PSB 411 Law Exam 1 Review

PSB 411 Law Exam 1 Review Chapter 1 Law: a framework through which people in a society resolve their disputes and problems in a way that does not involve force and consistently yields results that are acceptable to most of society Government regulates medicinal drugs very heavily because of the potential risks to users Orphan Drugs: sufficiently safe and effective to be marketed by the number of patients who need them is so small that it is not commercially feasible for manufacturer to market • Government must ensure availability Sources of Law 3 Branches of Federal Law: all serve as a check for the other in power 1. Legislative a. Makes laws 2. Executive a. Enforces laws b. President, vice president c. Departments and independent agencies d. Administrative agencies 3. Judicial a. Interprets laws US Constitution: supreme law • Any federal or state statue or regulation that conflicts with this is invalid • Ratified by federal convention in 1787 • Bill of Rights: first 10 amendments – added 1791 o In addition to, there have been 16 amendments added since it was enacted Legislature: elected body of persons with the primary responsibility to enact laws or statutes • Hierarchal order of statues: o Federal statues o State constitutions o State legislations o Ordinances • Under 10th amendment: states have the power to legislate in all areas except those prohibited by constitution Administrative Agency: may be created by legislature to implement desired changes in policies or administer a body of substantive law when the legislature itself cannot perform the functions • State board of pharmacy: created to administer and enforce state pharmacy practice acts • Agencies house in executive branch • CMS: Centers for Medicare and Medicaid Services o Responsible for reimbursement policies and procedures for pharmacies and other health care providers • FDA: Food and Drug Administration o Administers the federal food, drug and cosmetic act – FDCA • FTC: Federal Trade Commission o Enforces unfair business practices and antitrust violations • DEA: Drug Enforcement Administration o Administers the federal Controlled Substances Act: CSA • Notice and Comment Rulemaking: process used to promulgate regulations o Regulations have legal force of statutes o 2 sources for notice: ▪ Federal Register: daily publication that lists various federal actions, including proposed regulations, final regulations and various government notices ▪ CFR: Code of Federal Regulations: annually revised compilation of final regulations divided and indexed by subject manner • 50 titles divided by subject areas • Title 21 • 3 Legal Tests for validity of regulation: o Must be within scope of agency’s authority o Must be based on a statute that gives the agency the authority to promulgate the regulation o Must bear a reasonable relationship to the public health, safety and welfare • Judicial function: through enforcement activities o Resemble civil or criminal court proceedings ▪ Evidence, arguments and decision o Subject to judicial review Common Law: law developed from judicial opinions • Star decisis: to abide by decided cases o 2 purposes: ▪ Establishing continuity of decisions ▪ Expediting judicial decision making o Applies to lower courts within jurisdiction • Derived from England – dates back to 1066 AD Legislative Process Basis of Legislative Power: US Congress • Responsible for overseeing federal bureaucracy • Composed of o Senate: ▪ 100 members o House of Representatives ▪ 435 members • Primary Function: enact statutes through vote of the full membership Process: • Origination of Bills: o Lobbying groups, citizens, government officials and the president • Sponsor of Bill: must be a senator or representative; introduces the bill to Congress • After Introduction – bill moves to particular congressional committee that has jurisdiction over that subject o Committee stage – most important to life or death of bill • Public hearings, investigations • If consent of a majority of committee members, a report is issued detailing purpose of bill with amendments • Bill is placed on calendar – if not impressed, its placed so late on calendar that congress may not get to • Debate • If approved by both, it is signed by president of the senate and speaker of the house and sent to the president • Becomes a law upon the signature of the president or if he fails to return the bill to Congress in 10 days • Veto: if president disapproves o Can override with 2/3 vote State Legislature: modeled roughly after US Congress • Committees less prone to hold full hearings and do not issue major reports on bills Judicial Process Judicial Branch: article 3 of constitution provides that there will be a supreme court and additional federal courts as necessary District Court: trial court • Each state has at least one but some have 2 or more • Jurisdiction over: o Constitution or a federal law o Ambassadors or consuls o Admiralty and maritime issues o The US as a party o State vs state o State vs citizen of another state o Citizen vs citizen from another state Court of Appeals: 12 – one for each judicial court and the District of Columbia • Where appeals from district court go • Can review certain administrative agency decisions Supreme Court: • 9 justices who hold lifetime appointments from the president subject to senate confirmation • Cases must be submitted through a writ of certiorari: has discretion to hear what cases it wants to by granting or denying certiorari Court of Claims: hears disputes lodged against the US State Government: modeled after the federal system • Have legislative, executive and judicial State Court System: similar to federal system 1. State Supreme Court a. In MA it is the Supreme Judicial Court 2. Intermediate appellate courts: 16 states 3. State courts of general jurisdiction: trial courts a. Lower courts of limited jurisdiction i. Police, traffic, small claims, justice of the peace courts b. Special courts of limited jurisdiction i. Probate, juvenile and family courts Civil Court Procedures: 1. Selection of Court: a. Can only be filed in a court that has jurisdiction over both the subject matter and the parties involved 2. Parties: a. Plantif: person who brings the lawsuit i. Name appears first in the name of the case ii. Must prove standing: injury and interest is legally protectable b. Defendant: person against whom the lawsuit is brought 3. Statute of Limitations: period of time in which the suit must be brought - usually 2 years 4. Complaint, Summons and Answer: a. Complaint is filed with remedy requested with the clerk of court b. Clerk of court issues a summons, which is delivered with a copy of the complaint to the defendant c. Answer within 30 days 5. Discovery: a. Each party must give the other part all facts, evidence, and names of witnesses on which the party relies 6. Pretrial Motions: complaints a. Court either grants the motion or dismisses trial or allows corrections to be made to error 7. Jury Selection and Role: a. Voir dire: examination of jurers to determine they want them on the jury or not 8. Witnesses: a. Subpoena: an order to appear in court at a specified time and place 9. Trial: a. Summary judgment: either side can ask the judge to decide the case without trying the facts b. Directed verdict: made by defendant after plantiff’s case has been heard i. If granted, defendant wins 10. Verdict 11. Appeal: notice has to be filed within 30 days after trial court’s decision a. Appellant: the party bringing the appeal i. Name appears first b. Appellee: the party defending the appeal Criminal Court Procedure Diferences: • Indictment issued by grand jury • Grand jury hears evidence presented by government