30 Questions
What is compounding in the context of pharmacy?
The act of mixing or combining two or more ingredients to create a final product for dosing
Why is compounding not done solely for economic reasons?
Because it duplicates an approved drug product
What is a key consideration when mixing medicine with food in pediatric patients?
The type of food the child is eating
Who is primarily responsible for compounding activities?
Pharmacists
What is the main goal of compounding?
To improve patient care without duplicating an approved drug product
What is a key aspect of a compounding facility?
It must be inspected by regulatory authorities
What is a consideration when adding medicine to a baby's bottle?
The risk of feeding aversions
Why was the medication compounded in a gummy formulation for the pediatric patient?
The patient had difficulty swallowing tablets and liquids.
What was the outcome of the 1000-fold error in the compounded gummy formulation?
The patient experienced hypotension and bradycardia.
What is a challenge in pediatric medication administration, as indicated by Canadian federal regulations?
Lack of commercially available products with pediatric data.
What is a factor contributing to limited pediatric formulations, according to the Institute for Safe Medication Practices Canada?
Low incentive from manufacturers for pediatric formulations.
What would be an essential consideration for a pharmacist when recommending therapies for a pediatric patient?
Suitable dosage forms for effectiveness and safety.
What would be an important calculation for a pharmacist to perform when assessing prescriptions for a pediatric patient?
Performing simple dosing calculations.
What is a challenge in compounding and dispensing medications for pediatric patients, as indicated by the case study?
Lack of commercially available products with pediatric data.
What is a factor contributing to delayed or limited provincial/territorial reimbursement programs for pediatric formulations?
Low priority from government agencies for pediatric formulations.
What is a key consideration when modifying drug formulations for pediatric patients?
Pharmaceutical stability and effectiveness of the modified formulation.
What is a key consideration when evaluating the suitability of a dosage form for a pediatric patient?
Effectiveness and safety of the medication
What should be documented on a worksheet when compounding a medication for a pediatric patient?
The patient's weight and the dosage calculation
What is a benefit of using commercially available tablets or capsules when possible?
They have been tested for pharmaceutical stability and effectiveness
What should be considered when deciding whether to compound a medication for a pediatric patient?
The benefits of compounding versus the potential risks
What is a recommendation for pharmacists when communicating with prescribers about compounding a medication for a pediatric patient?
Discuss the benefits of compounding and the potential risks
What should be used to support the rationale for ingredients and units of measure in a compounded medication?
Standardized master formulas and references
What is a recommended step in the process of compounding a medication for a pediatric patient?
Independent double-check of the calculation and preparation
When assessing dosage forms, what should be considered to avoid medication errors?
Sound-alike and look-alike drugs
A 2-year-old girl (18 kg) has a urinary tract infection (UTI) and is prescribed Cephalexin 250 mg PO q8h. What would be an appropriate dosage form?
Cephalexin oral solution
What is a crucial consideration when altering dosage forms?
Patient's acceptance and feasibility
Which of the following situations may require specific dosage forms to avoid further complications?
Enteric tube administration
What should be considered when compounding a drug product, such as metronidazole 15mg/mL?
Pharmacokinetics and pharmacodynamics
Which of the following is a crucial consideration when dispensing medications, especially in pediatric patients?
Patient's age and weight
What should be considered when evaluating the stability and effectiveness of a compounded drug product?
Pharmacokinetics and pharmacodynamics
Study Notes
Compounding
- Compounding involves combining or mixing two or more ingredients, including at least one drug or pharmacologically active component, to create a final product in an appropriate form for dosing.
- Compounding is practiced primarily by pharmacists, but other healthcare professionals may also practice compounding activities when licensed.
- Regulatory authorities in each province/territory oversee compounding activities, which include non-sterile products and specialized products for IV solutions or ophthalmic preparations.
Key Points from Health Canada Policy on Compounding
- Compounding is done when there is a therapeutic need or lack of product availability, not solely for economic reasons.
- Compounding involves a patient-healthcare professional relationship and is actively regulated, with facility inspections by regulatory authorities.
- Risk management processes are in place, and customized therapeutic solutions are developed to improve patient care without duplicating approved drug products.
Recommendations for Pharmacy Managers/Pharmacists/Technicians
- Communicate the need for compounding with the prescriber and discuss alternatives.
- Compound only when the benefits outweigh potential risks.
- Use standardized master formulas, supported by references, rationale for ingredients, and consistent units of measure within systems.
- Use commercially available tablets/capsules and utilize software to build in additional checks, input patient weight.
- Document on a worksheet, perform an independent double-check, and refer to NAPRA guidelines.
- Use unique identifiers for ingredients and follow up with the family.
Clonidine Example
- Clonidine tablets can be compounded into a suspension.
- Dissolve and dose instructions are provided, along with supporting documentation.
Dosage Forms: Cautions
- Consider sound-alike, look-alike drugs (e.g., clobazam vs clonazepam, sulfadiazine vs sulfasalazine, DTaP vs Tdap).
- Be cautious when assessing dosage forms for enteral tube administration, ketogenic diet, or short bowel syndrome.
Alterations of Dosage Forms
- Consider therapeutics, drug coverage, PK/PD, pharmaceutics, safety, patient acceptance, and feasibility when altering dosage forms.
Dosage Forms Example
- For a 2-year-old girl (18 kg) with a UTI, an appropriate dosage form for Cephalexin 250 mg PO q8h might be a liquid formulation.
- Consider the patient's needs and feasibility when selecting a dosage form.
Compounding Errors
- A 1000-fold error occurred when compounding clonidine in a gummy formulation, leading to hospitalization due to hypotension and bradycardia.
- The incident highlights the importance of proper compounding procedures, regulation, and pediatric-specific guidance.
Learn about administering medicine to children, including mixing with food, drug-food interactions, and compounding. Understand the importance of receiving a full dose and managing feeding aversions.
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