Chapter 5 Technician Review

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Proper Storage of Drug Products

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Part of delivering an effective drug is related to the way the drug is stored in the warehouse and on the pharmacy shelf. Proper storage conditions for drug products are important, and the technician would be wise to be familiar with accepted guidelines. The storage conditions of drug products in the pharmacy are subject to spot inspections by the State Board of Pharmacy at any time. Accepted temperature guidelines for storage areas are as follows: Refrigerated areas are to be kept within a range of 2-8 degrees C (36-46 degrees F) as measured by a calibrated thermometer (which should be in place in case of an inspection). Room temperature is to be kept between 15-30 degrees C (59-86 degrees F). Remember that drugs are chemicals, some are sensitive to light, others to heat, humidity, or oxygen in the air. Some drugs react chemically with their packaging, for example, nitroglycerin will react with most forms of plastic and should be packaged in glass. Drugs may be sensitive to heat, light, humidity, and oxygen and should be stored appropriately!

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Dosage Forms and Drug Stability

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The form of the drug also contributes to stability. The stability of a drug (how well it retains its potency and form) is affected, as mentioned above, by things like water and air (e.g. An injectable drug). A drug that is packaged dry on the shelf may retain its potency longer than if it is reconstituted with water. The presence of water accelerates the breakdown of the drug and severely shortens its shelf life. The stability of a drug is greatly increased when it is in tablet form, as compared to other dosage forms (e.g. powder, solution).The presence of water may accelerate the breakdown of a drug and severely shorten its shelf life.

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Tablets and Other Solid Dosage Drugs

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A drug tablet carries most of the drug inside the dosage form, protected from air and moisture. Thus the tablet form may retain potency longer than a loose, powdered from of the same drug, simply because less of the drug is exposed. Various storage conditions may also help to protect the drug from breakdown. These include: Opaque glass or plastic packaging. Since the energy from light rays tends to speed up the breakdown (degradation) of most drug products, drugs are routinely packaged and dispensed in opaque bottles or bottles made of brown plastic or glass. Drugs should be kept out of direct sunlight, and care must also be taken to be sure that the container lid forms a tight seal against humidity and oxygen, which can also destroy the drug, Refrigeration. Colder temperatures tend to slow down any chemical reaction, so storage of drug products in a cool, dry place will help to retard chemical breakdown and retain potency. Refrigerated storage may also be utilized but this may not be appropriate for all drugs; the manufacturers label should be consulted prior to refrigerating a drug. Cooler temperatures also decrease the rate of growth of microorganisms, so storing sterile products in a cool environment will increase their shelf life accordingly. Dehydration. Drugs in solution tend to break down faster than those in powder form. Some drugs are received in powder form for this reason ( i.e. a longer shelf life) and are reconstituted just before use. If the drug is stored in solution form (hydrated), its shelf life is limited and, depending on the rate of use, much of it may degrade and must be discarded. The shelf life and potency of a drug may be extended using opaque packaging, refrigeration, and dehydration.

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Determining the Proper Storage Conditions for a Drug

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The manufacturers label on the stock bottle should be consulted to determine the proper storage conditions for a drug. The manufacturers label in addition to allowing us to accurately calculate the amount of drug dispensed per dose, gives additional information that is necessary for the proper handling of the drug. The label contains information about the temperature at which the drug should be stored and also states any storage conditions that should be avoided (e.g. cold, light, or humidity). For example, if the label states “protect from light”, this means that the drug is light sensitive and should be stored appropriately (e.g. packaged in amber glass or plastic). If the label states “keep container tightly closed” this means that drug is sensitive to oxygen or humidity in the air. Many drugs will absorb water out of the air, which decreases their potency. If there are no storage instructions, the drug should be stored at room temperature, away from bight light and heat. The label shown in Figure 5-1 is that of Pfizerpen, an injectable form of penicillin. The drug is received in a dry state within the vial and is to be reconstituted before use, according to instructions on the label. The label also gives instructions as to proper storage temperature for the drug, both before and after hydration. The instructions state that the hydrated suspension may be kept for one week in the refrigerator. The label may specify a specific temperature or range of temperature at which the drug should be stored. The technician must be familiar with what these temperatures mean, in terms of where in the pharmacy the drug should be stored. Table 5-1 should be committed to memory.

