Flashcards in Extemp Exam Deck (181):
What's the main aim of personalised medicine?
To ensure treatments meet the needs of INDIVIDUAL patients and to maximum efficacy of treatment, and significantly reduce the risk of undesirable side effects
Where are CYP450s found? What do they do?
Found on cells smooth endoplasmic reticulum
Highest conc in liver and small intestine
Add oxygen atoms to molecules, makes them more water soluble
10% of the population get little pain from codeine due to the enzyme _______
What two variants are being tested to determine more accurate dosing of warfarin based on a patients genotype?
Gene variations for the CYP2C9 enzyme that metabolises warfarin
And in the gene for the vitamin K epoxide reductase enzyme
How can we personalise the treatment of cancer with Trastuzumab (Herceptin)?
Drug binds to HER2 proteins, it's a monoclonal antibody
We can Test cancer patients to see if they have over production of HER2 BEFORE treating with this drug as these are the only patients who will benefit from it
Definition of a special?
A non-licensed medicine manufactured to fulfil the prescribers requirements
Manufactured under a 'Special Manufacturing License'
Definition of an import?
A product that has a product license in its country of origin
Definition of extemporaneous preparation?
Made under the supervision of a pharmacist under section 10 of the Medicines Act 1968
Which regulations exempt the need for a MA for a relevant medicinal product, which is supplied to fulfill a 'special need'?
HMR 2012 part 10: exception to requirements for a marketing authorisation
When can doctors give unlicensed medication?
If the licensed form is inappropriate for the patient
If there's evidence the unlicensed form is SAFE
As long as they monitor and follow it up
Remember doctors are liable if the unlicensed med causes harm
It's a legal requirements that specials products are _________ by the requesting pharmacist
Commissioned/ signed off
Any unlicensed meds must be made up in licensed premises, that is they've been inspected by the _____
E.g Registered pharmacies under supervision of a pharmacist
What are some of the risks associated with extemporaneous dispensing?
Feisty Cats Like Rapping Songs Quite Loudly
F= Failure of Formulation : eg microbiological contamination, bioequivalence issues, dose uniformity (overdose or underdose), issues with stability
C = Calculation errors
L = Labelling errors
R = Raw material contamination
S = Safety and efficacy unknown
Q = QA and GMP issues
L= lack of standards and specifications
In extemporaneous dispensing there's some risks to staff. What are these?
Liability, they have a lot of responsibility
May be exposed to harmful substances when crushing tablets or weighing and pouring etc
How can we minimise risk in extemporaneous dispensing?
Do risk assessments to ensure a safe outcomes
Record keeping to safeguard patients
Patient information- make sure pharmacy staff communicate with patients
Correct equipment and facilities available
How can we comply with quality requirements in extemp?
Make sure premises comply with GMP
Follow QA systems, eg following pharmacopeia monographs
Make sure batch testing systems are in place
Certificates of analysis for batchs
Yellow card ADR reporting schemes
When using a product within its licence, liability lies with the manufacturer if it all goes wrong. When using an unlicensed product, who does liability lie with?
The pharmacist AND the prescriber
What's an overall definition of specials and unlicensed medicines?
Medicinal products prescribed by doctors for specific indications for which a licensed product does not exist or is no longer available on the market.
Repackaged medicines are classed as specials/ unlicensed. Meds prepared by a manufacturer but aren't available in UK are also classed as this (unlicensed). What about medicines prepared for a specific patient, to use with doctors instructions?
This is classed as specials
Does a pharmacy require a specials manufacturing license?
No, all suppliers and manufacturers of specials must have one apart from pharmacies, as the law recognises that pharmacists should have the knowledge to safely prepare and supply medicines without a manufacturers license.
If a patient experiences an adverse effect for a product that has been prescribed within its terms of license, who can they prosecute?
Ie the ones who created the sPc
if it's a special/ unlicensed then the prescriber gets the blame
Specials don't need a Marketing authorisation, and can be given by a practitioner in the UK. Who may these practitioners be?
