MEP 3.3 Professional and legal issues: prescription‑only medicines Flashcards
what is required for rx
Patients:
- age if under 12
- name
- address
prescribers:
- signature
- name
- address
- particulars
date of rx
what are repeatable rx
private prescriptions that can be dispensed more than once.
how many times are repeatable rx repeated
The number stated by the prescriber.
If no number is stated, they can only be repeated once (dispensed twice) , unless the rx is for an oral contraceptive which can be repeated 5 times (dispensed 6 times)
which control drug schedule can be repeated
CD 4 & 5, not cd 2 & 3
what is the time limit for POM or CD 5 repeat
there is not, but the first dispensing must be made within 6 months of the appropriate date
what is the time limit for CD 4 repeat
If the prescription is for a Schedule 4 CD, the first
dispensing must be made within 28 days of the
appropriate date, following which there is no
time limit for remaining repeats
What is the record keeping for a Private prescription POM
Private prescriptions for a POM must be retained for 2 years from the date of the sale or supply or for
repeatable prescriptions from the date of the last
sale or supply
where are private POM recorded?
POM register
What are the requirements for a record keeping
> supply date
prescription date
medicine details: name, quantity, formulation, strength
prescriber name and address
patient name and address
when should a record take place
> on the day of sale
Where are CD 2 and 3 Recorded
> A CD register
what do dental rx look like
> FP10D
YELO
what can dentists prescribe
the medicines listed in the
Dental Prescribers’ Formulary
what are the legal requirements for the dispensing of EEA rx
- Patient’s details: full first names and surname, date of birth
- prescribers details: full first names, surnames, professional qualifications, direct contact details including email address, telephone number or fax number, work address
- prescribed medicine details: name of medicine, pharmaceutical form, quantity, strength , dosage
- prescriber signature
- date of issue - rx valid up to 6 months, scheduke 4 CD 28 days
Are faxed rx valid?
NO, because it is not written in indelible ink and has not been signed in ink by an appropriate practitioner
what are the risks of faxed rx
- uncertainty that the supply has been made in accordance with legally valid prescription
- risks of poor reproduction
- risks of non receipt of the original rx and therefore inability to demonstrate that a supply has been made in accordance
- risk that the original rx is subsequently amended by prescriber
- risks that the fax is sent to multiple pharmacies and mutilple supplies made
- risk that the rx is not genuine
- risk of insecure faxing system
what are the check list for forged prescriptions
- Is a large or excessive quantity prescribed and is this appropriate for the medicine and condition being treated?
- Is the prescriber known?
- Is the patient known?
- Has the title ‘Dr’ been inserted before the signature?
- Is the behaviour of the patient indicative? e.g. nervous, agitated, aggressive, etc.)
- Is the medicine known to be commonly
misused?
who do you report concerns about a rx to
Use judgement to determine the severity of the matter :
- discussions with patient and prescriber
- NHS counter fraud services for nhs rx only
- police
which countries abroad can prescriptions be approved in the uk
- EEA (European Economic Area) 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, Switzerland.
which EEA prescriptions can you supply
- POM
- CD 4
what are the legal requirements for the dispensing of EEA rx
- Patient’s details: full first names and surname, date of birth
- prescribers details: full first names, surnames, professional qualifications, direct contact details including email address, telephone number or fax number, work address
- prescribed medicine details: name of medicine, pharmaceutical form, quantity, strength , dosage
- prescriber signature
- date of issue - rx valid up to 6 months, scheduke 4 CD 28 days
which professions from abroad are approved ?
doctors and dentists as well as other professions with prescribing rights i.e. chiropodists or podiatrists, nurses (including community nurses), optometrists,
paramedics, pharmacists, physiotherapists and
therapeutic radiographers.
EEA emergency supply
- emergency supplies at the request of patient of hcp is legally possible
- 1, 2, 3 CD or unlicensed products cannot be supplied in an emergency to a patient of an approved hcp
what happens if the rx is not from an approved country
prescription is not valid and you should use your
professional judgement (e.g. refer to local GP), in
finding the best way to help the patient.
what happens if the rx is written in a foreign language
legally acceptable.
