111 Questions
Extemporaneous dispensing is also known as compounding.
True
Specials are only licensed medicines.
False
The hub pharmacy model is used in Belgium for compounding.
False
Regulation 167 of the Human Medicines Regulations 2012 exempts the requirement of marketing authorization for Specials.
True
Guidance Note 14-MHRA states that no record of procurement in pharmacy is required for Specials.
False
Extemporaneous preparations only include batch-produced sterile products.
False
Specials manufacturer can supply to anyone, including individuals.
False
The shelf life of a product with no formal stability data can exceed 30 days.
False
The Peppermint Water Case resulted in the death of a 3-week old baby.
True
It is important to picture the best-case scenario during risk analysis.
False
Electronic Balances should not be checked daily with standard weights.
False
The availability of Raw Materials is not important in the procurement and supply of specials.
False
Creams are more prone to microbial growth compared to ointments.
True
Physical problems like cracking and caking are not common in formulation.
False
The shelf life of a closed pack could be longer than that of an opened pack for certain products.
True
Traditional terms Elixir, Mixture, Linctus are no longer used in pharmacy.
True
Reefers are small cigars filled with drugs.
False
Coal Tar Solution BP (20%) is a clear solution.
False
Using the highest strength tablets is recommended to reduce overall excipients in oral liquids.
True
It is vital to ensure correct clinical interpretation of prescription in order to prevent dispensing errors.
True
Errors in pharmacy practice are usually insignificant.
False
Pharmacists should always use the same brand and strength to avoid errors.
True
The misuse of drugs is regulated by the Misuse of Drugs Act 1971.
True
Employment law is not relevant to pharmacy practice.
False
The Orange Guide introduces the concepts of a Quality Assurance System and Good Manufacturing Practices.
True
Specials Manufacturing License requires three key personnel: Head of Production, Head of Quality Control, and Head of Research.
False
Cleanrooms are not required for extemporaneous dispensing in the pharmaceutical industry.
False
What is another term for extemporaneous dispensing?
Compounding
Which of the following is considered as 'Specials' in the pharmaceutical context?
A mixed bag of products
In which country is all compounding performed in pharmacies?
Belgium
What is the purpose of Regulation 167 of the Human Medicines Regulations 2012?
Set conditions for the exemption from marketing authorisation
According to Guidance Note 14 by MHRA, what must be done regarding the procurement of 'Specials'?
Keep records of procurement in pharmacy
In the context of extemporaneous preparations, what does 'Specials manufacturer' refer to?
Manufacturer specializing in unlicensed medicines
What is the maximum shelf life if no formal stability data is available for a special?
30 days
What is a key requirement for the facilities in specials manufacturing?
Control of cross contamination
What is an important requirement for equipment in specials manufacturing?
Government stamped measures
What is the key advantage of an Unguator in the manufacturing process?
Closed system and operator protection
Why should electronic balances be checked daily with standard weights?
To ensure accuracy and calibration
What is a common problem with specials prescriptions related to creams and ointments?
Lack of details on prescriptions
How are ingredients of creams or ointments sometimes expressed on prescriptions?
% but don’t add up to 100%
What is one of the sources of formulae for specials manufacturing?
Compendia e.g. BP, Martindale
What is important when considering the availability of raw materials for manufacturing specials?
Pharmaceutical Grade, BP , PhEur or USP
What should be considered when formulating specials with regards to microbial considerations?
Presence of preservative system and allocation of shelf life
What are commonly requested non-sterile dosage forms in specials manufacturing for application to the skin?
Creams, Ointments, Pastes, Lotions, External Solutions
Which term is used to refer to Reefers?
Cigarettes injected with drugs
What is the primary purpose of the Orange Guide?
Introduction of a Quality Assurance System and Good Manufacturing Practices
What are the responsibilities of the Head of Production and the Head of Quality Control in Specials Manufacturing?
Ensuring regulatory compliance and process validation
What is the purpose of the Green Guide?
Guidance for Pharmaceutical Distributors
Which document provides professional guidance for the procurement and supply of Specials?
MHRA guidance note 14
What is the primary concern when scaling up from crushing tablets to using powder (API)?
QC Testing
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
MHRA Licences
What does the Green Guide provide rules and guidance for?
Pharmaceutical Manufacturers and Distributors
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
To prevent dispensing errors that can lead to overdose or sub-therapeutic dose
What is the primary purpose of Regulation 167 of the Human Medicines Regulations 2012?
