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Pharmacy OperationsGeneral Prescription Duties

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Pharmacy Operations, General Prescription Duties

PassAssured's Pharmacy Technician Training Program


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PassAssured's Pharmacy Technician Training Program


Obtaining Patient Information for the Patient Profile

Ambulatory Patient Profile Contents: Name

Date of Birth (DOB)

Address

Phone

Insurance

Allergies

Weight for children and infants

Institutional / Long-Term Care Patient Profile Contents: Name

Date of Birth (DOB)

Address

Height

Weight

Room number

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Patient record number

Primary physician

Allergies

Automatic stop order (are acceptable with antibiotics)

Additional Patient Information Which Should be Maintained: Diagnosis

Desired therapeutic outcome

Medication use

Herbals used

Dietary supplements used

Adverse reactions

Medical history

Psychosocial history

Patient characteristics

Socioeconomic history

Reimbursement

List of all prescription medications obtained from the pharmacy in the preceding twoyears

Pharmacist comments relevant to patient drug therapy

Processing Prescriptions and Medication Orders:Entering prescription/medication information in the patient profile - computerized with help ofdatabase program

Verify information

Compare new order to profile

Enter required information

Pharmacist initials

Reimbursement

Pharmacy policy and procedures followed

Appropriate Product Selection:

Brand vs. Generic

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Pharmacist may substitute a generic product for a brand name product is the following

criteria are met:

The physician has not indicated “Dispense as Written”

The Purchaser requests or agrees with the substitution

The substituted drug is equal to or less in price than the brand name drug.

If Savings are passed onto the consumer or a third party payer

And, if certain labeling requirements are met: The labeling requirement states the

manufacturers name must be on the label and the statement “generic equivalent

for…” must be on the label.

And last and most important is bio-availability.

Bioavailability must be the same in order for a pharmacist to exercise professionaljudgment in selecting a generic product for a patient.

The FDA reviews the generic products to make certain they are equivalent incomposition and have the same rate and extent of absorption in the systemiccirculation to the original brand name product.

The Orange Book contains two letter codes assigned to drugs for therapeuticequivalence and is an appropriate reference for drug related information. A rated Drugs –those which the FDA considers to be therapeutically equivalent and,therefore, substitutable where permitted by the prescriber.

FormulariesA Formulary is a document or listing of committee approved pharmaceuticals andtherapeutics in stock.The formularies listing is typically adapted by individual reimbursement companiesas a guide for payment schedules for specific drugs. Used in institutional facilities

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HMO's preferred products reimbursement differential

Goals- to manage the cost of rational drug therapy

Inventory Control Assess inventory

In-stock status

Commercially prepared vs. compounded

Bar Code Medication Administration (BCMA)BCMA- barcode system designed to prevent medication errors in healthcare settings andimprove the quality and safety of medication administration. The overall goals of BCMA are:

to improve accuracy,

prevent errors

generate records of medication administration.

Assisting the Pharmacist in Preparing and DispensingMedications:

Measuring and CountingTwo methods to measure liquids

Conical - Easy to handle, has a wide mouth

Cylindrical - More accurate by using the meniscus

When choosing use appropriate package for dosage form

Perform Necessary Calculations / Verification:Must be checked and verified by a pharmacist

Calculate twice, compound once

Compounding:

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USP Chapter 795 Pharmaceutical Compounding-Nonsterile Preparations

became official May 1, 2011. 795

Help to define Good Compounding Practices

provides general information to support a Pharmacy Technician’s ability to

extemporaneously compound preparations that are of acceptable strength, quality

and purity.

Definitions

For consistency in implementing 795, the technician should be familiar with these eleven

definitions:

1. Active pharmaceutical ingredient (API):Any substance or mixture of substances

intended to be used in the compounding of a drug preparation,

2. Added substances: Ingredients that are necessary to compound a preparation but

are not intended or expected to cause a pharmacologic response.

(Pic of BUD Label)

3. BEYOND-USE Date (BUD): The date after which a compounded preparation should

not to be used; determined from the date the preparation is compounded.

For Nonaqueous Formulations- The BUD is not later than the time

remaining until the earliest expiration date of any API or 6 months,

whichever is earlier

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Water-Containing Oral Formulations-BUD is not later than 14 days when

stored at controlled cold temperatures.

Water-Containing Topical/Dermal and Mucosal Liquid and Semisolid

Formulations The BUD is not later than 30 days

4. Component: Any ingredient used in the compounding of drug preparation, including

any active ingredient or added substance that is used in its preparation.

5. Compounder: A professional authorized by the appropriate jurisdiction to perform

compounding pursuant a prescription or medication order by a licensed prescriber.

