Review & Practice Exam, 3rd Edition - Sample Chapter 1, Lecture notes of Pharmacy

With few exceptions, this pharmacist check is legally required before dispensing any drug to a patient care area. Receiving and Processing ...

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This chapter applies to Section I
of the PTCB exam, Assisting the
Pharmacist in Serving Patients.
Chapter 1
Learning Outcomes
After completing this chapter, the technician should
be able to:
Defi ne the terms
Imedication order and prescription, and
list the common means by which they are received by the
pharmacy.
Defi ne commonly used pharmacy terms and abbrevia-
I
tions used in medication orders and prescriptions.
List the required elements on a prescription or
I
medication order.
Defi ne National Drug Code (NDC) numbers and put
I
into proper order for transmittal.
Verify correct Drug Enforcement Agency (DEA)
I
numbers.
Describe the steps required for proper prescription and
I
medication order processing.
Describe when a patient signature is required at the
I
point of sale.
Describe how prescriptions are transferred between
I
pharmacies.
Explain good compounding practices and aseptic
I
technique.
Give examples of drugs with Risk Evaluation and
I
Mitigation Strategy (REMS).
List and describe the equipment used in both sterile
I
and nonsterile compounding.
Describe the process utilized to prepare cytotoxic and
I
hazardous drugs.
Defi ne laminar airfl ow workbenches (LAFW) and
I
biological safety cabinets (BSC).
Describe the types of questions that may be answered by a
I
pharmacy technician.
List common references found in many pharmacies and
I
what information might be found in each.
Medication Orders and
Prescriptions Defi ned
Typically, the term medication order refers to a written
request on a physician’s order form or a transcribed ver-
bal or telephone order in an inpatient setting. This order
becomes part of the patient’s medical record. The term
prescription refers to a medication order on a prescrip-
tion blank to be fi lled in an outpatient or ambulatory
care setting. The two serve essentially the same pur-
pose. They both represent a means of communication
for the prescriber to give instruction to the dispenser of
the medication or to those who will be administering the
medication.
Pharmacy Terms and Abbreviations
Pharmacy personnel use a number of terms in their work.
An understanding of these terms helps a technician to be
effi cient and capable.
Some of these terms defi ne classifi cations of drugs.
For example, technicians must be able to differentiate
between generic and brand name drugs. A generic name
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Download Review & Practice Exam, 3rd Edition - Sample Chapter 1 and more Lecture notes Pharmacy in PDF only on Docsity!

This chapter applies to Section I

of the PTCB exam, Assisting the

Pharmacist in Serving Patients.

Chapter 1

Learning Outcomes

After completing this chapter, the technician should be able to:

 (^) Define the terms medication order and prescription, and

list the common means by which they are received by the pharmacy.

Defi ne commonly used pharmacy terms and abbrevia-

tions used in medication orders and prescriptions.

List the required elements on a prescription or

medication order.

Defi ne National Drug Code (NDC) numbers and put

into proper order for transmittal.

Verify correct Drug Enforcement Agency (DEA)

numbers.

Describe the steps required for proper prescription and

medication order processing.

Describe when a patient signature is required at the

point of sale.

Describe how prescriptions are transferred between

pharmacies.

Explain good compounding practices and aseptic

technique.

Give examples of drugs with Risk Evaluation and

Mitigation Strategy (REMS).

List and describe the equipment used in both sterile

and nonsterile compounding.

Describe the process utilized to prepare cytotoxic and

hazardous drugs.

Defi ne laminar airflow workbenches (LAFW) and

biological safety cabinets (BSC).

Describe the types of questions that may be answered by a pharmacy technician. List common references found in many pharmacies and what information might be found in each.

Medication Orders and Prescriptions Defined

Typically, the term medication order refers to a written request on a physician’s order form or a transcribed ver- bal or telephone order in an inpatient setting. This order becomes part of the patient’s medical record. The term prescription refers to a medication order on a prescrip- tion blank to be filled in an outpatient or ambulatory care setting. The two serve essentially the same pur- pose. They both represent a means of communication for the prescriber to give instruction to the dispenser of the medication or to those who will be administering the medication.

Pharmacy Terms and Abbreviations

Pharmacy personnel use a number of terms in their work. An understanding of these terms helps a technician to be effi cient and capable. Some of these terms define classifications of drugs. For example, technicians must be able to differentiate between generic and brand name drugs. A generic name

Pharmacy Technician Certification Review and Practice Exam

legibility is poor. These three abbreviations have been in- cluded in the chapter because they are still widely used.

Receiving and Processing Medication Orders in a Hospital

Medication orders come to the hospital pharmacy in vari- ous ways. They can be delivered to the pharmacy or one of its satellites in person or via some mechanical method, such as fax transmission or a pneumatic tube system. Orders may also be telephoned to the pharmacy by either the prescriber or an intermediary, such as a nurse. There are some legal restrictions on who may telephone in an order or a prescription, and who may receive that infor- mation in the pharmacy—particularly when controlled substances are involved. Ideally, every medication order should contain the following elements:  Patient name, hospital identification number, and room/bed location  Generic drug name (using generic drug names is recommended, and many institutions have policies to this effect)  Brand drug name (if a specific product is required)  Route of administration (with some orders, the site of administration should also be included)  Dosage form  Dose/strength  Frequency and duration of administration (if duration is pertinent—may be open-ended)  Rate and time of administration, if applicable  Indication for use of the medication  Other instructions for the person administering the medication, such as whether it should be given with food or on an empty stomach  Prescriber’s name/signature and credentials (some hospitals require a printed name, physician number, or pager number in addition to the signature to assist with identification)  Signature and credentials of person writing the order if other than prescriber  Date and time of the order