to determine whether a trial should be held o If yes – will issue an indictment leading to an arrest and trial Key MA State Agencies: • DMA: Department of Medical Assistance o Medicaid policy and reimbursement • DPH: Department of Public Health o Board of pharmacy Pharmacy Examples: • Criminal: o Pharmacist sells a controlled substance without a prescription • Civil: o Buyer of the controlled substance takes the drug and experiences an allergic reaction and the pharmacist knew of the allergy • Administrative Action: o Pharmacist appears in from of BOP for unprofessional conduct Federal versus State Law A state has the authority to regulate in any area that Congress has regulated, as long as there is no conflict between state and federal law Supremacy Clause of the Constitution: If conflict between federal and state law, federal law always prevails • Preemption doctrine Federal Authority to Regulate: • Interstate Commerce Clause: gives congress and federal administrative agencies the authority to regulate drug distribution • Reserves for states the authority to regulate the practice of pharmacy State Authority to Regulate: • 10th amendment of constitution: gives state government the authority to regulate pharmacy practice and the distribution of drugs • State laws considered valid as long as they do not conflict with federal law or the constitution o Must bear a reasonable relationship to the protection of public health, safety and welfare Chapter 4 Controlled Substances: have the potential for addiction and abuse Controlled Substances Act: CSA • Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 • 3 Titles: o Title I: establishes rehabilitation programs for drug users o Title II: provides for the registration and distribution of controlled substances o Title III: addresses the importation and exportation of controlled substances • Establishes a closed system for the manufacturing, distributing and dispensing of controlled substances o Must be registered with the DEA: Drug Enforcement Administration • Intent: reduce the diversion of controlled substances to illicit markets • Section 812: provides for 5 schedules of controlled substances o Complete list of all drugs under each DEA: administers all parts of the CSA; under executive branch • Replaced various departments and agencies • Created 1973 • Leaves routine investigation of pharmacies to state boards FDCA: Food, Drug and Cosmetic Act FDA: Food and Drug Administration Narcotic: natural or synthetic opium or opiate and any derivative • Poppy straw • Coca leaves • Cocaine • Ecgonine Schedule I: • Criteria: o High potential for abuse o Have no currently accepted medical use in treatment in the US o Lack accepted information on the safety of their use, even under medical supervision • Examples: o Opiate Derivatives: ▪ Dihydromorphine ▪ Heroin ▪ Morphine methylbromide o Hallucinogenic substances : ▪ Marijuana • Dronabinol: oral schedule III drug • Medical users may not lawfully possess, purchase or sell • Any physician who recommends to a patient could face revocation of DEA registration ▪ LSD: lysergic acid diethylamide ▪ Peyote ▪ Mescaline ▪ Psilocybin ▪ THC o GHB: gamma hydroxybutyric acid ▪ If made as date rape drug ▪ If approved by FDA, then schedule III Schedule II: • Criteria: o Have a high potential for abuse o Have a currently accepted medical use in treatment in the US or a currently accepted medical use with severe restrictions o Abuse of the drug or other substance may lead to severe physical or psychological dependence • Examples: o Narcotics: ▪ Opium ▪ Morphine ▪ Codeine • If mixed with APAP - III ▪ Fentanyl ▪ Hydromorphone ▪ Oxycodone ▪ Methadone ▪ Meperidine ▪ Dihydrocodeine ▪ Diphenoxylate ▪ Cocaine o Stimulants: ▪ Amphetamine ▪ Methamphetamine ▪ Phenmetrazine ▪ Methylphenidate o Depressants: ▪ Amobarbital ▪ Glutethimide ▪ Pentobarbital ▪ Secobarbital ▪ Phencyclidine Schedule III: • Criteria: o Have a potential for abuse less than that of the drugs in schedules I and II o Have a currently accepted medical use in treatment in the US o When abused may lead to moderate or low physical dependence or high psychological dependence • Contain many drugs whose ingredients are schedule IIs • Examples: o Depressants: ▪ Amobarbital ▪ Secobarbital ▪ Pentobarbital o Suppository form: ▪ Lysergic acid ▪ Methyprylone o Narcotics: ▪ Aspirin with codeine ▪ Acetaminophen with codeine ▪ Nalorphine o Stimulants: ▪ Benzphetamine ▪ Chlorphentermine ▪ Clortermine ▪ Phendimetrazine o Anabolic steroids o Dronabinol o Ketamine o GHB approved by FDA o Paregoric • Narcotic may not contain more than: o 1.8g of codeine or dihydrocodeine per 100ml or not more than 90mg per dosage unit o 300mg of dihydrocodeinone and ethylmorphine per 100ml or not more than 15mg per dosage unit o 500mg of opium per 100ml or per 100g or not more than 25mg per dosage unit o 50mg of morphine per 100ml or per 100g Schedule IV: • Criteria: o Have a low potential for abuse relative to the drugs or other substances in Sch. III o Have a currently accepted medical use in treatment in the US o When abused may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Sch. III • Examples: o Narcotics: ▪ Dextropropoxyphene ▪ Products that contain no more than 1mg of difenoxin and not less than 25mcg of atropine sulfate per dosage unit o Depressents: ▪ Alprazolam ▪ Barbital ▪ Chloral hydrate ▪ Chlordiazpoxide ▪ Diazepam ▪ Flurazepam ▪ Lorazepam ▪ Meprobamate ▪ Oxazepam ▪ Phenobarbital ▪ Triazolam o Stimulants: ▪ Diethylpropion ▪ Phentermine o Pentazocine Schedule V: • Criteria: o Have a low potential for abuse relative to the drugs or other substances in Sch. IV o Have a currently accepted medical use in treatment in the US o When abused may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in Sch. IV • Includes primarily anti-tussive preparations that contain codeine and anti-diarrheal products that contain and opiate o Robitussin with codeine – some states without RX o Phenergan with codeine • Cannot contain more than: o 200mg of codeine per 100ml or 100g o 100mg of dihydrocodeine, ethylmorphine, or opium per 100ml or 100g o 2.5mg of diphenoxylate and not less than 25mcg of atropine sulfate per dosage unit o 0.5mg of difenoxin and not less than 25mcg of atropine sulfate per dosage unit Authority for Scheduling: • Section 811 of CSA: grants the attorney general of the US the authority to place an unscheduled drug into a schedule, place a scheduled drug into a different schedule or remove a drug from scheduling • Opportunity for hearing needs to take place first • Must go through the secretary of the DHHS: Department of Health and Human Services Labeling: • All commercial containers of a controlled substance must be labeled with ID symbols designating the schedule in which the drug has been placed Registration CSA achieves control and accountability through registrations Frequency of Registrations: • Manufacturers and distributers must register annually • Dispensers every 3 years (attorney general decides) Exemptions of Registration: • An agent or employee of any registered manufacturer, distributer, dispenser if acting in the usual course of business or employment o pharmacists • A common or contract carrier or warehouseman whose possession is in the usual course of business or employment • An ultimate user who possesses for a lawful purpose • Individual Practitioners as Agents or Employees: o Physician, dentist, veterinarian, or other person licensed or registered to dispense controlled substances in the jurisdictions in which he/she practice o Does not include: pharmacist, pharmacy or institutional practitioner o Those who are working under another independent practitioner (excluding mid-level) who