informed choices
• Ensuring people feel able to speak openly
about their experiences of taking (or not taking medicines); their views about what medicines mean to them, and how medicines impact on their daily life (this includes any complaints or concerns they have about their medicines/services received)
• Involving people in decisions about their
medicines and self-care
• Being aware of how different aspects of
medicine-taking – e.g. quantity, formulation,
timing, patient beliefs – impact the individual
• Listening to people when they raise concerns about their medicines/treatment or that of a relative

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9
Q

PROBLEMS WITH A PUNITIVE CULTURE?

A

A punitive culture is based upon assigning blame
and punishment. It contributes to creating a
culture of fear. People and organisations see what
happens to others and if what they see is perceived
to be draconian or unjust, this leads to fear, stifling
reporting and stifling the raising of concerns. We
lose the opportunity to learn, and patient safety is
affected. A single instance of perceived punitive
action can have a wide effect on how large groups
of people choose to act.

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10
Q

WHY A NO-BLAME CULTURE IS INADEQUATE?

A

A no-blame culture may not be better than a
punitive culture. It can breed complacency or
nonchalance which can also impact upon patient
safety. At its worst it can appear unacceptable
to society overall due to the immunity from
accountability which can also be abused.
For example, there is a perception that at times
diplomatic immunity can be unfair and abused.

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11
Q

What are the error reporting standards?

A

Standard 1- Open and honest: Be honest and open when things go wrong
Standard 2- Report: Report patient safety incidents to the appropriate local or national reporting programme
Standard 3- Learn: Investigate and learn from all incidents including those that cause harm and those that are ‘no harm’ or ‘near miss’
Standard 4- Share: Share what you have learnt to make local or national systems of care
Standard 5- Act: Take action to change practice or improve local or national systems of care
Standard 6- Review: Review changes to practice

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12
Q

How do you handle dispensing errors?

A

1 Take steps to let the patient know promptly
2 Make things right (this may involve contacting the prescriber)
3 Offer an apology
4 Let colleagues involved in the error know.

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13
Q

When can the legal defence against criminal prosecution be used?

A

The legal defence against criminal prosecution
can be used when the error has been:
1 Dispensed in a registered pharmacy, and
2 Dispensed by or under the supervision of a
registered pharmacist, and
3 Supplied against a prescription, PGD or direction
from a prescriber, and
4 Promptly notified to the patient once the
pharmacy team are aware of the error.

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14
Q

What are the signs of abuse or neglect?

A

PHYSICAL ABUSE
Unusual/unexplained injuries, injuries in
inaccessible places, bite marks, scalds, fingertip
bruising, fractures, repeated injuries, age of injuries
inconsistent with account given by adult, injuries
blamed on siblings
NEGLECT
Poor growth and weight. Poor hygiene, dirty and
messy. Inappropriate food or drink
EMOTIONAL ABUSE
Evidence of self-harm/self mutilation, behavioural
problems, inappropriate verbal abuse, fear of
adults or a certain adult
SEXUAL ABUSE
Indication of sexually transmitted disease,
evidence of sexual activity or relationship that is
inappropriate to the child’s age or competence
ADDITIONAL SIGNS
Parent/carer delays seeking medical treatment
or advice and/or reluctant to allow treatment,
detachment from the child, lacks concern at
the severity or extent of injury, reluctant to give
information, aggressive towards child or children

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15
Q

When can you provide sexual advice to a young person or child?

A

• They have sufficient maturity and intelligence to
understand the nature and implications of the
proposed treatment
• They cannot be persuaded to tell her parents or
to allow the practitioner to tell them
• They are very likely to begin or continue having
sexual intercourse with or without contraceptive
treatment
• Their physical or mental health is likely to suffer
unless they receive the advice or treatment
• The advice or treatment is in the young person’s
best interests.

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16
Q

What age is sexual activity illegal?

A

Children under the age of 13 are legally too young
to consent to any sexual activity. Instances should
be treated seriously with a presumption that the
case should be reported to Social Services, unless
there are exceptional circumstances backed by
documented reasons for not sharing information.

Sexual activity with children under the age of 16 is
also an offence but may be consensual. The law is
not intended to prosecute mutually agreed sexual
activity between young people of a similar age,
unless it involves abuse or exploitation.

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17
Q

What are signs of abuse in vulnerable adults?