Nurse independent prescriber
Pharmacist IP or supplementary prescriber
Specials manufacturers can advertise their _______ but not their _______
Can advertise their services
But not their products!! Cannot advertise specials
HMR 2012 makes the exception that a pricelist of products they usually make can be published by manufacturers, can't include bespoke products in this!
What does be-spoke mean?
Custom made, completely tailored to an individual patient!
The HMR 2012 requires anyone selling or supplying an unlicensed medicines to keep a record of supply for _______?
What are transmissible spongiform encephalopathys?
Also known as prion diseases, caused by prions (infectious agents composed of proteins in a mis-folded form)
Progressive conditions effecting brains and nervous system
What are the TSE guidelines?
Unlicensed medicines for human use (transmissible spongiform encephalopathies) safety regulations 2003
All manufacturers, importers AND exporters MUST comply with these, otherwise the import is not allowed.
If an unlicensed medication is supplied and proves a risk of TSE, those who manufactured and imported the medication should be held liable as they should have checked TSE guidelines have been followed in the manufacture.
When do TSE guidelines NOT apply?
Don't apply to pharmacists making up unlicensed medicines in the pharmacy
What are chief pharmacists and superintendent pharmacists responsible for?
Responsible for making sure systems are in place to safeguard public health and the safety of patients being supplied unlicensed medication
What different things could a product be in order to be classified as hazardous?
Organ toxicity (at low doses)
What's the risk of cytotoxic chemotherapy agents to patients? Where's the riskiest place to make up cytotoxics?
Secondary neoplasms in patients
Preparing chemo on the wards
What engineering control can we use in grade C rooms? What should we use for hazardous substances?
Use biological safety cabinets in grade C rooms
Use ISOLATORS when handling hazardous materials
What is composite air flow?
Where airflow comes down and protects product from contamination
It is double filtered air
What types of gloves offer best protection?
Nitrile and neoprene gloves
What is the best practice with needles?
Using luer-lock syringes
Using vented needles or filter needles- these normalise vial pressures and minimise aerosols
Use chemo mats: these will absorb any spill ages
__________ of needles is not permitted in a healthcare setting
What's the process of decontamination?
Firstly remove organic matter using an aqueous cleaner or a detergent as this will inactive alcohol
Then do alcohol clean
Any biologics that may be present- denaturation is needed using liquid or gaseous chemicals
What will a PN bag contain?
Protein (AS AMINO ACIDS)
Carbohydrate (AS GLUCOSE)
What are micro nutrients?
Trace elements such as zinc
What is the difference between a 2 in 1 TPN solution and a 3 in 1?
2 in 1: the aqueous mix (I.e amino acids and glucos etc) are in a seperate section to the lipids
3 in 1; the aqueous solution (amino acids, glucose etc) is in the same bag as the lipids, all ingredients in one
What's a triple chamber TPN bag?
3 different sections
One for glucose, one for amino acids, one for lipids
What's the problem with sunlight and TPN bags?
Sunlight can break down any vitamin A in the bag
Also if a lipid emulsion is exposed to both oxygen and sunlight, lipid peroxides may form which can be harmful
You need to be careful of oxidation of Amino acids in TPN bags. Why?
Tryptophan degradation products may cause cholestasis
If a solution is BROWN it usually means it has oxidised
Some trace elements may catalyse the breakdown of vitamins. What's an example?
Copper catalysing the breakdown of vitamin C
Vitamin C in TPN bags will oxidise to oxalic acid. Unless you can get all your oxygen from out your bag which isn't usually possible! Oxidation catalysed by copper ions and light
Oxalic acid will precipitate with calcium
The loss of vitamin C from the bag needs to be supplemented so need to calculate estimated loss
What's the link between precipitation in TPN bags and pulmonary embolisms?