To exempt the requirement of marketing authorization for 'Specials'
What distinguishes extemporaneous dispensing in the pharmaceutical industry from compounding?
The method of preparation
What are 'Specials' commonly known as?
Unlicensed medicines
What is the purpose of the Green Guide?
To introduce Quality Assurance System and Good Manufacturing Practices
Why is it important to ensure correct clinical interpretation of a prescription in pharmacy practice?
To prevent dispensing errors
What is the primary concern when scaling up from crushing tablets to using powder (API)?
Maintaining homogeneity
What is a key consideration when making a suspension from tablets?
The highest strength tablets available
Why is it important to check tablet characteristics when preparing oral liquids?
To identify controlled-release tablets
What is the purpose of a Material Safety Data Sheet (MSDS) mentioned in the text?
To ensure the safe handling of coal tar solutions
What is a common ingredient mentioned for use in cream bases?
Salicylic Acid Powder
What is the primary reason for emphasizing the full understanding of required calculations in pharmacy practice?
To prevent dispensing errors and ensure correct clinical interpretation of prescriptions
Why should pharmacists always use the same brand and strength, with care for generics?
To ensure consistent drug quality and efficacy
Why is good practice to standardize to dose/5ml or dose/1ml in oral liquids?
To simplify dosage administration for patients
'Reefers' mentioned in the text are associated with:
'Reefers' (cigarettes injected with drugs)
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
Comply with Good Manufacturing Practices (GMP)
What is the purpose of the Orange Guide mentioned in the text?
To introduce concepts of a Quality Assurance System and Good Manufacturing Practices
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
The need for cleanrooms in extemporaneous dispensing
What is the primary purpose of the Green Guide mentioned in the text?
To provide guidance for the procurement and supply of Specials
Why should electronic balances be checked daily with standard weights?
To maintain accuracy in measuring pharmaceutical ingredients
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
The use of licensed medicines in extemporaneous dispensing
What is a key consideration when making a suspension from tablets?
The suitability of the tablet excipients for suspension preparation
Why is it important to check tablet characteristics when preparing oral liquids?
To confirm the tablet's suitability for crushing and dissolution
What should be done when considering shelf life, closed and open pack sizes, and storage conditions?
Conduct a risk analysis for potential errors in dispensing
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
The use of licensed medicines in extemporaneous dispensing
What should be considered when formulating specials with regards to microbial considerations?
The existence of a preservative system in the formula
What is another term for extemporaneous dispensing?
Non-sterile dosage form preparation
Why should pharmacists always use the same brand and strength, with care for generics?
To minimize excipient variation in pharmacy preparations
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
The lack of formal stability data required for extemporaneous preparations
What is the primary purpose of a Hub pharmacy model in the context of compounding?
One Compounding pharmacy serving a community.
What does Regulation 167 of the Human Medicines Regulations 2012 exempt from the requirement of marketing authorisation?
Extemporaneous preparations
What is the key role of Specials Manufacturers in the UK?
Use of Specials Manufacturers
What is the significance of Guidance Note 14 by MHRA in relation to the procurement of Specials?
Record of procurement in Pharmacy and reporting of Adverse Drug Reactions
In the context of extemporaneous dispensing, what distinguishes 'Specials' from other medicinal products?
Anything which does not have a UK Marketing Authorisation (MA)
What is the approach to compounding in certain European countries, such as Belgium?
All compounding performed in Pharmacies
What are the three traditional terms for oral solutions/suspensions?
Elixir, Mixture, Linctus
What are some less common non-sterile dosage forms in specials manufacturing?
Reefers (cigarettes injected with drug), Capsules and Powders, Bars of Soap, Lozenges/Pastilles, Lollipops, Suppositories/Pessaries
What are the different cream bases mentioned in the text?
Aqueous Cream, Hydrous Ointment (oily cream), Unguentum M (amphiphilic)
What is the importance of calculation skills in pharmacy practice?
Prevention of dispensing errors, ensuring correct clinical interpretation of prescription, avoiding overdose or sub-therapeutic dose
What is the primary document that introduces the concepts of a Quality Assurance System and Good Manufacturing Practices for pharmaceutical manufacturers and distributors?
Orange Guide
What are the two key personnel required for a Specials Manufacturing License?
Head of Production, Head of Quality Control
What are the 6 principles for the procurement and supply of specials?
Establish a clinical need, Understand the patient experience, Identify a preparation and supplier, Ensure effective governance, Monitor and review, Prescriber awareness of unlicensed status & liability
What are the key requirements for facilities in specials manufacturing?
