Unit 2- Federal Laws all

When does Federal Law requires that all prescriptions expire?

One year from the date written.

PRN

indicate refills as needed within the one year requirements of federal law.

1906: The Pure Food and Drug Act (PFDA)

This act required all foods and drugs to meet a standard of strength and purity.

1914: The Harrison Narcotic Act

This act regulated drugs that produced or sustain physical or psychological dependence. The importation, sale, manufacture and use of:Opium Marijuana Synthetic agents Derivatives

1938: The Federal Food, Drug, and Cosmetic Act (FFDDCA)

Required that:-Manufacturers of drugs and cosmetics must prove that their products are safe -Medical devices must be proved effective *This gave the FDA limited authority to remove products from the marketplace if they are found to be ineffective or unsafe.

1951: The Durham-Humphrey Amendments to the FFDCA

Further clarified the distinction between prescription and over-the-counter (OTC) drugs based on whether or not the drugs were habit-forming, narcotic, hypnotic, or potentially harmful.Required a physician's consent in order to dispense refills, giving rise to the legend, "Caution: Federal law prohibits dispensing without a prescription." Warning must be affixed to prescription containers for all Legend drugs.

1962: The Kewfauver-Harris Amendments to the FFDCA

This required drug manufactures to prove the safety and efficacy of their products before approval was given by the FDA for marketing.

1970: Poison Prevention Packaging Act

This act requires child-proof packaging.

1970: Controlled Substances Act (CSA)

Classified drugs based on their potential for abuse, Schedule I, II, III, IV, & V. Federal law requires that all controlled substances dispensed bear the following: "Federal law prohibits the transfer of this drug to any person other than patient for whom prescribed.

JCAHO (Joint Commission on Accreditation of Health Care Organizations)

The mission of the JCAHO is to improve the quality of care provided to the general public. JCAHO is responsible for accreditation of institutional settings.

1990: Omnibus Budget Reconciliation Act (OBRA-90)

This act required pharmacists to offer counseling to Medicaid patients regarding medications.

The Anabolic Steroids Control Act of 1990

This act places "any drug or hormonal substance chemically and pharmacologically related to testosterone" under regulatory provisions of the Controlled Substance Act.

1997: FDA Modernization Act

This act changed the legend requirements to "Rx Only" to be phased in by February 2003

1972: Drug Listing Act

Requires registered drug establishments to provide the Food and Drug Administration(FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution.

1983: Orphan Drug Act

Passed to expedite development of orphan drugs for rare diseases such as Huntington's disease, myoclonus, ALS (Lou Gehrig's Disease), Tourette syndrome, and muscular dystrophy.

1987: Prescription Drug Marketing Act of 1987 (PDMA)

is a part of the FDC Act, which was enacted to address certain prescription drug-marketing practices that have contributed to the diversion of drugs into a secondary gray market.▪ Examples:• Sale or distribution of free samples• Sale of deeply discounted drugs intended for use in hospitals and health care entities

1996: Health Insurance Portability and Accountability Act of 1996 (HIPAA)

the privacy rule took effect on April 14, 2003, and was the first comprehensive federal regulation designed to safeguard the privacy of protected health information (PHI).

2003: Medicare Prescription Drug, Improvement, and Modernization Act (Also called the Medicare Modernization Act or MMA)

This act produced the largest overhaul of Medicare in the public health program's history. The MMA was signed on December 8, 2003 creating Medicare Part D. These programs subsidize the costs of prescription drugs for Medicare beneficiaries and went into effect on January 1, 2006.

2005: The Combat Methamphetamine Epidemic Act of 2005

was to regulate, retail over-the-counter sales of:o Ephedrine (used illegally to make methamphetamine) o Pseudoephedrine (used illegally to make methamphetamine) o Phenylpropanolamine products (used illegally to make amphetamine)

2005: The Patient Safety and Quality Improvement Act of 2005

signed into law on July 29, 2005, was enacted in response to growing concern about patient safety in the United States and the Institute of Medicine's (IOM)1999 report,

2013 Drug Supply Chain Security Act (DSCSA) aka Track and Trace

Outlines steps to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. This will enhance FDA's ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. The system will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers.

The American Association of Pharmacy Technicians (AAPT)

founded in 1979, set forth a code of ethics that details the responsibilities of the pharmacy technician while protecting their right to due process. The code has 10 points that promotes practical and common sense standards of professionalism and integrity.

Food and Drug Administration

is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation's food supply, cosmetics, and products that emit radiation.

Drug Enforcement Administration (DEA)

to enforce the controlled substances laws and regulations of the United States and bring to the criminal and civil justice system of the United States, or any other competent jurisdiction, those organizations and principal members of organizations, involved in the growing, manufacture, or distribution of controlled substances appearing in or destined for illicit traffic in the United States; and to recommend and support non-enforcement programs aimed at reducing the availability of illicit controlled substances on the domestic and international markets.

Code of Ethics for Pharmacy Technicians:

Preamble Pharmacy technicians are healthcare professionals who assist pharmacists in providing the best possible care for patients. The principles of this code, which apply to pharmacy technicians working in any and all settings, are based on the application and support of the moral obligations that guide the pharmacy profession in relationships with patients, healthcare professionals and society.

