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PHR 4511H MIDTERM 2 VOCAB ONLY
Terms in this set (43)
the process through which new drug molecules are identified or synthesized which generate a desired action on an identified drug target in the body
the process through which a new drug candidate is "optimized," formulated, and tested for use in humans
that part of a drug molecule which produces the desired effect
the process of developing a dosage form for use in clinical practice
in life; tested on whole, living organisms
institutional review board
must review and approve all research involving human beings. IRBs help ensure that the risk‐to‐benefit ratio for patient involvement in research is reasonable, that patients are fully informed of all parameters of the study being conducted, that patient involvement is voluntary (with signed informed consent), and that the patients may voluntarily withdraw from the study at any time without penalty
informed and voluntary agreement for treatment made by a competent patient or research subject
an inert material designed to look exactly like an actual drug product. A "placebo effect" is an improvement in a patient's condition which cannot be attributed to medication or treatment with active ingredients being provided
randomized controlled trials
used to evaluate the efficacy of a new drug candidate against a placebo or other medications. Randomized controlled trials: These trials are typically "blinded" so that neither the patient nor treating investigator is aware of what the patient is receiving
To corrupt, debase, or make impure by the addition of a foreign or inferior substance or element; especially: to prepare for sale by replacing more valuable with less valuable or inert ingredients
all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such article. The term 'accompanying' is interpreted liberally to mean more than physical association with the product. It extends to posters, tags, pamphlets, circulars, booklets, brochures, instructions, websites, etc.
"The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any drug‐related problem" (WHO). An ongoing process that begins in clinical trials and continues throughout a product life cycle.
A reporting system for serious adverse events, product quality problems, product use errors, or therapeutic inequivalence/failures suspected to be associated with the use of an FDA‐regulated drug, biologic, medical device, dietary supplement or cosmetic. Consumers or heath professionals can submit MedWatch reports to the FDA.
a drug which bears this "legend" - "Caution: Federal law prohibits dispensing without a prescription."
FDA's authority under the Food and Drug Administration Amendments Act of 2007 to require a Risk Evaluation and Mitigation Strategy from manufacturers to ensure that the benefits of a drug or biological product outweigh its risks. REMS may include special training requirements or restrictions on prescribers/dispensers, as well as special patient guidelines/monitoring/registration.
Risk Evaluation and Mitigation Strategies can include:
‐ Special provider training
‐ Special certification/restrictions on dispensers
‐ Special guidelines/monitoring of patients (e.g., laboratory tests)
‐ Patient registries
Omnibus Budget Reconciliation Act of 1990 is a requirement for pharmacists to screen prescriptions, maintain patient profiles and documentation, and offer to counsel Medicaid patients receiving new prescriptions. The "offer to counsel" subsequently became a standard of practice for all patients.
a patient's pharmaceutical record relating to the medications they are currently taking, previous therapies, drug allergies, medical history, and other information relating to the patient.
Federal privacy protections for individually identifiable health information.
• Affects health plans, healthcare providers, billing services
• Privacy policies/procedures, privacy personnel
• Training and management
• Civil and criminal penalties
Procedures followed to prevent the contamination of a sterile product.
North American Pharmacist Licensure Examination - administered by the National Association of Boards of Pharmacy (NABP) - "measures a candidate's knowledge of the practice of pharmacy. It is just one component of the licensure process and is used by the boards of pharmacy as part of their assessment of a candidate's competence to practice as a pharmacist."
Multistate Pharmacy Jurisprudence Examination - administered by the National Association of Boards of Pharmacy (NABP) - "combines federal‐ and state‐specific questions to test the pharmacy jurisprudence knowledge of prospective pharmacists. It serves as the pharmacy law examination in participating jurisdictions."
the transfer of a pharmacist's license from one state to another, with procedures varying between states.
pharmacist conscience clause
The right to refuse to provide pharmaceutical services based on moral objections.
National Association of Boards of Pharmacy
The Ohio Automated Rx Reporting System (OARRS) is a tool to track the dispensing and personal furnishing of controlled prescription drugs to patients. OARRS is designed to monitor this information for suspected abuse or diversion (i.e., channeling drugs into illegal use), and can give a prescriber or pharmacist critical information regarding a patient's controlled substance prescription history. This information can help prescribers and pharmacists identify high-risk patients who would benefit from early interventions.
