MEP Notes Flashcards
Is professional indemnity required?
It is a requirement if you are registered with the GPhC that you have professional indemnity insurance in place before you start working in your role.
What does revalidation help pharmacy professionals to do?
- Keep their professional skills and knowledge up to date
- Reflect on how to improve
- Demonstrate to the public and patients how they provide safe and effective care
To revalidate, pharmacy professionals must submit which records each year??
- Four continuing professional development )CPD) records (at least two planned)
- A peer discussion
- A reflective account
What is the definition of an independent prescriber (IP)?
An independent prescriber is a practitioner, who is responsible and accountable for the assessment of patients with undiagnosed or diagnosed conditions and can make prescribing decisions to manage the clinical condition of the patient.
What is the definition of a supplementary prescriber (SP)?
A supplementary prescriber (SP) is a practitioner who prescribes within an agreed patient-specific written clinical management plan (CMP), agreed in partnership with a doctor or dentist.
What should independent and supplementary prescribers be restricted to?
Independent/ supplementary prescribers should restrict prescribing to their areas of clinical competence.
What does the prescribing competency framework set out?
Sets out the competencies expected of all prescribers to support safe prescribing.
It can be used by any prescriber at any point in their career to underpin professional responsibility for prescribing.
What does the competency framework for designated prescribing practitioners support?
Supports experienced independent prescribers to be effective.
What is a punitive culture?
It is based upon assigning blame and punishment. It contributes to creating a culture of fear.
Is a no-blame culture better?
May be better than a punitive culture but it is inadequate. It can appear unacceptable to society overall due to the immunity from accountability which can also be abused.
Instead which culture should be used?
the ‘right culture’ or a ‘just culture’.
What is a right/ just culture?
it is a culture based upon the principles of fairness, quality, transparency, reporting, learning and safety.
A just culture promotes an open culture (transparency and discussion), a reporting culture (raising concerns), and a learning culture (learning from mistakes).
What do these cultures support each other to create?
A safety culture - balancing accountability and learning and leading to improved patient safety.
What are the 6 RPS error reporting standards?
1) Open and honest
2) Report
3) Learn
4) Share
5) Act
6) Review
What is the national reporting and learning system (NRLS)?
Collects anonymously reported errors - (ENGLAND and Wales).
What about in Scotland?
In Scotland each NHS board operates its own reporting system
When can the legal defence against criminal prosecution (dispensing errors) 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 the patient once the pharmacy team are aware of the error.
What age is considered to be too young to consent to any sexual activity?
Children under the age of 13 are legally too young to consent to any sexual activity.
What about sexual activity under the age of 16?
Sexual activity with children under the age of 16 is also an offence but maybe 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.
To supply emergency contraception to someone under 16 in England and Wales which criteria must be met?
Fraser Criteria
What is the Fraser criteria?
- They have sufficient maturity and intelligence to understand the nature and implications of the proposed treatment
- 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
What about in Scotland, which criteria is used to supply EHC to under 16s?
The Age of Legal Capacity Act
What are vulnerable adults defined as?
Vulnerable adults are persons who are over the age of 18 and are at greater risk of abuse or neglect.
How many principles are there of medicines optimisation?
4 principles
In primary care, what sources can we use 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 records
- SCR
Which Law/ regulation underpins legislation regulating the authorisation, sale and supply of medicinal products?
The human Medicines Regulations 2012 consolidated most of the legislation regulating the authorisation, sale and supply of medicinal products for human use, made under the Medicines Act 1968.
Has the Medicines Act 1968 been fully replaced?
Not fully replaced and certain parts are still active.
Which regulation covers the prescribing and supply for animals?
The Veterinary Medicines Regulations 2013.
What are the three classes of medicinal products under the Human Medicines Regulations 2012?
- General sale medicines (GSL)
- Pharmacy (P) medicines
- Prescription-only medicines (POM)
What is the description of GSL?
General sale medicines, are also known as ‘General Sales List’ medicines, are those that can be made available as ‘self-selection’ items for sale in registered pharmacies.
They can also be sold in other retail outlets that can ‘close so as to exclude the public’.
Can GSL medicines be sold in a pharmacy without responsible pharmacist present or signed in?
Within a pharmacy, GSL medicines can only be sold when a pharmacist has assumed the role of responsible pharmacist; however, the pharmacist may be physical absent for a limited period of time while remaining responsible, thus permitting sales of general sale medicines during this absence.
What is a Pharmacy (P) medicine?
A pharmacy medicine (P) 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.
Can P medicines be accessible for self-selection by the public?
Pharmacy medicines must not be accessible to the public by self-selection.
Together GSL and P medicines are known as what?
collectively known as over-the-counter (OTC) or non-prescription medicines.
What is a prescription-only-medicine (POM)?
A POM is a medicine that is generally subject to the restriction of requiring a prescription written by an appropriate practitioner.
List all the appropriate practitioners (who can prescribe)?
- Doctors
- Dentists
- Supplementary prescribers
- Nurse independent prescribers
- Pharmacist independent prescribers
- EEA and Swiss approved health professionals
- Community practitioner nurse prescribers
- Optometrist independent prescribers (not for controlled Drugs, or parenteral medicines)
- Paramedic independent prescribers
- Physiotherapist independent prescribers
- Podiatrist independent prescribers
- therapeutic radiographer independent prescribers (for certain medications)
Some medicines can be classified into more than one category, what does this depend on?
- Formulation
- Strength
- Quantity
- Indication
- Marketing authorisation
What is a reclassified medication?
POM to P switch providing pharmacists with a larger range of medicines to select from to treat patients.
List the POM to P switches?
- Amorolfine nail lacquer
- Anti-malarials
- Chloramphenicol eye drops and eye ointment
- Emergency Contraceptives
- Mometasone 0.05% nasal spray
- Oral Lidocaine-containing products for teething
- Orlistat
- Proton-pump inhibitors
- Sildenafil
- Sumatriptan
- Tamsulosin
- Tranexamic acid
What are pseudoephedrine and ephedrine used for?
Are widely used decongestants pharmacy medicines.
What can pseudoephedrine and ephedrine be used to make that is a concern?
Due to their potential for misuse in the illicit production of methylamphetamine (crystal meth) - A class A controlled Drug - there are legal restrictions on the quantities that can be sold or supplied without prescription.
What is the maximum amount (the law) of how much pseudoephedrine or ephedrine that can be supplied?
Unlawful to supply a product or a combination of products that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any one time, without a prescription.
Can you supply a pseudoephedrine product and a ephedrine product at the same time?
It is unlawful to sell or supply any pseudoephedrine product at the same time as an ephedrine product without a prescription (Regulation 237 of human Medicines Regulations 2012).
What signs can be used to identify possible misuse of pseudoephedrine/ ephedrine products when a request is made?
- 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 tat 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 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 request)
Who can these suspicions be reported to?
- can be reported to your local GPhC inspector, local controlled drugs liaison police officer or accountable officer.
What are the three methods of emergency contraception?
- Copper intrauterine device (Cu-IUD)
- Oral Ulipristal acetate
- Oral levonorgestrel
Who needs to be involved in providing advice on all methods of emergency contraception?
Pharmacist
Which emergency hormonal medicines are licensed to be used?
Levonorgestrel 1500microgram tablet and ulipristal acetate 30mg tabs
Which age is levonorgestrel licensed for?
Aged 16 years and over
How long since UPSI can levonorgestrel be used?
Within 72 hours (3 days)
How long since UPSI can Ulipristal acetate be used?
Within 120 hours (5 days)
Can pharmacists give an advance supply of oral EHC?
Yes but the patient should be assessed to ensure that they are competent, they intent to use the medicine appropriately and it is clinically appropriate.
If you as a pharmacist are affected by your religious or moral beliefs and they will impact in your willingness to supply oral emergency contraception what should you do?
Inform your employer, your locum agency and colleagues you will be working with, as soon as possible.
Referral of the patient maybe an option but it may not always be possible. The GPhC have outlined factors to consider when deciding whether a referral is appropriate.
Can ulipristal acetate be given to patients under age of 16?
Yes under the age of 16 it is not contraindicated by the manufacturer. However, pharmacists may wish to consider several factors.
What factors must pharmacists consider when supplying EllaOne (Ulipristal acetate) to under 16?
- Children under the age of 13 are legally too young to consent to any sexual activity. These 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.
- Sexual activity with children under the age of 16 us 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).
Other than sale of EHC what other ways can women access EHC/ or we can signpost them to?
Family planning clinics
General practice (GP)
Providers of PGDs for EHC
Genitourinary medicine (GUM) clinics
Which two medicines have a marketing authorisation of all three GSL, P and POM depending upon pack size and formulation?
Paracetamol and Aspirin
What is the legal quantity restriction 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 15 or 32 dose units, this means that, in practice 96 is the maximum number that can be sold.
What about OTC effervescent paracetamol tablets?
There are no legal limits on the quantity of over-the-counter effervescent tablets, powders, granules or liquids that can be sold to a person at any one time. Use professional judgement.
What is the legal quantity restriction 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 15 or 32 dose units, this means that, in practice 96 is the maximum number that can be sold.
What about OTC effervescent Aspirin tablets?
There are not legal limits on the quantities of over-the-counter effervescent tablets or powders that can be sold to a person at any one time. use professional judgement.
What indications for solid dose OTC codeine and dihydrocodeine products now restricted to?
- Short-term treatment of acute, moderate pain that is not relieved by paracetamol, ibuprofen or aspirin alone.
What all other previous indications of codeine and dihydrocodeine been removed?
-cold, flue, cough, sore throats and minor pain have been removed.
What warning must be clearly put on the pack of codeine/dihydrocodeine products?
The warning ‘can cause addiction for three days use only’ must be positioned in a prominent clear position on the front of the pack.
What must both the PIL and packaging state?
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.
What are the 7 legal requirements of a prescription?
1) Signature
2) Prescriber Address
3) date
4) Particulars of prescriber
5) Patient name
6) patient address
7) Age if under 12 years
What are the signature requirements?
