MEP CHAPTER 3 Flashcards
What license is needed to administered or prescribe a sch 1 CD?
Home office licence
Schedule 2, 3 or 4 CDs can be administered to a patient by who?
doctor, dentist, pharmacist IP or nurse independent prescriber.
Supplementary prescriber
Person acting in accordance with the directions of a prescriber entitled to prescribe CDs.
Who can prescribe cocaine, diamorphine or dipipanone for treating addiction?
Medical prescribers who hold a special licence from the Home Secretary or Scottish Government’s Chief Medical Officer.
What indication can cocaine, diamorphine or dipipanone be given for using special license?
Addiction
Who CANNOT prescribe ocaine, diamorphine or dipipanone for addiction but only for treating organic disease/injury?
Pharmacist IP, nurse IP + supplementary prescribers
When is a license NOT needed for import/exporting Schedule 4 (Part II) CDs?
If for self-administration
What sch drugs is a licence needed to import or export it?
Schedule 1, 2, 3 and 4 (Part I) CDs
Are there any restrictions on the import or export of Schedule 5 CDs ?
NO
Who is regulatory body for import/exporting CDs?
Home office
What is recommended to carry if patient travelling with CD?
Covering letter signed by the prescriber is obtained that confirms the name of the patient, travel plans, name of the prescribed CDs, total quantities and dose.
When is a personal licence is not required by the Home Office when travelling with CDs?
IF a person travelling is carrying LESS than 3 months’ supply.
What 5 things should be included in covering letter for patient to carry when travelling with CDs?
Name of patient
Travel plans
Name of CDs
Qty + dose
Who should patients check with before travelling with CDs?
Embassies or high commissions for the countries they will be travelling through to ensure that the import export regulations in those countries are complied with.
The CD requisition forms apply to both — + —-?
Humans + animals
What act made CD requisition forms mandatory?
Misuse of Drugs Regulations 2001
What 2 schedule drugs are CD requisition forms needed for in community?
Schedule 2 and 3
What 2 places are exempt from using CD requisition forms?
Hospices + prisons are exempt.
What are the 6 requirements for a CD REQUISITION?
1 Signature of the recipient
2 Name of the recipient
3 Address of the recipient
4 Profession or occupation
5 Total quantity of drug
6 Purpose of the requisition
Why is CD requisition form manadatory?
Shipman Inquiry recommendation aimed at ensuring the purchase of all stocks of Sch 2 + 3 CDs are monitored in community.
If CD received by hospital pharmacy, and request is on behalf of ward/dept NOT in same entity is a CD req form needed?
Yes
what is CD requisition form used in prisons in england?
hospital-style requisition forms usually used
Are printed in a bound, book format
What type of CD requisition is used in Scotland prisons?
approved internal ordering form from the supplying pharmacy is used.
Are supplied made using faxed or photocopied requisition acceptable?
NO
What 3 CDs can midwife order using supply order?
Diamorphine
morphine
pethidine
What should midwife supply order contain?
Name of the midwife
Occupation of the midwife
Name of the person to whom the CD is to be administered or supplied
Purpose for which the CD is required
Total quantity of the drug to be
obtained
Signature of an appropriate medical officer
How long should requisitions be held onto for good practice?
2 years
When a requisition for a Schedule 1, 2 or 3 CD is received, it is a legal requirement to:? (2 things)
- Mark the requisition indelibly with the supplier’s name and address, where stamp is clear
2.Send the original requisition to the relevant NHS agency.
When does CD requsiition processing NOT apply?
By a person responsible for the dispensing + supply of medicines at a hospital, care home, hospice, prison or organisation providing ambulance services who must mark + retain the original requisition for two years
By pharmaceutical manufacturers or wholesalers
Against Vet requisitions
How long should vet requisition be retained for?
5 years
What CD schedule can a pharmist NEVER requisition?
CD 1
In an emergency, can a doctor/ dentist can be supplied with Sch 2/3 pending CD requisition form within 24 hrs?
yes
What are the 3 classes of medicinal products under human meds regulations 2012?
GSL
Pharmacy P meds
POM
Within a pharmacy when can GSLs be sold?
Only when pharmacist assumes role of RP - but can be gone for limited amount of time.
What is GSL?
Meds available self selection in registered pharmacies
Also sold in retail outlets
What is a P med? (OTC)
Pharmacy med- sold from registered pharmacy by pharmacist/ person acting under supervision of pharmacist
Not access via self-selection
What is POM?
Prescription meds written by docs, dentist, IP, EEA/swiss HCP, IP opto, paramedic, radiographer IP
What 2 types of drugs can optometrist IPs not give?
CDs
Parenteral medicines
What can pseudoephedrine be used to make?
Crystal Meth
What is max supply of Pseudoephedrine or Ephedrine without RX?
