Module 8 Compounding Non-sterile Preparations

Question 1

Any substance or mixture of substances intended to be used in the compounding of a preparation, thereby becoming the active ingredient in that preparation and furnishing pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans and animals or affecting the structure and function of the body.

Answer 1

Active Pharmaceutical Ingredient (API)

Question 2

Ingredients that are necessary to compound a preparation but are not intended or expected to cause a pharmacologic response if administered alone in the amount or concentration contained in a single dose of the compounded preparation. The term is used synonymously with the terms inactive ingredients, excipients, and pharmaceutical ingredients

Answer 2

Added substances

Question 3

A ventilated cabinet which may be used for compounding.

Answer 3

Biological safety cabinet (BSC)

Question 4

A report from the supplier of a component, container, or closure that accompanies the supplier’s material and contains the specifications and results of all analyses and a description of the material.

Answer 4

Certificate of Analysis (COA)

Question 5

the process of removing soil (e.g., organic and inorganic material) from objects and surfaces, normally accomplished by manually or mechanically using water with detergents or enzymatic products

Answer 5

Cleaning

Question 6

any ingredient used in the compounding of a preparation, including any active ingredient, added substance, or conventionally manufactured product.

Answer 6

Component

Question 7

a preparation intended to be nonsterile created by combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering of a drug or bulk drug substance

Answer 7

Compounded non sterile preparation (CNSP)

Question 8

personnel trained to compound preparations.

Answer 8

Compounder

Question 9

the process of combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a nonsterile medication.

Answer 9

Compounding

Question 10

a space that is specifically designated for nonsterile compounding. A visible perimeter should establish the boundaries of the nonsterile compounding area.

Answer 10

Compounding area

Question 11

packaging components that together contain and protect the dosage form.

Answer 11

Container-closure system

Question 12

a pharmaceutical dosage form, usually the subject of an FDA-approved application that is manufactured under current good manufacturing practice conditions.

Answer 12

Conventionally manufactured product

Question 13

a display of written, printed, or graphic matter on the immediate container of any article.

Answer 13

Label

Question 14

all labels and other written, printed, or graphic matter that are 1) on any article or any of its containers or wrappers, or 2) accompanying such an article.

Answer 14

Labeling

Question 15

a substance added to inhibit microbial growth.

Answer 15

Preservative

Question 16

a system of procedures, activities, and oversight that ensures that the compounding process consistently meets quality standards.

Answer 16

Quality Assurance (QA)

Question 17

the sampling, testing, and documentation of results that, taken together, ensure that specifications have been met before release of the CNSP.

Answer 17

Quality Control (QC)

Question 18

the process of adding a diluent to a conventionally manufactured product to prepare a solution or suspension.

Answer 18

Reconstitution

Question 19

visual inspection and testing performed to ensure that a preparation meets appropriate quality characteristics.

Answer 19

Release inspection and testing

Question 20

an agent for reducing, on inanimate surfaces, the number of all forms of microbial life including fungi, viruses, and bacteria.

Answer 20

Sanitizing agent

Question 21

tests, analytical methods, and acceptance criteria to which an API or other components, CNSP, container-closure system, equipment, or other material used in compounding CNSPS must conform to be considered acceptable for its intended use.

Answer 21

Specification

Question 22

extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or BUD.

Answer 22

Stability

Question 23

Pharmacists are the only health care providers formally trained in the art and science of compounding medications. Therefore they are expected to possess the knowledge and skills necessary to compound extemporaneous preparations.

Pharmacists have a responsibility to provide compounding services for patients with unique drug product needs.

Answer 23

Compounding

Question 24

The major difference between the two is on how the medicine would be administered rather than how it is compounded.

Nonsterile Preparations
* Oral liquids
* Creams and ointments
* Other topical products
* Suppositories
* Lozenge, mouthwash
* Sachets, oral powders
* Tablets, capsule

Answer 24

N/A

Question 25

Defined as combining, admixing, diluting, pooling, reconstituting other than as provided in the manufacturer’s labeling, or otherwise altering a drug or bulk drug substance to create a nonsterile medication.

Requirements found in Chapter 795 of the USP must be followed to minimize harm, including death, to patients that could result from:
* Excessive microbial contamination,
* Variability from the intended strength of correct ingredients,
* Physical and chemical incompatibilities,
* Chemical and physical contaminants, and/or
* Use of ingredients of inappropriate quality.

