Unit 2 : Pharmacy Law, Regulations, and Standards

Pharmacy Oversight

Pharmacy is governed by a wide range of laws and regulations passed by federal, state, and local governmental entities.

• They ensure pharmaceutical manufacturers bring safe products to market

• They ensure pharmacy personnel provide safe and effective care to customers

• Professional organizations establish standards that guide the manufacturing of pharmaceutical products and the conduct of pharmacy personnel.

  What Do Violations of Pharmacy Laws & Regulations Lead To?

• Adverse patient consequences

  • Medication complications

  • Injury and possibly death

• Personal consequences

  • Legal action

  • Loss of employment

  • Fines and/or jail time

History of Drug Regulation in the United States In the 19^th century

• Medical claims were not backed by science

• Medicines did not have to be proven safe or effective.

• Opium, morphine, codeine, and heroin were often found in medicines and were known as “miracle cures”

• Medications also contained high contents of alcohol

• Medicines were highly addictive and occasionally caused injury or death

• Laws, oversight agencies, and professional organizations emerged in the 20^th century as a way to regulate medicine.

Who Controls the Practice of Pharmacy?
Federal and State Regulatory Agencies include:

• Food and Drug Administration (FDA) 

• Drug Enforcement Administration (DEA) 

• Occupational Safety and Health Administration (OSHA) 

• Federal Trade Commission (FTC),

• Centers for Disease Control and Prevention (CDC) 

• Center for Medicare & Medicaid Services (CMS)

Professional organizations include:

• US Pharmacopeial Convention (USP) 

• Joint Commission

• National Association of Boards of Pharmacy (NABP) 

• Individual state boards of pharmacy

• American Pharmacists Association (APhA) 

• American Society of Health-System Pharmacists (ASHP)

The 4 Types of Oversight

• Laws

• Regulations

• Standards

• Ethics

Laws: overall rules that are passed by the legislative branches of federal, state and local governments to guide conduct. They establish the minimum acceptable standards to protect the public.

**The more stringent law or regulation ALWAYS applies when there is conflict between state and federal laws or regulations.

Regulations:  are a set of legislative written rules and procedures that exist to carry out a law.

ex) FDA:  Food and Drug Administration, a federal government agency that regulates the drug

 approval process, generic drug substitution, patient counseling, and adverse reaction reporting

 system.  A violation is the breaking of a federal law.

ex) DEA: Drug Enforcement Administration regulates the distribution, storage , documentation, and filling of prescriptions for controlled substances

Standards: guidelines, benchmarks or desired level of quality to  serve as the expected norm for a product or professional performance.  In pharmacy this represents the quality of drug products and professional conduct of the pharmacy team.

Ethics: the code of highest professional moral principles, ideals and values.  Can be an oath of ethics set by professional organizations.  

• The highest standard of practice for professionals 

• The highest standard of care for patients

• Holds us to be accountable for our actions and decisions

• LEADS TO TRUST WITH OUR PATIENTS

History of US Statutory Pharmacy Law and Oversight

Pure Food and Drug Act of 1906

 The purpose was to address problems of the use of dangerous ingredients, false marketing claims and inaccurate labeling.  It also prohibited  the sale or interstate transportation of adulterated or misbranded food and drugs.

• Adulterated Product:  a product that differs in quality standards in drug strength, quality, or purity from the original product.  

               ex) a drug contaminated with another drug or chemical

• Misbranded Product:  a  product whose label includes false statements about the identity or ingredients of the products contents.

      ex) a manufacturer promoting off-label medical uses with no scientific evidence to support the indication and no FDA approval

Food, Drug, and Cosmetic Act of 1938 (FD&C)

In 1937, over 100 individuals died as the result of poisoning from a sulfa drug product that contained a toxic chemical.  This leads to the creation of the FD&C of 1938. This act created the FDA. This is one of the most important pieces of legislation in pharmaceutical history.

• Food and Drug Administration (FDA)  A new government agency (federal)  that ensures pharmaceutical manufacturers obtain approval before releasing any new drug. Monitors safety standards.