720mg Pseudoephedrine OR 180mg Ephedrine at any 1 time
Cannot sell BOTH at one time
Can you sell Pseudoephedrine and Ephedrine?
NO only 1
List signs of possible Pseudoephedrine or Ephedrine missues?
Lack of symtpoms of cold/flu
Rehersed answers
aggressive
opportunistic
specific products
quantities
frequent
Buys other - lithium + acetone
Where to report suspicion if someone buying Pseudoephedrine or Ephedrine for bad reasons?
GPHC inspector
Local CD police
Accountable officer
What are 3 methods of emergency contraception?
Copper IUD
Oral ulipristal
Oral levonorgestrel
Age levonorgestrel licensed?
16 or over
within 72 hrs of sex
Can Pharmacists provide an advance supply of oral emergency contraception?
YES- if patient needs
What to do if child under 13 requests emergency contraceptive?
Too young to consent- need to treat this seriously, report to social services
What are fraser guidelines?
apply specifically to advice and treatment around contraception + sexual health when speaking to a young person under 16 years old.
Can pharmacists provide contraceptive to person under 16?
Yes- if they meet fraser criteria + consent sought.
What is Paracetamol and aspirin OTC legal restriction?
No more than 100 non effervescent tabs/caps sold at ONCE.
So 96 is max
What is most OTC paracetamol and aspirin pack sizes?
16 or 32 - so max is 96 tabs sold
Is there legal limits of OTC effervescent paracetamol and aspirin tabs/granules or liquids?
NO- but use professional judgement
Is soluble or dispersible formulations same as effervescent?
No - should be regarded as non-effervescent
What indication is OTC codeine and dihydrocodeine used for noe?
Short term acute, mod pain not relieved by paracetamol, ibu or aspirin
Can codeine be used to treat cold, flu, cough and sore throat?
Not anymore- removed
What pack size of codeine makes it a POM?
More than 32
What are labels for codeine?
Can cause addiction, Only 3 days use.
How many packs of OTC codeine recommended to be sold?
1 pack
What are 7 legal prescription requirements?
- Prescriber sign
- Prescriber address
- date
- prescriber details
- patient name
- patient address
- age
When is age of patient needed?
If under 12
What is rx validity in normal prescriptions?
6 months
For NHS prescription what is validity?
6 months - date when rx was signed or
date indicated by prescriber as date before which it should not be dispensed
What is validity for private rx?
6 months - from date it was signed.
Can carbon copies be used for RX?
Yes as long as signed in ink
Do copies of RX on email or patients phone on online account count as signature?
No
Can you accept a welsh RX?
Put patient safety first - find best way to help patient.
Can prescriptions be accepted from crown dependencies?
Satisfied that all requirements met to be legal
Can CD 2 + 3 be on RX from crown dependencies?
prescriber address has to be within UK
Which type of prescription can be repeated?
Only private mainly
not NHS
If number not stated on Rx how many times can it be repeated?
1 TIME-
dispensed twice
what is max times to repeat Rx for contraceptives
5 times
dispense 6 times in total
Can CD 2 and 3 be repeated?
No
When can 1st dispensing for Schedule 5 CD/POM be made?
Within 6 months
When should RX for CD 4 drug be dispensed first?
first dispensing within 28 days
Can repeat dispensing be done with FP10 or EPS?
No- FP10 only for urgent medicines
What is an instalment prescriptions?
Single RX for CD to be dispensed in several installments.
What is a repeat slip ?
Not an RX - list of meds which patients can use to reorder their reg meds
When is validity of owings for Schedule 2, 3 + 4 CD?
28 days of date
When is validity of owings fo P and GSL?
6 months
When is validity of owings fo POM + sch 5 CD?
6 months
When is validity of owings for POM if on PPP?
owing can exceed 7 days from when RX was written only if PPP checklist followed to ensure no risk of pregnancy
How long to keep private rx for POM?
2 years from supply
Where should Private RX for schedule 2 + 3 be sent?
Relavent NHS agency
Make POM register + keep it.
What should POM record include?
Supply date
Rx date
Med details
Rx details
Pt details
What 2 meds exempt from record keeping?
Oral contraceptives
sch2 CD- different register
What RX details not legal requirments for POM but important?
Name, strength, form, quantity, dose
Are faxed RX or online copies legal?
No- not written in indelible ink or signed
What are some risks of faxed/digital copies of RX?
Uncertainty that supply made with legal RX
risk of duplicates, fake rx, not secure source
Where are forged rx reported for NHS prescriptios only?
NHS counter fraud services
Police
Can repeat rx issued by approved HCP in approved country allowed?
Yes
List some approved HCP?
Chiropodists, podiatrists, nurses, optom paramedics, pharmacists, physios, radio
List some approved countries?