Transition of care
The movement of patients between various health care settings. The movement of a patient from one setting
of care (hospital, ambulatory primary care practice, ambulatory specialty care practice, long‐term care, home health, rehabilitation facility) to another
Medication reconciliation is the process of comparing a patient's medication orders to all of the medications that the patient has been taking. This reconciliation is done to avoid medication errors such as omissions, duplications, dosing errors, or drug interactions
-Up to 67% of patients' medication histories have one or more errors
-Up to 46% of medication errors occur when new orders are written at patient admission or
-Medication reconciliation is a process designed to prevent medication errors at patient
A group of diverse medical and health care systems, practices, and products that are not presently considered to be part of conventional medicine. Complimentary medicine is used together with conventional medicine, and alternative medicine is used in place of conventional medicine.
The use of multiple medications; often implying excessive use of medications resulting in adverse drug events.
medication safety zone
USP defines a medication safety zone as any critical area where medications are prescribed, transcribed, prepared, or administered. Chapter <1066> describes the optimal physical environment and procedures needed to promote accurate medication use. Standards are provided for illumination, interruptions and distractions, sound and noise, physical design and organization.
adverse drug event
injuries resulting from drug-related medical interventions. ADEs can occur in any health care setting, including:
-Inpatient, such as acute care hospitals
-Long-term care settings, such as nursing homes
Recognition of specific health professionals as patient care providers in the U.S. Social Security Act, which is required for reimbursement under Medicare.
The individualization of a patient's therapy based on his or her unique characteristics using genetic and other available information.  An emerging practice that uses an individual's genetic profile to guide decisions made in regard to the prevention, diagnosis, and treatment of disease. Knowledge of a patient's genetic profile is used to select the proper medication therapy and administer it using the optimal dose or regimen. Personalized medicine is being advanced through data from the Human Genome Project.
patient-centered medical home
The medical home, also known as the patient-centered medical home (PCMH), is a team-based health care delivery model led by a health care provider that is intended to provide comprehensive and continuous medical care to patients with the goal of obtaining maximized health outcomes. The provision of medical homes is intended to allow better access to health care, increase satisfaction with care, and improve health. The medical home is best described as a model or philosophy of primary care that is patient-centered, comprehensive, team-based, coordinated, accessible, and focused on quality and safety. It has become a widely accepted model for how primary care should be organized and delivered throughout the health care system, and is a philosophy of health care delivery that encourages providers and care teams to meet patients where they are, from the most simple to the most complex conditions. It is a place where patients are treated with respect, dignity, and compassion, and enable strong and trusting relationships with providers and staff. Above all, the medical home is not a final destination instead, it is a model for achieving primary care excellence so that care is received in the right place, at the right time, and in the manner that best suits a patient's needs.
accountable care organization
Accountable Care Organizations (ACOs) are groups of doctors, hospitals, and other health care providers, who come together voluntarily to give coordinated high quality care to the Medicare patients they serve. Coordinated care helps ensure that patients, especially the chronically ill, get the right care at the right time, with the goal of avoiding unnecessary duplication of services and preventing medical errors. When an ACO succeeds in both delivering high-quality care and spending health care dollars more wisely, it will share in the savings it achieves for the Medicare program.
The use of telecommunication and information technologies to provide comprehensive pharmacy services at a distance.
The use of mobile devices and global networks to deliver health services and information primary care provider A physician (M.D. - Medical Doctor or D.O. - Doctor of Osteopathic Medicine), nurse practitioner, clinical nurse specialist or physician assistant, as allowed under state law, who provides, coordinates or helps a patient access a range of health care services.
Permission or authorization granted by a hospital or other healthcare institution to a health professional to render specific diagnostic, procedural, or therapeutic services.
A credential is documented evidence of professional qualifications. Academic degrees, state licensure, residency certificates, training certificates, statements of CE credit, board certifications are examples.
chronic health condition
A disease that persists for a long time. A chronic disease is one lasting 3 months or more, by the definition of the U.S. National Center for Health Statistics. Chronic diseases generally cannot be prevented by vaccines or cured by medication, nor do they just disappear. Eighty-eight percent of Americans over 65 years of age have at least one chronic health condition (as of 1998). Health damaging behaviors - particularly tobacco use, lack of physical activity, and poor eating habits - are major contributors to the leading chronic diseases.
Supports active involvement of patients and their families in the design of new care models and in decision-making about individual options for treatment. The IOM (Institute of Medicine) defines patient-centered care as: "Providing care that is respectful of and responsive to individual patient preferences, needs, and values, and ensuring that patient values guide all clinical decisions."
pay for performance
Financial incentives to clinicians for better health outcomes. Clinical outcomes, such as longer survival, are too difficult to measure, so pay for performance systems usually measure process outcomes, such as measuring blood pressure, lowering blood pressure, or counseling patients to stop smoking. Also known as "P4P" or "value-based purchasing," this payment model rewards physicians, hospitals, medical groups, and other healthcare providers for meeting certain performance measures for quality and efficiency. It penalizes caregivers for poor outcomes, medical errors, or increased costs.
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