A Critical Review of Drug Testing Policy in The Philippines: Carissa Paz Dioquino and Roy Roberto Gerona
A Critical Review of Drug Testing Policy in The Philippines: Carissa Paz Dioquino and Roy Roberto Gerona
A Critical Review of Drug Testing Policy in The Philippines: Carissa Paz Dioquino and Roy Roberto Gerona
Abstract
The drug policy in the Philippines is written as the Comprehensive Dangerous Drugs Act of 2002 or Republic Act 9165.
Unlike drug policies in other countries, the law includes policies on drug testing. Aside from mandatory drug testing for
specific situations, the law states further that two testing methods should be employed—a screening test, and a confirma-
tory test to be performed if the former yields a presumptive positive result. Over 1000 drugs of abuse screening labora-
tories are scattered all over the Philippines, but only seven can perform confirmatory testing using either gas
chromatography-mass spectrometry (GC-MS) or liquid chromatography-mass spectrometry (LC-MS) technologies. In
the last 30 years, more sophisticated analytical technologies like liquid chromatography-tandem mass spectrometry
(LC-MS/MS) and high-resolution mass spectrometry such as liquid chromatography-quadrupole time-of-flight mass spec-
trometry (LC-QTOF/MS) have been developed not only to confirm what has been detected on screening tests, but also
to determine the presence of new psychoactive substances that are not usually detected in drug screening. New matrices
are also being utilized for the detection of drugs. The drug testing policy in the Philippines will have to keep up with the
changing drug trends and drug testing innovations in the world to truly address the current administration’s war on drugs.
With the adoption of new drug testing methods using modern analytical platforms, the cut-offs used for drug testing inter-
pretation should be updated.
Keywords
LC-QTOF/MS, NPS, drug testing, mass spectrometry
the US. The US federal government also crafted specific Drugs Act of 1972. The republic act states which activities
guidelines for proficiency testing of the drug testing labora- would be considered unlawful when handling dangerous
tories. The Drug Testing Advisory Board currently advises drugs and indicates the corresponding penalties.
the Substance Abuse and Mental Health Services Dangerous drugs were defined as those appearing in the
Administration (SAMHSA) on the certification of drug schedules of drugs taken from various international conven-
testing laboratories. As of August 2018, there are 25 tions on narcotics and psychotropic drugs. Other drugs not
Department of Health and Human Services appearing in the schedules were added through various reg-
(HHS)-certified laboratories in the US and one in Canada ulations issued by the Dangerous Drugs Board (like gamma
(SAMHSA, 2016, 2017). Today, the guidelines cover the butyrolactone and 5F-APINACA) following advice of
use of accredited home drug-testing kits (SAMHSA, 2012). international bodies and moves by other countries
In the European Union (EU), the status of workplace (Dangerous Drugs Board, 2018, 2019). Penalties for viola-
drug testing is different from country to country. tions included imprisonment and monetary fines.
Workplace drug testing is specified in law in less than ten Article 3 of the law addresses testing for dangerous
member states. In others, there are no specific laws about drugs. Authorized drug testing is mandatory for the follow-
drug testing. Many of the states put high value to the ing: applicants for firearms license and permit to carry fire-
right of privacy of individuals but also recognize special arms outside of residence, military and law enforcement
situations when drug abuse would be a threat to security officers, candidates for public office, and persons charged
or safety of third parties (Wicks, 2019). In 1998, the with criminal offenses who will be serving time for more
European Workplace Drug Testing Society was created. than six years. Authorized drug testing is also required for
This organization is composed of individuals from different students in secondary and tertiary schools depending on
countries in Europe and aims “to ensure that workplace school policy and for workers in government offices
drug testing in Europe is performed to a defined quality based on the drug free workplace program in the specific
standard in a legally defensible way and to provide an inde- office as well (Comprehensive Dangerous Drugs Act,
pendent forum for all aspects of workplace drug testing” 2002; Philippine Drug Enforcement Agency [PDEA],
(European Workplace Drug Testing Society, 2017). n.d.). The clause requiring applicants for a driver’s license
There is not much published literature on drug testing to have a drug test was repealed by the Anti-Drunk and
policies in Asia. It is however known that drug laws in Drugged Driving Act of 2003 (Mendez, 2013). An author-
this region are generally harsh and the approach to wrong- ized drug test is one that is performed in a government
doers is punitive. The death penalty is still the most severe forensic laboratory or any other drug testing laboratory
sentence for drug traffickers in some countries (Dangerous that has been accredited by the Department of Health
Drugs Act, 1980; Narcotics Act B.E. 2522, 2019). through the Health Facilities and Services Regulatory
Bureau.
