What Is a Formulation Record
In addition, these two websites (which are also included in the useful links) offer free recipes. The UNC website contains recipes that are already formatted into a formulation data set, while Secundum Artum provides the recipe with the necessary stability data, but unfortunately does not create a complete formulation data set. I`m working on it right now, so keep an eye out for downloadable formulation recordings in the future! As mentioned earlier, LIMs are the prescription that a pharmacy follows to prepare a particular formulation. Using a CFP to prepare each formulation ensures that the preparation is produced and packaged consistently with each reference. This ensures that the appearance and activity are consistent whenever they are prepared and delivered. Prior to implementation, the formulation records on the cards were in the form of a “recipe box” with handwritten notes, sometimes missing sources, and sometimes indicating that the formulation file came from another hospital (the photos are in the newspaper). I would say that this situation is unfortunately not uncommon, and that developing or purchasing evidence-based formulation records is one of the easiest things a pharmacy, community or stationery (or other) can do to improve the safety of compound drugs. * There may be formulations for compound preparations that are publicly available or available for sale. When reviewing the use of pre-existing formulations, the non-sterile formulation supervisor is responsible for ensuring that the napra standards for the main formulation dossier are met and are appropriate to the conditions and circumstances of pharmacy practice by assessing, modifying, adapting and/or updating them as necessary.
An MFF is often a complex and detailed document. Therefore, human error in numerical inputs, order of steps, etc. is not unexpected. A new MFF should be “blocked” and not used until a second qualified person has reviewed it in detail. That second person should independently verify all information relating to the MFF and perform calculations independently of its creator. Once the MFR has been verified as 100% correct, it can be used to produce formulations. For a given preparation, the MFF is prepared before the preparation is assembled. The CR is used during preparation to guide and record the actual process. In this learning module, MFRs and CRs are discussed in detail.
So now, the million-dollar question: Where can I find evidence-based formulation records? The CR is the pharmacy`s documentation attesting that a particular batch of a preparation has been manufactured in accordance with the relevant MFF. The CR is used to conduct a final review of the preparation. THE CR is used to determine which ingredients were contained in the preparation that a particular patient received, which is important in the event of a recall. For all these reasons, pharmacists and technicians must ensure that the RCs are always correct and complete. Are your preparation and formulation files compliant? Without further ado, here is your crash course: USP 795 and 797 (for sterile preparations) as well as the state councils of pharmacy (such as NC and KY) regulate the necessary components in a preparation dataset: Many pharmacy systems can create printable composition records from the data entered, which is easier, but in case your system doesn`t, I created a mix registration template, which meets these requirements, which you can find in the Store. Formulations can be obtained from the pharmacy from many sources. These may include medical literature, professional associations, hospitals, doctors and other preparation pharmacies, among others. In addition, the pharmacy can develop its own formulations. Regardless of the source of the formulation, the pharmacy must use a uniform model for its MFNs. To prepare a compound drug, a pharmacy must have a set of instructions that include a list of ingredients and preparation/preparation instructions.
In the preparation pharmacy, this document is called the Master Formulation Record (MFR). It`s like a “recipe” in the kitchen. In addition to a CFP, a compound record (CR) must be created for each preparation. The CR documents a patient-specific preparation. For example, the CR lists the batch numbers, expiry dates and weights of all ingredients actually used, the names of the people who prepare and verify the formulation, and the results of quality control tests performed on the preparation. Also, as a cautionary tale, it is best not to assemble complex formulations unless you have the training and experience to do so. Compounding is a specialty and should be treated this way! The components of the formulation dataset are regulated by USP 795, 797 (and remember – chapters below 1000 are considered mandatory!) and state pharmacy boards. Formulation registration and preparation registration is an easily overlooked area of compliance, but with many cases of patient harm related to the preparation, it is essential that pharmacies do whatever it takes for reasons of patient safety and their own responsibility.
Probably the most notable is that of the New England Compounding Center, but more recently, problems with formulations of levothyroxine compounds have received public attention and scrutiny. The non-sterile preparation supervisor is responsible for ensuring that key formulation files are developed, regularly reviewed and updated as required. If there are changes to the dataset, composite personnel should be notified. The following table summarizes and compares the standards, guidelines, and content of these two types of datasets. Remember that this is only a summary and the guide should be read and interpreted as a whole. Preparation records contain information about the medicinal products that have been administered to a particular patient and, as such, they are considered part of the patient`s medical record. RCs must be retained in accordance with the pharmacy`s medical record-keeping guidelines. As mentioned earlier, the CR is the primary document that a pharmacy uses to determine which formulas contained a certain amount of ingredients in the event of a recall. Therefore, RCs should be easily accessible. Paper versions of RCs may require time-consuming manual research to determine if a particular CR contains a particular ingredient.
Computerized RCs are often able to perform this search electronically. Since there are similarities between the contents of the main formulation dossier and the preparation dossier, some pharmacies may use a copy of the master formula as the basis for the preparation dossier. In addition, the prepared dispensing record of a prescription may also be used as a summary for the dispensing file if the information required by subsection 156(1) of the Drug and Pharmacies Regulation Act is appropriate to meet the requirements of NAPRA. The College is not a guideline on how the requirements of the standards are met, and it is the responsibility of the pharmacy to develop policies and procedures taking into account the systems and technologies at its disposal. .