Quiz

Case scenario

You are working in a compounding pharmacy and are presented with a prescription for an oral tacrolimus suspension for Patrick, age 8, who has had an organ transplant. Due to the hazardous nature of tacrolimus, compounding the medicine requires strict adherence to safety guidelines.

You begin by reviewing the prescription and consulting the stability data and available formulations for compounded oral tacrolimus suspension. You gather the necessary ingredients and equipment required.

With appropriate PPE in place, such as gloves, a gown, protective eyewear, and a N95 mask, you proceed to compound the medicine in a Class I BSC located in a designated compounding area in the pharmacy. Using proper compounding techniques, you measure out the required ingredients and mix them to form a uniform suspension.

Upon completion of compounding, you package the suspension in an appropriate container according to the stability requirements, label the final product with the appropriate dispensing and cautionary advisory labels and include the directions for administration and expiry date. You provide comprehensive counselling to the patient or caregiver regarding the proper administration, storage, and potential side effects of the oral tacrolimus suspension, including the additional instructions required for safe handling of the medicine.

Multiple choice questions

1. Which ONE of the following MOST accurately describes a hazardous medicine?

1. A medicine that causes organ toxicity exclusively at higher than therapeutic doses.
2. A medicine which is not known to cause reproductive or developmental toxicity.
3. A medicine with the same toxicity potential as an existing known hazardous medicine.
4. A commercial product of a known hazardous medicine is not considered hazardous.

2. Which ONE of the following is MOST appropriate when considering PPE used in hazardous medicines handling or compounding?

1. Gloves help to protect the skin and any style of latex glove is appropriate.
2. Integrity of PPE should be regularly checked.
3. Reading glasses with large lens can be worn as a substitute for safety goggles.
4. Shoe covers should be permeable and changed regularly.

3. There are many considerations when handling or compounding hazardous medicines. Which ONE of the following is MOST appropriate when considering these?

1. A risk assessment should be performed. This does not need to consider the controls available.
2. Protective measures should be utilised. The level of PPE required for each medicine remains the same regardless of activity.
3. Staff must be adequately and appropriately trained, and their skills should be validated.
4. It is sufficient to ensure compliance with practice and occupational health and safety guidelines only.

4. Which ONE of the following is CORRECT when handling or compounding hazardous medicines in the pharmacy setting?

1. Risk of exposure is medicine specific, and the Material Safety Data Sheet provides sufficient information as to regulatory requirements.
2. All Biological Safety Cabinets provide personnel, environmental and product protection.
3. The same risk applies to repackaging hazardous medicines during dispensing as to compounding raw ingredients, and the same PPE should be used.
4. Validation of controls and processes, and appropriate record keeping, is a key step in managing risk.