Ch 1 Introduction to Compounding

Non-sterile compounding

________ is the preparation of customized medications to meet specific patient needs…

compounding

_______ is used when commercially available products are unavailable or unsuitable…

compounding

_______ requires strict precision, safety and adherence to regulations…

Non-sterile compounding

________ has been a fundamental aspect of pharmacy practice in Canada and its rapidly evolving…

NAPRA’s standards

Provincial pharmacy regulatory bodies have adopted and enforced __________ now known as their (competences)…

Health Canada

As a federal level, _______ oversees the Food and Drugs Act, one of their roles is ensuring the distinction between compounding and manufacturing, as outlined in ______ policy on manufacturing and compounding drug products in Canada…

Does not

It is important to note that Health Canada ________ regulate pharmacy compounding directly, they allow provinces and territories to regulate pharmacy practice, including compounding…

All

Compounding personnel: ______ pharmacy staff members should understand NAPRA standards and be able to apply the standards to their daily compounding practices…

Pharmacy manager

_______ oversees and supervises all compounding activities, including organization and development…

Non-sterile compounding supervisor (Phc Or Pt)

_________ Manages daily compounding duties, ensures all equipment is available, approve and create master formulation records, implement quality assurance programs, and maintain records of all compounding activities…

Non-regulated personnel

_______ can compound under supervision, following provincial and territorial regulations…

Pharmacy technicians

As ______ we can prepare compounds, verify compounds and even advance to becoming a non-sterile compounding supervisor…

Cannot

Pharmacy technicians _____ perform clinical judgement, authorize renewals, release a prescription without pharmacist verification, or determine beyond-use dates…

Training program

All staff involved in non-sterile compounding must complete a _______…

Competency evaluations 

__________ can be performed regularly to ensure safe compounding practices are being performed…

Trained

Staff involved in cleaning compounding areas must be ________ to understand all cleaning and disinfection methods to ensure compounds are up to standards…

Policies and procedures

All pharmacies must develop and maintain a detailed _________ for all compounding activities including cleaning procedures…

3 years

Policies and procedures must be reviewed at least every ______ or sooner, they should be updated promptly in response to any changes affecting compounding regulations…

Master Formulation Record (MFR)

Before compounding any products, pharmacy personnel must assess whether it is necessary, appropriate, safe and feasible. All compounds must have a _______ which provides a valid “recipe” for that compound. if pharmacies do not have a MFR, they can be found from numerous sources, such as USP Compounding Compendium and The Hospital for Sick Children’s Compounding Guide. This ensures that the preparation is in best interest of the patient and complies with regulatory standards…

Level A

This compounding risk level are simple, non-hazardous compounds like oral solutions…

Level B

This compounding risk level are moderate risk, like transdermal patches…

Level C

This compounding risk level are high risk, and have hazardous ingredients like hormones and chemotherapies…

Medicinal ingredient

_______ An active pharmaceutical ingredient which causes a therapeutic effect…

Non-medicinal ingredient

_______ also known as excipients, they improve texture, stability, taste or delivery…

Quality and safety standards

Medicinal and Non-medicinal ingredients MUST meet both ______ and _________ before being used in a compound…

Oral compounds

Solutions, suspensions, emulsions, syrups, capsules and lozenges are all this type of non-sterile compound…

Topical compounds

Creams, ointments, gels, lotions and pastes are all this type of non-sterile compound…

Tailored compounds

These are formulations adjusted for specific patient needs, such as dosage modifications, allergen removal and flavouring, which is this type of non-sterile compound…

Veterinary compounds

These ae specialized medications created to address the unique needs of animals, which is this type of non-sterile compound….

Mortar and Pestle

This compounding equipment is used to grind and mix…

Ointment pads/slabs

This compounding equipment is what we use when mixing topical compounds ..

Spatulas and mixers

This compounding equipment is used to incorporate topical compounds together

Electronic balance

This compounding equipment is used to accurately weigh ingredients…

Measuring cylinders and beakers

This compounding equipment is used to accurately measure liquid components…

Ointment jars

This compounding equipment is used to place the final compound in for release to the patient…

Liquid bottles

This compounding equipment is used to place completed liquid compounds in for release to the patient…

Personnel, Premises, Sanitation, & Equipment

These Good Manufacturing Practices (GMP) elements focus on the environment and resources used in manufacturing to prevent contamination and ensure proper conditions…

Raw Materials, Processing Controls, & Quality Controls

These Good Manufacturing Practices (GMP) aspects ensure the quality of inputs, the consistency of the manufacturing process, and the final products adherence to standards…

Documentation, Complaint Handling and Recalls, & Packaging and Labeling

These Good Manufacturing Practices (GMP) components address record-keeping, handling product issues, an ensuring correct product presentation and information…

Pharmaceutical Elegance

______ refers to the final product’s professional appearance and quality…

Pharmaceutical Elegance 

______ includes, smooth texture, uniform consistency, correct odor, proper labeling and packaging and it enhances patient trust and adherence…

Beyond Use Date (BUD)

_______ The date after which a compound preparation should not be used…

Beyond Use Date (BUD)

______ are determined from the date of compounding plus the stability data on the master formula document, and expiry dates of products that are used…

NAPRA

If there are no stability data for BUD, ______ has default guidelines that can be followed…

Non-aqueous formulations

The stability data for ________ are to assign a BUD not later than the earliest expiry date of any ingredient, or 6 months, whichever is earlier…

Water-containing oral formulations

The stability data for _______ are to assign a BUD not later than 14 days with refrigeration required at controlled cold temperatures….

Water-containing topical/dermal mucosal liquid and semi-solid formulations

That stability data for ________ are to assign a BUD not later than 30 days…

Stability

______ refers to the ability of a compounded preparation to maintain its physical, chemical, microbiological, therapeutic, and toxicological properties throughout its assigned BUD…

Trissel’s stability of compounded formulations, Remington: The science and practice of pharmacy, and the CPS

Drug Formulation and stability references includes….

Visual Inspection

An important part of non-sterile compounding is completing a _________ of the final product. Pharmacy staff should inspect the final product for physical characteristics such as color, clarity, absence of particles, and signs of contamination. These are important steps to take to ensure that the patient recieves a safe and quality product…

Master Formulation Records

________ will state the expected end result of your compound (color, smell, etc…) Visual Inspection…

References

The safe and effective preparation of compounded medications relies heavily on the use of reputable, evidence-based _______. ________ are used to employ best practices, follow established regulations, understand ingredient standards, and adapt any recipes…

Lexi-Comp, CSHP, Children’s Hospital of Eastern Ontario, IWK Health Drug Information Resource, Sick Kids Pharmacy Compounding Recipes, & NIOSH

Aside from NAPRA and Health Canada, references that may be used in compounding pharmacies includes…