A

Physical abuse- Injuries which are unusual or unexplained. Bite marks, scalds, fingertip bruising, fractures. Repeated injury
Neglect- Failure to thrive – evidence of malnourishment. Poor hygiene, dirty and messy
Emotional abuse- Evidence of self-harm/self-mutilation. Inappropriate verbal abuse. Fear of certain people
Sexual abuse- Indication of sexually transmitted disease. Repeated requests for emergency hormonal contraception
Financial abuse-Sudden changes to their finances, e.g. getting into debt. Inappropriate, exploitative or
excessive control over the finances of the vulnerable adult
Additional signs- Delays seeking medical treatment or advice and/ or reluctant to allow treatment of the
vulnerable adult. Detachment from the vulnerable adult. Lacks concern at the severity or extent of injury or other signs. Is reluctant to give information. Aggressive towards the vulnerable adult.

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18
Q

What is medicine optimisation?

A
The goal is to help patients to:
• Improve their outcomes
• Take their medicines correctly
• Improve adherence
• Avoid taking unnecessary medicines
• Reduce wastage of medicines
• Improve medicines and patient safety.
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19
Q

What are the principles of medicine optimisation?

A
  1. Aim to understand the patient’s experience
  2. Evidence-based choice of medicines
  3. Ensure medicine use is safe as possible
  4. Make medicine optimization a part of routine practice.
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20
Q

What is medicine reconciliation?

A

Medicines reconciliation is the process of
identifying an accurate list of a patient’s current
medicines (including over-the-counter and
complementary medicines) and carrying out a
comparison of these with the current list in use,
recognising any discrepancies, and documenting
any changes. It also takes into account the current
health of the patient and any active or longstanding
issues. The result is a complete list of
medicines that is then accurately communicated.

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21
Q

Where can a patient’s drug history be taken from?

A
• Patient or patient’s representative
• Patient’s medicines
• Repeat prescriptions
• GP referral letters
• The patient’s GP surgery
• Hospital discharge summaries or outpatient appointment notes
• Community pharmacy patient medication
records
• Care home records
• Drug treatment centre records
• Other healthcare professionals and specialist clinics
• Patient medical records where available (e.g. in prisons or the Emergency Care Summary (Scotland), Summary Care Record (England), or Welsh GP Record)
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22
Q

How do you take a medication history?

A

• Explain to the patient why the history is being
taken
• Use a balance of open-ended questions (e.g.
what, how, why, when) with closed questions (i.e.
those requiring yes/no answers)
• Avoid jargon – keep it simple
• Clarify vague responses with further questioning
or by using other sources of information
• Keep the patient at ease

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23
Q

What information is required for a drug history?

A

• Generic name of the drug
• Brand name of the drug, where appropriate (for example, where bioavailability variations between brands can have clinical consequences, such as lithium therapy)
• Strength of the medicine taken
• Dose – both the prescribed dose and the actual dose the patient is taking (NB: This may best be described to the patient as a quantity of tablets rather than as milligrams of active ingredient)
• Formulation used (e.g. phenytoin – 100mg as a liquid does not deliver the same dose as a 100mg tablet)
• Route of administration (this could be an
unlicensed route – e.g. ciprofloxacin eye drops for the ear)
• Frequency of administration – this should
include the time of administration for certain
medicines (e.g. levodopa)
• Length of therapy, if appropriate (e.g. for
antibiotics)
• Administration device and brand for injectables (e.g. insulin)
• Day or date of administration for medicines
taken on specific days of the week or month.

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24
Q

Where can you find information for a clinical check?

A

In primary care, you may be able to obtain
information from:
• The prescription
• The patient, patient’s representative or carer
• The patient’s GP or other healthcare
professionals involved in the patient’s care
• The patient’s medication record
• Other patient medical records where available
(e.g. in Scotland – access to the Emergency Care Summary; access to the Summary Care Record where available; in a prison – access to medical records).

In secondary care, additional sources of
information available would include other
healthcare professionals involved in the patient’s
care (e.g. dieticians, microbiologists and
physiotherapists), medical and nursing care notes,
additional ward charts and laboratory results.

