Medication Administration Laws

Edited by Dr. Ryan Lambert Bellacov

Violation of Laws and Regulations

• When cases are filed in court the– party or person filing the case is called the

plaintiff– party being sued or that the case is against is

called the defendant

• Burden of proof– responsibility of plaintiff to prove his /her case – in crimes against the government the burden of

proof = reasonable doubt . Prosecutor or plaintiff must provide convincing evidence that the party committed the act, beyond any “reasonable” doubt of a normal person.

Violation of Laws and Regulations

• If the defendant is a licensed healthcare provider (i.e., physician, nurse, pharmacist)– the appropriate state medical board may examine

the case and determine whether or not the party’s license should be revoked or suspended

Civil Law

• Civil law is a term given to areas of the law that concern the citizens of the United States and the wrongs they may commit against one another

• Covers issues such as:– contracts

– tort: a wrong against another

Law of Agency and Contracts

• Law of agency and contracts is based on the Latin term respondeat superior, which translates to “let the master answer”

• General principle that applies to the employee-employer relationship – contracts made by employees are just as valid as

if the physician or the pharmacist who employed them made the contract

Law of Agency and Contracts

• A contract is made in the pharmacy when the technician receives a prescription from the patient at the window– by agreeing to get the prescription filled an implied

contract now exists:• pharmacy and pharmacist are obligated to provide the

patient with a service• if a mistake is made, the pharmacy and/or pharmacist

may be held liable, even though he or she was not the one who entered into the contract to provide service

– The pharmacist must “answer” for all of the acts of the employees

Torts

• Tort is the term that refers to personal injuries– a wrong that one citizen commits against another

• In a tort, the injured party sues the party that caused the injury

• Governments do not take part in tort lawsuits – the wrong was between two citizens and not against

the government and/or its laws and regulations

• The simplest tort is the “broken” contract

Torts• Standard of care is a level of care expected to

be provided by various healthcare providers• Used to judge the type of care provided to a

patient based on • Two criteria always taken into account include:

– the level of training of the healthcare provider – normal practices for the geographical area in which

the healthcare provider works

• Only those healthcare providers who work in the same geographical area and have the same level of training would be compared

Torts

A pharmacy technician is not expected to provide the same service or standard of care to a patient as the pharmacist. Similarly, a cardiologist would be expected to provide a different service or standard of care than that of a nurse practitioner at his office.

Torts• Malpractice a form of negligence in which

the standard of care was not met • In a case of negligence or malpractice, the

burden of proof is on the plaintiff to prove the four Ds of negligence: – duty – damages – dereliction – direct cause

• The burden of proof in civil court is lower than in a criminal case– plaintiff must prove his/her case by a

“preponderance of the evidence”

Torts

• In malpractice, a guilty defendant found guilty may be ordered to pay an award of money to the plaintiff – contributory negligence may be determined if two or

more causes are a factor in the negligence and personal injury to the patient

• All pharmacies, most practicing pharmacists, and some pharmacy technicians carry professional liability insurance to protect their business and personal assets

Torts

• Cases exist where the patient is found to have contributed to his or her own injury (e.g., not

taking medication as directed) and found to be comparatively negligent.

• In this case, the total award may be reduced by a certain percentage, depending on the judge or jury’s determination.

Torts

• When a crime is committed in violation of a state or federal law, the party is prosecuted– the victim or his or her family also sue the party in

civil court for monetary damages

• The person may be tried twice, facing two separate plaintiffs– in the criminal case, the defendant might face

monetary fines, probation, or prison – the civil case might result in monetary awards to

the victim/plaintiff

Learning Objectives

• Define the term drug and distinguish between over-the-counter and legend drugs

• Explain the parts of a National Drug Code number

• Categorize drugs by source as natural, synthetic, synthesized, or semisynthetic

• Explain the uses of drugs as therapeutic, pharmacodynamic, diagnostic, prophylactic, and destructive agents

Pharmaceuticals

• A drug is any substance taken into or applied to the body for the purpose of altering the body’s biochemical functions and thus its physiological processes– a medical substance or remedy used to change

the way a living organism functions

– also called a medication

Pharmaceuticals

Drugs products contain many components:

• an active ingredient is the biochemically reactive component of the drug

• inert ingredients or inactive ingredients have little or no physiological effect – stabilize the tablet or liquid formulation

