Pharmaceutical Industry Overview
Expert-defined terms from the Certificate in Pharmacy Benefit Management course at London School of Planning and Management. Free to read, free to share, paired with a professional course.
Abridged New Drug Application ( ANDA ) refers to an application for a gener… #
The ANDA process allows generic manufacturers to demonstrate bioequivalence to the reference listed drug, rather than conducting their own clinical trials. Related terms include generic drug, bioequivalence, and reference listed drug.
Adverse Event ( AE ) is any untoward medical occurrence in a patient admini… #
The AE can be related to the dose or the method of administration, and it is a critical aspect of pharmacovigilance activities. Related terms include serious adverse event, adverse drug reaction, and medication error.
Adverse Drug Reaction ( ADR ) is a response to a drug that is noxious and u… #
The ADR is related to the pharmacological properties of the drug, and it is a critical aspect of drug safety. Related terms include adverse event, side effect, and toxicity.
Bioavailability ( BA ) refers to the extent to which a drug or other substa… #
The BA can be affected by various factors, including the formulation of the drug, the route of administration, and the dosage form. Related terms include bioequivalence, pharmacokinetics, and pharmacodynamics.
Bioequivalence ( BE ) refers to the absence of a significant difference in… #
The BE is a critical aspect of generic drug approval, as it allows generic manufacturers to demonstrate that their product is equivalent to the reference listed drug. Related terms include bioavailability, pharmacokinetics, and pharmacodynamics.
Certified Pharmacy Technician ( CPhT ) is a technician who has passed a cer… #
The CPhT has demonstrated the knowledge and skills necessary to assist pharmacists with dispensing medication and other tasks. Related terms include pharmacy technician, certification, and licensure.
Clinical Trial ( CT ) is a research study in human volunteers to answer spe… #
The CT is designed to evaluate the safety and efficacy of a new drug or treatment, and it is typically conducted in phases. Related terms include investigational new drug, new drug application, and informed consent.
Contract Research Organization ( CRO ) is an organization that provides res… #
The CRO can provide a range of services, including clinical trial management, data management, and regulatory affairs. Related terms include contract research, pharmaceutical industry, and research and development.
Current Good Manufacturing Practice ( cGMP ) refers to the FDA's regulation… #
The cGMP is a critical aspect of drug manufacturing, as it helps to prevent contamination and adulteration. Related terms include good manufacturing practice, quality control, and quality assurance.
Dataset ( DS ) refers to a collection of data that is used to suppor… #
The DS can include information on adverse events, patient demographics, and treatment outcomes. Related terms include data management, data analysis, and data visualization.
Drug Interaction ( DI ) occurs when a drug affects the action of ano… #
The DI can be pharmacokinetic or pharmacodynamic, and it can have significant clinical consequences. Related terms include drug-drug interaction, drug-food interaction, and drug-drug-disease interaction.
Drug Utilization Review ( DUR ) is a process used to evaluate the approp… #
The DUR can help to identify potential problems with drug use and intervene to improve patient outcomes. Related terms include drug therapy, pharmacotherapy, and medication therapy management.
Electronic Health Record ( EHR ) is a digital version of a patient's med… #
The EHR can include information on diagnoses, treatments, medications, and test results. Related terms include electronic medical record, health information technology, and health information exchange.
Formulary ( F ) is a list of drugs that are approved for use… #
The F can help to control costs and improve patient outcomes by promoting the use of effective and safe medications. Related terms include preferred drug list, formulary management, and pharmacy and therapeutics committee.
Generic Drug ( GD ) is a drug that is equivalent to a bran… #
The GD is typically less expensive than the brand name drug and can help to increase access to medications for patients. Related terms include brand name drug, biosimilar, and reference listed drug.
Health Insurance Portability and Accountability Act ( HIPAA ) is a federal… #
The HIPAA requires covered entities to implement administrative, technical, and physical safeguards to protect patient data. Related terms include protected health information, privacy rule, and security rule.
Investigational New Drug ( IND ) is a new drug that is being inve… #
The IND is submitted to the FDA before human testing can begin, and it must include information on the drug's chemistry, manufacturing, and preclinical testing. Related terms include new drug application, clinical trial, and informed consent.
Medication Error ( ME ) is any preventable event that may cause or l… #
The ME can occur at any stage of the medication use process, including prescribing, dispensing, and administration. Related terms include adverse drug event, near miss, and sentinel event.
Medication Therapy Management ( MTM ) is a patient #
centric and comprehensive approach to medication use, it is a critical aspect of pharmacy practice. The MTM involves reviewing a patient's medications to identify potential problems and intervene to improve patient outcomes. Related terms include medication use review, pharmacotherapy, and drug therapy.
New Drug Application ( NDA ) is an application submitted to the FDA for … #
The NDA must include information on the drug's chemistry, manufacturing, preclinical testing, and clinical trials. Related terms include investigational new drug, clinical trial, and labeling.