Precipitation results in particles in the TPN bag
These can block small capillaries in the human
Results in pulmonary embolisms
When adding strong injections of calcium/ magnesium/ phosphate to a TPN bag whys it so important to MIX between additions or to DILUTE the solutions before adding to the TPN bag?
If this occurs you will get precipitation (insoluble precipitate forms)
You will therefore see cloudiness
This results in a risk of EMBOLISM
With calcium phosphate this precipitate formation depends on 4 factors, what are these?
(Also temperature, as precipitates more likely to form at high temp, so store in fridge!!)
What should the final pH of TPN mixtures be maintained at?
pH 5.00 and above!
should definitely be below 6 to reduce precipitation
Increasing temperature can also make formation of precipitates more likely. What can we use to stop precipitates forming?
What's the max concentration of glucose that should be used in peripheral veins? Why?
This avoids phlebitis (inflammation of veins)
High concentrations destabilise fat emulsions (40-50% conc)
High concentrations cause hyperglycaemia
Why are lipid emulsion tiny droplets of fats immersed in water designed to be the same size as chylomicrons?
Chylomicrons are lipoprotein particles found naturally in the body, so we know these are an ok size and won't block capillaries etc
What are the three stages of lipid instability that can happen with lipid emulsions in TPN bags?
1) fat droplets start to join (aggregation)
2) creamy layers are seen (Reversible with mixing)
3) cracking: oily layers sat on top of aqueous phase, not able to mix again. Cracking = danger to patient!! Lipid micro-embolisms
What causes destabilisation in lipid emulsions?
Electrostatic effects causing repulsion between lipid particles is GOOD- keeps lipid particles seperate
Some factors may interfere with this repulsion
Eg positive ions like Al +++ bring lipid particles together
Or pH; over 6 we can get precipitation
Glucose concentrations (40-50%)
Time (if we leave for a long time we get precipitation)
Amino acids act as a _______ in TPN bags
They therefore stabilise other constituents
And they ______ with metal ions
_____ pHs can cause precipitation of amino acids
Act as a buffer
Can chelate metal ions
Low pHs cause precipitation
What is the best type of TPN bag (container) to use? Why?
It's a good barrier to oxygen
It reduces oxidation reactions and loss of ingredients and stabilises the formulation, doesn't leach
PVC; problems with leaching
EVA; problems with letting in oxygen
We should seperate vitamins and trace elements in TPN bags. How can we do this?
Put vitamins in the lipids (fat emulsion) bag
Put trace elements in the amino acid/ glucose bag
As copper may catalyse breakdown of vitamin C !
Whys it important to allow PN feeds to warm up to room temperature ONE HOUR before use?
Cold infusions may cause cardiac arrest
Why do we need to be extra careful when adding calcium / magnesium to inorganic phosphates in TPN bags?
Precipitates are likely to form eg calcium phosphate
To stop this we need to MIX between additions
Would be good to use an inorganic phosphate SALT where possible
It's recommended that ALL PN bags are QC tested. What are some of the QC testing methods used?
Infusion bags may be needed for ____ drugs as in a syringe they're very concentrated whereas in a bag they're more dilute.
Infusion bags give the dose slower
What pH range do opthalmic solutions for the eyes need to be buffered at?
Need to be buffered in the pH range 4.5- 11.5
What TONICITY and osmolarity should be used for opthalmic solutions for the eye?
300 mOsm/ L is ideal
200-600mOsm/L is acceptable
TONICITY: 0.6- 1.8% sodium chloride is tolerated
Why should intrathecal formulations to be injected not really contain any other additives eg antimicrobials, antioxidants, pyrogens, preservatives?
They can be TOXIC to the CNS (intrathecal: going into spine)
Sodium chloride should be used as Tonicity agent
Particulates are ok (microspheres for slow release)
What is the ENDOTOXIN limit formula?
