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Chapter 10: Drug & Prescription Records

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The Harrison Narcotic Act of June 1914
The act called for all doctors, pharmacists, and vendors to register and submit paperwork for all drug transactions, but it was also used to shut down legitimate medical practices as well as dope clinics that were on violation.
The Volstead Act of 1919
The law prohibited the manufacture, transportation, and sale of beverages containing more than 0.5% alcohol.
The Marijuana Tax Act of 1937
Which required a transfer tax for all who sold marijuana.
The Food, Drug, and Cosmetic Act of 1938
Was aimed at controlling cosmetics and medical devices and required the first labeling of drugs with adequate directions for safe use. It also mandated premarital approval from the Food & Drug Administration for all new drugs.
FDA
Food and Drug Administration

Is under the jurisdiction of the U.S. Department of Health & Human Services and has the responsibility to patients as consumers to enforce all drug legislation, thereby protecting the public and keeping them informed of the potential dangers of drugs.
DEA
Drug Enforcement Administration

Which is part of the U.S. Department of Justice, regulates the manufacturing and dispensing of dangerous and potentially abused drugs.
The Controlled Substances Act (CSA) of 1970 (a title II) a.k.a. The Comprehensive Drug Abuse and Control Act
Which replaced the Harrison Narcotic Act, the Food, Drug, and Cosmetic Act, and the Durham-Humphrey laws

It is a federal law that requires the pharmaceutical industry to maintain physical security and strict record-keeping for certain types of drugs that intoxicate or can make a person "high," such as hallucinogens, a narcotics, stimulants, and some depressants.
Controlled drugs, which include both narcotics and certain no narcotics, are divided into five schedules on the basis of their potential for abuse, accepted medical use, and safety.
Schedule I:
-High abuse potential
-Listed medical use; with special permission these drugs can be used for research
-Use leads to severe dependence
-Must be ordered on a DEA form only by certain qualified medical researchers

Schedule II
-High abuse potential
-Limited medical use in the U.S.
-Severe psychic and/or physical dependence
-DEA order form for Rx (triplicate) handwritten by physician, no refills
-No refills by telephone
-Rx must be filled within a specific time period (6 mons in CA, 7 days in some states)
-In emergency, physician may telephone or fax Rx, but written Rx must go to pharmacy within a specific time period (72 hours in CA)
-Records retained in separate file

Schedule III
-Lower abuse potential than in Schedules I and II
-Moderate to low physical dependence; high psychological dependence
-May contain limited quantities of substances from Schedules I and II
-Written or verbal (phoned-in) Rx by physician only
-Refillable up to five times in 6 months

Schedule IV
-Lower abuse potential than in Schedule III
-Limited physical or psychological dependence
-Rx may be written by healthcare worker but signed by physician
-Rx may be phoned in by healthcare worker under order of the physician
-Refillable up to five times in 6 months

Schedule V
-Lower abuse potential than in Schedule IV
-a limited physical or psychological dependence
-State laws vary--may require Rx or may be sold over the counter
-Purchaser must be 18 years old and sign Exempt Narcotic Registration Form with the pharmacist in some states
The Omnibus Budget Reconciliation Act (OBRA) of 1990
Pharmacies have been responsible for the following:

Prospective Drug Utilization Review (ProDUR) - requires evaluation of drug therapy problems, therapeutic, multiple drug interactions (including over-the-counter drugs), incorrect drug dosage, duration of drug treatment, drug-allergy interactions, and evidence of clinical misuse and abuse.

Patient Counseling Standards - governs patient counseling, which involves the pharmacist offering to discuss the unique drug therapy regimen of each Medicaid receive my when filling prescriptions.

Maintenance of Patients Records - requires pharmacy providers to obtain, record, and maintain basic patient information such as name, address, telephone number, age, gender, history, disease states, known allergies, drug reactions, and a comprehensive list of medications.