When a new order is received, the first step is to ensure that the order is clear and complete. If information is missing—for example, the room number for the patient— the technician may be able to clarify the order without phar- macist intervention. Some clarifications, however, should

describes a unique chemical entity and can be applied to that entity regardless of its manufacturer. A brand name is trademarked by a manufacturer to identify its particu- lar “brand” of that chemical entity. For example, Ancef® is a brand name product of the generic entity cefazolin. Another pair of terms used to categorize drugs is leg- end and over-the-counter. A legend drug, also called a prescription drug, is one that may not be dispensed to the public except on the order of a physician or other licensed prescriber. The term comes from the federal legend that ap- pears on the packaging: “Federal law prohibits dispensing this medication without a prescription.” Over-the-counter medications may be sold to the public without a prescrip- tion as long as they are properly labeled for home use. One last term, formulary, is used in slightly different ways in institutional and retail settings. A formulary is a listing of approved drugs available for use. In a hospital, it refers to the drugs that are stocked by the pharmacy and approved for use in the facility. In the retail setting, the term is generally applied to an approved drug list associ- ated with a particular benefit plan. Pharmacy abbreviations are commonly used as a kind of shorthand in prescriptions and medication orders to con- vey information about directions for use. The abbreviations are then “translated” on the prescription label. Appendix A lists many commonly used pharmacy abbreviations. The abbreviations for time and frequency of medi- cation administration come from Latin phrases. Other commonly used abbreviations include those for routes of administration and those that designate units of measure. Lowercase Roman numerals are often used to denote a quantity, such as a number of tablets (i = one; ii = two). (See Chapter 14 of Manual for Pharmacy Technicians for a review of Roman numerals.) Another subset of abbreviations is called x-substitu- tions and includes the well-known and widely recognized Rx symbol, meaning prescription. Other common x- substitutions are dx for diagnosis and sx for symptoms. Abbreviations in medical records and in prescrip- tions are thought to be contributing factors in some medi- cal errors. One important example is the use of the letter U to abbreviate units. Because a U might be misread as a zero if sloppily written—and could therefore result in a tenfold dosing error—the Institute for Safe Medication Practices recommends that it never be used as an abbre- viation in prescriptions or medication orders; the word units should always be written out in its entirety. Other abbreviations that some consider unsafe are q., qid, and qod, which may be indistinguishable from each other if

Pharmacy Technician Certification Review and Practice Exam

information, such as date of birth, address, or phone number should be obtained to confirm the patient’s iden- tity. If the patient is bringing a prescription to you for the fi rst time, he or she needs to be registered by obtaining the following information:  Correct spelling of name  Address and phone number(s)  Insurance information from patient’s insurance card  Date of birth  Any drug allergies  Other prescriptions or over-the-counter (OTC) medications the patient takes regularly  Significant health conditions

Prescriptions may be received directly from the patient or from the prescriber by telephone, fax, or electronic transmission. Many pharmacies also accept refill requests over the Internet through a pharmacy Web page. Obtaining payer information is an important step in receiving a prescription in the outpatient setting. This in- formation is used for a number of purposes, including establishing the primary payer for the prescription, the patient’s portion of the reimbursement (copay), and in some instances the drug formulary. Reviewing a prescription for clarity and completeness is similar in the outpatient and the inpatient setting. The following prescription elements are typically present:  Patient name  Patient home address  Date the prescription was written  Drug name—either generic or brand  Drug strength and dose to be administered  Directions for use, including route of administra- tion, frequency, and, as applicable, duration of use (some durations are open-ended)  Quantity to be dispensed  Number of refills to be allowed  Substitution authority or refusal  Signature and credentials of the prescriber, and DEA number, if required  Reason for use, or indication (not generally required)

In an ambulatory practice, some special clarity and completeness issues must be considered. Receiving a prescription includes determining whether the prescrip- tion will be filled with generic or brand-name drugs. In many states when a prescriber uses “Dispense as Written” or DAW on a prescription blank, the brand name must be

generally set. These schedules are usually based on therapeutic issues or nursing efficiency or are designed to coordinate services, such as labora- tory blood draws or therapy schedules. Standard administration schedules and protocols are usually agreed upon by pharmacy, nursing, and the hospi- tal’s medical staff. Many pharmacies have a written document, such as a policy, that staff can refer to when the appropriate administration time is unclear.

  1. Enter any comments in the clinical comments field. The prescriber’s directions for proper use of the medications must be conveyed clearly and accurately. Additional instructions for the caregiver are often entered into the pharmacy information system for presentation on one of the many docu- ments printed from the profile (or for the nurses’ use in an electronic system) or simply as additional information for the pharmacists’ use at a later time. These special instructions might include storage information, such as the need to refrigerate, or spe- cial instructions, such as for chemotherapy drugs. Another example would be physician-specified parameters for use, such as, “hold if systolic BP less than 100 mm Hg,” or “repeat in one hour if ineffec- tive.” These types of instructions would typically be displayed on the medication administration record (MAR) and also on the medication label.
  2. Verify the prescriber name.
  3. Fill and label the medication. Once the computer entry has been completed and labeling materials generated, the medication order must be filled with the correct quantity of the correct drug. During this step, the technician should carefully review the label against the order and the product to be used to make sure the correct product has been chosen. This is the fi nal opportunity for the pharmacy to catch an error before dispensing to a patient care area. The medication order is then filled and left for the pharmacist to check. With few exceptions, this pharmacist check is legally required before dispensing any drug to a patient care area.