– provide the raw material for many topical creams and ointments

– ensure sterility of injectable products

– assist in the masking of unpleasant tasting medications for pediatric patients

National Drug Code (NDC)

• A National Drug Code (NDC) number is a unique number assigned to a product– identifies the manufacturer, drug, packaging size, and

type

– appears on all drug labels

• Contains ten characters– four or five digit labeler code, identifying the

manufacturer or distributor of the drug – a three- or four- digit product code, identifying the

drug (active ingredient and its dose form)– a two-digit package code

National Drug Code (NDC)

• NDC bar code numbers are used – for drug recalls

– to compare medications dispensed in the filling process to minimize medication errors

Parts of a National Drug Code (NDC) Number

Visit the NDC Directory

Classes of Drugs

Drugs are classified as over-the-counter (OTC) or legend

• legend drugs can be dispensed only with a prescription from a healthcare professional licensed in that state– labeled with the legend, “Caution: Federal Law Prohibits

Dispensing Without Prescription” or an equivalent symbol ( )

– the new legend in the updated labeling law is “ only”drug caution

legend

Classes of Drugs

• Drugs with potential for abuse are classified according to five drug schedules based on the potential for abuse and physical and psychological dependence– Schedule II drugs such as narcotics and

amphetamines have a high potential for abuse and dependence

– Schedule V cough syrups have a low potential for abuse and limited potential for creating physical or psychological dependence

Classes of Drugs

• Over-the-counter drugs can be dispensed without a prescription – proven relatively safe to be sold without prescription

• OTC drug labels – must contain all the information necessary for a

consumer to safely take the medication

Learn more about the Drug Facts label at the Consumer Healthcare Products Association Web site

Classes of Drugs

• Diet supplements, especially herbs, should be considered drugs – can cause side effects, adverse reactions, and

drug interactions

• Do not have the same stringent controls as legend and OTC medications

Learn more about independent testing of diet supplements by visiting ConsumerLab’s Web site

Classes of Drugs

• Diet supplements are considered “food supplements” to maintain health– a patient should not exceed the recommended daily

dose without the knowledge of a physician

– the MA can assist the providers by gathering information on patient use of diet supplements and adding this data to the computer profile

Classes of Drugs

• Homeopathic medications are very small dilutions of natural drugs claimed to stimulate the immune system

• Homeopathy is derived from the Greek words homos (i.e., similar) and pathos (i.e., suffering or disease)

Classes of Drugs

• Most homeopathics are OTC, but some are prescription only.

Discussion

What are the differences between the various classes of pharmaceuticals?

Answer: OTCs may be purchased without prescriptions while legend drugs require a prescription from an authorized practitioner; controlled substances have abuse potential, and homeopathic medications are natural extracts, usually OTC.

Sources of Drugs

• Drugs come from various sources • Can be classified as:

– natural

– synthetic (created artificially)

– synthesized (created artificially but in imitation of naturally occurring substances)

– semisynthetic (containing both natural and synthetic components)

Drugs from Natural Sources• Some drugs are naturally occurring biological

products – made or taken from single-celled organisms,

plants, animals, and humans

• Many herbal products come from natural sources

• Modern-day drugs from natural sources include:– penicillin (extracted from certain molds)– acetylsalicylic acid, commonly known as

aspirin, is derived from the bark of the white willow tree

• A synthesized drug is a drug that is created artificially

• A synthetic drug is a drug that is created artificially in imitation of naturally occurring substances– to exert a specific pharmacologic effect

• A semisynthetic drug is a drug that is created artificially and contains both natural and synthetic components

Synthetic, Synthesized, and Semisynthetic Drugs

Synthetic, Synthesized, and Semisynthetic Drugs

• Biotechnology combines the science of biology, chemistry, and immunology to produce synthetic, unique drugs with specific therapeutic effects

• These drugs can be created by means of the recombinant deoxyribonucleic acid (recombinant DNA) techniques of genetic engineering– using living organisms or parts of organisms for

specific purposes such as creating a synthetic drug

Synthetic, Synthesized, and Semisynthetic Drugs

• Deoxyribonucleic acid (DNA) is the complex, helically shaped molecule that carries the genetic code

• Contains the instructions, or recipe, for creating messenger ribonucleic acid (mRNA)– mRNA contains the recipe for arranging amino acids

into proteins for living organisms

• By transferring a segment of recombined DNA into a host cell, scientists can change what proteins the cell produces

• The Human Genome Project is the mapping of the biochemical instructions that make up the human body in health and disease– potential disease can be identified at an earlier

date, and new treatments can be specifically designed to treat them

Synthetic, Synthesized, and Semisynthetic Drugs

Learn more about the Human Genome Project

Discussion

Give examples of drugs from various sources.