Controlled Substances Act (CSA)

1970 As a section of legislation, the Comprehensive Drug Abuse, Prevention and Control Act 1970, were enacted to improve the administration and regulation of all parties involved with the manufacturing, distribution, and dispensing of controlled substances.

Prescription Drug Monitoring Program (PDMP)

Prescription drug monitoring program is an electronic database used to monitor controlled substances dispensed within a state. The database will flag patients using multiple providers and pharmacies, or if a refill for a controlled substance is too soon. These programs identify patients with insurance and also those that pay cash.

Schedule I:

Drugs in this category have the potential to be highly abused and are not accepted for medical purposes in the United States.These drugs are only legally used for investigational purposes. Examples of Schedule I drugs:• Heroin• Hallucinogenic substances• Marijuana• Opiates Derivatives

Schedule II:

-Drugs in this category have the potential to be highly abusive and are accepted for medical purposes, and have potentially severe psychological and physiologic dependence.-Prescriptions are not refillable and require an original prescription order.-Schedule II controlled substances require a written prescription which must be manually signed by the practitioner or an electronic prescription that meets all DEA requirements for electronic prescriptions for controlled substances.

Schedule II partial filling

-Partial Filling: This requires pharmacists to record the number of units dispensed and to dispense the remainder within 72 hours. If the remaining units cannot be dispensed to the patient within 72 hours, or further quantities cannot be dispensed, the physician must be notified.

Schedule II long term care RX

-For patients in a long term care facility (LTCF) or who are medically diagnosed as terminally ill in a hospice setting is valid for 60 days from the date of issuance.-Pharmacist must record that the patient is in a LTCF or is terminally ill.Pharmacist must record the date, quantity dispensed, and quantity remaining.Pharmacist's initials or signature must appear on the back of the prescription.

Emergency Situation Schedule II filing

• Prescription may be called into a pharmacy via telephone provided that certain criteria are met:o Immediate administration is required for proper treatment. o If no appropriate alternative is available, including a non-Schedule II controlled substance. o Prescribing physician cannot reasonably provide a written prescription. o Pharmacy must receive a hard copy of the prescription ("cover" original prescription)from the prescriber within 7 days.

Schedule II theft

Federal law states, in the event of suspected significant loss of Schedule II medication, the pharmacy is required to notify their local DEA Field Office of reportable thefts and losses using a DEA Form 106, entered electronically (unless Internet access is not available) through DEA's web portal within one business day of discovery of a theft. Although not specifically required by federal law or regulations, the registrant should also notify local law enforcement and state regulatory agencies.

Examples of Schedule II drugs

Codeine• Morphine Sulfate (MS Contin, Roxanol)• Oxycodone (Roxicodone)• Nalbuphine (Nubain)• Meperidine (Demerol)• Fentanyl (Duragesic) available in a patch, injection and Lozenges, not a tablet.• Hydromorphone (Dilaudid)• Oxycodone and Acetaminophen (Percocet, Roxicet)• Oxycodone and Aspirin (Percodan)• Methylphenidate (Ritalin)• Dextroamphetamine (Dexedrine)• Adderall (Amphetamine Mixture)

Hydrocodone

As of October 6, 2014, the US Drug Enforcement Administration (DEA) required all products to become a schedule II

Schedule III

There is less potential for abuse and dependence than Schedule II. Prescriptions may be refilled up to five times within six months of the date that the prescription was first issued.

Examples of Schedule III drugs:

• Tylenol with codeine,• Fioricet with Codeine• Benzphetamine (Didrex)• Phentermine (Adipex-P)• Phendimetrazine (Bontril, Melfiat, Prelu-2)

Schedule IV:

have less potential for abuse than Schedule III drugs. Rules for dispensing are the same as for Schedule III drugs.

Examples of Schedule IV drugs:

• Benzodiazepines:o Flurazepam (Dalmane)o Alprazolam (Xanax) o Lorazepam (Ativan)o Diazepam (Valium) o Oxazepam (Serax)o Midazolam (Versed)o Temazepam (Restoril)o Triazolam (Halcion) o Estazolam (ProSom) o Clonazepam (Klonopin) o Quazepam (Doral) o Clorazepate (Tranxene) o Chlordiazepoxide (Librium) • Meprobamate • Nonbenzodiazepine drugs with effects similar to benzodiazepines o Zolpidem (Ambien) o Eszopiclone (Lunesta)o Zaleplon (Sonata)

Schedule V:

a low potential for abuse and dependence as compared to Schedule III or IV.-May be legally sold over the counter without a prescription (historically referred to as exempt narcotics) provided the person buying the exempt narcotics is at least 21 years of age and the following criteria are met:-The substance must be sold by a pharmacist.-Not more than 240 ml (or 48 solid dosage units) of opium-containing substances, or 120 ml (or 24 solid dosage units) of non-opium containing controlled substances, may be dispensed within a 48-hour period. Must have bound book record containing: • Name of the purchaser • Date of sale • Pharmacist initial No refill limitations on prescriptions. --All refills must be dispensed in good faith based on the professional judgment of the pharmacist and physician.

