Pharma

• Are rules set to assure consumers that they get what they pay for.

  ● Law says, All preparations called by the same drug name must be of uniform strength, quality, and purity.

  Drug standards
• Drugs that are not registered or unknown to formulary

  ● Does not undergo regulation

  Counterfeit / Illicit drugs
• FDA responsibilities

  A.Inspecting plants where food, drugs, or cosmetics are made.

  B. Reviewing new drug applications and petitions for food

  additives.

  C. Investigating and removing unsafe drugs from the market.

  D. Assuring proper labeling of foods, cosmetics, and drugs.
• DEA responsibilities

  Concerned with controlled substances only.

  Enforces laws against drug activities, including illegal drug

  use, dealing, and manufacturing.

  • Monitors need for changing the schedules of abused drugs.
• The agency is responsible for licensing, monitoring, and regulation of cosmetics, drugs, foods, household hazardous products, medical devices and electromagnetic radiation emitting devices, pesticides, tobacco and related products, and vaccines for safety, efficacy, and quality in the Republic of the Philippines.

  Food and drug administration
• Modernized Pharmacy Law

  ➢ An Act Regulating and Modernizing the Practice of

  Pharmacy in the Philippines, Repealing for the Purpose Republic Act Numbered Five Thousand Nine Hundred Twenty-One (R.A. No. 5921), otherwise Known as the Pharmacy Law.


  Republic act no. 10918
• An Act to Ensure the Safety and Purity of Foods,

  Drugs, and Cosmetics being made Available to the Public by Creating the Food and Drug

  Administration which shall Administer and Enforce the Laws Pertaining thereto.

  RA no. 3720
• They enforce the law.

  ➢ The implementing arm of the Dangerous Drugs Board

  (DDB),

  Philippine Drug enforcement Agency
• An Act Instituting the Comprehensive Dangerous Drugs Act of 2002, Repealing Republic Act No. 6425, otherwise known as the Dangerous Drugs

  RA no. 9165
• FDA, PDEA, DDB - regulate the substances that are present or used in our country

  ● Drugs, foods, and cosmetics, etc., used for medical purposes are regulated by the FDA.

  ● Illicit and controlled substances are regulated by DDB, with the help of PDEA as its implementing arm.

  ● DDB is giving licenses to physicians to prescribe dangerous drugs potential for addiction but there’s medical use.
• The study of substances that interact with living systems through chemical processes.

  The study of drugs or medication action.

  Pharmacology
• A.K.A. Medical Pharmacology

  The science of substances used to prevent, diagnose, and

  treat disease.

  Pharmacotherapeutics
• The branch of pharmacology that deals with the undesirable effects of chemicals on living systems, from individual cells to humans to complex ecosystems.

  The study of poisons (its nature, effects, and detection)

  Toxicology
• Refer to pharmaceutical products that pertain to chemical compounds or biological substances, other than food, intended for use in the treatment, prevention, or diagnosis of disease in humans or animals. (see Pharmacy Law, R.A. 10918)

  Drugs
• All drugs are poisonous on a certain dose.
• • Common or General Name assigned to a drug usually based on the chemical name
  • A.K.A. Non-proprietary name
  • Example: ibuprofen, cetirizine, amoxicillin
  • Derived from its chemical name
  • Usually related to Official Name
  • Drug name that appears on the official reference (i.e. USP-NF)

  Generic Name
• United States Pharmacopeia and National Formulary

  • USP-NF monographs contain specifications (tests, procedures, and acceptance criteria) that help ensure the strength, quality, and purity of named items.
  • Drugs available in the Philippines generally follow USP-NF.
  • Usually the official name found in the USP-NF is also the generic name of the drug.

  NOTE/S: Not all the time the generic name and official name are the same


  Role of USP-NF Monograph
• • A.K.A. Brand Name or Proprietary Name
  • The name which pharmaceutical companies adapt to their particular drug product.
  • Copyrighted by and exclusive to the company.
  • Usually have the ® (Registered) or TM (Trade Mark) symbol on drug labels.
  • Example: Advil®, Virlix®, HimoxTM

  Trade name
• EXAMPLE:

  • Generic Name:
  • Montelukast
  • Font size is usually larger
  • Brand Name:
  • Kastaki®
  • Company
  • Unilab
  • Note: The Generic name can be used by other companies but the Brand name is specific to the company that has the rights to the name.

