Tips: Pharmacy Law

• Manufacturers of generic drugs can market their drugs at lower prices than their brand name counterparts because they don't have new drug development and research costs that the brand name companies have.

• Pharmacy technicians must maintain the privacy and confidentiality of patients' personal health information. This requires appropriate safeguards for pharmacy patient records, discarding patient information in a secure manner, and taking reasonable precautions to maintain privacy of pharmacy conversations about patients.

A History of the FDA & Drug Regulation in the U.S.

Year	Act	Purpose
1906	Food and Drug Act	Outlaws states from buying and selling food,drinks, and drugs that have been mislabeled and tainted.
1912	Sherley Amendment	Outlaws labeling drugs with fake medical claims meant to trick the buyer.
1930	FDA	Food and Drug Administration is named.
1938	Federal Food, Drug, and Cosmetic (FDC) Act of 1938	Requires new drugs to be proven safe prior to marketing; starts a new system of drug regulations; requires safe limits for unavoidable poisonous substances; and allows for factory inspections.
1951	Durha-Humphrey Amendment	Defines the type of drugs that cannot be used safely without medical supervision and limits the sale to prescription only by medical professionals.
1962	Kefauver-Harris Drug Amendments	Requires manufacturers to prove that their drug are effective prior to marketing.
1972	Over-the-Counter Drug Review	Nonprescription medications must be safe, effective and appropriately labeled.
1982	Tamper-Resistant Packaging Regulations	Makes it a crime to tamper with packaged products and requires tamper-proof packaging.
1984	Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act)	Allowed FDA to approve generic versions of brand-name drugs without repeating research to prove safety and efficacy; allowed brand-name drugs to apply for up to 5 years of additional patent protection for new drugs make up for time lost while their products were going through the FDA approval process
1988	Prescription Drug Marketing Act	Designed to eliminate diversion of products from legitimate channels of distribution and requires wholesalers to be licensed.
1997	Food and Drug Administration Modernization Act	Expands scope of agency activities and moves agency to the Department of Health and Human Services (DHHS)
2003	Medicare Prescription Drug Improvement and Modernization Act of 2003	Includes Medicare Part D which increases access to medications through private insurers.

 
Adapted from U.S. Food and Drug Administration, Center for Drug Evaluation and Research
 

Pharmacy Law

Ethical Principles
Ethical Principles guide the performance of tasks and responsibilities so they fall within a moral framework.

Ethical principles include complying with laws and regulations, maintaining competency and respecting patient privacy and confidentiality.

State Pharmacy Laws and Regulations
State pharmacy laws establish the legal requirements, restrictions and prohibitions for the practice of pharmacy.

State pharmacy laws and regulations distinguish between the tasks and responsibilities that pharmacists perform and those that the technicians are permitted to perform.

State Boards of Pharmacy
State boards of pharmacy are responsible for regulating the practice of pharmacy including pharmacies, pharmacists, pharmacy interns, and pharmacy technicians.

The state board regulates:

1. Licensing pharmacies and pharmacists
2. Registering or Licensing technicians
3. Inspecting pharmacies
4. Issuing rules and regulations
5. Investigating complaints
6. Disciplinary actions

Information on the various state boards is available through the National Association of Boards of Pharmacy (NABP)

Pharmacy Licensure
Every state requires pharmacies to have a valid current license or permit in order to operate the facility. Requirements include:

1. Record keeping
2. Security
3. A pharmacists in charge
4. A Licensed pharmacists on duty during operational hours

The categories for pharmacy licenses include:

1. Retail
2. Community
3. Institutional
4. Hospital
5. Nuclear
6. Mail-order
7. Long-term
8. Sterile compounding
9. nonresident

Most states require pharmacies that are located in a other state (i.e, nonresident pharmacies) to be licensed in the state if they mail, ship, dispense, or deliver prescriptions drugs to residents of the state.