If the label states storage temperature of :8-15 degrees Celsius, the drug should be refrigerated. Some common items would include Vaccines Suppositories Famotidine injection Succinylcholine Insulin Below 0 degrees Celsius, it refers to storage in the freezer. (Usually this is a warning as to how the drug should not be stored, many drugs are sensitive to extreme cold). 25 degrees Celsius (75 degrees Farenheight), this is normal room temperature. The drug may be stored on the pharmacy shelf. Label Warnings Might include the following:30 degrees Celsius or 85 degrees Farenheight (a “warm” room). Drugs will lose potency when exposed to heat. Above 35 degrees Celsius or 90 degrees Farenheight (“extreme” heat). This is too high a temperature for drug products. Freezer storage [0 degrees Celsius (32 degrees Farenheight) or less] Drugs are sensitive to extreme cold.

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Importance of Proper Packaging and Labeling

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The label may provide an indication of how the drug should be packaged. The type of drug packaging is important. For example, many drugs are light sensitive and are packaged in opaque or amber plastics. Some drugs react chemically with plastic, so they will carry a warning to use only glass packaging. The label also provides information for proper handling (e.g. shake well before using). The dosage form is clearly stated on the label (e.g. a suspension). (What does that mean in terms of handling the drug and drawing up the dose? Review Chapter 3). The label also states the amount (volume) of suspension in the bottle. This is useful in two ways. First, it tells us how many doses we can draw out of the bottle. Second, and very importantly, if the concentration of the drug suspension or solution is not given on the bottle, it can be calculated by dividing the total amount of drug in the bottle by the total volume of the drug suspension or solution in the bottle. Then the proper amount needed for dispensing can be calculated. The volume of drug solution stated on the manufacturers label allows accurate calculation of the number of doses available. This information may assist in accurate calculation of the drug concentration.

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Importance of Cleanliness and Sanitation During Storage

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In addition to following the manufacturer’s instructions when handling a drug, care must be taken to keep the drug clean and sanitary during storage. Dust on the bottle or shelves can contain molds, fungi, or bacteria that can enter the bottle when it is opened and contaminate the drug.

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Avoiding Cross-Contamination of Drugs Due to Improper Sanitation

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When more than one drug is handled at once, some residual may remain on the measuring device and will contaminate the second drug with another medication that may be harmful to the patient (even a trace of drug remaining on a counting tray could cause a severe allergic reaction should the patient happen to be allergic to it.) At the very least, the patient may receive trace amounts of a drug that is not appropriate for his or her condition. Patients who are allergic to penicillin may suffer serious consequences if exposed to even the tiniest trace of the drug. These may include life threatening anaphylactic reactions characterized by severe shock and an inability to breathe. Because of the serious nature of penicillin allergies and the potential for life threatening reactions in allergic patients, separate tablet counters and other equipment may be reserved for the measurement of penicillin. Cleanliness of measuring devices is extremely important to prevent cross contamination of drugs!

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Preparation of Unit Doses

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In an institution, it is more efficient to dispense an entire day’s worth of medication at one time, to be administered by the floor staff, rather than order each individual dose from the pharmacy. This dose is calculated, dispensed, and, usually, delivered to the patient care area by the technician once a day. A unit dosing system is used in an institutional pharmacy. Simply stated, it is the daily preparation and delivery of enough drug to last for the entire day. A unit dose is simply enough drug for one dose in the a prepackaged container (e.g., one 500 mg capsule or two 250 mg capsules of amoxicillin for a prescribed dose of 500 mg). Unit doses are stored in a medication cart and are filed under a patients name or hospital identification number. (see Chapter 1).

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Calculating a Daily Dose

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A daily dose is calculated from the physician’s order. The amount of medication per dose is multiplied by the number of doses per day ( a 24 hour period). For example, if an order is for “cimetidine 300 mg tid ac,” the calculation would be: This amount would be packaged appropriately and labeled with the patients name, location, and hospital number as well as the drug name, strength, and form, if appropriate. Tablets may be packaged in blister packs or other appropriate packaging to keep the drug sanitary and separate from other drugs. Injectable medications, other than controlled substances, may be sent in a prefilled syringe, vial, or dosette.