EL= K / M
K = max number of EU of endotoxin a patient may receive without suffering toxic reactions
M= maximum dose of substance per person (or per kg) per hour
What are the two values of K in the ENDOTOXIN limit equation?
K= 350 per person for parenteral preparations
K = 14 per person for intrathecal
This is because intrathecal injections are going into the spinal cord, therefore these will have a lower limit for endotoxins!! Don't want these on your nerves--ouch!
Fentanyl citrate has a bacterial endotoxin limit of 5.0 mg/L. Work out the maximum dose of it you can give for a parenteral formulation?
EL= K / M
M = K / EL
K for parenteral = 350 per person
350 / 5.0 = 70ml/ person/ hour
Fentanyl citrate has a bacterial endotoxin limit of 5.0 mg/L. Work out the maximum dose of it you can give for an intrathecal formulation?
EL = K / M
M = K / L
K for intrathecal = 14 per person
So M = 14 / 5,0 = 2.8 ml / person / hour
What does the orange guide set out?
Microbiological testing guidelines
Recommended limits for microbial contamination in rooms
Grade A = zero contamination, so that's inside an isolator
Grade B= ?
Open fronted cabinets
Grade C= room containing an isolator (the isolator itself is grade A)
What's grade D?
The room you get changed in
Settle plates are a passive technique using gravity to collect microbes. But they only represent 0.2% of the work surface. Contact plates are slightly better, the media includes a neutraliser, roll the plate on the surface for around __ seconds
5 seconds contact time
Why is sterility testing abit useless?
They take 14 days
Only tests the container for sampling
Poor indicators of low levels of contamination therefore no good for grade A rooms
What four environmental monitoring techniques could we use in grade A rooms?
Continuous particle monitoring
DOP (HEPA) filter testing (every 6 months)
Bubble point test
Visual inspection of products
What 5 things can we do to ensure we are contamination free? (All QA)
Use licensed starting materials
Use only CE marked devices
Seperate products and facilities (rooms)
Make sure you've got the appropriate shelf life, conduct stability studies
Validate cleaning procedures
What's the difference between luer lock and luer slip?
Luer lock: allows needle to be twisted onto the tip the locked into place, preventing accidental removal of the needle
Luer slip: allows needle to be pushed onto the tip not twisted, it's usually cheaper but less safe
What is the key difference between nuclear medicine and X. Rays
Nuclear med uses isotopes which show function. They show changes as they happen.
X rays only show structure. They show changes post event. Not whilst they're happening
What helps to give a clearer image with a gamma camera?
Allows only radioactivity from one angle to pass through, and absorbs the rest of the scatter
How do we make a radio pharmaceutical?
Mix radioactivity plus saline
What's a good radionuclide to use?
It has a 6 hour half life which is long enough to get a scan done but patient won't be radioactive when they leave
It's a gamma emitter
It decays to a stable isotope which is relatively low energy but suitable to be detected on a gamma camera
Also good as it combines to a large range of targeting tracers
What two radiopharmaceuticals are good to use in kidney transplants?
DMSA and MAG3
Can see renal scarring with DMSA
Used in children quite a lot
MAG3 used to see if kidney is functioning
Left kidney has poorer throughput of tracer
How can we use radiopharmacy to scan the lungs?
To look at breathing: patient inhales Krypton 81 gas
To look at perfusion: inject MAA
Look for mismatches between the two
Can diagnose pulmonary embolisms
What radiopharmaceutical is used in thyroid imaging?
What radiopharmaceutical Is used for the stomach?
What radiopharmaceutical is used in the bones?
Organic phosphate complex
Uptake depends on bone turnover
Bone metastasis: increased uptake: see black spots on scan
Colloid scans are small scans often used for imaging the _______ system.
What's the difference between certificate of conformity and certificate of analysis?
Certificate of analysis should be avaiable for any batch manufactured as 'special' and is evidence that critical parameters have been confirmed by physical, chemical or microbiological assay of a sample of the final product.