Receiving and Processing Prescriptions in an Outpatient Pharmacy

When welcoming a patient to the pharmacy, it is impor- tant to first identify him or her. If the patient has been to your pharmacy before, another piece of identifying

Assisting the Pharmacist

Prioritization of prescription processing in the outpa- tient pharmacy is generally an issue of customer service rather than patient care. Prescription processing includes many of the same steps as medication order processing in the inpatient setting:

 Identifying the patient: It is important to make sure that prescriptions are filled for and dispensed to the correct patient. Proper attention needs to be paid to similar or identical names to make sure the medica- tion is profi led on the right patient profile. Another important concern for the outpatient staff at this stage is to ensure that there is no forgery and that the individuals obtaining controlled substances are lawfully entitled to do so.  Creating, maintaining, and reviewing patient pro- fi les: A number of pieces of information are typical- ly collected in the patient profile—some according to law (which varies from state to state) and some for efficiency and convenience purposes for both the pharmacy and the patient. These pieces of informa- tion include the following:  Patient’s name and identification number  Age or date of birth  Home address and telephone number  Allergies  Principle diagnoses of patient  Primary health care providers for patient  Third-party payer(s) and other billing information  Over-the-counter medications and herbal supplements used by the patient  Prescription and refill history of the patient  Patient preferences (eg, child-resistant packaging waiver, preference for receiving prescriptions by mail)

Once the patient’s profile is located or created and the existing information is verified, selecting the appro- priate drug product is the next step in the order entry process. Most outpatient computer systems, like inpa- tient systems, allow drug product choice by typing in a mnemonic or by accessing an alphabetical listing of some sort. These are the typical prescription processing steps:

  1. Enter the patient’s medical record number or name and verify them. This safety step ensures that the drug is dispensed to the correct patient.

dispensed. The technician must know the requirements of their state.

Pop Quiz! If a prescription were ordered 1 tab qid, ac and hs, how would you write the label?

Po If a p tab q

Assessing Order Authenticity

Screening prescriptions for potential forgeries, particularly those for controlled substances, is part of routine prescrip- tion processing. The technician should screen prescriptions for anything that looks unusual, such as a dispense quantity in excess of normal quantities or an unusual or unrecogniz- able signature. Any suspicious prescription should be dis- creetly presented to the pharmacist for further evaluation. Prescription forgeries often take one of two forms: (1) erasure or overwriting of the strength or dispensing quantity of the drug (eg, changing a 3 to an 8), and (2) theft of preprinted prescription pads that may result in legitimate-looking prescriptions. One thing a technician can do to help prevent pre- scription forgery is determine if a DEA number on a controlled substance prescription is valid. A valid DEA number consists of two letters and seven numbers, such as “BB 1 1 9 7 9 6 7.” If the holder of the DEA number is a registrant, such as a physician or pharmacy, the first let- ter is an “A” or “B.” If the holder of the DEA number is a mid-level practitioner, such as a qualified nurse practitio- ner, the first letter is an “M.” The second letter is related to the registrant’s name. In the case of a physician, it is the fi rst letter of his or her last name. The seven numbers are also used to determine a legitimate DEA number. The odd group—the 1st, 3rd, and 5th numbers in the sequence, and the even group— the 2nd, 4th, and 6th numbers—are added in the follow- ing manner so that the sum relates to the 7th number:

BB 1 1 9 7 9 6 7 Odd Group 1 + 9 + 9 = 19 Even Group 1 + 7 + 6 = Sum of odd (19) and 2 × even group (14 × 2) = 19 + 28 = 47

The last digit of this odd/even group sum is the same as the last digit of the DEA number.

Assisting the Pharmacist

receives a message that the claim has been rejected, resolving these third party issues becomes a time- consuming part of the prescription process.

Collecting Payment and Patient Counseling Technicians are usually involved in point-of-sale (POS) transactions, which involve checking out patients and col- lecting payment when prescription orders are complete.

  1. Verify the patient’s name and other identifying information to ensure the medication is being given to the correct patient.
  2. Legal requirements regarding patient counseling must be met; offer to have the pharmacist visit with the patient if they would like counseling.
  3. New patients must be given a copy of the phar- macy’s patient privacy policy in compliance with Health Insurance Portability and Accountability Act ( HIPAA) regulations.
  4. The patients’ signature is required when they receive the HIPAA information and by some states if they refuse counseling and by some third party payers when they take possession of the prescription.

Transferring Prescriptions

The laws regarding the transfer of prescriptions between pharmacies vary among states and among different class- es of drugs. However, the pharmacist is always ultimately responsible for the information transferred. The transfer of a prescription to another pharmacy is usually initiated by a phone call from the pharmacy needing a transferred prescription. A technician may pull the original prescrip- tion from fi les or pull up the data on the computer, but the actual transfer of information is usually the responsibility of the pharmacist. The same is true for prescriptions being transferred into the pharmacy. In this case, the process begins when a patient requests to transfer the prescription from an- other location. At that point, the technician must obtain from the patient as much information as possible about the prescription. At a minimum, the pharmacist needs the patient’s name and the name of the pharmacy cur- rently holding the prescription. If a patient brings in an old container, it may be useful to troubleshoot the label. For example, if the label indicates that there are no re- fills, the physician will have to be called to authorize the refill.

language barriers, such as illiteracy or a primary language other than English.

