unit 5: republic act 9165

Comprehensive Dangerous Drugs Act of 2002

RA 9165

June 7, 2002

approval date

Dangerous Drugs Act of 1972 (March 30, 1972)

amended RA 6425

RA 10640 (JUL 15 2014)

RA 9165 was amended by ___

Administer

Section 3. Definition of Terms

Act of introducing any dangerous drug into the body of any person, with or without his/her knowledge, by injection, inhalation, ingestion or other means, or of committing any act of indispensable assistance to a person in administering a dangerous drug to himself/herself unless administered by a duly licensed practitioner for purposes of medication

Analyst

• Medical

• Technologist Chemist

• Chemical Engineer

• Pharmacist

Section 3. Definition of Terms

Refers to the professional who perform the drug testing

Authorized Specimen Collector

Section 3. Definition of Terms

person who is authorized to collect specimen from the client to secure and prevent alteration of Urine specimen

Clandestine Laboratory

Section 3. Definition of Terms

any facility used for the illegal manufacture of any dangerous drug and/or controlled precursor and essential chemical

Chain of Custody

Section 3. Definition of Terms

• The procedure to account for each specimen by tracking the handling and storage from point of collection to final disposal.

• This procedure require that the applicant’s identity is confirmed and that a chain of custody form that is used from the time of collection to receipt by the laboratory.

Chain of Custody Form

Section 3. Definition of Terms

The form used to document the procedures from the time of collection until receipt by the laboratory

Screening Test

Section 3. Definition of Terms

• A rapid test performed to establish potential/presumptive positive result

• Qualitative test

Single Band/Line in Control area

positive Drug test

Confirmatory Test

Section 3. Definition of Terms

analytical test using a device, tool or equipment with a different chemical or physical principle that is more specific which will validate and confirm the result of the screening test

Specimen

Section 3. Definition of Terms

body fluid that is collected from a person

Dangerous Drug Board (DDB)

spearheads programs, projects and other strategies on prevention of dangerous drug usage

Moro Virgilio M. Lazo

PDEA Director General

East Ave. Medical Center

• environmental and Occupational Health, Toxicology and Micronutrient assay

National Reference Laboratory

• Applicants for Firearms License

• Officers and members of the military, police and other law enforcements

• Candidates for Public Office

• Persons charged before the prosecutor’s office with criminal charge offense having am impossible penalty of imprisonment of not less than 6years and 1day

• Persons apprehended for the violations of this act

Mandatory Drug Testing

• Students of Secondary or Tertiary schools

• Officers and employees of public and private offices whether domestic or oversees

Random Drug Testing

• At least 20 sqm in floor area

• The work area must be at least 10 sqm with exhaust fan, sink, and storage cabinet, and a ref.

Technical Requirements for Licensing: Physical Plant

Screening Laboratory

• At least 60 sqm in floor area

• The clinical work area must have at least 30 sqm with exhaust fan, sink, stock room and instrumentation room

Technical Requirements for Licensing: Physical Plant

Confirmatory Laboratory

at least 5 clients at a time

Technical Requirements for Licensing:

A Laboratory of whatever category shall have within its premises an area which can receive or accommodate ___

• hand washing facility

• Toilet facility

• stall for the collection of the specimen

Technical Requirements for Licensing:

Facilities

A licensed Physician certified in Clinical Pathology

Technical Requirements for Licensing: Headship of the Laboratory

___ by the Philippine Board of Pathology

a licensed physician with training in Clinical Laboratory Management

Technical Requirements for Licensing: Headship of the Laboratory

If certified physician not available

Licensed Physician, Chemist, Medical Technologist, Pharmacist or a Chemical Engineer

Technical Requirements for Licensing: Headship of the Laboratory

In case when a Laboratory is a division of the Laboratory

2 years experience in analytical chemistry

Technical Requirements for Licensing: Headship of the Laboratory

A licensed Chemist with at least Master’s Degree in Chemistry, Biochemistry or branch of chemistry with at least ___

shall have a full time Medical Technologist, Chemist, Pharmacist, and Chemical Engineer with appropriate training in screening procedures for dangerous drugs

