Week 10: POMs Flashcards
What is a POM? (1)
A medicinal product that can only be sold/supplied in accordance with a prescription signed by an appropriate practitioner.
What does PSD mean? (1)
Patient specific direction e.g. Rx
Give e.g. of circumstances where POMs can be legally be supplied without a Rx. (3)
PGD
Emergency supplies
Patient specific direction in hospitals.
Give e.g. of products that are always POMs. (5)
Parenteral products
CDs unless the MA of product lists it as a P/GSL.
Cyanogenic substances unless for external use.
Medicinal substances that on administration emit radiation.
New chemical entities.
Give e.g. of products that can also be pharmacy medicines. (3)
Hydrocortisone 1% cream 15g
Naproxen 250mg - primary dysmenorrhoea
Codeine, dihydrocodeine and morphine (at low strengths)
What are the legal requirement for POM prescriptions? (10)
Must be issued by an appropriate practitioner
Be signed in ink by appropriate practitioner giving it.
Written in ink or indelible.
Address of appropriate practitioner.
The appropriate date
An indication of kind of appropriate practitioner.
Name and address of px.
If person < 12 yrs, px age.
Valid for 6 months from appropriate date.
Practitioner must be registered in the UK or be an approved health professional in approved country.
When should a repeatable prescription be dispensed? (1)
Should be dispensed for the first time within 6 months of the appropriate date and in acc. with directions contained on the Rx.
What does a repeatable Rx not always specify? (2)
The no. of repeats i.e. repeated only once.
Unless it’s a Rx for oral contraceptive which can be dispensed a total of 6 times (5 repeats) or not dispensed after end of the period of 6 months from the appropriate date.
What are ‘owings’? (2)
Px are given owing slips when the full quantity of medicines can’t be supplied at the time the px comes into the pharmacy. Supplied within the legal valid period of the Rx.
State the main features of a private Rx. (8)
Follows POM legal requirements.
Can be written on anything.
Can be written by any ‘appropriate practitioner’
Date on Rx is date when it was signed.
Rx must be satisfied it’s genuine.
No restrictions on what can be Rx (competence)
All rx written by approved health professional in approved country
Can be repeated.
State the main features of a repeatable Rx. (7)
Rx that can be repeated more than once.
No repeats allowed on FP10 unless part of NHS repeat dispensing scheme.
Repeat / repeat x?
No legal limit on no. of times a prescriber may request to be repeated.
No expiry of repeat Rx after it has been dispensed for the first time but prof. judgement should be used, considering clinical issues.
Px can retain Rx between repeats - pharmacy who dispenses the Rx for the final time must retain the Rx.
Repeatable Rx should be marked with name and address of the pharmacy and dispensing date to maintain an audit trail.
State the main features of prescribing by dentists. (6)
FP10(D) Rx (yellow) written by a dentist is valid only if the medicinal products are in the Dental Practitioner Formulary (DPF)
It’s against a dentists’ Terms of Service not to follow this.
It’s against a pharmacists’ Terms of Service to dispense such Rx.
DPT only has generic names but dentists can Rx a brand version of the generic product in the DPF.
A private Rx written by a dentist can legally be for any POM, P or GSL medicines (competence)
Dentists are required by the GDC to restrict their prescribing to areas in which they’re competent. Hence, dentists should only Rx medicines which have uses in dentistry.
State the main features of prescribing by community practitioner nurse prescribers. (5)
These include community nurses (District nurses + Health Visitors) who have under extra training.
Community nurse practitioners may prescribe a limited range medicines on a NHS Rx FP10P (lilac)
Medicines are listed in Nurse Prescriber’s Formulary (NPF) for community practitioners.
Similar Terms of Service issue to dental Rx.
Prescribers are recommended to Rx generically, except where it’s not clinically appropriate or no approved generic name.
What particulars is subject to ‘due diligence’? (5)
Address of appropriate practitioner.
Appropriate date.
Indication of kind of appropriate practitioner giving it.
Name and address of px.
If person is <12 yrs, person’s age.
What is the legal definition of due diligence? (1)
The sale/supply isn’t rendered unlawful if the person making the sale or supply, having exercised all due diligence, believes on reasonable grounds that the conditions has been met/Rx is genuine.
What is the working definition of due diligence? (1)
If any of the above particulars is missing (not incorrect) on a Rx, it’s not illegal to dispense as long as you have exercised due diligence.