NDC Numbers

NDC numbers are identification numbers used by drug manufacturers to identify their product. Each number is specific for a specific product. NDC numbers are used for verifying the correct drug has been used to fill the prescription and for remittance to third party companies.

 First group of numbers: represent the manufacturer.

All products made by a specific manufacturer will have the same first number.  Second group of numbers: represent the specific product.  Third group of numbers: represent the package size.

In most cases, NDC numbers must be transmitted to a third party in a 5-4-2 configuration, even though the manufacturers do not always present them to us in that configuration. If we do not bill the NDC # correctly, the third party company’s computer cannot read it correctly, and this could result in an error in payments, or no pay- ment at all.

NDC Format Corrected to 5-4-2 Format 0536-3922-01 0 0536-3922- 59930-1500-8 59930-1500- 0 8 38245-196-72 38245- 0 196-

The NDC format is very specific, so placement of the zeros to create a 5-4-2 format is also very specific. The zero is always placed at the beginning of the incorrect group of numbers.

Pop Quiz! What does the first letter of the DEA number signify?

Communication with Third Party Payers

Most claims for third party payers are handled by phar- macy benefits managers (see Chapter 3 of the Pharmacy Technician Certification Review) but if the pharmacy

Pharmacy Technician Certification Review and Practice Exam

in 1997, the Food and Drug Administration Moderniza- tion Act (FDAMA) was passed. This legislation clearly defined the roles of both compounding pharmacies and the FDA. In the summer of 2002, however, the legisla- tion was declared unconstitutional because of advertis- ing restrictions. Nonetheless, the guidelines of the 1997 FDAMA still offer a structure for compounding pharma- cists to follow until future legislation addresses the issue. The United States Pharmacopeia (USP 27) offers guidelines for compounding. The following chapters of the USP 27 review specific areas of compounding:  Chapter 795 Pharmaceutical Compounding— Nonsterile Preparations  Chapter 797 Pharmaceutical Compounding—Sterile Preparations  Chapter 1075 Good Compounding Practices

The following are key areas of compounding:

  1. Responsibility of the compounder
  2. Compounding environment
  3. Stability of compounded preparations
  4. Ingredient selection
  5. Compounded preparations
  6. Compounding processes
  7. Compounding records and documents
  8. Material Safety Data Sheets (MSDS) file
  9. Quality control
  10. Patient counseling

Pop Quiz! NDC numbers are always transmitted in what format?

Responsibility of the Compounder The compounder is responsible for all aspects of the com- pounding process, including, but not limited to, appropri- ately trained personnel and the key areas of Chapter 795 that follow. Special training is required for all personnel who prepare sterile products.

Compounding Environment The compounding area should have adequate space for equipment and support materials. Controlled tempera- ture and lighting are needed for chemicals and finished

Handling Restricted Use Medications

There are certain medications that can only be prescribed and dispensed in a community or ambulatory care phar- macy under specific conditions due to special precautions regarding their use. The FDA requires a Risk Evaluation and Mitigation Strategy (REMS) when it determines that a strategy is necessary to ensure the benefits of using the drug outweigh the potential risks. Examples of drugs with REMS include: alosetron (Lotronex©), clozapine (Clozaril©, Fazaclo©), isotretinoin (Accutane©, Amnest- eem©, Claravis©, Sotret©), thalidomide (Thalomid©), and dofetilide (Tikosyn©). The FDA has designated other drugs that are required to be dispensed with Medication Guides. A Medication Guide is patient information approved by the FDA to help patients avoid serious adverse events, inform them about known serious side effects, and provide directions for use to promote adherence to the treatment. These are available for specific drugs or classes of drugs and must be dispensed with the prescription.^9 Common examples dispensed in community and ambulatory care pharmacies include nonsteroidal anti-inflammatory drugs (NSAID) and antidepressants.

Investigational Drugs

Investigational Drug services may be a form of services seen in a hospital or specialty pharmacy service. Before a study is approved to be conducted, a study protocol is developed, reviewed, and approved by the Institutional Review Board of the facility. In order to carry out a suc- cessful drug study there are specific requirements and procedures that must be followed. These include:  proper storage  record keeping  inventory control  preparation  dispensing  labeling of all investigational drugs

Good Compounding Practices

Chemicals for compounding are approved by the Food and Drug Administration (FDA); however, the practice of compounding is controlled by the individual state boards of pharmacy. Certain aspects of compounding and the role of the FDA were not clearly defined in federal law until,

