UNIT 6 - RA 9165

Comprehensive Dangerous Drugs Act

Comprehensive Dangerous Drugs Act of 2002

RA 9165

When was RA 9165 established?

June 7, 2002

What does RA 9165 repeal

RA 6425

RA 6425 is also known as?

Dangerous Drugs Act of 1972

When was RA 6425 established?

March 30, 1972

RA 9165 was amended by what law?

RA 10640

When was RA 10640 established

July 15, 2014

It is the policy of the State to safeguard the integrity of its territory and the well-being of its citizenry particularly the youth, from the harmful effects of dangerous drugs on their physical and mental well-being, and to defend the same against acts or omissions detrimental to their development and preservation.

Declaration of Policy

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.

Administer

Refers to the professional who __perform the drug testin__g.

Analyst

What are the Certified Drug Analysts?

• Medical Technologist

• Chemist

• Chemical Engineer

• Pharmacist

person who is a__uthorized to collect specime__n from the client to secure and prevent alteration of Urine specimen.

Authorized Specimen Collector

any facility used for the __illegal manufacture__ of any dangerous drug and/or controlled precursor and essential chemical

Clandestine Laboratory

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

Chain of custody

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

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

Chain of Custody Form

There are hundreds of Dangerous drugs, but the most important and the most common tested in screening laboratory is?

• Methamphetamine (Shabu)

• Tetrahydrocanabinol (Marijuana)

Other parameters that are tested includes:

• Ecstasy

• Opium

• Cocaine

National Reference Laboratory for environmental and Occupational Health, Toxicology and Micronutrient assay

East Avenue Medical Center

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

Screening Test

a qualitative test

Screening test

an 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

Confirmatory test

Refers to the body fluid that is collected from a person

Specimen

What are the classifications of Drug Testing Laboratory by ownership?

• Government

• Private

What are the classification of Drug Testing Laboratory by Institutional Character?

• Institutional Based

• Freestanding

What are the classification of Drug Testing Laboratory by Service Capability?

• Screening Laboratory

• Confirmatory Laboratory

Conditions wherein drug testing is mandatory:

• 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 6**years and 1day**

• Persons **apprehended for the violations of this act**

Conditions wherein there is random drug testing:

• Students of Secondary or Tertiary schools

• Officers and employee of public and private and private offices whether domestic or oversees.

Technical Requirements for licensing of a **Screening Laboratory**

• 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 of a **Confirmatory Laboratory**

• At least 60sqm in floor area

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

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

at least 5 client at a time

A laboratory of whatever category shall have ______,__ ___**_____** and ______ for the collection of the specimen

Hand washing facility, toilet facility, and a stall for the collection of the specimen

Technical Requirements for licensing in terms of headship of the laboratory

• A licensed Physician certified in Clinical Pathology by the Philippine Board of Pathology

• If not available, a licensed physician with training in Clinical Laboratory Management.

• In case when a Laboratory is a division of the Laboratory, Licensed Physician, Chemist, Medical Technologist, Pharmacist or a Chemical Engineer.

• A licensed Chemist with at least Master’s Degree in Chemistry, Biochemistry or branch of chemistry with at least 2years experience in analytical chemistry.

Technical Requirements for Licensing in terms of Personnel of a **screening laboratory**

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 in terms of Personnel of a **confirmatory 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 Requirement for Licensing in terms of Laboratory Equipment of a **screening laboratory**

shall have a necessary equipment or kit.

Technical Requirement for Licensing in terms of Laboratory Equipment of **confirmatory laboratory**

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

The Laboratory shall have access to an **_____________** approved by the DOH for the authentication of results.

Application Service Provider

This government organization licenses and accredits drug testing centers

DOH

DOH in terms of 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

  • At least basic technologically advanced equipment and materials

• Appoint qualified and duly trained technical and other personnel

What are the technical requirement for **accreditation** in terms of **records**

• The Laboratory shall maintain a record of all of its personnel.

• The records must include the resume, training and experience, certification, PRC license, incident report (if any) and other information, which will established the competence of an employee.

What are the technical requirement for **accreditation** in terms of **security**

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.

What are the technical requirement for **accreditation** in terms of **chain of custody**

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

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•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 (1 year)**

Technical Requirement for Accreditation

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Storage of laboratoy reprots and specimens

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specimens can be stored for:

• Minimum of 5 days (negative)

• 15 days (positive but not challenged)

• 1 year

Technical Requirement for Accreditation

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•Urine Specimen Collection, Handling and Disposal

• The Laboratory shall follow the DOH prescribed guidelines in the collection, handling and disposal of specimens.

• Universal precautions must be observed at all times.

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T or F

T

match the following

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•Yellow

•Green

• Black

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Infectious waste such as gauze pad contaminated with urine specimen

Non-biodegradable waste (paper, office supply waste)

Biodegradable waster (food waste)

•Yellow – Infectious waste such as gauze pad contaminated with urine specimen

•Green – Biodegradable waster (food waste)

• Black – Non-biodegradable waste (paper, office supply waste)

Technical Requirement for Accreditation

* Equipment and instruments

•Screening Laboratory:

drug testing kits

Technical Requirement for Accreditation

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* Proficiency Testing

• The results must sent back to NRL within ______ after the results.