Drug Use Review Board - require that state Medicaid programs maintain a board; individual states may require the board to be comprised of specific types of professionals.
The California Compassionate Use Act of 1996
To ensure that people who are seriously ill have the right to obtain and use marijuana for medical purposes.
Chemical name
Indicates the chemical content of the drug compound.
Brand name
Indicates ownership by a manufacturer and serves as a trademark that is protected from competition for a specific length of time.
Generic name
When a patent expires from the pharmaceutical company that originally developed and manufactured a drug, the drug may then be manufactured by other pharmaceutical companies.
OTC
Over-the-counter drugs
Drug Formulary
Is a listing of a wide range of drugs that have been preamp proved by a third party organization.
United States Pharmacopeia (USP)
Published to provide drug standards for identification, to indicate the purity of the drugs, and to ensure uniformity of strength.
Physicians' Desk Reference (PDR)
Provides essential prescription information on major pharmaceutical products, is invaluable to the physician and medical assistant. Not all drugs are included, drugs listed are paid by the pharmaceutical companies.
Routes of Administration
Medication may be administrated in various ways depending on how fast the drug is to be absorbed into the body.
Prescriptions
-Is an order to prepare medications written by a physician, directed to a pharmacist.
-Is a legal document, many physicians prefer to write out all orders themselves.
Four standard components of the prescription
1. Superscription - the first element of a prescription, represented by either the word "recipe" (Latin for "take") or y the familiar symbol "Rx." This is usually imprinted on the prescription pad.
2. Inscription - the name of the drug or medication (generic or brand name), the quantity of ingredients, and the dosage amount and/or dose strength (DS for double strength). The amount of active drug in each capsule, tablet, or suppository is usually given in milligrams. The strength of creams, ointments, and topical liquid medicines is usually given as a percentage. The strength of oral liquid medications is given as milligrams per milliliter.
3. Subscription - directions to the pharmacist on the total quantity of the drug to be given for the prescription and the form of the medication (e.g., capsules, tablets).
4. Signature or transcription - instructions to the patient, which are included on the label, so the patient will know how to take or apply the medication. The instructions are often written in Latin abbreviations, which the pharmacist must translate. Sometimes written instructions are supplemented with verbal directions to the patient; for example, whether to take the medication around the clock or during waking hours only.
State Prescription Regulations
CA requires security prescription forms for all Schedule II, III, and IV drugs and some Schedule V drugs. The tamper-resistant security forms have special features required by the CA Board of Pharmacy.

1. Colored background - which is harder to copy
2. Resistant paper - resists erasures and alterations
3. Copy alerts - the word "VOID" appears when photocopied
4. Tracking devices - identification and batch numbers
5. Thermocratic ink - the reverse side reveals the word "SAFE" when rubbed
Formatting errors
When writing multiple medication names and dosages n a patient medical record, it is advisable to write them in list form instead of paragraph form.
The administrative medical assistant's responsibility with regard to drugs and prescriptions is to...
Assist the physician by being knowledgeable about federal and state statutes on medications, to help patients, and to record drug information.
Medication Aides/Assistants
Typically, state laws require the completion of a short training course, and applicants may be required to pass a test.
Pharmaceutical Representative
or "detail reps" may schedule an appointment to visit the physician and leave drug sample and literature.
Drug classification
If sample medications are kept in the office, the medial assistant must make sure that they have not expired and are organized so that all physicians can easily find them to give to patients.
Medication Instruction
-Pharmacists are encouraged by the FDA to provide printed instructions with every new prescription.
-Some physicians ask their medical assistants to instruct patients about drug dosages and drug schedules.
Medication Schedule Card
Some practices use patient medication schedule cards to help patients keep track of their medicines.
-useful is patient has an emergency or sees a specialist and the primary care physician does not have an opportunity to supply medical records.
Drug Dispensing Containers
Various drug dispensing containers are sold at pharmacies or provided by pharmaceutical representatives to aid patients in separating their medication according to the days of the week and times of day they need to take them.
Medication Log
Some offices use a drug flow sheet or medication log for all medications the patient takes, including drugs prescribed by the attending as well as other physicians.
-useful for patients on multiple medications and shows, at a quick glance, the usage habits of a patient or whether a drug might be contraindicated.
Medication Refills
1. Name and phone number of the patient
2. Name and spelling of the medication
3. Dosage strength
4. Number of tablets or capsules in the prescription
5. Prescription number
6. Name and phone/fax number on e-mail address of the pharmacy.
7. How many refills remain on the prescription
Charting prescription
The medical assistant must see that all oral prescription orders and refills are promptly committed to writing and recorded in patients' medical records. The items to record are:
1. Date of refill approval
2. Name of the medication
3. Dosage strength
4. Number of tablets or capsules

Adding the phone number of a patient's pharmacist to the chart and ledger card is also a good idea, because it provides the assistants with a ready reference for telephoning a prescription refill.
Drug Abuse Prevention Measures
Physicians may be approached y people who exhibit varying extremes of drug-seeking behavior. The medical assistant must be able to recognize those patients who might be drug misuser or abusers.
Protecting Prescription Pads
1. Storing unused prescription pads in a safe pace, preferably under lock and key
2. Minimizing the number of pads in use at one time
3. Not leaving prescription pads in unattended office areas or examining rooms and making sure the physician does not leave them in a car
4. Having prescription blanks numbered consecutively by printers so that if one is missing, it will be noticed quickly.
5. Asking the physician to avoid signing prescription blanks in advance
6. Making sure the physician writes and signs prescription orders in ink or indelible pencil to recent alterations.
7. Checking to make sure the amount of medication prescribed is written out or in Roman numerals, as well as expressed in an Arabic numeral, thus preventing changes.
8. Not permitting prescription blanks to be used as memo pads for notes; drug abusers can erase notes and use the blanks to obtain drugs
9. Obtaining tamper-proof prescription pads that are tinted so erasures or white correction ink is easily detected.
Periodically check the expiration dates
shelf life
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