Answer 25

Nonsterile Compounding

Question 26

Pharmacists and support staff shall possess the education, training, and skills necessary to properly and safely perform compounding duties at the level at which they are involved. All pharmacy personnel who are involved in the preparation of drugs shall be proficient in the art and science of compounding and shall continuously update their knowledge and skills through regular training.

The person should be trained on the following:
Compounding standards and guidelines
Proper use and care of compounding equipment
Pharmaceutical techniques
Aseptic technique
Properties of dosage forms to be compounded
Literature
Proper handling
Use and interpretation of symbols and abbreviations
Pharmaceutical calculations
Knowledge on PPE
Product preparation and compounding
Packaging and labelling
Transport and storage
Quality assurance
Proficiency in computer usage
Cleaning and disinfection
Policies and procedures in compounding

Answer 26

Compounding Staff

Question 27

Responsibility of Compounding Personnel
The pharmacist is responsible and authorized to perform the following:
1. Inspect, approve or reject all components, drug preparation containers, closures, in-process materials, and labelling.
2. Prepare and review all compounding records to ensure that no errors have occurred in the compounding process.
3. In addition to compounding, the pharmacist provides other services, such as the following:
Provide drug searches on specific chemicals in different dosage forms, strengths, bases, and the like to accommodate physicians’ specific needs,
Provide follow-up information in response to a practitioner’s request for information regarding a compounded medication, and
Consult with practitioners regarding a particular dosage form when discussing services with a health care provider.

Answer 27

N/A

Question 28

The compounding room should be situated away from the high traffic areas within the pharmacy department. It should be large enough to ensure good flow of people, equipment, and materials for the compounding personnel to work comfortably and safely. The room should allow cleaning and disinfecting without any constraints.

Answer 28

Facilities

Question 29

Equipment, instruments, and other compounding accessories must be appropriate for the type or preparation to be compounded, and these should be properly maintained.

Calibration and preventive maintenance should be properly documented.

Answer 29

Equipment

Question 30

1. Personnel
2. Facility and Equipment
3. Compounded Preparations
4. Quality Assurance Program

Answer 30

Policies and Procedures

Question 31

1. Preliminary Preparations
2. Compounding
3. Final Check
4. Sign-Off
5. Cleanup

Answer 31

Compounding Process

Question 32

Geriatric Dosing Considerations:

Answer 32

Older patients have more conditions requiring medication. and polypharmacy is common. Polypharmacy is a term indicating the use of multiple medications. The need for multidrug therapy on top of the long-term use of maintenance drugs would also increase the possibility of drug interactions and adverse drug effects. Difficulties in patient adherence is also common, often due to impaired cognition, confusion over the different dosing schedules of the multiple medications, and economic reasons.

Question 33

Geriatric Dosing Considerations
Special considerations are as follows:

Answer 33

•Therapy is often initiated with a lower-than-usual adult dose.
•Dose adjustment may be required based on the therapeutics response.
•The patient’s physical condition may determine the drug dose and route of administration needed.
•The dose may be determined, in part, on the patient’s weight, body surface area, health and disease status, and pharmacokinetic factors.
•Concomitant drug therapy may affect drug/dose effectiveness.
•A drug’s dose may produce undesired adverse effects and may affect patient adherence.
•Complex dosage regimens of multiple drug therapy may affect patient adherence.

Question 34

Geriatric Dosing Considerations

Answer 34

Cumulative reductions in physiologic capacity and function becomes more profound with age.
•Kidney function is a major consideration in drug dosing since it results to reduced drug elimination, thus increasing the possibility of toxic drug levels in the body and adverse drug events.
•Liver function must also be considered as it is the main organ for drug metabolism. However, impaired organ function may also be due to other factors such as lifestyle, disease, and other medications, so these must be monitored not only in the elderly but also in patients of all ages who are at risk.

*A pharmacist’s intervention would include adjusting the dose or the frequency of administration of a drug based on the measured level of impairment.

Kidney function is measured by the “creatinine clearance”.

•Creatinine is a metabolic breakdown product of muscle and usually has a consultant value in an individual. Its value ranges from 0.6 mg/100 mL of serum to 1.2 mg/100 mL of serum. Creatinine is almost exclusively eliminated by kidneys! Therefore, if the level of creatinine increases in the serum, it is likely that the capability of kidneys to eliminate drugs is reduced. As a general rule, if the serum creatinine level (Ccr) is doubled, the kidney function is one half. If the Ccr is quadrupled, the renal (kidney) function is one-fourth or 25%.