EEA countries + switzerland
What details are needed on RX from approved HCP?
Patient details
Prescriber details
Prescribed medicine details
signature
Date of issue
When is validity of schedule 4 CDs?
28 days after the appropriate date
e.g. if 1st Nov date then 28 day will run till 29th
so 30th Nov = NO compliant to supply.
What should you do to confirm status of approved HCP?
Check their status on the register
Are Schedule 1, 2, 3 without MA valid in Uk?
NO
Can schedule 1, 2 + 3 CD including phenobarbital be supplied emergency to patient of approved health professional?
No, only in UK
When should prescription be sent if emergency supply at request of prescriber?
72 hrs.
What is a military RX?
doctor gives out dispensing function to trained person.
Smaller medical centres have community pharmacies under a MOD contract
What form is millitary rx written?
FMED 296
How is military rx treated if sent to non-contracted pharmacy?
As private rx - not to invoice directly but charge patient.
What form are rx for schedule 2 + 3 CDs written on?
FP10PCD pink form
Can schedule 2 + 4 drug written on MOD FMED 296 be dispensed?
NO
What are legal RX of labels?
Patient name
Name/ address of pharmacy
date dispense
Directions
Name of med
Precautions - for external use
What 2 extra things does RPS recommend appear on label?
Keep out of the reach + sight of children
Use med only on skin - if applicable
Does the inner container need to be labelled?
Good practice as outside usually thrown away.
How to label meds broken down from bulk containers for dispensing? (6)
Name of med
Quantity of meds in container
Ingredients of med
Handling/storage req
Expiry
Batch ref number/ lot
How are parenteral POMS given to another person?
Directions of appropriate practiser except life saving
e.g. naloxone or adrenaline
What is covert administration of meds used for?
people who actively refuse their medication and who are considered to lack mental capacity in accordance.
What regulation allows adrenaline to be given to anyone to save a life?
regulation 238 of human meds regulations 2012
What is a PSD?
written instruction from a doctor, dentist or non-medical prescriber for a Med to be given to a named patient.
How are PSDs given?
Enough info needed for person to give meds safely but NOT LAW/
Directions on pt chart copied onto discharge.
What are some exemptions that allow POMS to be sold without rx?
PGD
PSD
Emergency supply
Opto/podiatrist signed orders
Salbutamol+ Epipens to schools
Naloxone
What is a PGD?
A PGD is 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 condition.
Can morphine/ diamorphine be supplied in PGD?
can supply, offer to supply and administer diamorphine or morphine under a PGD for the immediate, necessary treatment of sick people
Do PGDs need labels?
Only POMS supplied do.
What 4 criteria to meet to do emergency supply at request of prescriber?
Relevant prescriber
emergency
RX given within 72 hrs
Directions
NO CDS EXCEPT PHENOBARBITAL IN uk
When can phenobarbital be given as emergency supply?
Only by UK doc, dentist, nurse, pharm for epilepsy treatment.
Can CD 1, 2 3 be supplied as emergency?
No - except phenobarbital by UK HCP
When is POM register made for emergency supply?
On day of supply or following day
What does POM reg need to include? (6)
The date POM supplied
The name (including strength and form where appropriate) and quantity of medicine supplied
The name + address of the prescriber requesting the emergency supply
The name + address of the patient for whom the POM was required.
The date on RX (this can be added to the entry when the prescription is received by the pharmacy).
The date on which the prescription is received (added to the entry when RX is received in the pharmacy)
What 5 conditions for emergency supply at request of Patient?
Interview
previous treatment
immediate need
Dose
Not CDS, except phenobarbital
Can an EEA/swiss patient make requisitions?
Cannot be given if NO MA valid in UK
What is maximum quantity of CD in emergency supply?
Max 5 days
What is max supply for emergency supply POM?
no more than 30 days supplied unless if insulin/oiment/cream or inhaler.
What to do if emergency supply product is insulin, ointment, cream or inhaler, contraceptive, antibiotic
Give smallest pack size available and a full treatment cycle should be given.
Smallest amount for full course.
What is included in POM reg for emergency supply at request of patient?
The date the POM was supplied.
The name (including strength and form where appropriate) and quantity of medicine supplied.
The name + 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 + why a prescription cannot be obtained, etc.
What should be on label for emergency supply?
Words ‘emergency supply’ need to be added.
What is the community pharmacy consultation service?
Enables 111, 999 to refer patients to pharmacy for emergency meds
Can pharmacists supply certain meds with signed patient order from registered optom/podiatrist?
Yes- but should be one legally sold/supplied by them rather then one they can only administer.
Are usual RX requirements needed for signed patient order?
No because not a prescription
What 2 medications can schools obtain on signed order?