State the main features of original pack dispensing (OPD). (6)
Starts on the 1st Jan 2025, allows pharmacists to supply a drug in its original pack even if the quantity dispensed is a different quantity to the Rx.
Quantity of drug dispensed must be within 10% (above or below) of the quantity on the Rx.
Only applicable to EPS NHS Rx + private Rx.
Not applicable to supplies under a SSP + non-Rx supplies, CDs Sch. 2-4 + specials.
Non-mandatory.
Pharmacist must believe that giving a different quantity to what’s Rx is reasonable and appropriate and will not cause px to fail to follow ‘the medication regimen as intended by Rx.’
What is the main benefit of the Original Pack Dispensing Law? (2)
May end blister cutting + repackaging of meds - saves time for pharmacy team.
What do you need to consider when dispensing valproate-containing medicines?
Only full packs of valproate-containing medicines can be supplied to px. (Closest to quantity of Rx)
Can’t be split or repackaged!
Applicable to all Rx (NHS + Private) for male/females.
What is the main benefit of dispensing valproate-containing medicines? (2)
Ensures px can see the warnings on the box.
Already contains a PIL/px card.
What would be the main exemption of not dispensing valproate-containing medicines in its original box? (1)
When supplied under MDS - risk assessment required and px to be given a PIL.
What do you need to consider when labelling a valproate-containing product? (1)
Ensure the label doesn’t cover the px safety warnings printed by the manufacturer on the pack.
Explain the main features of an electronic Rx. (3)
All POM legal requirements apply.
Must be signed with an advanced electronic signature and sent electronically to the person dispensing it.
All drugs (incl. CDs Sch. 2/3) can legally be sent as electronic Rx.
What does advanced electronic signature mean? (4)
Uniquely linked to person giving the Rx.
Capable of identifying signatory.
Signatory can maintain under their control.
Linked to the date to which it relates to in a way that any data changes is detectable.
What are the legal requirements for non-UK Rx?
Patient’s full first name(s), surname + DOB.
Prescriber’s full first name (s), surname, prof. qualifications, direct contact details, incl. email address + telephone no. / fax no. (w/h international prefix), work address (incl. country they work in)
Name of medicine(s) (brand name where app.), form, quantity, strength + dose.
Prescriber’s signature
Date of issue (signed date)
What type of medicinal products is not eligible as a non-UK Rx? (2)
CD Sch. 1-3
Products w/out a UK MA.
What precautions do you need to consider for non-UK Rx? (6)
Rx is likely to be written in a foreign language.
Check registration status of prescriber and there’s no international database of prescribers.
Check if Rx is clinically safe.
Exercise due diligence for these Rx if unable to confirm registration status.
It’s not obligatory to dispense Rx if there’s any doubts/concerns - clinical/legal appropriateness.
If unable to dispense, need to help px obtain medicine.
What are the potential risks associated with faxed Rx? (7)
Uncertain that supply has been made in acc. with a legally valid Rx.
Risks of poor reproduction
Risks of non-receipt of original Rx = inability to demonstrate that a supply has been made in acc. to a rx.
Risks that the original Rx is amended by prescriber where the supply would not have been made in acc. with the Rx.
Risks the fax/original copy is sent to/received by multiple pharmacist and duplicate supplies are made.
Risks of Rx isn’t genuine.
Risks of the system of sending/receiving of fax/digital copy of Rx isn’t secure or from a reputable source.
Explain the benefit and risk with photos, scans or emails of Rx. (3)
+ Useful for px in confirming what has been Rx.
+ Can be shown to any HCP involved in their care.
- Not legally valid Rx for same reason as faxes i.e. they’re copies of the original Rx.
What precaution is considered when you think the Rx is forged? (1)
Exercise the due diligence clause - ‘provided that the pharmacist has exercised all due diligence and believes on reasonable grounds that the Rx is genuine.’
What factors indicate that the Rx is forged? (6)
Is a large/excessive quantity prescribed and is this appropriate for the medicine and condition being treated?
Is the prescriber known?
Is the px known?
Has the title ‘Dr’ been inserted before the signature?
Is the px’s behaviour indicative? (e.g. nervous, agitated, aggressive etc.)
Is the medicine known to be commonly misused?
If the Rx is forged, what actions is taken place? (3)
Check signature carefully (check against the genuine Rx from the same prescriber.)
Confirm details with prescriber. (E.g. whether a Rx has been issued, the original prescriber’s intention and whether there’s been any alterations).
