© paradigm publishing, inc. 1 chapter 2 pharmacy law, regulations, and standards

© Paradigm Publishing, Inc. 1

Chapter 2

Pharmacy Law, Regulations,and Standards


The Need for Drug Control

• Laws in the US are generally stricter than in other countries.

• Many organizations exercise control:– Courts– Federal and state legislatures– Federal and state agencies– US Pharmacopeia– Professional organizations– Individual institutions (hospitals, pharmacies, etc.)


History of US Statutory Pharmacy Law

• During the 1800s, drugs in the US were unregulated.

• Opium was widely available without a prescription.

• Traveling medicine shows proclaimed the latest “miracle cure.”

• There were major concerns regarding the purity of imported drugs.


Pure Food and Drug Act of 1906

• Passed to fight abuses in drug formulation, labeling, and marketing

• Forbade drug labels from containing false information

• Proved to be unenforceable


Food, Drug, and Cosmetic Act of 1938

• Response to manufactured drugs that were more powerful and potentially dangerous

• Created the FDA• Required drug makers to

– File new drug applications (NDAs)– Prove that the product was safe for human use– Conduct studies and submit results

• Required drugs to be safe, but not necessarily effective


Terms to Remember

new drug application (NDA) the process through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the United States


Durham-Humphrey Amendment of 1951

• Established distinction between prescription and non-prescription drugs

• Authorized verbal prescriptions• Allowed prescription refills


Kefauver-Harris Amendment of 1962

• Passed in response to thalidomide-caused birth defects

• Required drugs to be not only safe but also effective

• Required drug makers to file investigational new drug application (INDA)

• Lengthened time to market – balanced by patent protection for drug makers


Terms to Remember

Controlled Substances Act (CSA) laws created to combat and control drug abuse

controlled substance a drug with potential for abuse; organized into five schedules that specify the way the drug must be stored, dispensed, recorded, and inventoried


Comprehensive Drug Abuse Prevention and Control Act of 1970

• Referred to as the Controlled Substances Act

• Created to combat drug abuse• Classified drugs according to their

potential for abuse– Schedule I: not legally dispensed– Schedule II: no refills– Schedule III – V: limits on refills


Comprehensive Drug Abuse Prevention and Control Act of 1970

CSA ranked drugs according to their potential for abuse and addiction.


Terms to Remember

child-resistant container a medication container with a special lid that cannot be opened by 80% of children but can be opened by 90% of adults; a container designed to prevent child access in order to reduce the number of accidental poisonings


Poison Prevention Packaging Act of 1970

• Passed to prevent accidental childhood poisonings

• Applies to both prescription and OTC drugs

• Requires child-resistant containers that– Cannot be opened by 80%

of children– Can be opened by 90% of

adults


Poison Prevention Packaging Act of 1970

The Act allows some drugs to be dispensed in non-childproof packages.


Drug Listing Act of 1972

• Gives FDA authority to compile a list of currently marketed drugs

• Each drug is given a unique National Drug Code (NDC)

• Allows FDA to maintain a database of drugs by– Use– Manufacturer– Active ingredients


Terms to Remember

orphan drug a medication approved by the FDA to treat rare diseases


Orphan Drug Act of 1983

• Developing and marketing orphan drugs is prohibitively expensive.

• Orphan Drug Act encourages their development by– Giving tax incentives– Granting exclusive licenses– Allowing expedited review and approval

• Over 250 orphan drugs have been approved by FDA.


Terms to Remember

brand name

the name under which the manufacturer markets a drug; also known as the trade name


Terms to Remember

generic name

a common name that is given to a drug regardless of brand name; sometimes denotes a drug that is not protected by a trademark; for example, acetaminophen is the generic drug name for Tylenol


Drug Price Competition and Patent-Term Restoration Act of 1984

• Was a response to pressure to reduce drug costs

• Encouraged the creation of generic drugs

• Extended patent licenses to allow manufacturers to recoup research and development costs


Drug Price Competition and Patent-Term Restoration Act of 1984

• Generics are comparable to brand name drugs in– Dosage form– Safety– Strength– Quality– Performance

• Generics must demonstrate bioequivalence to brand name product.

• Over 60% of prescriptions in community pharmacies are filled with generics.


Prescription Drug Marketing Act of 1987

• Prohibits re-importation of drugs into US by anyone but the manufacturer

• Passed in response to concerns over safety and competition issues

• Has become a major issue as seniors travel to Canada for prescriptions or order medications by mail


Anabolic Steroid Act of 1990• Anabolic steroids are a

synthetic version of testosterone.

