MEP Flashcards
Restrictions around GSL medication
- Can be sold in registered pharmacy, and any retail outlets
- Can only be sold when pharmacist assumes responsibility, but can when pharmacist not present
- Due to EU or UK marketing authorisation
Restrictions surrounding P medication
- Can only be sold in registered pharmacies
- Can be sold by pharmacist or person acting under supervision of pharmacist
- Can only be sold when pharmacist assumes responsibility, but can when pharmacist not present
- Self-selection of P meds are prohibited
Restrictions surrounding POM medication
- Prescription only medication
- Subject to restriction of requiring a Rx written by appropriate prescriber
Restrictions surrounding pseudoephedrine and ephedrine
- Sale of a product containing more than 720mg pseudoephedrine OR 180mf ephedrine at any time without a Rx
- Must not sell both products at the same time without Rx
- Meaning you can sell more than one pack of each but as long as combined strengths do not exceed those stated above
Why are the restrictions on pseudoephedrine and ephedrine in place?
Due to potential misuse in illicit production of Methylamphetamine (crystal meth)
Restrictions in place on sale of codeine and dihydrocodeine and packaging
- Only sell up to 32 dose units as a P medication, any higher is POM
- Each pack MUST have the warning, ‘Can cause addiction. For three days use only’
What are the 4 phases that constitute a CPD
- Reflection
- Planning
- Action
- Evaluation
What is the minimum number of CPDs required to be submitted per year
9 CPDs
How many annual CPDs must start at reflection stage?
3 reflection CPDs
What are the regulation on relevance of CPDs submitted
Entries must be relevant to the safe and effective use of practice of pharmacy and your own scope of practice
Restrictions on sale of EHC
MUST NOT be sold to patients representative, due to possible abuse (forced sexual activity)
Which EHC are licenced for sale OTC?
- Levonorgestrel 1500mcg tablets
- Ulipristal acetate 30mg tablets
At what age and time period after unprotected sex can levonorgestrel be sold?
- 16 years and over
- Within 72 hours (3 days) of unprotected sex
At what age and time period after unprotected sex can ulipristal be sold?
- No age limit
- Within 120 hours (5 days) of unprotected sex
Thoughts relevant to a child under 13 requiring sale of EHC
- 13 is too young to consent to sexual activity
- Instance should be treated as serious event and reported to social services (Frasers guidelines)
- Pharmacist can provide contraception or sexual health advice to children under 13 years old
- Can sell Ulipristal
Can an advanced supply of EHC be sold?
- Pharmacists can provide an advanced supply of oral EHC (professional judgement)
- Patient should be assessed to ensure that they are competent, they intend to use properly and its clinically appropriate
Can a pharmacist refuse supply of EHC on religious or moral beliefs?
Yes
by which other services can patients acquire EHC?
- Family planning clinics
- GPs
- Providers of PGDs for EHC and genitourinary medicine (GUD) clinics
Which medications interact with EHC tablets?
- Barbiturates e.g. phenobarbital
- Primidone
- Phenytoin
- Carbamazepine
- Rifampicin
- Rifabutin
- Ritonavir
- Griseofulvin
- Ciclosporin
- St. John’s Wort
All reduce effectiveness of OTC EHC- referral to GP
Other reasons for pharmacist’s refusal to sell EHC, and refer
- Signs of abuse
- Unprotected sex outside of licence
- Pregnancy
- Feel sick
- Vaginal bleeding
Can Levonorgestrel and Ulipristal be used again in the same menstruation cycle?
- Levonorgestrel- YES
- Ulipristal- NO
Regulations surrounding the responsible pharmacist (RP)
- In order to conduct business, registered RP must be in charge
- Pharmacist must be physically present to accept responsibility
- Can only be the RP in charge of ONE PREMESIS at any given time
Legal requirements for the RP notice board
Must be displayed conspicuously in the registered pharmacy, and include:
* Your name
* Your GPhC number (NOT RPS membership number)
* That you are the responsible pharmacist in charge of that premises
Regulations surrounding RP register
- Can be paper or electronic
- Pharmacist must sign the register (must be physically present at pharmacy for this)
Register must include:
* Date and time when the RP became the RP
* Date and time when RP ceased to be the RP
* Date and time at which absence of RP commenced and returned to premises
Register must be kept in pharmacy for 2 years ready for inspection by GPhC
Regulations surrounding RP absence
- RP can be absent for up to 2 hours in each 24 hours (between midnight and midnight)
- Where there are 2 RPs assigned, total absence between them must not exceed 2 hours
- Sale and supply of GSL medicines can take place during absence
- Sale of P medicines, and handing out of POMs can NOT take place
Regulations surrounding private human prescriptions
- Private Rx itself must be retained for 2 years
- Record made in paper or electronic register and retains for 2 years
- Record should be made on the day of sale, or if impractical, the following day
- Rx for oral contraception and Sch 2 meds are exempt from record keeping
What information must a private Rx record contain?
- Supply date
- Prescription date
- Medicine details (name, quantity, form, strength)
- Prescriber details
- Patient details
What are the legal requirements for emergency supply requested by prescriber?
- Appropriate practitioner
- Immediate need- satisfied it is emergency and Rx can’t be obtained
- Promised an obtained Rx within 72 hours (3 days)
- Directions- medicine is supplied in accordance with directions from prescriber
- Not CD 1,2 or 3, except phenobarbital for epilepsy
- Record kept- entry in POM register (retained for 2 years)
What are the legal requirements for emergency supply requested by a patient?
