Pcare4 Law&Ethical Policies

LAWS
AND ETHICAL POLICIES

GOVERNING PHARMACY
PRACTICE
Generics law of 1988

RA NO. 6675
Guidelines on Dispensing Prior to the Generics Act of 1988
1. PrescripEon or Ethical Drugs can be dispensed only

upon prescripEon of a registered physician, denEst
or veterinarian
2. Non-PrescripEon or OTC drugs- can be dispensed
without a prescripEon. Pharmacist must give
important informaEon and direcEon for use of the
drug
3. All prescripEons shall be kept on le for 2 years
and recorded in a prescripEon book registered by
the BFAD ready for inspecEon during business
hours of the outlet.
3
Addi?onal Guidelines on Dispensing to Implement The

Generics Act of 1988
1. All drug outlets are required to pracEce generic
dispensing

a.drugstores/boEca
- inform buyer on available drug products
generically equivalent
- posEng a list of drug products using generic
names with brand names & prices

4
AddiEonal Guidelines on Dispensing to Implement The Generics Act

of 1988
b. Hospital Pharmacies
- upon admission, paEent may have the opEon to
buy drugs outside the hospital pharmacy
-hospitals using acceptable formulary system &
pricing by the DOH & using generic names shall be
exempted:
1) record prescripEons in the Rx book
2) inform paEent on available generic drug with
prices
Addi?onal Guidelines on Dispensing to Implement The

Generics Act of 1988
In dispensing drug products not in their original

containers, pharmacist shall place the required label:
Name of paEent
dosage strength
Generic name of the drug expiry date
Brand name, if any
direcEons for use
Manufacturer

name of pharmacist

For parEal lling:
Date of parEal lling
QuanEty served & balance of unserved
Name & address of drugstore
Viola?on on the Part of Dispensers and Outlets

Imposing a parEcular brand or product on the buyer
Inaccurate dispensing
Failure to post or make accessible the required informaEon
on drug products
Failure to inform the buyer on available products that meet
the prescripEon
Failure to indicate the generic name on the label
Failure to record and keep prescripEon
Failure to report to the nearest DOH oce any cases of
violaEve, erroneous or impossible prescripEon
7
Generic Dispensing Flowchart

PrescripEon Drugs
OTC Drugs
Rx not required
Rx required
evaluaEon
Rx correct- ll & le
Rx incorrect
erroneous
ViolaEve & impossible
Inform the buyer
dispense
8
Privilege of the Senior Citizens

Under the Expanded Senior Citizens Act
20% discount:
On purchase of medicine
anywhere in the country
Requirements to avail the privilege

ID issued by the city or municipal mayor or of the barangay
captain of the place where the senior citizen or the elderly
resides
the passport of the elderly person or senior citizen
concerned
The prescription of the doctor indicating the generic name
of the drug
other documents that establish that the senior citizen or
elderly person is a citizen of the Republic and is at least
sixty (60) years of age
10
Philippine Drug Enforcement Agency
REPUBLIC ACT NO. 9165 OTHERWISE KNOWN AS THE

COMPREHENSIVE DANGEROUS DRUGS ACT OF 2002
WAS SIGNED INTO LAW ON 07 JUNE 2002, WHICH
REPEALED REPUBLIC ACT NO. 6425, OTHERWISE
KNOWN AS THE DANGEROUS DRUGS ACT OF 1972, AS
AMENDED. R.A. 9165 TOOK EFFECT ON 04 JULY 2002.

*Published on June 19, 2002 in Manila Standard and Manila Times
PDEA Updates
11
THE PHILIPPINE DRUG ENFORCEMENT AGENCY

(PDEA) serves as the implemenEng arm of the Board.
They shall be responsible for the ecient law
enforcement of all provisions pertaining to Dangerous
Drugs and Controlled Precursor and EssenEal
Chemicals.
PDEA Updates
12
Comprehensive Dangerous Drug Act 2002 (R.A. 9165)

Dangerous Drugs refers to:

Those listed in Schedules annexed to the 1961 Single
ConvenEon on NarcoEc Drug, as amended by the 1972
Protocol.