Prescription need to be signed in ink by an appropriate practitioner in his or her own name.
An advanced electronic signature can be used to authorise an electronic prescription
How long are prescriptions valid?
A prescription is valid for up to six months from the appropriate date
For Schedule 2,3 or 4 - valid for 28 days from date written on the prescription.
For NHS prescriptions the appropriate date is the later of either the date on which the prescription was signed or a date indicated by the appropriate practitioner as the date before which it should not be dispensed.
For private prescriptions, the appropriate date will always be the date on which it was signed.
What regarding particulars do prescriptions require?
Prescriptions require particulars that indicate the type of appropriate prescriber.
When is age a legal requirement on prescriptions?
If under 12 years old.
What does indelible mean in regards to prescriptions?
Prescriptions need to be written in indelible ink - they may be computer generated or typed.
Is it permissible to issue carbon copies of NHS prescriptions?
Yes as long as they are signed in ink
Do same requirements apply to homecare prescriptions?
yes, however some homecare service providers may also required additional information such as GMC number of prescribing doctor.
What is an advance electronic signature?
An advanced signature is a signature that is linked uniquely to the signatory, capable of identifying the signatory and created using means over which the signatory can maintain sole control.
Do copies of ‘electronic prescriptions’ on an email or on a patient’s phone in their online account meet the requirements of an advanced electronic signature?
No they do not meet the requirements of an advanced electronic signature.
Does a a copy of a prescription in an online account or one that is emailed to a pharmacist constitute as a legitimate electronic prescription?
No
Can we dispense a prescription in Welsh language?
There is currently no law or act that specifies that prescription in Wales have to be bilingual.
if the pharmacist is not a Welsh speaker and can’t understand the prescription, the ROS advice is to put patient safety first.
What does the RPS Welsh Pharmacy Board recommend that medicines are labelled in which language and why?
Recommends that medicines should be labelled in English to ensure that if a patient is seen by a non-Welsh speaker these important instructions are understood.
Can we dispense prescriptions from the crown dependencies (Jersey, Guernsey and Isle of Man).
Must be satisfied that all prescription requirements are present for the prescription to be legally valid.
- NOTE - Prescriptions for CD 2 and 3 CDs, the prescriber’s address must be within the UK.
What are repeatable prescriptions?
They are private prescriptions which contain a direction that they can be dispensed more than once e.g. repeat x 5
If on a repeatable prescription the number isn’t stated, how many times can this prescription be repeated?
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).
Are CD 2, 3, 4 and 5 allowed to be on repeatable prescriptions?
Prescriptions for CD 2 and 3 are not repeatable; however, those for CD 4 and 5 are repeatable.
How long within must the first dispensing of a repeatable prescription be made?
Within six months of the appropriate date, following which there is no legal limit for the remaining repeats.
How long within must the first dispensing of a repeatable prescription be made for a CD 4 item?
First dispensing must be made within 28 days of the appropriate date, following which there is no time limit for remaining repeats.
But pharmacist should use professional judgement.
Can a repeatable prescription be dispensed in different pharmacies and can the patient keep the prescription?
The aptient can choose to have repeats dispensed from different pharmacies and retain the prescription. To maintain an audit trail mark on the prescription the name and address of the pharmacy from where the supply has been made and the date of supply.
In prisons and other residential custodial secure environments, are NHS FP10 forms used for routine prescribing?
No as a customised prescription form, generated by the clinical IT system, is used instead, however, these are still considered a NHS prescription.
Are FP10s still available in these settings?
Yes, but they are only used to access urgent medicines (e.g. out of hours) or are supplied to a released person to access medicines that couldn’t be supplied to them on release. Therefore, the NHS repeat dispensing scheme using FP10s or EPS cannot be used.
What are repeat slips?
These are not prescriptions, themselves, but a list of medications which patients can use to reorder their regular medications.
What are NHS repeat dispensing service?
Where the prescriber authorises a prescription with a specified number of ‘batch’ issues that may be dispensed at specified intervals from a pharmacy (England and Wales only).
How long are CD 2. 3 and 4 scripts valid for?
but CD 4 = 28 days
How long are POMs scripts valid for?
6 months
How long are CD 5 scripts valid for?
6 months
How long must private prescriptions for a POM be retained in the pharmacy?
2 Years from the date of sale/ supply
How long must private repeatable prescription for a POM be retained in the pharmacy?
2 years from the date of the last sale or supply
Where must private prescriptions for CD 2 and 3 CDs be submitted to?
To the relevant NHS agency
For private CD 2 prescriptions where must record be entered?
Into the POM register (written or electronically), which should be retained for two years from the date of the last entry in the register.
What must the private prescription record in the POM register include?
- Supply date
- Prescription date ( the date on the prescription)
- Medicine details (The name, quantity, formulation and strength of medicine supplied (where apparent from the name)
- Prescriber details (the name and address of the practitioner)
- Patient details (The name and address of the patient)
When should the private prescription register entry be made?
Same day of the sale/supply or on the next following day
Which private prescriptions are exempt from record keeping?
- Prescriptions for oral contraceptive
-
Do record keeping for private prescriptions for CD 2 need to be made in the POM register?
No, as they legally need to be entered in a separate CD 2 controlled drug register.
How long should a clinical audit be retained for?
5 years from creation date
How long do clinical diaries need to be retained for?
2 Years starting from the end of the year to which they relate
For a POM prescription is name, strength, form, quantity and dose legal requirements?
No they are not but they are important to identify which medicine to supply.
Also important from a pricing and remuneration perspective.
Are FP10s allowed for patients while they are in prison?
- No they are not allowed (unless authorised by the Prison Trust).
What about FP10s for those who are about to be discharged from prison?
YEs for those who are about to be discharged from prison withou the usual methods for ensuring continuity of supplt of their medicines (e.g. those released unexpectedly form court, those who fail to obtain a take-out supply of their medicines or those who fail to obtain a same or next day prescribing appointment with a drug treatment agency) can be given an FP10 or FP10(MDA) prescription to take to their community pharmacy.
Do prisoners who have been discharged unexpectedly need to pay for their FP10 prescription?
NO, these FP10 forms have the same name and address of the prison printed on them and the patient is exempt from payment by virtue of having HMP in the address.
What is falsified medicines directive (FMD)?
The ‘safety features’ elements of the Falsified Medicines Directive (FMD) legislation and delegated regulation
Does FMD apply in GB?
No longer apply in GB
- The government are looking at alternative options
Legally what items can dentists prescribe?
Legally dentists can write prescriptions for any POM
What does the General Dental Council advise dentists in regards to prescribing?
- Densitsts should restrict their prescribing to areas in which they are competent and generally only prescribe medicines that have uses in dentistry
What about dentists prescribing on a NHS prescription (any restrictions??)???
- Dentists are restricted to the medicines listed in the Dentals Prescriber’s Formulary (Part XVIIa of the Drug Tariff for England and Wales).
This is also reproduced in the BNF
Is a fax prescription counted as a valid prescription?
- No - as it is not written in indelible ink and has not been signed in ink by an appropriate practitioner
Can a prescription be done which has been emailed or printed out or presented on a patient’s mobile phone?
No similar thing applies to Fax prescriptions where signature is not indelible.
Can repeatable prescriptions issued by an approved health professional in an approved country be legally supplied in the UK?
Yes - from the EEA or Switzerland
List all the approved countries which can allow prescriptions to be dispensed in the UK?
EEA Countries and Switzerland:
Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Republic of Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, The Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden and Switzerland
What are the prescription requirements on a prescription from an approved health professional from an approved country?
- Patient details
- Prescribers details (Prescriber’s full name, professional qualifications, direct contact details including email address and telephone or fax number (with international prefix), work address (including the country they work in)
- Prescribed medicine details (Name of the medicine - brand name where appropriate, pharmaceutical form is needed, quantity, strength and dosage details
- Prescribers signature
- Date of issue - Prescriptions are valid for up to six months from the appropriate date (prescription for schedule 4 CDs 28days). For prescriptions from these countries the appropriate date is the date on which the prescription was signed.
Legally if a prescription is written in a foreign language is this acceptable?
Yes it is, however you will need to have enough information to enable the safe supply of medicines considering patient care and wellbeing.
If you are unable to confirm registration status of the approved health professional can you still supply through the out of UK prescription?
Yes it may still be possible to make a safe and legal supply in the interest of patient care.
- It would be beneficial to keep a record of the details of any interventions and steps taken.
Can CD 1,2 or 3 drugs be given from a prescription from approved outside UK country?
No it is not allowed
Can emergency supplies be given to a patient from outside the UK but from an approved country (both request at prescriber and patient)??
Yes but then a prescription needs to be received within 72 hours
- CD 1, 2 and 3 CDs (including phenobarbital) or unlicensed products cannot be supplied in an emergency to a patient of an approved health professional.
Is it obligatory to dispense a prescription from an approved country if presented with one?
No and you can refer to an approved prescriber based in the UK as an alternative
Where are most military prescriptions dispensed?
- Large medical centres have retained their in-house dispensary
- Smaller medical centres have outsourced the dispensing process to designated community pharmacies under a Ministry of Defence (MOD) contract.
What are military prescriptions written on?
- Written on a military form FMed 296
In the unusual event if a FMed 296 is presented to a non-contracted pharmacy, can it be dispesned?
Yes but the prescription should be treated as a private prescription.
- In these circumstances, non-contracted pharmacies are not to invoice the MOD directly but are to charge the patient the appropriate fee.
Can a prescription for CD 2 and 3 drugs be written on an MOD FMed296 form??
No this cannot legally be dispensed as CD 2 and 3 drugs should be written on a FP10PCD
Where are prescriptions with a British Forces post office address stamp usually generated?
Usually generated abroad and are normally not seen in the UK,
- If there is any doubt, pharmacists are advised to check the registration status of the doctor, dentist or independent prescriber
What information needs to legally be present on the label of a dispensed medicinal product?
- 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 reach and sight of children’
- ; Use this medicine only on your skin’ where applicable
In secure environments it is also recommended what else is put on the label?