6. Compounding: the preparation, mixing, assembling, altering packaging and labeling

of a drug, drug delivery device or device in accordance with a licensed practitioner’s

prescription, medication order, or initiative based on the

practitioner-patient-pharmacist-compounder relationship in the course of professional

practice.

Compounding includes the following:

Preparation of drug dosage forms for both human and animal patients

Preparation of drugs or devices in anticipation of prescription drug orders,

on the basis of routine, regularly observe prescribing patterns

Reconstitution or manipulation of commercial products that may require the

addition of one or more ingredients

Preparation of drugs or devices for the purposes of, or as an incident to,

research (clinical or academic), teaching, or chemical analysis, and

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Preparation of drugs and devices for prescriber’s office use where

permitted by federal and state law.

7. Hazardous drug: any drug identified by at least one of the following six criteria:

Carcinogenicity

Teratogenicity or developmental toxicity

Reproductive toxicity in humans

Organ toxicity at low doses in humans or animals

Genotoxicity

New drugs that mimic existing hazardous drugs in structure or toxicity

8. Manufacturing: the production, preparation, propagation, conversion, and/or

processing of a drug or device, either directly or indirectly, through extraction from

substances of natural origin or independently through means of chemical or

biological synthesis; the term includes any packaging or repackaging of the

substance(s)or labeling or relabeling of its container and the promotion and

marketing of such drugs or devices.

9. Preparation: compounded drug dosage form or dietary supplement or a device to

which a compounder has introduced a drug.

10. Stability: The extent to which a preparation retains, within specified limits and

throughout its period of storage and use, the same properties and characteristics that

it possessed at the time of compounding.

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11. Vehicle: A component for internal or external use that is used as a carrier or diluent

in which liquids, semisolids, or solids are dissolved or suspended.

The following are guidelines for distinguishing between compounding

and manufacturing.

Pharmacists may compound, in reasonable quantities, drug preparations that are

commercially available in the marketplace if a pharmacist–patient–prescriber

relationship exists and a valid prescription is presented.

Pharmacists may compound nonprescription medications in commercially

available dosage forms or in alternative dosage forms to accommodate patient

needs as allowed by individual state boards of pharmacy.

Pharmacists may compound drugs in limited quantities prior to receiving a valid

prescription, on the basis of a history of receiving valid prescriptions that have

been generated solely within an established pharmacist–patient–prescriber

relationship, and provided that the prescriptions are maintained on file for all such

preparations dispensed at the pharmacy.

Pharmacists should not offer compounded medications to other pharmacies for

resale; however, a practitioner may obtain compounded medication to administer

to patients, but it should be labeled with the following: “For Office Use Only,” date

compounded, use-by date, and name, strength, and quantity of active ingredients.

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An exception to this may be the outsourcing of some compounded preparations by

hospitals to contract compounding pharmacies.

Compounding pharmacies and pharmacists may advertise or otherwise promote

the fact that they provide prescription compounding services.

Three general categories of non-sterile compounding

Simple compounding is described as making a preparation from a USP

monograph or that appears in a peer-reviewed journal article containing specific

quantities of all components, procedures and equipment and stability data; it also

involves reconstituting or manipulating commercial products that may require the

addition of one or more ingredients as directed by the manufacturer.

Moderate compounding is a step up and requires special calculations or

procedures to determine quantities of components for the preparation or per

individualized dosage units or making a preparation for which stability data is not

available and the USP default BUDs are used. This even includes the mixing of

two commercial products for which stability of the mixture is not known.

Complex compounding requires special training, environment, facilities,

equipment and procedures to produce an acceptable preparation. This can include

transdermal dosage forms, modified- release preparations, some inserts and

suppositories where a systemic effect is intended. It would also include innovative

dosage forms for which little information may be currently available.

It is the compounder’s responsibility for compounding preparations ofacceptable:

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Strength Quality purity appropriate packaging labeling official standards Relevant scientific data and information.

Compounders engaging in compounding should have to continually expandtheir compounding knowledge by:

participating in seminars studying appropriate literature consulting colleagues.

Responsibility of the Compounder

The compounder is responsible for ensuring that the quality is built into the compounded

preparations of products, with key factors including the following general principles.

Personnel are capable and qualified to perform their assigned duties. Ingredients used in compounding have their expected identity, quality, and purity. Compounded preparations are of acceptable strength, quality, and purity, with

appropriate packaging and labeling, and prepared in accordance with goodcompounding practices, official standards, and relevant scientific data andinformation.

Critical processes are validated to ensure that procedures, when used, willconsistently result in the expected qualities in the finished preparation.

The compounding environment is suitable for its intended purpose. Appropriate stability evaluation is performed or determined from the literature for

establishing reliable beyond-use dating to ensure that the finished preparationshave their expected potency, purity, quality, and characteristics, at least until thelabeled beyond-use date.