Use contact details of prescriber that are obtained from a source other than the suspicious Rx (e.g. directory enquiries)
What are exemptions of making a POM record? (3)
Health Rx/Oral contraception Rx
Separate record made in CD register
Wholesale dealing + order or invoice (or copy of it) retained for 2 yrs.
Where can Rx records be kept? (2)
Bound book
Electronically (backups/ facility for inspections to examine them without interruption to pharmacy)
When would it be appropriate for hospital pharmacies to make Rx records? (1)
When registered under the GPhC.
When should entries be made for prescriptions? (1)
Made on the same day or if not possible, the next following day.
How long should Rx records be kept for? (1)
2 yrs (POM reg. must be kept for 2 yrs from the date of last entry)
How long should the Rx be kept for? (1)
2 yrs from date of last supply/sale.
What details should be recorded as part of the Rx? (7)
Supply date
Drug Name, quantity, form, strength.
Rx Date
Practitioner name + address
Px name + address.
Ref. no. (marked on Rx, typed onto dispensing label)
For second + subsequent supplies on a repeat, record supply date + original ref. no. of first supply.
What is the fate of a NHS Rx? (1)
Send to the NHSBSA at the end of the month.
What is the fate of a private Rx (non-repeatable)?
Keep at the pharmacy for 2 yrs.
What is the fate of a private Rx (repeatable)? (2)
If there’s any outstanding repeats, hand Rx back to patient or offer to retain at the pharmacy.
If final repeat has been dispensed, keep a copy of the Rx for 2 yrs and send the original to the NHSBSA.
Describe the Hubs + Spokes model. (2)
Dispensing a Rx via the hub pharmacy sent by the spoke pharmacy.
Must still be registered under the GPhC.
What are the advantages of dispensing from a hub? (4)
Efficient
Lower operating costs
Frees up pharmacist time = can do other clinical activities.
Use of automation = reduced errors, safer dispensing and cheaper.
What are the disadvantages of hub dispensing? (5)
Accountability/liability
Operational failure
Affect px/pharmacy relationship
Unsuitable if px needs medicines quickly/urgently
Confidentiality/security of info.
What are internet (online) pharmacies? (1)
A.K.A. distance-selling pharmacies.
What are the disadvantages of internet (online) pharmacies? (6)
More likely to fail GPhC regulatory standards e.g. operation models lacking real time/F2F consultation, commercial> clinical, weak checking, Hx/px symptoms taken at face value without verification/identity checks.
Concerns about medicines that are subject to abuse, misuse + overuse e.g. CDs, Z drugs, weight loss medicines
Prescribing high-risk drugs
Medicines requiring monitoring
Prescribing medicines outside the prescriber’s scope of practice
High vol. of Rx issued within a short time.
Risks of illegal websites posing as online pharmacies (counterfeit issues)
How would you verify that the internet (online) pharmacy is legitimate and not counterfeit? (3)
GPhC has a voluntary internet pharmacy logo - only used by pharmacies. (Registered pharmacy logo)
MHRA considers a logo that can be used by any retailer as long as they’re registered under them.
Px are encouraged to check when they buy medicines online - refer to GPhC guide.
Describe what the SSP is and what it process entails. (6)
Serious Shortage Protocols:
- Allows pharmacist to supply something different to what’s specified on the Rx.
Includes:
- Dispensing a smaller quantity
- Dispensing an alt. form/strength (of the same drug)
- Dispensing a generic equivalent for a branded Rx.
- Dispensing an alt. drug with similar drug effect.
What factors do you need to consider when undergoing the SSP? (11)
Px’s GP needs to be informed of a switch of medicine but not if a diff. form/quantity has been dispensed.
Supply is the pharmacist’s prof. responsibility.
Pharmacist must use their prof. judgement to determine whether it’s appropriate to use a SSP for a drug supply or not based on the individual circumstances of the px.
SSP’s can only be used if the Rx presented is legally valid.
Px/carer must consent to receive the medicine supplied under the SSP - if not, they need GP referral.
The pharmacist needs to ensure that the px understands the difference between Rx drug and alt.
Px who usually pay a Rx charge but receives a smaller quantity of the medicine are exempt from Rx charge payment.
Once a supply is made under a SSP (even if a lower quantity of medicine is supplied), the original Rx is not valid anymore and no further supply can be dispensed.
SSP’s can be specify other checks/actions to be undertaken before the switch.
Each SSP is time limited (expiry date/review date) which can extend if medicine is still in short supply.
Pharmacy contractors are notified of any new SSPs via email to their NHS email address.
