Medicines, Ethics and Practice Flashcards
What records must pharmacy professionals submit every year for revalidation?
Four CPD records (at least 2 planned)
A peer discussion
A reflective account
What is ‘punitive culture’?
Is based upon assigning blame and punishment- can lead to reduced reporting and reduced raising of concerns
What is a ‘no-blame culture’?
Where nobody is blamed for mistakes- can lead to complacency and nonchalance. Lack of accountability.
What is a ‘right culture’ or a ‘just culture’?
A culture based upon the principles of fairness, quality, transparency, reporting, learning and safety,
Emergency Supply by the Pharmacist
-Must be an immediate need for the POM, and it MUST have been previously prescribed for the person requesting it.
-No greater quantity than for 5 days must be supplied for phenobarbital or schedule 4 or 5 CD’s.
-YOU CANNOT GIVE AN EMERGENCY SUPPLY FOR A SCHEDULE 1,2 OR 3 DRUG.
-No greater than 30 days supply for other POM’s, eccept if the medication is insulin, an ointment/cream, an inhaler, oral contraceptive or antibiotic.
-Prescription book entry must contain the date of supply, the name/quantity/strength of medication supplied, name and address of the patient, the nature of the emergency.
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What are some examples of class A drugs?
-Cocaine
-Diamorphine hydrochloride (heroin)
-Fentanyl
-Methadone
-Morphine
-Oxycodone
-MDMA
What are some examples of class B drugs?
-Cannabis
-Barbiturates
-Codeine phosphate
-Dihydrocodeine
-Ketamine
-Pholcodine
-Oral amfetamines
What are some examples of class C drugs?
-Buprenorphine
-Most benzodiazepines
-Tramadol
-Zolpidem
-Zopiclone
-Gabapentin and pregabalin
-Androgenic and anabolic steroids
Controlled drugs are divided into 5 schedules. These specify the requirements for importing, exporting, production, supply, possession, prescribing and record keeping for such drugs.
Schedule 1 drugs are not medicinally used. A Home Office Licence is required for their production, possession or supply. A CD register must be used to record details of these drugs if received or supplied by a pharmacy.
What are some examples of schedule 1 drugs?
Hallucinogenic drugs (LSD)
Ecstasy-type substances
Raw opium
Cannabis
Schedule 2 CDs are subject to full CD requirements in relation to prescriptions, safe custody and the need to keep a CD register. Possession, supply and procurement is authorised for pharmacists.
What are some examples of schedule 2 CDs?
-DIamorphine hydrochloride (heroin)
-Morphine
-Methadone
-Oxycodone
-Major stimulants, e.g. amphetamines
-Cocaine
-Ketamine
-Cannabis-based products for medicinal use in humans
What is the difference between the ‘class’ system of CDs and the ‘schedule’ system?
Class= intended to reflect the harm associated with the drug
Schedule= reflects the laws/regulations surrounding the production, supply, etc of that drug.
Schedule 3 drugs are subject to special prescription requirements. Records in regsisters do not need to be kept, however. Invoices must be retained for 2 years.
What are some examples of schedule 3 CDs?
-Buprenorphine (CD cupboard)
-Gabapentin
-Midazolam
-Pregabalin
-Temazepam
-Tramadol
-Pentazocine
Schedule 4 CDs are not subject to CD requirements. Records do not need to be kept (exept for Sativex).
What are some examples of schedule 4 CDs?
-Zolpidem
-Zopiclone
-Benzodiazepines (except temazepam and midazolam)
-Sativex
-Androgenic and anabolic steroids
Schedule 5 drugs includes preparations of certain CDs, and are exempt from virtually all CD requirements, other than the retention of invoices for two years.
What are some examples of schedule 5 CDs?
Codeine
Pholcodine
Morphine
Prescription Requirements for Schedule 2&3 Drugs
- Name and address of patient
-Form and strength of medication
-Total volume/quantity in both words and figures
-Dosing instructions are specific (not just ‘as directed’)
What does it mean if a solution concentration is written as ‘ppm’?
mg/L (so 1 ppm would be 1mg/L)
For examples, 3500-ppm would be 3500mg/L
What does molarity mean?
mol/L (number of moles of solute per litre of solution)
What is % w/v?
g/100ml, so how many grams are in 100ml of solution written as a percentage.
