PTCE: The Basics of Order Entry and Processing, Part 2

Non-Sterile Compounding Procedures
The steps for compounding non-sterile formulations are as follows:
1. Obtain the prescription.
2. Document and calculate the ingredients needed to fill the prescription.
3. Wash your hands.
4. Obtain the equipment, ingredients, and materials needed to fill the prescription.
5. Clean the compounding area and equipment.
6. Obtain verification of the ingredients used and the quantities calculated prior to compounding.
7. Compound the preparation using the calculated formula.
8. Label the preparation.
9. Document the preparation on the compounding log.
10. Clean and store all equipment and materials.

The pharmacist then performs another check, termed the “final check,” where he or she will verify the ingredients used, the calculations performed, the weight of the ingredients, the color, the odor (if present), and the pH (if needed). Auxiliary labels may be added as warranted. The pharmacist then signs off on the compound; this ensures consistency and accuracy.
Batch orders are prepared in anticipation of medication orders. These preparations may be determined based on need, and they should maintain similar standards. All batch orders should maintain consistency of ingredients. Labels for batch orders must contain a lot number, and extra labels should be tossed after a batch has been completed. Labeling requirements should be consistent with the formatting presented on the master formulation record.

Compounding a Specific Formulation
- CAPSULE: This is a solid dosage form that consists of a gelatin shell, or a plant-based alternative (such as hydroxypropyl methyl cellulose (HPMC)), that encloses the active ingredient, typically a powder.
○ The powder that is used to fill a capsule is mixed using geometric dilution, and the particle size is grinded to a fine powder using trituration.
○ The punch filling method is used to gather and compress the powder together to form a dense cake. The capsule components are separated and then held vertically, and the open end of the base is punched in the powder until it is filled. Each capsule is then weighed to ensure an appropriate fill weight.
○ The capsule machine method utilizes a capsule machine, made of metal plates, to make up to 100 capsules at one time.
○ Capsule sizes vary, with the smallest size being 000 and the largest size being 5. The size of the capsule and the approximate amount contained within are inversely proportionate. The largest size, 000, can hold an average of 1,000 mg of powder, whereas the smallest size, 5, holds an average of 100 mg of powder.
- SOLUTION: This is a liquid dosage form in which the active ingredients are completely dissolved in a liquid vehicle.
○ The solvent is a substance, typically a liquid, that dissolves the solute, resulting in a solution.
○ The solute is the active ingredient that is dissolved in the solution.
○ The active ingredient should be triturated in order to reduce the particle size and to ensure an even distribution of particles.
- SUSPENSION: This is a coarse dispersion in which the internal phase (the active ingredient) is dispersed in the external phase (a suspending medium). The internal phase consists of insoluble solid particles that are dispersed in a suspending agent.
○ Physical stability and sedimentation, or the settling of particles, are common problems that exist with this formulation. Patients must shake the formulation well before using it.

○ To prepare a suspension, the active ingredient is triturated or levigated with a vehicle containing a wetting agent used to reduce the particle size of the insoluble internal phase and form a smooth paste. The soluble ingredients are dissolved in a vehicle and added to the paste to form a slurry. At this point, a flocculating agent can be added to form loose aggregates (called flocs) that increase the sedimentation rate, and a suspending agent is used to thicken the suspending medium, reducing sedimentation of the suspended particles and stabilizing the end product.
- OINTMENT: This is a preparation that contains an oil base, sometimes referred to as “water in oil.” A base is selected, and then the product is prepared using one of two methods: incorporation or fusion.
○ Incorporation is a technique in which the components are mixed until a uniform preparation is attained. A mortar and pestle, spatula, or ointment mill may be used depending upon the scale of the product that is being produced.
○ Fusion utilizes heat to melt part of the entire individual ointment components. These components are then cooled with constant stirring until they are congealed. The congealed ointment can then be passed through an ointment mill or rubbed with a spatula in a mortar to ensure uniform texture throughout.
- SUPPOSITORY: This is a solid dosage form that uses oleaginous (fatty) or water-soluble bases to prepare a formulation that is used rectally or vaginally. The base maintains its solid, hard shape at room temperature. However, at body temperature, it will melt to a nonirritating oil. Suppositories are placed in aluminum wrappers and kept in a refrigerator to avoid melting. Suppositories are generally prepared three different ways: via hand rolling, using a compression mold, or through the use of a fusion mold.
○ Hand rolling is the oldest and simplest method of preparation. Grated cocoa butter and active ingredients are triturated in a mortar. The mass is formed into a ball in the palm of the hands and then rolled into a cylinder with a spatula or a small board. The cylinder is then cut into small uniform pieces, and one end is rolled to produce a conical shape.
○ Compression molding uses a special mold to compress the mixed mass ball of base and active ingredients into the cylinder, which is then closed. Pressure is applied at one end to release the mass from the other end of the mold. A moveable end plate is then removed, additional pressure is applied to the mass in the cylinder, and the formed suppository is ejected. The suppository can then be weighed to ensure accuracy.
○ Fusion molding is similar to compression molding but involves the use of heat to melt the suppository base. The active drug is then dispersed or dissolved into the melted base. The mixture is poured into the mold and allowed to congeal, and then the formed suppositories are removed and weighed for accuracy.

