Monitoring_VVG risk_NN1 :_: Post_NN1 marketing_NN1 surveillance_NN1 and_CC signal_NN1 detection_NN1 Introduction_NN1 to_TO risk_VVI management_NN1 Risk_NN1 management_NN1 is_VBZ the_AT process_NN1 of_IO assessing_VVG a_AT1 product_NN1 's_GE benefits_NN2 and_CC risks_NN2 ,_, followed_VVN by_II developing_VVG and_CC implementing_VVG tools_NN2 to_TO minimize_VVI its_APPGE risk_NN1 ._. 
The_AT goal_NN1 is_VBZ to_TO maintain_VVI the_AT benefits_NN2 of_IO a_AT1 drug_NN1 while_CS reducing_VVG the_AT risks_NN2 as_RG much_DA1 as_CSA possible_JJ ._. 
Ultimately_RR ,_, the_AT balance_NN1 of_IO benefits_NN2 and_CC risks_NN2 determines_VVZ whether_CSW the_AT drug_NN1 will_VM be_VBI withdrawn_VVN from_II the_AT commercial_JJ market_NN1 ,_, or_CC in_II the_AT case_NN1 of_IO new_JJ drug_NN1 applications_NN2 ,_, approved_VVN or_CC disapproved_VVD ._. 
The_AT importance_NN1 of_IO risk_NN1 management_NN1 has_VHZ been_VBN recognized_VVN by_II the_AT U.S._NP1 Food_NN1 and_CC Drug_NN1 Administration_NN1 (_( FDA_NP1 )_) for_IF many_DA2 years_NNT2 ._. 
The_AT FDA_NN1 defines_VVZ three_MC phases_NN2 of_IO risk_NN1 management_NN1 :_: (_( 1_MC1 )_) risk_VV0 assessment_NN1 ,_, (_( 2_MC )_) surveillance_NN1 ,_, and_CC (_( 3_MC )_) intervention_NN1 ._. 
These_DD2 phases_NN2 form_VV0 a_AT1 cycle_NN1 that_CST is_VBZ repeated_VVN to_TO provide_VVI continual_JJ assessment_NN1 and_CC intervention_NN1 and_CC optimize_VVI the_AT benefit-risk_JJ ratio_NN1 of_IO a_AT1 drug_NN1 ._. 
Often_RR ,_, the_AT importance_NN1 of_IO surveillance_NN1 in_II the_AT process_NN1 of_IO risk_NN1 management_NN1 is_VBZ overlooked_VVN ._. 
At_II the_AT time_NNT1 of_IO initial_JJ marketing_NN1 ,_, the_AT data_NN available_JJ to_TO evaluate_VVI the_AT risks_NN2 of_IO a_AT1 medication_NN1 are_VBR limited_VVN ._. 
Information_NN1 regarding_II chemical_JJ structure_NN1 ,_, abuse_NN1 liability_NN1 in_II animals_NN2 and_CC humans_NN2 ,_, and_CC clinical_JJ trial_NN1 data_NN allow_VV0 useful_JJ characterization_NN1 of_IO many_DA2 risks_NN2 ._. 
Pre-marketing_JJ risk_NN1 assessment_NN1 before_II drug_NN1 approval_NN1 could_VM be_VBI improved_VVN by_II development_NN1 of_IO standards_NN2 for_IF assessing_VVG tamper-resistance_NN1 ,_, improved_JJ animal_NN1 models_NN2 that_CST can_VM address_VVI formulation-related_JJ variables_NN2 (_( e.g._REX ,_, onset_NN1 ,_, duration_NN1 )_) ,_, and_CC the_AT redesign_NN1 of_IO human_JJ laboratory_NN1 studies_NN2 providing_VVG appropriate_JJ models_NN2 for_IF comparing_VVG formulations_NN2 ._. 
Although_CS risks_NN2 can_VM be_VBI identified_VVN before_II marketing_NN1 and_CC addressed_VVN in_II a_AT1 risk_NN1 management_NN1 strategy_NN1 ,_, some_DD risks_NN2 will_VM not_XX become_VVI apparent_JJ until_CS after_CS the_AT drug_NN1 is_VBZ in_II widespread_JJ use_NN1 in_II multiple_JJ populations_NN2 ._. 