And in the Schedules annexed to the 1971 convenEon
on Psychotropic substances.
PDEA Updates
13
Comprehensive Dangerous Drugs Act of 2002

(R.A. 9165)
A. Schedule annexed to the 1961 Single ConvenEon on NarcoEc

Drug as amended by 1972 Protocol and these are:
1. Opium & its acEve components & derivaEves
2. Cocaine & its derivaEves
3. Marijuana & its derivaEves
4. Khat & its acEve components
5. Hallucinogenic drugs
6. All preparaEons made from any of the foregoing
7. Other dugs & chemical preparaEons whether natural or syntheEc
with the physiological eects of a narcoEc or a hallucinogenic drug.
PDEA Updates
14
Comprehensive Dangerous Drugs Act of 2002

(R.A. 9165)
B. Psychotropic Substances annexed to 1971 ConvenEon

1. SEmulants uppers, sEmulates the CNS

ex. Amphetamines
2. Self-inducing sedaEves downers, depressant

ex. Barbiturates
3. Any drug which produces physiologic acEon similar to

amphetamine
4. HypnoEc drugs
5. All others with the same physiologic eects as above.
PDEA Updates
Substances frequently used in the illicit manufacture of

Narco?c Drugs & Psychotropic Substances

PRECURSORS

ESSENTIAL CHEMICALS
PDEA Updates
SUBSTANCES UNDER CONTROL

TABLE I
TABLE 2
Ergometrine
Ergotamine
Anthranilic acid
Lysergic acid
Ethyl ether
1-phenyl-2-propanone
PhenylaceEc acid
Pseudoephedrine
Piperadine
N-acetylanthranilic acid
Methyl ethyl ketone
Norephedrine
Ephedrine
PDEA Updates
Acetone
SUBSTANCES UNDER CONTROL

TABLE 1
TABLE 2
3,4-methylenedioxyphenyl-
2-propanone
Toluene
Sulfuric acid*
Safrole/Isosafrole
Hydrochloric acid*
AceEc Anhydride
Piperonal Potassium Permanganate
*With the excepEon of hydrochloric acid and sulfuric acid, the salts
of the substances listed in the tables of the convenEon, whenever
the existence of such salts is possible, are also controlled.
PDEA Updates
DRUG DISTRIBUTION NETWORK

Bulk Manufacturers
Producers of Primary raw materials

(USA, Australia, United Kingdom, Hungary, Italy etc)
Distributor/Wholesaler
Sale directly to retail outlets
Pharmaceu?cal Manufacturers
Processing into nal dosage forms
Pa?ents
Rx
PDEA Updates
Dispensers (Retailers)
Sales/Dispensing directly to paEents
FEES
S-2 Medical PracEEoners
P1,500/3yrs
S-3 Retail Dealer of Dangerous Drugs/Exempt 1,000/yr

Dangerous Drug PreparaEons
S-4 Wholesale Dealer of Dangerous Drugs/Exempt 3,000/yr

S-C Compounders, Producers, Manufacturers 3,000/yr
of Dangerous Drug PreparaEons/Exempt
PDEA Updates
Speaker : Ms. Mae Unite 20
REQUIREMENTS FOR REGISTRATION TO DEAL IN DANGEROUS

DRUGS
1. Current LTO BFAD
2. Current Mayors Permit
3. Updated CRBN / SEC RegistraEon
4. Updated PRC ID Card (Pharmacist)
5. Current PTR (Pharmacist)
6. TIN (E.O. 98 dated 4/28/99)
7. Leoer of AuthorizaEon of Pharmacist-In-Charge
8. Statement of Under Oath (Pharmacist-In-Charge)
PDEA Updates
REQUIREMENTS FOR REGISTRATION TO DEAL

IN DANGEROUS DRUGS
9. a) NBI Clearance (S3, S4, S5I, S5C)

b) Barangay Clearance (S1, S6)
10. Duly accomplished applicaEon form
11. CPR (Manufacurer/Importer) New Drug Products only
12. Leoer requesEng applicaEon of S-License
NEW APPLICANT WILL UNDERGO PSI
PDEA Updates
RECORD KEEPING REQUIREMENTS

Every pharmacist dealing in dangerous drugs shall

maintain and keep an original record of sales,
acquisitions and deliveries of dangerous drugs
indicating the following information:
1. License number and address of the pharmacist
2. Name, address and license umber of manufacturer,
importer or wholesaler from whom the dangerous
drugs have been purchased
3. Quantity and name of the drugs purchased or acquire
4. Date of acquisition or purchase
PDEA Updates
23
RECORD KEEPING REQUIREMENTS