Off #
Label Use (OLU) occurs when a drug is used for a purpose or population that is not approved by the FDA, it is a critical aspect of pharmacotherapy. The OLU can be appropriate in certain circumstances, but it can also increase the risk of adverse events. Related terms include labeling, indications, and contraindications.
Over #
the-Counter (OTC) refers to a drug that can be purchased without a prescription, it is a critical aspect of self-care. The OTC is typically used to treat minor conditions, such as headaches or cold symptoms. Related terms include prescription drug, nonprescription drug, and self-medication.
Patient #
Centered Care (PCC) is an approach to healthcare that focuses on the needs and preferences of the patient, it is a critical aspect of patient safety. The PCC involves involving patients in decision-making and providing care that is respectful and responsive to their needs. Related terms include patient engagement, shared decision-making, and patient empowerment.
Pharmaceutical Benefit Manager ( PBM ) is a company that manages … #
The PBM can help to control costs and improve patient outcomes by managing formularies, negotiating prices with pharmaceutical companies, and monitoring drug use. Related terms include pharmacy benefit management, health plan, and employer.
Pharmacogenomics ( PGx ) is the study of how genetic variations affe… #
The PGx can help to identify patients who are more likely to respond to a particular drug or experience adverse events. Related terms include genomics, genetic testing, and precision medicine.
Pharmacokinetics ( PK ) is the study of how a drug is absorbed</i… #
The PK can help to predict how a drug will behave in the body and identify potential issues with dosage or drug interactions. Related terms include pharmacodynamics, bioavailability, and clearance.
Pharmacy ( P ) is a healthcare facility where medications are… #
The P can be retail, hospital, or clinic-based, and it is typically staffed by pharmacists and pharmacy technicians. Related terms include pharmacist, pharmacy technician, and medication therapy management.
Pharmacy Benefit Management ( PBM ) is the process of managing pr… #
Related terms include pharmaceutical benefit manager, health plan, and employer.
Pharmacy Technician ( PT ) is a healthcare professional who assis… #
The PT can help to free up pharmacists to focus on patient care activities, such as counseling and medication therapy management. Related terms include certified pharmacy technician, pharmacy, and pharmacist.
Precision Medicine ( PM ) is an approach to medicine that involve… #
The PM can help to improve patient outcomes by targeting specific genetic mutations or biological pathways. Related terms include genomics, genetic testing, and pharmacogenomics.
Preauthorization ( PA ) is the process of obtaining approval … #
The PA can help to ensure that medications are used appropriately and only when necessary. Related terms include prior authorization, step therapy, and quantity limits.
Prescription ( Rx ) is a written order from a licensed healthcare… #
The Rx can be electronic or paper-based, and it must include specific information about the medication, such as the name, dose, and instructions for use. Related terms include prescriber, medication order, and prescription label.
Quality Assurance ( QA ) is the process of ensuring that products… #
The QA involves testing and inspecting products to ensure that they meet specifications and regulatory requirements. Related terms include quality control, good manufacturing practice, and current good manufacturing practice.
Regulatory Affairs ( RA ) is the process of ensuring that product… #
The RA involves obtaining approvals from regulatory agencies, such as the FDA, and ensuring that products are labeled and marketed in compliance with regulations. Related terms include regulatory compliance, regulatory agency, and labeling.
Risk Evaluation and Mitigation Strategy ( REMS ) is a strategy that… #
The REMS involves implementing measures to minimize the risk of adverse events, such as education and training for healthcare providers and patients. Related terms include risk management, adverse event, and medication error.
Serious Adverse Event ( SAE ) is an adverse event that results</i… #
The SAE must be reported to the FDA and other regulatory agencies in a timely manner. Related terms include adverse event, adverse drug reaction, and medication error.
Therapeutic Equivalence ( TE ) refers to pharmaceutical equivalents … #
The TE can be demonstrated through bioequivalence studies or in vitro studies. Related terms include bioequivalence, pharmaceutical equivalent, and pharmaceutical alternative.
Value #
Based Care (VBC) is an approach to healthcare that focuses on improving patient outcomes while reducing costs, it is a critical aspect of healthcare reform. The VBC involves paying providers based on quality and value rather than volume of services provided. Related terms include accountable care organization, pay-for-performance, and bundled payment.
Wholesale Acquisition Cost ( WAC ) is the price at which a drug</… #
The WAC can be used as a benchmark for pricing and reimbursement purposes. Related terms include average wholesale price, manufacturer's suggested retail price, and pharmacy dispensing fee.
World Health Organization ( WHO ) is a global health organization th… #
The WHO provides guidance and support to countries on a range of health issues, including access to medicines, infectious diseases, and noncommunicable diseases. Related terms include global health security, international health regulation, and health systems strengthening.