These_DD2 events_NN2 are_VBR detected_VVN by_II postmarketing_VVG surveillance_NN1 ,_, which_DDQ provides_VVZ data_NN for_IF intervention_NN1 as_II31 well_II32 as_II33 informing_VVG potential_JJ revisions_NN2 to_II the_AT risk_NN1 management_NN1 assessment_NN1 ._. 
Postmarketing_VVG surveillance_NN1 is_VBZ a_AT1 core_NN1 component_NN1 of_IO risk_NN1 management_NN1 because_CS without_IW data_NN to_TO guide_VVI interventions_NN2 ,_, risk_NN1 assessment_NN1 is_VBZ based_VVN largely_RR on_II expert_NN1 assessment_NN1 ,_, which_DDQ is_VBZ based_VVN in_II turn_NN1 on_II pre-marketing_JJ information_NN1 ._. 
While_CS a_AT1 useful_JJ and_CC important_JJ adjunct_NN1 in_II decision_NN1 making_VVG ,_, expert_NN1 assessment_NN1 can_VM be_VBI misleading_JJ ._. 
Numerous_JJ medications_NN2 have_VH0 been_VBN approved_VVN for_IF marketing_NN1 ,_, for_REX21 example_REX22 ,_, only_RR to_TO receive_VVI warnings_NN2 or_CC be_VBI withdrawn_VVN because_CS expert_JJ assessment_NN1 did_VDD not_XX identify_VVI specific_JJ problems_NN2 during_II the_AT pre-marketing_JJ phase_NN1 ._. 
For_IF examples_NN2 ,_, see_VV0 the_AT FDA_NN1 list_NN1 of_IO new_JJ warnings_NN2 and_CC withdrawals_NN2 of_IO marketed_JJ drugs_NN2 ._. 
Postmarketing_VVG surveillance_NN1 Postmarketing_VVG surveillance_NN1 is_VBZ the_AT practice_NN1 of_IO monitoring_VVG a_AT1 pharmaceutical_JJ product_NN1 or_CC device_NN1 after_CS it_PPH1 has_VHZ been_VBN released_VVN on_II the_AT general_JJ market_NN1 ._. 
Pharmaceutical_JJ products_NN2 have_VH0 been_VBN subjected_VVN to_II various_JJ forms_NN2 of_IO postmarketing_VVG surveillance_NN1 for_IF as_CS31 long_CS32 as_CS33 drugs_NN2 have_VH0 existed_VVN ._. 
Today_RT ,_, some_DD type_NN1 of_IO postmarketing_VVG surveillance_NN1 is_VBZ required_VVN for_IF all_DB pharmaceutical_JJ products_NN2 in_II the_AT U.S._NP1 Pharmaceutical_JJ manufacturers_NN2 have_VH0 developed_VVN extensive_JJ adverse_JJ event_NN1 reporting_NN1 systems_NN2 that_CST accept_VV0 spontaneous_JJ reports_NN2 of_IO adverse_JJ events_NN2 from_II patients_NN2 or_CC health_NN1 care_NN1 professionals_NN2 ._. 
In_II some_DD cases_NN2 ,_, adverse_JJ event_NN1 surveillance_NN1 can_VM identify_VVI a_AT1 new_JJ ,_, but_CCB real_JJ ,_, risk_VV0 when_RRQ an_AT1 unexpected_JJ event_NN1 is_VBZ reported_VVN and_CC ,_, perhaps_RR followed_VVN by_II reports_NN2 of_IO a_AT1 cluster_NN1 of_IO similar_JJ or_CC related_JJ events_NN2 ._. 