Pharmacy Technicians
The requirements for technicians vary from state to state. Common requirements include:

1. Registration or license
2. Permitted tasks
3. Prohibited conduct
4. Qualifications for registration or license include:
5. Minimum age
6. High school diploma or equivalent
7. Completion of a training program
8. An examination

The State Board of Pharmacy in each state is the best resource for obtaining the current requirements.

Patient Counseling
State laws and regulations set the requirements for patient counseling by pharmacists regarding their prescription medications.

The offer to council differs from patient counseling.

The offer to counsel occurs when patient is asked if he/she would like to receive information from the pharmacists.

Whereas counseling is providing information to the patient.

DEA Schedule Drugs from the Top 200 Drug List

Schedule	Brand Name	Generic Name	Function
DEA Schedule II	Percocet®	Oxycodone/APAP	Pain Relief
	Concerta®	Methylphenidate	A.D.H.D.
	OxyContin®	Oxycodone	Pain Relief
	Vyvanse®	Lisdexamfetamine	A.D.H.D.
	Duragesic®	Fentanyl	Narcotic Analgesic
	Dolophine®	Methadone	Anti-addictive
	Adderall®	Amphetamine / Dextroamphetamine	ADHD / Narcolepsy
	Demerol®	Meperidine	Narcotic Analgesic
	Vicodin®	Hydrocodone/APAP	Pain Relief
DEA Schedule III	Suboxone®	Buprenorphine	Opiate Addiction
	Tylenol® #2,3,4	Codeine / APAP	Pain Relief
	AndroGel®	Testosterone	Low T (testosterone)
DEA Schedule IV	Ambien®	Zolpidem	Insomnia
	Xanax®	Alprazolam/td>	Anti-Anxiety
	Klonopin®	Clonazepam	Anti-Anxiety
	Soma®	Carisoprodol	Muscle Relaxer
	Valium®	Diazepam	Anti-Anxiety
	Ativan®	Lorazepam	Anti-Anxiety
	Lunesta®	Eszopiclone	Sleep Aid
	Restoril®	Temazepam	Sleep Aid
	Adipex®	Phentermine	Weight Loss

 

The DEA Sch. Drugs listed above are from the Top 200 list, and this is just a partial list of those Schedule Drugs.  View full list of controlled substances can be found on the Drug Enforcement Website.
 

Definition of Controlled Substance Schedules

Drugs and other substances that are considered controlled substances under the Controlled Substances Act (CSA) are divided into five schedules.

Substances are placed in their respective schedules based on whether they have a currently accepted medical use in treatment in the United States, their relative abuse potential, and likelihood of causing dependence when abused.

Schedule	Classification	Examples
Schedule I (CI)	Substances in this schedule have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.	Some examples of substances listed in Schedule I are: heroin, lysergic acid diethylamide (LSD), marijuana (cannabis), peyote, methaqualone, and 3,4-methylenedioxymethamphetamine ("Ecstasy").
Schedule II (CII)	Substances in this schedule have a high potential for abuse which may lead to severe psychological or physical dependence.	Examples of Schedule II narcotics include: hydromorphone (Dilaudid®), methadone (Dolophine®), meperidine (Demerol®), oxycodone (OxyContin®, Percocet®), and fentanyl (Sublimaze®, Duragesic®). Other Schedule II narcotics include: morphine, opium, codeine, and hydrocodone. Examples of Schedule IIN stimulants include: amphetamine (Dexedrine®, Adderall®), methamphetamine (Desoxyn®), and methylphenidate (Ritalin®). Other Schedule II substances include: amobarbital, glutethimide, and pentobarbital.
Schedule III (CIII)	Substances in this schedule have a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence.	Examples of Schedule III narcotics include: products containing not more than 90 milligrams of codeine per dosage unit (Tylenol with Codeine®), and buprenorphine (Suboxone®). Examples of Schedule IIIN non-narcotics include: benzphetamine (Didrex®), phendimetrazine, ketamine, and anabolic steroids such as Depo®-Testosterone.
Schedule IV (CIV)	Substances in this schedule have a low potential for abuse relative to substances in Schedule III.	Examples of Schedule IV substances include: alprazolam (Xanax®), carisoprodol (Soma®), clonazepam (Klonopin®), clorazepate (Tranxene®), diazepam (Valium®), lorazepam (Ativan®), midazolam (Versed®), temazepam (Restoril®), and triazolam (Halcion®).
Schedule V (CV)	Substances in this schedule have a low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics.	Examples of Schedule V substances include: cough preparations containing not more than 200 milligrams of codeine per 100 milliliters or per 100 grams (Robitussin AC®, Phenergan with Codeine®), and ezogabine.

