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