5. name, address and community tax certificate number of the buyer

6. Special number of the prescription and the name of the physician,
dentist, veterinarian or practitioner issuing the same
7. Quantity and name of the dangerous drugs sold or delivered and
8. Date of sale and delivery
A certified true copy of such record covering a period of six months
duly signed by the pharmacists or the owner of the drugstore,
pharmacy or chemical establishment shall be forwarded to the
Dangerous Drug Board within 15 days following the last day of June
and December of each year, with a copy thereof furnished the city or
municipal health Officer concerned.
24
RESTRICTIONS ON DISPENSING
Ocial Prescrip?on Form
(DDB Form 1-72)
Original (White)
Duplicate (Yellow)
Triplicate (Blue)
Used in Full or Used for _____ only
(BR #11 s. 1973)
PDEA Updates
25
BOARD REGULATION NO. 3-s. 2003

PRESCRIPTION LIMITS (Dangerous Drugs)
a) For Cancer Pa?ents:
(i) Morphine Sulfate (tablets [oral])
3000mg
Morphine Sulfate (ampoules/vials)
448mg
(ii) Fentanyl patch 25 ug/hour
30 patches
Fentanyl patch 50 ug/hour
15 patches
Fentanyl ampoules 50 ug/ml
10 ampoules (1 ml)
PDEA Updates
3 ampoules (2ml)
BOARD RESOLUTION NO. 3-s 2003

Con?nua?on of Fentanyl Ampoules 50 ug/ml
50 ampoules (2 ml) for use in PaEent Controlled Analgesic (PCA)

machine
10 ampoules (10 ml) for use in PaEent Controlled Analgesic (PCA)

machine
(iii) OxyconEn
1,200 mg
OxyconEn 10 mg
120 tablets
OxyconEn 20 mg
60 tablets
PDEA Updates

OxyconEn 40 mg
30 tablets
OxyconEn 80 mg
15 tablets
(iv) Demerol
14 vials
(v) Dangerous Drugs (ampoules or
20 pieces
hypodermic tablets)
Dangerous Drugs (tablets)
40 pieces
Dangerous Drugs (capsules)
PDEA Updates
40 pieces

b) Ordinary circumstances:
(i) Benzodiazepines (anxiolyEc or hypnoEc 30 tablets or capsules

or both)
Benzodiazepines (anxiolyEc or hypnoEc 10 ampoules x 1 ml

or both)
3 ampoules x 2 ml
2 ampoules x 3 ml
2 ampoules x 5 ml
1 ampoule x 10 ml
Benzodiazepines (muscle spasm/ 90 tablets 95 mg

dystonia/tetanus)
PDEA Updates

(ii) Phenobarbital preparaEons
2 weeks supply
2 booles (100 tablets
each for Epilepsy paEents)
(iii) Sodium Penthotal

3 vials (in case of
hospital use)
(iv) Demerol
3 ampoules
(v) Other Dangerous Drugs (in vials

1 vial (in case of
hospital use)

PDEA Updates
BOARD REGULATION NO. 2-C, S. 1988

Prescrip?on shall show:
Date
Name/address of prescribing physician/pracEEoner
Name/address of paEent
Name of dangerous drugs, exact quanEty of dangerous drugs
prescribed in words and enclosed in parenthesis the roman
numeral to depict the quanEty of the drug to be prescribed.
Its strength and total number of units to be supplied.
PDEA Updates
BOARD REGULATION NO. 2-C, S.

1988
DirecEon for use.
Signature of the prescribing physician/pracEEoner

PTR (physician/pracEEoner)
Dangerous Drugs License (physician/pracEEoner)
PDEA Updates
RA NO.9502
UNIVERSALY ACCESIBLE CHEAPER
AND QUALITY MEDICINE ACT OF
2008
33
CHAPTER 3
DRUGS AND MEDICINES PRICE REGULATION
Sec. 17. Drugs and Medicines Price RegulaEon

Authority of the President of the Philippines.-
maximum retail price
Sec. 18. Drugs and Medicines Price Monitoring
and RegulaEon Authority of the Secretary of
the Department of Health.
34
CHAPTER 3

Sec. 19. FuncEons and ResponsibiliEes of the secretary

of health.
Power to recommend the maximum retail price
Power to include other drugs and medicines in the list
subject to price regulaEon.
Power to implement cost-containment and other
measures.
Power to impose administraEve nes and penalEes 50k to
5M
Power to depuEze government enEEes
Other powers necessary to implement provisions of this
chapter.- records, document, ooks of account, bills of
lading, records of purchase and sale, nancial statement
35
CHAPTER 3
SecEon 23. list of drugs and Medicines that are

subject to Price RegulaEon.
All drugs and medicines indicated for the treatment of

chronic illnesses and life threatening condiEons
Drugs and medicines indicated for the prevenEon of
diseases
Drugs and medicines indicated for prevenEon of
pregnancy
AnestheEc agents
Intravenous uids
PNDF EssenEal Drug list
36
CHAPTER 3
SecEon 25. Penalty for price manipulaEon.

