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sleep-inducing sedatives
Essential Drugs list/NDF o Secobarbital, Phenobarbital,
list of drugs prepared and updated by DOG on Barbital, Amobarbital
a basis of health conditions
Other drugs containing salt/derivative of a salt
Core list – drugs that meet the care needs of of barbituric acid
majority of population
Any salt, isomer, or salt of an isomer of
Complementary list – list of alternative drugs Amphetamine
used when there is no response to core o Benzedrine or Dexedrine
essential drug when there is a hypersensitivity o Any drug which produces a
reaction to the core essential drug or when for pharmacologic action similar to
one reason or another, the core essential drug Amphetamine
cannot be given
Hypnotic drugs
o Methaqualone or any other
compound producing similar
Classification of Drugs pharmacologic effects
1. Rx/ethical drugs
Dispensed only upon written order/validly-
registered licensed physician, dentist, or Prohibited Drugs
veterinarian Include:
Used for management/Tx of a opium, active components, derivatives:
condition/disease o Heroin & Morphine
2. Non-Rx/OTC drugs Cocoa leaf, derivatives
Dispensed even without Rx o Cocaine alpha & beta, Eucaine
Used by consumers for the Hallucinogenic drugs
prevention/symptomatic relief of minor or self- o Mescaline, Lysergic Acid
limiting ailments Diethylamide (LSD), other subs.
3. Dangerous drugs producing similar effects
Either prohibited/regulated drugs Indian hemp, derivatives
Special Rx form, use is monitored by DDB All preparations made from AOTA
Other drugs (natural/synthetic) with
physiological effects of a narcotic drug
Regulated drugs
Include:
A.O. 63 s. 1989: “Rules and Regulations to Implement Dispensing
Requirements”
o BN
Guidelines on dispensing o Manufacturer
All Rx dispensed in the drugstores, botica or o Dosage strength
hospital pharmacy shall be o Expiry date
o Kept in file for two years o Directions for use
o Recorded in an Rx book duly- o Name of pharmacist
registered by FDA (open for In partial filling of Rx, ff. shall be written on the
inspection by FDA inspectors at any face of the Rx:
time during business hours of the o Date of partial filling
outlet) o Quantity served + balance of Rx
o Rx book shall be kept for 2 years unserved
after last entry o Name and address of drugstore
All drug outlets are required to practice generic The partially-filled Rx shall be returned to the
dispensing buyer after recording the partial filling in the Rx
Drug stores, boticas, other drug outlets: book. Drugstore which completes the filling of
o Shall inform Pt/buyer of all available the Rx shall keep the Rx in file.
drug products generically equivalent Dispensing Drugs in List A and B
to the one prescribed with their o Dispensing must be done by the
corresponding prices pharmacist who shall affix signature
o Shall post in a conspicuous place in on the Rx filled
their establishment a list of drug o Order & instruction of doctor as
products using generic names with written on Rx must be precisely
their brand names, if any, and followed
corresponding prices o Partial filling for List A drugs shall
Hospital pharmacies not be allowed
o Those operating on the acceptable
formulary system and pricing policy Violations on the Part of the
and using generic terminology in
procurement, prescribing,
Dispenser and Outlet
1. Imposing a particular brand or product on the
dispensing, and recording of drugs
buyer.
shall be exempted from the
2. Inaccurate dispensing.
following:
3. Failure to post or make accessible the required
Recording of Rx filled in the
up-to-date information on drug product
Rx book, provided such Rx
4. Failure to adequately inform buyer on available
shall be kept in file for 2
product that meets the Rx.
years
5. Failure to indicate the GN/official name
Individually informing the
designated by FDA & other required information
Pt/buyer on the available
on the drug outlet’s label of the dispensing drug.
generic equivalents and their
6. Failure to record and keep Rx filled.
corresponding prices
7. Failure to report to the nearest DOH office
For drug products in unit dose or products
incorrect Rx within 3 months after receipt of such
which are not in their original containers the
Rx.
pharmacist shall write legibly on the required
drug outlet’s label the ff.:
o Name of Pt Penalties for Violating A.O.63
o GN of drug
suspension or revocation of the LTO of the appropriate administrative sanctions by the
drug outlet by the Secretary of Health PRC
professionals directly involved in the violation
shall be recommended by the Secretary for
R.A. 9165: “The Comprehensive Dangerous Drugs Act of 2002”
DDB
PDEA
Records Required for
Drug resistant & eventually free Philippines Transactions on Dangerous
2015: 2.3% (1.8M) of population uses
dangerous drugs
Drugs and Precursors and
o 10-69 years old Essential Chemicals
Common drugs of abuse Pharmacist
Cannabis sativa – Marijuana shall maintain and keep an original record of
Methamphetamine HCl sales, purchases, acquisitions, and deliveries of
Cocaine dangerous drugs, indicating:
National Anti-Drug Program of Action (2014) o License # & address of pharmacist.
Pillars of the Program o Name, address & license of
Drug Supply Reduction manufacturer, importer, or
Drug Demand Reduction wholesale.
Civic Awareness and Response o Quantity and name of the
Alternative Development dangerous drugs purchase or
Regional and International Cooperation acquired.
Licenses (Dangerous Drugs) o Date of acquisition or purchase.
S-1 Retail Distributor or Dispenser (P500) o Name, address, & community tax
S-2 Prescriber (P500 – P1500 for 3 years) certificate number of the buyer
S-3 Retail Distributor or Dispenser (P1000) o Serial # of the Rx & name of the
S-4 Wholesale Distributor (P1000) practitioner
S-5-I Importer (P3000) o Quantity & name of the dangerous
S-5-C Manufacturer (P5000) drugs sold/delivered
S-5-E Exporter (P5000) o Date of sale/delivery
S-4-D Bulk Depot/Storage (P5000) o Certified true copy of such record
Licenses (Controlled Precursors and Essential covering a period of 6 months, duly
Chemicals) signed by the pharmacist or the
P-1 Retail Distributor or Dispenser (P500) owner of the drugstore, pharmacy,
P-3 End User (P2500) or chemical establishment, shall be
P-4 Wholesaler Distributor (P3000)
forwarded to the Board within 15
P-5-I Importer (P5000)
days following the last day of June
P-5-C Manufacturer (P5000)
and December of each year, with a
P-5-E Exporter (P5000)
copy thereof furnished the city or
P-5-D Bulk Depot/Storage (P5000)
P-5-IM Importer/End User (P5000)
municipal health officer concerned
P-6 Research/Analysis/Instructional Program (P500) o Physician, dentist, veterinarian, or
What to do with Expired Dangerous Drugs practitioner authorized to prescribe
Surrender to supplier any dangerous drug shall issue 1
original and 2 duplicates
Surrender to PDEA laboratory
o Original shall be retained by
Dangerous Drugs Pathway in Hospital
pharmacist for 1 year
Floor stocks
o 1 copy shall be retained by buyer
o Requisition form
o Second copy shall be retained by
Controlled Drugs Administration Sheet
person issuing the prescription
o Wastage: signed by pharmacist and
o All Rx issued by the medical
nurse as witness
practitioners shall be written on
forms exclusively issued by and
obtainable from the DOH
o Such forms shall be made of a
special kind of paper
o Such forms shall only be issued by
the DOH through its authorized
employees to licensed physicians,
dentists, veterinarians, and
practitioners
o Prescriber shall inform DOH of Rx
within 3 days
o No Rx shall be reused nor refilled