SDLM Master Formulation and Compounding Record - Non-Sterile

LEARNING OBJECTIVES

  1. Describe the difference between a Master Formulation Record (MFR) and a Compounding Record (CR).
  2. List the key elements of a MFR.
  3. List the key elements of a CR.
  4. Understand the importance of accuracy and completeness of Master Formulation and Compounding Records.

LEARNING MODULE

In order to prepare a compounded medication a pharmacy must have a set of instructions that include an ingredient list and preparation/preparatory instructions. In the compounding pharmacy this document is called the Master Formulation Record (MFR). It is comparable to a “recipe” in cooking. In addition to a MFR, each time a preparation is made a Compounding Record (CR) must be produced. The CR documents a patient-specific preparation. For example, the CR will list the lot numbers, expiration dates and weights of all the actual ingredients used, the names of the persons preparing and checking the formulation and the results of any quality control tests performed on the preparation.

For a given preparation, the MFR is prepared before the preparation is compounded. The CR is used during the preparation to guide and record the actual process. This learning module will discuss MFR’s and CR’s in detail.


Master Formulation Records

As previously stated, MFRs are the recipe a pharmacy follows to prepare a particular formulation. Using a MFR to prepare each formulation helps to guarantee that the preparation is made and packaged in a consistent manner each time it is referenced. This assures the appearance and activity is consistent every time it is prepared and dispensed.

Formulations may be obtained by the pharmacy from many sources. These may include, among others, medical literature, professional organizations, hospitals, physicians, and other compounding pharmacies. In addition, the pharmacy may develop its own formulations. Regardless of the source of the formulation, the pharmacy must use a consistent format for its MFRs.

MFR’s may be electronic or paper, but either form should contain:

  • Name, strength and dosage form: This information should be consistent with the name placed on the final preparation label.

  • All ingredients and their quantities: MFRs should be consistent in their use of units of measurement. Weights should be expressed in the same units that balance uses to weigh ingredients. This avoids the risk of errors caused by repeated unit conversions from written instructions to practical task; i.e.: A MFR reads milligrams, whereas the balance reads in grams. This results in the pharmacist or technician having to make repeated conversions during the compounding process. This type of situation lead to errors and should be avoided.

  • Quantity produced: A MFR may list the quantity of preparation as a standard amount, such as 100 grams. This is also referred to as the batch quantity. Listing a standard quantity, such as "100 grams", allows consistency between formulations, and in many cases, makes checking formulations more intuitive; example: Seven (7) grams of an active ingredient in a total of 100 g of a preparation is easy to identify as a 7% formulation, whereas it requires a calculator to determine that 33.6 g of the drug in 480 grams of a preparation is also a 7% formulation. A disadvantage of standard quantities is that they may require re-calculation when a different quantity is being prepared. Compounding computer systems are frequently able make these calculations automatically.

    Listing the quantity the pharmacy typically produces, the batch quantity, avoids the need for additional calculations prior to compounding. A disadvantage of this method is that it typically results in MFRs that are more difficult to intuitively check.

  • Detailed steps required for producing the formulation: Precise instructions should be listed. These steps include the order of mixing, how ingredients should be mixed, for how long they should be mixed, and any other important intermediate steps.

  • Equipment required: In order to assure consistency, the equipment and supplies used to prepare a formulation should be the same each time. In addition, how the equipment and supplies are to be used should be spelled out. The MFR should say, “Mix ingredients in a blender at medium speed for 3 minutes".

  • Quality control procedures/tests: The MFR should list any quality control tests that should be performed during the compounding of the preparation. For the preparation of capsules, it may say, “Perform weight assessment on 10% of the capsules”.

  • Beyond-use date:: The Beyond-use date (BUD) of the formulation may be determined from a number of sources. The BUD may be assigned based upon USP 795 requirements or it may be obtained from suitable reference materials. MFRs should document the source/reference of the BUD.

  • Labeling information:: The MFR should include any pertinent labeling information; example, "Shake Well before Use" or "Keep in Refrigerator".

  • Packaging information:: Consistent and appropriate packaging is required. A change in container may affect the stability of a preparation, or it may cause a patient to question the change in appearance. The MFR should list the type of packaging required for the formulation; example: "5-mL amber serum vials".

  • Description of the finished preparation:: A description of a finished preparation allows the person preparing the formulation to perform a simple quality control check on the preparation, by comparing their finished preparation to the description; example: "Clear, colorless solution". If the finished preparation contains particles, then the compounder will be alerted to check their work.

  • Source: The source of all formulations should be documented and referenced.

  • Literature references: If relevant, any literature references should be documented; example: References of scientific studies related to the formulation.

  • Relevant calculations: Calculations related to the formulation should be documented in the MFR; example: If ingredients are dosed in units, but weighed in grams, then the conversion calculation should be documented in the MFR.

  • Developer/verifier information: The name or identifier of the person who created the MFR and the name and date of verification of the MFR should be recorded in the MFR.


