PTCB Study Guide: Overview

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Brand Name Drugs and Generic Drugs

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The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective. 
 
Before a new drug is approved, the manufacturer must submit a New Drug Application (NDA) to the FDA. The NDA includes: 
<ol>
<li>Info about the drug</li>
<li>Results from human clinical trials </li>
<li>Results from animal clinical trials</li>
<li>How drugs acts in the body</li>
<li>How it is manufactured, processed and packaged</li>
</ol>
Most companies market new drugs with a trade or brand name. Lipitor is an example of a brand name for a drug that is produced and distributed by the manufacturer Pfizer. 
<ol>
<li>The generic name for Lipitor is atrovastatin</li>
<li>Pfizer developed atrovastatin</li>
<li>Pfizer submitted a NDA to the FDA</li>
<li>FDA approved atrovastatin</li>
<li>Pfizer is granted patents for an average of 11 years.</li>
<li>Once the patent expires other drugs companies may apply for approval of generic or copies of the drug.</li>
</ol>
Generic equivalents contain the same active ingredients and have the same dosage form, strength and formulations as their brand name counterparts. 
 
Generic drug companies must submit an Abbreviated New Drug application (ANDA). Generic manufactures must meet the same standards for: 
<ol>
<li>Manufacturing</li>
<li>Quality</li>
<li>Labeling</li>
<li>They do not need to repeat the original research.</li>
<li>Must show bioequivalence to the brand name drug.</li>
</ol>
Generic Drug Substitution 
Pharmacists are permitted to substitute the generic equivalent drug for the brand name unless the prescriber prohibits generic substitution. 
 
Generic substitution is regulated by state laws. These laws and regulations set requirements for when pharmacists may or may not substitute therapeutically equivalent generic drugs for brand name drugs. 
Indications of no substitution include: 
<ol>
<li>“Dispense as written”</li>
<li>“DAW”</li>
<li>“no substitution”</li>
<li>“do not substitute” </li>
<li>“DNS”</li>
</ol>
Pharmacists use the “Orange Book” to find the FDA’s decision on whether or not a generic drug is therapeutically equivalent to the brand name.

Brand Name Drugs and Generic Drugs

The FDA approves all drugs that are available for distribution in the U.S. to assure that they are safe and effective. Before a new drug...

1:09 PM

Controlled Substances

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Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, abuse, diversion, and addiction. 
 
The Federal law regulating controlled substances is the Controlled Substance Act. 
 
The Law and its regulations controls over the manufacture, import, export, distribution, ordering, dispensing and prescribing of controlled substances. 
Pharmacies must comply with both State and Federal controlled substance laws. 
 
Schedules of Controlled Substances 
The Federal Controlled Substance Law created five classifications for controlled substances numbering I, II, III, IV, and V. 
 
A drug is placed into a controlled Schedule based on certain criteria, such as it’s potential for abuse or addiction and its medical use. 
 
Schedule I is the most restrictive and Schedule V is the least restrictive of the controlled substances. 
 
Labeling Controlled Substances 
The symbol that indicates a controlled substance is the capital letter “C” with the appropriate roman numeral placed inside the “C” symbol. 
 
Dispensing Controlled Substances 
For a controlled substance prescription to be valid, it must be prescribed by a licensed prescriber for a legitimate medical purpose in the normal course of the prescriber’s professional practice. 
 
The prescribing practice must be registered with the DEA and be licensed to prescribe controlled substances by the state. Controlled substances prescription must contain: 
<ol>
<li>The date issued</li>
<li>The patients full name & address</li>
<li>The practitioners name, address & DEA registration number</li>
<li>The drug name</li>
<li>Strength</li>
<li>Dosage form </li>
<li>Quantity prescribed</li>
<li>Direction of use</li>
<li>Number of authorized refills</li>
<li>Signature of prescriber</li>
</ol>
Federal law allows Schedule III and IV prescriptions to be refilled up to five times within six months after the issuing date. 
 
Schedule V prescriptions may be refilled more than five times, but have a six-month the limit on refills. 
 
Schedule II prescriptions may not be refilled and are not transferable between pharmacies. 
Federal law allows schedule III, IV, and V prescriptions to be transferred from one pharmacy to another for refill (if the state permits). 
 
Pharmacies are required to maintain complete and accurate records for all controlled substances that they purchase , receive, distribute or dispense. 
 