What particulars should be included in the dispensing label when Rx under the SSP? (3)
Indicator the the supply was made under the SSP.
Ref. no. of SSP
(Ensures a permanent record in px’s PMR.)
Give e.g. of drugs that have been issued under the SSP. (3)
Fluoxetine
Haloperidol
HRT
(All of which are at certain strengths/presentations of short supply)
Give e.g. of drugs that are not eligible for SSP. (2)
Brand-specific product is required.
Certain drugs used for epilepsy.
Describe what a PCU is. (1)
Prescription collection units which are automated Rx collection machines + lockers.
What do you need to consider for using PCU’s? (5)
Px should consent (opt in) to use this method for medicine collection.
Collection of medicine is allowed at anytime even when the pharmacy itself is closed + no pharmacist is on the premises.
Px should only be able to access the PCU using a password or secure code (sent in text/email)
There should be a clear audit trail available of when medicines are stored in the machine and when they’re collected by px.
Storage space of these machines are limited = small no. of px can use this depending on their circumstances.
Give e.g. of medicines that are unsuitable in the PCU. (3)
Fridge items
CDs requiring safe custody.
Bulky items
What should not be done when administering a POM?
Not to be administered to anymore but yourself unless you are an appropriate practitioner or acting in acc. to the directions of an appropriate practitioner.
Give e.g. of products that are suitable to be administered by an appropriate practitioner.
Injectable products that are administered for purpose of saving life in an emergency:
- Adrenaline
- Glucagon
- Smallpox
Give e.g. of HCP’s that can administer specific POMs. (3)
Midwives
Paramedics
HCP’s that can administer medicines are part of the PGD.
What does an emergency supply mean? (1)
An urgent supply of a POM without a valid Rx present at the time of dispensing.
What are the 2 main types of emergency supply?
Emergency supply at the request of the px.
Emergency supply at the request of the prescriber.
What are the conditions for an emergency supply at the request of a px? (4)
Pharmacist needs to interview the px and is satisfied:
- That there’s an ‘immediate need’ for POM and it’s impractical to obtain the Rx without ‘undue delay.’
- That the POM has been dispensed by an appropriate prescriber on a prev. occasion.
- Dose appropriate to take.
What factors do you need to consider when carrying out an emergency supply at the request of a px? (7)
No provision of CD schedule 2/3 unless it’s phenobarbital (Na) for epilepsy.
Max. 5 days supply for CDs
Max. 30 days supply for other POMs except:
- Inhaler (asthma relief)
- Ointment / Creams
(smallest pack available for supply.)
- Oral contraceptive (supply full tx cycle)
- A liquid antibiotic for oral administration = smallest quantity that supplies a full course should be given.
What records should be made for emergency supply at the request of the px? (5)
Pharmacist has to make a POM register entry either on the day of supply or if not possible, the next following day:
- Supply date
- Medicine name, quantity, form + strength (dose = good practice)
- Px’s name + address
- Nature of emergency (why px needs POM, reason on why a Rx can’t be obtained)
What particulars should be included on the packaging of the POM when supplied as an emergency supply to a px?
- Supply date
- Medicine name, quantity, strength, form. (Dose = good practice)
- Px name
- Pharmacy name + address
- ‘Emergency supply’ statement
- ‘Keep out of reach and sight of children’
Can you emergency supply a CD at the request of a px? (2)
CD Sch. 1-3 not allowed except phenobarbital for epilepsy tx.
If a request is made by a px from an approved country, an emergency supply isn’t allowed if medications is ANY CDs Sch 1-3.
What are your professional obligations when dispensing a POM via emergency supply? (1)
Each emergency supply should be considered individually using professional judgement to decide which course of action will be for the best interest of px - whether to supply or not.
What conditions apply to an emergency supply at the request of a prescriber? (3)
Pharmacist who is supplying the POM is satisfied that the supply has been requested by an appropriate practitioner who by reason by some emergency is unable to give a Rx immediately.
Appropriate prescriber has undertaken to provide the person lawfully conducting the retail pharmacy business with a Rx within 72 hrs.
POM sold/supplied in acc. with the directions of appropriate practitioner.
Can you emergency supply a CD at the request of a prescriber? (3)
Not allowed for CD Schedule 1-3 except for phenobarbital / phenobarbital sodium for epilepsy tx.
Good practice requirements relating to max. recommended duration of Rx still applies. (30 days = FP10PCD)
If the prescriber is an approved country HCP, any medicine supplied to the px MUST have a UK MA.