For_REX21 example_REX22 ,_, when_CS a_AT1 report_NN1 to_II a_AT1 pharmaceutical_JJ manufacturer_NN1 revealed_VVD that_CST a_AT1 patient_JJ developed_JJ fulminant_JJ hepatic_JJ failure_NN1 during_II treatment_NN1 with_IW troglitazone_NN1 (_( Rezulin_NP1 )_) ,_, a_AT1 hypoglycemic_JJ agent_NN1 for_IF the_AT treatment_NN1 of_IO diabetes_NN1 mellitus_NN1 ,_, this_DD1 previously_RR unrecognized_JJ risk_NN1 was_VBDZ documented_VVN and_CC triggered_VVN a_AT1 regulatory_JJ response_NN1 ._. 
Detailed_JJ analysis_NN1 of_IO individual_JJ cases_NN2 and_CC perhaps_RR the_AT discovery_NN1 of_IO other_JJ cases_NN2 allow_VV0 the_AT identification_NN1 of_IO potential_JJ associations_NN2 between_II drug_NN1 exposure_NN1 and_CC the_AT event_NN1 ._. 
After_CS a_AT1 relationship_NN1 has_VHZ been_VBN identified_VVN ,_, more_RGR focused_JJ data_NN collection_NN1 and_CC analysis_NN1 allow_VV0 the_AT manufacturer_NN1 and_CC the_AT FDA_NN1 to_TO investigate_VVI the_AT events_NN2 and_CC take_VVI appropriate_JJ action_NN1 ._. 
The_AT term_NN1 adverse_JJ event_NN1 has_VHZ typically_RR indicated_VVN undesired_JJ effects_NN2 that_CST occur_VV0 during_II intended_JJ use_NN1 of_IO a_AT1 product_NN1 ._. 
The_AT discovery_NN1 of_IO congenital_JJ malformations_NN2 after_II the_AT use_NN1 of_IO thalidomide_NN1 during_II pregnancy_NN1 occurred_VVD during_II the_AT normal_JJ therapeutic_JJ use_NN1 of_IO the_AT drug_NN1 in_II pregnant_JJ women_NN2 ._. 
Conversely_RR ,_, adverse_JJ drug_NN1 effects_NN2 that_CST occur_VV0 with_IW non-therapeutic_JJ intent_NN1 are_VBR often_RR not_XX considered_VVN adverse_JJ events_NN2 ._. 
For_REX21 example_REX22 ,_, toxic_JJ epidermal_JJ necrolysis_NN1 (_( TEN_MC )_) during_II the_AT use_NN1 of_IO phenytoin_NN1 is_VBZ a_AT1 well-known_JJ adverse_JJ event_NN1 ,_, but_CCB respiratory_JJ arrest_NN1 and_CC coma_NN1 following_VVG abuse_NN1 of_IO an_AT1 opioid_NN1 is_VBZ generally_RR considered_VVN separately_RR because_CS it_PPH1 is_VBZ the_AT expected_JJ pharmacological_JJ effect_NN1 of_IO an_AT1 intentional_JJ overdose_NN1 ._. 
In_II truth_NN1 ,_, all_DB unintended_JJ effects_NN2 of_IO medication_NN1 use_NN1 ,_, even_RR abuse_VV0 and_CC intentional_JJ overdose_NN1 ,_, are_VBR adverse_JJ events_NN2 that_CST should_VM be_VBI reported_VVN ._. 
Surveillance_NN1 systems_NN2 for_IF misuse_NN1 ,_, abuse_NN1 and_CC diversion_NN1 of_IO prescription_NN1 drugs_NN2 An_AT1 effective_JJ surveillance_NN1 system_NN1 informs_VVZ risk_NN1 management_NN1 decisions_NN2 by_II providing_VVG current_JJ ,_, as_II31 well_II32 as_II33 sensitive_JJ and_CC specific_JJ information_NN1 ._. 
The_AT timeliness_NN1 of_IO surveillance_NN1 data_NN is_VBZ crucial_JJ ._. 
However_RR ,_, classic_JJ epidemiology_NN1 studies_NN2 are_VBR carried_VVN out_RP over_II longer_JJR periods_NN2 of_IO time_NNT1 and_CC the_AT results_NN2 are_VBR often_RR reported_VVN a_AT1 year_NNT1 or_CC more_RRR after_II the_AT research_NN1 was_VBDZ performed_VVN ._. 