is registered to dispense controlled substances may administer or dispense, but not prescribe, using the registration of the employer o If working for hospital or other institution: may administer, dispense and prescribe controlled substances under the registration of the hospital or institution ▪ Designated special code number by hospital that is available upon request ▪ Intern, resident, foreign-trained physician • Officials of the armed services, public health service or bureau of prisons, who are authorized to prescribe, dispense or administer controlled substances in usual course of official duties o Cannot purchase controlled substances Activities Requiring Registration: • Manufacturing schedules I-V • Distributing • Reverse distributing of controlled substances • Dispensing schedule II-V or instructing • Conducting research with sch. I-V • Conducting a narcotic treatment program using any narcotic drug listed in sch. II-V • Importing and exporting controlled substances Dispense: to deliver a controlled substance to an ultimate user or research subject by, or pursuant to the lawful order of, a practitioner, including the prescribing and administering of a controlled substance and the packaging, labeling, or compounding necessary to prepare the substance for such delivery • Dispenser: a practitioner who so delivers a controlled substance to an ultimate user or research subject Practitioner: a physician, dentist, veterinarian, scientific investigator, pharmacy, hospital, or other person licensed, registered, or otherwise permitted, by the US or the jurisdiction in which he practices or does research, to distribute, dispense, conduct research with respect to, administer, or use in teaching or chemical analysis, a controlled substance in the course of professional practice or research Hospital Pharmacy: may dispense controlled substances without a separate registration Mid-level Practitioners: recognized as individual practitioners who may register as dispensers, providing state law has granted them independent or collaborative prescriptive authority • Nurse practioners • Nurse midwives • Nurse anesthetists • Clinical nurse specialists • Physician assistants • Pharmacists who are engaged in collaborative practice agreements in some states o Have authority to administer, initiate and modify drug therapy in accordance with requirements Manufacturing: production, preparation, propagation, compounding, or processing of a drug, either directly or indirectly, either by extraction from natural origin or by chemical synthesis • Any packaging, repackaging, labeling or relabeling • Coincidental activity: chemical analysis and preclinical research • Pharmacist can manufacture and distribute a narcotic substance to other practitioners in preparation not exceeding 20% of the complete product • FDA guidelines state that pharmacy that compounds and distributes a product to other practitioners must be registered – contrast to CSA Distributing: to deliver a controlled substance • Practitioners registered to dispense may distribute without registration provided that: o The practitioner to whom the drug is distributed is registered to dispense o It is recorded with the proper information by both practitioners o If drug is I or II, the 3rd copy of DEA form 222 is executed o Total number of dosage units does not exceed 5% of total units of controlled substances distributed and dispensed in 1 year o Those returning drugs to supplier Research: • Research with schedule I drugs requires applicant to submit protocol with the application • Dispensers are allowed to conduct research with substances listed in II-V without registering separately as researchers Separate Registrations: each location needs to have its own DEA registration • Not necessary to have for warehouses where controlled substances are stored by or for a registrant unless substances distributed to multiple places Applications for Registration: • No activity may begin until application is granted and a certificate of registration is issued • About 60 days before expiration, will receive registration form from DEA in mail • DEA Form 224: any person wishing to register with DEA as a dispenser • DEA Form 225: manufacturers, distributors, and narcotic treatment programs • Can modify by applying in writing to DEA Discontinuation of Business: registrant must return certification of registration for cancellation, together with any unexecuted Form 222 order forms to the Registration Unit (voided), Drug Enforcement Administration, and Department of Justice Transfer of Business: must submit proposal for transfer in person or certified mail to special agent of DEA in area • Proposal must be submitted at least 14 days in advance unless waived by agent • Required information: o Information of both parties o Whether the business activities currently registered will be continued at the present address or at another address o Whether the transfer has a quota to manufacture or procure any controlled substance in I or II o Date when controlled substances will transfer • Complete inventory Security Requirements Storage: • Schedule I: in a securely locked, substantially constructed cabinet • Schedule II-V: o Individual practitioners: securely locked cabinet o Pharmacies and institutions: may disperse throughout entire stock of non-controlled in a manner that will obstruct theft or diversion • Etorphine hydrochloride and diprenorphine: must be stored in a safe or steel cabinet equivalent to a US government class V security container Penalties Drug Trafficking: • violating ranges from imprisonment of 10 years to life, a fine up to $4 million if specified quantities of certain schedule I drugs and cocaine are involved, or both • other schedule I and II: imprisonment of not more than 20 years, a fine up to $1 million or both • penalties less severe for III-V and marijuana Distributing or Dispensing in Violation of CSA: • failing to make, keep or furnish any required records or reports and not including all required information • ex – pharmacy in violation for not including prescriber’s DEA number or address on RX • knowledge or intent: the penalty is criminal o up to 1 year in prison, a fine of up to $25,000, or both for 1st offenses • negligence: o violator subject to civil penalty not more than $10,000 Order Form 222 Violation: • penalty is up to 4 years in prison and a fine of up to $30,000 Illegal Possession: • penalty for 1st time: up to 1 year in prison and/or a fine of up to $1000 • if cocaine – much more serious penalties Pharmacy Inspections Inspections may be routine or triggered by: • a fear of an imminent danger to the public health, safety and welfare • a formal complaint • the belief that a specific violation has occurred or will occur 4th Amendment: protects individuals from unreasonable searches and seizures • no search warrant can be ordered unless there is probable cause for the search and must be specific Exclusionary Rule: no evidence obtained pursuant to an illegal search can be used in court against a defendant DEA Inspections: • CSA provides that the DEA may enter and inspect any place where controlled substance records are kept or persons are registered under the CSA • Inspector is allowed to: o Examine and copy all records ▪ To determine the legitimacy, accuracy and compliance with the law o Inspect premises within reasonable limits o Take an inventory of the controlled substances • Inspector is not allowed to: o Inspect financial data o Sales data other than shipment o Pricing data • Consent requirement: inspector must obtain a written statement of informed consent to the search, signed by the owner or pharmacist in charge o Constitutional right to