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)