These_DD2 time_NNT1 frames_NN2 are_VBR very_RG long_JJ in_II31 terms_II32 of_II33 drug_NN1 abuse_NN1 surveillance_NN1 ._. 
For_REX21 instance_REX22 ,_, by_II the_AT time_NNT1 the_AT results_NN2 are_VBR reported_VVN ,_, the_AT abuse_NN1 conditions_NN2 in_II the_AT area_NN1 may_VM have_VHI changed_VVN ._. 
While_CS traditional_JJ epidemiologic_JJ studies_NN2 provide_VV0 crucial_JJ information_NN1 in_II31 terms_II32 of_II33 general_JJ characteristics_NN2 of_IO abuse_NN1 ,_, they_PPHS2 do_VD0 not_XX provide_VVI information_NN1 that_CST a_AT1 risk_NN1 management_NN1 program_NN1 can_VM act_VVI upon_II in_II a_AT1 timely_JJ manner_NN1 ._. 
Thus_RR ,_, the_AT FDA_NN1 often_RR requests_VVZ that_DD1 surveillance_NN1 data_NN be_VBI provided_VVN on_II a_AT1 quarterly_JJ basis_NN1 although_CS more_RGR frequent_JJ monitoring_NN1 may_VM be_VBI needed_VVN for_IF specific_JJ reasons_NN2 such_II21 as_II22 the_AT introduction_NN1 of_IO a_AT1 new_JJ product_NN1 ._. 
Data_NN for_IF surveillance_NN1 should_VM be_VBI available_JJ within_II weeks_NNT2 or_CC months_NNT2 depending_II21 on_II22 the_AT precise_JJ application_NN1 of_IO those_DD2 data_NN ._. 
A_AT1 surveillance_NN1 program_NN1 should_VM also_RR cover_VVI all_DB regions_NN2 within_II the_AT United_NP1 States_NP1 because_CS drug_NN1 abuse_NN1 of_IO specific_JJ drugs_NN2 and_CC products_NN2 can_VM be_VBI localized_VVN ._. 
Again_RT ,_, data_NN generated_VVN for_IF a_AT1 valid_JJ national_JJ estimate_NN1 are_VBR important_JJ ,_, but_CCB do_VD0 not_XX provide_VVI all_DB the_AT information_NN1 needed_VVD to_TO allow_VVI targeted_JJ investigation_NN1 and_CC intervention_NN1 ._. 
Specific_JJ information_NN1 for_IF every_AT1 3-digit_JJ ZIP_NN1 code_NN1 (_( or_CC similar_JJ specific_JJ geopolitical_JJ unit_NN1 )_) should_VM be_VBI available_JJ ._. 
Product_NN1 specificity_NN1 is_VBZ also_RR important_JJ because_CS not_XX all_DB products_NN2 are_VBR equal_JJ in_II31 terms_II32 of_II33 abuse_NN1 ._. 
Generic_JJ versions_NN2 of_IO products_NN2 may_VM be_VBI abused_VVN more_RRR ,_, less_RRR ,_, or_CC the_AT same_DA as_CSA their_APPGE branded_JJ counterparts_NN2 ._. 
In_II some_DD cases_NN2 ,_, abusers_NN2 may_VM prefer_VVI certain_JJ formulations_NN2 or_CC brand_NN1 names_NN2 ._. 
Using_VVG brand_NN1 names_NN2 ,_, for_REX21 instance_REX22 ,_, allows_VVZ an_AT1 abuser_NN1 to_TO be_VBI more_RGR certain_JJ that_CST they_PPHS2 have_VH0 not_XX purchased_VVN a_AT1 counterfeit_JJ drug_NN1 ._. 
On_II the_AT other_JJ hand_NN1 ,_, a_AT1 generic_JJ drug_NN1 may_VM be_VBI easier_JJR or_CC less_RGR expensive_JJ to_TO obtain_VVI ._. 
Further_RRR ,_, certain_JJ formulations_NN2 may_VM be_VBI easier_JJR to_TO abuse_VVI ._. 