The law provides further that two testing methods should
Drug testing policy in the Philippines be employed for authorized drug testing—a screening test
and a confirmatory test. The confirmatory test would be per-
Drug testing policy in the Philippines is explicitly stipulated
formed if the screening test yields a presumptive positive
in Republic Act 9165 (RA 9165), known as the
result. The implementing rules and regulations for the law
Comprehensive Dangerous Drugs Act of 2002. It was tasked the Department of Health to accredit and monitor
enacted into law on the first regular session of the twelfth
these drug testing centers (PDEA, n.d.).
congress of the Republic of the Philippines on June 7,
In 2003, the guideline for the accreditation of drug
2002 and was signed by then President Gloria testing laboratories in the Philippines was released jointly
Macapagal-Arroyo. This law replaced the Dangerous
by the Department of Health and the Dangerous Drugs
Board. Immunoassays, thin layer chromatography and
Table 1. Cut-off values for drug testing in the Philippines point of care testing kits were identified as acceptable
(National Reference Laboratory, 2014). methods for screening, while confirmatory tests had to be
conducted in an analytical laboratory that uses gas
Initial screen Confirmation
chromatography-mass spectrometry (GC-MS) or “some
Drugs (ng/mL) (ng/mL)
such modern and accepted method” (Dangerous Drugs
Marijuana 50 15 Board [DDB], 2003; Health Facilities and Services
Cocaine 300 100 Regulatory Bureau, n.d.). While neither RA 9165 nor the
Opiates 2000 2000 Implementing Rules and Regulations for RA 9165 specified
Amphetamine 1000 250 a biologic specimen for drug testing, the guideline stated
Phencyclidine 25 25 procedures for urine collection. No other biologic matrix
Methamphetamine 500 250
was mentioned in the guideline. Cut-off values for the dif-
Benzodiazepines 300 300
ferent substances of abuse that can be tested in the
Dioquino and Gerona 3
Philippines have been set by the National Reference In accordance with the law, the Dangerous Drugs Board
Laboratory (NRL). Table 1 lists the cut-off values as they issued board resolutions to enforce mandatory and author-
appear in the manual of operations for screening drug- ized drug testing for persons carrying firearms, for the
testing laboratories. renewal of the driver’s license, for military and law enforce-
Over 1000 drugs of abuse screening laboratories are ment agents and for those occupying positions in govern-
scattered all over the Philippines but only seven can ment offices. Random drug testing was also required for
perform confirmatory testing. Most screening laboratories secondary and tertiary school students (Dangerous Drugs
use point of care testing kits in which a positive or negative Board, n.d).
test is detected visually through a color reaction on the test The National Anti-Drug Action Plan 2015–2020 is an
strip. Only testing kits that have been approved by the coun- important guidance document for Philippine government
try’s Food and Drug Administration can be used in the agencies that provides direction for the overall effort to
laboratories. Some laboratories use thin layer chromatog- address the problem of substance abuse in the country.
raphy for screening. The confirmatory laboratories use The vision for a drug-resistant and possibly a drug-free
either GC-MS or liquid chromatography-mass spectrometry Philippines will be achieved by reducing illicit manufactur-
(LC-MS) for drug testing. Three of these laboratories are ing and trafficking of drugs and drug related crimes, by
run by law enforcement or drug enforcement agencies reduction of marijuana cultivation, and by reduction in
(i.e. Philippines National Police, Philippine Drug the prevalence of drug use. The main strategies identified
Enforcement Agency, and National Bureau of in the plan are supply reduction, demand reduction, civic
Investigation). Only four laboratories are available for awareness, treatment and rehabilitation, alternative devel-
general cases. Two laboratories (i.e. Drugcheck opment, and regional and international cooperation.