Pharmacy Technician Certification Review and Practice Exam

Equipment Used in Nonsterile Compounding

Compounding requires specialized equipment to obtain the best quality medications. An electronic balance is commonly used for speed and accuracy of measurement (see Figure 1-1). Graduates (ie, glass or plastic cylinders and conicals) are used to measure the volume of liquid ingredients (Figure 1-2). It is recommended to use the smallest graduate that will hold the volume to be mea- sured. In addition, it is important to measure the volume of liquid accurately by placing the graduate on a stable surface (ie, counter top of work area) and read the mea- surement at the bottom of the meniscus. An ointment slab (also called a “pill tile”) is a square glass tile that is used for preparing and mixing creams and ointments. Similarly, many facilities use ointment paper (eg, pads of 12” × 12” disposable parchment pa- per) instead of an ointment slab because of convenience in reducing clean-up time (Figure 1-3). Mortars and pestles are used to crush, grind, and blend various ingredients. The mortar is a deep bowl, and the pestle is a club-shaped tool that when stamped or pound- ed vertically into the well of the mortar causes the con- tents of the mortar to become pulverized (see Figure1-4). Mixing is usually achieved by moving the pestle in a circular motion in the mortar. Mortars are available in a variety of materials and sizes. Glass, porcelain, ceramic, and Wedgwood™ are commonly used. Wedgwood™ of- fers a rough surface to allow grinding and reduction of particle size but is very difficult to clean and thus prevent cross contamination of preparations. Glass and porcelain offer smooth, easily cleaned surfaces. Ointment mills are commonly found in compound- ing pharmacies. Most have three rollers with small, adjustable spaces between the rollers (see Figure 1-5). When preparations pass through the rollers, particle size is reduced.

Parenteral Drug Administration

Medications can be administered to patients in numer- ous ways. Medications not given to patients by mouth (enterally) are referred to as parenterally administered. Parenteral administrations can include intravenous (IV), intramuscular (IM), and subcutaneous (SQ), or below the skin. IV solutions are commonly administered to patients as a means of replacing body fluids and as a vehicle for

Figure 1–1. Electronic balance.

Assisting the Pharmacist

take medications orally. Direct administration of IV med- ications into the blood also provides a predictable rate of administration. Certainly, IV medications have disadvan- tages, such as the risk of infection, the pain of the injec- tion, and the immediate effect of the administration in the

introducing drugs into the body. Medications are not ben- eficial to the patient until they reach the blood and are distributed to the body. IV medications are introduced directly into the blood and therefore have the most rapid onset of action. IV medications, therefore, have many benefits over oral medications, which have to be absorbed from the gastrointestinal tract, or IM medications, which have to be absorbed through the muscle mass. IV medi- cations can be given to patients who are unconscious, un- cooperative, nauseated, vomiting, or otherwise unable to

Figure 1–2. Graduated conicals and cylinders.

Figure 1–4. Mortar and pestle.

Figure 1–3. Ointment slab.

Figure 1–5. Ointment mill.

Assisting the Pharmacist

 Development and maintenance of a sterile com- pounding area complete with sterilized equipment and supplies  Development and maintenance of the skills needed to properly use an LAFW

Aseptic Technique Aseptic technique is a means of manipulating sterile products without contaminating them. Proper use of an LAFW and strict aseptic technique are the most important factors in preventing the contamination of sterile prod- ucts. Thorough training in the proper use of the LAFW and strict aseptic technique, followed by the development of conscientious work habits, is of utmost importance to any sterile products program.

Sterile Compounding Area, the Clean Room Sterile parenteral solutions must be free of living micro- organisms and relatively free of particles and pyrogens. Room air typically contains thousands of suspended particles per cubic foot, most of which are too small to be seen with the naked eye. These suspended particles include contaminants such as dust, pollen, smoke, and bacteria. Reducing the number of particles in the air im- proves the environment in which sterile products are pre- pared and can be done by following several practices. A sterile compounding area’s counters, work surfac- es, and floors should be cleaned daily while walls, ceil- ings, and storage shelving should be cleaned monthly at a minimum. Segregated compounding areas must be separate from normal pharmacy operations, nonessen- tial equipment, and other materials that produce parti- cles. For example, the introduction of cardboard into the clean environment should be avoided. Traffic flow into a clean area should be minimized. Floors should be dis- infected periodically, and trash should be removed fre- quently. Trashcans should be taken outside the IV room before pulling the trash from the container. This will minimize the creation of particulate matter and the risk of spills in the clean room. More sophisticated aspects of clean room design include special filtration or treatment systems for incoming air, ultraviolet irradiation, air-lock entry portals, sticky mats to remove particulates from shoes, and positive room air pressure to reduce con- taminant entry from adjacent rooms or hallways. Clean rooms are often adjoined by a room, called an anteroom, that is used for nonaseptic activities related to the clean

 (^) Particulate matter —Particulate matter refers to unwanted particles present in parenteral products. Some examples of particulate matter are micro- scopic glass fragments, hair, lint or cotton fibers, cardboard fragments, undissolved drug particles, and fragments of rubber stoppers, known as cores. Particulate matter that is injected into the blood- stream can cause adverse effects. Improvements in the manufacturing processes have greatly reduced the presence of particulates in commercially avail- able products. Care must be taken in the pharmacy so that particulate matter is not introduced into products. All products should be visually inspected for particulate matter before dispensing. Some institutions may use inline filters to help minimize the amount of particulate that reaches the patient.  (^) Pyrogens —Pyrogens, the by-products or remnants

of bacteria, can cause reactions (eg, fever and chills) if injected in large enough amounts. Because a py- rogen can be present even after a solution has been sterilized, great care must be taken to ensure that these substances are not present.  (^) Phlebitis —Phlebitis, or irritation of the vein, may

be caused by the IV catheter, the drug being ad- ministered (because of its chemical properties or its concentration), the location of the IV site, a fast rate of administration, or the presence of particulate matter. The patient usually feels pain or discomfort, often severe, along the path of the vein. Red streak- ing may also occur. If phlebitis is caused by a par- ticular drug, further diluting the drug, then giving it more slowly, or giving it via an IV catheter placed in a vein with a higher, faster-moving volume of blood may be helpful.