Surveillance_NN1 systems_NN2 must_VM be_VBI able_JK to_TO identify_VVI the_AT specific_JJ product_NN1 accurately_RR and_CC consistently_RR ._. 
Different_JJ prescription_NN1 drugs_NN2 may_VM also_RR be_VBI abused_VVN by_II different_JJ portions_NN2 of_IO the_AT population_NN1 ._. 
For_REX21 example_REX22 ,_, individuals_NN2 initiating_VVG abuse_NN1 of_IO drugs_NN2 may_VM prefer_VVI certain_JJ drug_NN1 products_NN2 specifically_RR because_II21 of_II22 their_APPGE brand_NN1 name_NN1 ,_, as_CSA noted_VVN above_RL ._. 
Drug_NN1 dealers_NN2 may_VM prefer_VVI formulations_NN2 that_CST contain_VV0 a_AT1 large_JJ amount_NN1 of_IO the_AT drug_NN1 so_CS21 that_CS22 this_DD1 can_VM be_VBI divided_VVN and_CC sold_VVN profitably_RR ._. 
New_JJ initiates_VVZ often_RR prefer_VV0 to_TO use_VVI a_AT1 product_NN1 orally_RR but_CCB with_IW time_NNT1 and_CC experience_NN1 may_VM switch_VVI to_II more_RGR potent_JJ and_CC riskier_JJR injection_NN1 routes_NN2 of_IO administration_NN1 leading_VVG them_PPHO2 to_TO choose_VVI a_AT1 different_JJ formulation_NN1 ._. 
There_EX are_VBR also_RR unintended_JJ victims_NN2 of_IO prescription_NN1 drug_NN1 abuse_NN1 ,_, and_CC surveillance_NN1 systems_NN2 may_VM need_VVI to_TO include_VVI these_DD2 individuals_NN2 ._. 
For_REX21 example_REX22 ,_, pediatric_JJ deaths_NN2 have_VH0 occurred_VVN in_II31 association_II32 with_II33 the_AT use_NN1 or_CC abuse_NN1 of_IO prescription_NN1 opioid_NN1 products_NN2 by_II their_APPGE caregiver_NN1 (_( e.g._REX pills_NN2 left_VVN within_II reach_NN1 of_IO young_JJ child_NN1 )_) ._. 
Thus_RR ,_, surveillance_NN1 systems_NN2 may_VM need_VVI to_TO include_VVI pediatric_JJ cases_NN2 ._. 
Other_JJ potential_JJ victims_NN2 include_VV0 family_NN1 members_NN2 and_CC friends_NN2 ,_, who_PNQS may_VM suffer_VVI theft_NN1 ,_, loss_NN1 of_IO financial_JJ support_NN1 ,_, or_CC potentially_RR infectious_JJ complications_NN2 like_II hepatitis_NN1 or_CC human_JJ immunodeficiency_NN1 virus_NN1 ._. 
The_AT role_NN1 of_IO quality_NN1 in_II data_NN collection_NN1 and_CC analysis_NN1 is_VBZ often_RR neglected_VVN ._. 
The_AT processes_NN2 needed_VVN to_TO ensure_VVI data_NN integrity_NN1 and_CC accuracy_NN1 are_VBR not_XX used_VVN in_II some_DD systems_NN2 ._. 
Quality_NN1 control_NN1 systems_NN2 are_VBR necessary_JJ to_TO assure_VVI that_CST data_NN are_VBR collected_VVN appropriately_RR ,_, managed_VVD cleanly_RR and_CC reported_VVN accurately_RR without_IW sacrificing_VVG time_NNT1 ._. 
Attentive_JJ quality_NN1 control_NN1 always_RR reveals_VVZ sources_NN2 of_IO errors_NN2 that_CST can_VM affect_VVI the_AT impact_NN1 of_IO surveillance_NN1 data_NN ._. 
A_AT1 quality_NN1 improvement_NN1 program_NN1 is_VBZ needed_VVN to_TO address_VVI quality_NN1 issues_NN2 and_CC assure_VVI that_CST the_AT system_NN1 consistently_RR improves_VVZ itself_PPX1 ._. 