What records should be made when carrying out an emergency supply at the request of a prescriber? (6)
An entry made in the POM register on the day of supply or if not possible, the next following day:
- Supply date
- Medicine name, quantity, form, strength. (Dose = good practice)
- Practitioner’s name and address
- Patient’s name and address
- Rx date + Rx date received
Explain the conditions associated with making an emergency supplies in a pandemic. (3)
Pandemic should officially be announced by DofH.
Conditions for making an emergency supply at the request of a px is more relaxed that the pharmacist will not need to interview the person who requests the medicine.
All legal requirements still apply.
What does ‘pharmacy first’ entail? (6)
Urgent Medicine Supply
‘Advanced service’
Same legal framework used for an emergency supply.
Px who presents in the pharmacy have been referred via NHS 111 for an urgent supply (pharmacist can refer px to NHS 111 if they just present in the pharmacy)
If px is exempt for their NHS Rx you will need to treat it as an NHS supply because they won’t pay for the medicine.
Extra NHS paper work needs to be completed for an NHS supply (in add. to POM register entry)
What is a PGD? (3)
Patient Group Direction
A written instruction for supply of named medicines in an identified clinical situation.
It applies to groups of px who may not be individually identified before presenting for tx.
Who can supply under a PGD? (1)
By an appropriate prescriber e.g. nurses, pharmacists, pharmacy technicians etc.
What details should a PGD contain? (13)
Organisation name
PGD date + expiry date
Medicine details
Class of prof who may supply/administer.
Doctor/dentist and pharmacist signature
App. health organisation signature.
Clinical condition to which PGD applies.
Excluded Px details
When further advice/referral should be given.
Dose, route, frequency + tx duration.
Warnings, incl. potential s/e
Follow-up action details.
Record details to be kept.
What medicines can be included on a PGD? (8)
All POMs, Ps GSLs
Only certain CDs:
- Sch. 2: Diamorphine, morphine + ketamine (only by certain people for immediate + necessary tx of sick/injured persons)
- Sch 3: Midazolam
- Any S4 pt. 1
- Any Sch 5
May include unlicensed (‘off-label’) use if justified by current best clinical practice + if the PGD clearly records medicine status.
Can’t include unlicensed medicines.
What health conditions is eligible for PGDs? (7)
Best for single tx episodes:
- Nitrofurantoin for UTI
- EHC
- Topical antimicrobials for impetigo, conjunctivitis
- Acute Analgesia
- Immunisation programme
- Antiviral medicines for influenza/COVID
What health conditions is unsuitable for a PGD? (9)
Unsuitable for long-term conditions:
- Diabetes
- Hypertension
- Epilepsy
- Angina
- Heart Failure
OR
Medicines that need complex/frequent monitoring:
- Warfarin
- Insulin
Explain the process of how hospitals prescribe POMs for inpatients. (5)
A PSD is found on an inpx chart.
Most entries on inpx charts are directions to administer but can be taken as authority to supply, which can be changed to an order form to be used in the pharmacy for take home medication for discharge.
PSDs don’t need to comply with Rx requirements for this to occur.
Good practice for this to be made by a pharmacist /checked by a pharmacist.
Pharmacist isn’t prescriber as original written direction was done by a prescriber.
What is the difference between independent + supplementary prescribers? (2)
Independent prescribers (IP):
- Responsible for initial clinical assessment and preparation of a clinical management plan (CMP) of a px.
Supplementary prescriber (SP):
- Can take responsibility for px management who has been assessed by the IP.
What criteria applies for supplementary prescribing to occur? (6)
Supplementary prescriber must be a nurse, midwife, pharmacist, chiropodist, dietician, physiotherapist, podiatrist, optometrist or radiographer who has undertaken an extra period of training and working with an IP.
IP has to be a doctor/dentist - IP can’t be nurse/pharmacist.
Voluntary partnership with prescribers with px agreement to have their care in this manner.
CMP must be patient-specific and condition and sets out what responsibility is delegated, agreed and signed by both prescribers.
Communication + record access = required.
What is the framework for SP? (4)
No legal restriction on medicine range / condition.
Any medicine can be Rx (incl. CDs, unlicensed, off-label use) as long as the medicine is included in the CMP.
No restriction on the location of supplementary prescribing.
Hence, offers greater flexibility provided fundamental principles are followed.
What is a clinical management plan (CMP)? (6)
Written plan relating to tx of a px.
Agreed by px, doctor/dentist (IP) and SP.
CMP may refer to national/local guidelines or give a reference to BNF drug monographs.