The prisoner number is also included on the label as a definitive patient identifier
What does the National patient safety agency recommend regarding outer container and labelling?
The outer container may be discarded and, therefore, the labelling information could be lost, so the actual container (e.g. inhaler or tube of cream) should be labelled rather than the outer container.
Can prescribing and dispensing/supply and administration be performed by the same healthcare professional?
- Wherever possible these should be done by separate healthcare professionals.
- Exceptionally, where clinical circumstances make it necessary and in the interests of the patient, the same healthcare professional can be responsible for all three.
Where this occurs an audit trail, documents and processes should be in place to limit errors.
Who can administer parenteral POMs?
- can be administered to another person in accordance with the directions of an appropriate practitioner or by an appropriate practitioner.
There is an exemption to administration of parenteral POMs when does this apply?
- Exemption allows administration for saving life in an emergency
What is an example of administering a life saving parenteral POM?
- Naloxone as emergency first aid for a drug-related overdose, or administering adrenaline for the emergency treatment of anaphylaxis
Which other further exemptions apply?
- Administration of smallpox vaccine or administration linked to medical exposure (including radioactive medicines)
What is covert administration?
- it is the term used when medicines are administered in a disguised format without the knowledge or consent of the person receiving them, for example in food or in a drink.
Who is medicines covertly administered to?
- to those people who actively refuse their medication and who are considered to lack mental capacity in accordance with an agreed management plan
Is adrenaline a POM?
Yes
How is adrenaline given?
It is given intramuscularly for the treatment of anaphylaxis
Which brands of adrenaline may you commonly see in a pharmacy?
- Epipen
- Emerade
- Jext
Which regulation allows the administration of adrenaline by anyone for the purpose of saving life in an emergency?
- Regulation 238 of the Human Medicines Regulations 2012.
If a pharmacist administers adrenaline what else must they ensure to do?
- Ensure that an ambulance is called by dialling 999 and reporting that there is a case of suspected anaphylaxis.
What is a PSD?
Generally it is a written instruction from a doctor, dentist or non-medical prescriber for a medicine to be supplied or administered to a named patient on an individual basis.
Who do PSDs relate to and do they need to have specific requirements for a normal prescription?
PSDs relate to a specific named patient but do not need to comply with the requirements specified for a prescription.
In a hospital ward, what are written PSDs encountered on?
- on inpatient charts as directions to administer
- While the law does not stipulate what should be included in a PSD, sufficient information must be available for the person administering the specified medicine to do so safely.
Can a PSD be used to make a sale or supply?
If the PSD is sufficiently clear, then yes it can
Can PSDs be verbal or telephoned?
For the purpose of administration (rather than supply) Yes it is possible by an appropriate practitioner.
however, a written authorisation should be used whenever possible and any applicable standards that require the authorisation to be in writing should be adhered to.
What do some hospital shave in place to permit in an emergency the administration of medicines following a telephoned or verbal request from an appropriate practitioner?
- Formulated policies - usually involving two nurses checking one another
What are some of the exemptions that allow POMs to be sold or supplied without a prescription?
- Patient group directions (PGDs)
- Patient specific Directions (PSDs)
- emergency supplies
- Optometrist or podiatrist signed patient orders
- Supply of salbutamol inhalers to schools
- Supply of adrenaline autoinjectors to schools
- Supply of naloxone by individuals providing recognised drug treatment services
What is a PGD?
PGDs (Patient group directions) 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.
Can diamorphine or morphine be given under a PGD by pharmacists?
Pharmacists can supply, offer to supply and administer diamorphine or morphine under a PDG for the immediate, necessary treatment of sick or injured persons.
How should POMs supplied under a PGD be labelled?
Same way as if supplied against a prescription
Who or what professions are considered as ‘relevant prescribers’?
- Doctor
- Dentist
- A supplementary prescriber
- Pharmacist independent prescriber
- Community practitioner nurse prescriber
- Physiotherapist independent prescriber
- Podiatrist independent prescriber
- Therapeutic radiographer independent prescriber
- Optometrist independent prescriber
- paramedic independent prescriber
Are healthcare professionals from countries outside of the EEA or Switzerland recognised as ‘relevant prescribers’?
NO they are not
What are the conditions that must be met for an emergency supply at the request of a prescriber?
- Relevant prescriber
- Emergency (satisfied it is an emergency)
- 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 CDs, except phenobarbital
- Record must be made in POM register
Can CDs be given on emergency supply at the request of a prescriber?
nope CDs 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
When must the entry be made into the POM register when giving an emergency supply at the request of the prescriber?
Should be made on the day of the supply (or, if impractical, on the following day).
What must the record in the POM register of a emergency supply at the request of the prescriber include?
- the date of the POM supplied
- The name (including strength and form where appropriate) and quantity of medicines 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).
What are the conditions for an emergency supply at the request of a patient?
- Interview (Regulation 225 Human Medicines Regulations 2012 requires a pharmacist to interview the patient. RPS recognises this may not always be possible e.g. for a child so recommends to use professional judgement and consider the best interest of the patient.
Immediate need - for the POM (Legislation does not prevent a pharmacist from making an emergency supply when a doctor’s surgery is open.
- Previous treatment - the POM must previously have been used as a treatment and prescribed by a UK, EEA or Swiss health professional
- Dose - the pharmacist must be satisfied of knowing the dose that the patient needs to take
- Not for CDs, except phenobarbital (Phenobarbital can be supplied to patients of UK-registered prescribers for the purpose of treating epilepsy
For an emergency supply at the request of a patient what is the maximum days supply of CD 4 or 5 or phenobarbital can be given?
- 5 days’ treatment
For other POM, how many days emergency supply can be given at the request of a patient?
- no more than 30 days can be supplied except in the following:
- if the POM is insulin, an ointment, a cream, or an inhaler for asthma (i.e. the packs cannot be broken) the smaller pack available in the pharmacy should be supplied.
- If the POM is an oral contraceptive, a full treatment cycle should be supplied
Is a record needed to be kept when supplying an emergency supply at the request of the patient?
Yes it is required to be made on the same day or if impractical then on the following day
What does the record for an emergency supply at the request of a patient need to include?
- The date of the POM was supplied
- The name (including strength and form where appropriate) and quantity of medicine supplied
- The name and address of the patient for whom the POM was supplied
- Information on the nature of the emergency such as why the patient needs the POM and why a prescription cannot be obtained etc.
What additional labelling requirement is there when suppling a POM as an emergency supply?
- needs to include the words ‘ Emergency supply
Can a pharmacist refuse to give an emergency supply?
Yes, if they deem it is not appropriate to give an emergency supply
- But patient should be referred or told how to get relevant prescription
A record could be made of why request was refused for audit purposes
Can optometrists and podiatrists authorise the supply of POMs by writing prescriptions?
No unless they are additionally qualified as independent or supplementary prescribers
What way can POMs be supplied by pharmacies from optometrist or podiatrist?
Accordance with a signed patient order from any registered optometrist or podiatrist
To produce a written order dose the optometrist or podiatrist need to have additional prescribing qualification?
No this is not required- Any registered optometrist or podiatrist can give a written order for a POM
What is the restriction of POM that can be given on written order by optometrist and Podiatrist?
The medicine requested must be one which can be legally sold or supplied by the optometrist or podiatrist rather than one which they can only administer.
- Optometrists who have undertaken additional training and are accredited by the GOC as ‘additional supply optometrists’ can issue signed patient orders for an extended range of medicines
For a signed patient order, are there any prescription requirements?
The signed patient order is not a prescription therefore, the usual prescription requirements would not be needed.
Does a record need to be made in the POM register when supplying against a signed order from optometrist or podiatrist?
Yes
Which drugs can schools obtain supplies of using a signed order?
- Adrenaline auto-injectors (AAIs) and/or Salbutamol inhalers
Can these be given for routine use?
No these can be administered in an emergency, by persons trained to administer them, to pupils previously prescribed such medication and where parental consent has been received.
Who needs to sign the signed order from the school for supply?
Signature of the principal or head teacher
What information should be included on the 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 principle or head teacher
For the school signed order, does an appropriately headed paper need to be used?
- Ideally yes however, this is not a legislative requirement
Is a school allowed only a specific brand of AAIs or salbutamol inhaler?
The department of health advises schools to hold an appropriate quantity of single brand of AAI device to avoid confusion in administration and training.
The decision as to how many brands the school can purchase will depend on local circumstances and is left to the discretion of the school.
How many AAIs or Salbutamol inhalers can be obtained by the school through a signed order?
The number that can be obtained by individuals schools is not specified in legislation
What records need to be kept in the pharmacy when supplying a signed order from a school?
The signed order needs to be retained for 2 years from the date of supply or an entry made into the the POM register
Is it a legal requirement to retain the signed order from school?
You have to do one or the other or both;
1) retain signed order for 2 years OR
2) Write an entry in the POM
Even when the signed order is retained, it is good practice to make a record in POM register for audit purposes.
What must an entry in the POM register include?
In line with normal record keeping requirement an entry in the POM register would include:
- Date the POM was supplied
- Name, quantity and where it is not apparent formulation and strength of POM
- Name and address, trade, business or profession of the person to whom the medicine was supplied
- Purpose for which it was sold or supplied
What type of school can you supply against a signed order for AAIs or salbutamol inhaler?
All primary and secondary schools in the UK - including maintained schools, independent schools, pupil referral units and maintained nursery schools.
What is naloxone?
Naloxone is an opioid antagonist which can completely or partially reverse the central nervous system depression, especially respiratory depression, caused by natural or synthetic opioids.
What is naloxone licensed for?
- For the treatment of suspected acute opioid overdose
Is Naloxone a POM medicine?
Yes but the Human MEdicines 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, PGD or PSD.
Can Nasal naloxone also be given without a prescription by drug treatment services?
Yes this has been included since February 2019
What is Lawful drug treatment defined as?
