Drugs with the potential for misuse or abuse either psychologically or physiologically
What are schedule I drugs?
Drugs that have the highest potential for abuse. There is no routine therapeutic use for these drugs and they are not available for regular use. May be obtained for "investigational use only" by applying to the DEA.
What are examples of schedule I drugs?
heroin and LSD
What are schedule II drugs?
Have valid medical use but a high potential for abuse, both psychological and physiologic.
Can a schedule II drug be prescribed over the telephone?
In an emergency, if a written prescription cannot be provided. However, a written prescription must be provided within 72 hours with the words "authorization for emergency dispensing" written on the prescription.
Can schedule II drugs be refilled?
No. A new prescription must be written every time.
What are examples of schedule II drugs?
amphetamines and barbiturates
What are schedule III drugs?
Drugs that have potential for abuse, but the potential is lower than schedule II. Contain a combination of controlled and noncontrolled substances.
What type of dependence does schedule III drugs cause?
a moderate to low physiologic dependence and a higher psychological dependence.
Can a verbal order be given to the pharmacy for schedule III drugs?
Yes. And the prescription may be refilled up to five times within 6 months.
What are examples of schedule III drugs?
certain narcotics such as codeine and nonbarbiturate sedatives.
What are schedule IV drugs?
have a lower potential for abuse; can cause psychological dependency but limited physiologic dependency
What are examples of schedule IV drugs?
non narcotic analgesics and anti-anxiety agents such as lorazepam
What are schedule V drugs?
drugs that have the least potential for abuse; contain a moderate amount of opioids and are used mainly as antitussives and antidiarrheals.
What is the national provider identifier?
a 10 digit number assigned to a provider used for administrative and financial transactions adopted under HIPPA.
Who must the provider share their NPI with?
other providers, health plans, clearinghouses, and any entity that may need it for billing purposes
What is the purpose of the NPI?
to uniquely identify a health care provider in standard transactions such as health care claims; also may be used to identify providers on prescriptions, internal files, in coordination of benefits between health plans, in patient medical record systems, in program integrity files, etc.
How does a provider apply for an NPI?
through a web-based application or by filling out and mailing a paper application to the NPI Enumerator
When may a generic drug be produced?
when the patent on the brand name drug expires other manufactures can produce the same drug formula under its generic name
What is the allowed change in bioavailability between generic and brand name drugs?
less than 4%
How is bioavailability tested?
a single dose of the generic drug is administered to 18 healthy human subjects. the peak serum concentration and the area under the plasma concentration curve (AUC) are measured. the generic drug must be within 80-125% of those obtained for the brand name drug.
What is the mean AUC of generic drugs when compared to brand name drugs?
usually within 3%
What are the practitioner's roles and responsibilities when prescribing medication?
1. drug selection, 2. concerns related to ethics and practice, 3. patient education, 4. prescriptive authority
How should a practitioner select a drug?
conduct a risk-benefit analysis, evaluating therapeutic value versus the risk associated with each drug
What should a practitioner consider when selecting a drug?
subtle or significant differences in action, side effects, interactions, convenience, storage needs, route of administration, efficacy, cost, and patient preference
What is the main issue related to ethics and practice when prescribing medication?
the lack of clinical indication for a drug; a drug should only be prescribed if they are necessary for the well-being of the patient and will be effective in treating the problem
What should the practitioner educate the patient on when prescribing a drug?
its intended therapeutic effect, potential side effects, and strategies for dealing with possible adverse reactions.
Who regulates prescribing practices of each practitioner?
the state through statutes (laws enacted by legislature) and rules and regulations (administrative policies determined by regulatory agencies)
Who is prescriptive authority regulated by specifically?
the State Board of Nursing, Board of Medicine, or Board of Pharmacy depending on the state
What is independent practice?
no requirements for mandatory physician collaboration or supervision
What is collaborative practice?
requires a formal agreement with a collaborating physician, ensuring a referral-consultant relationship
What is supervised practice?
overseen or directed by a supervisory physician
What is delegated practice?
prescription writing is a delegated medical act
What are the rules with prescription samples?
1. a pharm rep's Sample Request Form must be signed (includes name, strength, & quantity), 2. sample must be recorded on the Record of Receipt of Drug Sample sheet, 3. must be stored away from other inventory, 4. must be inspected monthly for expiration dates, proper labeling & storage, presence of intact packaging and labeling, & appropriateness for practice, 5. can't be disposed in the trash
How are prescription samples dispensed?
each must be labeled with patient's name, clear directions for use, and cautions
What are some issues that lead to preventable adverse drug reactions?
1. lack of drug knowledge, 2. lack of patient information, 3. poor communication
What are problems associated with lack of drug knowledge?
1. lack of knowledge about the indications and contraindications of a drug 2. underuse, overuse, and misuse of drugs 3. lack of knowledge related to drug-drug interactions
What is need to know information regarding the patient when prescribing drugs?
adequate drug history including OTC medications, allergies, reactions to medications
What occurs with poor communication?
results from poor handwriting, incorrect abbreviations, misplaced decimals, and misunderstanding of verbal prescriptions; also, failure to discuss potential side effects
What are some special populations to consider?
children, elderly, and pregnant or breast feeding women
What should be considered with children?
prescriptions are written in weight (kilograms)
What should be considered with elderly?
larger print, drug interactions (multiple drugs), when to take drugs, & must consider renal function
What must be included when writing a prescription?
1. date, name, address, and date of birth of patient, 2. prescriber's name, address, and phone number, 3. name of drug, 4. dose, dosage regimen, & route of administration, 5. allowable substitutions, 6. prescriber's signature and license number
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