Verification and MFR Security

A MFR is often a complex and detailed document. Consequently, human error in numerical entries, order of steps, etc..., is not unexpected. A new MFR should be “locked”, and not used until a second qualified individual has verified it in detail. This second individual should independently verify all of the information on the MFR and perform calculations independently of its creator. Once the MFR is verified as 100% correct, it can be used to prepare formulations.

The pharmacy must develop a system to secure and protect its MFRs. An accidental change in the MFR may result in an improperly prepared compounded medication that could result in serious injuries to a patient. All personnel must understand that only authorized personnel can change a MFR, and each time a MFR is changed, it must be verified by a second individual. Old versions of MFRs should be removed from active use, but archived for reference.


The Compounding Record

While a MFR is the recipe for producing a compounded medication, the CR details particulars of a patient-specific prescription. A MFR is very similar to a CR. A MFR can be designed to collect data necessary for use as a CR. CRs contain much the same data as MFRs, but it is specific to the particular prescription:

  • Name, strength and dosage form: Same as MFR.

  • CR Identifier: This allows the pharmacy to trace a compounded preparation to its particular CR. This is a legal and risk management requirement. A CR provides traceability in case a recall must be performed. This identifier is typically an individual lot number or a combination of a prescription number and compounding date. Using this information, the pharmacy must track which CR corresponds to each dispensed prescription.

  • All ingredients and their quantities, the manufacturer, lot number and expiration date: The CR identifiers allow a pharmacy to determine which CR contains information about a particular preparation; this information allows the pharmacy to determine which ingredients were used, the quantities used, and the source of all of the ingredients in the preparation.

  • Documentation that details steps required to produce the formulation: The CR of a complex formulation may contain documentation showing that individual steps in the preparation were performed; example: The individual weights of particular dosage units, results of intermediate steps, and/or the pH of a mixture.

  • Results of quality control procedures/tests: Same as MFR.

  • Packaging information: The lot number and manufacturer of all packaging materials must be recorded.

  • Relevant calculations: Generally, calculations should be performed as part of the development of the MFR. This helps compounding personnel focus on the compounding of the preparation without the distraction of having to perform calculations. However, some formulations may require calculations during preparation. These results should be documented as well.

  • Labeling information: A CR should include a copy of the prescription and/or container labels for reference and risk management purposes.

  • Compounder/final check information: The CR must contain the name or identifier of any individuals involved in preparing the compounded medication, and the name or identifier of the pharmacist performing the final check on that preparation.


Compounding Record Storage and Access

Compounding Records contain information about the medications that were dispensed to a particular patient and, as such, they are considered a part of the patient's medical record. CRs should be retained in accordance with the pharmacy's medical record retention policies. As previously noted, the CR is the primary document a pharmacy uses to determine which preparations contained a particular lot of ingredients in case of a recall. As such CRs should be readily available. Paper versions of CRs may require a tedious manual search to determine if a particular CR contained a particular ingredient. Computerized CR’s are often able to perform this search electronically.


Conclusion

Master Formulation Records are one of the most important components for assuring that preparations are compounded properly, accurately and consistently every time they are prepared. Extreme diligence must be given to the preparation of MFRs, as technical expertise and attention to detail is required to avoid errors. An error that goes undetected in a MFR will result in that error repeating itself with every issue of its related CR. Therefore, the implementation of a system of double checks before a MFR is released for use in a compounding practice is paramount.

The CR is the pharmacy's documentation that a particular batch of a preparation was prepared according to its corresponding MFR. The CR is used to perform a final check of the preparation. The CR is used to determine what ingredients were contained in the preparation that a particular patient received, which is important in case of a recall. For all of these reasons, pharmacists and technicians must assure that CRs are always accurate and complete.


LEARNING ASSESSMENT

  1. Which of the following item(s) is/are a component of the Master Formulation Record?
    1. The name or identifier of the individual that prepared the preparation.
    2. The name and quantity of each ingredient.
    3. Detailed steps for preparing the formulation.
    4. The source of the BUD data.
    5. B, C and D are all components of a Master Formulation Record.

  2. A Master Formulation Record documents information particular to the lot numbers of ingredients regarding specific batch preparations.
    1. True
    2. False

  3. Select the best possible answer. All formulations prepared in a compounding pharmacy must have:
    1. Master Formulation Records.
    2. Compounding Records.
    3. Either a Master Formulation Record or a Compounding Record.
    4. Both Master Formulation Records and their corresponding Compounding Records.

  4. Which of the following statements is/are correct?
    1. Master Formulation Records should be changed by the person preparing a formulation to account for their individual style of compounding.
    2. Master Formulation Records should be verified by a second qualified individual before it is allowed to be used in practice.
    3. Master Formulation Records should be signed by all individuals involved in making the preparation.
    4. Compounding Records should contain a copy of the prescription label for the preparation that is being dispensed.
    5. B and D are correct.

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