Philippines Inc. and Lab Tox Analytical Laboratory Inc.) There has been plenty of government action in the
are private entities. The government runs the two remaining Philippines for supply and demand reduction in the last
laboratories (i.e. Southern Philippines Medical Center in six years through a program dubbed as “Oplan Tokhang”,
Davao City and NRL in Quezon City). As a result of this program, the National Household
The National Reference Laboratory (NRL) sets the stan- Survey in 2019 reported a drop in the number of substance
dards for drug testing in the country and accredits all users from 4 million in 2016 to 1.67 million. This survey
screening and confirmatory drug-testing laboratories. The also revealed that 81.6% respondents approved of the anti-
manual of operations prepared by the NRL is used by all drug operations (Dangerous Drugs Board, n.d.). The
the screening and confirmatory drug testing laboratories. success of “Oplan Tokhang” however will always be over-
It details infrastructure requirements for drug testing labora- shadowed by the many human lives that have been unjustly
tories like the use of waterless toilets in the facility to lost during the anti-drug campaign. Many international
prevent individuals from diluting their urine samples. It rights groups have criticized the current administration’s
also details procedures for sample collection, storage and program because of human rights violations. The perpetra-
transport. The use of the chain of custody form during spe- tors of these abuses that disrespect human lives will be
cimen handling is mandatory in the testing laboratories. brought to justice in the future.
There are also procedures to assess the validity of a col- The Dangerous Drugs Board also refined guidelines for
lected urine sample. The roles of each laboratory personnel mandatory drug testing in the past six years and pushed for
are defined and the recording and reporting requirements the creation of drug free workplace programs in both gov-
are discussed. All the laboratories also undergo proficiency ernment and private offices in the country (Dangerous
testing annually conducted by the NRL (National Reference Drugs Board, n.d.). While these directives are welcome,
Laboratory, 2014) compliance is wanting in the multitude of offices across
The NRL performs targeted drug testing on urine the country.
samples using GC-MS and LC-MS platforms. Levels of In the framework of the National Drug Action Plan, ana-
the following drugs of abuse or their metabolites can be lytical laboratories can confirm drug use in support of
tested in urine samples: marijuana (delta 9 hydroxy tetra- potential diagnosis and treatment of substance abuse.
hydrocannabinol, nor-9-carboxy tetrahydrocannabinol), Data derived from their operations may give a more accur-
benzoylecgonine (cocaine metabolite), opiates (morphine, ate picture of the substance use profile in the country. The
codeine, 6-monoacetylmorphine), amphetamines (metham- Philippine government, for example, is aware of the emer-
phetamine, amphetamine), phencyclidine and benzodiaze- gence of new psychoactive drugs (NPS) in the drug scene,
pines (nordiazepam, oxazepam) (National Reference citing this as one of the problems it faces. However, there is
Laboratory, 2014). Not all confirmatory laboratories have no existing testing facility for new psychoactive substances
the capability to perform targeted drug testing for all in the country. Clearly, the currently available technology
these drugs. The confirmatory test for methamphetamine in the Philippines for the targeted detection of substances
and tetrahydrocannabinol are the most commonly per- of abuse in the country as discussed above is inadequate
formed procedures. to address this growing threat. The lack of sufficient
4 Drug Science, Policy and Law
financial resources to update analytical technologies for drugs (Wu et al., 2012). Nevertheless, analytical platforms