‘Persons employed or engaged in the provision of drug treatment services provided by, on behalf of or under arrangements made by one of the following bodies:
- A) an NHS body
- B) a local authority
- C) Public Health England or
D) Public Health Agency
Who can administer naloxone to save a life?
Anyone can administer naloxone for the purpose of saving a life and there is evidence for the effectiveness of training family members or peers in how to administer the drug.
The 2015 amendments has widened the groups of people who are eligible to receive supplies of naloxone. Which people does this include?
- people likely to witness an overdose including family members, peers and staff in regular contact with drug users where naloxone may be required
What does PPP stand for?
Pregnancy prevention programme
Give few examples of drugs that need PPP?
- oral retinoids
- Valproate
- Thalidomide
- Lenalidomide
- Pomalidomide
They carry a high risk of causing foetal malformations and/or can increase the risk of spontaneous abortion when taken by women and girls
What is the aim of PPP?
It protects females of childbearing potential by minimising the risk of becoming pregnant while taking these medicines.
What is the term given if a drug can harm the foetus in pregnant women?
Teratogen drug
Teratogenic
Which oral retinoids are classed as ‘a powerful human teratogen’?
- Acitretin
- Alitretinoin
- Isotretinoin
Under PPP, for high risk drug (teratogens) how long is the prescription valid?
7 days,
Prescription presented after seven days should be considered expired and the patient should be referred back to the prescriber for a new prescription.
Pregnancy status may need to be reconfirmed by a further negative pregnancy test.
Ideally when should the prescription for a high risk drug (Teratogen) that requires PPP be dispensed?
- Ideally should be dispensed on the date the prescription is written (i.e. the same day)
Under PPP, for a high risk teratogenic drug, what is the maximum days supply that can be given on a prescription?
- Maximum of 30 days’ supply.
- A quantity for more than 30 days can only be dispensed if the patient is confirmed by the prescriber as not being under the PPP.
For oral retinoids, are repeat prescriptions, free sample distributions or faxed prescriptions allowed?
NO - pharmacists should not accept these
Is an emergency telephone request at the request of a PPP specialist prescriber allowed for oral retinoids?
Yes - only at the request of a PPP specialist prescriber together with confirmation that pregnancy status has been established as negative within the preceding seven days.
Valproate is used to treat which conditions?
- Epilepsy
- Bipolar disorder
- Prophylaxis of migraine (unlicensed use)
Does valproate require PPP?
Yes
What should pharmacists do when dispensing valproate prescriptions?
- Ask if they have had a review with their prescriber and are aware of PPP
- Those planning pregnancy should be advised to make an appointment with their prescriber - continue with contraception and valproate treatment in the meantime
- IF there is unplanned pregnancy while taking valproate advise the patient NOT to stop treatment and to arrange URGENT appointment
- Provide a patient card every time valproate is dispensed
- Dispense in original pack wherever possible - if dispensing in white boxes ensure a PIL is provided and a valproate warning label/ sticker added to the box
- Emphasise the importance of the need for an annual specialist review
- Report any suspected side effects to valproate medicines via the Yellow card scheme
What is the advantage of biosimilar medicines?
- Cost savings for the NHS and increased access to treatment for patients
Are biosimilar medicines the same as generic medicines?
No
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.
Give few examples of a biologic?
- Vaccines
- Blood and blood products
- Somatic cells
- DNA
- Human cells and tissues
- Therapeutic proteins
What is the term given for the first or original biologic on the market?
- The originator/ or reference product
What is a biosimilar medicine?
A biosimilar medicines is a biologic medicine that is similar to an already licensed biological medicines 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.
When can a biosimilar be marketed?
Only after the patent protecting the originator product and any period of marketing exclusively have expired.
Why is a biosimilar medicine not a generic medicine?
- Due to 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.
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 decisions to change the brand of a biologic used to treat a patient must only be made by a prescriber following discussions with the patient.
How are biosimilar medicines prescribed compared to generic medicines?
- 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.
When reporting ADRS for biosimilar medicines what should be included?
- Record both the brand name and batch number of the biologic medicine
What is an advanced therapy medicinal product (ATMP)?
IT 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
What are combined ATMPs?
ATMPs which contain one or more medical devices as an integral part of the medicine
Give an example of what is meant by combined ATMPs?
- Cells embedded in a biodegradable matric or scaffold
Are there many ATMPs available?
Majority of ATMP use is in clinical trails; however, some are now available as licensed medicines e.g. talimogene laherparepvec for metastatic melanoma, and axicabtagene ciloleucel for large B cell lymphoma - treatment commonly known as CAR-T cell therapy
Who is responsible for governance and management of ATMPs?
- The Chief Pharmacist
When prescribing CD 2 and 3 drugs the prescriber’s ….. needs to be within the UK?
Prescriber’s address needs to be within the UK
Under what can CD 1s be prescribed?
Under Home Office licence
Can doctors prescribe CD 2-5?
Yes
Do doctors require a home office licence to prescribe cocaine, diamorphine or dipipanone for treating addiction?
Yes
Can doctors prescribe unlicensed and/or off-label medicines?
Yes
To practice medicines in the UK, doctors are required to register with which board?
Registered with GMC and hold a license to practise
Which drugs can doctors authorise an emergency supply for?
All drugs except CD 1,2 or 3s (expect phenobarbital for treatment of epilepsy)
Can dentists prescribe CD 2-5?
Yes
Do dentists require a home office licence to prescribe cocaine, diamorphine or dipipanone for treating addiction?
Yes
Can dentists prescribe unlicensed and/or off-label medicines?
Yes
Can dentists prescribe any medications legally?
Yes - but they should restrict prescribing to treatment of dental conditions but legally can prescribe any medicine within their clinical expertise
What are NHS dental prescriptions restricted to?
They are restricted to the medicines listed in the Dental practitioner’s Formulary
Can dentists request emergency supplies and which drugs?
All drugs like doctors, but no CD 1, 2 or 3 (except for phenobarbital for epilepsy)
Can veterinary surgeons prescribe CD 2 to 5 drugs?
Yes for the treatment of animals only
For veterinary prescriptions, do prescriptions for CD 2 and 3 drugs need to be on the standardised forms?
No but must include the RCVS registration number of the prescriber
Can veterinary surgeons prescribe unlicensed and/or off-label medicines?
YEs where the medicines is not licensed for the animal intended then it needs to be prescribed under the veterinary Cascade
Can Veterinary surgeons authorise an emergency supply for items which can be prescribed?
No (emergency supply legislation applies to human use only)
Can a nurse/midwife independent prescriber prescribe CD 2-5 drugs?
Yes - but not cocaine, diamorphine or dipipanone for treating addiction
Can nurse/ midwife independent prescriber prescribe unlicensed and/or off-label medicines?
Yes -
unlicensed medicines are excluded from the Nurse Prescribers’ Formulary in Scottish Drug Tariff and therefore are not reimbursed on NHS prescriptions in Scotland
Can a nurse/midwife independent prescriber authorise an emergency supply for items which they can prescribe?
Yes - but not CD 1, 2 or 3 (except for phenobarbital for treatment of epilepsy)
Can an optometrist independent prescriber prescribe CDs 2-5?
No
Can optometrist independent prescribers prescribe unlicensed and/or off-label medicines?
Only ‘off-label’ medicine (i.e. using a licensed medicine outside of its approved use)
What are optometrist independent prescribers limited (restricted to) prescribing?
Only for treating conditions affecting the eye and surrounding tissue only
Can optometrists prescribe parenterals?
No - parenteral prescriptions are not allowed
Can paramedic independent prescribers prescribe CDS 2 to 5?
No - this may be changing
Can paramedic independent prescribers prescribe unlicensed and/or off-label medicines?
Only ‘off-label’ medicines (i.e. using a licensed medicine outside of its approved use)
Can pharmacists independent prescribers prescribe CD 2 to 5?
Yes but not cocaine, diamorphine or dipipanone for treating addiction
Can pharmacist independent prescribers prescribe unlicensed/ off label medicines?
Yes
Can pharmacist independent prescribers authorise an emergency supply for items which they can prescribe?
Yes - but not for CD 1, 2 or 3 (except for Phenobarbital for treatment of epilepsy)
Which CDs 2-5 can physiotherapist independent prescribers prescribe?
For oral administration:
- diazepam, dihydrocodeine, lorazepam, morphine, oxycodone and temazepam
- For injection - morphine
- For transdermal administration - fentanyl
Can physiotherapists independent prescribers prescribe unlicensed and/ or off-label medicines?
Only ‘off-label’ medicines (i.e. using a licensed medicine outside of its approved use)
Can physiotherapists independent prescribers authorise an emergency supply for items which they can prescribe?
Yes - but not any CD 1, 2 or 3 (including phenobarbital is not allowed)
Can podiatrist/chiropodist independent prescribers prescribe CD 2 to 5?
Restricted to the following for oral administration only:
- Diazepam, Dihydrocodeine, lorazepam and temazepam
Can podiatrist/Chiropodist independent prescriber prescribe unlicensed and/or off-label medicines?
Only ‘off-label’ medicines (i.e using a licensed medicine outside of its approved use)
Can podiatrists/chiropodist independent prescribers authorise an emergency supply for items that they can prescribe?
Yes but not for CD 1, 2 or 3 CDs (including phenobarbital is not allowed)
Can therapeutic radiographer independent prescribers prescribe CD 2 to 5?
No - but this may change
Can therapeutic radiographer independent prescriber prescribe unlicensed and/or off-label medicines?
Only ‘off-label’ medicines (i.e using a licensed medicine outside of its approved use)
Can therapeutic radiographer independent prescriber authorise an emergency supply for items which can be prescribed by them?
Yes but not CD 1, 2 or 3 CDs (including phenobarbital is not allowed)
Which professions can be a supplementary prescriber?
- Dietician
- Midwife
- Nurse
- Optometrist
- Paramedic
- Pharmacist
- Physiotherapist
- Podiatrist/chiropodist
- Radiographer (diagnostic/ therapeutic)
Can supplementary prescribers prescribe CD 2-5?