However, you will need to have
enough information to enable the safe supply of
medicines considering patient care and wellbeing.
what can you use to check the registration status of approved health care professions of international prescribers
- there is no international database and not all of the approved countries have a register of practitioners or online registers in english
- however you can use the general medical council or general dental cvouncil
what happens if youre not able to obtain registration status of the international medical professional
- you can make safe and legal supply in the interest of patient care
- beneficial to keep record of interventions and ste[s taken
which medicines can you not supply for EEA
Schedule 1, 2 and 3 CDs and medicinal products without a marketing authorisation valid in the UK are not permitted. Consider referral to an appropriate UK-registered prescriber if such items
are required.
what is military rx
- FMed 296
who deals with Military rx
- military primary healthcare medical centres
- designated pharmacies under the ministry of defence (MO) contract
- community pharmacies not covered by the contract will boot routinely handle military prescriptions
what happens when military rx is presented to a non contracted pharmacy
- the rx should be treated as a private rx
- charge the patient the appropriate fee , it is up to the patient to recover any costs incurred from their military unit
what happens when a military personnel presents an NHS or other private rx
- pay appropriate fee and request a receipt to reclaim any costs, if eligible
UNLESS they are exempt and present an exemption certificate
what happens when a military personnel presents a CD 2 or 3 rx
- should be written on a pink FP10PCD form.
- if written on MOD FMed 296, it cannot be legally dispensed,
when should you pay attention to a military rex
- handwritten FMed 296 : majority of FMed are computer generated, so unlikely to see handwritten ones, especially for MOD accoutable drugs
- British forces post office (BFPO) address stamp
when should you pay attention to a military rx
- handwritten FMed 296 : majority of FMed are computer generated, so unlikely to see handwritten ones, especially for MOD accoutable drugs
- British forces post office (BFPO) address stamp: these rx have been generated abroad and are not nromally seen in the uk
what are MOD accountable drugs
CD 3, 4, 5, codeine, sedatives and medicine for erectile dysfunction
what are the label requirements for dispensing
*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:
“(e.g. For external use only)”.
The RPS recommends the following also appears
on the dispensing label:
* ‘Keep out of the reach and sight of children’
* ‘Use this medicine only on your skin’
where applicable.
NB: In secure environments it is strongly
recommended that the prisoner number
is also included on the label as a definitive
patient identifier.
Additional information can be added to the
dispensing label if the pharmacist considers
it to be necessary
where do you place labels
- the actual container e.g the inhaler or tube of cream as the outer container can be lost
how and when is labelling optimised ?
if pharmacist is of the opinion that the the directions for use, name or common name of the medicine, or precautions, relating to the use of the medicine, are not appropriate on the prescription,
they can substitute these with appropriate particulars of a similar kind when producing the dispensing label without contacting the prescriber.
> > it’s good to make a record
how is medicines broken down from bulk containers labelled
- Name of the medicine
- Quantity of the medicine in the container
- Quantitative particulars of the medicine
(i.e. the ingredients) - Handling and storage requirements where
appropriate - Expiry date
- Batch reference number (e.g. LOT number or BN).
what is assembly and pre packing medicines
The assembly or pre-packing of medicines by the pharmacy to be supplied to a separate legal entity
> (e.g. for a NHS Trust to supply a different NHS Trust or an out of hours medical practice)
what does assembly and prepacking medicines require
> requires the appropriate licence from the MHRA (medicines and healthcare products regulatory agency,
> i.e. Manufacturer’s/importer’s licence (MIA) or Manufacturer ‘specials’ licence (MS)).