Need not repeat advice from guidelines in CMP.
Need not repeat advice from BNF in CMP.
Kept as simple as possible.
What particulars should be included in the CMP? (8)
Px name
Illness/conditions treated
Start date + review date by IP
Reference to medicine class to be prescribed.
Any restrictions/limitation of prescribing.
Px sensitivities
How any adverse drug effects should be reported
Any circumstances when SP should refer to IP or seek advice of IP.
What are the criteria for IP? (5)
Nurse and pharmacists can be empowered to prescribe any drug for any condition provided they are:
- Fully trained + accredited
- Prescribe within their area of competence
- Have access to px records and to diagnose when prescribing for an existing long-term condition or to info. on which to base an accurate diagnosis.
- Take responsibility for their actions.
What does prescribing with competence mean? (5)
Must be aware of limits of skills, knowledge, competence and work within these.
Seek advice and make referrals where appropriate.
Accountable for own actions
Professional/managerial sanctions
Civil + criminal law applies.
What are the 3 types of nurse prescribers?
Community practitioner nurse prescribers.
Nurse supplementary prescribers
Nurse Independent prescribers.
- Can Rx any medicine as long as within their level of competence.
- No CDs restrictions
- Allowed to mix medicines prior to adniministration or direct others to do so.
What can pharmacist IPs prescribe? (2)
Can Rx any medicine (licensed, unlicensed, off-label) as long as within their level of competence.
No CD restrictions.
What can Optometrist IPs prescribe? (2)
Can only Rx licensed medicines (off-label use allowed) for ocular conditions affecting eye/eye tissues.
Not allowed to Rx CDs/Parenteral products.
What can physiotherapist IP’s prescribe? (3)
Can Rx any licensed medicines for any condition within their area of expertise and competent relating to human movement + function.
CDs - only diazepam, dihydrocodeine, lorazepam, oxycodone and temazepam for oral administration. Morphine for oral administration/inejction. Fentanyl for transdermal administration.
Can Rx off-label, if accepted clinical good practice.
What can podiatrist IP Rx? (3)
Limited to foot, ankle, linked structures disorders.
CDs - Diazepam, Dihydrocodine, Lorazepam + Temazepam for oral administration.
Can Rx off-label if accepted.
What can therapeutic radiatiographer and paramedic IPs Rx? (3)
Can Rx any medicines for any medical condition within their competence.
Can Rx off-label if accepted clinical good practice.
Can Rx certain CDs
How do you check the prescribing status of a non-medical prescribers? (4)
The prof. register will be annotated to show what prescribing rights (if any) the HCP has.
Pharmacists should verify the prescriber’s status before dispensing a Rx.
It’s not a responsibility (+impossible) to check an IP is competent to prescribe the medicine on the Rx but the pharmacist will need to do a clinical check.
It’s not the responsibility of the dispensing pharmacist to check a medicine Rx by a SP is included in a CMP.
Explain the implications for self-prescribing and prescribing for family or friends. (7)
Not illegal but considered as poor professional practice.
GPhC advises that pharmacists mustn’t prescribe for themselves or for anymore with whom they have a close personal relationship. This is important in the case of CDs and drugs that are liable to misuse.
Prescriber’s judgement may be impaired or influenced by family member/friend they are prescribing for.
Dispensing pharmacists need to be aware of this and be vigilant - esp. misuse/CD drugs. Contact CDs accountable officer.
In an emergency, after prof. judgement, a pharmacist may decide that it’s appropriate to dispense a medicine that has been self-Rx or prescribed for family of friends of prescribers.
When refusing supply, pharmacists need to be aware that person requesting supply is likely to be disappointed. Explain to person concerned why supply has been refused.
Where there’s a risk of px harm or public, raise concerns to appropriate prof. body.
Explain the implications for prescribing and dispensing by the same person. (4)
It’s good professional practice that the same person shouldn’t prescribe and dispense a medicine to a px.
RPS states that this allows more flexibility so the same person can Rx and dispense/supply if clinical circumstances make it necessary and it’s in the best interest of the patient.
A risk assessment should be carried out to ensure that the service is appropriate and risks are identified + mitigated.
Px should always have a choice where their Rx is dispensed.
Explain the implications of self-checking the dispensing of prescriptions. (4)
Self-checking = same person dispenses the Rx and performs accuracy checks.
It’s good professional practice for 2 people to be involved in the dispensing process to reduce risk of errors + maximise px safety.