  Trade Name
• EXAMPLE:

  • Generic Name:
  • Metformin
  • Brand Name:
  • Company:
  • Ritemed
  • Note: This product has no brand name but instead are marketed through the company’s name.

  Trade Name
• EXAMPLE:

  • Generic Name:
  • Phenyleprine
  • Chlorpheneramine
  • Paracetamol
  • Brand Name:
  • Neozep Forte

  Company:

  • unilab

  Note: There are cases of Combination Drug products. Where there are

  or more geUnilabname

  Trade Name
• • The exact molecular formula of the drug.
  • Usually, a very long name and difficult to pronounce.
  • Example:
  • Generic name: Paracetamol
  • Brand name: Tempra
  • Chemical Name:
  • N-acetyl-para-N-acetyl-para-aminophenol (APAP)
  • Chemical formula: C8H9NO2

  Chemical name
• Brand name vs Generic Drugs

  Active ingredient: No difference

  Price: Higher (BN) - Lower (GN)

  Insurance coverage: Covered if no Generic form exists (BN) - Normally always covered (GN)

  Inactive ingredients: Tested and Approved by the FDA (BN) - May differ but acceptable (GN)

  Strength/Dosage: No Difference

  Appearance/Look: Drugs are standard (BN) - Packaging and drug look different (GN)
• Drug Classification

  Chemical group –> Mechanism of action —> Primary effect
• Drugs that are classified based on the chemical structure

  Example:

  • ß-lactam antibiotic
  • Steroid
  • Penicillin
  • Cefalexin

  Chemical Group
• Drug classes that share a common molecular mechanism of action by modulating the activity of a specific biological target.

  • For receptors, these activities include agonist, antagonist, inverse agonist, or modulator.
  • Enzyme target mechanisms include activator or inhibitor.
  • Ion channel modulators include opener or blocker.

  Example:

  • Dopamine antagonist
  • ACE inhibitor


  Mechanism of action / Site of action
• MODE OF ACTION

  • drug classes that is categorized by the anatomical or functional change the drugs induced.

  Example:

  • Diuretic or Antidiuretic
  • Decongestant

  Primary Effect
• THERAPEUTIC EFFECT

  • Drug classes that are categorized by the pathology the drugs treat.

  Example:

  • Analgesics
  • Antibiotic
  • Anticoagulant
  • Antidepressant

  Primary Effect
• Related Drug Terminologies

  Legal Terms —> Drug action
• OTC Drugs

  • Over-the-counter drugs; no purchasing restrictions by the FDA.
  • Products with no Rx on the packaging, can be dispensed w/o prescription. Pharmacy counseling is recommended.


  Legal terms
• • A.K.A. Legend drugs; determined unsafe for OTC purchase due to possible adverse effects if taken without physician’s advice.
  • Products that bear the Rx Symbol in their packaging require prescription.


  Prescription Drugs
• • Drugs controlled by a special prescription requirement because of the danger of addiction or abuse. These drugs are classified through schedule numbers C-I to C-V
  • Has a distinct symbol on its label (shown on photo). It requires a special prescription from a physician with a valid S-2 license issued by PDEA.

  Controlled Substances

  
• • These are terms you usually find when searching about drug information (i.e. Textbook, PPD, MIMS, Drug leaflets)
  • It is easier to find specific information once you understand what is listed under each heading.

  Drug Action
• Contains the list of medical conditions or disease for which the drug is meant to be used.

  Drug Action: Indications
• Drug Action Terms

  Indication, Actions, Contraindications, Cautions, Side effects or Adverse drug reactions (ADR), Interactions
• Contains the description of cellular changes that occur as a result of the drug.

  Durg Action: Actions
• Contains the list of conditions for which the drug should not be given.

  Drug Action: Contraindications
• Contains the list of conditions or patient types that demands closer observation for specific side effects when given the drug.

  Drug action: Cautions
• Contains the list of unintended, unpleasant or dangerous secondary effects other than the desired effect of the drug.

  Drug action: SIde effects or Adverse Drug Reactions (ADR)
• Contains the list of other drugs or specific food that may alter the effect of the drug, generally should not be given during the course of therapy.

  Drug action: Interactions