Certificate of conformity is a signed statement by the manufacturer that they believe the product complies with the purchasers (pharmacists) specification.
What are the three types of non spore forming bacteria?
Staphylococcus streptococcus and micrococcus
Name 5 fungal spores
What kinds of bacteria produce spores?
Yeast beginning with R
In Aseptics should the room be kept at a positive or negative pressure?
Doesn't let any outside air into the room
What kind of disinfectants need to be used in grades A and b and C and d areas?
STERILE disinfectants in grades A and B
Spore free disinfectants in grades C and D
How do you clean a laminar flow cabinet?
Use sterile neutral detergent at start and end
Use alcohol sprays
And weekly bleach
What's the maximum expiry of aseptic products?
Can be longer if made in a licensed facility
There are two disinfection methods of the Aseptics area (isolator/ cabinet) what are these?
2) spray-wipe-spray with 70% alcohol
Note: alcohol is not sporicidal so you need to Wipe in order to mop up any spores
Work in spray booths with fume extractors or drip trays and wear gloves
Use aerosol sprays
Wet all surfaces including labels (paper is a source of contamination)
Let the alcohol DRY or it won't work
What is process validation?
Competency of facilities and operators process simulation
What is operator validation?
Staffs competency in technique
Operator and process validation should be done at least ___ times initially and regularly thereafter
What kind of things does cleaning validation involve?
Surface sampling before and after cleaning
Swabs and contact plates
Remove chemical contamination
Incubate samples for 5 days
How long should agar plates be incubated for and at what temp?
Incubate for 5 days at 30-35 degrees
What's a Universal Operator Broth validation test?
Assesses an operators ability to maintain the sterility of materials during the preparation of Aseptically prepared injectables
It's a way operators can show competency in Aseptics
Can also do end of session broth tests
Clinical trials: if you're looking at a product already with a product licence, you only have to submit a ____.
New agents have to subunit an ______ ______ which is much more complex.
What is the definition of an Investigational Medicinal Product?
A form of an active substance/ placebo being taste or used as a reference in a clinical trial including products already with a marketing authorisation but are used or assembled, or packaged in a different way to the authorised form or when used for an unauthorised indication, or used to get further information on an authorised form.
What is reconstitution with reference to IMPs?
Either dissolving the IMP for administration into the trial subject or diluting/ mixing the IMP with some other substance used as a vehicle for the purpose of administering
It is NOT mixing up several ingredients including the API as this is manufacture
When doles reconstitution need to be done?
As close to administration to a patient as possible
When is something classed as manufacture?
When you're mixing up several ingredients including the API
When you're dispensing / reconstituting an IMP do you need to label?
If something is classed as manufacture, what license is needed?
An IMP license
It's signed off before going to the trial patient
What do we usually use as a diluent in protein injectables?
But some proteins may be insoluble at high salt, so may require dilute saline.
Do not use dextrose, can react with Lysines and form Schiffs bases
What factors can denature proteins/ make them less stable / cause them to form aggregates?
Freezing or thawing
Low or high pHs
Low or high Salts: could poss make protein more stable
What 6 things can cause a protein to denature?
Salt bridges breaking/ moving
H bonds breaking
Structural water: getting in structure of protein
Hydrophobic surfaces (proteins are more hydrophillic)
What type of aggregate do insulin and growth hormone form? How can this be dissociated?
Dilution or alter pH
What can irreversible non covalent protein aggregates be dissociated by?
Can you filter out soluble aggregates of proteins using a 0.2 micron filter?
These have a very small aggregation number
So they are very small
Can't visually detect: I.e they won't make the solution turbid like insoluble aggregated
Liquid proteins should be shipped and stored at a temp of ____-. They should also be ______ before administration.
Should be mixed
What is lyophilisation?
Dehydration process used to preserve a protein and it's excipients by removing all water and forming a solid powder. Requires reconstitution before administration.