refuse until administrative warrant has been issued o Any incriminating evidence found may be seized and used in a criminal prosecution o Notice of inspection has been presented o Consent is voluntary and not coerced o Consent may be withdrawn at any time o Pharmacist may give limited consent – put in writing and signed by both parties Administrative Inspection: • AIW: probable cause requirement much easier to satisfy o “valid public interest” o Examples: ▪ Large purchases of controlled substances ▪ Need to ensure compliance with record keeping requirements of the CSA ▪ Passage of a substantial period of time since last inspection (1-3 years) • Must contain: o Name and address of premises to be inspected o Statement of the statutory authority for the warrant o Statement of the nature and extent of the inspection o Statement that the premises either have not been previously inspected or when the last one was • May only be served during normal business hours and completed in a reasonable manner • Refusal of consent: o Maximum penalty of $25,000 fine, up to 1 year imprisonment or both State Pharmacy Board Inspections: • Some state laws allow the inspection of pharmacies without warrants o Some state courts have decided that a pharmacy is pervasively regulated ▪ Pharmacies should expect to be inspected Opioid Treatment Programs Narcotic Addict Treatment Act of 1974: • legalized the practice of administering methadone to addicts as a therapeutic alternative to heroin • required practitioners who wished to conduct maintenance or detoxification treatment for addicts using controlled substances to do so only by being separately registered by the DEA as NTPs: narcotic treatment programs • only methadone and LAAM (levo-alpha-acetyl-methadol) are approved for the treatment of narcotic addiction • FDA regulated NTPs with some overlap jurisdiction with the DEA Opioid Treatment Programs: OTPs • Replaced the narcotic addict treatment act • Transferred enforcement to the SAMHSA: Substance Abuse and Mental health services Administration • Physicians had to apply for certification • Must be reaccredited every 3 years • Only methadone and LAAM Detoxification Treatment: dispensing of an opioid agonist treatment medication in decreasing doses to an individual to alleviate adverse physiological and psychological effects incident to withdrawal from the continuous or sustained use of an opioid drug and as a method of bringing the individual to a narcotic drug-free state within such period Maintenance Treatment: dispensing of an opioid agonist treatment medication at stable dosage levels for a period in excess of 21 days, in the treatment of an individual for opioid addiction Opioid Addiction: a cluster of cognitive, behavioral and physiological symptoms in which the individual continues use of opiates despite significant opiate-induced problems Opioid Dependence: repeated self-administration that usually results in opiate tolerance, withdrawal symptoms, and compulsive drug taking • May occur with or without the physiological symptoms of tolerance and withdrawal Compounder: any person who engages in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in schedules II-V for use in maintenance or detoxification treatment by another narcotic treatment program Methadone: synthetic narcotic analgesic • Used both for treatment of severe pain and in the detoxification and maintenance of narcotic addicts in OTPs • Any licensed, registered pharmacy may dispense methadone, but only for its analgesic indication • Cannot be prescribed or dispensed for its anti-tussive nature Drug Addiction Treatment Act: DATA • Provides for office-based treatment of opiod-dependent patients by amending the CSA to allow qualifying physicians to prescribe and dispense schedules III-V opioids that have been approved by the FDA for maintenance or detoxification treatment • Subutex and suboxone o Buprenorphine sublingual tablets ▪ Intended for beginning treatment ▪ Dispensed from physicians office o Buprenorphine-naloxone tablets ▪ Long term therapy ▪ Naloxone – added to deter people from crushing and injecting tablets • Qualifying physician: a physician board certified in addiction psychiatry or addiction medicine, or alternatively, who has at least 8 hours of authorized training in the treatment and management of opioid-dependent patients o Each may not treat more than 30 dependent patients ▪ After MD has been in program for 1 year increases to 100 o Must obtain a special DEA number CSA Laws Controlled Substance Registrant Protection Act of 1984: • Before the passage, it was not a violation of federal law when criminal robbed a pharmacy of controlled substances • Mandates that a federal investigation occur if any of the following conditions are met: o The replacement cost of the controlled substance taken is $500 or greater o A registrant or other person is killed or suffers “significant” injury o Interstate or foreign commerce is involved in the planning or execution of a crime ▪ Steal in one state and take to another • Penalty: o Maximum of 20 years imprisonment, a max $25,000 fine, or both o If dangerous weapon used: ▪ Max of 25 years imprisonment, a fine up to $35,000 or both o If death results: ▪ Life imprisonment, a max fine of $50,000 or both Chemical Diversion and Trafficking Act of 1988: • In effort to curb the illicit manufacture of controlled substances • Places 20 chemicals and tableting/encapsulating machines under federal control that are commonly used in illegal manufacturing of controlled substances • Examples: o Anthranilic acid o Benzyl cyanide o Ephedrine o Ergotamine o Ergonovine o Norpseudoephedrine o Phenylacetic acid o Phenylpropanolamine o Acetone o Benzyl chloride o Ethyl ether o Toluene • Must verify legitimacy of customers before concluding transactions • Maintain records of transactions and report certain transactions to DEA Anabolic Steroids Act of 2004: • Promote muscle growth • Amendments to the act of 1990: made them a schedule III o Definition and eliminating requirement to prove muscle growth o Increasing list of 23 to 59 steroids including precursors o Providing for automatic scheduling of salts, esters, and ethers of schedule III anabolic steroids without the need to prove they promote muscle growth o Excluding certain OTC products from regulation • Anomaly in schedule III: they have not been found to have moderate or low physical dependence, or high psychological dependence • Penalty: o 3 years of imprisonment, a fine or both o 6 years imprisonment with the involvement of a minor Combat Methamphetamine Epidemic Act of 2005: • Regulates the OTC sale of any product containing ephedrine, pseudoephedrine (PSE) or phenylpropanolamine (PPA) by placing into new category – scheduled listed chemical products • Have been purchased in large quantities as precursor chemicals to manufacture meth • Restrictions: o 3.6g of ephedrine base, PSE base or PPA base to a single purchaser per day o No consumer may purchase more than 9g of the listed products within a 30 day period or 7.5g within 30 day period if purchased by mail order o All non-liquid forms must be sold in 2 unit blister packs or unit dosage packaging • Log record must be kept for 2 years after last entry • April 8, 2006 o Restrictions set • September, 30, 2006 o Seller places the products where the customers do not have direct access before sale is made o Log book: ▪ Product name ▪ Quantity sold ▪ Name and address of purchaser ▪ Date and time of sale o Id required o Seller must self-certify to US attorney general Chapter 5 Prescriptions Prescription: an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user • May not be issued in order for practitioner to obtain controlled