Answer: Drugs may come from natural sources (quinine from cinchona bark), may be synthetic (barbiturates), or may be semisynthetic (semisynthetic penicillins), or may result from biotechnology (human insulin).

Uses of Drugs

• Medications are used to:– treat and cure illness

– aid in diagnosis

– prevent illnesses

• The action of a medication cannot be fully accounted for without considering the dose form selected

Therapeutic Agents

• A therapeutic agent is any drug that helps to: – maintain health

– relieve symptoms

– combat illness

– reverse disease processes

Pharmacodynamic Agents

• A pharmacodynamic agent is one that alters bodily functioning in a desired way– stimulate or relax muscles– dilate or constrict pupils– increase or decrease blood sugar

Diagnostic Agents • A diagnostic agent facilitates an examination or

conclusion as to the nature or extent of a disease condition

• Radiopharmaceuticals are chemicals containing radioactive isotopes, used diagnostically (and also therapeutically) – nuclear pharmacy is the procuring, storage,

compounding, dispensing, and provision of information about radiopharmaceuticals

Get more information on nuclear pharmacy technician training programs at the American Pharmacists Association Web page

Prophylactic Agents

• A prophylactic agent prevents illness or disease from occurring– antiseptic– germicidal liquid iodine– any vaccine is considered a prophylactic agent

Destructive Agents

• A destructive agent has a -cidal action, meaning it kills bacteria, fungi, viruses, or even normal cells or abnormal cancer cells – many antibiotics are bactericidal (they kill bacteria)

– radioactive iodine is used to destroy some of the thyroid gland in patients with hyperthyroidism

– antineoplastic drugs used in cancer chemotherapy to destroy malignant tumors

Discussion

Give examples of the various uses of drugs.

Answer: Drugs may be used to maintain health (aspirin to prevent heart attack), to relieve symptoms (analgesics), combat illness (antibiotics), or reverse disease processes (antihypertensives).

Comparison of Dose Forms and Delivery Systems

• Dose form refers to the physical manifestation of a drug as a solid, liquid, or gas that can be used in a particular way – common dose forms include tablets, capsules, creams,

ointments, solutions, injections, and aerosols

• Delivery system may mean any of the following:– device used to deliver the drug – design feature of the dose form that affects the delivery

of the drug – means for transporting a drug to its site(s) of action within

the body

Comparison of Dose Forms and Delivery Systems

• Delivery systems differ in pharmacological properties– sites of action– rate of delivery– quantities of active ingredient delivered

• Choice of delivery system depends on– active ingredient to be delivered– amount of active ingredient to be delivered– means or route by which ingredient is to be delivered– to what sites, at what rate, over what period of time, for

what purpose

Solid Dose Forms

• used more frequently than any other form • are safest for self-administration

Tablets 

• A tablet is a solid dose form produced by compression containing one or more active ingredients and, commonly, other pharmacological ingredients including:– diluents– binders (promote adhesion of materials in tablet)– lubricating agents (give a sheen and aid in

manufacturing process)– disintegrates (help break up ingredients)– solubilizers, colorings, flavorings

Tablets 

• Some tablets are scored once or twice to facilitate breaking into portions for half or even quarter doses

• Unscored tablets should not be broken because the dose may not be equal in each piece– a tablet-splitter may be used for some unscored tablets – odd-shaped tablets are often difficult to cut, even with a tablet

splitter

Tablets

• Careful tablet splitting may be a way to reduce medication costs, but it is not recommended for all drugs

• Patients must be warned not to take a full tablet if such action would result in an overdose of medication

Tablets 

• Compression tablets are the most inexpensive and common dose form

• Multiple compression tablets (MCTs) are produced by multiple compressions– created for appearance alone, to combine

incompatible substances into a single medication, or to provide for controlled release in successive events, or stages

(a) Two layers or compressions(b) Three layers or compressions

Tablets • A caplet is an oblong tablet that is a hybrid of

the capsule and tablet– offers the advantage of easier swallowing than a

large tablet and more stability (and longer shelf life) than a capsule

• Most tablets are uncoated• A coating is a special outside layer that

dissolves or ruptures at the site of application• Formulated to

– mask bitter taste – prevent drug destruction in stomach– delay release of drug into the intestines