5g/100ml= 5%
REMEMBER:
- 1 TO 7 solution of drug X= 8 total parts
-1 IN 7 solution of drug X= 7 total parts
Displacement Factors:
If it says, for example, Drug X has a displacement factor of 0.3ml per 600mg of the drug, that means that if you add 600mg of the drug to a solution, the solution volume will INCREASE by 0.3ml.
e.g. Dissolve 600mg of drug X in 10ml, the final solution volume = 10.3ml.
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Remember:
Moles= Mass/MR, the mass is in grams.
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What are the rules for selling GSL medications?
- Can be sold in a pharmacy or other retail outlets
-To be sold in a pharmacy, a pharmacist must be signed on as the responsible pharmacist, but can be absent for a limited period of time
Supply Pseudoephedrine and Ephedrine OTC
- Can be used to potentially make crystal meth- reason behind OTC limitations
- Unlawful to supply the product, or combination of products, that contain more than 720mg of pseudoephedrine OR 180mg of ephedrine at any time without a prescription.
-Cannot sell a pseudoephedrine product alongside an ephedrine product without a prescription.
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What are the three methods of emergency contraception?
Copper IUD
Oral ulipristal acetate
Oral levonorgestrel
Oral Emergency Contraceptives (Levonorgestrel 1500mcg and ulipristal acetate 30mg)
-Available as P medicines
-Levonorgestrel is licensed in over 16s up to 72h after UPS or contraception failure
-Ulipristal licensed up to 120h after UPS or contraception failure
What is the maximum number of aspirin tablets that can be sold OTC?
100 per patients
What are the 6 prescriptions requirements in order to make a prescription legal?
- Prescriber signature
- Address of prescriber
- Date
- Particulars of prescriber
- Patient name
- Patient address
(7. Patient age IF under 12 years old)
Repeat Prescriptions
-Prescriptions for schedule 2&3 drugs are NOT repeatable (they are for 4 and 5)
-The first dispensing for a repeat prescription must be within 6 months of the date on the script; there is no legal time limit for the remaining repeats. For schedule 4 CDs, it must be within 28 days for the first issue.
-If no repeat number is specified (how many repeats are prescribed) then the script can only be repeated once (dispensed twice)- for oral contraceptives, it is different and can be dispensed six times in total.
Record Keeping
-Private prescriptions for a POM must be retained for _ years from the date of supply.
-A record should be made in the POM register: supply date, prescription date, medicine details (name, quantity, formulation, strength), prescriber details and patient details
-Private prescriptions for Schedule 2&3 drugs- submit to relevent NHS agencies
-Private prescriptions for oral contraceptives are exempt from record-keeping, as are scripts for schedule 2 CDs where a separate CD register record has to be made.
What details need to be included in a POM book entry?
-A record should be made in the POM register: supply date, prescription date, medicine details (name, quantity, formulation, strength), prescriber details and patient details
When dentists are prescribing on an NHS dental prescription, they are restricted to the medicines listed in the Dental Prescribers’ Formulary.
Why does a fax of a prescription not fall within the definition of a legally valid prescription?
-Not written in indelible ink
-Not been signed in ink by an appropriate prescriber
Schedule 1, 2 and 3 drugs cannot be supplied via an emergency supply (including phenobarbital).
True or False?
True
There are times where POMs may be sold or supplied without a prescription. What are some examples?
- PGDs
-PSDs
-Emergency suplies
-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 is a PGD?
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.
Emergency Supply at the Request of a Prescriber
-Prescription cannot be provided immediately, e.g. patient is unablt to collect prescription, etc
-The prescription must be sent over within 72 hours of the emergency supply
-Not allowed for Schedule 1, 2 and 3 CDs (phenobarbital allowed for the treatment of epilpesy)
-Entry must be made into POM register (date of supply, details of the drug, prescriber details, patient details, date on the prescription and the date the prescription was received).
Emergency supplies are only legal when GP surgeries are closed.
True or False?
False
Emergency supplies can still be done when doctor surgeries are open- use professional judgement
Length of Treatment for Emergency Supplies
-Schedule 4&5 CDs- up to five days treatment
-Other medications- up to 30 days treatment
-Insulin, creams, inhalers etc- smallest possible pack size
-Oral contraceptive- full treatment cycle
What is a signed order, and what needs to be included in order for it to be legal?