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25
What is a medication review?
• Seeking the person’s (and/or their carer’s) perspective of their medicines and how they will take them • Identification of the aims of the drug therapy (from a clinical perspective and from the person’s perspective) • Assessment of whether the medicines are essential or not • Assessment of the person’s level of adherence to the medicines • Assessment of the effectiveness (both clinical and cost effectiveness) of the medicines • Assessment of the safety of the medicines, and • Decision and actions regarding stopping or continuing the medicines.
26
What should a medication review aim to do?
* Identify and discuss the person's goals * Identify and discuss any adherence issues * Identify and assess medicines with potential risks to cause harm * Identify and assess the use of any unnecessary medicines * Agree with the person the actions to be taken regarding medicines, including stopping * Share any decisions with the person, their carers, healthcare professionals, pharmacist * Review and adjust as needed or refer if required
27
What are examples of polypharmacy problems?
• A person may be taking medicines that are no longer suitable or the best available for them • The benefit of a particular medicine is lower than its possible harm • Sometimes taking a combination of medicines has the potential to harm, or actually cause harm • The practicalities of using the medicines are no longer manageable or are causing harm or distress.
28
What should a patient consultation include?
• What is the medicine and why has it been prescribed? How does it impact upon the medical condition and how does it alleviate the symptoms? e.g. This is a blood pressure medicine which should lower your blood pressure to normal levels which will help prevent further complications • How and when to take the medicine • How much to take and what to expect, e.g. antibiotics need to be taken regularly and the course completed even after symptoms subside • What to do if the patient misses a dose • What are the likely side effects and how to manage them • If applicable, any lifestyle or dietary changes that need to be made or that can affect the treatment • Additional information relating to storage requirements, expiry dates, disposal and monitoring requirements can also be included where appropriate • Check patient understanding by asking them to describe back to you the key information you have provided.
29
Rules of GSL medicine?
Within a pharmacy, GSL medicines can only be sold when a pharmacist has assumed the role of responsible pharmacist; however, the pharmacist may be physically absent for a limited period of time while remaining responsible, thus permitting sales of general sale medicines during this absence
30
What are P medicines?
A pharmacy medicine is a medicinal product that can be sold from a registered pharmacy premises by a pharmacist or a person acting under the supervision of a pharmacist. Pharmacy medicines must not be accessible to the public by self-selection. Together with GSL medicines, P medicines are collectively known as over-the-counter (OTC) or non-prescription medicines.
31
What are POM medicines?
A prescription-only medicine (POM) is a medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner.
32
Rules regarding pseudoephedrine and ephedrine?
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
33
What are signs of possible misuse of a drug?
SIGNS OF POSSIBLE MISUSE The following signs in combination can be useful for identifying when a request is more likely to be suspicious: • Lack of symptoms Not suffering from cough, cold or flu symptoms, or unable to describe these in the patient if buying for someone else • Rehearsed answers Gives answers that appear to be rehearsed or scripted • Impatient or aggressive In a rush or hurrying to complete the transaction • Opportunistic Waiting for busy periods in the shop or until less experienced staff are available • Specific products Wants certain brands that contain only pseudoephedrine or ephedrine • Paraphernalia Wishes also to purchase other items which can be used to manufacture methylamphetamine (e.g. lithium batteries, chemicals such as acetone) • Quantities Requests large quantities • Frequency Makes frequent requests
34
Who can suspicions be reported to?
Suspicions can be reported to your local GPhC inspector, local Controlled Drugs liaison police officer or accountable officer.
35
Who can suspicions be reported to?
Suspicions can be reported to your local GPhC inspector, local Controlled Drugs liaison police officer or accountable officer.
36
What oral emergency contraceptives are available from a pharmacy?
Levonorgestrel 1500 microgram tablet Ulipristal acetate 30mg tablet 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. Ulipristal acetate is licensed for emergency contraception within 120 hours (five days) of unprotected sexual intercourse or failure of a contraceptive method.
37
Supply of EHC to under 16s
The supply of ulipristal acetate to patients under the age of 16 years is not contraindicated by the manufacturer. However, pharmacists may wish to consider the following additional factors: • Children under the age of 13 are legally too young to consent to any sexual activity. Instances should be treated seriously with a presumption that the case should be reported to social services, unless there are exceptional circumstances backed by documented reasons for not sharing information • Sexual activity with children under the age of 16 is also an offence but may be consensual. The law is not intended to prosecute mutually agreed sexual activity between young people of a similar age, unless it involves abuse or exploitation. • Pharmacists can provide contraception or sexual health advice to a child under the age of 16 and the general duty of patient confidentiality applies, so where there is a decision to share information, consent should be sought whenever possible prior to disclosing patient information. This duty is not absolute and information may be shared if you judge on a case-by-case basis that sharing is in the child’s best interest (e.g. to prevent harm to the child or where the child’s welfare overrides the need to keep information confidential). Remember that it is possible to seek advice from experts without disclosing identifiable details of a child and breaking patient confidentiality – and that where there is a decision to share information, this should be proportionate.