Tablets • Sugar-coated tablets (SCTs) contain an

outside layer of sugar – protects the medication – improves appearance and flavor– BUT makes tablets much larger and heavier and

more difficult to swallow

• Film-coated tablets (FCTs) contain a thin outer layer of a polymer – thinner, lighter in weight, and cheaper to

manufacture than sugar coatings– colored to provide an attractive appearance

Tablets

• Enteric-coated tablets (ECTs) are designed to resist destruction by acid of gastric fluids– release the active ingredient once it reaches the

higher pH of the intestine

• ECTs are used for drugs that are:– destroyed by gastric acid– irritating to the esophageal tract or stomach– better absorbed by the intestines

Tablets

Enteric-coated tablets (ECTs) should not be split.

Tablets

• A controlled-release medication is designed to regulate the rate at which a drug is released from the tablet and into the body

• May vary the rate of dissolution or the release of the active drug

Tablets

Controlled-release dose forms should not be split.

Controlled-release Medications

• A delayed-release dose form does not release the active drug immediately after administration

• An extended-release dose form allows reduced frequency of dosing – also called long-acting, timed-release, and sustained-

release dose forms

• A transdermal system dose form is designed to deliver drugs to systemic circulation by passage

through the skin – similar to how the extended-release tablets act by

passage through the stomach and/or small intestine

Controlled-release Medications

Watch the drug labels very carefully! Delayed-release medication is not the same as extended- or controlled-release medication of the same drug!

Other Tablet Types

• Chewable tablets have a flavored and/or colored base – designed to be masticated (chewed)

• Effervescent tablets are granular salts that release gas – dispense active ingredients into solution when placed in

water or juice

• Buccal tablets (and gum) are placed in the buccal pouch– between the cheek and the gum– dissolved and absorbed by the buccal mucosa

Other Tablet Types

• Sublingual tablets are designed to be dissolved under the tongue – medication dissolved under the tongue is absorbed

very quickly – immediately enters the bloodstream

• Vaginal tablets (or inserts) are placed into the vagina – by means of an applicator– dissolved and absorbed through the vaginal mucosa

Capsules 

• A capsule is a solid dose form consisting of a gelatin shell that encloses the drug– usually swallowed whole– tasteless and are easier to swallow than tablets

• Contains powders, granules, liquids, or some combination with one or more active ingredients

• Since a capsule is enclosed, flavorings are not common for this dose form

Capsules

• Can be designed in a controlled-release dose form

• Controlled-release capsules are taken less often– increases compliance

• Long-acting form may give better control over the disease state – may be initially more expensive– but fewer need to be purchased

• Takes a longer time for side effects to subside

Suppositories

• A suppository is a solid dose forms designed for insertion into body orifices – rectum or the vagina or, less commonly, the urethra

• May be the preferred dose form in some cases when patient has nausea and vomiting

• Avoided when possible because of patient discomfort

Suppositories

The patient must remove the foil before inserting the suppository!

Effervescent Salts 

• Effervescent salts are granules or coarse powders containing one or more medicinal agents – contains some combination of sodium bicarbonate

with citric acid, tartaric acid, or sodium biphosphate

• Release carbon dioxide gas when dissolved– causes a distinctive bubbling

Implants or Pellets 

• Implants, or pellets, are dose forms placed under the skin by means of minor surgery

• Used for long-term, controlled release of medications

• Advantages include enhanced patient compliance and convenience

• Complications at the site of insertion have limited widespread use

Lozenges, Troches, or Pastilles 

• Lozenges are dose forms containing active ingredients and flavorings that are dissolved in the mouth– also known as troches or pastilles– generally have local effects

Plasters 

• Plasters are solid or semisolid and medicated or nonmedicated preparations that adhere to the body– contain backing material such as paper, cotton, linen,

silk, moleskin, or plastic

Powders and Granules 

• Usually ordered in bulk, dispensed as needed in the prescribed amount

• Granules are larger than powders– formed by adding very small amounts of liquid to powders and

passing the mixture through a screen or a granulating device

• Granules – are generally of irregular shape– have excellent flow characteristics– are more stable than powders– may contain colorings, flavorings, and coatings– may have controlled-release characteristics

Discussion

What factors may influence the choice of a dosage form for a drug?