View Full List of Controlled Substances

Key Notes: Pharmacy Law

• If the state and federal laws or regulations differ, both laws and regulations must be followed, including the more stringent requirements, whether federal or state. 

• The qualifications for pharmacy technician registration or licensure generally include minimum age, high school graduation or the equivalent, completion of training program, including pharmacy employer training programs, and an  examination.

• State pharmacy laws do not permit pharmacy  technicians to perform pharmacy tasks and responsibilities that are limited to pharmacists and require the professional judgement, education, and training of a pharmacist.

• Patient counseling must be provided by the pharmacists. Technicians are not authorized to counsel patients on their medications.

• Prescription monitoring programs require pharmacies to submit information on controlled-substance prescriptions to help states identify potential diversions and abuse.

• Pharmacists use the "Orange Book" to find the FDA's determination that a particular manufacturer's generic drug is therapeutically equivalent to the brand name.  

Key Terms: Pharmacy Law

Controlled Substances - Drugs are chemicals whose possession and use are regulated under the Federal Controlled Substances Act and by state controlled substance laws and regulations. Controlled substances are subject to stricter regulations than other prescription and non-prescription drugs.

Drug Enforcement Administration (DEA): The federal agency that administers and enforces federal laws for controlled substances such as narcotics and other dangerous drugs and illegal substances. The DEA is part of the U.S. Department of Justice.

Legend Drug - A drug that is required by federal law to be dispensed by prescription only. It is the old term for drugs that are now identified as “Rx Only”.

Prescription Monitoring Programs (PMPs): or prescription drug monitoring programs (PDMPs) are state-run programs that store and distribute prescriptions for federally controlled substances. These serve physicians, physician assistants, nurse practitioners, dentists and other prescribers, as well as law-enforcement agencies, and support legitimate medical use of controlled substances while limiting drug abuse and diversion.

Pharmacy Practice Settings

The profession of pharmacy is practiced in many environments, which are commonly divided into ambulatory care and institutional settings.

1. Ambulatory Care, or outpatient, settings serve patients living in their own homes or similar situations and include community clinics, home care and mail order.
2. Institutional or inpatient settings are those in which patients reside in a facility where they receive long or short-term care from health professionals.  

Community Pharmacy
The community pharmacy is the corner drug store or the local retail or grocery store pharmacy.

Mail-Order Pharmacy
Pharmacist and technicians also work in mail-order facilities, through which patients have their prescriptions filled and refilled through the mail. Mail-order pharmacies are really more like warehouses with pharmacists and technicians.

Hospital Pharmacy
Pharmacists are directly involved with patient care and have daily interactions with physicians, nurses, other care givers.

Pharmacists develop plans of pharmaceutical care, medication management and with other caregivers, monitor the patients drug therapy.

In addition to direct patient care, pharmacist evaluate trends in medication and physician prescribing, develop guidelines for medication use, educate patients and healthcare professionals, and implement and maintain drug distribution.

In the hospital setting Pharmacy technicians can:

1. Enter physician med orders into the computer
2. Prepare IV drug admixtures
3. Repackage and label unit dose medications
4. Restock automated dispensing units
5. Deliver medications
6. General paper work  

Home Health Care
Home health care is defined as “physician ordered services provided to patients at their residences, be it in their own homes or any other setting in which the patient lives. Such services include:

1. Personal care
2. Hospice & Respite Care
3. Shopping assistance
4. Drug and infusion therapy
5. Speech, physical and occupational therapy
6. Technician duties in a home care setting may include
7. Preparing sterile injectable products
8. Maintaining computerized patient profiles
9. Delivering medications and supplies to a patient’s home.