Federal law requires that pharmacy to keep controlled substance records for two years and have them readily available for DEA inspection if requested. Examples of records include: 
<ol>
<li>Invoices</li>
<li>Receipts of purchases</li>
<li>Inventory of records</li>
<li>Records of transfer</li>
</ol>
State Prescription Monitoring Programs, require pharmacies to report information on controlled substance prescriptions dispensed for drugs in Schedules II, III, IV and V. (varies from state to state.) The programs help states identify potential diversion and abuse. Required information includes: 
<ol>
<li>Patient info</li>
<li>Prescriber info</li>
<li>Pharmacy ID</li>
<li>Prescription info</li>
</ol>

Controlled Substances

Controlled substances are subject to stricter controls through Federal and State laws and regulations due to their potential for misuse, a...

12:04 PM

Pharmacy Law

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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: 
<ol>
<li>Licensing pharmacies and pharmacists</li>
<li>Registering or Licensing technicians</li>
<li>Inspecting pharmacies</li>
<li>Issuing rules and regulations</li>
<li>Investigating complaints</li>
<li>Disciplinary actions</li>
</ol>
 
Information on the various state boards is available through the <a href="https://www.nabp.net/" target="_blank">National Association of Boards of Pharmacy (NABP) </a> 
 
Pharmacy Licensure 
Every state requires pharmacies to have a valid current license or permit in order to operate the facility. Requirements include: 
<ol>
<li>Record keeping</li>
<li>Security</li>
<li>A pharmacists in charge</li>
<li>A Licensed pharmacists on duty during operational hours</li>
</ol>
The categories for pharmacy licenses include: 
<ol>
<li>Retail</li>
<li>Community</li>
<li>Institutional</li>
<li>Hospital</li>
<li>Nuclear</li>
<li>Mail-order</li>
<li>Long-term</li>
<li>Sterile compounding</li>
<li>nonresident</li>
</ol>
 
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: 
<ol>
<li>Registration or license</li>
<li>Permitted tasks</li>
<li>Prohibited conduct</li>
<li>Qualifications for registration or license include:</li>
<li>Minimum age</li>
<li>High school diploma or equivalent</li>
<li>Completion of a training program</li>
<li>An examination </li>
</ol>
 
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.

Pharmacy Law

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

12:40 PM

Pharmacy Practice Settings

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The profession of pharmacy is practiced in many environments, which are commonly divided into ambulatory care and institutional settings. 
 
<ul>
</ul>
<ol>
<li>Ambulatory Care, or outpatient, settings serve patients living in their own homes or similar situations and include community clinics, home care and mail order.</li>
<li>
Institutional or inpatient settings are those in which patients reside in a facility where they receive long or short-term care from health professionals.  </li>
</ol>
<ul>
</ul>
 
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: 
<ul>
</ul>
<ol>
<li>Enter physician med orders into the computer</li>
<li>Prepare IV drug admixtures</li>
<li>Repackage and label unit dose medications</li>
<li>Restock automated dispensing units</li>
<li>Deliver medications</li>
<li>General paper work  </li>
</ol>
<ul>
</ul>
 
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: 
<ul>
</ul>
<ol>
<li>Personal care</li>
<li>Hospice & Respite Care</li>
<li>Shopping assistance</li>
<li>Drug and infusion therapy</li>
<li>Speech, physical and occupational therapy</li>
<li>Technician duties in a home care setting may include</li>
<li>Preparing sterile injectable products </li>
<li>Maintaining computerized patient profiles</li>
<li>Delivering medications and supplies to a patient’s home.</li>
</ol>
<ul>
</ul>
 
Long-Term Care 
Long-term care facilities are those institutions where patients stay for extended periods. They include: 
<ul>
</ul>
<ol>
<li>Nursing Homes</li>
<li>Psychiatric or behavioral health institutions </li>
<li>Intermediate care facilities for mentally disabled patients</li>
<li>Skilled nursing facilities </li>
</ol>
<ul>
</ul>
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: 
<ul>
</ul>
<ol>
<li>Inventory purchasing and management</li>
<li>

Sterile product preparations</li>
<li>Surgical Pharmacy</li>
<li>Nuclear Pharmacy</li>
<li>Veterinary Pharmacy</li>
<li>Non-sterile (extemporaneous) compounding  </li>
</ol>
<ul>
</ul>

Pharmacy Practice Settings

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

11:25 AM

Pharmacy Technician Certification

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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: 
<ol>
<li>i. Assisting the pharmacist in serving patients, including activities related to dispensing prescriptions, distributing medications, and collecting and organizing information.</li>
<li>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.</li>
<li>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.</li>
</ol>
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. <a href="http://ptcb.org/" target="_blank">Refer to the PTCB Website to verify current eligibility requirements and test specifics.</a>

Pharmacy Technician Certification

Some states require registration of pharmacy technicians, whereas other states require certification; still others are considering the mat...

5:47 PM