Imprisonment of nlt 5 years and nmt 15 years or a ne
of 100k nor more than 10M. Suspension or revocaEon
of its LTO , professional or business license.
Display of Maximum Retail Price xed and approved by
order of the President of the Philippines for drugs and
medicines subject to price regulaEon.
The maximum retail price shall be printed on the label of the
immediate container of the drug and medicine and the minimum
pack thereof oered for retail sale with the words RETAIL PRICE
NOT TO EXCEED preceding it and UNDER DRUG PRICE
REGULATION on a red strip.
37
CHAPTER 6
AMENDMENTS TO RA No. 6675
(GENERICS ACT OF 1988)

SEC. 6. Who Shall Use Generic Terminology.-
A) All government health agencies & their personnel as
well as other governments agencies shall use generic
terminology or generic names in all transacEons related to
purchasing, prescribing, dispensing and

administering of drugs & medicines.
B) All medical, dental & veterinary pracEEoners including
private pracEEoners shall write prescripEons using generic
name. The brand name may be included if so desired.
38
CHAPTER 6
c) Any organizaEons or company involved in the
manufacture, importaEon, repacking, markeEng

and/or distribuEon of drugs & medicines shall
indicate prominently the generic name of the
product. In the case of brand name products, the
generic name shall appear prominently and
immediately above the brand name in all product
labels as well as in adverEsing and other promoEonal
materials.
39
CHAPTER 6
}D) Drug outlets including drugstores, hospital and
non hospital pharmacies & non tradiEonal outlets

such as supermarkets and stores, shall inform any
buyer about any and all other drug products having
the same generic name together with their
corresponding prices so that the buyer may
adequately exercise his opEon. Within one year auer
the approval of this Act, the drug outlets referred to
herein shall post in conspicuous places in their
establishments a list of drug products with the same
generic name and their corresponding prices.
40
CHAPTER 6
E). There shall appear prominently on the

label of a generic drug the following
statement: THIS PRODUCT HAS THE SAME
THERAPEUTIC EFFICACY AS ANY OTHER
GENERIC PRODUCT OF THE SAME NAME.
SIGNED: BFAD.
41
CHAPTER 6
SEC. 8. REQUIRED PRODUCTION.- Subject to

the rules and regulaEons promulgated by the
Secretary of Health, every drug
manufacturing company operaEng in the
Philippines shall be required to produce,
distribute and make widely available to the
general public an unbranded generic
counterpart of their branded product. (the
medicine it produces in the form of generic drugs, subject to the rules &
regulaEons of the DOH.)
42
CHAPTER 7
(THE PHARMACY LAW)
} SECTION 25.- Sale of Medicine, PharmaceuEcals, Drugs,

Devices.
} No medicine, pharmaceuEcal or drug except for those
which are non-prescripEon or over the-counter, of whatever
nature and kind or device shall be compounded, dispensed,
sold or resold, or otherwise be made available to the
consuming public except through a prescripEon drugstore or
hospital pharmacy duly established in accordance with the
provision of this Act. Non-prescripEon or over-the-counter
drugs may be sold in their original packages, booles,
containers or in small quanEEes, not in their original
containers to the consuming public through supermarkets,
convenience stores and other retail establishments.
43

CHAPTER 7
(THE PHARMACY LAW)

PharmaceuEcal, drug or biological manufacturing
establishments, importers and wholesalers of drugs,

medicines, or biological products, shall not sell their products
for resale, except only to retail drugstores, hospital
pharmacies or to other drug wholesalers under the
supervision of registered pharmacist, and supermarkets,
convenience stores, other retail establishments for over-the-
counter drugs, duly licensed by the Bureau of Food and Drugs.
44
PPHA CODE OF ETHICS FOR

PHARMACISTS

PREAMBLE
PHARMACISTS are health professionals who help

individuals protect themselves against diseases, maintain
good health and make the best use of their medications.
The pharmacists promote raEonal use of drugs and ensure
the provision of safe, eecEve and quality drugs for
improved paEent care and quality of life. This code,
prepared and supported by pharmacists, is intended to
state publicly the principles that form the fundamental
basis of their roles and responsibiliEes which are based on
moral obligaEons and virtues and to guide pharmacists in
their relaEonship with paEents, health professionals and
society.
45
CODE OF ETHICS FOR PHARMACISTS