• Abuse by athletes has been widely reported.

• Adverse side effects are serious and permanent.

• Act identifies anabolic steroids as a Class III drug, allowing greater restrictions.


Omnibus Budget Reconciliation Act of 1990

• Requires state standards of practice for drug utilization reviews

• Pharmacist must screen for– Therapeutic duplication– Drug-disease contraindication– Drug-drug interactions– Incorrect dosage or duration of treatment– Drug-allergy interactions– Clinical abuse/misuse

• Possibility of loss of Medicaid reimbursements used to enforce rules



Also requires pharmacist to offer to review and discuss with the patient

– name and description of medication– dosage form– dose– route of administration– duration of drug therapy– action to take after a missed dose– common severe side effects or adverse effects



Also requires pharmacist to offer to review and discuss with the patient —continued

– interactions and therapeutic contraindications, ways to prevent the same, and actions to be taken if they occur

– methods for self-monitoring of the drug therapy– prescription refill information– proper storage of the drug– special directions and precautions for

preparation, administration, and use by the patient


Dietary Supplement Health and Education Act of 1994

• FDA has limited oversight in diet supplement market.

• Manufacturers are not required to prove– Safety– Effectiveness– Standardization


Dietary Supplement Health and Education Act of 1994

• Act provided definitions and guidelines on diet supplements.

• FDA may only review “false claims” advertisements and monitor safety.

• FDA may remove unsafe supplements, but burden is on FDA to prove that the product is unsafe.


Health Insurance Portability and Accountability Act of 1996

• HIPAA has wide-ranging provisions.• For pharmacies, impact is mostly on

confidentiality of patient records:– Must document and provide to patient

information on how health information is safeguarded

– Must have an employee training program with yearly renewals


Food and Drug Administration Modernization Act

• Passed to update labeling on prescription medications

• Authorizes new drug application (NDA) fees which are used by FDA to accelerate review of new drugs


Medicare Prescription Drug, Improvement, and Modernization

Act of 2003• Better known as Medicare Part D• Provides prescription drug coverage to

patients eligible for Medicare– Voluntary program– Patients pay an extra premium– Usually have a deductible

• Also established health/savings accounts (HSAs)


Combat Methamphetamine Epidemic Act of 2005

• Methamphetamine– Highly addictive stimulant– Made from OTC products

• Restricts the availability of products used to make it:– Pseudoephedrine– Ephedrine

• Products must be stored “behind the counter” and purchases must be documented.


National Oversight Agencies

• Food and Drug Administration (FDA)• Drug Enforcement Administration (DEA)• Occupational Safety and Health

Administration (OSHA)• National Association of Boards of

Pharmacy (NABP)• State boards of pharmacy


Food and Drug Administration (FDA)

• Under Department of Health and Human Services (HHS)

• FDA’s Center for Drug Evaluation and Research (CDER) impacts pharmacy:– New drug development and review– Generic drug review– Over-the-counter drug review– Post-drug approval activities



• Primary responsibility and authority to enforce the law

• Has no legal authority over the practice of pharmacy in each state

• FDA activities– Requires manufacturers to file applications for

investigative studies and drug approvals– Provides guidelines for packaging and

advertisement– Oversees the recall of dangerous products– Produces annual Orange Book reference

Safety Note



The FDA regulates OTC labeling so it is understandable to a layperson.


Terms to Remember

Drug Enforcement Administration (DEA)

the branch of the US Justice Department that is responsible for regulating the sale and use of drugs with abuse potential



• Most of its effort spent on illegal drug trafficking, but also supervises legal use of controlled substances

• Inspects medical facilities and pharmacies; usually just those where suspicious activity has been detected

• Maintains an audit trail of narcotics from manufacturer to warehouse to pharmacy to patient



DEA registration is required for all individuals, institutions, and businesses involved in controlled substances, including

– Manufacturing– Distributing– Dispensing– Researching– Instructional activities– Detoxification programs– Importing / exporting– Compounding



• CSA defines who may prescribe controlled substances.

• Prescriptions must be written for a legitimate reason related to the physician’s practice (e.g., dentist can prescribe narcotics for dental pain but not for back pain).

• Except for emergencies, prescription must be written rather than phoned or faxed.