how is assembly and prepacking medicines labelled
> The MHRA can be contacted for further details on the licence and any labelling requirements
where can repeat prescriptions be dispensed
the patient can choose to have repeats dispensed from different pharmacies
what is done to repeatable rx
to maintain an audit trail mark on the rx, the name and address of the pharmacy from where supply has been made and the date of supply
what sort of forms do prisons and other residential custodial secure environments use
- FP10 form not used for routine prescribing
- a customised rx form generated by the clinical it system, is used instead
when are fp10 forms used for prisons and custodial settings
- to access urgent medicines (out of hours)
- to a released person to access medicines that couldn’t be supplied to them on release
can prisoners have repeat dispensing scheme
- no as they dont use FP10s or EPS but customised forms
what are repeat slips
they are not prescriptions themselves but a list of medications which patient can use to reorder their regular medication
are repeatable prescriptions and repeat slips
NO, they are 2 separate things
what are instalment rx
they provide for a single rx for a CD to be dispensed in several installments
what is the 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
what is the 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
what is the validity of owings on POM
6 months from the date
what is the validity of owings on CD sch 5
6 months from the date
what is the validity of owings on P and GSL medicines
6 months from the approprate date
what is the validity of owings on sch 2,3 and 4 CDs
28 days after the approprate date
which type rx are recorded
Private POM rx
who is responsible for self administration
patients , unless risk assessment indicates otherwise
who else can administer medicine
registered healthcare professionals can administer of delegate the administration of medicines
non registered hcp who are appropriately trained, assessed as competent and meet relevant organisational guidance
what are hcp / non hcp who administer medicines help accountable for
their actions, non actions and omissions
what should the administerer of medicine know
- understanding of the medicines being administered
- awareness that they can seek adice from a prescriber or pharmacy professional
when can parental POMs be administered
can be administered to another person in accordance with the directions of an appropriate practioner or by the
when is administeration exempted
to save a life in an emergency and a list of parenteral medicines can be found in schedule 19 of the human medicines regulations 2012
name 3 example of administering a parenteral medicine for emergency
naloxone as an emergency first aid for a drug related overdose
adrenaline for emergency treatment of anaphylaxis
small pox vaccine
which classes of persons can also administer POM under certain conditions
Midwives, paramedics , first aid personells , life support provider , podiatrists, nhs body or local authority operating an occupational health shceme, commander of an aircraft
what is covert administration of medicines
when medicines are administered in a disguised format without the knowledge or consent of the person recieving them, for example in food or drink
why are medicines administered covertly
patients who actively refused medication
patients who lack mental capacity in accordance with an agreed management plan
what should be followed for covert administration
organisational policies and procedures
what should pharmacist who are asked to sign covert administration documentation check
what they are being asked to sign off as this may indicate :
- they have to perform a clinical medicaion review and
- provided advice on how medicines should be administered
- what to do if a patient consumes only part of their food or drink
what is adrenaline
A POM given intramuscularly for anaphylaxis
give an example where a pharmacist expected to recognise and treat an anaphylactic reaction
offering a vaccination service
what should pharmacist have access to incase of anaphylactic administration
an anaphylaxis pack, and must have received the training in the recognition of anaphylaxis and administration for adrenaline
what doesa anaphylaxis pack include
ampoules of adrenaline and syringes and needles or prefilled syringes
who can administer adrenaline
anyone for the purpose of saving life in an emergency - by the regulations 238 of human medicines regulations 2012
what should a pharmacist do after administering adrenaline
call am ambulance
when is adrenaline administered
an anaphylactic emergency
what exemptions allow POMs to be sold or supplied with a rx
- Patient group directions (PGDs)
- Patient specific directions (PSDs)
(see section 3.3.9) - 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 are patient group direction (PGDs)
- a written direction that allows the supply and/or administration
- of a specified medicine or medicines, by named authorised health professionals,
- to a well defined group of patients requiring treatment for a specific conditon
when is supply and administration of medicines under a PGD used
for those in limited situations where this offers an advantage for patient care without comprimising patient safety
which sch 2 drug can pharmacists supply / administer under a PGD and which situation
MORPHINE OR DIAMORPHINE
For the immediate ,necessary treatment of sick or injured persons
when is a PGD developed
only be developed after careful
consideration of all the potential methods of supply and/or administration of medicines, including prescribing, by medical or nonmedical prescribers.
how is pgd labelled
POM supplied under PGD are labeled the same way as rx
what is patient specific directions
a written instruction from a doctor, dentist or
non-medical prescriber for a medicine
to be supplied or administered to a named patient
after the prescriber has assessed that patient
on an individual basis.