1. A pharmacist places the well being of the
paEent at the center of professional pracEce.
2. A pharmacist promotes the welfare of each
individual in a caring and compassionate
manner
3. A pharmacist serves the needs of the individual,
community and society
4. A pharmacist respects the rights of paEents and
upholds condenEality of paEents record
46
CODE OF ETHICS FOR PHARMACISTS

5. A pharmacist acts with honesty, integrity and
professionalism in relaEonship with the paEents and
other health professionals
6. A pharmacist respects the abiliEes, values and contribuEon
of colleagues and other health professionals and work
with them closely to ensure beoer paEent care.
7. A pharmacist is commioed to conEnuously enhance
professional competence
8. A pharmacist, in coordinaEon with the government and
other health professionals helps in the formulaEon and
implementaEon of health care policies, standards and
programs designed for the benet of society.
47

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LAWS

AND ETHICAL POLICIES

Generics law of 1988

Guidelines on Dispensing Prior to the Generics Act of 1988

1. PrescripEon or Ethical Drugs can be dispensed only

Addi?onal Guidelines on Dispensing to Implement The

AddiEonal Guidelines on Dispensing to Implement The Generics Act

Addi?onal Guidelines on Dispensing to Implement The

In dispensing drug products not in their original

Viola?on on the Part of Dispensers and Outlets

Generic Dispensing Flowchart

Inform the buyer

Privilege of the Senior Citizens

Requirements to avail the privilege

Philippine Drug Enforcement Agency

REPUBLIC ACT NO. 9165 OTHERWISE KNOWN AS THE

Philippine Drug Enforcement Agency

THE PHILIPPINE DRUG ENFORCEMENT AGENCY

Philippine Drug Enforcement Agency

Comprehensive Dangerous Drug Act 2002 (R.A. 9165)

Dangerous Drugs refers to:

Comprehensive Dangerous Drugs Act of 2002

A. Schedule annexed to the 1961 Single ConvenEon on NarcoEc

Comprehensive Dangerous Drugs Act of 2002

B. Psychotropic Substances annexed to 1971 ConvenEon

2. Self-inducing sedaEves downers, depressant

3. Any drug which produces physiologic acEon similar to

Philippine Drug Enforcement Agency

Substances frequently used in the illicit manufacture of

Philippine Drug Enforcement Agency

SUBSTANCES UNDER CONTROL

Methyl ethyl ketone

SUBSTANCES UNDER CONTROL

DRUG DISTRIBUTION NETWORK

Producers of Primary raw materials

Sale directly to retail outlets

Processing into nal dosage forms

Sales/Dispensing directly to paEents

Philippine Drug Enforcement Agency

S-3 Retail Dealer of Dangerous Drugs/Exempt 1,000/yr

S-4 Wholesale Dealer of Dangerous Drugs/Exempt 3,000/yr

Speaker : Ms. Mae Unite 20

Philippine Drug Enforcement Agency

REQUIREMENTS FOR REGISTRATION TO DEAL IN DANGEROUS

Speaker : Ms. Mae Unite 21

Philippine Drug Enforcement Agency

REQUIREMENTS FOR REGISTRATION TO DEAL

9. a) NBI Clearance (S3, S4, S5I, S5C)

Speaker : Ms. Mae Unite 22

RECORD KEEPING REQUIREMENTS

Every pharmacist dealing in dangerous drugs shall

RECORD KEEPING REQUIREMENTS

5. name, address and community tax certificate number of the buyer

Philippine Drug Enforcement Agency

Philippine Drug Enforcement Agency

BOARD REGULATION NO. 3-s. 2003

Morphine Sulfate (ampoules/vials)

(ii) Fentanyl patch 25 ug/hour

Fentanyl patch 50 ug/hour

Fentanyl ampoules 50 ug/ml

BOARD RESOLUTION NO. 3-s 2003

Con?nua?on of Fentanyl Ampoules 50 ug/ml

50 ampoules (2 ml) for use in PaEent Controlled Analgesic (PCA)

10 ampoules (10 ml) for use in PaEent Controlled Analgesic (PCA)

Pcare4 Law&Ethical Policies

Pcare4 Law&Ethical Policies