Groups_NN2 of_IO surveillance_NN1 systems_NN2 have_VH0 emerged_VVN due_II21 to_II22 the_AT need_NN1 for_IF multiple_JJ perspectives_NN2 in_II the_AT surveillance_NN1 of_IO CNS_NP1 drugs_NN2 ,_, For_REX21 example_REX22 ,_, the_AT Researched_VVN Abuse_NN1 ,_, Diversion_NN1 and_CC Addiction-Related_JJ Surveillance_NN1 System_NN1 (_( RADARS_NN2 ?_? 
System_NN1 )_) includes_VVZ multiple_JJ simultaneous_JJ perspectives_NN2 on_II prescription_NN1 opioid_NN1 and_CC stimulant_JJ abuse_NN1 ._. 
The_AT RADARS_NN2 ?_? 
System_NN1 's_GE Drug_NN1 Diversion_NN1 System_NN1 provides_VVZ a_AT1 criminal_JJ justice_NN1 perspective_NN1 on_II prescription_NN1 drug_NN1 abuse_NN1 by_II surveying_VVG more_DAR than_CSN 300_MC diversion_NN1 investigators_NN2 from_II jurisdictions_NN2 in_II all_DB 50_MC states_NN2 ._. 
The_AT Key_JJ Informant_NN1 System_NN1 provides_VVZ the_AT perspective_NN1 of_IO substance_NN1 abuse_NN1 treatment_NN1 professionals_NN2 by_II surveying_VVG approximately_RR 160_MC designated_JJ key_JJ informants_NN2 from_II a_AT1 variety_NN1 of_IO treatment_NN1 facilities_NN2 across_II the_AT United_NP1 States_NP1 ._. 
The_AT Poison_NN1 Control_NN1 System_NN1 provides_VVZ information_NN1 on_II acute_JJ incidents_NN2 involving_VVG prescription_NN1 drug_NN1 both_RR in_II the_AT home_NN1 and_CC in_II the_AT emergency_NN1 care_NN1 system_NN1 ._. 
Data_NN include_VV0 acute_JJ and_CC chronic_JJ exposures_NN2 for_IF all_DB ages_NN2 from_II 47_MC poison_NN1 centers_NN2 ,_, including_II rural_JJ ,_, urban_JJ ,_, and_CC suburban_JJ areas_NN2 of_IO the_AT United_NP1 States_NP1 ._. 
The_AT Opioid_JJ Treatment_NN1 Program_NN1 System_NN1 provides_VVZ the_AT perspective_NN1 of_IO opioid_JJ dependent_JJ patients_NN2 by_II surveying_VVG patients_NN2 in_II 75_MC methadone_NN1 treatment_NN1 programs_NN2 about_II their_APPGE individual_JJ drug_NN1 use_NN1 ._. 
The_AT Survey_NN1 of_IO Key_JJ Informant_NN1 Patients_NN2 (_( SKIP_NN1 )_) complements_VVZ the_AT Opioid_JJ Treatment_NN1 Program_NN1 by_II anonymously_RR surveying_VVG approximately_RR 300_MC patients_NN2 nationwide_RL ._. 
The_AT College_NN1 Survey_NN1 provides_VVZ information_NN1 about_II young_JJ new_JJ abusers_NN2 of_IO prescription_NN1 drugs_NN2 by_II surveying_VVG 2000_MC college_NN1 and_CC university_NN1 students_NN2 across_II the_AT nation_NN1 ._. 
Finally_RR ,_, the_AT Health_NN1 Care_VV0 Professional_JJ System_NN1 aggregates_VVZ information_NN1 from_II the_AT other_JJ systems_NN2 that_CST are_VBR specific_JJ to_II health_NN1 care_NN1 professionals_NN2 ._. 
All_DB of_IO these_DD2 RADARS_NN2 System_NN1 components_NN2 provide_VV0 current_JJ data_NN every_AT1 quarter_NN1 or_CC more_RGR frequently_RR ._. 
