Federal Law 2

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.

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

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

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.

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.

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

This act requires child-proof packaging.

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.

Founded in 1979
The American Association of Pharmacy Technicians (AAPT) 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.

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.

•A pharmacy technician’s first consideration is to ensure the health and safety of the patient, and to use knowledge and skills to the best of his/her ability on serving patients.
•A pharmacy technician supports and promotes honesty and integrity in the profession, which includes a duty to observe the law, maintain the highest moral and ethical conduct at all times and uphold the ethical principles of the profession.
•A pharmacy technician assists and supports the pharmacists in the safe and efficacious and cost effective distribution of health services and healthcare resources.
•A pharmacy technician respects and values the abilities of pharmacists, colleagues and other healthcare professionals.
•A pharmacy technician maintains competency in his/her practice and continually enhances his/her professional knowledge and expertise.

•A pharmacy technician respects and supports the patient’s individuality, dignity, and confidentiality.
•A pharmacy technician respects the confidentiality of a patient’s records and discloses pertinent information only with proper authorization.
•A pharmacy technician never assists in dispensing, promoting or distribution of medication or medical devices that are not of good quality or do not meet the standards required by law.
•A pharmacy technician does not engage in any activity that will discredit the profession, and will expose, without fear or favor, illegal or unethical conduct of the profession.
•A pharmacy technician associates with and engages in the support of organizations, which promote the profession of pharmacy through the utilization and enhancement of pharmacy technicians.

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

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

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

Act of 1996 (HIPAA)
HIPAA is the most significant piece of federal legislation to affect pharmacy practice since OBRA-90.
The privacy rule component of HIPAA took effect on April 14, 2003, and was the first comprehensive federal regulation designed to safeguard the privacy of protected health information (PHI).

1.Health information that does not identify the patient
2.Health information that does not provide a basis to identify the patient

A. Use and disclose of patient health information for a number of pharmacy services:
1. Dispensing prescriptions
2. Billing the patient's insurance provider for payment
3. Providing medication therapy management
4. Other pharmacy patient services and health care operations
5. Contacting the patient’s physician
6. Contacting the patient’s health care providers (example: discuss drug therapy or laboratory test results)

Pharmacies must notify their patients of their privacy rights (called "Notice of Privacy Practices") and obtain the signature of the patient's or the patient's authorized representative.

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

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.

To Err is Human: Building a Safer Health System. The goal of the act is to improve patient safety by encouraging voluntary and confidential reporting of events that adversely affect patients.
Patient Safety Act authorized the creation of Patient Safety Organizations (PSO) to improve the quality and safety of U.S. health care delivery. The Patient Safety Act encourages clinicians and health care organizations to voluntarily report and share quality and patient safety information without fear of legal discovery.