Technical Requirements for Licensing: Personnel

Screening Laboratory

shall have full time Medical Technologist, Chemist, Pharmacist and Chemical Engineer who has completed an extensive appropriate training in chromatography, spectroscopy. The analyst must pass the proficiency test

Technical Requirements for Licensing: Personnel

Confirmatory Laboratory

shall have a necessary equipment or kit

Technical Requirements for Licensing: Laboratory Equipment

Screening Laboratory

shall have a necessary equipment for screening, qualitative and quantitative examination in addition to the basic equipment

Technical Requirements for Licensing: Laboratory Equipment

Confirmatory Laboratory

Integrated Drug Test Operations Management Information System (IDTOMIS)

Technical Requirements for Licensing: Application Service Provider

The Laboratory shall have access to an Application Service Provider approved by the DOH for the authentication of results

DOH

Accreditation of Drug Testing Centers and Physicians:

• License and accredit drug testing centers

• Appoint technical and other personnel for effective implementation of this law

• Accredit physicians who shall conduct the drug dependency exam and after care

• Control of regulations, licensing and accreditation division

• Establish, operate and maintain drug testing canters in government hospitals

• Appoint qualified and duly trained technical and other personnel

• resume

• training and experience

• certification

• PRC license

• incident report (if any)

Technical Requirement for Accreditation: Records

The Laboratory shall maintain a record of all of its personnel. The records must include ___

Security

Technical Requirement for Accreditation:

The laboratory shall have security measures to control access to the premises to ensure that only authorized personnel handle or have access to specimens or gain access to the lab

1. Information identifying the specimen

2. Date and time of the specimen

3. Name of the testing laboratory

4. Name of the signatures of all individuals who had custody of the samples during the collection process

Technical Requirement for Accreditation: Chain of Custody

1 year

Technical Requirement for Accreditation: Storage of Laboratory Reports and Specimens

Report pertaining to specimens for laboratory report shall be kept by the testing laboratory for a minimum period determined by DOH

Minimum of 5 days

Technical Requirement for Accreditation: Storage of Laboratory Reports and Specimens

Specimens can be stored for: negative

15 days

Technical Requirement for Accreditation: Storage of Laboratory Reports and Specimens

Specimens can be stored for: positive but not challenged

Yellow

Technical Requirement for Accreditation: Urine Specimen Collection, Handling and Disposal

Infectious waste such as gauze pad contaminated with urine specimen

Green

Technical Requirement for Accreditation: Urine Specimen Collection, Handling and Disposal

Biodegradable waster (food waste)

Black

Technical Requirement for Accreditation: Urine Specimen Collection, Handling and Disposal

Non-biodegradable waste (paper, office supply waste)

Drug Testing Kits

Technical Requirement for Accreditation: Equipment and instruments

Screening Laboratory

• Weighting scale

• Glassware's used in testing (beaker, Erlenmeyer flask, pipettes)

• Automatic pipettes

• Chromatographs

• Spectrometer/Mass Spectrometer

• Biological Safety Cabinet

Technical Requirement for Accreditation: Equipment and instruments

Confirmatory Laboratory

• analyst who performed the test

• head of the Laboratory

Technical Requirement for Accreditation: Laboratory Report

Signatory

the test result shall report the analyte and the concentration

Technical Requirement for Accreditation: Laboratory Report

Confirmatory

• 1 copy for the client

• 1 copy must be forwarded to DOH and must include the membrane of the drug test kit

Technical Requirement for Accreditation: Laboratory Report

2 two copies must be produced

continuing assessment of proficiency

Technical Requirement for Accreditation: Proficiency Testing

NRL shall conduct a ___

satisfactorily passed the testing

Technical Requirement for Accreditation: Proficiency Testing

in order for the laboratory to renew their license

3 weeks after the results.