- Interview and satisfied the need is immediate- establish Rx can’t be obtained
- Previous treatment- check PMR or contact prescriber directly
- Dose- appropriate and safe
- Not CD 1, 2 or 3, except phenobarbital for epilepsy
- Length of treatment- if supply is CD (phenobarbital or Sch 4&5) MAX 5 days treatment. POM- MAX 30 days supplied (professional judgement- can give less)
Are there any exceptions to the length of POM supplied under emergency supply?
- If an insulin, ointment, cream or inhaler (i.e. packs can’t be broken), supply smallest pack
- If POM is oral contraceptive, supply full treatment cycle
- If POM is a liquid antibiotic, supply the smallest quantity to complete course of treatment
Record requirements for ES by request of prescriber
- Date POM supplied
- Name, form, quantity and strength of medication
- Name and address of prescriber requesting medication
- Name and address of patient for whom the medication was requested for
- Date on prescription (can be added once Rx is obtained- up to 3 days after)
Record requirements for ES by request of prescriber
- Date of POM supplied
- Name, form, quantity and strength of medication
- Name and address of patient requesting medication
- Nature of emergency
Any label requirements for emergency supplied mediation?
MUST have the words, “Emergency supply” on label
Prescription requirements for vet Rx (POM-V, POM-VPS only)
Prescriber details
- Name and address
- Telephone number
- Qualification
- Signature
- Name and address of owner
- Identification of species of animal
- Address of animal (if different to owner)
- Date of Rx
- Medication name, quantity, dose and strength
- Clear administration instructions (‘AS DIRECTED’- not acceptable)
- ‘UNDER THE VETERINARY CASCADE’
- For Sch 2, 3, must contain ‘THE ITEM HAS BEEN PRESCRIBED FOR AN ANIMAL OR HERD UNDER THE CARE OF VET’
- if repeatable, number of times it can be repeated must be present
- Any necessary warnings or withdrawal
How long as POM-V and POM-VPS valid for?
- Regular valid for 6 months
- Sch 2, 3 and 4 are valid for 28 days
Legal requirements surrounding vet Rx label on medication
- Name of prescribing veterinary surgeon
- Name and address of animal owner
- Name and address of pharmacy
- Identification of species of animal
- Date of supply
- Expiry date of product
- Medication details
- Dosage and admin. instructions (asd- not acceptable)
- Any warnings or withdrawal info
- The words ‘FOR ANIMAL USE ONLY’ and ‘KEEP OUT OF REACH OF CHILDREN’
What records must be made for POM-V and POM-VPS Rx
- Paper or electronic records
- Must be kept for 5 years
- Pharmacists that supply POM-V and POM-VPS MUST take an annual audit
Record must include:
- Name of medicine
- Date of receipt or supply
- Batch number
- Quantity
- Name and address of the supplier or recipient
- Name and address of prescriber
What might a signed order be used for?
- Optometrist and podiatrist because they can’t write a Rx
- Also used for school head office to request salbutamol for school
Legal requirements for signed orders record making
Record must be made in POM register
- Date POM was supplied
- Name, quantity, form and strength of POM
- Name and address, trade, business or profession of the person to whom the POM was supplied
- The purpose for which it was sold or supplied
Can schools request supply of Adrenaline Auto-Injectors (AAIs) without Rx?
Yes- since legislation change in March 2017
Provided it is for individual emergency use, and not for profit
What information should be present on signed order from a school for an AAI?
Order must be signed by the principle or head teacher at the school concerned and state”:
- Name of the school for which the AAI is required
- The purpose for which the AAI is required
- Total quantity required
Which medications require entry into CD register?
Any Sch 1+2
What must be recorded in CD register when a pharmacy premises receives a CD i.e. through order from distributer
- Date supply received
- Name and address from whom received
- Quantity received
What must be recorded in CD register when a CD is supplied to a patient
- Date supplied
- Name and address of recipient
- Prescriber or licence holders details (address not required)
- Details of person collecting (if not patient, record their name and address)
- Whether proof of identity was requested
- Whether proof of identity was provided
Legal regulations surrounding CD requisition
- Only for Sch 2+3
- MUST use standard CD requisition form
- Faxed requisition is not acceptable
- Requisitions of Sch 2+3 are not required for transfer of CD from one pharmacy to another
- Emergency supply can be made to doctor or dentist, providing requisition will be provided within 24 hours (failure to provide will be an offence to the doctor or dentist)
Legal requirements for CD requisition form information
- Signature of recipient
- Name of recipient
- Address of recipient
- Profession or occupation
- Total quantity for drug
- Purpose of requisition
Legal requirements for processing of CD requisition form
- Mark form indelibly with suppliers name and address (pharmacy’s)
- Retain a copy for 2 years from date of supply
- Send the original to relevant NHS agency (‘MARK AND SEND’)
When is ‘mark and send’ of CD requisition form not necessary
When requisition made by:
- Hospital or care home
- Pharmaceutical manufacturers or wholesalers
- Prison pharmacy
- Against midwife supply order
- Against veterinary requisition (original requisition retained for 5 years)
Which medication can a midwife request to obtain using a midwife supply order
- Diamorphine
- Morphine
- Pethidine
What information must a midwife supply order contain?
- Name of midwife
- Name of person the medicine is for
- Purpose to which medicine is required
- Total quantity of drug
- Signature of appropriate medical officer
