Modul 3 - ASESMEN RISIKO PELAYANAN RESEP RACIKAN

Summary

This video discusses the risk assessment of compounded prescriptions, emphasizing strategies to ensure safety, efficacy, and quality. It covers the benefits of compounding, such as customizing dosage forms, improving patient compliance, and providing unavailable medications, while addressing risks like technical errors, drug instability, and potential toxicity. The video outlines methods to minimize these risks, including using standard formulas, proper equipment, and trained personnel. It explains a structured approach to assessing technical and clinical risks, combining them into a risk ranking matrix to guide safe compounding decisions. Practical examples illustrate how to apply these principles effectively in pharmacy practice.

Takeaways

• 😀 The primary goal of compounded prescription risk assessment is to minimize errors in the compounding process and improve the quality of preparations.
• 😀 Compounded preparations offer customized dosage forms and compositions that may not be available commercially, improving patient comfort and compliance.
• 😀 Technical risks include uncertainty in safety, efficacy, bioavailability, and potential failure in preparation design due to improper handling or storage conditions.
• 😀 Clinical risks involve potential overdose or underdose, drug toxicity, narrow therapeutic index, and severe side effects of the active substances.
• 😀 To minimize technical risks, use validated standard formulas, pharmaceutical-grade ingredients, simple compositions, appropriate equipment, and trained personnel.
• 😀 Clinical risk mitigation involves identifying high-risk prescriptions, considering alternative therapies, reviewing evidence, and ensuring precise dosing.
• 😀 Technical risk scoring considers the complexity of compounding, ingredient safety, equipment, and calculation steps, with scores categorized as low, medium, or high.
• 😀 Clinical risk scoring evaluates side effects, therapeutic index, long-term use, drug interactions, and dose strength for each drug in a prescription.
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• 😀 The Compounding Risk Ranking Matrix combines technical and clinical risk scores to determine overall risk: green (safe), yellow (caution), red (avoid).
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• 😀 Proper documentation of compounded preparations, clinical outcomes, and adverse events is essential for future reference and ensuring safety.
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• 😀 Even simple compounded preparations should be assessed for both technical and clinical risks to ensure patient safety and preparation efficacy.
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• 😀 Limiting shelf-life and ensuring proper storage conditions are critical for maintaining stability and bioavailability of compounded preparations.

Q & A

What is the primary goal of risk assessment in compounded prescriptions?

The primary goal is to minimize errors in the compounding process and improve the quality of the resulting preparations by reviewing the preparation steps and identifying critical points to ensure safety and efficacy.

How do compounded preparations benefit patients compared to commercially available drugs?

Compounded preparations can be tailored to the specific dosage, composition, and form needed for each patient, improving comfort, compliance, and accessibility, especially when certain drugs or dosage forms are unavailable on the market.

What are the main types of risks associated with compounded preparations?

The main risks are technical risks, such as formulation errors, low bioavailability, and instability, and clinical risks, including uncertainty of efficacy, overdose, underdose, side effects, and narrow therapeutic index complications.

How can technical risks in compounding be minimized?

Technical risks can be minimized by using standard formulas from pharmacopoeias or journals, keeping formulations simple, using pharmaceutical-grade ingredients, ensuring proper equipment and trained personnel, controlling storage conditions, and limiting shelf-life for sensitive formulations.

What is the focus of clinical risk assessment in compounded prescriptions?

Clinical risk assessment focuses on the potential consequences of overdose or underdose of active substances in the preparation, including therapeutic index, side effects, drug interactions, and long-term use, but it is evaluated from the drug perspective, not directly on the patient.

Describe the scoring system used for technical and clinical risk assessment.

Technical risk is scored as 0-2 (low), 3-4 (moderate), and 5-7 (high). Clinical risk is scored as 0-2 (low), 4 (medium), and 5-6 (high). These scores are then combined in a compounding risk ranking matrix to guide safe compounding decisions.

How does the compounding risk ranking matrix guide decision-making?

The matrix combines technical and clinical risk scores: 4-6 (green) allows safe compounding, 8 requires risk mitigation while compounding, and 10-12 (red) indicates high risk, suggesting reconsideration, consultation with the prescribing doctor, or using alternative therapies.

What factors are considered when assessing technical risk in a prescription?

Factors include the complexity of calculations, number of preparation steps, whether the drug is part of a special risk group, the suitability of equipment used, and the potential for dose variation during compounding.

What steps should be taken if a prescription is identified as high clinical risk?

For high clinical risk prescriptions, pharmacists should conduct a thorough risk assessment, consider alternative therapies, consult the prescribing doctor if necessary, and review all available evidence on the preparation and active substances to ensure safety.

Why is documentation important in compounded prescription risk assessment?

Documentation of preparation steps, observed risks, clinical effects, and outcomes ensures that future compounding can be performed safely, provides a reference for similar prescriptions, and supports continuous improvement in quality and safety.

Can you provide an example of low-risk compounded prescription and why it is considered low risk?

An example is compounding Paracetamol 500 mg x10 and Diazepam 5 mg x10 into 10 capsules using a simple pulverizer method. Technical risk is low due to simple preparation, and clinical risk is low because the drugs have minor side effects and do not have a narrow therapeutic index, placing the combination safely in the green zone of the risk matrix.