what do PSD relate to
a specific named patient but do not need to comply with the requirements specified for a rx
where are PSD encountered on hospital ward
on in patient charts as directions to administer
what is an emergency supply
a pharmacist working in a registered pharmacy can supply POMs to a patient without a rx on the request of a ‘relevant prescriber’ or a patient
what are the ‘relevant prescribers’
A doctor
* A dentist
* A supplementary prescriber
* A nurse independent prescriber
* A pharmacist independent prescriber
* A community practitioner nurse prescriber
* A physiotherapist independent prescriber
* A podiatrist independent prescriber
* A therapeutic radiographer independent
prescriber
* An optometrist independent prescriber
* An EEA or Swiss health professional
(see section 3.3.5)
* A paramedic independent prescriber
which ‘relevant prescriber’ is not accepted for emergency supply in the uk
hcp from countries outside of the EEA or switzerland
what are the conditions for emergency supply at the request of a prescriber
- a relevant prescriber
- Pharmacist is satisfied that the rx can’t be provided due to an emergency
- the prescriber agrees to provide a written rx within 3 days
- the medicine is supplied in accordance with the prescriber’s directions
can cds be supplied through emergency supply
NOT CD 1 2 OR 3
which CD can be supplied in am emergency supply
sch 3 phenobarbital
who can authorise the supply of the cd in emergency supply
UK prescribers - doctors nurses pharmacist, independent
should you record emergency supply?
yes
where and when do you make an emergency supply record
POM register on the day of supply (if impractical the day after)
what should an emergency supply entry include
- The date the POM was supplied
- The name (including strength and form where
appropriate) and quantity of medicine supplied - The name and address of the prescriber
requesting the emergency supply - The name and address of the patient for whom
the POM was required - The date on the prescription (this can be added
to the entry when the prescription is received
by the pharmacy) - The date on which the prescription is received
(this should be added to the entry when the
prescription is received in the pharmacy)
what happens when a patient requests an emergency suppy
- interview of patient
- ensure that theres an immediate need for the POM
- ensure that the POM has been used as previous treatment as prescribed by a uK, EEA or swiss
- Pharmacist must be satisfied with the dose patient needs to take
- ensure its not a cd except phenobarbital
- length of treatment»_space; max for Cd: 5 days, POM : 30 days (except insulin, cream,inhaler or oral contraceptive
- an entry must be made
what record is made for patient request emergency sipply
The date the POM was supplied
* The name (including strength and form where
appropriate) and quantity of medicine supplied
* The name and address of the 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.
when is emergency supply denied
records shows multiple requests
if denied emergency supply , what should pharmacist advice
- how to obtain a prescription or appropriate medical care – referral to doctor etc
what CPCS
Community pharmacy consultation service
what does CPCS allow
enables
NHS 111, urgent care settings and 999 providers
to refer patients to a community pharmacy for an
emergency supply of regular medicines under
the NHS.