YEs but not cocaine, diamorphine or dipipanone for treating addiction
Can supplementary prescribers prescribe unlicensed and/ or off-label medicines?
Yes
Can supplementary prescribers prescribe authorise an emergency supply for items which they can prescribe?
Yes - but not CD 1, 2 or 3 (except phenobarbital for epilepsy)
For supplementary prescribers what is prescribing restricting to?
Restricted to areas of clinical competence and included within an agreed written clinical management plan (written and agreed with a prescriber and often the patient)
Can a community nurse prescriber prescribe CDS 2 to 5?
No
Can a comunity nurse prescribe prescribe unlicensed and/or off-label medicines?
No - other than Nystatin off-label for neonates
Can a community nurse prescribe authorise emergency supply for items which they can prescribe?
Yes just not CDs
What is prescribing for community nurse prescriber restricted to?
Restricted to dressings, appliances and licensed medicines listed in the Nurse prescribers Formulary
Can EEA or Swiss registered approved health professionals prescribe CD 2 to 5?
only CD 4 and 5
Can EEA or Swiss registered approved health professionals prescribe unlicensed and/or offlabel medicines?
No
Can EEA or Swiss registered approved health professionals prescribe authorise an emergency supply for items which they can prescribe?
Yes just no CD 1, 2 or 3 (also phenobarbital is not allowed)
What regarding marketing authorisation can can EEA or Swiss registered approved health professionals only prescribe?
Can only prescribe items which have a recognised marketing authorisation within the UK
What is the registration body for Dentists?
General Dental Council (GDC)
What is the registration body for Dieticians?
Health and Care Professions Council (HCPC)
What is the registration body for Doctors?
General Medical Council (GMC)
What is the registration body for Nurses/ Midwives?
Nursing and midwifery Council (NMC)
What is the registration body for optometrists?
General Optical Council
What is the registration body for Orthoptists?
Health and care professions Council (HCPC)
What is the registration body for paramedics?
Health and care professions council (HCPC)
What is the registration body for Pharmacists?
General Pharmaceutical Council (GPhC)
What is the registration body for Physiotherapists, podiatrists/chiropodists and radiographers?
Health and care professions council (HCPC)
What is the registration body for Veterinary surgeons?
Royal college of Veterinary Surgeons (RCVS)
Can prescribers legally self prescribe for them selves or for those who they have a close relationship with?
Yes, but it is generally considered poor practice.
The professional judgment of the prescriber may be impaired or influenced by the person they are prescribing for.
Which regulating body is responsible for the responsibility for the oversight and enforcement of the wholesale distribution of medicines?
MHRA - The Medicines and Healthcare Products Regulatory Authority (MHRA)
Anyone trading medicines, other than to a patient is required to have what?
- Hold a wholesaler licence - also known as a wholesale distribution authorisation
- Comply with the Good Distribution Practice (GDP) standards, and pass regular GDP inspections
- Have a suitable experienced ‘Responsible Person’ named on the license to ensure that medicines are procured, stored and distributed appropriately
Can pharmacies take part in trading medicines?
Yes those who engage in the commercial trade of medicines e.g. to wholesalers, other pharmacies, or other authorised or entitled to supply medicines.
Wholesale distribution authorisations (WDA) (h) & (V) are specific to what?
WDA (H) is specific to human medicines
WDA (V) is specific to veterinary medicines
Do pharmacies supplying stock to another pharmacy within the same legal entity require a WDA?
No
What are other exemptions of not needing WDA?
- Registered pharmacies and hospitals supplying small quantities of medicines to healthcare professionals for treatment or onward supply to their patients, or to the community pharmacies or hospitals to meet a patient’s individual needs are not required to hold a WDA 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
For wholesaling of CDs 2-5 what else is required along with WDA(H)?
- Home office CD licence
When a POM is supplied from a registered pharmacy to a healthcare professional or organisations, what record requriements is there?
An entry needs to be made in the POM register or the signed order/invoice needs to be retained for two years from the date of supply.
Even where the signed order/ invoice is retained, it is good practice to make a record in the POM register for audit purposes.
Does legislation specify what details need to be included on a signed order?
No - although local standard operating procedures (e.g. local NHS Trust policies or company SOPs) may require templates to be used.
It would be advisable for the details required for a POM register entry (i.e. the list above) to be requested as a minimum for a signed order as this information would be required to complete the POM register.
What is one way that minimises medicines shortages?
- by limiting medicines which can be traded or exported
- the MHRA publishes a list of medicines that cannot be parallel exported
What do serious shortage protocols (SSPs) enable?
They enable Pharmacists in England, Wales and Northern Ireland to make amendments to prescriptions and supply and alternative medicines to those in short supply.
List the classifications categories of veterinary medicines?
POM-V POM-VPS NFA-VPS AVM-GSL Exempt medicines under schedule 6 of the veterinary medicines regulations - exemptions for small pet animas (SAES) Unauthorised veterinary medicine
What is 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
What is POM-VPS?
HINTS VPS = Veterinary Surgeon, Pharmacist, Suitably qualified person
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.
What is 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
What is AVM-GSL?
An authorised veterinary medicine that is available on general sale
What does the category ‘exempt medicines under schedule 6 of the veterinary medicines regulations-exemptions for small pet animals’?
An unlicensed veterinary medicines that does not require a marketing authorisation because it meets criteria laid out in schedule 6 of the Veterinary Medicines Regulations.
What is the category - Unauthorised veterinary medicine?
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.
This includes any human medicine used for animals.
What must be on a veterinary prescription for it to be legally valid?
1) Name, address, telephone number, qualification and signature of the prescriber. Where CD 2 or 3 CDs have been prescribed, the 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 prescription all supplies must be made within 6 months or shorter if indicated by prescriber). Prescriptions for CD 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
Note also: Where CDs 2 or 3 have been prescribed, a declaration that ‘the item has been prescribed for an animal or herd under the care of the veterinarian’ usual CDs prescription requirements apply.
Are standardised forms required for veterinary medicines?
No
What statement needs to be included on a veterinary prescription for CDs 2 or 3?
‘prescribed for the treatment of an animal or herd under my care’
How long are veterinary medicines retained for and do they need to be submitted to NHSBSA?
Retained for 5 years and not submitted to the relevant NHS agency.
For veterinary prescriptions how many days supply can a CD 2 or 3 prescription be for?
Recommended that it is good practice for only 28 days’ worth of treatment to be prescribed (unless in situations of long term ongoing medication (e.g. epilepsy in dog)
For human prescriptions what is the maximum quantity of CD 2, 3 or 4 CDs that can be given?
Should not exceed 30 days supply
If more than 30 days is prescribed the prescriber should be able to justify the quantity requested.
What number must veterinary prescriptions for CD 2 and 2 CDs include?
The RCVS registration number of the prescriber
How long is a CD 2,3 or 4 veterinary prescription valid for?
28 days from the appropriate date
Does usual CD content requirement (e.g. total quantity in words and figures, etc.) apply to veterinary medicines?
Yes
Does a veterinary medicine with a GB or UK marketing authorisation need to be given?
Yes where one exists it should be supplied and if clinically appropriate
Is it unlawful to supply a human medicine against a veterinary prescription?
Yes unless it is prescribed by a veterinary surgeon and specifically states that it is ‘for administration under the cascade’ or other wording to this effect.
Outline the Veterinary Cascade?
1) Supply a veterinary medicine with a GB or UK-wide marketing authorisation for the species and condition indicated
2) Where above is not possible, a veterinary medicine with a Northern Ireland (NI) marketing authorisation for the species and condition indicated can be supplied
3) Where above is not possible, A GB, NI, or UK wide veterinary medicine licensed for another species or different condition can be considered
4) a) A GB, NI or UK-wide licensed human medicine
4) b) A veterinary medicine authorised outside the UK can be considered
5) An extemporaneous or a specially manufactured medicine can be considered
For products not authorised in GB or UK-wide (including those licenced in NI) what is required?
A special import Certificate is required
Can you sell unauthorised veterinary medicines or P or GSL medicines for animal use?
NO it is unlawful unless this takes place under the veterinary Cascade.
This applies even if a veterinary surgeon asks the animal owner verbally to purchase an over-the-counter human product from a pharmacy
What are the legal requirements whcih pharmacies who supply NFA-VPS medicines or prescribe POM-VPS medicines need to do?
- Advise on how to use the product safely
- Advise on any applicable warnings and contraindications on the packaging or label
- Be satisfied that the receipt intends to use the medicine correctly and is competent to do so
- Prescribe or supply the minimum quantity required for treatment
Is the physical presence of the pharmacist required when supplying POM-V, POM-VPS and NFA-VPS?
Yes
What must appear on the label of dispensed veterinary medicine under the Cascade?
- Name of the prescribing veterinary surgeon
- Name and address of the animal owner
- Name and address of the pharmacy
- Identification and species of the animal
- Date of supply
- Expiry date of the product
- The name or description of the product or its active ingredients and content quantity
- Dosage and administration instructions
- If appropriate, special storage instructions
- Any necessary warnings for the user (e.g. relating to administration, disposal, target, species etc)
- Any applicable withdrawal period (i.e. time between when an animal receives a medicine and when it can safely be used for used)
- The words ‘ for animal treatment only’
- The words ‘keep out of reach of children’ as recommended by RPS.
If the medicine is not prescribed under the Cascade then is a dispensing label required?
If not prescribed under the cascade then a dispensing label is not required.
However, the RPS advises that it would be appropriate to generate a dispensing label for all veterinary medicines, particularly for individual animals (pets).
What records must be kept when making supply of POM-V and POM-VPS?
- Records of receipts and supply
- 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 the documents that show the required information or can make appropriate records in their private prescription book.
Records can be kept electronically
How long must records for POM-V and POM-VPS be retained for?
5 years
What must pharmacies that supply POM-V and POM-VPS undertake?
An annual audit
How must suspected ADRs from veterinary medicines be reported?
Through the adverse reaction scheme for veterinary medicines - both animal ADRs and human ADRs should be reported.