NPS testing and to support programs to increase awareness like LC-QTOF/MS that allow non-targeted data acquisition
on the ill effects of emerging substances of abuse at the are proving to be responsive to this challenge. Non-targeted
grassroots aggravates this problem (Dangerous Drugs data acquisition allows collection of data on all ions present
Board, 2015). in biological samples that can then be later queried using
drug databases and libraries. If all drugs in the database
or library have available reference materials, data on their
Current global trends in drug testing exact mass, retention time, and mass spectra allow targeted
The 2021 United Nations Office on Drugs and Crime analysis. On the other hand, if the database or library only
(UNODC) World Report indicated a steady rise in the contains information on the exact mass (and possibly mass
prevalence of substance users and individuals with sub- spectra) of potential drug candidates, suspect screening on
stance use disorders over the last 10 years. The growth tentative drug matches can be performed (Gallardo et al.,
rate in substance users across regions vary widely with 2009). The latter allows for the discovery of novel recre-
strongest growth projected for low-income countries ational drugs and has paved the way for identifying NPS
(World Drug Report, 2021). The same report also reiterated that have not been previously reported and for which no
a warning about NPS in circulation around the world. prior commercial reference standard is available. Several
Typically, NPS are chemical derivatives or analogs of con- methods for targeted analysis and suspect screening of
trolled substances designed to produce effects similar to the illicit drugs and NPS using LC-QTOF/MS have recently
controlled substances they mimic (Liechti, 2015; Young been published (Kleis et al., 2021; Lung et al., 2016;
et al., 2015). A significant proportion of them have minor Montesano et al., 2017; Ojanperä et al., 2012).
structural differences from the traditional illicit drug they Along with the advancement of new analytical technolo-
mimic and yet they are not detected in urine drug screens gies, the utilization of alternative matrices for drug testing is
(Hohmann et al., 2014; UNODC, 2017; Weinstein et al., increasingly becoming popular. These matrices which
2017). include oral fluid, dried blood spot, and hair offer several
In the last 30 years, more sophisticated analytical tech- advantages over blood and urine: (1) ease of sampling pro-
nologies like liquid chromatography-tandem mass spec- cedure; (2) no requirement of cold chain for storage and
trometry (LC-MS/MS) and high-resolution mass shipment in the cases of DBS and hair; and (3) ability to
spectrometry such as liquid chromatography-quadrupole offer historical data of drug intake in the case of hair
time-of-flight mass spectrometry (LC-QTOF/MS) have (Moeller et al., 2017; Rao, 2014; Vincenti et al., 2013).
been developed not only to confirm what has been detected Non-invasive matrices like oral fluid has appealed to field
on screening tests, but also to determine the presence of drug testing such as sobriety test for motorists while dried
NPS that are not usually detected in drug screening blood spots are ideal for drug test subjects where subjects
(Barroso and Gallardo, 2015; Graziano et al., 2019; Pasin have limited blood volume such as in new born drug screen-
et al., 2017; Wu et al., 2012; Yuan et al., 2015).These plat- ing. Hair is a useful matrix when other sample matrices are
forms offer excellent specificity, sensitivity, and accuracy. unavailable such as in cases where human remains are in
Moreover, these are directly compatible with common bio- advanced stages of decomposition or when historical drug
logical samples available for testing like blood and urine. intake is needed such as in drug adherence or drug abstin-
The analysis typically requires only simple preparation ence monitoring.