Occupational Safety and Health Administration (OSHA)• Ensures the safety and health of US

workers• OSHA’s role in pharmacies, hospitals,

and home health care is to– Protect against inadvertent needle sticks– Ensure safe disposal of syringes– Oversee policies to protect employees

from unnecessary drug exposures


Terms to Remember

National Association of Boards of Pharmacy (NABP)

an organization that represents the practice of pharmacy in each state and develops pharmacist licensure exams

reciprocation the administrative process for relicensure of pharmacists in another state


National Association of Boards of Pharmacy (NABP)

• Has no regulatory authority• Primary role is to develop national

pharmacist license examination• Coordinates reciprocation of

pharmacists practicing in other states• Provides guidance to state boards of

pharmacy• Developed Model State Pharmacy

Practices Act for national continuity


State Boards of Pharmacy

• Consist of leaders from the pharmacy community and also consumer members

• Review applications and administer examinations developed by NABP

• Maintain a database of active pharmacists

• Inspect all new pharmacies• Provide regulations regarding refilling of

prescriptions


Legal Dutiesof Pharmacy Personnel

• Role of the pharmacy tech– Not defined by federal statute– Not uniformly defined from state to state– Constantly changing

• Some states limit the ratio of pharmacy techs to pharmacists.


Legal Dutiesof Pharmacy Personnel

• Duties not required to be done by pharmacists may be carried out by the pharmacy technician.

• All technicians’ duties must be carried out under the direct supervision of the pharmacist.


Duties Typically Performed by Pharmacists

Dispensing, recordkeeping, and pricing– receiving a verbal, or oral, prescription in person or

by telephone– preparing the written form of the verbal prescription

from a doctor’s office or another pharmacy– interpreting and evaluating prescriptions– reviewing patient profile (e.g., medication history,

duplication of medications, allergies, drug interactions)

– verifying and certifying records– transferring prescriptions to other pharmacies

(See Table 2.5)



• Preparing Doses of Precompounded Medications– checking/verifying finished prescriptions

• Preparing Doses of Extemporaneously Compounded, Nonsterile Medications– checking and verifying that drugs were selected

properly– calculating weights and measures– verifying that weighing and measuring were done

properly– verifying finished product

(See Table 2.5)



Transporting Medications to and from floors/units in a hospital (especially controlled substances)

– checking and verifying delivery records– examining returned medications for

integrity and reusability– emptying returned medications into

stock containers

(See Table 2.5)



• Replenishing floor stocks (especially controlled substances)– checking and verifying– replenishing stocks– certifying and checking drug stations– disposing of unused items and discontinued

medications

• Verifying finished product against original order or prescription

(See Table 2.5)


Duties Typically Performed by Pharmacy Technicians

Dispensing, recordkeeping, and pricing

– receiving written prescriptions and conveying them to the pharmacist

– answering and properly directing telephone calls

– preparing records, including patient profiles and billing records

(See Table 2.6)

Safety Note


Some states allow certified pharmacy technicians to accept prescriptions over the telephone.



Preparing Doses of Precompounded Medications

– retrieving medications from shelf or supply cabinet

– selecting containers– preparing labels– counting or pouring medications– reconstituting prefabricated medications– pricing prescriptions

(See Table 2.6)



Preparing Doses of Extemporaneously Compounded, Nonsterile Medications

– retrieving medications from shelf or supply cabinet– selecting equipment for the compounding operation– weighing and measuring– compounding– preparing labels– selecting containers– packaging– maintaining and filing records of extemporaneous

compounding– cleaning area and equipment

(See Table 2.6)



Transporting Medications to and from floors/units– preparing cart, tray, or other means of

conveyance– delivering controlled drugs– maintaining delivery records– distributing medications to wards– organizing medications for administration to

patients– retrieving, reconciling, and recording credit for

medications not administered– returning unused medications to unit dose bins

and injectables to stock

(See Table 2.6)

Safety Note



Some states allow a “tech check tech” system in which one technician is allowed to check another technician’s work preparing unit dose carts.



Replenishing Floor Stocks– Checking for expiration dates– Removing overstocks

(See Table 2.6)


Terms to Remember

United States Pharmacopeia (USP) the independent scientific organization responsible for setting official quality standards for all drugs sold in the United States as well as standards for practice


Terms to Remember

United States Pharmacopeia–National Formulary (USP–NF)

a book that contains US standards for medicines, dosage forms, drug substances, excipients or inactive substances, medical devices, and dietary supplements


United States Pharmacopeia

• Publishes United States Pharmacopeia–National Formulary (USP–NF)

• Contains standards for– Medicines– Dosage forms– Drug substances,

excipients, inactive substances

– Medical devices– Dietary substances

• Rose out of the FDC Act of 1938• Recognized by FDA and accrediting agencies

© paradigm publishing, inc. 1 chapter 2 pharmacy law, regulations, and standards

Documents

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