Signed orders can be used by schools to obtain supplies of adrenaline autoinjectors and salbutamol inhalers from a pharmacy/
Must include:
-School name
-Product details
-Strength (if relevent)
-Purpose for which the product is required
-Total quantity required
-Head teacher signature
Records must be kept by the pharmacy for two years OR an entry made in the POM register (best to do both)
What are some examples of medications that carry a high risk of foetal malformations if the patient were to get a pregnant whilst taking them?
Oral retinoids (acitretin, isotretinoin)- for severe skin conditions
Valproate
Thalidomide
Lanalidomide
What is a biologic?
A medicine made from a variety of natural sources that may be human, animal or microorganism in origin.
Veterinary Prescription Requirements
-Name, address, telephone number, qualification and signature of prescriber.
-Name and address of owner
-Identification and species of animal
-Date; Rx are valid for 6 months (sch 2,3,4 CDs are 28 days)
-Name, quantity, dose and administration instructions of the medicine
-Necessary warnings
The Veterinary Cascade
-The Cascade is an exemption within the Veterinary Medicines Regulations and specifies that where a licensed veterinary product is unavailable, other medicines can be considered.
-Unlawful to supply a human medicine against a veterinary prescription unless it is prescribed by a vet and specifically states that it is ‘for administration under the Cascade’.
IMPORTANT: ‘for administration under the veterinary cascade’ is only a legal requirement if the medication being prescribed is a HUMAN POM, not required if it is a medication that is only used in animals.
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Labelling of Veterinary Medicines
-Name of vet
-Name and address of the animal owner
-Name and address of the pharmacy
-Identification and species of animal
-Date of supply
-Product expiry date
-Name of product
-Administration instructions
-‘For animal treatment only’
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Record Keeping- Veterinary Prescriptions
-Name of medicine
-Date of the supply
-Batch number
-Quantity
-Name and address of recipient
-Name and address of prescriber
Keep records and documents for at least 5 years
For how long do veterinary prescription records need to be kept?
5 years
Responsible Pharmacist Legal Requirements
-Display a notice that give RP details in the pharmacy
-Making and keeping records
-Pharmacy procedures
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Responsible Pharmacist: Absence From the Pharmacy
-Legally can be absent from a registered pharmacy for 2 hours in a 24 hour day, and continue to sell GSL medicines. Must return within reasonable promptness and be contactable. No P or POM allowed.
-If another pharmacist is present, GSL, P and POM medicines can be sold and supplied, but the absent responsible pharmacist is still accountable for what happens.
How long does a GP have to send over the original copy of a prescription if they have faxed a prescription over for a POM?
72 hours
How many days supply of phenobarbital can be supplied on an emergency supply for epilepsy?
5 days
Which CDs can pharmacist independent prescribers not prescribe?
Diamorphine
Dipipanone
Cocaine
What is the minimum length of time a record of the responsible pharmacist needs to be kept?
5 years
Pregnancy Prevention Programme Script Validity
- Isotretinoin script validity is _ days
-Sodium valproate script validity is 6 months
7
How long should the CD register be kept after the last entry?
2 years
What does ‘bioavailability’ mean?
The craction of the drug that reaches the systemic circulation and is expressed a number from 0 to 1. Basically how much drug can be ‘used’ for its indication.
Remember: Private AND NHS prescriptions for schedule 2 and 3 CDs should be submitted to the relevent NHS agency.
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REMEMBER: mEq/L is the same as mmol/L.
How often should SOPs in a pharmacy be reviewed?
At least every 2 years
How long do doctors have to supply a script if they have requested an emergency supply for a patient?
72 hours
What does a P value of <0.05 represent?
Indicates a result that is significant
NHS scripts can have a date of issue and also a date on it for when the prescription can be dispensed, for example ‘dispense on 10/4/23’, even if the script was issue 3/4/23. For private scripts, the date of issue has to be the date that a script can be supplied from, can’t state a later date.
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Where can you look to see which drugs can be prescribed by a dentist on an FP10D script?
BNF
Which classification is used to help determine how to manage a patient that presents with a sore throat?
FeverPAIN score
Which classification is used to determine whether a patient requires anticoagulation?
CHA2-DS2-VASc score
Which classification is used to aid the prescribing decisions for contraceptive methods?
UKMEC score