substances for supplying practitioner for purpose of general dispensing to patients • Medication order in a hospital is not a prescription Prescription for controlled substance can only be written by practitioner who: • Authorized to prescribe controlled substances in the state in which he or she is licensed to practice • Registered or exempt from registration under the CSA Must be a bonified doctor/patient relationship: • Patient has medical complaint • Medical history taken • Physical examination performed • Logical connection to drug prescribed DEA Registration Number: • 9 character number consisting of 2 letters followed by 7 numbers • Mid-level practitioners begin with M • Distributers begin with P or R • The second letter is usually, but not always, the first letter of person’s name • To check validity: o Add first, third and fifth digits o Add sum of the second, fourth and sixth digits, multiply by 2, to the first sum o Determine whether the right-most digit of this sum corresponds with the 9th check digit Pharmacist: a person licensed by a state to dispense controlled substances, as well as any other person (intern) authorized to dispense under the supervision of a pharmacist Prescriber may not pre-date or post-date prescriptions • Must be signed on date issued Information required on controlled RX: • Full name and address of patient • Drug name, strength, dosage form, quantity prescribed, directions for use • Name, address and registration number of practitioner • Written for gamma-hydroxybutyric acid must include medical need • If omissions or errors, pharmacist may add necessary info and make corrections on prescription provided that state law allows • Must be written in ink or indelible pencil or typewritten and manually signed by prescriber • Service member: need service id number and registration number Purpose of controlled RX: • Issued for a legitimate medical purpose • Acting in usual course of professional practice • Corresponding responsibility resting on pharmacist Corresponding Responsibility Doctrine: indicates that both the prescriber and pharmacist legally responsible for proper prescribing and dispensing of controlled substances Knowingly: • Use common sense and professional judgment • Recognized the possibility of wrongdoing but consciously refused to conduct a proper investigation Addiction: psychological dependence characterized by compulsive use of the drug despite harm, a loss of control, and a pre-occupation with obtaining opioids Physical dependence: state of adaptation in which withdrawal occurs when the drug is stopped or quickly decreased • Normal and expected with long-term opioid use • If purpose of RX is to gradually withdraw the pain patient from dependence, it is legitimate o Ex – tapered dosage • If purpose to detoxify – not legit Exceptions to Addict Treatment: • Prescriber can administer but not prescribe narcotic drugs from office supply to an addict for a max of 3 days for the purpose of relieving acute withdrawal symptoms while arrangements are being made for referral for treatment • No more than 1 days medication may be administered to the person at one time • Permit a physician or authorized hospital staff member to administer or dispense narcotic drugs to maintain or detoxify a hospitalized patient incidental to treating a condition other than the addiction PMPs: prescription monitoring programs • Many states have – replaces multi-copy CII RXs • Require electronic reporting of all controlled substance prescription information Emergency Situations: • Pharmacist may dispense a CII on the oral authorization of an individual practitioner, provided that: o Quantity prescribed and dispensed limited only to the amount necessary to treat the patient for the emergency period o Must be immediately reduced to writing and shall contain all required information, except the signature o Within 7 days, the prescriber must deliver a written prescription to the pharmacist ▪ Must have “Authorization for Emergency Dispensing” written on face ▪ Date of oral order ▪ If mailed: post-marked by 7 days ▪ If don’t receive, pharmacist must notify DEA • Emergency Situation: o Immediate administration of controlled substance is necessary for the proper treatment of the patient o No appropriate alternative is available o Not reasonably possibly for the physician to provide a written prescription to the pharmacist before dispensing Faxed Prescriptions for CII: • Permitted, but only if pharmacist receives the original written, signed prescription before the actual dispensing • Pharmacy files original • Fax may serve as original: o For a narcotic CII to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous, or intraspinal infusion o For a resident of a LTCF: long-term care facility o CII narcotic for a patient enrolled in hospice certified by Medicare or licensed by the state ▪ Hospice patient must be noted on script Partial Filling: • If pharmacist unable to supply full prescribed amount • Must note amount given and balance remaining that is owed within 72 hours • If unable to fill within time frame, prescriber must be notified o No further quantity can be supplied without a new prescription • Can use in situation where rxis questionable and MD cannot be contacted at the immediate time • LTCF or patient with terminal illness: allow for dispensing of unit dosage but for no longer than 60 days from the date of issuance o Must be written on face: “LTCF patient” or “terminally ill” • For each partial filling, must be recorded: o Date o Quantity dispensed o Remaining quantity authorized to be dispensed o ID of dispensing pharmacist Multiple Prescriptions: • Permitted with following restrictions: o Total quantity cannot exceed 90 day supply o Practitioner must determine there is a legitimate medical purpose and be acting in the usual course of professional practice o Must write instructions on each rx as to the earliest date on with the prescription can be dispensed o Must be permissible under state law o Must comply fully with all other CSA and state law requirements Electronic Transmission Prescriptions: DEA regulations do not provide for this (modem and electronic mail) • Most states do allow e-prescribing of controlled substances • DEA permits if treated as oral rx o E-signing is not applicable to prescriptions, only to other record keeping • For CII-V pharmacist must call prescriber to get oral rx and then reduce it to writing Refills: • CIII & CIV: o May not be filled or refilled more than 6 months after the date of issuance or more than 5 times, whichever comes first o May get authorization of new rx via phone Automated Refill Records: • Storage and retrieval of refill info • Printout must be verified, dated and signed by each pharmacist who refilled prescriptions on the list • Maintained in separate file for 2 years • Must include: o Name of prescriber o Name and address of patient o Quantity dispensed on each refill o Sate of dispensing of each refill o Name or id code of dispensing pharmacist o Number of original prescription order • If kept at central location, must be able to retrieve within 48 hours • Must have auxiliary system in case primary goes down Labeling: • CII: o Show date of filling • CIII-V: o Show date of initial filling o Show both dates • Label must include: o Pharmacy name and address o Serial number of the prescription o Name of patient o Name of prescriber o Directions for use and cautionary statements • CII-IV: o Cautionary statement: ▪ “Caution: federal law prohibits the transfer of this drug to any person other than the person for whom it was prescribed” • Does not apply to institutions: o If CII, no more than 7 day supply dispensed at one time o If