NOTE: Any time a drug is added to a suppository base, it will displace an amount of the base as a function of its density. Density is considered in suppositories because the components are measured by weight but are compounded by volume. For example, if the drug has the same density as the base, the drug will displace an equivalent weight of the base. If the density of the drug is greater than that of the base, it will displace a proportionally smaller weight of the base.

- ENEMA: This is a liquid formulation that is inserted into the rectum to relieve constipation and for bowel cleansing. Water-based solutions, like Castile soap, sodium phosphate, and normal saline, are used to irritate the colon lining, draw water from the bloodstream into the colon, or expand the colon and prompt evacuation.

Medical Devices and Equipment Used for Administration
Dosage delivery devices are intended to facilitate proper dispensing of the product by the patient, the parent, or the caregiver. These devices are calibrated to ensure proper measurement of the appropriate dose. These devices contain markings at designated intervals, and the most common units are teaspoons, tablespoons, or milliliters.

Oral Devices
Oral pediatric medications are dispensed with an administration device that is suitable for the child’s age. Medication cups, droppers, calibrated spoons, and oral syringes are used to accurately measure and dispense medications. Oral cups may contain measurements for teaspoons, tablespoons, and milliliters. The liquid is poured into the cup and measured to the bottom of the meniscus to maintain accuracy. Oral cups are reserved for volumes that are greater than 5 mL, and droppers, calibrated spoons, and oral syringes are used for volumes that are less than 5 mL. Oral droppers are used to administer small amounts of liquid medication to the eyes, ears, and, in rare cases, the mouth. They are calibrated by the manufacturer and should not be interchanged or used to administer other products. Oral droppers are not commonly used anymore for oral administration due to safety concerns and difficulty maintaining consistency while using the device. Calibrated spoons are hollowed spoons that allow for volumetric measurements up to 5 mL. The medication is poured into the hollow inside and measured in teaspoons or milliliters. The most commonly used delivery device is the oral syringe. Pharmacies generally carry 1, 3, 5, and 10 mL oral syringes, and a selection is based on the volume of medication to be given in one dose. Oral syringes provide precise and accurate measurements of medications. Depending upon the size of the syringe, the amount that is dispensed on each line varies.

Table: Oral Syringe Calibration
Calibration markings on various oral syringes.

Oral syringes may also be used with bottle adapters, small plastic inserts that fit into the bottle opening, to draw out liquid from the inverted bottle. One must be cautious when purchasing bottle adapters that are not provided by the medication manufacturer, as they may not fit well and can lead to spillage and inaccuracies in dosing.
To draw up a medication with an oral syringe, follow these steps:
1. Unscrew the cap that is located on the medication bottle.
2. Check for the clear syringe bottle adapter in the bottle, or attach an adapter cap that was sent with the syringe. If an adapter cap is used, screw the cap onto the medication bottle opening.
3. Insert the syringe into the bottle adapter, and press down until the syringe is snug. The plunger should be fully depressed to avoid withdrawing any liquid.
4. Invert the bottle with the attached syringe so that the bottle is upside down.
5. Draw up the prescribed amount of medication into the syringe by pulling back on the plunger to the prescribed medication dose.
6. Turn the bottle upright, remove the syringe, and administer the prescribed dose.

Injectable Syringes
Injectable syringes are also used to administer medications. Figure 7-3 depicts the parts of a syringe and a needle.



Parts of a syringe and a needle

A needle has two parts: the shaft and the hub. The shaft is the stem and has a bevel (diagonal point) on one end. The hub is the other end of the needle and attaches to the syringe. Also, note that the shaft contains a hollow bore, referred to as the lumen. Needles are referred to by their size. Needle lengths vary from Filter needles are specialized needles that contain a filter that is used to catch any particles that may be present in an ampule. The filter needle is used to withdraw solution from the ampule. Then, an unfiltered needle can be attached to add the medication to the bag of solution.
Syringes have two main components: the barrel and the plunger. The barrel is a hollow tube with an open end on one side. Within the barrel is a plunger, which is a piston-type rod that moves within the barrel and is used both to draw and to release fluid. The tip of the syringe contains a point of attachment that is used to attach a needle. Some syringes contain a tapered tip that allows the needle to be held on by friction. Other needles have a locking device that allows the needle to be secured by turning and locking the needle in place. Graduation lines indicate the volume of solution. Capacity varies with syringes and ranges in size from 1 mL to 60 mL. Syringes are also disposable and should not be reused.

