Law module one

vitohuxo's version from 2016-05-10 03:48


Question Answer
statute (law) takes precendence over regulations (rules)
what is an emergency rule(governor must concur)• Director of the department of community health determines that an imminent danger to the health or lives of individuals in this state can be prevented or controlled by scheduling a substance • Administrator determines that the substance should be scheduled or rescheduled as a controlled substance
how long does an emergency rule last?until am identical or similair rule is enacted into law or promulged....or until a date fixed in the rule or 6 months after the date of its filing, whichever comes first. can be extended ONCE for not more than 6 months.
duties of board of pharmacyo Protection of the public – has the obligation to discipline licensees who have adversely affected the public's health, safety, and welfare o Regulate, control, and inspect the character and standard of pharmacy practice and of drugs and devices manufactured, distributed, prescribed, dispensed, administered, or issued in this state o Procure samples and limit or prevent the sale of drugs and devices that do not comply with the law
members of board of pharmacy11 members- 6 pharmacists, 4 public, and 1 technician. appointed by the governor.
terms number for board of pharmacy2 full terms and one half (a term is 4 years)
board of pharmacy disciplinary subcomittee3 professional and 2 public members. excludes the chair of the board
in order for disc subcomittee vote to pass what must happen?must be majority and one public member has to vote that way
chairperson of disc subcomittee is apointed bychair of the full board. must be a public member.
an inspector can seize drugs without warrant if:owner consents, immenant danger to the public, emergency circumstance not enough time get warrant
drug approval pre-clinical stepanimal testing
proposal for human testinginvestigational new drug application (IND)
phase 1 study20-80 people. SE and how metabolized/excreted. ***safety
phase 2 studyfew dozen to 300 people. look at effectiveness. people with disease
phase 3 studyseveral hundred to 3000 people. look at safety and effectiveness. diff populations and dosages.
formal step asking FDA consider drug for approval. NDA- new drug appplication
FDA has how many days to decide if want to file NDA so can be reviewed?60 days
a generic drug must have:same active ingreds (inactive can vary), same strength, dosage form, route of admin, use indication, bioequivalent, same batch requirments for identity, srength, purity, and quality
approval to market a genericANDA= abbreviated new drug application
within _________ days need to respond to discrepanices on teh inspection report by pharmacy inspection process30 days
package insertmandated by FDA- intended for health professionals though! not required to be given to the patient
patient package inserthow to safely use a product. shall be dispensed to patients with every dispensing and in institutional at beg and every 30 days. drug benefits and risks.
drugs that require patient package insertoral contraceptives, estrogenic drug products, IUDS, and progestational drugs
consumer medication informationnot required. printed consumer medication information. usually given though to patients
medication guidesrequired on certain drug products. that pose a serious and sig health concern- serious adverse events
medication guides required for these drug productsNSAIDS, PPIS, antidepressants, bisphosphanates, atypical antipsychotics, ADHD meds, long acting opiods
are medication guides required for inpatient?no if professional available to answer questions- REMs may require inpatient for darbo and epo
pregnancy categoriesA and B= only if clearly needed, C= benefit outweighs risk, D= positive evidence fetus exists, X= may cause fetal harm
HIPAA is enforced bydepartment of health and human services office of civil rights
HIPAA pharmacies mustpost entire notice of privacy practices, notice given to every individual, select a compliance officer. • Shall not disclose their contents or provide copies without the patient's authorization, to any person except to any of the following: o Patient for whom the prescription was issued o Another pharmacist acting on behalf of the patient o Authorized prescriber who issued the prescription o Licensed health professional who is currently treating the patient o An agency or agent of government responsible for the enforcement of laws relating to drugs and devices o A person authorized by a court order o A person engaged in research projects or studies with protocols approved by the board
cousneling rule for medicaidOBRA 90
michigan counseling ruleboard of pharmacy mandates counseling on all new prescriptions patient has not had before. more than an offer to counsel and applies to all patients.
NDCuniversal product indentifier for drugs. required on all presctiption and OTC drug labels.
does the NDC guarentee a product is FDA approved?nope
REMS may include one or more of the followingmed guide, PPI, elements to assure safe use (prescribers, patients, certain setting dispensed, ect)
poison prevention packaging exempt itemsnursing home/hospital, drugs to be admin by isntituational personel, topical application, eye drops, nasal (dosage forms not intended for oral), bulk containers received by the pharmacy
who can request exemption? Patient, physician, or caregiver can request exemption - must get in writing
topical application not exempt poison prevention packaging? lidocaine
nasal spray not exempt poison prevention packaging?afrin
mailing drugs controlled substancesmailer must be registered with the DEA OR 2. Be exempted from DEA registration, such as military, civil defense, and law enforcement personnel, in performing official duties.
mailing drugs to other countrynope. must be registered as an exporter. def not controls
class 1 recallserious adverse consequences or death- recall stock from pharmacy and notify patients
class 2 recalluse may cause temporary or medically reversible adverse consequences. recall stock from pharmacy
class 3 recallnot likely to cause adverse events. may include stock from the pharmacy.
market withdrawaloccurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
medical device safety alertissued in situations where a medical device may present an unreasonable risk of substantial harm. In some case, these situations also are considered recalls.
drug samples only time a pharmacist can accept and dispense isin a hospital pharmacy. no controls. A pharmacist described in this subsection may dispense a prescription for complimentary starter dose drugs written or transmitted by facsimile, electronic transmission, or other means of communication by a prescriber.”
sample= As used in this section, "complimentary starter dose" means a prescription drug packaged, dispensed, and distributed in accordance with state and federal law that is provided to a dispensing prescriber free of charge by a manufacturer or distributor and dispensed free of charge by the dispensing prescriber to his or her patients. 333.17745(13) receipt of sample

Recent badges