Who can supply authorised retailers with veterinary medicines (Wholesaling)?
Only the manufacturer of a veterinary medicine or a holder of a wholesale dealers authorisation (WDA)
Can an authorised retailer supply another authorised retailer veterinary medicines when there is a short supply?
Yes to relieve a temporary supply shortage, without a WDA.
It is only intended to prevent shortages of available medicines and not intended to exempt wholesaling supply from the need for a WDA.
What does the 1971 Act impose in regards to CDs?
Imposes prohibitions on the supply, manufacture, import and export of CDs - except where permitted by the 2001 Regulations or under licence from the secretary of State.
What does the Safe Custody Regulations detail?
Details the storage and safe custody requirements for CDs.
Who is the enforcement body for CDs offences?
Home office - via the police
What did the Health ACT 2008 introduce?
- The concept of an ‘accountable officer’ and requires healthcare organisations, to have standard operating procedures in place for using and managing CDs
Does legislation provide details on which specific CD SOPs should be in place?
- No this is no longer specified
What does RPS recommended on keeping up to date organisational policies and procedures in place regarding the safe and secure handling of medicines?
Not exclusively to this risk:
- Security, including access to CDs
- Ordering and receipt
- record-keeping, including audit requirements
- Prescribing and clinical monitoring
- Administration, including any witness requirements
- Supply, including prompt access to ensure care is not compromised
- Denaturing and disposal, including any witness requirements
- Use and storage of patients’ own CDs
- Transport (including transfer between care settings) inlcuding records
- Investigation and reporting concerns
What are accountable offciers responsible for?
Responsible for supervising and managing the use of CDs in their organisation or setting.
What is the roles and responsibilities of an accountable officer?
- 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 regarding the management of CDs in a required time frame
- The appointment of authorised witnesses for the destruction of CDs
If an organisation foes not require to appoint a CDAO then who performs the same role?
CDAO not required in some settings e.g. general practice, dental clinic, community pharmacy), then an appointed ‘controlled drugs lead’ performs the same role.
Which regulations classifies CDs into the five Schedules?
The 2001 Regulations
List the Five CD shedules?
Schedule 1 (CD Lic POM)
Schedule 2 (CD POM)
Schedule 3 (CD No Register POM)
Schedule 4 (CD Benz POM and CD Anab POM)
Schedule 5 (CD INV P and CD INV POM)
Explain what is Schedule 1 (CD Lic POM)?
- 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
Explain what is schedule 2 (CD POM)?
- 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. amphetamine), Quinalbarbitone and ketamine.
Explain what is Schedule 3 (CD No Register POM)
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
Explain the two parts of Schedule 4 (CD Benz POM and CD Anab POM)
Part 1 (CD Benz POM) - contains most of the benzodiazepines (such as diazepam), non-benzodiaepines hypnotics (such as zopliclone), and Sativex (a cannabinoid oralmucosal mouth spray)
Part II (CD Anab POM) - Contains most of the anabolic and androgenic steroids, together with clenbuterol (an adrenoreceptor stimulant) and growth hormones.
Exaplin what is schedule 5 CDs?
Schedule 5 (CD INV POM or CD INV P)
contains preparations of certain CDs (such as codeine, pholcodine and morphine) that are exempt from full control when present in medicinal products of specifically low strengths,
Which CDs have additional and strict prescription requriements?
CD 2 and 3
How long are CD prescriptions valid?
CD 2, 3 and 4 = 28 days
Which CDs require address of prescriber to be within the UK?
CD 2 and 3 = Yes
CD 4 and 5 = No
Which Can can EEA and Swiss healthcare professionals legally prescribe?
CD 2 and 3 = No
Cd 4 and 5 = Yes
Which CD schedules allow repeatable prescriptions?
CD 2 and 3 = Not allowed
CD 4 and 5 = Yes, allowed
Which Cd schedules allow an emergency supply to be given?
CD 2 = Not allowed
CD 3 = Not allowed (except phenobarbital for epilepsy by a UK-registered prescriber)
CD 4= Yes E/S allowed
CD 5 = Yes E/S allowed
Which CDs require a Requisition and require it to be marked by the supplier?
CD 2 + 3 = Yes
CD 4 and 5 = No not needed
How long are invoices for CDs 2 and 3 retained for?
Minimum of two years
Which CDs require licence to import or export?
CD 2 = yes CD 3 = Yes CD 4 (Benz POM) = Yes CD 4 (Anab POM) = Yes (unless the substance is imported or exported by a person for self-administration) CD 5 = No, not required
How many years does NICE recommend to retain all CDs invoices for?
For a minimum of 6 years for the purpose of HM Revenue and Customs
What are some of the mechanisms for the lawful possession of CDs?
- Home office licence
- Home office group authority (e.g. there is currently a group authority covering paramedics that allows them to possess and supply certain CDs
- Legislation: class of person (e.g. postal operator etc.)
- Legislation : class of drug (certain classes of CDs are lawful (e.g. schedule 4 part II drugs when contained in medicinal products and schedule 5 drugs.
- Patients (Persons who have been prescribed these by appropriate prescribers.
What licence is required to possess schedule 1 CDs?
- A home office licence; however, a pharmacist can take possession of such CDs for the purpose of destruction or to handover to a police officer.
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.
Is a licence required for a pharmacy to import or export CD 1,2,3 and 4 (Part I) CDs?
Yes
IS a licence needed for CD schedule 4 (part II)?
Yes, unless it is imported or exported by a person for self-adminstration
Are there any restrictions for import or export of CD 5?
No
How many months’ supply of CD can a patient have without requiring a personal licence?
A personal licence is not required by the Home Office if a person travelling is carrying less than three months’ supply of CDs.
However, it is advised that a covering letter signed by the prescriber is obtained that confirms the name of the patient, travel plans, name of the prescribed CDs, total quantities and doses.
Which CDs require a standardised requisition form?
CD 2 and 3
(this applies to both requisitions for human and for veterinary use.
Who are exempt from the requisition requirements of CD 2 and 3?
Hospices and prisons
What are the legal requirements for a controlled drug requisition?
1) Signature of the recipient
2) Name of the recipient
3) Address of the recipient
4) Profession or occupation
5) Total quantity of drug
6) Purpose of the requisition
Which standardised requisition form is used in England?
FP10CDF
If a request is made by a hospital pharmacy and the request is on behalf of a ward or department within the same legal entity is a standardised requisition form requried?
No - approved form not required but if it isn’t within the legal entity then Yes it is required
In prisons instead of standardised forms what are used to obtain CD supplies?
Hospital-style requisition forms (instead of a standardised form) are usually used and are printed in a bound, book format-sequentially numbered with a carbon copy of each requisition to provide a robust audit trail.
Where the persons in charge, or acting in charge of a hospital issues and signs a requisition, who else must this be signed by?
Must also be signed by a doctor or dentist employed or engaged in that hospital.
Are supplied made against a faxed or photocopied requisition acceptable?
No this is not allowed
Is it a legal requirement to use standardised requisition form if request is from another pharmacy?
No not legally required however the home office advises that supplies from one registered pharmacy to another registered pharmacy should only be made after receiving a written requisition on an approved requisition form
On an emergency can a doctor or a dentist be supplied with a CD 2 or 3 drug if they cannot give requisition straight away?
Yes provided that this will be given within 24 hours.
If the purchaser cannot get the medication then what must the messenger (who is picking the supplies up for the purchaser) present?
Present a written authorisation
HOw long should the pharmacy retain the written authorisation given by the purchaser tot he messenger?
2 years
What marking and sending is required by the pharmacy when processing requisition forms?
It is a legal requirement to
- Mark the requisition indelibly with the supplier’s name and address (i.e. the name of the pharmacy); where a pharmacy stamp is used this must be clear and legible
- Send the original requisition to the relevant NHS agency
As a good practice, pharmacies should retain a copy of the regulation for two years from the date of the supply
Which circumstances do requisition processing not apply?
When the supply is made:
- By a person responsible for the dispensing and supply of medicines at a hospital, care home, hospice, prison or organisation providing ambulance services who must mark and retain the original requisition for two years.
- by pharmaceutical manufacturers or wholesalers
- Against veterinary requisitions (the original requisition should be retained for 5 years)
Which CDs can a midwife obtain through a midwife supply order?
- Diamorphine
- Morphine
- Pethidine
What information must the midwife supply order contain?
- 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.
What are the prescription requirements for CD 2 and 3?
1) signature (The prescription may be signed by another prescriber other than the name prescriber and still be legally valid). However, the address of the prescriber needs to be applicable to the signatory for the prescription to be legally compliant. The CD register entry should record the details of the actual prescriber (the signatory) rather than the named prescriber.
2) Date - The prescription needs to include the date. CD prescriptions are valid for 28 days from the appropriate date indicated on the prescription
3) Prescriber’s address - must be within the UK
4) Name of CD - good practice to write the name of the medicine in full as it appears ni the manufactures summary of product characteristics.
Although the name of the medicine is not specified as a requirement under the 2001 regulations.
5) Form - The formulation must be stated Abbreviations ‘tabs’ and ‘caps’ are acceptable.
6) Strength - the strength only needs to be written on the prescription if the medicine is available in more than one strength.
If more than one strength prescribed, this should be written separately (i.e. separate dose and total quantity)
Dose - Dose does not need to be in both words or figures, however, it must be clearly defined.
8) Total quantity (must be written in both words and figures.
9) Quantity prescribed - recommendations that the maximum quantity should not exceed 30 days. This is not a legal restriction but prescribers should be able to justify the quantity requested (on a clinical basis) if more than 30 days’ supply is prescribed.
10) Name of patient
11) Address of the patient (If homeless then NFA is acceptable)
12) Dental prescriptions (Where the CD is written by a dentist, the words ‘for dental treatment only’ must be present
13) Instalment direction - valid instalment direction is required
Does sugar or sugar free products have a greater potential for abuse?
Sugar free and/ or colour free products have a greater potential for abuse; therefore RPS advises that these are only supplied when specifically prescribed.