Aseptic Preparation of

Parenteral Products

As the use of parenteral therapy continues to expand, the need for well-controlled admixture preparation has also grown. Recognizing this need, many pharmacy depart- ments have devoted increased resources to programs that ensure the aseptic preparation of sterile products. The fol- lowing are the main elements on which these programs focus:

 Development and maintenance of good aseptic tech-

nique in the personnel who prepare and administer sterile products

Pharmacy Technician Certification Review and Practice Exam

prefi lter, which is similar to a furnace filter, removes only gross contaminants and should be cleaned or replaced regularly. The prefiltered air is then pressurized to en- sure that a consistent distribution of airflow is presented to the final fi ltering apparatus. The fi nal filter constitutes the entire back portion of the hood’s work area. This high effi ciency particulate air, or HEPA, filter removes 99.97% of particles that are 0.3 micron or larger, thereby eliminating airborne microorganisms, which are usually 0.5 microns or larger.

Vertical LAFW

Laminar fl ow workbenches with a vertical flow of fi ltered air are also available. In vertical LAFW, HEPA-filtered air emerges from the top and passes downward through the work area (see Figure 1-6). Because exposure to some antineoplastic (anticancer) drugs may be harmful, these drugs are usually prepared in vertical LAFW to minimize the risk of exposure to airborne drug particulates. The types of vertical laminar airflow hoods (LAH) used for the preparation of antineoplastics contain airflow within the hood and are referred to as biological safety cabinets (BSC). The critical principle of using LAFW is that noth- ing must interrupt the flow of air between the HEPA fil- ter and the sterile object. The space between the HEPA filter and the sterile object is known as the critical area. The introduction of a foreign object between a sterile object and the HEPA filter increases wind turbulence in the critical area and the possibility that contaminants from the foreign object may be carried onto the ster- ile work surface and thereby contaminate an injection port, needle, or syringe. To maintain sterility, nothing should pass behind a sterile object in a horizontal LAH or above a sterile object in a vertical LAFW. Materials placed within the LAFW disturb the pat- terned fl ow of air blowing from the HEPA filter. The zone of turbulence created behind an object could potentially extend outside the hood, pulling or allowing contaminat- ed room air into the aseptic working area. When laminar airfl ow is moving on all sides of an object, the zone of turbulence extends approximately three times the diame- ter of that object. When laminar airflow is not accessible to an object on all sides (for example, when placed ad- jacent to a vertical wall), the zone of turbulence may ex- tend six times the diameter of the object. Working with objects at least 6 inches from the sides and front edge of the hood, without blocking air vents is therefore advis- able to maintain unobstructed airflow between the HEPA

room operation, such as order processing, gowning, and stock storage. Sterile products should be prepared in Class 100 en- vironments, which means environments containing no more than 100 particles per cubic foot that are 0.5 micron or larger in size. LAFWs are frequently used to achieve a Class 100 environment.

Laminar Airflow Workbenches The underlying principle of laminar airflow workbenches (LAFW) is that twice-filtered laminar layers of aseptic air continuously sweep the work area inside the hood to prevent the entry of contaminated room air. There are two common types of LAFW: horizontal flow and vertical flow.

Horizontal LAFW

LAFW that sweep filtered air from the back of the hood to the front are called horizontal LAFW (see Figure1-6). Horizontal fl ow workbenches use an electrical blower to draw contaminated room air through a prefilter. The

Figure 1–6. Horizontal and vertical laminar airflow workbench with the basic components labeled.

Pharmacy Technician Certification Review and Practice Exam

Pop Quiz! Work inside an LAFW must be done at least how many inches from the sides?

Handwashing Touching sterile products while compounding is the most common source of contamination of pharmacy-prepared sterile products. Because the fingers harbor countless bacterial contaminants, proper hand washing is extreme- ly important. Every entry into a sterile product should include scrubbing your hands, nails, wrists, and forearms to elbows thoroughly for at least 30 seconds with a brush, warm water, and appropriate bactericidal soap before per- forming aseptic manipulations. Dry hands completely, using either lint-free disposable towels or an electronic hand dryer.

Gloving After appropriate hand washing is complete and attire is put on, antiseptic hand cleansing should be performed using a waterless, alcohol-based surgical hand scrub just prior to the last item worn before compounding begins, sterile gloves. Sterile gloves are only sterile until they touch something unsterile or until they are torn and al- low bacteria from the hands to enter the work area. For example, if it becomes necessary to scratch or touch the face while wearing gloves, they will need to be changed. For these reasons, always wash your bare hands thor- oughly as noted above, before unwrapping and putting on the gloves. Occasionally, workers develop allergies to latex as a result of repeated use of latex gloves. As a result, many institutions have now turned to using only non-latex gloves.

Equipment and Supplies Another important factor in aseptic preparation of sterile products is the correct use of appropriate sterile equip- ment and supplies, including syringes and needles.