Long-Term Care
Long-term care facilities are those institutions where patients stay for extended periods. They include:

1. Nursing Homes
2. Psychiatric or behavioral health institutions
3. Intermediate care facilities for mentally disabled patients
4. Skilled nursing facilities

Most of these facilities do not have pharmacies on site but contract with local community pharmacies for needed services; pharmacists and technicians thus do not have direct patient interaction.

Specialty Pharmacy Services
Just as pharmacists may choose to specialize in an area of pharmacy (e.g, ambulatory care, cardiology, infectious diseases, nutrition, oncology, organ transplant, or pediatrics), so may technicians. Technicians may specialize in areas  such as:

1. Inventory purchasing and management
2. Sterile product preparations
3. Surgical Pharmacy
4. Nuclear Pharmacy
5. Veterinary Pharmacy
6. Non-sterile (extemporaneous) compounding 

Key Notes: Intro to Pharmacy

• Pharmacists are ultimately responsible for the technicians' activities and performance and are legally held liable for the technicians work.

• Training prerequisites for pharmacy technicians vary from state to state and from employer to employer.

• Most consumers believe that all pharmacy technicians have been trained and certified before they are allowed to prepare prescriptions.

Ten Characteristics of a Professional

To the ethical principles, ASHP adds ten characteristics of a professional. These characteristics are applicable to pharmacy technicians.

1. Knowledge and skills of the profession
2. Commitment to self-improvement of skills and knowledge
3. Service orientation
4. Pride and service to the profession
5. Covenantal relationship with patient
6. Creativity and innovation
7. Conscience and trustworthiness
8. Accountability for his/her work
9. Ethically sound decision making
10. Leadership

© American Pharmacists Association (APhA)

Code of Ethics for Pharmacy Technicians

This code outlines ten guiding principles that pharmacy technicians are encouraged to follow. Violations of these values and qualities not only is unprofessional but may be against federal or state law.

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.

Principles

1. 1. 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 in serving patients.
2. 2. 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.
3. 3. A pharmacy technician assists and supports the pharmacists in the safe and efficacious and cost effective distribution of health services and healthcare resources.
4. 4. A pharmacy technician respects and values the abilities of pharmacists, colleagues and other healthcare professionals.
5. 5. A pharmacy technician maintains competency in his/her practice and continually enhances his/her professional knowledge and expertise.
6. 6. A pharmacy technician respects and supports the patient's individuality, dignity, and confidentiality.
7. 7. A pharmacy technician respects the confidentiality of a patient's records and discloses pertinent information only with proper authorization.
8. 8. 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.
9. 9. 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.
10. 10. 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.

Source: The Pharmacy Professionals

Code of Conduct

As pharmacy technicians, and under the supervision of a licensed pharmacist, PTCB certificants and candidates have the obligation to: maintain high standards of integrity and conduct; accept responsibility for their actions; continually seek to improve their performance in the workplace; practice with fairness and honesty; and, encourage others to act in an ethical manner consistent with the standards and responsibilities set forth below. Pharmacy technicians assist pharmacists in dispensing medications and remain accountable to supervising pharmacists with regard to all pharmacy activities, and will act consistent with all applicable laws and regulations.

A. Responsibilities Relating to Legal Requirements.
B. Responsibilities to PTCB/Compliance with Organizational Policies and Rules. 
C. Responsibilities to the Public and Employers.

View and download the PDF Code of Conduct document.

Tips: Intro to Pharmacy

• Whether or not your state requires technician certification, becoming certified and maintaining the certification is advantageous. The knowledge and skills that are tested by either PTCE or the ExCPT are pertinent to any technician working in ant pharmacy practice setting. Becoming certified demonstrates a commitment to your profession and to your career.

• Become an active member of your local pharmacy technician organization; regularly read pharmacy  technician related publications; such as newsletters and journals; and find opportunities for continuing education.