Allows it to be shipped at ambient temperatures
Mix the powder before reconstitution, mix the solution after reconstitution.
With lyophilisation is there More or less risk of contamination ?
More risk of contamination
Due to additional manipulation being required
Genetic manipulation definition?
The manipulation through genetic engineering of living organisms or their components to produce useful products like pest controls and protein drugs
What are the 4 steps in cloning?
1) fragmentation (isolate your DNA fragment and amplify it using PCR)
2) ligation - glue together pieces of DNA in a desired sequence
3) transfection: insert new DNA into cells
4) screening and selection: select cells that have successfully been transferred with the new DNA
What two ways could we transfect DNA?
Could put recombinant DNA plasmids into E.coli and allow it to replicate
Could put our plasmid into a lipofection reagent, forming a DNA- lipid complex which can be endocytosed into mammalian cells and release DNA.
How can we increase the circulatory time of proteins?
Couple protein to albumin
Couple to PEG
Makes protein bigger so less likely to be cleared
Biosimilars are like generic versions of proteins
They increase access for patients as prices come down
Patents expire after ____ years
How can we come up with the whole genome assembly?
Overlap gene fragments from 5 different individuals
Combine these to make a big consensus sequence
Consensus sequence then connected together into scaffolds
Then mapped to genome with STS physical map information
What are strict orthologs?
Comparing human, fly and worm genomes
Looking for "best hits"
What is a transposon?
A DNA sequence that can change it's position in the genome
siRNA can lead to mRNA degredation by making it dsRNA
Directs degredation by enzymes ____________
Endonucleases and exonucleases
How can we improve absorption in biotechnology?
Alter the barriers (in lung or gut) eg penetration enhancers
Alter Formulation, eg shift to lymphatic uptake rather than venous
Overcome blood barriers
Improve retention time in tumours eg via the EPR effect
What's the difference between reproductive cloning and therapeutic cloning?
Reproductive cloning: generating an animal with the same nuclear DNA as another animal
Therapeutic cloning: involves human stem cells harvested from human embryos
Issues as it destroys the embryo
What is PQS?
A management system to direct and control an organisation with regards to QUALITY
What three main factors / aims does PQS involve?
Achieving product realisation so taking something from an idea and turning into a product
Establishing control of this transformation process
To enable continual improvement by reassessing procedures and following things up all the time
Definition of quality
The totality of characteristics satisfying the stated and implied needs
It's all about complying with the specification and meeting the needs of customers eg patients
What is the ICHQ10?
It is a model of an effective quality system
It describes a model PQS implemented throughout a products life cycle
Developed by the expert working group of harmonization of technical requirement for pharmaceuticals for human use
It states that implementing a quality system will enable a pharmaceutical organisation to meet ethical and regulatory obligations
GMP concerns ______ and ________
Production and quality control
GMP vs PQS?
GMP is compulsory, it's the bare minimum
PQS is not
GMP is not a system,
Following GMP does NOT lead to PQS, have to do extra as GMP is just QC and production only, no QA etc
PQS is a management tool
What are cold chain products?
Medicinal products that need to be stored and shipped at lower than ambient temperatures to ensure their quality and efficacy
So need to store at colder temperatures
Are all at risk of damage from _______ as well as _______
From freezing as well as elevated temperatures
Temperatures and storage rooms need to be monitored and recorded how often?
Plus reviewed regularly too
With fridges, we should aim for __ oC
Pharmaceutical fridge _______oC
Blood bank fridge _________oC
Pharmaceutical fridge: 2-8oC
Blood bank fridge: 2-6oC
How can we monitor fridge temperatures?
Use a calibrated electronic min/max thermometer with an accuracy of +/- 0.5 oC
Should be able to read this without opening fridge door
Base of a fridge is not a shelf. Should be a gap of ~______ between bottom shelf and base.
How can we control temperature during transport?