Syringes

Syringes are made of either glass or plastic. Most drugs are more stable in glass, so glass syringes are most often used when medication is to be stored in the syringe for an extended period. Some medications may react with the

plastics in the syringe, which would alter the potency or stability of the final product. Disposable plastic syringes are most frequently used in preparing sterile products be- cause they are cheaper, durable, and are in contact with substances only for a short time. This minimizes the po- tential for incompatibility with the plastic itself. Syringes are composed of a barrel and plunger (see Figure 1-7). The plunger, which fits inside the barrel, has a flat disk or lip at one end and a rubber piston at the other. The top collar of the barrel prevents the syringe from slip- ping during manipulation; the tip is where the needle at- taches. To maintain sterility of the product, the syringe tip or the plunger should not be touched. Many syringes have a locking mechanism at the tip, such as the Luer-lock, which secures the needle within a threaded ring. Some syringes, such as slip-tip syringes, do not have a locking mechanism. In this case, friction holds the needle on the syringe. Syringes are available in numerous sizes, ranging from 0.5 to 60 milliliters (ml). Calibration marks on syringes represent different increments of capacity, depending on the size of the syringe. Usually, the larger the syringe ca- pacity, the larger the interval between calibration lines. For example, each line on a 10 ml syringes represents 0.2 ml, but on a 30 ml syringe, each line represents 1 ml. To maximize accuracy, the smallest syringe that can hold a desired amount of solution should be used. Syringes are accurate to one-half of the smallest incre- ment marking on the barrel. For example, a 10 ml syringe with 0.2 ml markings is accurate to 0.1 ml and can be used to measure 3.1 ml accurately. A 30 ml syringe with 1 ml markings, however, is only accurate to 0.5 ml and should not be used to measure a volume of 3.1 ml. Ide- ally, the volume of solution should only take up one-half to two-thirds of the syringe capacity. This avoids inad- vertent touch contamination when the syringe plunger is pulled all the way back.

Figure 1–7. A syringe with the basic components labeled.

Assisting the Pharmacist

the syringe and is often color-coded to correspond to a specifi c gauge. The tip of the needle shaft is slanted to form a point. The slant is called the bevel, and the point is called the bevel tip. The opposite end of the slant is called the bevel heel. Needles are sent from the manufacturer individually packaged in paper or plastic overwraps with a protective cover over the needle shaft. This guarantees the sterility as long as the package remains intact. Damaged pack- ages should be discarded. No part of the needle itself should be touched. Needles should be manipulated by their overwrap and protective covers only. The protective cover should be left in place until the needle or syringe is ready to be used. A needle shaft is usually metal and is lubricated with a sterile silicone coating so latex vial tops can be penetrated smoothly and easily. For this reason, needles should never be swabbed with alcohol. Some needles are designed for special purposes and therefore have unique characteristics. For example, nee- dles designed for batch filling have built-in vents (vent- ed needles) to avoid the need to release pressure that might form in the vial. Another example is needles with built-in filters, meant to be used with products requiring filtering, such as drugs removed from a glass ampule.

Drug Additive Containers Injectable medication additives may be supplied in an ampule, vial, or prefilled syringe. Each requires a differ- ent technique to withdraw medication and place it in the fi nal dosage form.

When measuring with a syringe, the final edge (clos- est to the tip of the syringe) of the plunger piston, which comes in contact with the syringe barrel, should be lined up with the calibration mark on the barrel that corre- sponds to the volume desired (see Figure 1-8). Syringes are sent from the manufacturer assembled and individually packaged in paper overwraps or plastic covers. The sterility of the contents is guaranteed as long as the outer package remains intact. Therefore, packages should be inspected, and any that are damaged should be discarded. The syringe package should be opened within the LAH to maintain sterility. The wrapper should be peeled apart, not ripped or torn. To minimize particulate contamination, discarded packaging or unopened syring- es should not be placed on the LAFW work surface. Syringes may come from the manufacturer with a needle attached or with a protective cover over the sy- ringe tip. The syringe tip protector should be left in place until it is time to attach the needle. For attaching nee- dles to Luer-lock-type syringes, a quarter turn is usually sufficient to secure the needle to the syringe.

Needles

Like syringes, needles are commercially available in many sizes. Sizes are described by two numbers: gauge and length. The gauge of the needle corresponds to the diameter of its bore, which is the diameter of the inside of the shaft. The larger the gauge, the smaller the needle bore. For example, the smallest needles have a gauge of 27, whereas the largest needles have a gauge of 13. The length of a needle shaft is measured in inches and usually ranges from 3/8 to 3 1/2 inches. The components of a simple needle are the shaft and the hub (see Figure 1-9). The hub attaches the needle to

Figure 1–8. A close-up of a syringe showing how to measure 1.5 ml. Note that the final edge of the plunger piston is used to make the measurement.

Figure 1–9. A needle with the basic components labeled.

Assisting the Pharmacist

or heavily contaminated. If only one pair is worn, tuck the glove under or over the gown cuff so that the skin is not exposed.

Biological Safety Cabinets One of the most important pieces of equipment for han- dling hazardous drugs safely is the Biological Safety Cabinet (BSC). A BSC is a type of vertical LAFW that is designed to protect workers from exposure as well as to help maintain product sterility during preparation. BSCs must meet standards set by the National Sanitation Foun- dation (NSF Standard 49). Do not use horizontal LAFWs to prepare hazardous drugs. BSCs must be operated con- tinuously, 24 hours per day, and they should be inspected and certified by qualifi ed personnel every 6 months.

Preparing Hazardous Drugs Before technicians handle a cytotoxic or other hazardous drug, they must demonstrate proper manipulative tech- nique and use of protective equipment and materials.