The person performing accuracy check shouldn’t be involved in the assembly process to reduce the potential risk to px of a dispensing error.
It’s recommended that you take short mental break between dispensing and accuracy checking.
What particulars should be included in the container when dispensing medicinal products? (11)
Px name
Pharmacy name + address
Dispensing date
Product name
Direction for product use
Precautions relating to product use.
‘Keep out of sight and reach of children.’
‘Use this medicine only on your skin’ where applicable
It’s good practice to include:
- BNF cautionary and advisory warning labels.
- Other non-BNF labels e.g shake bottle, store in fridge
- Not to place label on outer container since this can be discarded by px (e.g. creams, ointments)
What does HMR 2012 state about labelling? (6)
A pharmacist can exercise professional skill and judgement to use more appropriate wording on the label if info. on the Rx is inappropriate.
Applicable:
- Direction for use
- Name of medicine
- Precautions relating to its use.
It’s good practice to make a record of your intervention.
Doesn’t allow generic substitution of a branded medicine with a generic medicine.
When would it be appropriate for pharmacist to break down medicines from bulk containers? (1)
Dispensing against Rx not received.
What particulars needs to be included when labelling medicines broken down from bulk containers? (9)
Product name
Appropriate quantitative particulars (ingredients)
Quantity in container
Special handling/storage requirements (if any)
Expiry date
Batch ref. preceded by BN or Lot No.
When pack is dispensed the label for the packing is removed and replaced with a dispensing label.
No license needed.
What is required before assembly + pre-packing medicines is carried out? (1)
MHRA license
What is wholesaling? (5)
Selling of a medicinal product if it’s sold to a person who sells/supplies it to someone else or administers it to someone else in the course of their business.
They don’t take or use the product themselves.
It’s a sale so money must change hands.
Anyone trading medicines other than px must have a wholesaler license from MHRA.
Pharmacies supplying stock to another pharmacy within the same legal entity aren’t required to have a Wholesaler License.
What guidance does the MHRA give about wholesaling from a pharmacy? (5)
There’s no need for supplying pharmacy to hold a wholesaler licence providing that the supply of medicine is to another pharmacy or HCP for tx or onward supply to a px and it:
- Takes place on an occassional basis AND
- Small quantity supplied AND
- Not-for-profit basis supply AND
- Supply not for onward wholesale distribution
Which professional may a retail pharmacy wholesale medicines to? (4)
POM medicine sales may only be made if purchaser is authorised to sell or supply goods or to administer them to human beings in the course of their business or prof. practice.
E.g. practitioners, another retail pharmacy, hospital/clinic, ophthalmic opticians or any other person or other person exempted from POM order but only for exempted products
Also, NHS trusts, ship owner/master, armed forces etc.
Exercise cautions when selling any POM without a Rx.
What other points do you need to consider when carrying out wholesaling? (4)
Medicine request can be written via a requisition (signed order)
No legal requirements for details that must appear on a requisition unless it’s a CD. + for pharmacy to label stock but it’s good practice to do so.
It’s ideal to supply in whole packs.
Hospital pharmacies that aren’t registered pharmacies may not wholesale without a wholesaler’s licence.
What records should be made when making a wholesale deal? (7)
If the pharmacy hasn’t got a wholesaler’s licence then there’s no legal obligation to make a record in the POM register so long as the signed order is kept for 2 yrs from the supply date.
It’s good practice to make a record in the POM register (keep invoice for 2 yrs),
If there’s no signed order then legally a POM register entry must be made.
Details to be recorded in POM register:
- Supply date
- Name, quantity, form, strength of medicine. (Dose = good practice)
- Purchaser’s name, address, trade, business or profession.
- Purpose for which the POM is sold/supplied.
What are the implications of optometrist signed orders for px? (11)
Optometrists cannot write prescriptions for POMs unless they are an IP or a SP
* BUT pharmacists working in a registered pharmacy can supply certain POMs
directly to patients if they receive a signed order from an optometrist
* This signed order is NOT legally considered a Rx so there are no legal requirements
* This list of medicines that they can prescribe is available on the MHRA website
* The list has two sections – drugs for administration and drugs for supply
* Only a drug listed in the ‘drugs for supply’ list can be supplied to a patient of the
optometrist
* Some optometrists who have undertaken additional training can be ‘additional
supply optometrists’ and can issue signed orders for a wider range of medicines
(see MHRA list)
* Check register of opticians if they are qualified to do this
* The medicine should be labelled as a dispensed medicinal product and a PIL
should be supplied.