Answer: Choice of dosage form may be influenced by release properties, drug stability, or route of administration.

Liquid Dose Forms

• Liquid dose forms consist of one or more active ingredients in a liquid vehicle

• Two major categories are:– solutions, in which active ingredients are

dissolved in the liquid vehicle

– dispersions, in which undissolved ingredients are dispersed throughout a liquid vehicle

Liquid Dose Forms

• Advantages over solid dose forms are: – ease of swallowing

– ease of adjusting the dose

– tablets or capsules cannot always be divided

• Disadvantage is:– less stable than their solid counterparts

Liquid Dose Forms

Care should be taken to monitor storage conditions of the liquid dose forms, to rotate stock, and to check expiration dates often.

Solutions

• Solutions are classified by vehicle as:– aqueous (water based)

– alcoholic (alcohol based)

– hydroalcoholic (water and alcohol based)

• A solvent is the vehicle that makes up the greater part of a solution

• A solute is an ingredient dissolved in a solution

Solutions

• An enema is usually a water-based solution administered rectally for cleansing the bowel or delivering active drug

• A collodion is a vehicle that is a volatile liquid dissolved in a mixture of alcohol and ether and used for a variety of topical uses – upon application to skin, the solvent vaporizes, leaving

a film coating containing medication

Solutions

• Aromatic water is a solution of water containing volatile oils or other substances

• An elixir is a clear, sweetened, flavored hydroalcoholic solution containing water and ethanol

• A syrup is an aqueous solution thickened with a large amount of sugar or a sugar substitute– may contain additional flavorings, colors, or aromatic

agents

– often the preferred vehicle to mask the taste for pediatric medications

Solutions

• An extract is a potent dose form derived from animal or plant sources – from which most or all the solvent has been evaporated

– used in the formulation or compounding of medications

• A fluidextract is a liquid dose form prepared by extraction from plant sources

• A tincture is an alcoholic or hydroalcoholic solution of extractions from plants

• Spirits are alcoholic or hydroalcoholic solutions containing volatile, aromatic ingredients

Solutions

A low-alcohol or alcohol-free product is preferred for most pediatric products.

Solutions

• Parenteral solutions are products that are prepared in a sterile environment for administration by injection

• Two major delivery systems exist:– intravenous (IV) infusions: fluids administered

directly into a vein

– injections

• intravenous (IV) – into a vein

• intramuscular (IM) – into the muscle

• subcutaneous (SQ or SC) – under the skin

• intradermal (ID) – into the skin

Dispersions 

• Dispersions are undissolved ingredients mixed throughout a liquid vehicle– Classified by size of the dispersed ingredient(s)

into suspensions and emulsions containing:• relatively large particles

• magmas, gels, and jellies (contain fine particles)

• ultrafines particles, less than a micron in size, called a colloidal dispersion

• A suspension is a dispersion of a solid in a liquid

• An emulsion is a dispersion of a liquid in another liquid

Dispersions

• Solutions are classified by route of administration – oral (taken by mouth)

– topical (lotions applied to the skin)

– injectable suspensions

• Emulsions vary in their viscosity, or rate of flow. Some common types are:– oil-in-water (O/W) emulsion: emulsion containing

a small amount of oil dispersed in water

– water-in-oil (W/O) emulsion: emulsion containing a small amount of water dispersed in an oil

Suspensions

Suspensions should always include a “Shake Well” label.

Dispersions

• A lotion is a liquid for topical application containing insoluble dispersed solids or immiscible liquids

• A gel is a dispersion containing fine particles for topical use on the skin – particles are ultrafine– colloidal dimensions– linked to form a semisolid

Dispersions

• An ointment is a semisolid emulsion for topical application

• May be medicated or nonmedicated and may contain various bases:– oleaginous or greasy bases such as petroleum jelly– W/O emulsions such as lanolin– O/W emulsions such as hydrophilic

ointment– water-soluble or greaseless bases

such as polyethylene glycol ointment

Dispersions

• Pastes are like ointments but contain more solid materials and are stiffer and apply more thickly – Zinc oxide paste– Acetonide dental paste

• Creams are considered O/W emulsions. Apply smoothly to the skin and leave a very thin film. Most creams are considered vanishing.

Discussion

Why do the differences between solutions and dispersions have advantages in pharmaceutical practice?