38
Legal amount of paracetamol
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.
39
Legal amount of aspirin
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.
40
What are the rules regarding codeine?
INDICATION - now restricted to the short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone. All other previous indications, including cold, flu, cough, sore throats and minor pain have been removed. PACK SIZES - over 32 tablets = POM PIL- The warning ‘Can cause addiction. For three days use only’ must be positioned in a prominent clear position on the front of the pack. In addition, both the PIL and packaging must state the indication and that the medicine can cause addiction or headache if used continuously for more than three days. The PIL must also contain information about the warning signs of addiction.
41
What are the 7 prescription requirements?
1. Signature in ink 2. Address 3. Date (valid for 6 months) 4. Particulars (appropriate practitioner) 5. Name of patient 6. Address of patient 7. Age of patient if under 12
42
Repeatable prescriptions
Found on private prescriptions If a number is not stated, they can only be repeated once (dispensed twice) unless the prescription is for an oral contraceptive in which case it can be repeated five times (dispensed six times in total) • Prescriptions for Schedule 2 and 3 CDs are not repeatable; however, those for Schedule 4 and 5 are repeatable • The first dispensing must be made within six months of the appropriate date, following which there is no legal time limit for the remaining repeats • If the prescription is for a Schedule 4 CD, the first dispensing must be made within 28 days of the appropriate date, following which there is no time limit for remaining repeats
43
What are the rules regarding record keeping?
``` Must be retained for 2 years. Must include: • 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) • Prescriber details The name and address of the practitioner • Patient details The name and address of the patient. ```
44
Risks of supplying against a fax?
1 Uncertainty that the supply has been made in accordance with a legally valid prescription 2 Risks of poor reproduction 3 Risks of non-receipt of the original prescription and therefore inability to demonstrate that a supply had been made in accordance with a prescription 4 Risks that the original prescription is subsequently amended by the prescriber in which case the supply would not have been made in accordance with the prescription 5 Risks the fax is sent to multiple pharmacies and duplicate supplies are made. 6 Risks that the prescription is not genuine 7 Risks that the system of sending and receiving of the fax is not secure
45
How to detect forged prescriptions?
• Is a large or excessive quantity prescribed and is this appropriate for the medicine and condition being treated? • Is the prescriber known? • Is the patient known? • Has the title ‘Dr’ been inserted before the signature? • Is the behaviour of the patient indicative? (e.g. nervous, agitated, aggressive, etc.) • Is the medicine known to be commonly misused? Further investigation? 1 Scrutinise the signature carefully – possibly checking against a known genuine prescription from the same prescriber 2 Confirm details with the prescriber (e.g. whether or not a prescription has been issued, the original intention of the prescriber and whether or not there has been an alteration) 3 Use contact details for the prescriber that are obtained from a source other than the suspicious prescription (e.g. directory enquiries)
46
What should a label contain?
It is a legal requirement for the following to appear on dispensed medicinal products: • Name of the patient • Name and address of the supplying pharmacy • Date of dispensing • Name of the medicine • Directions for use • Precautions relating to the use of the medicine. The RPS recommends the following also appears on the dispensing label: • ‘Keep out of the reach and sight of children’ • ‘Use this medicine only on your skin’ where applicable.
47
How do you label batch medicines?
• Name of the medicine • Quantity of the medicine in the container • Quantitative particulars of the medicine (i.e. the ingredients) • Handling and storage requirements where appropriate • Expiry date • Batch reference number (e.g. LOT number or BN).
48
How is adrenaline administered?
Adrenaline is a POM and is given intramuscularly for the treatment of anaphylaxis. Brands of adrenaline intramuscular injections in your pharmacy may include Epipen®, Emerade® and Jext®. Regulation 238 of the Human Medicines Regulations 2012 allows adrenaline to be administered by anyone for the purpose of saving life in an emergency. Therefore pharmacists using their professional and clinical judgement can administer adrenaline in an emergency to persons presenting with symptoms of anaphylaxis. If a pharmacist administers adrenaline they must also ensure that an ambulance is called by dialling 999 and reporting that there is a case of suspected anaphylaxis.
49
What is a PSD?
A written instruction from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient after the prescriber has assessed that patient on an individual basis.
50
What is a PGD?
A PGD is a written direction that allows the supply and/or administration of a specified medicine or medicines, by named authorised health professionals, to a well-defined group of patients requiring treatment for a specific condition.
51
Relevant prescribers from which an emergency supply can be accepted?
``` • 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 ```
52
Emergency supply at request of PRESCRIBER