Can get validated temperature control systems such as thermal packaging that keeps the contents at a constant temp, temperature controlled containers, refrigerated vehicles
Hormone based medicines are very sensitive to ________
Diagnostic test strips are very sensitive to _________
Hydrocortisone is useless in the ________
___________ can cause stomach and kidney damage
_________ can kill
Sensitive to temperature changes
V sensitive to humidity
Useless in the heat
Decayed antibiotics can cause stomach/ kidney damage
Deteriorated insulin / GTN can kill
What medicines are most likely to be counterfeit?
High values drugs like Viagra
High volume mid priced drugs like Lipitor
High value IV lines like epogen
It's all about the money money money
What extra label must be on all creams?
For external use only
For a cream that is diluted, what's the expiry?
This is freshly prepared
2 week expiry
For creams that are non diluted, what is the usual expiry given?
What is trituration?
The grinding together of two or more substances to achieve a homogenous mixture.
Could be mixing two powders or two creams
Incorporation into the base
What powdered substance DONT you need to weigh excess of?
Cream or ointment, which is best for an emollient for dry skin etc?
Ointment, specifically hydrophobic ointments and water emulsifying ointments
Ointments act as emollients as they have a better occlusive action than creams, this means they provide hydration
Which is more prone to contamination, creams or ointment?
Higher water content
For a diluted ointment, what's the expiry?
2 weeks expiry
As it's classed as freshly prepared
For ointments that haven't been diluted, what's their expiry?
What extra label must be on all ointments?
For external use only
What is the classification of freely soluble?
1 in 1 to 1 in 10
What is classed as soluble?
1 in 10 to 1 in 30
What is classed as slightly soluble?
1 in 30 to 1 in 1000
What is classed as very slightly soluble?
1 in 1000 to 1 in 10,000
What's the order we should dissolve solute in?
Start with the LEAST soluble in the vehicle first
Then the next least soluble
The most soluble dissolved last
What should we dissolve solutes in?
Flat bottomed beaker to avoid caking
Double strength chloroform water strength:
Single strength chloroform water strength:
Double strength 1 in 20
Single strength 1 in 40
Max strength of chloroform as an antibacterial agent?
0.5% w/w or w/v
A solution that is freshly prepared ie made within the previous 24 hours usually has an expiry of?
Anything that is recently prepared must be discarded after _______
And stored at 15- 25 oC
Anything that is freshly prepared must not be more than 24 hours before it is issued for use. It is given an expiry of?
Do solutions need to be stored in vertical fluted bottles?
No since the HMR 2012
Store in fridge: what's the temp range?
Store in cool place: what's the temp range?
2-8 oC for fridge
8-15 oC for cool place
What is the usual expiry date of solutions?
What is generally on the label of solutions?
Shake well before use
Sometimes store in a cool place
What's the difference between a coarse and colloidal suspension?
Coarse: particle size is greater than 1mm diameter
Colloidal: particles are less than 1mm diameter
General expiry date for suspensions?
(2 if freshly prepared)
Label for suspensions?
Shake the bottle
(Not to be taken by mouth for inhalations)
(For external use only for any not oral)
Specials can be prescribed by doctors, dentists, nurse IPs, pharmacist IPs, supplementary prescribers.
Who can extemporaneous products be prescribed by?
Only a doctor or dentist
Not pharmacist IP nurse IP etc
How long must pharmacists keep records of extemporaneous supplies for?
What's the usual expiry of pharmaceutical powders?
2 weeks expiry
What's the inert diluent used to bulk out powders?
What is the maximum one stage dilution in pharmaceutical powders?
1 in 20
What is a LEGAL requirement for the label of any product not intended for oral use?
For external use only
Or not to be taken by mouth on ear, eye, nasal, vaginal, rectal preparations
What label is advised on all products extemporaneously prepared unless otherwise stated?
Store in a cool dry place
What four kinds of organisms are we likely to find in a clean room?
A big white and quite dry colony is likely to be ?
What's bout yellow?
What about white?