Discussion

Why do the differences between solutions and dispersions have advantages in pharmaceutical practice?

Answer: Solutions do not require shaking, but are only appropriate for particles that dissolve in suitable vehicles. Some dispersions have a thicker consistency that is an advantage for topical use.

Inhalation Dose Forms

• Inhalations are gases, vapors, solutions, or suspensions intended to be inhaled via the nasal or oral respiratory routes

• A spray consists of a container with a valve assembly that, when activated, emits a fine dispersion of liquid, solid, or gaseous material – an aerosol is a spray in a pressurized container with a

propellant to carry the active ingredient to its location of application

– breath-activated devices of powders in place of aerosolized propellants

• Most sprays and aerosols are for – topical application to skin or to oral mucous membranes – inhalation aerosols breathed in through the nose or

mouth

Discussion

What are some of the uses for inhalation dose forms?

Answer: Sprays and aerosols are often used for nasal decongestants and for inhalation of antiasthmatic drugs. Many anti-inflammatory medications are available both as a nasal spray for allergies and as an aerosol for inhalation for asthma.

Delivery Systems

• A delivery system may be– a device used to deliver the drug– a design feature of the dose form that affects the

delivery of the drug– how a medication is formulated to release the

active ingredient

Inhalation Delivery Systems

• One of the most rapid means of administering medication

• Gases such as oxygen, nitrous oxide or “laughing gas,” and ether are administered by inhalation

• Medicated inhalations intended for the lung are administered via – metered-dose inhalers (MDIs)

• hand held, breath-activated, propellant-driven inhalers

– nebulizers– vaporizers and humidifiers

• mechanical devices which deliver moisture to the air

Inhalation Delivery Systems

• A nebulizer is a device used to deliver medication in a fine-mist form to the lung

– deliver a mist containing extremely small, or micronized, powder

– a “nebulized” mist of medication may be more effective than an “aerosolized” spray in delivering medications into the deeper areas of the lung in infants and young children

Syringe, Injection, and Infusion Delivery Systems

• Injections of medications act rapidly to control and treat symptoms

• Syringes are calibrated devices used to accurately draw up, measure, and deliver medication through a needle

• Injections must be sterile because they introduce medication directly into the body

Syringe, Injection, and Infusion Delivery Systems

Only trained professionals and healthcare providers should give injections, and some risk to the patient is always present.

Syringe, Injection, and Infusion Delivery Systems

• Glass syringes are fairly expensive• Plastic syringes are easy to handle,

disposable, and come from the manufacturer in sterile packaging – clearly preferred– used both within and outside the hospital setting

• Different states have different regulations on the sale of syringes – potential diversion for injection of illegal drugs– some states may require a prescription or the

placement of syringes behind the prescription counter to control their sales

Syringe, Injection, and Infusion Delivery Systems

insulin syringe (measures from 30 to 100 U)

tuberculin syringe (with cannulas ranging from 0.01 mL to 1 mL [used for skin tests and drawing up very small volumes of solution])

standard hypodermic syringes in sizes from 1mL to 60mL

Syringe, Injection, and Infusion Delivery Systems

• Injections may be administered to almost any organ or part of the body

• Injectables come prefilled or are filled at the time of injection from single or multidose vials – single-dose vials generally have no preservative – multiple-dose vials, although they contain a

preservative, should be dated and discarded (usually after thirty days)

– ampules are small glass containers that are opened by breaking off the neck of the container

Syringe, Injection, and Infusion Delivery Systems

Other devices for injection include:• A patient-controlled analgesia

(PCA) infusion device used by a patient to deliver small doses of medication for chronic pain

• Jet injectors, which use pressure rather than a needle to deliver the medication

• Ambulatory injection devices that the patient can wear while moving about

Syringe, Injection, and Infusion Delivery Systems

Only the patient should control the PCA pump button.

Syringe, Injection, and Infusion Delivery Systems

• Intravenous (IV) infusion– method for delivering a large amount of fluid over a

prolonged period of time at a slow, steady rate – used to deliver blood, water, other fluids, electrolytes,

nutrients

• IV infusions are used to:– deliver pain-killing or blood clot buster medications– replenish body fluids– deliver nutrients to patients who cannot or will not feed

themselves

Intrauterine and Cervical Delivery Systems 

• An intrauterine delivery system is a way to deliver medication to prevent conception or treat cancer– drug-releasing device placed into the uterus

– may contain a progestin hormone to prevent pregnancy on a long-term (1 to 5 years) basis

• Cervical delivery systems are placed as a ring surrounding the cervix to slowly release medication – replaced monthly by the patient and used as

contraceptive aids

Intrauterine and Cervical Delivery Systems 

Occasionally, the patient will expel these devices spontaneously and may experience a high risk of pelvic infection.