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Exceptions to Unit Dosing

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Exceptions to unit dosing include those medications that cannot be accurately measured for a unit dose, such as creams and ointments, and liquids for oral medication. These medications are sent to the patient floor in bulk, packaged in a tube, jar, or bottle, as appropriate. When the exchange of medication takes place each day ( unused medications are picked up and new doses delivered), these bulk medication are not replaced, but simply transferred from the previous day’s medications to the current medications. With this system, the patient is charged only for the medication that is used. Unused drugs are picked up and returned to the pharmacy for credit. In the past, narcotics, and other Schedule drugs were not included in the daily dose system of dispensing. This is no longer the case, as most institutions now have computerized carts that require the nurse or pharmacy technician to enter a specific code, assigned only to them, in order to unlock the drawers within the cart. In addition, when withdrawing drugs, the nurse must enter information into the computer, such as the name of the patient for whom the drugs are intended, as well as such information as the drug to be administered, making the storage of controlled substances more secure. This computerized system can also record the wastage due to partial dosing or contamination.Exceptions to unit dosing include medications that cannot be measured accurately for a unit dose, such as creams and lotions, and liquids for oral dosage.

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Use of Pharmacy Inventory as Floor Stock

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To further decrease the workload of the pharmacy and increase the availability of medication to the patient floors, the pharmacy may send drugs to individual patient floors to use as floor stock. In this case, the nurse’s station or emergency room staff would be responsible for keeping a supply of the drugs and drug products on hand that are normally needed on a routine basis. Drugs would then be inventoried by the floor staff and ordered in quantities from the pharmacy. If an item is used often, it might be ordered daily. If it is not used often, it would be ordered less frequently. Even though the storage and inventory are done by the floor staff, the pharmacy staff is still responsible for ensuring that the drugs are properly stored and dispensed. Periodic checks must be made to ensure that the following criteria are met: Proper Storage Conditions: All drugs must be stored at the proper temperature. Pharmacy personnel may measure the temperature of storage areas, such as refrigerators, and must ensure that all drugs are stored appropriately and in a sanitary manner, according to the instructions on the manufacturers labels. This may include checking to see if drugs that are supposed to be refrigerated are being left on the counter when not in use, or if caps, are being left off of the bottles when not in use. ( If this happens, the drug potency may be reduced and contamination may occur.) Proper Dispensing Conditions: Drugs must be dispensed in a clean, sanitary manner that is appropriate to the particular drug, and the dispensing area and utensils must be clean and sanitary. In addition, sloppy handling may lead to contamination and caps may be left off of the stock bottles, exposing the drug to air, light, and humidity, which would lower the drug potency. Improper handling may also expose the drug to dust and microorganisms in the air, such as bacteria, fungi, and viruses. Proper Sanitation of Dispensing Areas: Inspections may be conducted to ensure that the general environment of the dispensing area is clean and sanitary. This includes inspections of equipment used for measuring drugs for dispensing to ensure that they are clean and being properly used. No dirt, clutter, used syringes or needles, or contaminated materials should be present in the dispensing area (e.g. urine or blood specimens, or other laboratory specimens) nor should any food or drink be present. Proper Record Keeping: Proper records must be kept of disposition of drugs, just as in the pharmacy. A current inventory of floor stock, records of drugs dispensed to patients, and records of drugs ordered and received must all match. This is especially important with controlled substances, particularly Schedule II drugs. Any discrepancies must be reported immediately to the pharmacist and supervising professional (e.g. head nurse) on the floor.

Drugs that are used on a routine basis may be kept on the patient floor as floor stock, which is maintained by the medical staff and supervised by the pharmacy.

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Documenting Drug Transfer from the Pharmacy to Floor stock Areas

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Proper Record Keeping Accurate records must be kept of the transfer of drugs from the control of the pharmacy to the control of the patient care area. When requested drugs are delivered to patient care areas, the technician must receive a signature of the person accepting the drugs and must provide complete inventory of drugs delivered.Information and Signatures Required for Transfer of Controlled Substances If the delivery to the patient care area contain controlled substances, additional paperwork is required that specifies the exact amount of drug to be transferred and includes all information about the drug: the generic name, proprietary name, dosage and dosage form, manufacturer, lot number, and expiration date. The signature of the head nurse or supervising medical professional is required for delivery of any controlled substance (particularly Schedule II drugs) to be used as floor stock outside the main pharmacy, unless the drugs are placed into a locked, secure area (e.g. a computerized medication cart). A signature by any other person is not acceptable. The receipt of the drug(s) by the patient care area is acknowledged by this signature, and responsibility for the drugs disposition and appropriate records are transferred at this time.