Technical Requirement for Accreditation: Proficiency Testing

The results must sent back to NRL within ___

revocation of its license and accreditation

Technical Requirement for Accreditation: Proficiency Testing

Failure to pass the proficiency testing shall be given another chance, failure to pass the second one shall result in ___

presence of line

Drug Testing Result: Negative

absence of line

Drug Testing Result: Positive

1 year

Technical Requirement for Accreditation: Validity of the Test Result

P300

Technical Requirement for Accreditation: Allowable Service Fee

Private Hospital/Free Standing Laboratory

P250

Technical Requirement for Accreditation: Allowable Service Fee

Public Hospital

1. BHFS application form

2. Mayor’s Permit

3. 1 set of floor plan

4. List of personnel, list of credentials, health certificate

5. List of Equipments

6. Contract of License (if facility is rented)

Licensing and Accreditation:

License to Operate

• Copy of DOH license to operate

• Documentation of CCF

• Quality Control Program (Screening Laboratory)

• Certification for Quality Control Standard System by a DOH recognized certifying body (Confirmatory Laboratory)

• Proficiency Testing Result

• Procedure Testing Manual

Licensing and Accreditation:

• Name of the owner

• Head of the Laboratory

• Procedures and Specialty

• Validity Report

• Signature of the Bureau or CHD Director

Content of License to Operate

1 year

Validity of LTO: Screening

2 years

Validity of LTO: Confirmatory

90 days

Renewal of LTO/COA:

before the expiration of license

• Application for renewal

• Notarized List of Personnel

• List of Equipments

• Current Certificate of Accreditation

• Current Mayor’s Permit

Renewal of LTO/COA:

License to Operate

• Current license to Operate

• Current Certification for Quality Standard System (Confirmatory Laboratory)

Renewal of LTO/COA:

Certificate of Accreditation

considered lapsed and will be cancelled

Terms and Conditions of Licensing/Accreditation:

A license/accreditation that is not renewed on the expiry date shall be ___

DOH via BHFS

Terms and Conditions of Licensing/Accreditation:

Any change in management name or ownership, floor plan, reliever, equipment, etc shall be reported to ___

• Issuance of fraudulent result

• Failure to protect the confidentiality of a drug test result

• Failure to participate in a proficiency testing

• Failure to refer a positive result to a confirmatory laboratory.

• Refusal to CHD to inspect their laboratory

• Any act which is contrary to the accepted clinical laboratory practice.

Violations

Issuance of False or Fraudulent Drug Test Results

Violations:

Any person authorized, licensed or accredited who issues false or fraudulent drug test results knowingly, willfully, or through gross negligence

6 years and 1 day to 12 years

Violations: Fraudulent Results

Imprisonment

Php 100, 000 to Php 500,000

Violations: Fraudulent Results

Fine

revocation of license to practice / closure of drug testing center

Violations: Fraudulent Results

Additional penalties

not be more than 60 days

Suspension or Revocation of LTO/COA:

preventive suspension

24 hours

Laboratory Examination or Test on Apprehended/Arrested Offenders:

Any person apprehended or arrested for violating the provisions of this act shall be subjected to screening laboratory examination within ___

15 days

Laboratory Examination or Test on Apprehended/Arrested Offenders:

If found to be positive, the results of the screening laboratory exam shall be challenged within ___ after the receipt of the result through a confirmatory test in any accredited laboratory

Gas chromatography/mass spectrometry

Laboratory Examination or Test on Apprehended/Arrested Offenders:

GOLD STANDARD

Liquid chromatography/ mass spectrometry

Laboratory Examination or Test on Apprehended/Arrested Offenders:

PLATINUM STANDARD

Franklin M. Drilon

President of the Senate

Gloria Macapagal-Arroyo

President

Anti-Drunk and Drugged Driving Act of 2013

RA 10586

on site field sobriety test and ABA testing

RA 10586:

A driver of a motor vehicle involved in a vehicular accident resulting in the loss of human life or physical injuries shall be subjected to ___

random terminal inspections and quick random drug tests

RA 10586:

The LTO shall conduct ___ of public utility drivers

RA 10640

An act to further strengthen the anti-drug campaign of the government, amending for the purpose section 21 of republic act no. 9165, otherwise known as the “comprehensive dangerous drugs act of 2002″

July 15, 2014

RA 10640 Approval Date

immediately

RA 10640:

A certification of the forensic laboratory examination results, which shall be done by the forensic laboratory examiner, shall be issued ___

Philippine Drug Enforcement Agency (PDEA)

RA 10640:

To implement effectively the provisions of Section 21, the ___ shall issue the necessary guidelines on the IRR for the purpose in consultation with the Department of Justice (DOJ) and relevant sectors to curb increasing drug cases

Jose De Venecia, Jr.

Speaker of the House of Representatives