can optometrist or podiatrist authorise supply of POM by writing a rx
No except theyre qualified as independent
or supplementary prescribers
however Pharmacists can supply certain POMs directly to patients in accordance with a signed patient order from any registered optometrist or podiatrist - must be one that’s on their formulary
is signed patient order a rx
no so does not require usual rx requirements
what medicines can schools obtain
adrenaline auto injections and or salbutamol inhalers on a signed order
when can these medicines be administered
emergency by a trained individual
what information must be on a school’s signed order
- Name of the school
- Product details (including spacer if
relevant) - Strength (if relevant)
- Purpose for which the product is required
- Total quantity required
- Signature of the principal or head teache
how many medicines can schools obtain
not specified in legislation as is dependent on school size, number of children affected, past experience etc
how long is the school signed order retained for in the pharmacy
2 years from the date of supply or an entry made into the POM register
what type of schools
all primary and secondary
can naloxone be obtained wihtout a rx, PGD or PSD
yes because of the high amts of deaths
who can administer naloxone
anyone for the purpose of saving a life
which medicines can increase risk of foetal malformations or spontaneous abortion
oral retinoids
valporate
thalidomide
lenalidomide
pomalidomie
what does the PPP do
prevent pregnacy
what is the pregnancy prevention programme (PPP)
protects females of child bearing potential by minimising the risk of becoming pregnant while taking these medicine
how do pharmacy ensure PPP
- ensure risky medicines not dispensed for females that may be pregnant or considering becoming pregnant unless they follow the manufacturer’s PPP or the prescriber agrees
Provide examples of oral retinoids
acitretin, alitretinoin, isotretinoin
what are oral retinoids described as in their SPC
- powerful human teratogen inducing a high frequency of severe and life threatening birth defects
what are the distribution controls of oral retinoids for females at risk of pregnancy
- rx validity : under PPP, rx valid for 7 days
- quantity: max supply is 30 days, more can be dispensed if patient is confirmed by prescriber as not being under PPP
- no repeat rx, free sample distribution or faxed rx. telephone rx accepted if emergency
what are the distribution controls of oral retinoids for females at risk of pregnancy
- rx validity : under PPP, rx valid for 7 days
- quantity: max supply is 30 days, more can be dispensed if patient is confirmed by prescriber as not being under PPP
- no repeat rx, free sample distribution or faxed rx. telephone rx accepted if emergency supply at the request of a PPP specialist prescriber
together with confirmation that pregnancy status
has been established as negative within the
preceding seven days.
who is oral retinoids containdicated in
pregnant women and women of potential child bearing unless all the conditions of PPP are met
what is valproate PPP
valproate is used to treat epilepsy and bipolar disorder. It can cause harm to an unborn child when taken during pregnancy
when is valproate given
- when nothing works
- patient is part of pPP
what should pharmacists do when a patient when dispensing valproate to female patients of child bearing age
- ask patients if theyre on a PPP, have had a review with their doctor and are aware of risks
- those planning pregnancy should be advice to speak to their prescriber for a review
- if unplanned pregnancy, patient should be advised to not stop taking valproate and arrange to see their prescriber for a review
- emphasize the need for annual specialist review
- report any suspected side effects via the yellow card scheme
what should pharmacist give patient when valproate is dispensed
patient card
how should valproate be dispensed
in original packs
if dispensed in while boxes ensure PIL is provided and a warning label /sticker is added in the box
ensure dispensing label does not cover warning label/ sticker
what is biologic
medicine made from a variety of natural source that may be human animal or microorganism
what are some examples of biologic
vaccine
blood
blood products
somatic cells
dna
human cells
what is a biosimilar
a biological medicine that is similar to an already licensed biologic medicine in terms of quality, safety and efficacy. it treats the same condition as the original
when is biosimilar marketed
after the patent
protecting the originator product and any
period of marketing exclusivity have expired
why are biosimilars not a generic medicine
.
- biosimilars are complex in strucutre and bigger molecules and result from complex production methods
- 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
can you switch between original biologic and biosimilar
yes but only made by prescriber following discussion with patient
how is biosimilar prescribed
by brand to avoid automatic substitution
how are biosimilar ADR reported
- both brand name and brand number are provided
when can sch 1 cd be prescribed
only under the home office license