CIII-V, no more than a 34 day supply or 100 dosage units, whichever is less o Drug not in possession of the ultimate user before administration o Institution maintains safeguards and records regarding proper administration, control, dispensing and storage of drug o System is adequate Transferring: • May transfer CIII-V on one-time basis only if state allows • If real-time sharing computer system, may transfer back and forth • Transferring pharmacist must: o Write “void” on face of the invalidated prescription o Record on the back: name, address, and DEA number of pharmacy to which rx is transferred as well as the name of the pharmacist receiving the information o Record the date of transfer and the name of the pharmacist transferring the info • Receiving pharmacist must: o Write “transfer” on face of prescription o Reduce to writing: ▪ Date of original issuance ▪ Original number of refills authorized ▪ Date of original dispensing ▪ Number of refills remaining and the date/location of previous refill ▪ Transferring pharmacy’s name, address, DEA number and the prescription number ▪ Name of transferring pharmacist ▪ The pharmacy’s name, address, DEA number and prescription number from which the rx was originally filled • Both have to be kept for 2 years from the date of last refill Central Fill Pharmacy: • Retail pharmacy receives prescription and then sends it to a 2nd pharmacy to prepare and deliver back to the 1st pharmacy for dispensing to the patient • Means to assist in handling increased volumes • May be registered as pharmacies as long as state allows o Must complete DEA Form 224 • Label: must contain unique identifier indicating it was filled at a central location • Retail pharmacy may contract to another state as long as both states allow • Controlled rx’s may be faxed or electronically sent Automated Dispensing Systems: ADSs • Mechanical system that performs operations or activities, other than compounding or administration, relative to the storage, packaging, counting, labeling, and dispensing of medications, and which collects, controls and maintains all transaction information • Allows dispensing of single dosing units reducing problem of excess stock • May be installed in LTCFs provided that state law permits • Pharmacy must maintain a separate DEA registration at the LTCF site PMPs and NASPER PMPs: electronic prescription monitoring programs • Requires pharmacists to electronically transmit to the state a record of each controlled substance dispensed • Allow investigators to obtain data without having to visit National All Schedules Prescription Electronic Reporting Act of 2005: NASPER • Provides grant funding to states to develop or enhance PMPs • States that receive funding must meet specified standards, share data with other states, collect specific information from rx, and allow prescribers and dispensers access to patient records to determine therapeutic duplication and whether diversion, abuse or fraud may exist Record Keeping Three Types of Records: • Inventory • Drugs received • Drugs dispersed Negligent recordkeeping may result in fines of up to $10,000 per offense Intentional: up to 1 year imprisonment plus a fine General Record Keeping Requirements: • Controlled substances records must be kept for at least 2 years at place of registration • May maintain certain records (financial and shipping records) at central location if DEA notified • Central Record Conditions: o Executed order forms, prescriptions and inventory records must be maintained at each registered location o If records electronic, the registrant must provide access to with the records o Registrant agrees to deliver all or any part of the records to the registered location within 2 business days on receipt of written request by DEA o Registrant refuses: special agent in charge may cancel any central recordkeeping without a hearing • Do not need permission to store records on an in-house computer system • Records of all CI and CII must be maintained separately from all other pharmacy records • CIII-V must be readily retrievable Inventory Records: • Initial inventory when pharmacy begins business o Complete and accurate record of all controlled substances • Biennial Inventory: o Every 2 years after initial inventory o Any date within the 2 years o Must be taken at the beginning of business or at close of business o Maintained in written, typewritten or printed form • When drug is newly scheduled by DEA, registrant must take an inventory on effective date of scheduling o New schedules released in Federal Register • CI or II: must make an exact count or measure of substance • CIII-V: estimated count or measure permissible • If container holds more than 1000 tablets exact count required • Must include: o Name of substance o Dosage form o Strength o Number of units or volume in each container o Number of containers o Signature of person doing inventory Records of Receipt: • Invoices are acceptable for CIII-V • CI or CII: DEA Form 222 must be used • Receiving Order: o Date of receipt must be written on the enclosed invoice or DEA Form 222 o Controlled substances must be identified in some manner ▪ CIII-V: marked with red astrick or underlined in red • Must Contain: o Name of substance o Dosage form o Strength of substance o Number of dosage units or volume in the container o Number of commercial containers received o Date of receipt o Name, address and registration number of supplier Records of Dispersal: • Any record that document the removal of drugs from pharmacy and records of dispersal • Include prescriptions, record books, DEA Form 222, invoices and institutional records, records of dispersal, and records of theft or loss • Prescriptions: o An order for medication which is dispensed to or for an ultimate user o May be filed in 3 ways: 1. 3 separate files: • One file for CII • Second file for CIII-V • Third file for non-controlled drugs 2. 2 separate files: • One file for CII • Second file for CIII-V together with non-controls 3. 2 separate files: • One file for all controlled drugs • Second file for non-controlled drugs o If 2 or 3: CIII-V need to be stamped with red C no smaller than 1” in lower right hand corner 1. Waived for electronic recording keeping system • Nonprescription CV Sales: o Codeine cough syrups and antidiarrheals o Dispensing Requirements: 1. Dispensing done by pharmacist • Non-pharmacist employee may perform sale 2. No more than 240ml (8oz) or 48 dosage units of any substance containing opium, no more than 120ml (4oz) or 24 dosage units of any other controlled substance may be dispensed to same purchases in any given 48 hour period 3. 