Cleanrooms, MHRA Licences, Quality Management System, Full GMP Compliance, SOP’s/QC worksheets/Environmental monitoring/Training records, Validation System, Full audit trail
What are the 8 requirements for facilities in specials manufacturing?
Space, Work bench with cleanable surfaces, Somewhere to store clean equipment, Raw materials’ storage, Equipment storage and cleaning, Control of cross contamination
What are some considerations when scaling up from crushing tablets to using powder (API)?
QC testing, TSE compliance certificate, Shelf life extension/Stability Testing (ICH), Full set of Processing Equipment, Bulk storage-Quarantine and Released
What are the 9 requirements for equipment in specials manufacturing?
Government stamped measures, Balances, Unguators or Topitec, Mortar and Pestle (avoid wood), Stirring rod, Spatulas, Tiles, Method of heating e.g. water bath, microwave
What are some patients for whom 'Specials' are commonly required?
Paediatric, Geriatric, Terminally ill, Drug Misusers, Special Needs, Tube fed, Allergies
What are the considerations for Risk Analysis in specials manufacturing?
Risk to Patient, Cross Contamination, Nil or little formal stability data, Excipient suitability, Risk to Dispenser, Risk to other employees
What are some regulations that need to be complied with in the context of specials manufacturing?
Medicines Act 1968, Human Medicines regulation 2012, MHRA: Specials Manufacturing Licence, MHRA: Wholesale Dealers Licence, Retention of licence depends on successful MHRA inspections, Misuse of Drugs Act 1971, Licences issued by Home Office, Registered Pharmacy Premises
What are the common problems with specials prescriptions?
Short shelf life, Cost, Lack of details, Computer-generated prescriptions, Finding a formula, Regional differences
What is emphasized as a potential consequence of errors in pharmacy practice?
Tragic consequences
What are the sources of formulae for specials manufacturing?
Compendia e.g. BP, Martindale, Hospital, GP’s own, Published literatures or journal articles
What are some aspects to consider when managing patients in pharmacy practice?
Collection and delivery arrangement, Compliance, Accurate dosing, Pack down options
What should be considered when formulating specials with regards to microbial considerations?
Preservative system, Susceptibility to microbial growth, Physical problems, Chemical degradation
What are the considerations for the shelf life, closed and open pack sizes, and storage conditions of specials?
Preservative system, Cross contamination, Physical and chemical degradation, Shelf life based on formula, Closed pack longer than opened pack
What are the commonly requested non-sterile dosage forms for application to the skin in specials manufacturing?
Creams, Ointments, Pastes, Lotions, External Solutions
What is the primary purpose of the Green Guide mentioned in the text?
Introduction of a Quality Assurance System and Good Manufacturing Practices
What distinguishes extemporaneous dispensing from compounding in the pharmaceutical industry?
Extemporaneous dispensing is based on individual prescriptions, whereas compounding involves the preparation of batches.
What is an important requirement for equipment in specials manufacturing?
Regular maintenance and calibration
Study Notes
Extemporaneous Dispensing
- Also known as compounding or specials
- Specials are licensed medicines exempt from marketing authorization
- Hub pharmacy model used in Belgium for compounding
Regulation and Guidance
- Regulation 167 of Human Medicines Regulations 2012 exempts Specials from marketing authorization
- Guidance Note 14-MHRA states no record of procurement in pharmacy is required for Specials
Characteristics of Specials
- Shelf life can exceed 30 days without formal stability data
- Can be supplied to anyone, including individuals
- Manufacturer can be anyone, including pharmacists and doctors
Formulation and Manufacturing
- Creams are more prone to microbial growth compared to ointments
- Physical problems like cracking and caking are not common in formulation
- Using highest strength tablets recommended to reduce overall excipients in oral liquids
- Errors in pharmacy practice are usually insignificant
Quality and Safety
- The Orange Guide introduces Quality Assurance System and Good Manufacturing Practices
- Specials Manufacturing License requires three key personnel: Head of Production, Head of Quality Control, and Head of Research
- Cleanrooms not required for extemporaneous dispensing in pharmaceutical industry
Other
- Reefer refers to small cigars filled with drugs
- Coal Tar Solution BP (20%) is a clear solution
- The Misuse of Drugs Act 1971 regulates drug misuse
Test your knowledge on extemporaneous dispensing and 'specials' in the MPharm Programme Principles Of Extemporaneous Preparations. Learn about the definition of extemporaneous dispensing and the characteristics of 'specials'.
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