Adrenaline auto-injectors
Salbutamol inhalers
What 6 pieces of info included in signed order?
Name of school
Product details
Strength
purpose
total qty
signature of head teacher
What should be used to write signed order ideally?
Headed paper
Schools can buy salbutamol inhalers + adrenaline provided it meets 3 criteria :
Small amounts
occasional basis
not for profit
How long signed order kept?
2 years from supply date/POM entry
What 4 things does POM reg
need for signed order?
Date the POM was supplied
Name, quantity and where it is not apparent formulation and strength of POM supplied
Name and address, trade, business or profession of the person.
Purpose for which it was sold or supplied.
Who are oral retinoids initiated by?
Dermatologist, prescribing GP with derm role, specialist nurse.
What is max supply for oral retinoinds?
30 day supply
Only more if confirm as not being under PPP.
Repeat prescriptions allowed for oral retinoids?
NO
When is telephone request should only be accepted for oral retinoids?
if an 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
What to do if unplanned pregnancy and taking valproate?
Do not stop treatment and see prescriber urgently.
What is a biologic medicine
Med made from natural sources that may be human, animal or microorganism in origin. E.G.include vaccines, blood + blood products, somatic cells, DNA, human.
WHAT IS A BIOSIMILAR?
Similar to an already licensed biologic medicine in terms of quality, safety and efficacy.
When can biosimilar be marketed?
after patent of original expires
How are biologics prescribed?
By brand
How are SEs of biosimilars reported?
Brand + batch number given
record it - good practice
What is an advanced therapy medicinal product (ATMP)?
biological medicinal product based on genes, tissues or cells
tissue engineered, somatic cell therapy, gene therapy medicinal product.
Where does the prescribed need to be based if prescribing schedule 2 + 3 CD drugs?
adress in UK
Can community practitioner nurse prescribe sch 2-5 CD?
No
What off label med can community nurse prescriber prescribe?
Nystatin off label for neonates only
Can a dentist prescribe Sch2-5?
Yes- home office license needed
What is needed to prescribe cocaine, diamorphine or dipapanone for addiction?
Home office license
Can dentist and doctor authorise emergency supply?
Yes- phenobarbital , NOT other CD 1,2 ,3
What controlled drugs can EEA, swiss doctor prescribe?
Schedule 4 + 5 only
Can EEA/swiss HCP prescribe unlicensed or offlabel?
Only off label meds
What 5 CDs can paramedic IP prescribe?
Morphine- oral /inj
Diazepam - oral/ inj
Midazolam - oromucosal / inj
Lorazepam - inj
Codein- oral
What 3 CDs can PHYSIO IP prescribe?
Oral admin- diazepam, dihydrocodeine, lorazepam, morphine, oxy, temazepam
Morphine inj
transdermal - fentanyl
What CD can podiatrist give?
Oral - diaz, dihydrocodeine, lorazepam, temazepam
Which 5 HCP are covered by exemptions as they can supply certain medicines?
Midwives
Opthoptist
optometrist
paramed
Podiatrist/chiropodist
Can you prescribe for friends family?
Strongly recommended not to - refuse supply unless urgent.
Min of how many people involved in dispensing process?
2
What 3 things needed for trading medicines?
Have wholesale license - WDA
Comply with GDP standards
Need suitable RP named on licensed in order to store/distribute
What type of meds are wholesale distribution authorisations specific to?
Human meds or vet meds
In what case do pharmacies not need a WDA?
If pharmacy giving stock to another pharmacy in same legal entity.
But legal entity should have WDA and pharmacy supplying meds should be named on it.
When do pharmacies/hospitals supplying small qty of meds NOT need a WDA?
If transaction occasional
qty is small
Supply not based on profit
Supply is not for future wholesale distribution
If wholesaling CD schedule 2 to 5 what else is needed?
Home office CD license
Who can receive meds via wholesale?
Doc, dentist, pharmacies, hosp, midwives, chiropodists, optometrists, paramedics, owner/ master of ship, 1st aiders, Occupational Health schemes
NHS trusts, Drug tx services
What is needed to be done when a POM is supplied from pharmacy to a healthcare professional/organisation?
Entry in POM reg or Signed order/ invoice
How long to keep POM reg/Signed order invoice?
2 years
What schedule and act states which person needs a
to provide a written signed order?
Schedule 17 Human meds regulation 2012
If not needed- good practice to get one for audit trail.
What 4 things should POM register have?
- Date POM given
- Name, qty, and formulation/ strength
- Name, address, trade, business or profession of person who med was given to
- purpose for it.
When making supply under Wholesale Dealer’s license what should you follow?
Good distribution practice.
What is serious shortage protocol (SSP)?
Pharmacists in England, wales + NI can make changes to RX + supply alternatives.