  • Manufacturers now have to file a New Drug Application (NDA) for each new drug to prove with data that the drug is safe in humans.

  • The act did not require proof that the drug is effective or useful for the purpose for which it was sold

  • The FDA has the power to approve or deny any new drug.

  • Details labeling requirements for drugs

Durham-Humphrey Amendment of 1951 (amended the FD&C Act of 1938)

• Drugs are now separated into two categories: Legend (drugs that require a prescription) and patent (drugs that do not require a prescription, manufacturer label directions only)

  • Prescription drug containers must have “Caution:    Federal Law Prohibits Dispensing Without a Prescription”.

Authorizes pharmacists permission to take prescriptions verbally, rather than in writing,

and the refilling of prescriptions over the telephone.

Kefauver-Harris Amendments of 1962

• Passed due to Thalidomide incident.

• Drug manufacturers have to file an Investigational New Drug Application (INDA) with the FDA.  Must provide drug-animal studies before initiating clinical trials in humans.  Drugs must be safe and effective.

• Established patents. Manufactures must prove drugs are both safe and effective (takes around 7-10 years )then granted FDA approval to market the drug. Prescription drug advertising under the authority of the FDA.

• Must have informed consent by research subjects in clinical trials.

• Established Good Manufacturing 

•   Practices (GMP) requirements for pharmaceutical manufacturing

1965 Social Security Amendment

• Also known as the Medicare and Medicaid Act, signed by President Lyndon B. Johnson, established two health insurance programs: Medicare and Medicaid.

• Medicare: A health insurance program for people aged 65 and older, Medicare included two parts: Part A (Hospital Insurance) and Part B (Medical Insurance). Medicare paid for hospital costs and physicians' services, and other medical and health services.

• Medicaid: A health insurance program for people with limited income. 

 The Social Security Act Amendments of 1965 were funded by a tax on employee earnings, matched by contributions from employers. The program was well received, with nearly 20 million beneficiaries enrolling in the first three years

Comprehensive Drug Abuse Prevention and Control Act of 1970 (Controlled Substances Act, CSA)
A federal law enacted to combat and control drug abuse 

• Classified drugs with potential for abuse, or risk of abuse and dependence as Controlled Substances and placed them into one of five schedules based on potential for abuse and accepted medical use.

Schedule I:  not commercially available or legally dispensed in the US; illegal drugs with no accepted medical use. 

•   Highest potential for abuse and addiction

Schedule II:  may be prescribed, but are the most highly regulated drug category, no refills allowed.

Schedule III, IV, V:  generally have progressively less abuse and addiction potential than Schedule II. May refill a max of 5 times in 6 months

• In July of 1973, President Nixon used an executive order to establish the Drug Enforcement Administration (DEA) 

DEA classifies new drugs into the appropriate schedule, using input from the FDA and manufacturers data.  They can also reclassify a drug’s schedule

• In October of 2014 hydrocodone was reclassified from a Schedule III to a Schedule II drug.

CSA also determined who may have the authority to prescribe CS.  Prescribers must now be authorized and monitored by the DEA jurisdiction in which they are licensed.

Physicians, physician assistants, nurse practitioners, dentists, veterinarians, podiatrists, and psychiatrists.

• Prescriptions must be written for a legitimate reason, medical purpose, based on the practitioners professional practice

• Practitioners must have a DEA license in the US

Poison and Prevention Packaging Act of 1970

Created to prevent accidental poisonings in children, the Poison Prevention Packaging Act (PPPA) was signed into law in 1970 by President Richard Nixon. 

• Enforced by the Consumer Product Safety Commision

• Requires that most OTC and RX drugs be packaged in Child-Resistant Containers.  

• Patient can request all their medications be dispensed in non-child resistant containers. This will need to be a signed request by the patient if at all possible for legal purposes.

• Non-Child-Resistant containers include, azithromycin, medrol dosepak, birth control pills, SL NTG and inhalers

• Child-resistant packaging is a container that cannot be opened by 80%

  of children under 5 years old but can be opened by 90% of adults.

Drug Listing Act of 1972

• The FDA  assigns all marketed drugs and new drugs a unique identifier number known as the National Drug Code (NDC) number.  

