Legal (Midterms)

• ASIN Law - RA 8172
• ASIN Law (RA 8172)

  Purpose:

  • Elimination of micronutrient malnutrition (particularly iodine deficiency) through a cost-effective preventive measure
• Fortificants - nutrients added to processed foods at levels above the natural state
• Food-grade salt - for human and animal consumption

  Industrial salt - not for human consumption
• Department of Environment and Natural Resources (DENR) - Identify areas that are suitable for use as salt farms with the purpose of protecting such areas
• RA 8976 - Philippine Food Fortification Act of 2000
• Fortificant - a substance, in chemical or natural form, added to food to increase its nutrient value
• Nutrition Facts - statement or information on food labels indicating the nutrient(s) and the quantity
• Nutrition Labeling - system of describing processed foods or food products on the basis of their selected nutrient content
• Sangkap Pinoy Seal Program (SPSP) - strategy to encourage food manufacturers to fortify processed foods or food products with essential nutrients
• Wheat flour: Vit. A and Iron
• Schedule II - Methylphenidate
• Schedule I

  • Fentanyl
  • Fentanyl Citrate
  • Morphine
  • Oxycodone
  • Oxycodone/Naloxone
  • Pethidine
• S3 License - license of pharmacists
• Triplicate Copy - retained by the prescribing practitioner
• Philippine Drug Enforcement Agency (PDEA) - organization responsible for dangerous drugs
• Thirty (30) - day supply of Philippine Schedules 2,3, and 4, dangerous drugs per prescription
• Sixty (60) - days supply of Philippine Schedule 4 drugs for the treatment of epilepsy and dystonia
• With erasure - sign of fraudulated prescription
• 2 years after last entry in register - retention of register and commercial documents
• Semi-Annual Report - copy is submitted to PDEA every 6 months
• Permit to Construct - new hospital construction, substantial alteration, enlargement
• License to Operate - given after construction
• Considered Lapsed + Registration is Cancelled (new application shall be required) - LTO that is NOT renewed for 2 consecutive years
• AO 147 S. 2004: Revised Rules and Regulations Governing the Registration, Licensure, and Operation of Hospitals and Other Health Facilities in the Philippines

  Fine:

  • NMT 500 for the 1st offense
  • NMT 1k for each following offense
• A hospital or health facility that has been denied a license, or whose license has been suspended or revoked, can request an administrative hearing conducted by the Secretary of Health
• Counterfeit Drugs - drug which is deliberately and fraudulently mislabeled with respect to identity and/or source
• Wrong ingredients - counterfeit drugs
• Counterfeit drug/medicine - an unregistered imported drug product (with registered counterpart brand in the Philippines) EXCEPT drugs brought in the country for personal use
• Counterfeit drug/medicine - a drug which contains no amount of or a different active ingredient or less than eighty percent (80%) of the active ingredient it purports to possess as distinguished from an adulterated drug including reduction or loss or efficacy due to expiration
• Filing of Administrative Complaint

  Brand owner - affidavit of complaint

  Consumer - letter of complaint

  Brand owner & Consumer - administrative complaint
• Local Incidence

  Commonly counterfeited - popular medicines with high demand (Antihypertensive, antibiotics)
• Most common sign that a medicine is unregistered: purchased in an unlicensed outlet/establishment and was not issued with an official receipt
• Counterfeit drug/medicine:

  • Correct ingredients but not in the amount as provided
  • Wrong ingredients
  • Without active ingredients
  • Insufficient quantity of active ingredient
• Counterfeit drug/medicine: Bearing without authorization of the trademark, trade name or other identification mark
• Counterfeit drug/medicine - refilled in containers by unauthorized persons
• Local Incidence:

  Lifestyle medicines

  • Slimming products
  • Products for erectile dysfunction containing ingredients present in Viagra or Cialis
• Dangerous drugs covered under Philippine Schedule V are to be prescribed as necessary
• Authorization for Emergency Dispensing

  Prescriber: To inform PDEA within 7 days after prescribing where the emergency occurred.

  Pharmacist: To inform PDEA within 7 days after dispensing the DDP.
• Warning - refers to the notice printed on the tobacco product or its container and/or displayed in print or aired in broadcast