Drug Information

Pharmacy technicians are challenged with drug informa- tion questions frequently throughout the workday and are called upon to become knowledgeable about the handling, availability, and uses of medications. A basic knowledge of the resources available will make the technician more resourceful and better able to assist the pharmacist with certain drug information requests. Pharmacy reference books and electronic media (including the Internet) that are available in all practice settings often hold answers to typical day-to-day practice-related questions. Before responding to a drug information question, technicians must clearly differentiate questions that fall within their scope of practice from those that must be answered only by a pharmacist. Technicians should identify themselves as pharmacy technicians so the person asking the question will know the type of information that may appropriately be conveyed. If there is any doubt about the nature of the question, the technician should defer the question to the pharmacist. It is important for the technician to learn who the person ini- tiating the request is and to obtain the necessary contact information (phone, fax, pager, etc.) in case the person needs to be called back. The search for and response to drug information requests will be different depending on who is requesting the information. Knowing information

Many labels also now contain a bar code that con- tains information regarding the medication, the patient, and the anticipated administration. These are generated by the pharmacy computer to reduce the frequency of medication administration errors. Each product should also include an expiration date, beyond which it should not be used.

Preparation and Handling of

Cytotoxic and Hazardous Drugs

Some medications can be hazardous to those who touch or inhale them. Because hazardous drugs initially involved drugs used to treat cancer, the terms antineoplastic and chemotherapeutic were used to describe them. Preparation of these agents requires special proce- dures for labeling, storage, and transport. Use of protec- tive clothing, BSCs, and special handling of spills and waste are also important. Special techniques related to the actual administration of these products to patients are not covered here. Additional information is available from ASHP in the form of a Technical Assistance Bulletin on Handling of Cytotoxic and Hazardous Drugs.

Protective Apparel

There is no substitute for good technique, but protective apparel is another fundamental element in protecting per- sonnel who handle or prepare hazardous drugs. Most procedures require the use of disposable cover- alls or a solid front gown. These garments should be made of low-permeability, lint-free fabric. They must have long sleeves and tight-fitting elastic or knit cuffs. They should not be worn outside the work area and should be changed immediately if contaminated. Shoe and hair covers may also be required, depending on the institution’s policies. Wearing gloves is essential when working with haz- ardous drugs. Wash hands thoroughly before putting on the gloves and after removing them. Use good quality, disposable, powder-free latex gloves, such as surgical latex. These gloves are preferred because of their fit, elasticity, and tactile sensation. If only powdered gloves are available, wash powder off before beginning to work. Non-latex gloves are also available for those with an al- lergy to latex. If two pairs are needed, tuck one pair under the cuffs of the gown and place the second pair over the cuff. If an outer glove becomes contaminated, change it immediately. Change both the inner and the outer gloves immediately if the outer glove becomes torn, punctured,

Pharmacy Technician Certification Review and Practice Exam

result in miscommunication and delivery of inaccurate in- formation. Both scenarios could be potentially harmful to the patient. Examples of questions that require a pharma- cist’s interpretation and that should not be answered by a technician are provided in Table 1-2.

Conducting the Search: Choosing the Right References The key to answering questions quickly and accurately is knowing where the necessary information is likely to be found. The first step is to consult tertiary references, then secondary references, and finally primary references. Tertiary references are general references that present documented information in a condensed and compact for- mat. They include textbooks; compendia (eg, American Hospital Formulary Service, Drug Information (AHFS DI), Drug Facts and Comparisons ); computerized sys- tems such as Micromedex ®^ Clinical Information System; review articles; and much of the information found on the Internet. Tertiary references are easy to use, conve- nient, readily accessible, concise, and compact. Disad- vantages of tertiary references are that information may not be timely, the information could contain errors, and tertiary references may not offer enough information on a specific topic because of space restrictions.

about the requestor, their training, and their knowledge of the subject will have an impact on what the final response will be and how it will be given. Obtaining background information will help to determine what the needs of the requestor are and will make the search for information more efficient. Background information is especially im- portant to determine if the question pertains to a specific patient or if it is a question that requires interpretation, and therefore the expertise of a pharmacist. The urgency of the request and the extent of the information needed should also be determined so an appropriate amount of time is allotted to answer the request. Classifying the type of request helps to narrow the search and makes the search process more efficient. Table 1-1 lists common types of questions that technicians may get, with examples of each. Technicians should not interpret a patient-specific question or provide information that may require profes- sional judgment. A simply stated question can actually be a complex patient-specific situation. The pharmacist has to find out more about the patient’s specific problems and apply clinical judgment to answer the question appropri- ately. Many times, the person requesting the information may indirectly be asking for a pharmacist’s point of view or interpretation of a situation, and may thus require an in- depth analysis and recommendation from the pharmacist. Attempting to interpret or answer such a question could

Table 1–1. Classifications of Drug Information Questions

Question Classification Examples

General Drug Information What is the brand name of warfarin? Do Naprosyn and Aleve contain the same active ingredient? Who manufactures Enbrel? Is Prilosec available as a generic? Is it a prescription or over-the-counter (OTC) product? Availability and Cost What dosage forms of Imitrex are available in your pharmacy? Is Zoloft available as a liquid? If so, what size and concentration is available? What are the prices of Adalat CC and Procardia XL? How long is the shortage of albumin expected to last? Storage and Stability Should Lovenox be stored in the refrigerator? How long is a flu shot stable after it is drawn up in a syringe? Calculations How many milliliters are in an ounce? Preparation How should ampicillin be reconstituted? Pharmacy Law In what controlled substance schedule is zolpidem (Ambien)? Can Tiazac be substituted for Cardizem CD (is it AB rated)? How many times can a prescription be transferred from one store to another? Miscellaneous Where can I find the phone number for Sanofi Aventis? When will the patent for Lipitor expire? Where can I get more Lovenox teaching kits? Where can I find the Vaccine Information Sheet for the influenza vaccine?