Transdermal Delivery Systems

• A transdermal delivery system (TDS) is a method for delivering medications percutaneously (through the skin)

• Also known as a “patch”– consists of a backing, a drug reservoir, a control

membrane, an adhesive layer, and a protective strip– the strip is removed, and the adhesive layer is

attached to the skin

Transdermal Delivery Systems

• Drug movement is by osmosis through the control membrane, delivering medication systemically, rather than locally

• Medication delivery can be controlled over 24 hours or longer – improves patient convenience and compliance

Other Delivery Systems

• Unit dose disposable syringes are prefilled syringes that contain a single premeasured dose of medication and are thrown away after use

• An oral syringe is a device without a needle to administer medication to pediatric or elderly patients unable to swallow tablets or capsules– a calibrated device consisting of a plunger and a

cannula, or barrel– used for administration of precisely measured amounts

of liquid medication by mouth

Other Delivery Systems

• A bulb syringe is a device used to irrigate eyes or ears with water – bulb is first depressed to expel the air that it contains,

and the tip is then inserted into the liquid to be administered

– bulb is released while the end is in the liquid, and liquid rises to fill the vacuum created

– end of the bulb is then removed from the liquid, and the liquid is administered by depressing the bulb again

Other Delivery Systems• A dropper uses a bulb to create a vacuum for

drawing up a liquid– contains a small, squeezable bulb at one end and a

hollow glass or plastic tube with a tapering point– may be incorporated into the cap of a vial or other

container

• gtt is an abbreviation for unit of pharmaceutical measurement for droppers and IV infusions to indicate drops– due to the differing viscosities of fluids, the size of a

drop varies considerably from medication to medication

• Droppers are often used for otic or ophthalmic administration, as well as for oral medications

Other Delivery Systems

• Ocular inserts are a type of contact lens device with active medication for administration in the eye– small, transparent membranes – placed between the eye and the lower conjunctiva

• Hospices and long-term care facilities use straws (long, hollow tubes) prefilled with pain medications

• Another delivery system for contraceptives is the polyurethane sponge

Discussion

What are some advantages of the specialized medication delivery systems?

Answer: Delivery systems enable more efficient delivery of medications to their sites of action, greater convenience, and/or patient safety.

Drug References

• Official legal standards for drugs in the U.S. are established by the United States Pharmacopeial Convention (USP)

• Standards are published in two reference works– the United States Pharmacopeia– National Formulary (NF)– Both are revised every 5 years– also printed in a combined edition

• United States Pharmacopeia–National Formulary (USP–NF)

Drug References

• The Physician’s Desk Reference– published annually with reprints of package inserts

from the pharmaceutical manufacturers of most drugs

– useful for identifying unknown drugs by color, shape, and coding

Drug References

• Drug Facts and Comparisons– factual information on:

• product availability• indications• administration and dose• pharmacological actions• contraindications• warnings and precautions• adverse reactions• overdose and patient instructions

– updated monthly with new inserts– available on CD-ROM

Drug References

• USP Drug Information– originally published by USP– patient counseling information for the pharmacist

• The American Hospital Formulary Service (AHFS) – information on drugs commonly used in the hospital

• The Handbook of Nonprescription Drugs– published by the American Pharmacists Association

– provides a good reference for OTC drugs

Drug References

• FDA Electronic Orange Book – officially named Approved Drug Products with

Therapeutic Equivalence Evaluations– available online– information on generic equivalency of drugs that may

have many sources

View the FDA Electronic Orange Book

Drug References

• Remington: The Science and Practice of Pharmacy – useful in compounding pharmacy for drug stability and

compatibility information

• The Lawrence Review of Natural Products – scientific monographs on herbal medications

• Homeopathic Pharmacopeia of the United States – compilation of standards for the source, composition,

and preparation of homeopathic medications

Go to this book’s Information Resources Center (IRC) and visit the Resources page found in the Pharmacy Library for a list of these and other valuable resources

Discussion

• What drug references are available in your practice or educational setting?

• Have you referred to them? For what kinds of information?