• It consists of 10 or 11 characters that identify the manufacturer or distributor, the drug formulation, and the size and type of packaging of each drug manufactured. 

1st Set of Numbers: labeler, such as the drug manufacturer, repackager, or distributer

2nd Set of Numbers: the product code, which identifies the specific strength, dosage form (i.e. capsule, tablet, liquid) and formulation of a drug for a specific labeler

3rd Set of Numbers: the package code, which identifies package sizes and types. For example, the NDC for a 100-count bottle of Prozac 20 mg is 0777-3105-02.

• The FDA requests the NDC number appear on all drug labels but does not require it.

• The NDC Code allows the FDA to maintain a database of drugs for tracking.

1976 Medical Device Amendment
Requires pre-market approval for safety and effectiveness of life-sustaining and life-supporting medical devices.

Created a three-class, risk based classification system for all medical devices.

• Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and non-electric wheelchairs

• Class II devices are intermediate-risk devices. Examples include syringes, pregnancy tests, powered wheelchairs, contacts, 

• Class III devices are high-risk devices that are very important to health or sustaining life. Examples include pacemakers, cochlear implants, defibrillators

Orphan Drug Act of 1983

An orphan drug is a medication for treatment of rare diseases or conditions of which there are fewer than 200,000 cases in the United States.

• The act provides tax incentives and exclusive licensing of products for manufacturers to develop and market orphan drugs.

• The FDA moves these drugs faster through the approval process to get them to the patients with these conditions.

ex) Cystic fibrosis, blood cancers, Glioblastoma, and multiple    myeloma

Brand Name Drug: the name under which the manufacturer markets a patented drug, also known as the trade name.

Generic Drug: a drug that contains the same active ingredient as the brand name product and delivers the same amount of medication to the body for a similar medicinal effect. Same intended use, quality, performance, safety, route of administration, and dosage form.

Drug Price Competition and Patent Term Restoration Act of 1984  (Hatch-Waxman Act)

Aimed at reducing healthcare cost due to brand name dominance in the market.

•  Established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) 

• Must demonstrate bioequivalence (having similar strength and outcomes to a brand name product)

• Extended patents on brand named drugs

Prescription Drug Marketing Act of 1987
Requires all drug wholesalers be licensed by the states

• Prohibited the sale, trading, or distribution of drug samples to persons other than those licensed to prescribe them

• Prohibited anyone from filling a prescription in another country and transporting it back  into the US. Only a manufacturer can reimport drugs.

  Anabolic Steroids Control Act of 1990
  An anabolic steroid is a synthetic drug that mimics the human hormone testosterone.  It is used to build muscle mass, enhance strength and performance of the user.  Commonly misused in professional athletes.

  
  Prior to 1990, these drugs were illegally manufactured, imported and sold on the black market.  

  
  This act made anabolic steroids a Schedule III drug.  Allowed the FDA to enforce steroid drug standards, confiscate and prosecute those responsible for illegal use, production and imports.

  
  Led to random drug testing in athletes; trainers can no longer recommend these drugs.

  Omnibus Budget Reconciliation Act of 1990 (OBRA-90)

  • Created to address the increasing costs of pharmaceutical expenditures for Medicaid. In order to receive Medicaid funding, the Act requires each state to establish a Drug Utilization Review Board 

  
  

  • Led to standards for pharmacist-to-patient education and counseling:  Drug Utilization Review (DUR) and Medication Therapy Management (MTM) for Medicaid patients.     

  
  

  DUR must be performed before each prescription is filled or delivered to a patient. This is built into the pharmacy software and alerts the pharmacists to check for potential drug errors in dosage, drug interactions, allergies, clinical use/abuse.

  
  MTM service used to optimize therapeutic outcomes for individual patients.  Focuses on medication therapy review, personal medication record, medication-related action plan, intervention/referral, and documentation and follow up.

  • Under the law, a pharmacist or technician must make the offer to counsel the patient and if they refuse the offer, it must be documented.
    