Diabetic Administration Supplies
Many injectable diabetes medications come in prefilled insulin pens. Those pens will require needles for administration. Insulin is injected subcutaneously and requires a thin, short needle for comfort and to avoid reaching muscles.
The most common injection sites that are used are the abdomen, thighs, buttocks, and upper arms. The best technique to avoid injecting muscles is to gather the skin and fat between the fingers and inject the folds. Typically, 29-gauge to 32-gauge needles are used.
Insulin syringes are available in 30 unit (3/10mL), 50 unit (5/10mL), and 100 unit (1 mL) volumes.
Monitoring blood is an important part of managing diabetes. Home blood glucose monitoring (BGM) was introduced in the 1970s and revolutionized self-care of people with diabetes. BGM is a staple part of diabetes management and continues to help patients reach their glycemic targets. There are two main ways to measure blood glucose levels. The first option is to use a glucometer, which is a traditional fingerstick device. The second option is a continuous glucose monitoring (CGM) device, a portable electronic device used to continuously track blood sugar levels.

Glucometer
A glucometer, also known as a blood glucose monitor, is a small, handheld device that scans a small blood sample to measure the amount of glucose in the blood. There are many different types, from basic models to more advanced meters. Use of a BGM requires test strips, alcohol pads, lancets, or a lancing device in order to take a blood glucose reading. First, a test strip is inserted into a meter. Then, the patient will wipe a fingertip with an alcohol swab and use a lancet or a lancing device to prick the finger and produce a drop of blood. Finally, a test strip is touched to the blood until it has absorbed enough blood to begin the test. The cost of blood glucose monitors varies, and insurance coverage may also be limited to specific models or limits on the total number of test strips allowed. Patients may use a BGM multiple times a day to track blood glucose levels.
Test strips are small plastic strips that provide a blood glucose reading. The thin plastic strip is coated with a fine layer of gold and contains chemicals. As the blood is drawn into the strip, it mixes with the chemicals, and an electrical signal travels from the strip to the meter, providing a good glucose reading.
Lancets are single-use, small needles that are used to prick the skin to obtain a small blood sample. Lancet gauge sizes vary; the higher the gauge, the smaller the perforation made by the lancet. In addition, lancets can be used with a lancing device, a device that uses a spring to drive the lancet into the skin and retract it very quickly. Lancing devices are adjustable, allowing the user to change the depth of penetration depending on the thickness of the skin, the presence of calluses, and the sensitivity of the fingertips. These are a great way for patients to obtain enough blood without causing unnecessary pain. The following steps demonstrate how to use a common lancing device.
1. Wash your hands, and then take the cap off the lancing device and insert a new lancet with the safety cap still on.
2. Remove the safety guard off the lancet to expose the needle by twisting or pulling the cap. Then, carefully place the lancing device cap back on.
3. Select your depth by twisting the base to the appropriate number. Typically, the smallest number represents the most shallow depth.
4. Slide or press a button on top of the lancing device to load the lancet so it is ready to puncture when prompted.
5. Press the device evenly and firmly along the chosen fingertip, and then pull the device away from your finger.
6. Wait for a drop of blood, or gently “milk” the fingertip to squeeze blood toward the puncture hole to gather more blood. Transfer the blood sample into the glucometer.
7. Apply pressure to your fingertip using a small piece of gauze, place an adhesive bandage, and then properly dispose of the used lancet.

Continuous Glucose Monitoring (CGM) Device
This portable electronic device displays real time blood glucose levels using a sensor that is inserted into the arm or stomach. An applicator is used to insert the sensor, which will need to be replaced every 10–14 days depending on the model. The sensor measures interstitial glucose, glucose found in the fluid between the cells. A transmitter sends reading results to a monitor or smartphone. Some monitors may be part of an insulin pump, or it may be a separate device that can be clipped to clothing or carried in a pocket.

Unit-of-Use Bottles
Some drugs, as per the manufacturer, are to be dispensed in their original stock bottle container due to sensitivity, stability, integrity, or safety concerns. Many times the manufacturer will provide bottle sizes or containers that meet the length of therapy or last for 1 month’s supply.