methods, obviating the need for chemical derivatization Drug testing result interpretation also needs to evolve
commonly required in gas chromatography (Graziano with analytic technologies. The interpretation of drug test
et al., 2019; Pasin et al., 2017; Wu et al., 2012; Yuan results as being positive or negative has been based on
et al., 2015). the detection of drugs above a specific level known as the
LC-MS/MS has become the gold standard for the quan- cut-off value. These values are specific for the drugs
titative, targeted analysis of illicit and prescription drugs in being tested. Generally, cut-off values for screening tests
urine and blood. Quantitative assays for specific classes of are higher than those for confirmatory tests. Screening
drugs or comprehensive panels covering hundreds of drugs tests detect the presence of a larger number of substances
have been published and implemented for clinical and with similar chemical structure. Immunoassays are the
forensic testing in the last 30 years (Barroso and basis for most screening tests. In such tests, drugs with
Gallardo, 2015; Beck and Ericsson, 2014; Gallardo et al., similar chemical structures will react with antibodies devel-
2009; Seger, 2012; Wu and French, 2013). The advent of oped for a particular group of substances (Moeller et al.,
NPS in the last decade, however, demonstrated the limita- 2017). The screening test for opioids, for example, will
tions of targeted testing even for those developed in be positive if an individual has been exposed to codeine,
LC-MS/MS. The rapid evolution of NPS molecular struc- hydrocodone, morphine, and other opiates at specific
tures has made even comprehensive targeted drug panels levels. Exposure to heroin is detected by this screening
inadequate in identifying novel illicit and recreational test through the presence of 6-monoacetylmorphine, a
Dioquino and Gerona 5
metabolite of heroin. Many immunoassay tests exist even and come up with clear and actionable messages about
for a single class of drugs and may differ in selectivity, sen- the harm and danger of drug use and what can effectively
sitivity, and the variety of drugs they cross-react with. be done at various social contexts to prevent its spread.
Confirmatory tests use more sophisticated analytic plat- Establishing a response network that brings together dif-
forms that allow identification and quantification of individ- ferent agencies and organizations is also critical so that
ual drugs present in a given biologic sample. there is synergy in the efforts to combat the social and
Cut-off values were intended to be used for workplace health hazards of drug abuse. Ideally, the network can be
drug testing when they were first introduced. Thus, effectively run by a government-mandated center that
cut-off values in confirmatory tests were set to distinguish would coordinate interagency programs to educate the
bystander exposure from intentional use of drugs. The public on the psychosocial roots of drug use and abuse,
current technology for confirmatory drug testing, assist in conducting comprehensive drug surveillance, dis-
however, can detect drugs at lower levels than the cut-off seminate information on current drug trends, coordinate
values (Krock et al., 2017). In the clinical setting, when drug law enforcement, oversee standardized drug testing,
evaluating patient adherence to abstinence from taking implement effective drug rehabilitation programs, and
opioids, using the same cut-off value as in the workplace assist in designing impactful drug control and regulation
could give a false negative result, giving the clinician the policy.
wrong impression that a patient is no longer taking a drug Partnerships with more advanced regional and inter-
when he/she could be taking it at a low dose. In the forensic national drug testing laboratories would benefit local drug
setting, when the time a biological sample is taken is not at testing efforts. Such partnerships will allow transfer of
the peak from exposure, using cut-off values for workplace expertize in utilizing advanced analytic platforms that will
testing should not be applicable. Any level for any drug allow drug testing laboratories to expand the menu of sub-
detected should be reported. Drug test results using stances of abuse that can be tested and significantly improve
modern analytic techniques should be reported as actual the efficiency of drug testing for shorter analysis time. This
levels detected; cut-off values can then be applied depend- will help in resolving criminal cases more rapidly so that
ing on the purpose for which drug testing is administered. justice can be served in a timely manner. Moreover, diagno-
sis of clinical cases can be facilitated to allow appropriate
implementation of treatment regimens. These partnerships
Recommendations for the way forward will also encourage exchange of information on latest
The Comprehensive Dangerous Drugs Act of 2002 is broad drug trends and best practices that can effectively address
but the Philippines must catch up with developed countries drug use and abuse. Recreational drug use and abuse is a
in the science and technology of drug testing. There is much global problem.