• Failure to pass the proficiency testing shall be given another chance, failure to pass the second one shall result in revocation of its license and accreditation

3 weeks

Technical Requirement for Accreditation

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* Proficiency Testing

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

revocation of its license and accreditation

Technical Requirement for Accreditation

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•Laboratory Report

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Signatory must be the ___ __who performed the test. and also the ----__

analyst & head of the laboratory

Technical Requirement for Accreditation

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•Laboratory Report

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• For screening, the test result must be reported as __________

• For Confirmatory, the test result shall report the _________

• positive and negative

• analyte and concentration

Technical Requirement for Accreditation

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•Laboratory Report

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* what are 2 copies that must be produced:

• 1 copy for the client

• 1 copy to be forewarded to DOH which INCLUDES the membrane of the drug test kit

Unlike pregnancy test result, a negative drug test result indicates a _________, and a positive result is an__ ______.

presence of line, absence of line

Licensing and Accreditation

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• The following must be submitted to DOH via BHFS before certificate of accreditation and license to operate is given:

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)

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• 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

What is the content of license to operate

• Name of the owner

• Head of the Laboratory

• Procedures and Specialty

• Validity Report

• Signature of the Bureau or CHD Director

validity of LTO

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screening: _____

confirmatory: ____

1, 2 years

Renewal of LTO/COA

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* It shall be filled _____ before the expiration of license

90 days

Renewal of LTO/COA

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what are the requirements need to renew License to operate:

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\

• Application for renewal

• Notarized List of Personnel

• List of Equipments

• Current Certificate of Accreditation

• Current Mayor’s Permit

Renewal of LTO/COA

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requirements for renewal of Certificate of Accreditation

• Current license to Operate

• Current Certification for Quality Standard System (Confirmatory Laboratory)

Monitoring of Laboratories

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The bureau or the CHD is not allowed to conduct a visit on the site (Laboratory) unannounced

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T or f

f - CAN CONDUCT VISIT UNANNOUNCED

Terms and Conditions of Licensing/Accreditation

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A license/accreditation that is not renewed on the expiry date shall be considered lapsed and will be cancelled

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t OR f

t

Terms and Conditions of Licensing/Accreditation

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Any change in management name or ownership, floor plan, reliever, equipment, etc shall be reported to the _____ __via__ ______

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DOH via BHFS

Terms and Conditions of Licensing/Accreditation

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License/Accreditation shall be placed in an area where it is _____

seen by the client

Violations of RA 9165

• 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.

Issuance of False or Fraudulent Drug Test Results

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penalties:

\- Imprisonment: **6 years and 1 day to 12 years** AND

\- Fine: **Php 100, 000. 00 to Php 500, 000. 00**

\- Additional penalties: revocation of license to practice / closure of drug testing center

Suspension or Revocation of LTO/COA

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• Based on its own inspection of any complaint, it shall be investigated and after due hearing, and depending on the judgment. Revocation or suspension of the license will be done.

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T or F

T

Suspension or Revocation of LTO/COA

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If any violation is done (under section 17) preventive suspension shall be done. And should not be more than ______

60 DAYS

Reapplication for LTO/COA

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• A Laboratory whose certificate of accreditation has been revoked may be reapply for the issuance of a new one upon compliance with the requirements established hereunder and/or the correction of the deficiency or violation.

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T OR F

T

Laboratory Examination or Test on Apprehended/Arrested Offenders

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

24 HOURS

Laboratory Examination or Test on Apprehended/Arrested Offenders

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• 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

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\

15 days

What is the **gold standard** confirmatory testing

Gas chromatography/mass spectrometry

What is the **platinum** confirmatory testing

• Liquid chromatography/ mass spectrometrty

When was RA 9165 established

January 23, 2002

President of the Philippines that approved RA 9165

Gloria Macapagal Arroyo

How many sections does RA 9165 have

102

also known as the Anti-Drunk and Drugged Driving Act of 2013

Republic Act No. 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 ____________, whenever practicable, and, thereafter chemical tests, including a drug screening test and, if necessary, a drug confirmatory test as mandated under__ _______

sobriety test and ABA testing

RA 9165

The LTO shall conduct random terminal inspections and quick random drug tests of public utility drivers

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t OR f

t

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″

Republic Act 10640

What does RA 10640 ammend. Section and RA

Section 21 of RA 9165

also known as comprehensive dangerous drugs act of 2002

RA 10640

RA 10640 is a consolidation of House Bill _____ __and Senate Bill__ __ __and was finally passed by the house of representatives and the senate on__ ____

2285, 2273, June 9 2014

When was RA 10640 approved

July 15, 2014

President who approved RA 10640

President Benigno Aquino

REPUBLIC ACT 10640

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• …. representative of the ____________ who shall be required to sign the copies of the inventory and be given a copy thereof: Provided, That the physical inventory and photograph shall be conducted at the place where the search warrant is served; or at the nearest police station or at the nearest office of the apprehending officer/team, whichever is practicable, in case of warrantless seizures: Provided, finally, That noncompliance of these requirements under justifiable grounds, as long as the integrity and the evidentiary value of the seized items are properly preserved by the apprehending officer/team, shall not render void and invalid such seizures and custody over said items.

National Prosecution Service or media

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

immediately

To implement effectively the provisions of Section 21, the ________ __shall issue the necessary guidelines on the IRR for the purpose in consultation with the__ _______) and relevant sectors to curb increasing drug cases

Philippine drug enforcement agency, department of justice

RA 10640

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To expedite the immediate disposition and destruction of seized/confiscated plant sources of dangerous drugs at the eradication site, the seizing officer or forensic chemist shall get and preserve their representative samples, after their seizure and confiscation, and perform field or screening test at the site, as far as practicable. The release of the certification or chemistry report shall be after the confirmatory test of the samples examined.

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T or F