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