    Dietary Supplement Health and Education Act of 1994

    
    Legislation states that supplement manufacturers are not required to provide proof of efficacy or standardization to the FDA; only need to  prove consumer safety and make truthful claims. They only need to prove consumer safety and make truthful claims.

  
  

  • Cannot claim a supplement is a cure for an ailment, only to support health.

  
  

  • FDA may only review false claims of supplements and monitor safety issues and remove a product if necessary.
    
    Health Insurance Portability and Accountability Act of 1996 (HIPAA)
    
    The first comprehensive federal regulation designed to safeguard the privacy of protected health information, improve portability and continuity of coverage, combat waste and fraud, and simplify the administration of health insurance.

  • Protected Health Information (PHI): Established safeguards for protecting the confidentiality of patient health records and information; handling of medical records, including personal prescription profiles. Those in healthcare must undergo annual training.

  • All healthcare facilities must provide a document (Notice of Privacy Practices) to each patient that states the data privacy policy and this acknowledgement must be saved.

    Pharmacy personnel can only discuss or transmit prescription data to the patient, parents of children under 18 years old, and appropriate healthcare providers.

  
  

  • Ensures the portability of moving health insurance from one employer to another; emphasis on being able to communicate medical records electronically, using national codes for prescribers and pharmacy providers.

  • protects health insurance coverage for workers and their families when they change or lose their jobs. 

    • requires the coverage and limits restrictions that group health plans can place on benefits for preexisting conditions.

  Food and Drug Administration Modernization Act of 1997
  

  • Enacted to update the drug approval processes, streaming them to accelerate the time until the release of newly patented and manufactured drugs

  
  

  • FDA must regulate medical devices

  • Biological Drugs must go through new drug approval processes

  
  Allows pharmacists to compound nonsterile/sterile medications for individuals if the medications meet established USP standards.  Pharmacies can create personalized drugs for individuals with specific needs.  Does not have to adhere to Current Good Manufacturing Practices (product labeling directions for use, or NDA applications)

  
  ( Updated prescription drug labeling to now read “RX Only” not “Caution: Federal law….”)
  

  Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Medicare Modernization Act (MMA))
  Updated the Medicare System and initiated the option of a prescription Drug Insurance Program, known as Medicare 

Part D

      -Help for patients with economic hardship or a patient needing high cost medications

Launched Medicare Part C, Medicare Advantage Program, as a comprehensive healthcare insurance program option

Encouraged pharmacists to provide annual reviews of medication profiles and ongoing therapies of Medicare patients taking high cost meds or have certain chronic health conditions.

Combat Methamphetamine Epidemic Act of 2005

• All products containing pseudoephedrine (PSE) and ephedrine are moved to Behind-the-Counter location and restricted the amount that can be purchased at one time or  in a 30 day period.

All pharmacy employees must complete a training program for the handling of PSE products.

• Must present legal identification and be 18 years old to purchase

• Log must be kept for 2 years

• Enforced by the DEA along with state agencies.

Patient Protection and Affordable Care Act of 2010 (Affordable Care Act (ACA))
Mandated healthcare coverage under the threat of personal penalties for all US Citizens. 

 Three main parts:

1. Improving Quality and Lowering Health Care Costs

-free preventative care

-prescription discounts for seniors

-protect against healthcare fraud 

-small business tax credits

2. New Consumer Protections

-pre-existing conditions

-consumer assistance

3. Access to Healthcare

A-health insurance marketplace

• Allowed healthcare teams to be formed to serve Medicare Part D patients and study the effectiveness in patient outcomes and cost reductions. These teams are composed of prescribers, pharmacists, and other healthcare related partners.
  

  Drug Quality and Security Act of 2013 (DQSA)
  
  Also known as the Compounding Quality Act

In 2012, 64 patients died when a Massachusetts compounding facility distributed a contaminated product to multiple states

The goal of this act is to better protect patients from drugs contaminated in the compounding process and sold in different states.

Compounding facility must comply with Current Good Manufacturing Processes (USP)

• Protection from counterfeit drugs

• Electronic tracking system to trace drugs from ingredient sources through the compounding and distribution process.
                                       

National Oversight Agencies and Organizations

Food and Drug Administration

The FDA’s Office of Medical Products and Tobacco oversees drugs. 

