Classification, Description, and Prevention of Errors
Compounding errors can be divided into the following categories:
- General Errors,
- Incorrect Ingredients,
- Incorrect Concentration,
- Incorrect Use of Equipment,
- Physicochemical Issues,
- Microbiological Contamination,
- Analytical Testing Issues,
- Microbiological Testing Issues, and
- Miscellaneous Errors.
Over the next several weeks, we will look at errors using the format or subject-headings of "Error Type," "Description," and "Avoiding the Error."
INCORRECT INGREDIENTS
Error Type |
Description |
Avoiding the Error |
Use of incorrect active pharmaceutical ingredients (APIs) |
A number of different occasions can arise involving an incorrect API. For example, the incorrect ingredient accidently is obtained; the incorrect salt form, ester form, hydrated form, particle size, or other form can be mistakenly used. |
Double-check the exact name and form of the ingredient to be used for the prescription. If any questions arise, check with another compounder to confirm the exact name and form of the API to be used. If appropriate, check with the prescriber to confirm the exact form of the API that was ordered. For suspensions, confirm that the particle size is reduced appropriately. |
Use of incorrect form of API |
As above, the incorrect form can involve an incorrect salt, ester, or hydrate or even the particle or crystalline form to be used. |
Confirm the exact form of the API that was prescribed, and, if necessary, check with the prescriber. Also, check the United States Pharmacopeia–National Formulary (USP–NF) monographs or official product labeling for clarification on which form is to be used. |
Use of incorrect excipients |
Excipients can markedly alter the final preparation and its bioavailability and efficacy. In fact, numerous instances of incompatibility can occur between an excipient and an API and even between excipients. |
Confirm the compatibility of each of the excipients with the API and with each of the other excipients to ensure their suitability for the preparation. When using levigating agents, confirm that they will be compatible or miscible with the finished preparation. |
Use of incorrect supplies |
The use of incorrect packaging, compounding personnel protective equipment (PPE), and so on can result in an altered preparation and potential harm to the compounder. |
Confirm the appropriateness of the packaging and other supplies used in compounding the preparation. Also, confirm the proper use of PPE for the compounder. |
Unintended presence of another medication |
This generally involves the accidental use of another medication instead of the one prescribed. It can also result from interactions between ingredients and the degradation of ingredients to produce another ingredient with some untoward effects. |
Confirm each and every ingredient that is to be used, and confirm there are no interactions involving chemical reactions that may occur. |
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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