The_AT Navippro_NN1 ?_? system_NN1 consists_VVZ of_IO two_MC major_JJ proprietary_JJ databases_NN2 and_CC draws_VVZ from_II other_JJ public_JJ databases_NN2 across_II the_AT United_NP1 States_NP1 ._. 
The_AT proprietary_JJ databases_NN2 are_VBR ASI-MV_JJ Connect_VV0 and_CC Web_NN1 informed_VVD Services_NN2 (_( WIS_NP1 )_) :_: internet_NN1 monitoring_NN1 and_CC surveys_NN2 on_II prescription_NN1 drug_NN1 misuse_NN1 ._. 
The_AT public_JJ databases_NN2 used_VVN include_VV0 American_JJ Association_NN1 of_IO Poison_NN1 Control_NN1 Centers_NN2 '_GE New_JJ Core_NN1 System_NN1 Database_NN1 (_( NCSBeta_NP1 )_) ,_, FDA-Adverse_JJ Event_NN1 Reporting_NN1 System_NN1 (_( AERS_NN2 )_) ,_, Drug_NN1 Abuse_NN1 Warning_NN1 Network_NN1 (_( DAWN_NP1 Live_VV0 !_! )_) ,_, 
DEA_NP1 news_NN1 ,_, and_CC Medline_NP1 articles_NN2 ._. 
Other_JJ systems_NN2 are_VBR also_RR available_JJ ._. 
Often_RR ,_, manufacturers_NN2 construct_VV0 their_APPGE own_DA systems_NN2 by_II melding_VVG data_NN from_II one_MC1 or_CC more_DAR surveillance_NN1 systems_NN2 with_IW their_APPGE own_DA monitoring_NN1 of_IO adverse_JJ events_NN2 and_CC media_NN surveillance_NN1 ._. 
In_II some_DD cases_NN2 ,_, unique_JJ approaches_NN2 have_VH0 yielded_VVN insights_NN2 into_II abuser_NN1 's_GE perceptions_NN2 of_IO prescription_NN1 drugs_NN2 ._. 
Conclusion_NN1 and_CC recommendations_NN2 Assessment_NN1 of_IO misuse_NN1 ,_, abuse_NN1 ,_, and_CC diversion_NN1 of_IO prescription_NN1 drugs_NN2 must_VM address_VVI its_APPGE occult_NN1 nature_NN1 and_CC involves_VVZ fundamentally_RR different_JJ surveillance_NN1 compared_VVN to_II other_JJ pharmaceutical_JJ products_NN2 ._. 
Current_JJ best_JJT practice_NN1 is_VBZ to_TO use_VVI multiple_JJ detection_NN1 systems_NN2 to_TO assess_VVI misuse_NN1 ,_, abuse_NN1 and_CC diversion_NN1 of_IO CNS_NP1 active_JJ drugs_NN2 by_II various_JJ populations_NN2 in_II a_AT1 timely_JJ ,_, sensitive_JJ ,_, and_CC specific_JJ manner_NN1 ._. 
Data_NN should_VM be_VBI available_JJ within_II weeks_NNT2 ,_, to_II able_JK to_TO detect_VVI reasonable_JJ changes_NN2 in_II abuse_NN1 rates_NN2 ,_, and_CC must_VM accurately_RR identify_VVI the_AT product(s)_NN2 involved_VVN as_II31 well_II32 as_II33 the_AT specific_JJ geographic_JJ location_NN1 ._. 
Furthermore_RR ,_, the_AT best_JJT surveillance_NN1 systems_NN2 also_RR can_VM provide_VVI preliminary_JJ information_NN1 about_II further_JJR research_NN1 and_CC intervention_NN1 needed_VVN in_II those_DD2 areas_NN2 ._. 
Several_DA2 surveillance_NN1 challenges_NN2 persist_VV0 for_IF manufacturers_NN2 and_CC regulators_NN2 of_IO CNS_NP1 active_JJ drugs_NN2 ._. 
