chapter 3 of mep Flashcards
GSL
medications that are available by self selection. can be sold in spaces that can “close as to exclude the public”
P meds
can be sold from a registered pharmacy premise by a registered pharmacist or a person acting under the supervision of a pharmacist. they should not be accessible for self selection. GSL and P meds are considered OTC meds
Prescription only medicines
medicine that is restricted to requiring a prescription written by an appropriate practitioner. an appropriate practitioner includes :
doctors
dentists
supplementary prescribers
nurse independent prescribers
EEA and Swiss approved health professionals
community practitioner nurse prescriber
optometrist independent prescriber
paramedic independent prescriber
physio independent prescriber
therapeutic radiographer
Pseudoephedrine and ephedrine
widely used decongestant however they can be used to make crystal meth. it is only legal to sell 720mg of pseudophedrine or 180mg of ephedrine without a prescription. it is unlawful to prescribe both at once (hmr 237)
oral contraceptives
a pharmacist should be involved in all sales of these . they may only sale 1500 mcg of levonorgestrel or ulipristal acetate 30mg tablets.
paracetamol and aspirin
available in a range of sizes , formulations and strengths. paracetamol may not be sold otc more than 100 tablets . aspirin may not be sold otc more than 100 tablets.
codeine and dihydrocodeine
tight restrictions on these due to their addictive properties . cannot be sold in more than 32 doses. must put on packet - can cause addiction , only use for 3 days
particulars needed on a general prescription
a signature
address of prescriber
date
particulars of prescriber
name of patient
address of patient
age of patient (if under 12)
what schedules are repeatable
sch2 and 3 are not repeatable
sch4 and 5 are repeatable
record keeping of general prescriptions
must be retained for 2 years.
supply date
prescription date
medicine details
prescriber details
patient details
dental prescriptions
dentist can prescribe all POMS but dental council advises they stick to prescribing medications only related to dental problems
faxed prescriptions
does not fall into the guidelines for a valid prescription. it is not written in ink and has not been signed by an appropriate. they are associated with risks such as :
risk of poor production
risk of it being fake
risk of it being changed by prescriber
risk that it was sent to multiple pharmacy
checklist for fraudulent prescriptions
is a large excessive quantity prescribed
is the prescriber known
is “dr” before the signature
is the patient behaviour off
is the meds commonly misused
EEA health professional script requirements
patient details
prescriber details
prescribed medicine details
prescriber
date of issue
military prescriptions
military prescriptions are to be written on a military form called FMED296
Controlled drug prescriptions should be written on a pink FP10PC form
legal requirements for the labelling of dispensed medicinal products
name and address of the supplying pharmacy
date of the dispensing
name of the medicine
directions for use
precautions relating to the use of medicine
‘keep out of the reach of children’
‘use this medicine only on your skin’
labelling of medicine broken down from bulk containers for dispensing
name of the medicine
quantity of the medicine
quantitive particulars of the medicine
handling and storage requirements
expiry date
batch reference number
Regulation 238 allows
adrenaline to administered by anyone for the purpose of saving a life In a emergency situation
PSD
legislation does not define it , however, it is generally accepted to mean 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 patient basis
exemptions to sale and supply of medicines without a prescription
pgd
psd
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
pgd
written directions that allow the supply and or administration of a specified medicine or medicines by named authorised health professionals to a well defined patient group
regulation 225 requires
a pharmacist to interview a patient looking for an emergency supply
what is a biologic
it is a medicine made from a variety of natural sources that may be human animal or micro-organism in origin . examples include vaccines , blood and blood products.
controlled drug prescriber restrictions
when prescribing schedule 2 and 3 drugs CD’s , the prescribers address must be in the uk
schedule 1 drugs can be prescribed under a home office licence
anyone trading medicines to anyone other than a patient is required to
hold a wholesaler licence
comply with good distribution practice standards and pass GDP inspections
have a suitable experienced responsible person named on the licence to ensure that medicines are procured stored and distributed properly
wholesaling of CD
the home office and the MHRA have advised that if a WDA is required this also means that if supplies include CD’s in schedule 2 to 5 in the misuse of drugs regulation 2001 , then it is likely that a home office licence is also needed
persons and organisations that can receive medicines
doctor
dentist
registered pharmacy
hospital clinics and independent medical agencies
midwives
chiropodists
optometrists
paramedics
owner or master of ship
orthoptists
first aid organisations
certified first aiders
working for national life boat institution
occupational health schemes
drug treatment services
NHS trusts
at entry in the POM register it must include
date the pom was supplied
name quantity and where it is not apparent the formulation and strength
name , address and trade business or profession of the person to whom the medicine was supplied
prescription requirements for pom-v and pom-vps supplied under a veterinary cascade
name , address , telephone , qualification and signature of the prescriber
where schedule 2 and 3 CD’s have been prescribed , the royal college of veterinary surgeons registration number of the prescriber must also be included
name and address of the owner
indentification and species
address of animal if it is different to owner
date of the rx