Relevant prescriber -The pharmacist is satisfied that the request is from one of the prescribers stated above Emergency- The pharmacist is satisfied that a prescription cannot be provided immediately due to an emergency (e.g. patient cannot collect the prescription from the prescriber, the prescriber is unable to drop off prescription at the pharmacy and patient urgently needs the medicine(s), etc.) Prescription within 72 hours- The prescriber agrees to provide a written prescription within 72 hours Directions- The medicine is supplied in accordance with the direction given by the prescriber Not for CDs, except phenobarbital- Schedule 1, 2 or 3 CDs cannot be supplied in an emergency whether requested by UK, EEA or Swiss health professionals. Phenobarbital (also known as phenobarbitone or phenobarbitone sodium) is the exception and can be authorised by UK doctor, dentist, nurse or pharmacist independent prescriber or supplementary prescriber in an emergency for the treatment of epilepsy. Record kept- An entry must be made into the POM register on the day of the supply (or, if impractical, on the following day). The entry needs to include: • The date the POM was supplied • The name (including strength and form where appropriate) and quantity of medicine supplied • The name and address of the prescriber requesting the emergency supply • The name and address of the patient for whom the POM was required • The date on the prescription (this can be added to the entry when the prescription is received by the pharmacy) • The date on which the prescription is received (this should be added to the entry when the prescription is received in the pharmacy) Labelling- Usual labelling requirements apply
53
Emergency supply at request of PATIENT
Interview Immediate need Previous treatment Dose Not for CDs except phenobarbital Length of treatment- 5 days for CD, POM 30 days - supply smallest pack available and full treatment cycle for EHC Records kept Labelling- must contain emergency supply on label
54
What is the law regarding supply to schools?
Signed order- • Name of the school • Product details (including spacer if relevant) • Strength (if relevant) • Purpose for which the product is required • Total quantity required • Signature of the principal or head teacher Retain signed order for 2 years ``` Advise on: • Explain how to use and store correctly • Advise on the most appropriate spacer device for the different age groups and how to use them correctly • Advise on correct storage, care and disposal • Advise importance of record keeping, regular date checking and when to replace ```
55
What is naloxone?
Naloxone is an opioid /opiate antagonist which can completely or partially reverse the central nervous system depression, especially respiratory depression, caused by natural or synthetic opioids and is licensed for the treatment of suspected acute opioid overdose. Naloxone remains a POM but the Human Medicines (Amendment) (No.3) Regulations 2015 allow staff engaged or employed in “lawful drug treatment services” to obtain naloxone from a wholesaler and make direct supplies to patients without a prescription, patient group direction (PGD) or patient specific direction (PSD).
56
What is a pregnancy prevention programme?
Certain medicines, e.g. oral retinoids, valproate, thalidomide, lenalidomide and pomalidomide, carry a high risk of causing foetal malformations and/or can increase the risk of spontaneous abortion when taken by women and girls. Pregnancy Prevention Programmes (PPP) protect females of childbearing potential by minimising the risk of becoming pregnant while taking these medicines.
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ORAL RETINOIDS PPP
Oral retinoids (including acitretin, alitretinoin and isotretinoin) are used for severe skin conditions. They are described in their Summary of Product Characteristics (SPCs) as ‘a powerful human teratogen inducing a high frequency of severe and life-threatening birth defects’ and therefore contraindicated in pregnant women and women of childbearing potential unless all of the conditions of the PPP are met. Only initiated by a specialist Prescriptions only valid for 7 days Confirm pregnancy status Quantity for maximum 30 day supply No repeats, faxed or free sample distributions
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VALPROATE PPP
Valproate is used to treat epilepsy, bipolar disorder and for preventing migraine (unlicensed). However, valproate can seriously harm an unborn child when taken during pregnancy and should be not taken by women and girls unless nothing else works and the person taking valproate is part of a pregnancy prevention programme (PPP). WHAT PHARMACISTS SHOULD DO: • Have a conversation with female patients of child-bearing age who are prescribed valproate to find out if they have had a review with their doctor, are aware of the risks and are on a PPP • Those planning pregnancy should be advised to schedule an appointment with their prescriber to review treatment and to continue with contraception and valproate treatment in the meantime • If there is an unplanned pregnancy whilst a patient is taking valproate medicines advise the patient NOT to stop their treatment and to arrange to see their prescriber urgently to review treatment • Provide a patient card every time valproate is dispensed • Dispense valproate preparations in original packs whenever possible. If dispensing in 'white boxes' ensure a patient information leaflet is provided and a valproate warning label/sticker added to the box • Ensure the dispensing label does not cover the warning label/sticker • Emphasize the importance of the need for an annual specialist review • Report any suspected side effects to valproate medicines via the Yellow Card Scheme
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What are Biosimilars?
WHAT IS A BIOLOGIC? A biologic is a medicine made from a variety of natural sources that may be human, animal or microorganism in origin. Examples of a biologic include vaccines, blood and blood products, somatic cells, DNA, human cells and tissues and therapeutic proteins. In general, the first or original biologic on the market is termed the originator or reference product. WHAT IS A BIOSIMILAR? A biosimilar is a biologic medicine that is similar to an already licensed biologic medicine in terms of quality, safety and efficacy. A biosimilar is specifically developed and licensed to treat the same disease(s) as the original innovator product. A biosimilar can only be marketed after the patent protecting the originator product and any period of marketing exclusivity have expired. WHY IS A BIOSIMILAR MEDICINE NOT A GENERIC MEDICINE? Due to the complexity of structure and greater molecule size of biologics as well as their inherent heterogeneity