There is assurance that processes are always carried out as intended or specifiedand are under control.

Compounding conditions and procedures are adequate for preventing errors. Adequate procedures and records exist for investigating and correcting failures or

problems in compounding, testing, or in the preparation itself.Two Types of compounding

Extemporaneous-on the sport compounding for one specific patient Bulk- Preparing and packaging for more than one patient

o Must include lot numbers and expiration dates of ingredients

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o Documentation of procedure on prescription/medication order

The Remington's Pharmaceutical Sciences: reference book used to look upformulas.

Definitions: Desiccation- the act or process of desiccating or the state of being or becoming

desiccated. This is the complete or nearly complete deprivation of moisture or ofwater not chemically combined.

Colation- (straining) the process of separating a solid from a fluid by pouring themixture on a cloth which will permit the fluid to pass through, but will retain thesolid.

Distillation- the process that involves a change of state - from liquid to vapor andback to liquid.

Filtration- the process of separating liquids from solids with the purpose ofobtaining optically transparent liquids.

Levigation- the process of producing a smooth dispersion of a drug with aspatula.

Trituration- the grinding of tablets into a fine powder in a porcelain mortar.

Stability- the ability for medication to maintain chemical and physical integrity overtime.

Sublimation- the process of distilling volatile solids

Gelatin capsules are used for extemporaneous compounding. Size vary from 5 (thesmallest) to 000 the largest.

"Controlled Room Temperature" is defined as between 15 - 30 degrees centigrade and59 - 86 degrees Fahrenheit.

"Refrigeration" is defined as between 2 to 8 degrees C or 46 to 59 degrees F.

Suspending or thickening agents are added to suspensions to thicken the suspendingmedium and the sedimentation rate. Examples: Acacia, Tragacanth, Bentonite

Weighing:To ascertain a definite weight of a material to be used in compounding or manufacturing adosage form.

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Two classes of balance or scales:

Class A Balanceo 6 mg sensitivity

o Accurately weighs between 120 mg and 15 gm

Class B Balanceo 30 mg sensitivity

o Accurately weighs between 650 mg and 120 gm

Process Paper is placed on each pan

Balance or "zero"

Desired weight is placed on right tray (weights)

Substance on the left to be measured until balanced

Reconstitution: Liquids that are stored as powders because of stability limitations

Must add water

Label with time and date when reconstituted

Expiration date on label - Exp. in 14 days

Refrigeration is often (not always) required to increase stability

Aseptic Technique / IV AdmixturesMust be prepared under special circumstances to prevent the introduction of contaminantssuch as bacteria and other microorganisms from the environment, devices, equipment, andpeople.

Controlled Substances:

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Require Strict Inventory Control Documentation of Receipt - Commercial invoice

Documentation of Distribution – Narcotic inventory record

DEA Form 222 must be used to purchase or transfer schedule I and II controlledsubstance

DEA Form 106 is used to report theft or loss of controlled substances

DEA strongly encourages submitting the DEA Form 106 and 222 online

Packaging Preparations for Prescriptions and Medication Orders

PrescriptionsPackaged appropriately with consideration of light sensitivity

Medication OrdersUnit doseMultiple dose

Labeling Prescriptions and Medications Orders:

PrescriptionsA prescription label should be affixed to the medication packaging so that it can be readeasily.

Label may Contain: Name and address of pharmacy

Date of issuance

Prescription number

Drug name, strength, and quantity

Directions

Patient's name

Prescriber's name

Expiration date

Number of refills

Lot number

Pharmacists initials

Auxiliary labels

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Federal transfer label

Patient Med Pak LabelsMay provide multiple medications to a specific non-institutionalized patientLabel created with: day and time or period and time in which the contents within eachcontainer are to be taken

Labels also contain: Serial number identifying each prescription order

Pharmacy name and address

Patient name

Name of prescribing practitioner

Medication name, strength and quantity

Physical description of each medication

Directions to medication use and precautions

Date of preparation

Date of expiration

Medication Orders:Unit dose dispensing systems provide a single dose of medication for oneadministration time.

Labels should contain: Drug name and strength

Lot number

Expiration date

Directions for administration

Auxiliary labels

Name and address of dispensing pharmacy

Multiple Dose:

Labels should Contain: Patient name and room number

Drug name, strength, and quantity

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Directions for administration

Lot number

Expiration date

Auxiliary labels

Competencies in Unit Dose Drug Distribution:

Advantages of Unit Dose

Reduce medication errors

Increase drug use control within institutions

Minimize drug waste and pilferage

Reduce nursing preparation time

More accurate and efficient billing

Fully utilize involved members of the health care team

Enhance or improve the quality of patient care

Unit-dose systems provide each patient with a storage bin with a twenty-four hoursupply of drugs.