Some Schedule V controlled substances

may not be classified as OTC products in certain states.Drugs in this schedule include:• Cough suppressants containing small amounts of codeine (e.g., promethazine + codeine)• Preparations containing small amounts of opium or Diphenoxylate (used to treat diarrhea)

The Code of Federal Regulations states that the partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V

is permissible, provided that: • Each partial filling is recorded in the same manner as a refilling. • The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed. • No dispensing occurs after 6 months of the date on which the prescription was issued.

Record keeping Requirements:

Every pharmacy must maintain complete and accurate records on a current basis for each controlled substance • purchased • received • stored • distributed • dispensed • or otherwise disposed ofThese records are required to provide accountability of all controlled substances starting with the manufacturing process, to the dispensing pharmacy and to the patient. The potential for diversion of controlled substances is reduced using this closed system.

at least two years

All required records concerning controlled substances must be maintained for _________________ for inspection and copying by duly authorized DEA officials.

separately

Records and inventories of schedule II controlled substances must be maintained ________________ from all other records of the registrant.

All records and inventories of schedules III, IV, and V controlled substances must be maintained

either separately from all other records or in such a form that the information required is readily retrievable from the ordinary business records.

DEA form 222

Executed and unexecuted official order forms

DEA Form 106

Reports of Theft or Significant Loss

DEA Form 41

Inventory of Drugs Surrendered for Disposal

Combat Methamphetamine Epidemic Act of 2005Paper Prescriptions Records Option 1

• A file for schedule II controlled substances dispensed. • A file for schedules III, IV and V controlled substances dispensed. • A file for all non-controlled (Legend) drugs dispensed. Paper Prescriptions Records Option 2 (Two separate files): • A file for all schedule II controlled substances dispensed.• A file for all other drugs dispensed non-controlled (Legend) and those in schedules III, IV and V). If this method is used, a prescription for a schedule III, IV or V drug must be made readily retrievable by use of a red "C" stamp not less than one inch high. If a pharmacy has an electronic recordkeeping system for prescriptions which permits identification by prescription number and retrieval of original documents by prescriber's name, patient's name, drug dispensed, and date filled, the requirement to mark the hard copy with a red "C" is waived.

you should use the stricter of the two

if there is a conflict between federal and state requirements for filing prescriptions, (DEA recognizes that the pharmacy must choose a filing system that would comply with both federal and state law)

Electronic Prescription Records

• If a prescription is created, signed, transmitted, and received electronically, all records related to that prescription must be retained electronically.• Electronic records must be maintained electronically for two years from the date of their creation or receipt. However, this record retention requirement shall not pre-empt any longer period of retention which may be required now or in the future, by any other Federal or State law or regulation, applicable to pharmacists or pharmacies.• Records regarding controlled substances must be readily retrievable from all other records. Electronic records must be easily readable or easily rendered into a format that a person can read.Records of electronic prescriptions for controlled substances shall be maintained in an application that meets the requirements of 21 C.F.R. §1311. The computers on which the records are maintained may be located at another location, but the records must be readily retrievable at the registered location if requested by the DEA or other law enforcement agent. The electronic application must be capable of printing out or transferring the records in a format that is readily understandable to an Administration or other law enforcement agent at the registered location. Electronic copies of prescription records must be sort able by prescriber name, patient name, drug dispensed, and date filled.

signed daily by the pharmacist.

Federal law mandates a log of controlled substances dispensed be documented and

Transfer or Disposal of Controlled Substances

• Return to supplier must issue an official order form (DEA Form 222)• Send to "Reverse Distributor" must issue an official order form (DEA Form 222)• Receive permission from DEA to destroy onsite use DEA Form 41 (Inventory of Drugs Surrendered)• Two witnesses are required to oversee the disposal of controlled substances onsite• CIII thru CIV prescriptions can be transferred to another pharmacy only onceRequired records must be maintained for two years.

DEA Number Verification

John Doe, MD AD0865937Add together the first, third and fifth digits:0+6+9=15Add together the second, fourth, and sixth digit and multiply this sum by two:(8+5+3) x 2=32Add the result of step one and two together:15+32=47The last digit of this sum should correspond with the ninth digit of the DEA registration number - AD0865937.A: Identifies type of prescriberD: First letter of last name

A prescriber DEA number is needed for?

All outpatient prescriptions for controlled substances.

Investigational Drugs Phase I

Initial introduction of drug for human use (Physician must order).A patient participating in an investigational drug study must sign an informed consent. Participation is voluntary and the patient may withdraw at any time. Clinical studies are performed on 5 to 20 volunteer patients.

Investigational Drugs Phase II

Establishes effectiveness and relative safetyLimited trialsPatients are closely monitored

Investigational Drugs Phase III

Specifies effective / indicationsMore precise definitions of adverse effects

Investigational Drugs Phase IV

Post-marketing trialsLong termNo control groups involvedAll remaining investigational drugs should be returned to the person(s) responsible for the drug.