resulting from their production methods, it is not possible to make an identical copy of the originator biologic. Biosimilars are licensed for use based on extensive data on quality, safety and efficacy compared to the originator product. It is not possible to characterise a biologic to the same extent as a small molecule drug, where an identical copy can be produced, known as a generic medicine. IS IT POSSIBLE TO SWITCH BETWEEN AN ORIGINATOR BIOLOGIC AND A BIOSIMILAR? Any decision to change the brand of a biologic used to treat a patient must only be made by a prescriber following discussions with the patient. It is recommended that, at the point of dispensing, the pharmacist confirms the patient has received the biologic they expect and that they are aware of how to store and use the medicine. HOW WILL A BIOSIMILAR BE PRESCRIBED? In contrast to generic products, all biosimilars will have their own unique brand name. The MHRA has recommended that all biologics should be prescribed by brand to avoid automatic substitution. HOW ARE ADVERSE DRUG REACTIONS TO BIOSIMILARS REPORTED? It is important that both the brand name and batch number of a biologic medicine are provided when reporting suspected adverse drug reactions to biologics to facilitate effective safety monitoring. To support patient safety, pharmacists should consider it good practice to record the brand name and batch number of any biologic medicine (including biosimilars) supplied to a patient.
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``` What are ADVANCED THERAPY MEDICINAL PRODUCTS (ATMPS)? ```
An advanced therapy medicinal product (ATMP) is a biological medicinal product based on genes, tissues or cells which is either: • a gene therapy medicinal product • a somatic cell therapy medicinal product, or • a tissue engineered product
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Prescribing and dispensing by the same person?
Where exceptionally it is in the interests of the patient for the same pharmacist prescriber to be responsible for prescribing, clinical check and supply of medicines on the same occasion, it would be good practice to: ensure processes are in place to limit errors (i.e. taking a break or implementing additional checks), maintain an audit trail, and to document reasons.
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What are the requirements for wholesaling?
Anyone trading medicines, other than to a patient, is required to: • Hold a wholesaler licence – also known as a wholesale distribution authorisation (WDA) • Comply with the Good Distribution Practice (GDP) standards, and pass regular GDP inspections • Have a suitable experienced ‘Responsible Person’ named on the licence to ensure that medicines are procured, stored and distributed appropriately.
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When is a WDA not required?
Registered pharmacies and hospitals supplying small quantities of medicines to healthcare professionals for treatment or onward supply to their patients, or to other community pharmacies or hospitals to meet a patient’s individual needs are not required to hold a wholesale distribution authorisation provided: • 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.
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Signed orders record keeping
An 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.
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Categories of veterinary medicine
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 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. A written prescription is only required if the supplier is not the prescriber NFA-VPS- A category of medicine for non-food animals that can be supplied by a veterinary surgeon, a pharmacist or a suitably qualified person. A written prescription is not required AVM-GSL- An authorised veterinary medicine that is available on general sale Exempt medicines under Schedule 6 of the veterinary medicines regulations – exemptions for small pet animals (SAES)- An unlicensed veterinary medicine that does not require a marketing authorisation because it meets criteria laid out in Schedule 6 of the Veterinary Medicines Regulations - Exemptions for small pet animals Unauthorized veterinary medicines- An unlicensed medicine that does not have a marketing authorisation and is not eligible for exemption through the SAES. It can only be prescribed by a veterinary surgeon under the Cascade (see Diagram 16). This includes any human medicine used for animals
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Prescription requirements for veterinary medicine
1 Name, address, telephone number, qualification and signature of the prescriber. CDs- Royal College of Veterinary Surgeons (RCVS) registration number of the prescriber must also be included. 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. prescriptions are valid for six months or shorter if indicated by the prescriber (the Veterinary Medicines Directorate (VMD) has confirmed in the case of repeatable prescriptions all supplies must be made within 6 months or shorter if indicated by prescriber). Prescriptions for Schedule 2, 3 and 4 CDs are valid for 28 days. 5 Name, quantity, dose and administration instructions of the required medicine NB: The VMD advises that ‘as directed’ is not an acceptable administration instruction. 6 Any necessary warnings and if relevant the withdrawal period (i.e. the time that must elapse between when an animal receives a medicine and when it can be used for food). 7 Where appropriate, a statement highlighting that the medicine is prescribed under the veterinary Cascade (e.g. ‘prescribed under the Cascade’ or other wording to the same effect). 8 If the prescription is repeatable, the number of times it can be repeated. Records to be retained for 5 years
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What is the veterinary cascade?
1. Supply a veterinary medicine with a GB or UK-wide marketing authorisation for the species and condition indicated WHERE THIS IS NOT POSSIBLE 2. A veterinary medicine with a Northern Ireland (NI)* marketing authorisation for the species and condition indicated can be supplied WHERE THIS IS NOT POSSIBLE 3. A GB, NI* or UK-wide veterinary medicine licensed for another species or different condition can be considered WHERE THIS IS NOT POSSIBLE 4.a A GB, NI* or UK-wide licensed human medicine OR 4.b A veterinary medicine authorised outside the UK* can be considered WHERE THIS IS NOT POSSIBLE 5. An extemporaneous or a specially manufactured medicine can be considered