• The practice of pharmacy is most affected by the FDA’s office of the Center for Drug Evaluation and Research (CDER):

-new drug development and review

- generic drug review

-OTC drug review

-post-drug approval activities

• The FDA is a “public watchdog” that enforces regulations.

• The FDA makes sure that there is truth in advertising for both food and drug packaging, labeling, advertising, and marketing. 

• FDA is responsible for the annual publishing of Approved Drug Products with Therapeutic Equivalence Evaluations known as “The Orange Book”. The Orange Book is a reference used in pharmacy to identify all drugs that are approved for both safety and efficacy. Makes sure the generic options are safe substitutes for the brand name drug. 

  Additional FDA publications:

• “The Purple Book”: lists of licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations.  It is a guide to approved bioengineered drugs (drugs designed by manipulating genes in living substances to affect the genes in certain patient cells)

• “The Green Book”:  FDA Approved Animal Drug Products (guide to drugs for use in veterinary medicine)

Drug Enforcement Administration
The DEA is the primary agency responsible for enforcing the laws regarding potentially addictive controlled substances, both legal and illegal.

• Any entity that is involved with controlled substances must register with the DEA so that it can track the ingredients and control the drugs.

• They inspect all medical facilities, including pharmacies, where suspicious activity is detected.

• They work with state drug and narcotic agencies responsible for routine unannounced physical inspections

• Investigates issues of unsafe prescribing, dispensing or forging of controlled drug prescriptions. Watches prescribing and dispensing trends

• Can track the flow of narcotics from the manufacturer → warehouse → pharmacy  → patient

US Pharmacopeial Convention
An independent, nonprofit, scientific organization.

• The FDA works with the USP and uses its quality standards for prescription drugs, OTC drugs, and dietary supplements.

US Pharmacopeia –National Formulary (USP-NF) is an annual book of standards or compendium.  All new drugs approved by the FDA must meet USP-NF standards.

USP covers:  Dietary supplements, Homeopathic product, Sterile and hazardous compounding standards

National Council for Prescription Drug Programs (NCPDP)

A not-for-profit organization of members in the pharmacy service industry that issues six digit NCPDP Processor ID Numbers (BINS) which pharmacies and pharmaceutical providers use for online electronic records transmissions.

Prescribers and pharmacies also have a National Provider Identifier (NPI), a unique 10-digit number, issued by the Centers for Medicare and Medicaid Services for government reimbursement.

Pharmacies use these numbers: In their DEA and FDA interactions In ordering, purchasing, and tracking their medications. In processing 3rd party prescription claims to insurance

Established industry standards to facilitate online-prescribing and exchanges of health information between pharmacies and medical offices

National Association of Boards of Pharmacy (NABP)
This is the only professional organization that represents all 50  state boards of pharmacy. 

• NABP has developed a model for state practice acts and regulations to help individual state boards of pharmacy build their own regulations.

• Operates the Verified Internet Pharmacy Practice Sites (VIPPS) which is an accreditation program for internet pharmacies recognized by 17 states.  Developed in 1999, it helped patients in the US find legitimate internet pharmacies, protect patient’s privacy, authenticate prescription orders, offer consultation between pharmacies and patients.

State Boards of Pharmacy (BOP)

• Governor-appointed leaders from the pharmacy community and consumer representatives make up the membership of each BOP. 

• Governs over hospital, community, retail and other practices.

• BOP works with the State Department of health and advises legislators on pharmacy law and regulations

• Each state board is responsible for overseeing the inspection of all new pharmacies and maintains a database of all active pharmacist licenses and pharmacy technician licenses.

• They set the legal pharmacist to pharmacy technician ratio

• They oversee the licenses and certifications of pharmacist and technicians

Occupational Safety and Health Administration (OSHA)

• OSHA is an agency of the Department of Labor

  • Its primary mission is to ensure the safety and health of US workers.

• Establishes and enforces workplace regulations and standards; provides training, outreach, and education.

• Encourages continual improvement in workplace safety and health.