18 years of age 4. Furnish ID if not known 5. Maintain a record book which contains: • Name and address of purchaser • Name and quantity of controlled substance purchased • Date of purchase • Name or initials of pharmacist who dispensed • Distribution from Pharmacy to Practitioner: o Invoice of CIII-V 1. Name of substance 2. Dosage form 3. Strength 4. Number of dosage units or volume in container 5. Number of commercial containers distributed 6. Date 7. Name, address and registration number of person receiving o CII: 1. Purchaser must execute DEA Form 222 o Total number of dosage units distributed must not exceed 5% of total units of controlled substances distributed and dispensed in 1 year • Institutional: o Medication or chart orders o Not prescriptions o Must contain the minimum information necessary to provide an acceptable record for drug dispersal and must be readily retrievable for controlled substances o Discharge medications need a prescription because they are not immediately being administered • Disposal or Destruction: o DEA Form 41: request disposal 1. List the name of drug, number of containers and content of containers o 4 ways of disposal: 1. Transfer to a registrant authorized to possess substance 2. Delivery to DEA agent or nearest DEA field office 3. Destruction in presence of DEA agent or authorized personnel 4. Any other means authorized by DEA o Without DEA Presence: 1. Pharmacy prepare DEA Form 41 listing all drugs and letter requesting permission at least 2 weeks prior • Pharmacist must forward signed copies of 41 to DEA • May make request once in calendar year • Data and method of destruction and names of 2 witnesses 2. Forward substances to DEA registered distributer • Distributer issue DEA Form 222 to pharmacy and submits 41 to DEA 3. Blanket authorization: hospitals or clinics to dispose of used needles, syringes or other injectables only • Records of Theft or Loss: o Must notify nearest DEA office in writing and submit DEA Form 106 o Significant Loss: 1. Quantity lost in relation to type of business 2. Specific drugs lost or stolen 3. If it can be attributed to individuals or unique activities o Who ever is in possession and in control of substance needs to fill out 106 o Spillage/breakage not considered a loss Record Keeping Requirements for Practitioners: • Must keep records of controlled substances they dispense but not what they prescribe Readily Retrievable: • Certain records kept by automatic data processing systems that they can be separated out from all other records in a reasonable time • And/or records are kept on which certain items are asterisked, redlines or identifiable by some other manner DEA Form 222 Only registrants may obtain To obtain initially: must submit an order form requisition • Part of application for registration To obtain refills: requests them in writing from nearest DEA office • DEA Form 222a mailed to registrant Request must be signed and dated by the same person who signed the most recent application for registration or by person authorized by power of attorney Issued in mailing envelopes that contain either 7 or 14 forms and a max of 6 books at a time Each form contains 3 copies Serially numbered and issued with the name, address and registration number, the authorized activity and the schedules authorized to handle Execution: • Must prepare and execute all 3 copies together using typewriter pen or indelible pencil • 10 numbered lines • Last line completed must be noted • Order forms for etorphine hydrochloride and diprenorphine must contain only orders for these substances • Name of drug, finished form (tab/cap), number of units or volume in container and number ordered • NDC optional o Wholesaler responsible • Submits copy 1 and 2 and retains copy 3 • Supplier records number of containers sent and date of shipment o If can’t be filled completely – supply balance in 60 days of the date on the form • Supplier retains copy 1 and forwards copy 2 to DEA • If error: void and file all 3 copies and start with new form • Upon receiving order: o Must record the number of containers received of each item and date • Must be kept for 2 years and maintained separately from all other records Controlled Substance Ordering System: CSOS • Electronic equivalent to form 222 • Allows registrant to order controlled substances not in CI or CII and non-controlled substances • Registrant must apply for digital certificate for signing the order and submit proof of identity o One for each location – can’t be central Power of Attorney • Authorizes a designated person to obtain and execute order forms • Must be filed with executed order forms and made available for inspection • May be revoked by granting person at any time Practitioner cannot write a prescription to obtain drugs for official use Lost or Stolen Forms: • Purchaser must execute another with a statement noting the serial number of the lost form, date of lsot form and the fact that the substances ordered were not received to supplier • Copy 3 of the 2nd order form, copy 3 of lost form and statement must be retained together • If supplier eventually receives, will mark “not accepted” and send back – placed with file • Purchaser or supplier must immediately notify DEA and provide serial number of missing form • If entire book and serial numbers not known, must report the date or approximate date of issuance • If found, DEA must be notified Law Exam 2 Review Federal FDCA: Federal Food, Drug and Cosmetic Act: • Provides for the comprehensive regulation of all drugs introduced into interstate commerce • Intent of law is to protect consumers from adulterated or misbranded drugs, food, cosmetics or devices • Drug must be proven safe and effective • Provides the nucleus of today’s law • Expanded definition of misbranding and adulteration under earlier act • Drugs be labeled with “adequate directions for use” Pure Food and Drug Act: • Prohibited the adulteration and misbranding of foods and drugs in interstate commerce • 1912 – amended to prohibit false and fraudulent efficacy claims • Failed to achieve purpose – required government to prove fraudulent intent Durham-Humphrey Amendment: • Established 2 classes of drugs: o Prescription and over the counter • “Caution: Federal law prohibits dispensing without a prescription” • Authorizes oral prescriptions and refills Food Additives Amendment: • Require that components added to food products must receive premarket approval for safety • Delaney Clause: o Anticancer provision Color Additive Amendment: • Requires manufactures to establish the safety of color additives in foods, drugs, and cosmetics Kefauver-Harris Amendment: • Strengthened new drug approval process requiring drugs to be proved safe and effective • After thalidomide • Establish GMP requirement • Added extensive controls for clinical investigations Medical Device Amendment: • Provide more extensive regulation administrative authority regarding safety and efficacy of medical devices • Classification of devices according to their function • Premarket approval Orphan Drug Act: • Provide tax and exclusive licensing incentives for manufacturers to develop and market these drugs or biologics Drug Price Competition and Patent Term Restoration Act: • Waxman-Hatch Amendment • Streamline generic approval process while giving patent extensions to innovator drugs • Intent to make generic drugs readily available to public Prescription Drug Marketing Act: • Sales restrictions and record keeping requirements for prescription drug samples • Prohibits the resale of sample • Require state licensing of drug wholesalers Prescription Drug User Fee Act: • Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies Nutrition Labeling and Education Act: • Mandates nutrition labeling on food products and authorizes health claims on product labeling, as long as they are made in compliance with FDA regulations DSHEA – Dietary Supplement and Education Act: • Defines dietary supplements and permit manufactures to make certain claims that otherwise would have been illegal under the FDCA • FDA regulate as food not drugs • Criticism: o Lack quality standards for strength and purity Dietary Supplement: • A product that is intended for ingestion, to supplement the diet and contains any one or more of: o Vitamin o Mineral o Herb or other botanical o Amino acid o Dietary substance for use by humans to supplement the diet by increasing the total dietary intake o Concentrate, metabolite, constituent, extract, or combo of previous FDAMA – Food and Drug Administration Modernization Act: • Streamline regulatory procedures to ensure expedited availability of safe and effective drugs and devices • Expands FDA authority over OTC drugs • Establishes ingredient labeling requirements for inactive ingredients