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Label requirements for veterinary medicine
• 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’.
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Record keeping for veterinary medicine
It is a requirement to keep records of receipt and supply of POM-V and POM-VPS products showing: • Name of the medicine • Date of the receipt or supply • Batch number • Quantity • Name and address of the supplier or recipient • If there is a written prescription, record the name and address of the prescriber and keep a copy of the prescription • Pharmacists can either keep all documents that show the required information or can make appropriate records in their private prescription book • Records can be kept electronically • Records and documents must be kept for at least five years • Pharmacies that supply POM-V and POM-VPS medicines must undertake an annual audit.
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Who is responsible for the use of CDs?
Accountable officers are responsible for supervising and managing the use of CDs in their organisation or setting. Their roles and responsibilities include: • Oversight of the monitoring and auditing of the management, prescribing and use of CDs • Ensuring that systems are in place for recording concerns and incidents involving CDs and the operation of these systems • Attendance at Local Intelligence Network meetings • Submission of occurrence reports which describe the details of any concerns the organisation has had regarding the management of CDs in a required time frame • The appointment of authorised witnesses for the destruction of CDs
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What drugs are included in Schedule 1?
Most Schedule 1 drugs have no therapeutic use and a licence is generally required for their production, possession or supply. Examples include hallucinogenic drugs (e.g. ‘LSD’), ecstasy-type substances and raw opium.
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What drugs are included in Schedule 2?
Pharmacists and other classes of person named in the 2001 Regulations have a general authority to possess, supply and procure Schedule 2 CDs when acting in that capacity. Schedule 2 includes opiates (e.g. diamorphine, morphine, methadone, oxycodone, pethidine), major stimulants (e.g. amfetamines), quinalbarbitone and ketamine.
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What drugs are included in Schedule 3?
Schedule 3 CDs include minor stimulants and other drugs (such as buprenorphine, temazepam, tramadol, midazolam and phenobarbital) that are less likely to be misused (and less harmful if misused) than those in Schedule 2. From 1st April 2019, gabapentin and pregabalin were rescheduled as Schedule 3 CDs
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What drugs are included in Schedule 4?
• Part I (CD Benz POM) Contains most of the benzodiazepines (such as diazepam), non-benzodiazepine hypnotics (such as zopiclone), and Sativex (a cannabinoid oromucosal mouth spray) • Part II (CD Anab POM) Contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoceptor stimulant) and growth hormones
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What drugs are included in Schedule 5?
Schedule 5 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.
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Who can prescribe cocaine, diamorphine or dipipanone for treating addiction?
Only medical prescribers who hold a special licence from the Home Secretary or Scottish Government’s Chief Medical Officer can prescribe cocaine, diamorphine or dipipanone for treating addiction. This special licence is not required if treating organic disease or injury. Pharmacist independent prescribers, nurse independent prescribers and supplementary prescribers may not prescribe cocaine, diamorphine or dipipanone for treating addiction, but may prescribe these medicines for treating organic disease or injury.
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What are the legal requirements for CD 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 ```
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Which CD drugs can a midwife obtain?
* Diamorphine * Morphine * Pethidine. The order must contain the following: • Name of the midwife • Occupation of the midwife • Name of the person to whom the CD is to be administered or supplied • Purpose for which the CD is required • Total quantity of the drug to be obtained • Signature of an appropriate medical officer – a doctor authorised (in writing) by the local supervising authority or the person appointed by the supervising authority to exercise supervision over midwives within the area
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Prescription requirements for a CD?
1. Signature 2. Date- valid for 28 days 3. Address of prescriber- within the UK 4. Name of CD 5. Form 6. Strength 7. Dose 8. Total quantity- in words and figures 9. Quantity prescribed- max 30 day supply 10. Patient name 11. Patient address 12. Dental wording where appropriate 13. Installment wording where appropriate
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Record keeping for CD's
For Controlled Drugs received, the following must be recorded: • Date supply received • Name and address from whom received • Quantity received. 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.
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When is child-resistant packaging not required?
Suitable, child-resistant packaging should be used for supplying all solid, all oral and external liquid dose preparations unless there is a good reason for not doing so. Such reasons may include: • Specific request The patient, carer or representative requests a packaging that is not child resistant, perhaps due to difficulty in opening it. The request may be met by supplying a non-child-resistant lid • Original pack The original pack may not be child resistant and there may be reasons underpinning why the medicine should remain in the original container. It may also be the case that no child-resistant packaging exists for a particular liquid medicine so it is not possible to change the container Where appropriate, the patient should be counselled to keep medicines away from the reach and sight of children.