Table: Examples of Medications That Are Dispensed in Their Original Packaging

Unit Dose Systems
Unit dose systems are medications that are prepackaged for single administration. These medications may come already prepackaged from the manufacturer or may be packaged by the pharmacy into unit dose systems. Hospitals commonly use unit dose systems because they are safer for the patient, more efficient and economical for the institution, and a more efficient use of personnel. Unit dose systems contain the medication name, strength, manufacturer name, lot number, NDC number, expiration date, and barcode. Long-term care pharmacies use blister card unit dose systems that provide 30 to 90 doses of medication at one time. Each card contains the medication name, strength, manufacturer name, expiration date, and lot number. A barcode and an NDC number may also be used to identify the medication.

Spacers
Spacers are devices that attach to an inhaler and hold medication until it is breathed in. A tube-based spacer is a device that is placed between the mouth and the inhaler. A valved holding chamber (VHC) is a type of spacer that has a one-way valve at the mouthpiece that is used to trap and hold the medication until the patient is ready to take a slow, deep breath. The valve stops the patient from accidently exhaling into the tube. Spacer devices may also have antistatic coatings (to prevent the medication from sticking to the inside of the spacer), compact sizes, whistles (that sound when the medication is inhaled too fast), flaps (to indicate the number of breaths taken), and various size masks.

Medication-Specific Numbers
The National Drug Code number, most commonly referred to as the NDC, is a ten-digit, three-segment number that identifies the labeler (manufacturer), product, and package.



 

National Drug Code
The NDC consists of three segments:
- FIRST SEGMENT: This sequence of four or five numbers identifies the labeler (manufacturer or distributor). The Food and Drug Administration (FDA) assigns this segment.
- SECOND SEGMENT: These three or four middle digits refer to the product strength, dosage form, and formulation.
- THIRD SEGMENT: The final one or two digits identify the package form and size.

The NDC is used to verify product selections when filling a prescription. Pharmacy technicians can also scan the NDC barcode when ordering or to verify counts.
Medications also contain a second set of numbers called a lot number. This is a unique number that is issued by the manufacturer. It is assigned to a batch of medications during production.
This number helps to identify and, in the event of a problem, isolate any medications with potential problems that occurred during production. It is usually stamped on the side of the packaging. Recalls will always state the lot number(s) involved for consumer verification. When a pharmacy receives a recall notice, they will pull the medication from shelves, medication carts, and storage areas to return it to the manufacturer.
The third set of numbers that is found on medications is the product expiration date. This set of numbers can be found on over-the-counter (OTC) medications, as well as on prescription medications. OTC medications and stock prescription medications receive an expiration date as determined by the manufacturer. Prescription medications that are repackaged and placed into vials for patient use also receive a beyond-use date. Typically, the expiration date for a prescription medication is set for 1 year from the date the medication was repackaged unless the manufacturer’s expiration date comes before that. Medications that are reconstituted (e.g., children’s antibiotics) and intravenous (IV) medications also have a beyond-use date.
Expired medications may be returned to the distributor for reimbursement. Each distributor determines its own return policy and may require authorization before returns are accepted and reimbursement is granted. When Schedule II medications are beyond their expiration date, a DEA 41 form must be completed, and the destruction of the expired drug must be witnessed. Some strategies that are used to decrease the amount of expired drugs in the pharmacy include using colored stickers to designate the month of expiration, writing the number associated with the month of expiration on the bottle in a visible area, and placing new products behind old products on the shelf (i.e., rotating stock).
Medications that are returned to the pharmacy cannot be sold. These medications are placed in a separate waste bin until they are removed by a reverse distributor. Medications that are filled but are not picked up by the patient can be returned to stock. These medications should not be added to the original stock container. Instead, these medications are kept in the original vial and all patient-specific information is removed. These medications can then be recounted into a new bottle and used again for another patient. This rule also applies to pharmacies that deliver medications. Medications that never leave the possession of the driver may be returned to stock. In the hospital setting, unit dose medications may be returned to stock. However, the storage condition of the product should be considered. For example, if a medication that requires refrigeration is found on the countertop, it may need to be discarded.

Medical Terminology
Health care professionals use medical terms to describe the human body, including its components. These terms are also used to describe any procedures that are performed, any conditions that affect the body, and any diagnoses that are made. Each medical term is made of three distinct parts: the prefix, the root word, and the suffix. The prefix is placed at the front of a word and is used to describe or change its meaning. It can also be used to indicate a location, a time, or a number. “Pre” means “before.” The root word gives the word its meaning and often indicates an organ, a tissue, or a condition. The suffix is located at the end of a word and is used to change the meaning. Medical terms can contain multiple root words and often use combining vowels, like “i” and/or “o,” to ease pronunciation. The combining vowel(s) can be found between root words or when a suffix begins with a consonant. A root word plus a vowel equals a combining form. For example, “micr” + “o” = “micr/o.”

Table: Examples of How Combining Forms and Suffixes Are Used to Form Medical Terms