Which two pieces of information does an instalment direction combine?
1) Amount of medicine to be supplied per instalment (this is in addition to the dose)
2) Interval between each time the medicine can be supplied
If on a CD 2 or 3 prescription if a minor typographical error or spelling mistake, or where either the words or figures (but not both) of the total quantity has been omitted, who may amend this?
- A pharmacist can amend the prescription indelibly so that it becomes compliant with legislation.
The prescription must also be marked to show that the amendments are attributable to the pharmacist (e.g. name, date, signature and GPhC registration number)
Which errors can pharmacists not amend on CD 2 or 3 prescriptions?
- missing date
- incorrect dose
- Form
- stregnth
What additional requirements do private CD 2 and 3 CD prescriptions have?
1) standardised form - Private prescription that are not on the designated standardised form must not be accepted unless they are veterinary prescriptions.
2) Prescriber identification number (this number is not the prescriber’s professional registration number (i.e. the GMC number), it is a number issued by the relevant NHS agency and the prescriber can obtain it from their local primary care organisation.
3) Submission (Must submit the original private prescription to the relevant NHS agency) This requires an identifying code assigned to the pharmacy for this purpose by the local primary care organisation).
What standardised form is used for CD 2 and 3 drugs in England?
FP10 PCD
Do veterinary prescriptions for CDs need to be written on the standardised forms or be sent to NHSBSA?
Standardised form is not needed and does not need to be submitted to the relevant NHS agency.
How long must veterinary CD prescriptions be retained in the pharmacy?
- Forms must be retained for 5 years
Can other medicines be prescribed on the same private prescription form as CDs?
No - medicines that are not CDs should not be prescribed on the same form as a Schedule 2 or 3 CD This is because the form needs to be sent to the relevant NHS agency so the pharmacist would be unable to comply with the requirement to keep private prescriptions for a POM for two years.
If the CD prescription directions state that the dose must be supervised, the pharmacist should contact who if the person sends a representative to collect with a letter?
Should contact the prescriber before the medicine is supplied to the representative since the supervision will not be possible.
Appropriate record of this conversation should be made
Is supervision of a CD a legal requirement?
No - not a legal requirement under the 2001 Regulations.
Is signing the back of the CD 2 or 3 prescription a legal requirement?
No it is good practice
Do instalment prescriptions need to be signed by the patient at every collection?
No only needs to be signed once
Can a delivery driver sign on behalf of a patient?
Yes or representative of the patient, however, a robust audit trail should be available to confirm successful delivery of the medicine to the patient.
Which two CD 3 drugs require safe custody?
- Temazepam and buprenorphine
Keep TB locked up
What standard must a prison CD cabinet meet?
Should meet the ‘Sold secure silver standard’.
Access to CDs (including handling of CD keys) should be documented. True or False?
True - The policy should prevent unauthorised access to CDs (e.g. the electronic logs from a room or cabinet with electronic access or audit trail for holders of the CD keys)
A key log can be used to keep an audit trail of who has had access to the keys
Does safe custody apply to patient returns, out of sate and obsolete CDs?
YEs until they can be destroyed
To minimising risk of supplying these to the patients what should be done?
- These stock should eb segregated from other pharmacy stock and be clearly marked (e.g. mark the stock as ‘patient returns waiting to be destroyed or ‘out of date, waiting authorised witness to destroy’ etc.)
Pharmacies are required to do what before destroying CDs?
Require to denature the CDs
Usually this process requires an appropriate licence but pharmacies can register an exemption without needing to obtain a licence
In England and wales what is the exemption called given by the Environmental Agency to be able to get rid of CDs (denature)?
T28 Exemption
This exemption needs to be registered with the Environment Agency
Which Cds need to be denatured before disposal?
The Home Office has advised that all CDs in Schedule 2, 3 and 4 (Part I) should be denatured and, therefore, rendered irretrievable before disposal.
Does CD 2 destruction require a witness?
Yes
Does patient returned CDs desctruction need a witness?
Does not require a witness by an authorised person
In community pharmacies is CD 3 buprenorphine need to be entered on the CD register legally?
No
In prisons, is CD 3 buprenorphine need to be entered on the CD register legally?
Yes to maintain a robust audit trail - therefore any destruction should be recorded
Also recommended that a robust audit trail is maintained for CD 4s such as diazepam and chlordiazepoxide
Who is authorised to witness the destruction of CDs?
Various individuals and classes of person (e.g. police Constables) are authorised to witness the destruction of CDs. This authority is derived from the Home secretary.
It can also be derived from the secratory of state for health or from an accountable officer
What does an accountable officer have the power to authorise in terms of CD destruction?
Power to authorise other persons to witness the destruction of CDs
Can an accountable officer be an authorised witness directly?
No - the 2001 regulations prevent an accountable officer from being an authorised person directly
Persons authorised by the accountable officer are usually senior members of staff who are not involved in the day to day management or use of CDs
Which patient returned CD require denaturing?
CD 2, 3 and 4(Part I)
Is an authorised witness required for the destruction of patient returned CDs?
No - however, it is preferable for denaturing to be witnessed by another member of staff familiar with CDs (Preferably a registered health professional)
What record keeping is required for patient returned CDs?
- A record should not be made in the CD register but records of patient-returned CD 2 CDs and their subsequent destruction should be recorded in a separate record for this purpose
Which expired/obsolete/ unwanted stock CDs require denaturing?
CD 1, 2, 3 and 4 (Part I)
Is an authorised witness required for destruction of expired/ obsolete/ unwanted CDs?
Yes, if schedule 2.
For CD 3 medicines it would be good practice to have another member of staff witness the denaturing.
What record keeping is required for destruction of expired/ obsolete/ unwanted CDs?
An entry should be made in the CD register for CD 2s.
How are patches denatured?
Remove the backing and fold the patch over on itself. Place into a waste disposal bin or a CD denaturing kit.
What CD schedule is Sativex?
Schedule 4 (Part I)
Are pharmacists required to keep records of Sativex CD 4 Part I?
Yes the home office strongly recommends the use of a CD register for making records relating to sativex.
For controlled drugs received, what must be recorded?
- Date supply received
- Name and address from whom received
- Quantity received
For controlled drugs supplied, what 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 provided
How should the CD register be separated (Laid out)?
The class, strength and form be specified at the head of each page of the CD register
- The register is required to be a bound book register
- It is also a requirement that different classes are kept in a separate part of the register and that within each class, a separate page is used for different strengths and formulations of each drug.
Are multiple registers for the same class of CDs allowed?
Yes if approved by the Home Office
How many CD registers do Prisons have?
They have one legally compliant register that records all the details as specified.
However, since there are often several areas in each prison where CDs are stored, administered or issued, each of these areas should maintain a CD record book (similar to those used by hospital wards).
Also recommended is that movement of CDs between these areas be recorded by internal requisition so that robust audit trails are maintained.
What are the requirements of entries made in the CD register?
- Entered chronologically
- Entered Promptly - entries must be made on the day of the transaction or on the following day
- In ink or indelible - entries and corrections must be in ink or indelible (or computerised)
- Unaltered - Entries must not be cancelled, obliterated or altered. Corrections must be made by dated marginal notes or footnotes.
The register should be marked to show who the amendments made are attributable to (e.g. name, initials/signature, GPhC number if applicable).
What following points regarding record keeping should be adhered to when maintaining CD registers?
Location - each register should be kept at the premises to which it applies
Duration - registers should be kept for two years from the date of the last entry
Form - records can be kept in their original form or copied and kept in an approved computerised form
Inspection - a copy of the register, and other details of stock, receipts and supplies, must be made available to authorised persons (e.g. GPhC inspector or CD liaison officer) upon request.
Are electronic CD registers allowed as an alternative to having a bound-book CD register?
Yes
What does legislation require that computerised entries must be?
- Attributable
- Capable of being audited
- Compliant with best practice
- Electronic CD register must also be accessible from the premises and capable of being printed.
- Access control systems should be in place to minimise the risk of unauthorised or unnecessary access to the data.
- Adequate back-ups must be made of computerised registers.
- Arrangements musts be made so that inspectors can examine computerised registers during a visit with minimum disruption to the dispensing process.
What safeguards need to be incorporated into the software for a electronic CD register?
- The author of each entry is identifiable
- Entries cannot be altered at a later date
- A log of all data entered is kept and can be recalled for audit purposes
What is the aim of a running balance?
To ensure that irregularities or discrepancies are identified as quickly as possible.
For most organisations, how frequently should stock checks of CDs occur?
At least once a week, but these may be more or less frequent based on risk assessment, volume of CDs dispensing, frequency of past irregularities or incidents, or if there are several different pharmacists in charge over short periods.
(recommended once a week, not necessarily required to be on the same day every week).
If possible how many people should carry out the CD stock checks?
- Two people
What are some of the common reasons for stock to b at zero blance?
- drug not being recorded
- Destruction of the drug (i.e. expired and obsolete) or discontinuation of the drug by the manufacturer
Is a running balance a legal requirement?
No it is not a legal requirement, it is a matter of good practice and is a recommendation from the shipman inquiry.
(It is intended that once electronic registers are in common use this will become a legal requirement)
How many constituents does cannabis contain?
More than 400 chemical constituents, including cannabinoids, terpenoids and phenolic compounds, many of which have potential for medicinal use.
Which is the most common of the cannabinoids whihc has psychoactive properties?
- Psychoactive compound tetrahydrocannabinol (THC) and the non-psychoactive compound cannabidol (CBD).
What are the categories of cannabis-based products?
Licensed products
- THC combined with CBD (Sativex)
- Nabilone
- CBD (Epidyolex)
Synthetic compounds
- Dronabinol
Cannabis-based products for medicinal use (CBPMS)
- As set out in the 2018 regulations
What CD schedule does sativex belong to
CD 4 (Benz)
What cannabinoids does sativex contain?
THC and CBD
What is the use of sativex (a licensed product)?
Moderate to severe spasticity in multiple sclerosis
What does nabilone contain (a licensed product)?