Food: • Articles used for food or drink for man or other animals • Chewing gum • Articles used for components of any such article Drug: • Articles recognized by pharmacopedia • Intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease • Intended to affect the structure or any function of the body • Intended for use as a component of any article listed above Device: • An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory which is: o Recognized o Intended for use in diagnosis of disease or in the cure, mitigation, treatment, or prevention of disease o Intended to affect the structure or any function of the body and which does not achieve any of its principle intended purposes through chemical action within or on the body Drug Eluding Stent: • Mixture or drug and device • Epipen, insulin pen, inhaler Cosmetic: • Articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into or otherwise applied to human body • Does not include soap Label: • Display of written, printed or graphic matter upon the immediate container Labeling: • All labels and other written, printed or graphic matter upon any article or any of its containers or wrappers or accompanying such article • Package insert • Not accompanying = advertising Official Compendia: • USPC: USP • HPUS National Drug Code Number: • 1st Series: o Manufacturer • 2nd Series: o Drug Product • 3rd Series: o Package size Misbranded/Adultered: • 1st offense – imprisonment and/or fine • Strict liability – no excuse • A pharmacist who unknowingly and innocently receives an adulterated or misbranded drug and sells it to a consumer has violated the FDCA Product Tampering: • Improper interference with the product for the purpose of making objectionable or unauthorized changes • Federal offense to tamper with consumer products • Requires certain OTC drugs, cosmetics, and devices be manufactured with tamper resistant packaging • Violation may result in misbranding, adulteration or both Product Recalls: • FDA does not have statutory authority to order a product recall but may ask a company to recall a product as an alternative to injunction action or seizure • Manufacturer may initiate a product recall without FDA involvement • 3 Classes: o Class 1: ▪ Reasonable probability that the product will cause serious, adverse health consequences or death o Class 2: ▪ May cause temporary or medically reversible health consequences but probability of serious adverse consequences is remote o Class 3: ▪ Not likely to cause adverse health consequences • Manufacturer responsible for notifying sellers of recall • Sellers responsible for contacting consumers • Pharmacist responsible for knowing which drugs have been recalled New Drug: • A drug that is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug’s labeling Clinical Study Phases: • 4 Phases: o Phase 1: ▪ Purpose is to detect adverse effects, not efficacy o Phase 2: ▪ Purpose is to determine the efficacy of the drug and the dosages at which efficacy occurs o Phase 3: ▪ Large amount of people to test safety and efficacy o Phase 4: ▪ Post-marketing and surveillance activities After NDA approval, a manufacturer may not make any changes in the drug or its production 3 Procedural Categories: • Production • Labeling Changes o Black box warnings • Minor changes Medwatch: • Voluntary process to report to FDA Durham-Humphrey Amendment: • Different labeling requirements for drugs, depending if they are prescription or OTC • Prescription Drugs: o Toxicity or other potentiality for harmful effect, or the method of its use, or collateral measures necessary to its use, is not safe for use except under the supervision of a practitioner • 3 Categories for ingredient: o I – ingredients recognized as safe and effective and not misbranding o II – ingredients that are not recognized as safe and effective or that are misbranded o III – ingredients for which data available are insufficient to permit classification • Switch from Prescription to OTC: o Manufacturer may request the switch o Manufacturer may petition the FDA o Drug may be switched through the OTC drug review process • Patient Package Inserts: o Prescription drug labeling for the pharmacist o Exceptions: ▪ Oral contraceptives ▪ Estrogen containing drugs ▪ DES – diethylstilbestrol ▪ IUD contraceptive device • Medication Guide: o For drugs posing a serious or significant concern o Patient labeling so he/she can understand risk/benefits o Accutane, lotronex, lariam, and lindane (lotion and shampoo) • Of-Label Use: o No unreasonable risk to patient, RPh may dispense drug o Pharmacists may provide drug information to providers unless for promotional reasons Approved Drug Products with Therapeutic Equivalence Evaluations: • The Orange Book: o Each state has generic substitution laws allowing a pharmacist to substitute a generically equivalent drug for the prescribed drug o Responsible for ensuring that the substituted generic drug product is bioequivalent to prescribed drug o Pharmaceutical Equivalents: ▪ Products contain same active ingredients and are identical in strength and are in the same dosage form o Therapeutic Equivalents: ▪ Pharmaceutical equivalents that can be expected to have the same clinical effect and safety ▪ Codes: • 2 letter coding system for evaluations • A: • B: o Considered therapeutically equivalent to a reference drug product o Not considered to be therapeutically equivalent • 2nd letter describes dosage form or nature of product • NTI – Narrow Therapeutic Index: o There is less than a 2-fold difference in median lethal dose and median effective dose or o Less than a 2-fold difference in the minimum toxic concentrations and minimum effective concentration in the blood o Carbamazepine o Clonidine o Levothyroxine o Lithium o Phentoin o Warfarin • FDA Bioequivalence Standards: o Allows for a range of 80-125% Use of alcohol in Pharmacy Practice: • Tax paid alcohol • Tax free alcohol PPPA - Poison Prevention Packaging Act: • Drugs Exclusions for safety cap: o Pg 10!!! • Purpose: o Protect children from accidental poisonings with “household substances” • Household Substance: o Any substance that is customarily produced for or used in the household and is designated: ▪ Hazardous substance ▪ Economic poison ▪ Food, drug or cosmetic ▪ Household fuel • Pharmacy: o Requires the use of child resistant containers for packaging of most OTC drugs and nearly all rx drugs o Containers must be manufactured such that 80% of children less than 5 years old cannot open them, whereas 90% of adults can • Exemptions: o Patient request o Manufacturer can market one size of an OTC product for elderly in noncompliant packaging – warning o Drugs dispensed to institutionalized patients o Certain rx drugs: ▪ SL nitroglycerin ▪ SL and chewable forms of isosorbide dinitrate in strengths 10mg or less ▪ Sodium fluoride products containing not more than 264mg ▪ Anhydrous cholestryamine in powder form ▪ Methylprednisolone tablets containing no more than 84mg OBRA 90 - Omnibus Budget Reconciliation Act: • Mandates changes in the way that pharmacy is actually practiced • Recognizes a public expectation of RPh’s that goes beyond oversight of drug distribution to include detection and resolution of problems with drug therapy • Goal – save money • Establishes federal policy rewuiring drug use review (DUR) to ensure that drug therapy is safe and effective • Applies only to Medicaid rx’s • Net result: o Increased the standard of care owed by RPh to all patients • Framework: o Rebates: ▪ Requires manufacturers to provide pharmaceuticals to Medicaid at their “best price”, lowest price at which they sell the product to any customer ▪ Exception - valium o Demonstration Projects o DUR: ▪ Retrospective Review: •