what can doctors and dentists prescribe
> sch 2 - 5 ; home office license for cocaine, diamorphine or dipipanone
> unlicensed of off label med
> emergency supply including phenobarbital but no other sch 1 2 3
> dentists limited to dental ocnditions
what can vet med prescribe
> unlicensed and off label but needs cascade
sch 2 - 5 , but must include RCVS reg number
no emergency supply
only for animals
what can nurse / midwife / independent prescriber prescribe
> sch 2 - 5 but not cocaine , diamorphine or dipipanone
> unlicensed med & off label but unlicensed meds are exluded from nurse formulary
> emergency supply include phenobarbital but no other sch 123 Cd
what can Optometrist independent prescriber prescribe
> > NO sch 2 -5 cd
only off label medicines
emergency supply
no parenteral preparations
difference between off label and unlicensed
off label : licensed medicine outside of its approved use
unlicensed: not officially approved for treating condition as not undergone clinical trials for effectiveness
Paramedic IP prescribe
> > no sch 2 - 5
only off label
emergency supply but not sch 1 2 3 including phenobarbital
Pharmacist IP prescribe
> > sch 2 - 5 but not cocaine diamoprhine or dipipanone
> > unlicensed and off label
> > emergency supply incl phenobarbital but no other sch 1 2 3
Physiotherapist IP prescribe
> > only certain sch 2 - 5 cd :
For oral administration - diazepam, dihydrocodeine, lorazepam, morphine,
oxycodone and temazepam
For injection – morphine
For transdermal administration - fentanyl
> > only off label
> > emergency supply but not sch 1 2 3 incl phenobarbital
Physiotherapist IP prescribe
> > only certain sch 2 - 5 cd :
For oral administration - diazepam, dihydrocodeine, lorazepam, morphine,
oxycodone and temazepam
For injection – morphine
For transdermal administration - fentanyl
> > only off label
> > emergency supply but not sch 1 2 3 incl phenobarbital
Podiatrist/chiropodist independent prescriber
> > only these CDs for oral administration - diazepam, dihydrocodeine,
lorazepam and temazepam
> > only off label
> > emergency supply but not sch 1 2 3 incl phenobarbital
Therapeutic radiographer independent prescriber
> > no sch 2 - 5
only off label
> > emergency supply but not sch 1 2 3 incl phenobarbital
Supplementary prescriber: dietician, midwife, nurse, optometrist, paramedic, pharmacist, physiotherapist,
podiatrist/chiropodist, radiographer (diagnostic/therapeutic)
> > sch 2 - 5 not cocaine, diamorphine or dipipanone for treating addiction
> > unlicensed and off label
> > emergency - includes phenobarbital for epilepsy but no other Schedule 1, 2 or 3 CDs
> > prescribing restricted to areas of clinical competence
community practitioner nurse prescriber
> > no sch 2 - 5
no unlicensed other than nystatin for neonates
emergency supply
What can EEA or swiss registered hcp
> > only sch 4 and 5
off label
emergency
which hcp are covered by human medicines regulations exemptions
- Midwives
- Opthoptists
- Optometrists (see also section
- Paramedics
- Podiatrists/chiropodists
should the same person prescribe and dispense ?
no to ensure patient safety
what is the exception for prescribing and dispensing by THE SAME PERSON
pharmacist prescriber but its good practice to ensure processes are in place to limit errors
what should pharmacists do when dispensing a prescribers self prescribed rx or rx for close family and familiy
pharmacist should consider that:
> it’s poor practice to self rx or for close personal relationship
> the professional judgement of the prescriber may be impaired or influenced
> regulatory bodies advise against it
> the abuse potential of drug being requested
> CD only supplied in exceptional circumstances and details documented
whats the most appropriate action when dispensing a prescribers self prescribed rx or rx for close family and family
to refuse
what is the labelling requirements to appear on dispensed medicinal products
- Name of the patient
- Name and address of the supplying pharmacy
- Date of dispensing
- Name of the medicine
- Directions for use
- Precautions relating to the use of the medicine:
“(e.g. For external use only)”.
The RPS recommends the following also appears
on the dispensing label: - ‘Keep out of the reach and sight of children’
- ‘Use this medicine only on your skin’
where applicable.
Patient specific directions PSD
a written instruction from a doctor, dentist or
non-medical prescriber for a medicine
to be supplied or administered to a named patient
after the prescriber has assessed that patient
on an individual basis.
what should PSD include
A PSD, signed by a qualified, registered prescriber, at a minimum should specify:
Name of patient and/or other individual patient identifiers
Name, form and strength of medicine (generic or brand name where
appropriate)
Route of administration
Dose
Frequency
Start and finish dates.
Signature of prescriber.
Example of patient group directions
vaccine for over 65
when is home office license required
schedule 1 , cocaine , diamoprhine or dipipanone
which rx do dischargered prisoners use
FP10
do discharged prisoners have to pay if the FP10 form have the name and address of the prison
no