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What is the medical defence for driving under the influence of drugs?
The statutory medical defence may be raised at any point providing that the drug was: • Lawfully prescribed, supplied or purchased over the-counter, for medical or dental purposes; and • Taken in accordance with advice given by the prescriber or supplier, and in accordance with any accompanying written instructions (provided these are consistent with any advice given by the prescriber).
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What does being a responsible pharmacist involve?
1. Secure the safe and effective running of the pharmacy 2. Display a notice 3. Complete the pharmacy record 4. Establish, maintain and review pharmacy procedures
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What does a RP notice need to include?
``` This needs to include: • The name of the responsible pharmacist • The GPhC registration number • The fact that the responsible pharmacist is in charge of the pharmacy at the time ```
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What is required in a RP record?
• Be recorded accurately and reflects who the responsible pharmacist is and was at any given date and time (including any absences). • Should be made contemporaneously personally by the responsible pharmacist. An entry may be made remotely as long as the record complies with all the relevant and professional requirements. • Any alterations or amendments made for both paper-based and electronic pharmacy records need to identify when and by whom the alteration/amendment was made. • For electronic records appropriate measures should be made to back up the record and be kept on the pharmacy premises, available for GPhC inspection if required. THE FOLLOWING DETAILS MUST BE RECORDED IN THE PHARMACY RECORD: • The responsible pharmacist’s name • The responsible pharmacist’s registration number • The date and time at which the pharmacist became the responsible pharmacist • The date and time at which the responsible pharmacist stopped being the responsible pharmacist • If you are absent from the premises: – The date of absence – The time which the responsible pharmacist left the pharmacy premises – The time at which the responsible pharmacist returned to the pharmacy premises
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What must the pharmacy procedures cover?
1 The arrangements to secure that medicinal products are: • Ordered • Stored • Prepared • Sold by retail • Supplied in circumstances corresponding to retail sale • Delivered outside the pharmacy and • Disposed of in a safe and effective manner 2 The circumstances in which a member of pharmacy staff who is not a pharmacist may give advice about medicinal products 3 The identification of members of pharmacy staff who are, in the view of the Responsible Pharmacist, competent to perform certain tasks relating to the pharmacy business 4 The keeping of records about the arrangements 5 The arrangements which are to apply during the absence of the Responsible Pharmacist from the premises 6 The steps to be taken when there is a change of Responsible Pharmacist at the premises 7 The procedure which is to be followed if a complaint is made about the pharmacy business 8 The procedure which is to be followed if an incident occurs which may indicate that the pharmacy business is not running in a safe and effective manner and 9 The manner in which changes to the pharmacy procedures are to be notified to pharmacy staff
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What are the rules regarding the absence of a RP?
Legislation allows the responsible pharmacist to be absent for up to a maximum period of two hours during the pharmacy’s business hours between midnight and midnight. If there is more than one responsible pharmacist in charge of the pharmacy during the pharmacy’s business hours, the total period of absence for all the responsible pharmacists must not exceed two hours. If the responsible pharmacist is absent, the following arrangements must be in place: • Only be absent if the pharmacy can continue to run safely and effectively • Remain contactable with the pharmacy staff, where this reasonably practical and be able to return with reasonable promptness. • If the responsible pharmacist cannot remain contactable and return with reasonable promptness, she/he must arrange for another pharmacist to be contactable and available to provide advice (this does not need to be another responsible pharmacist). If a responsible pharmacist is absent from the premises as a minimum she/he must record: • The date of absence • The time which the responsible pharmacist left the pharmacy premises • The time at which the responsible pharmacist returned to the pharmacy premises Professional checks, sale of P/POM medicine, wholesale of medicine and emergency supply requires supervision of a pharmacist
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What are the standards for pharmacy professional?
``` 1 Provide person-centred care 2 Work in partnership with others 3 Communicate effectively 4 Maintain, develop and use their professional knowledge and skills 5 Use professional judgement 6 Behave in a professional manner 7 Respect and maintain the person’s confidentiality and privacy 8 Speak up when they have concerns or when things go wrong 9 Demonstrate leadership ```
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Confidentiality
• Understand the importance of managing information responsibly and securely, apply this to their practice • Reflect on their environment and take steps to maintain the person’s privacy and confidentiality • Do not discuss information that can identify the person, when the discussions can be overheard or seen by others not involved in their care • Ensure that everyone in the team understands the need to maintain a person’s privacy and confidentiality • Work in partnership with the person when considering whether to share their information, except where this would not be appropriate