Type of Unit Dose Systems

Centralized:o Definition - med. cart, one pharmacy

Decentralized:o Definition: satellite pharmacy

o Combination of Both

Verification:

Five "Rights" of Medication:

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o Right medication (NDC a great check)

o Right patient

o Right dose

o Right route

o Right time

Three Check Points:o Retrieving bottle from stock

o Counting from bottle

o Returning bottle to stock

Pharmacist's Authorization:o Pharmacist is ultimately accountable to patient.

Medication Errors:It is important to follow established policies and procedures because they formally establisha system to prevent the occurrence of medication errors.

All the following could contribute to a medication error:

Failure to rotate stock appropriately, preparing three prescriptions at a time, reading the drugproduct label fast, and abbreviations are frequently the source of medication errors.

Misinterpretation of Abbreviations can lead to:Improper transcription of physician instructions for medication useDispensing the wrong drug, strength, or dosage formInappropriate therapeutic or formulary substitution

Abbreviations that can easily be mistakenSome abbreviations can be misinterpreted. Always double check the prescription with thepharmacist if there is any doubt on the abbreviations written. Here is a short list of the mostcommon abbreviation errors.

HS-Half Strength hs-At Bedtime

D/C- Discountinue DC-Discharge

IU- International Unit IV- Intravenous

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Q.D.- Every Day Q.I.D.-Four times a day

Q1D- Once Daily Q.I.D.- Four times a day

ss-1/2 SS- Sliding Scale

SSRI- Sliding Scale Regular Insulin SSRI- Selective Serotonin ReuptakeInhibitor

Q.O.D.-Every other day Q.I.D-Four Times a Day

UD-As Directed UD- Unit Dose

O.D.-Once Daily OD- Right Eye

Errors may lead to: Increased risk of serious adverse effects Worsening of disease signs or symptoms Death

Reporting Procedures:

Supplemental Information at the Direction of the Pharmacist Package Inserts Required Every Time Drug Dispensed, New Rx and Refills

o Oral contraceptives

o Estrogens

o Progesterones

o Isotretinoin

o Intrauterine devises

o Isoproterenol inhalation products

o Albuterol Inhalers

Computer Generated Patient Information Sheets Websites Patient Education Videos

Quality Control Quality control is a process of checks and balances. Quality is defined by what our patients perceive. Quality improvement is an important part of meeting regulatory agency (e.g.,

JCAHO) requirement.

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Universal Precautions

Universal Precautions are a simple set of effective practices designed to protect healthworkers and patients from infection with a range of pathogens. These practices are usedwhen caring for all patients regardless of diagnosis. In practice, the implementation ofUniversal Precautions includes the following interventions:

Handwashing after any direct contact with patients Safe collection and disposal of needles(hypodermic and suture) and sharps(

scalpel blades, lancets, razors, scissor), with required puncture-and liquid-proofsafety boxes in each patient care area

Wearing gloves for contact with body fluids, non-intact skin and mucousmembranes

Wearing a mask, eye protection and a gown (and sometimes a plastic apron) ifblood or other body fluids might splash

Covering all cuts and abrasions with a waterproof dressing Promptly and carefully cleaning up spills of blood and other body fluids Using a safe system for hospital waste management and disposal

Filling a prescription in a pharmacy

1. Drop off station

a. Greet the customer with a smile

b. Verify patient information

Name

Date of birth

Address

Phone number

Allergies

Prescription medications, vitamins, herbals, disease states

c. Verify insurance information

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2. Production station

a. Enter patient information

b. Enter Doctor information

c. Enter prescription information

Medication

Strength

Quantity prescribed

Sig

Day supply

d. Insurance adjudication

e. Drug interaction review

f. Scan prescription

g. Print label

h. Compare written prescription from prescriber to prescription label to verifyinformation was entered correctly

i. Pull appropriate medication from pharmacy shelf

j. Check the ndc on medication bottle with ndc on label

k. Scan prescription label and medication bottle to ensure they match

l. Count medication on counting tray or pour into counting machine

m. Label the prescription vial

n. Auxiliary labels

3. Verification station

a. Pharmacists check prescription by comparing written prescription to label foraccuracy

b. Pharmacist reviews prescription for interactions with any of the medicationspatient is currently taking

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c. Technician must leave medication stock bottle with prescription bottle for thepharmacist to check

4. Check out station

a. Bag prescription

b. Verify patients name and date of birth when the patient picks up medication

c. Verify if patient needs counseling by the pharmacist

d. Scan prescription to ring up

e. Have patient sign for prescription

f. Collect co-payment from patient

g. Give change if applicable

h. Thank the patient

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