name , quantity and dose and admin instruction of the required medicine
any necessary warnings and if relevant the withdrawal period
state if the med is prescribed under the cascade
how many repeats if the prescription is repeatable
veterinary cascade
an exemption within the veterinary medicines regulations and specifies that where a licensed veterinary product is not available other medicines in a strict order of preference can be considered
labelling of dispensed veterinary medicines
name of the prescribing veterinary surgeon
name and address of the animal owner
name and address of the pharmacy
identification and species
date of supply
expiry date
name or description of product or its active ingredients
dosage and administration
if appropriate special storage instructions
any necessary warnings
any applicable withdrawal periods
‘for animal treatment only’
‘keep out of reach of children’
record keeping for veterinary medicines
name of the medicine
date of receipt
batch number
quantity
name and address of the supplier or recipient
keep copy of rx if written
records can be kept electronically
must be kept for 5 years
report adverse reactions to SADRS
wholesaling veterinary medicines
only the manufacture of a veterinary medicine or a holder of a wholesale dealers authorisation may routinely supply authorised retailers with veterinary medicines
legislation applicable to CD’s and pharmacy include
the misuse of drugs act 1971
the misuse of drugs regulations 1973
the misuse of drugs act 2001
the health act 2006
controlled drugs regulations 2013
health act 2006 introduced
the concept of an accountable officer and requires healthcare organisations and those providing health to have standard standard operating procedures in place for using and managing CD’s
responsibility of accountable officers
oversee the monitoring and auditing of the management and prescribing and use of CD’s
ensuring that systems are in place for recording concerns and incidents involving CD’s and operation of these systems
attendance at local intelligence network meetings
submission of occurrence reports which describer the details of any concerns of the organisation regarding the management of CD’s in a required time frame
the appointment of authorised witnesses for destruction of CD’s
classification of drugs into schedules
schedule 1 - CD’s with no true medical use
schedule 2 - CD’s which are fully controlled
schedule 3 - CD’s no register POM
schedule 4- CD’s Benzodiazipines pom / anabolic steroids
schedule 5 - CD’s inv p and CD’s inv POM
schedule one
no medical use
licence required
LSD , MDMA
schedule two
have a general authorisation to prescriber , posses , supply and procure these medicines
diamorphine , morphine , ketamine , quinalbarbitone
schedule three
minor stimulants and other drugs
less likely to be misused
temazepam and tramadol
schedule four
split into two parts
p1 - benzodiazipines
p2- anabolic steroids
schedule 5
low risk drugs make from schedule 2 drugs
codeine , morphine low strength
possession and supply of CD’s
home office licence needed
legislation - class of person
legislation - class of drug patients
administration of controlled drugs
schedule 1 drugs may only be administered or prescriber under a home office licence. schedule 2,3,4 may be administered by : a doctor , dentist , independent prescriber or nurse independent prescriber
import , export and travellers with CD’s
a licence is needed for a pharmacy to import or export schedule 1,2,3 and 4 p1 CD’s . a licence is needed for 4 p2 unless the substance is imported or exported by a person for self administration. no restrictions on import or export of schedule 5 medicines
requisition requirements for schedule 1,2,3 controlled drugs
signature of the recipient
name of the recipient
address of the recipient
profession or occupation
total quantity
purpose of the requisition
mandatory requisition forms
GB- FP10CDF
SCOT-CDRF/GP10A
WALES-WP10CDF
midwifes can obtain the following for supply
diamorphine
morphine
pethidine
midwifes can obtain the following for supply
diamorphine
morphine
pethidine
order for the supply from a midwife must contain the following
name of the midwife
occupation of the midwife
name of the person to whom the CD is to be administered or supplied
purpose for which the CD is required
total quantity of the drug to be obtained
prescription requirements for schedule 2 and 3 drugs
signature
date
prescribers address
name of controlled drug
form
strength
dose
total quantity
quantity prescriber
name of patient
address of patient
dental rx - for dental treatment only
safe custody of CD’s
keep schedule 2 and 3 CD’s in a locked safe cabinet or room in which is constructed as to prevent unauthorised access to the drugs
CD’s that must be kept under safe custody
schedule 1 drugs
schedule 2 drugs except some liquid preparations
schedule 3 drugs unless exempted under misuse of drugs regulation 1973:
gabapentin
mazindol
meprobamate
midazolam
pentazocine
phenobarbital
prcegablin
tramadol
common schedule 3 drugs who need safe custody are temazepam and brunenorphine
destruction of CD’s
schedule 2,3 and 4 drugs must be denatured before disposal
schedule 2 needs a witness of destruction
in prisons schedule 3 should also be witnessed
what must be record in a CD register when the pharmacy have received drugs
date and supply received
name and address from whom received
quantity received
for controlled drugs supplied the following must be recorded in the CD register
date supplied
name and address of recipient
details of authority to posses- prescriber or licence holders details
quantity supplied
details of person collecting
whether proof of identity was provided
whether proof of identity was requested off the person collecting
all CD register entries should be
entered chronologically
entered promptly - the day of or the day after in ink or to be indelible
unaltered
the following should be adhered when maintaining CD’s
location
duration
form
inspection
CBMP
contains cannabis , cannabis resin , cannabinol or a cabbinol derivative
produced for medicinal use in humans
a product that is regulated as a medicinal product or an ingredient of a medicinal product