that can be learned about innovations in drug testing. The Along with developing local expertize on more
policy must also keep up with the changing drug trends in advanced analytic methodologies for drug testing, updating
the world. Drug users are becoming more adventurous in the analytic platforms in the country’s laboratories is appro-
their drug explorations. More options for the variety of priate. More funding opportunities aimed to improve
drugs that can be abused and the method by which they research infrastructure have become available in recent
can be acquired have become available. The chemical cre- years. Allocating a fraction of these resources to technolo-
ativity of drug manufacturers also allows users to evade the gies that address one of the country’s leading social and
efforts of law enforcement agencies to curb misuse of psy- health problem is a prudent investment that will signifi-
chotropic substances. cantly bring about social and health benefits to the
To respond effectively to these challenges, various country. Considering that most of these modern instruments
experts including laboratory scientists (chemists and may be very costly, a few sentinel laboratories can be iden-
medical technologists), medical toxicologists, and law tified and supported to acquire these platforms and develop
enforcers must work more closely together to implement the required expertize to maximize their utility in compre-
standardized protocols for seizing samples that will pre- hensive drug testing. The interagency network can then
serve sample integrity and ensure accurate identification be tapped to streamline the efficient flow of samples from
and quantification of substances of abuse. The response the various organizations that can tap into the analytical ser-
should also include input from other stakeholders, including vices of the sentinel laboratories.
emergency physicians, psychiatrists, substance use disorder Finally, with the adoption of new drug testing methods
counselors and other medical professionals, pharmacolo- using modern analytical platforms, the cut-offs used for
gists and pharmacists, epidemiologists and public health drug testing interpretation should be updated. This update
experts, policy makers, and social advocates to determine should take into consideration the purpose for which drug
accurate trends in drug use and abuse, devise efficacious testing is being conducted. Drug monitoring for drug
intervention and treatment regimens to curb drug use and rehabilitation, workplace drug testing, and toxicology
drug addiction, legislate effective drug regulation policy, testing are administered for widely differing reasons.
6 Drug Science, Policy and Law
Thus, their interpretation should incorporate both analytical Dangerous Drugs Board (2019) Series 2019 Board Regulation 4
capabilities and characteristics and the ultimate purpose for Inclusion of gamma-butyrolactone (GBL) and all compounds,
which they are administered. Furthermore, with the avail- mixtures or preparations containing any quantity of the same,
ability of other matrices more suitable for specific types by whatever official, common or usual names, chemical name
or designated brand name, in the list of dangerous drugs.
of testing, recommendations for matrices other than urine
Available at: https://www.ddb.gov.ph/images/Board_Regulation/
should also be formulated. For example, causality in toxi-
2019/BOARD_REG_NO._4_S._2019.pdf
cology testing is better established by blood drug levels Department of Health and Human Services Substance Abuse and
rather than urine, while historical drug intake of a decedent Mental Health Administration (US) (2017) Mandatory guide-
can only be appropriately accomplished by segmental hair lines for federal workplace drug testing programs. Fed
analysis. Register 82(13): 7920–7970.
European Workplace Drug Testing Society (2017) By-laws.
Declaration of conflicting interests Available at: http://www.ewdts.org/data/uploads/documents/
ewdts-byelaws-jan-2017.pdf.
The author(s) declared no potential conflicts of interest with
Gallardo E, Barroso M and Queiroz JA (2009) LC-MS: A power-
respect to the research, authorship, and/or publication of this
ful tool in workplace drug testing. Drug Testing and Analysis
article.
1(3): 109–115.
Graziano S, Anzillotti L, Mannocchi G, et al. (2019) Screening
Funding methods for rapid determination of new psychoactive sub-
The author(s) disclosed receipt of the following financial support stances (NPS) in conventional and non-conventional biological
for the research, authorship, and/or publication of this article: matrices. Journal of Pharmaceutical and Biomedical Analysis
This work was supported by the Philippine-California Advanced 163: 170–179.
Research Institutes—Commission on Higher Education (grant Health Facilities and Services Regulatory Bureau (n.d.)
number IHITM 2017-031). Implementing rules and regulations governing accreditation
of drug testing laboratories in the Philippines (as revised).
Available at: https://hfsrb.doh.gov.ph/?page_id=15
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