• To perform duties in a competent manner, technicians develop the ability to to determine the best course of action in a specific situation. Applying critical thinking allows pharmacy technicians to prioritize, problem-solving, and troubleshoot issues that arise that may not require the judgement of a pharmacists but that still call for careful attention. 

• Demonstrating an eagerness to learn and take on more responsibilities can help advance your career. 

Pharmacy Technician Certification

Some states require registration of pharmacy technicians, whereas other states require certification; still others are considering the matter. There is no national requirement for certification at this time.

Most consumers believe that all pharmacy technicians have been trained and certified before they are allowed to prepare prescriptions.

Technicians who wish to become certified ma take the national Pharmacy Technician Certification Exam (PTCE) offered by the PTCB. To take the exam, candidates must have earned a high school diploma (GED or foreign diploma) and submit the appropriate form, fee, and supporting documents. Candidates are not eligible if they have been convicted of a drug - or pharmacy- related  felony, or have had any felony convictions at any time during the last five years before applying for the PTCE.

The PTCE is a two hour, closed book, computer based exam consisting of eighty multiple choice questions plus ten non-scored questions. Each question has four possible answers from which to choose , with only one being the best, or correct answer. The score is based on the most correctly answered questions.

The questions are written to assess the knowledge and skills that are deemed necessary to perform the work of pharmacy technicians. The exam divides these activities into three functions areas:

1. i. Assisting the pharmacist in serving patients, including activities related to dispensing prescriptions, distributing medications, and collecting and organizing information.
2. ii. Maintaining medication and inventory control systems pertaining to activities related to purchasing medications and supplies, controlling inventory, and storing, preparing, and distributing medications according to policies and procedures.
3. iii. Participating in the administration and management of pharmacy practice, including administrative activities that deal with such issues as operations, human resources, facilities and equipment, and information systems.

Of the scored questions on the examination, 66% of the exam tests on topics in function area i, 22% on topics in function area ii, and the remaining 12% on topics in function area iii. Candidates who pass the exam may use the designation CPht (certified pharmacy technician) after their names.

To maintain the certification, technicians must re-certify every two years by completing at least twenty hours of continuing  education. A maximum of ten hours may be earned at the technician’s workplace under the direct supervision of a pharmacist. These hours must be special assignments or training; regular work hours do not apply. At least one hour of continuing education must be related to pharmacy law. Refer to the PTCB Website to verify current eligibility requirements and test specifics.

Key Terms: Intro to Pharmacy

Accreditation is the process in which certification of competency, authority, or credibility is presented. The standards for accreditation are set by a peer review board whose members include faculty from various accredited colleges and universities.

Certification: A voluntary process by which a non-governmental agency or association grants recognition to an individual who has met certain predetermined qualifications specified by the agency or association.

Health-System Pharmacy: The practice of pharmacy that is part of a health-system. A health-system is two or more health care practice settings (e.g., hospital, home care, ambulatory clinic) that have a working relationship with each other and are managed or owned by the same business entity.

Home Health Care: Physician-ordered health care services provided to a patient in the home or other settings in which the patient lives.

Licensure: The process by which an agency of the government grants permission to an individual to engage in a given occupations upon finding that the applicant has attained a degree of competency necessary to ensure that public health, safety, and welfare will be protected.

Medication Therapy Management (MTM): A service or group of services that optimizes therapeutic outcomes for a patient. Such services include: assessment of a patients health status; formulation of a medication treatment plan; selection; initiation, modification, or administration of medication therapy.

Pharmaceutical Care involves cooperation between the pharmacist, the patient, and other health care professionals in designing, implementing, and monitoring a therapeutic medication plan.

Pharmacist: a person licensed to prepare and dispense drugs and medicines; druggist; apothecary; pharmaceutical chemist.

Pharmacy:

1. Also called pharmaceutics. the art and science of preparing and dispensing drugs and medicines.
2. a drugstore.

A Pharmacy Technician assists pharmacist by performing routine, day-to-day functions of the practice of pharmacy that do not require the judgement of a pharmacist.

Registration: A pharmacy technician may be required to be registered with a state board of pharmacy before being legally able to carry out some pharmacy functions.