Antimicrobial Resitance

• Mikrobyo (Microbes)

  • Found everywhere: air, soil, and water.
  • Present on the skin and inside the body.
• Antimicrobial Resistance (AMR)

  • The ability of microbes to protect themselves against antimicrobials (medicines for infections).
• Types of Antimicrobials

  1. Antibacterials: For infections such as urinary tract infections (UTI) and pneumonia.
  2. Antivirals: For colds, cough, and flu.
  3. Antifungals: For fungal infections like ringworm, athlete’s foot, and jock itch.
  4. Antimalarials: For malaria.
• How AMR Develops?

  1. Impeksyon: Magsisimula sa mikrobyo na maaaring makuha sa paglanghap, maruming pagkain, hayop, at insekto.
  2. Pagdami: Ang mikrobyo ay maaaring dumami sa loob ng katawan kahit wala kang nararamdamang sintomas.
  3. Sakit: Ang impeksyon ay nagdudulot ng sakit.
  4. Paggamot:

  • Tamang pagsusuri at tamang paggamit ng iniresetang antibiotic ng doktor.
  • Ang wastong gamutan ay nakatutulong sa ganap na paggaling

  5. Pagkalat:

  • Ang resistant na mikrobyo ay maaaring maihawa sa ibang tao, hayop, at buong komunidad.
• Paano Maiiwasan ang Masamang Epekto ng Impeksyon?

  1. Gumamit ng gamot lamang kung ito ay inireseta ng doktor.
  2. Tamang dosage ang kailangang sundin.
  3. Sundin ang tamang direksyon sa paggamit ng antibiotic, tulad ng Oral (iniinom), Sublingual (nilalagay sa ilalim ng dila) at IV (intravenous)
  4. Tapusin ang itinakdang regimen:

  • Sundin ang tamang dosis, dami, at haba ng gamutan na inireseta ng doktor.

  5. Huwag ipamigay o gamitin ang natirang antibiotic mula sa naunang gamutan.
• Medication Safety

  • Ensures the safe and quality usage of medicines.

  Impact:

  • Adverse Drug Events (ADEs), including:
  • Medication Errors
  • Adverse Drug Reactions (ADRs)

  Role of Pharmacists: Prevent these impacts and ensure patient safety
• Drug Development

  • The process of bringing a new pharmaceutical drug to the market.

  The Drug Development Process

  • Discovery and Development. 
  • Preclinical Research. 
  • Clinical Research.
  • FDA Review. 
  • FDA Post-Market. 
  • Safety Monitoring
• Steps in Drug Discovery and Development

  Step 1: Drug Discovery and Target Validation

  Step 2: Preclinical Testing

  Step 3: IND Application Filing

  Step 4: Phase 1 Clinical Studies

  Step 5: Phase 2 Clinical Studies

  Step 6: Phase 3 Clinical Studies

  Step 7: NDA Filing

  Step 8: FDA Decision (PDUFA Date)

  Step 9: Phase 4 Clinical Studies
• Step 1: Drug Discovery and Target Validation

  • Identify a target molecule (gene/protein) linked to the disease.
  • Test multiple molecules to find promising leads.
  • Outcome: Multiple potential compounds identified for testing.
• Step 2: Preclinical Testing

  • Test drugs in lab settings (in vitro) and on animals (in vivo) for safety and efficacy.
  • Outcome: Narrow down to 1 to 5 promising candidates over several years.
• Step 3: Investigational New Drug (IND) Application Filing

  • Submit an application to the FDA with preclinical data, safety profile, and manufacturing details.
  • Outcome: IND approval allows human trials and starts the drug’s patent exclusivity period.
• Step 4: Phase 1 Clinical Studies

  • Test on a small group of healthy individuals for safety, absorption, side effects, and dosage.
  • Outcome: Promising drugs move to Phase 2.
• Step 5: Phase 2 Clinical Studies

  • Test on 100+ patients with the disease to assess safety, efficacy, and optimal dose.
  • Outcome: Successful drugs progress to Phase 3.
• Step 6: Phase 3 Clinical Studies

  • Large-scale trials (hundreds to thousands of patients) focus on safety and efficacy with FDA-approved trial designs.
  • Outcome: Drugs meeting endpoints are prepared for FDA approval filing.
• Step 7: NDA Filing

  • Submit extensive research and safety data to the FDA for review. A decision date (PDUFA) is set for approval or rejection.
  • Outcome: Approval enables commercial production.
• Step 8: FDA Decision (PDUFA Date)

  • FDA approves, denies, or requests additional data through a Complete Response Letter (CRL).
  • Outcome: Approval allows immediate production; CRL outlines required changes.
• Step 9: Phase 4 Clinical Studies

  • Post-approval studies monitor long-term safety and report adverse effects.
  • Outcome: Ensures ongoing drug safety for public health.