* A record needs to be made in the POM register
* If in doubt, ask for help as this is an unusual supply of a POM
What are the implications of podiatrist signed orders for px? (9)
Podiatrists (also known as chiropodists) cannot write prescriptions for POMs unless they are an IP or a SP
* BUT pharmacists working in a registered pharmacy can supply certain POMs directly to patients if they receive a signed order from a podiatrist AND the podiatrist has an annotation on their professional register to allow this
* Check Health and Care Professions Council website – (POM-S) means qualified to sell, supply or administer selected POMs , all P and GSL medicines. (POM-A) means qualified to administer selected POMs
* This signed order is NOT legally considered a Rx so there are no legal requirements
* This list of medicines that they can prescribe is available on the MHRA website.
The list has two sections – drugs for administration and drugs for supply
* Only a drug listed in the ‘drugs for supply’ list can be supplied to a patient of the
podiatrist
* The medicine should be labelled as a dispensed medicinal product and a PIL
should be supplied.
* A record needs to be made in the POM register
* If in doubt, ask for help as this is an unusual supply of a POM
What are the implications for supplying medicines to schools? (8)
Schools can obtain supplies of adrenaline auto-injectors (AAIs) and salbutamol inhalers from a pharmacy on a signed order
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.
There is no information in the legislation regarding a maximum number that can be obtained.
Keep the signed order for 2 years and it is good practice to make a record in the POM register
- The pharmacist should ensure the school knows how to store and use the medicine correctly, as well as drawing their attention to the expiry date. Record-keeping and regular date checking should be advised.
Salbutamol:
* Note that the school may also need to purchase a spacer (appropriate to the age of the pupils) to use with the inhaler and they may ask for advice on how to use the inhaler
* The DHSC has provided guidance for schools regarding this and storage, care and disposal of inhalers
Adrenaline AAIs:
* The DHSC has produced guidance to schools on the use of adrenaline auto-injectors including the recognition and management of an allergic reaction/anaphylaxis
What particulars should be included when making medicines supply to schools?
The signed order (on letter headed paper isn’t a legal requirement) must include:
name of the school
* name of the medicine and strength (if relevant)
* purpose for which the product is required
* total quantity required
* signed by the principal or head teacher
What is a dispensing error?
An error made during the dispensing process from receipt of the Rx
through to the supply of the dispensed medicine, where the error means the patient receives a medicine which differs in some way from that intended by the prescriber.
Give examples of a dispensing error. (5)
incorrect labelling of the medicine
- a medicine intended for another patient being dispensed to the
wrong patient - the wrong medicine (drug ingredient) being dispensed
- the medicine being dispensed at the wrong strength or in the
wrong dosage form - the supply of an out-of-date medicine
What does the Medicines Act 1968 state about dispensing errors? (1)
‘No person shall, to the prejudice of the purchaser, sell any medicinal product which is not of the nature or quality demanded by the purchaser’
Why should erros be decriminalised? (5)
This law means that if a dispensing error is made the pharmacist has committed a criminal offence
- For many years this has been recognised as being a hindrance to pharmacists reporting errors and learning from errors to improve patient safety
- This law was drafted at a time when extemp dispensing was common and it was intended to guarantee the quality of the ingredients
- The RPS argued that errors should be a matter handled by the professional regulatory body and not by the legal system
- BUT need to ensure that any errors are not deliberate
What does the pharmacy order 2018 consist of? (5)
Came into force on 16 April 2018
- Applies to community pharmacies, hospital
pharmacies and prison pharmacies - The legislation does not decriminalise dispensing errors.
- Section 64 has been retained.
It provides a statutory (legal) defence which could
be used if a dispensing error is made
Explain the implications of legal defence. (7)
Making a dispensing error is not a criminal offence if
* Medicinesarepreparedbyaregistrant(pharmacistorPT)
or acting under their supervision AND
* Medicines were supplied from a registered pharmacy
premises AND
* Registrant was acting in the course of their profession AND
* Medicines were supplied in pursuance of a Rx or from the direction of a prescriber AND
* If you are aware of the error there was a prompt notification of the error
* If all above apply, this is the legal defence to section 64
HOWEVER:
If the intention was to cause harm (i.e., the error was deliberate)
* Or if criminal negligence was suspected
* Then criminal sanctions would still apply
AND
Accountability is important
* ‘Fitness to Practise’ – the GPhC have stated that it is
unlikely that a single dispensing error would result in referral to the FtP committee unless aggravating factors were present