• Pharmacy facilities must follow OSHA legal standards and regulations for their facility and processes, all employees must comply
  

  Centers for Disease Control and Prevention (CDC)

• A federal agency, under the Department of Health and Human Services, provides guidelines to protect the public from large-scale health issues and illnesses.

• Works to fight infectious diseases and stop epidemics (regional widespread contagious diseases) and pandemics (globally widespread epidemics)

• Focuses on educational awareness of health, disease and addiction prevention and environmental health, disease.

• Vaccines and preventive prescriptions link pharmacy to the CDC. We also follow CDC guidelines in handwashing and temperatures for vaccine storage 

State Departments and Boards of Health
Each state has a department or board of health to oversee the public health of state citizens. At times they may require the help of pharmacies when we encounter an epidemic or public health threat

Can establish their own regulations for infectious disease and other health issues.  ie) set up vaccine clinics

 Drug and Professional Standards

US Pharmacopeia Pharmacy Practice Standards
In addition to setting quality drug standards, USP also developed standards for practice by pharmacists and pharmacy technicians; and standards related to compounding.

USP-NF:  General Chapters

<795> nonsterile compounding

 <797> sterile compounding

Sets standards involving the storage, packaging, and preparation of nonsterile and sterile compounded preparations

Chapter <800> addresses the handling of hazardous substances in compounding, storage , shipping and other handling methods (ie) chemotherapy

• Many organizations are using USP standards that provide accreditation.  Accreditation is the status achieved by meeting the quality standards and requirements designated by the accrediting organization

  The Joint Commision 
  

• Nongovernmental , nonprofit professional healthcare association that sets high standards of care for hospitals and other healthcare institutions.

• It provides rigorous inspections of their facilities in its approval processes for official accreditation.  Many insurance carriers and governmental agencies require this for the hospitals to receive reimbursement

 American Society of Healthsystem Pharmacists (ASHP)’

• Support for pharmacists in hospital and health-systems pharmacies

• Advocates to government agencies about public policy issues related to medicine and public health

American Pharmacists Association
Policy setting for the pharmacy profession; Mainly community pharmacy

Legal Responsibilities of Pharmacy Personnel

Facility Manager is responsible for making sure all personnel are properly trained and that correct processes are established.

Pharmacists carry the majority of the burden of liability.  They oversee all the work of the technicians.

No  specific federal definition of the pharmacy technician’s role yet exists.  Their responsibilities are under constant review and change as states recognize the constant need to adjust the technician’s role to keep up with the needs and demands of the profession

The Courts and Pharmacy Professionals: Types of Lawsuits

Criminal Law:  between the government and the offending parties. Punishment can result in monetary fines, probation, loss of professional license or ability to practice, or prison.

Civil Law:  between citizens .  Results in monetary awards

The plaintiff is the party (person or group) filing the case.  The plaintiff is responsible for providing evidence to prove their case, the burden of proof.  Must eliminate reasonable doubt.

The defendant is the entity (person or group) being sued, for whom the case is against.

The state board of pharmacy reviews pharmacy cases, and lesser cases are often settled out of court; or they can ask for a criminal investigation. The board will determine if a defendant’s licence should be revoked, suspended, not reissued, or the person be put on probation.

Civil Laws: Torts and Personal Injuries
In civil law a victim’s family may sue for monetary damages.

Torts address wrongs that one citizen commits against another, with the injured party suing the party that caused the injury.

The most common tort in the medical/pharmacy arena is negligence (carelessness).

Malpractice, defined as improper, illegal or neglectful professional activity, is a form of negligence; failing to offer the minimum standard of care that results in injury.

4 Ds of Negligence

When a case of negligence or malpractice is brought, the burden is on the plaintiff to prove:

1. Duty: the plaintiff must first prove that the defendant  had a duty to provide care, or that there was a written or implied contract for care between the two parties.

1. Dereliction: plaintiff must then prove the defendant was derelict (lacking) in this duty.

2. Damages: dereliction caused actual damages to the plaintiff.

3. Direct Cause: the damages were directly caused by the defendant’s derelict conduct.