01.B Glossary

• Adverse Drug Reaction -


  A response to a

  medicinal product which is noxious and

  unintended and which occurs at doses

  normally used in man.
• Adverse Event -

  Any untoward medical

  occurrence in a patient or clinical

  investigation subject administered with the

  pharmaceutical product that does not

  necessarily have causal relationship with the

  treatment for which the product is used.
• Competency Standard -

  Describes a specific

  function to be carried out by a pharmacist

  who is deemed professionally qualified.
• Competency Standard


  Describes a specific

  function to be carried out by a pharmacist

  who is deemed professionally qualified.
• Continuing Professional Development - 


  The responsibility of individual pharmacists for

  systematic maintenance, development and

  broadening of knowledge, skills and attitudes,

  to ensure continuing competence as a

  professional, throughout their careers.
• Distribution -


  The division and movement of

  pharmaceutical products from the premises

  of the manufacturer of such products, or

  another central point, to the end user thereof,

  or to an intermediate point by means of

  various transport methods,
• Dossier - 


  A compilation of documents which

  contains administrative, quality, non-clinical

  and clinical data on a particular product to be

  submitted to regulatory authorities for

  evaluation and approval.
• Element - 


  Lists actions and processes that

  are expected to be performed in

  demonstrating a specific competency.
• Evidence - 


  Consists of outputs, outcomes,

  and/or examples relevant in achieving the

  competency.
• Entrepreneurship -

  Ability to create and

  grow a new enterprise as a result of risk

  taking and innovation.
• Good Compounding Practice - 


  A set of

  guidelines for the preparation of compounded

  formulations for dispensing and/or

  administration to humans or animals.
• Good Distribution Practice - 


  Part of quality

  assurance which ensures that the quality of a pharmaceutical product is maintained through ad.
• Good Storage Practice - 


  Part of quality

  assurance which ensures that the quality of a

  pharmaceutical product is maintained

  through adequate control throughout the

  storage thereof.
• Health Promotion - 


  Process of enabling

  people to increase control over, and to

  improve, their health through the use of

  various individual-based, social and

  environmental interventions.
• Health Vigilance - 


  Process of monitoring,

  assessing or evaluating and improving the

  safety of any food, food supplement, drug,

  cosmetic, medical device and other health

  products carried out by companies on their

  products and by government agencies on all

  related products.
• Institutional Pharmacy - 


  A drug

  establishment procuring drugs to be

  dispensed whether at a cost or as part of

  benefits to their employees and/or their

  dependents.
• Interprofessional Collaboration - 


  Process of

  developing and maintaining collaborative

  teamwork with other healthcare practitioners

  or institutions by contributing expertise and

  skills within the prescribed scope of practice

  to optimize client/patient health outcomes.
• Learning Space - 


  The physical environment

  dedicated to facilitate student learning and

  development.
• Merchandising Plan -


  A systematic approach

  aimed at maximizing return on investment

  through planning sales and inventory to

  increase profitability.
• Performance Criteria - 


  Are evaluative

  statements that specify the activities or tasks

  needed to be accomplished in order to carry

  out specific processes.
• Personnel - 


  People employed or engaged as

  part of the pharmacy workforce.
• Pharmacy Services - 


  Service or group of

  services rendered to the sale of a

  pharmaceutical product from a drug retailer;

  provision of pharmaceutical care by a member

  of the pharmacy workforce as an inseparable

  part of providing healthcare.
• Pharmacy Compounding - 


  A practice in

  which a licensed pharmacist combines, mixes

  or alters ingredients in response to a prescription to create a medication tailored to the medical needs of an individual patient.
• Planogram - 


  A visual representation, diagram

  or model that indicates the placement of retail

  products on shelves in order to maximize

  sales.
• Post-Marketing Surveillance - 


  The close

  observation of drug effects, whether adverse

  or beneficial, following the marketing of a drug

  product; continued monitoring of safety after

  a pharmaceutical product or medical device

  has been placed on the market.
• Product Life Cycle - 


  All phases in the life of

  the product from the initial development

  through marketing until the product’s

  discontinuation;
• Professional Partners - 


  Other members of

  the healthcare team, which may be composed

  of, but not limited to physicians, nurses,

  physical therapist, and social worker.
• Public Health Pharmacy - 


  The practice of

  pharmacy involving the provision of services

  in relation to policy development, practice and

  professional regulation, and delivery of

  medicines-based interventions for large

  groups of people or community.
• Qualification - 


  Set of credentials and

  competencies indicative of one’s ability to

  perform specific roles and functions.
• Quality Assurance - 


  Covers all matters that

  individually or collectively influence the

  quality of a product; the sum total of the

  organized arrangements made with the

  objective of ensuring that medicinal and other

  health products are of the quality required for

  their intended use.
• Quality Audit - 


  An examination and

  assessment of all or part of a quality system

  with the specific purpose of improving it.
• Quality Management - 


  Aspect of

  management function that determines and

  implements the quality policy as formally

  expressed and authorized by management.
• Quality Risk Management


  A systematic

  process, applied both proactively and retrospectively, for the assessment, control, communication and review of risks to the

  quality of the medicinal and other health

  products.
• Quality System - 


  Sum of all that is necessary

  to implement an organization’s quality policy

  and meet quality objectives; includes

  organization structure, responsibilities,

  procedures, systems, processes and

  resources.
• Regulatory Pharmacy - 


  The practice of

  pharmacy that ensures compliance of

  products (e.g., medicines, cosmetics, devices)

  with administrative, scientific, legal and

  ethical standards.
• Standard Operating Procedure -

  An authorized, written procedure giving

  instructions for performing operations.
• Therapeutic Alliance - 


  Relationship between

  the healthcare professional and client/patient

  resulting to agreement regarding the goals

  and methods of therapy.
• Validation - 


  Set of activities aimed at proving,

  in accordance with the principles of Good

  Manufacturing Practice, that any procedure,

  process, equipment, material, activity or

  system actually leads to the expected results.