A synthetic non-natural Cannabinoid)
What legal category does nabilone belong to?
POM
What is the use of nabilone?
Nausea and vomiting caused by cytotoxic chemotherapy, unresponsive to conventional antiemetic treatments.
What does epidyolex (CBD) contain?
- Cannabidol
What CD schedule does epidyolex belong to?
CD 5
What is the use of epidyolex?
Seizures associated with Lennox-Gastaut syndrome or Dravets Syndrome (adjunctive treatment with clobazam)
Name a synthetic cannibinoid compound?
Dronabinol
A synthetic, nature identical, version of THC
What is the legal category of Dronabinol?
CD scehdule 2
What is the use (indication) of dronabinol?
Available as a special (approved by US Food and Drug Administration) to treat loss of appetite in people with AIDS and to treat severe nausea and vomiting caused by cancer chemotherapy in patients with inadequate response to conventional antiemetic treatments.
Which doctors can only prescribe cannabis based products for medicinal use (CBPM)?
- Specialist doctors on the GMC’s Specialist Register
What are the three broad requirements that a product should satisfy for the definition of CBMP?
- The product is or contains cannabis, cannabis resin, cannabinol or cannabinol derivative
- It is produced for medicinal use in humans; and
- It is a product that is regulated as a medicinal product, or an ingredient of a medicinal product
Are there any licensed CBPMs?
no currently the only CBPMs are unlicensed medicines
Patients should be made aware that the product being prescribed is unlicensed and a note of this should be made in the patient’s medical records.
What legal category are CBPMs?
CD 2
What is CBD (cannabidol) oil derived from?
CBD oil is typically extracted from strains such as industrial hemp, which contain high concentrations of CBD and low concentrations of the psychoactive tetrahydrocannabinol (THC).
What are CBD oil products available marketed as?
Marketed as food supplements and are classes as ‘novel foods’.
Novel foods including CBD food products, are regulated by the Foods Standard Agency and need to be safety evaluated, authorised and approved before they can be placed on the market.
What is the sale of CBD products enforced by?
- local trading authorities
NOTE - if any medicinal claims are made these products will fall under medicines legislation
Are CBD oil allowed to contain THC?
No they must not contain THC which remains a controlled substances, under Home office legislation
What has the home office warned about pure CBD?
Pure CBD is very difficult to isolate and that if a product contains THC it is Highley likely to be a controlled drug
A licensed preparation containing a highly purified liquid containing cannabidol is available, what is this product called?
Epidyolex
This is used for seizures associated with Lennox-Gastaut Syndrome or Dravets Syndrome
Where a product says ‘use by’ or ‘use before’ what does this expiry date mean?
It should be used before the end of the previous month
For example, use by 06/2022 means that the product should not be used after 31 May 2022
What does the term expiry date mean?
MHRA’s advice to pharmaceutical manufacturers is - the term ‘expiry date’ should be taken to mean that the product should not be used after the end of the month stated.
Therefore, an expiry date of 12/2022 means that the product should not be used after 31 December 2022.
Who is the enforcement body for wasted products in England and Wales?
- Environmental Agency
When taking in waste/ expired medicines in blister packs can you take tablets/ capsules put of the blisters (de-blister)?
No- blister strips can be removed from their inert outer packaging but tablets and capsules should not be de-blistered
(NOTE - an exemption applies to CD tablets and capsules, which require denaturing)
Do CD liquids need to be denatured?
Yes
Before being able to obtain the most dangerous poisons, chemicals which can be used as explosive prescursors, what must the patient present?
A licence issued by the home office
What record keeping is required when someone is buying poisons or chemicals and requires to present their licence?
- Pharmacy teams will need to check that the licence is valid, unaltered and matches the request
- Transaction details must be added to the licence, substances must be suitably labelled and regulated poisons register
What does REACH stand for?
(Registration, Evaluation, Authorisation and restriction of CHemicals).
In secure environments, when medicines are dispensed from an ‘in-house’ pharmacy for administration or supply to patients within a prison, does the pharmacy need to be registered with the GPhC?
No but good practice to follow GPhC regulations
What is the difference between homeopathic and herbal products?
- Homeopathic products are often dertived from herbs and are called by their botanical name e.g. aloe, and also because a single manufacturer may produce both homeopathic and herbal products
What is homepathy defined as?
- Defined as holistic complementary and alternative therapy based on the concept of ‘like to treat like’ and involves the administration of dilute and ultra dilute products prepared according to methods given in homeopathic pharmacopeias
What do herbal preparations contain?
- Contain plant-derived materials, either as raw or processed ingredients which may be from one or more plants.
Is there scientific evidence to support the efficacy of homeopathic products?
No scientific or clinical evidence to support the efficacy of homeopathic products above the placebo effect, although anecdotal reports of their effectiveness have been published.
Does the RPS endorse homeopathy as a form of treatment or support the prescribing of homeopathic products on the NHS?
No
What advice should be given to patients about what homeopathic products use should be limited to?
- Should only be used for the treatment of minor, self-limiting conditions and must never be used for the treatment of serious medical conditions.
For the purpose of licencing does the MHRA require homeopathic products to demonstrate efficacy?
No only quality and safety
What licencing must herbal remedies have?
They must have either a full marketing authorisation based upon safety, quality and efficacy or a traditional herbal registration (THR) based upon safety, quality and evidence of traditional use.
For charitable donation of medicines is a licence still required?
Yes a wholesale dealer’s licence (WDA(H)) is required regardless of whether the medicine is stock surplus to the requirements of the pharmacy or general stock that is to be donated for charitable use or in times of conflict
can patient returns be donated to charity?
No it is forbidden
Is there a legal age a child needs to be to pick up a prescription?
No - professional judgement of the pharmacist
What is the definition of a medical device?
It is described in the MEdical Devices Regulations 2002 as any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software necessary for its proper application intended by the manufacturer to be used on human beings for the purpose of
- diagnosis, prevention, monitoring treatment or alleviation of disease
- compensation for an injury or handicap
- Control of cenception
Who are all medicinal products regulated by?
MHRA
What are all devices required to carry (mark the symbol of)?
the CE or UKCA mark denoting compliance with the medical devices regulations and indicating that the device performs as intended, is fit for purpose with all associated risks reduced as far as possible.
What does a ‘statutory medical defence’ exist to protect?
Protect patients who may test positive for these specified drugs as a result of taking medicines in accordance with advice from a healthcare professional or the patient information leaflet.
Which drugs are specified in the first group (driving limits)?
Cannabis (THC) Cocaine (and a cocaine metabolite) Heroin/ diamorphine metabolite Ketamine Lysergic acid diethylamide (LSD) MDMA (ectasy) Methylamfetamine
Which drugs are specified in the second group (driving limits)?
Amfetamine Clonazepam Diazepam Flunitrazepam Lorazepam Methadone Morphine or opiate and opioid-based drugs e.g. codeine, tramadol oxazepam Temazepam
What is the website to find out more about retention of pharmacy records?
https://www.sps.nhs.uk/
articles/retention-of-pharmacy-records/
In order to lawfully conduct a retail pharmacy business the pharmacist should be signed in as what?
The pharmacist in charge must be the responisble pharmacist
What information needs to be included on the RP display notice?
- 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
Can a pharmacy record be kept electronically?
Yes it can
How should the pharmacy record (log) be recorded?
- be recorded accurately and reflect 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
What details must be included in the pharmacy record (Log)?
- the RP’s name
- the RPs 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 absent from the premises - the date of absence, the time which the RP left the premises, the time at which the RP returned to the pharmacy
How long should the RP log (Pharmacy record be retained)?
The pharmacy owner or superintendent pharmacist must keep the pharmacy record for a period of 5 years.
How long can a RP be absent during the pharmacy’s business hours between midnight and midnight?
Up to 2 hours
What if there is more than two responsible pharmacists?
The total period of absence for all the responsible pharmacists must not exceed two hours
If RP is absent, what arrangeents must be in place?
- only be absent if the pharmacy can continue to run safely and effectively
- remain contactable with the pharmacy staff - where reasonable be able to return with reasonable promptness
- If the RP cannot be contactable then they must arrange for another pharmacist to be contactable and available to provide advice (this does not need to be another responsible pharmacist)
Which activities require a RP/ supervising pharmacist to be physically present at the pharmacy?
- Professional check (clinical and legal check) of a prescription
- Sale/supply of P medicines (physical presence is required of the pharmacist
- sale/supply of POMs (e.g. handing dispensed medicines to patient, patient representative or a delivery person).
- supply of medicines under a patient group direction (PGD)
- wholesale of medicines
- emergency supply of medicines(s) at the request of a patient or healthcare professional
Which activities can take place with a responsible pharmacist in charge of the pharmacy where the supervising pharmacist may not to be physically present at the pharmacy?
The assembly process (including assembly of compliance aids (monitored dosage systems):
- Generating a dispensing label
- Taking medicines off the dispensary shelves
- Assembly of the item (e.g. counting tablets)
- labelling of containers with the dispensing label
- accuracy checking
Which activities can take place with a responsible pharmacist in charge of the pharmacy but dos not require supervision of a pharmacist?
Sale of GSL medicines
processing waste stock medicines or patient returned medicines (excluding CDs)
Which activities can take place without a responsible pharmacist in charge of the pharmacy but requires the support staff undertaking the activity to be appropriately trained?
- ordering stock from pharmaceutical wholesalers
- receiving stock from pharmaceutical wholesalers into the building (excluding CDs)
- putting medicinal stock received from the wholesaler away onto the pharmacy shelves (GSL, P, and POMs, excluding CDs)
- Date checking (excluding CDs)
- stocking pharmacy with consumables
- cleaning of the pharmacy
- responding to enquiries (about medicine issues)
- accessing the PMR
- receviing prescriptions directly from EPS system (England only) patients or collecting from surgery
- Processing of prescription forms that have been dispensed (e.g. counting number of items dispensed, sorting prior submission for reimbursement)
- Delivery person conveying medicines to patient
- Receiving patient returned medicines (excluding CDs)