The_AT acceptable_JJ level_NN1 of_IO misuse_NN1 ,_, abuse_NN1 and_CC diversion_NN1 has_VHZ not_XX been_VBN defined_VVN ._. 
The_AT rate_NN1 of_IO abuse_NN1 ,_, or_CC the_AT change_NN1 in_II the_AT rate_NN1 of_IO abuse_NN1 ,_, that_DD1 warrants_VVZ intervention_NN1 has_VHZ not_XX been_VBN defined_VVN ._. 
Since_CS some_DD level_NN1 of_IO misuse_NN1 and_CC abuse_NN1 occur_VV0 with_IW all_DB CNS_NP1 drugs_NN2 ,_, the_AT FDA_NN1 and_CC other_JJ authorities_NN2 should_VM begin_VVI the_AT process_NN1 of_IO explicitly_RR designating_VVG tolerable_JJ levels_NN2 of_IO misuse_NN1 and_CC abuse_NN1 ._. 
The_AT tolerable_JJ level_NN1 of_IO diversion_NN1 must_VM also_RR be_VBI defined_VVN ,_, but_CCB raises_VVZ different_JJ issues_NN2 because_CS it_PPH1 involves_VVZ the_AT criminal_JJ justice_NN1 system_NN1 ._. 
An_AT1 important_JJ emerging_JJ issue_NN1 involves_VVZ identifying_VVG specific_JJ drugs_NN2 that_CST should_VM always_RR require_VVI surveillance_NN1 ._. 
The_AT list_NN1 of_IO drugs_NN2 reported_VVN to_TO be_VBI abused_VVN is_VBZ long_JJ and_CC many_DA2 contrasts_NN2 and_CC contradictions_NN2 are_VBR apparent_JJ ._. 
While_CS extended-release_JJ opioid_JJ medications_NN2 are_VBR scrutinized_VVN closely_RR ,_, other_JJ opioid_JJ products_NN2 seem_VV0 less_RGR closely_RR examined_VVN ._. 
It_PPH1 seems_VVZ logical_JJ that_CST branded_JJ products_NN2 and_CC products_NN2 from_II generic_JJ drug_NN1 manufacturers_NN2 should_VM be_VBI required_VVN to_TO have_VHI equally_RR rigorous_JJ risk_NN1 management_NN1 programs_NN2 ._. 
Benzodiazepine_VV0 drugs_NN2 seem_VV0 to_TO receive_VVI little_DA1 attention_NN1 despite_II widespread_JJ evidence_NN1 of_IO abuse_NN1 ._. 
Similarly_RR ,_, anticholinergic_JJ drugs_NN2 like_II diphenhydramine_NN1 are_VBR sometimes_RT abused_VVN by_II adolescents_NN2 ._. 
The_AT effects_NN2 can_VM be_VBI dramatic_JJ (_( hallucinations_NN2 )_) ,_, but_CCB outcomes_NN2 are_VBR generally_RR mild_JJ ._. 
Perhaps_RR risk_VV0 management_NN1 should_VM be_VBI required_VVN for_IF these_DD2 drugs_NN2 as_RR21 well_RR22 ._. 
Another_DD1 issue_NN1 concerns_VVZ the_AT precise_JJ elements_NN2 that_CST should_VM be_VBI required_VVN in_II a_AT1 surveillance_NN1 system_NN1 for_IF abuse_NN1 of_IO prescription_NN1 drugs_NN2 ?_? 
In_II the_AT past_NN1 ,_, a_AT1 wide_JJ variety_NN1 of_IO systems_NN2 have_VH0 been_VBN accepted_VVN by_II the_AT FDA_NN1 ._. 
While_CS general_JJ risk_NN1 management_NN1 guidance_NN1 has_VHZ been_VBN developed_VVN FDA_NP1 ,_, more_RGR specific_JJ analyses_NN2 and_CC guidance_NN1 are_VBR needed_VVN to_TO improve_VVI surveillance_NN1 methodology_NN1 for_IF drugs_NN2 which_DDQ are_VBR misused_VVN ,_, abused_VVN ,_, diverted_VVN and_CC these_DD2 activities_NN2 ._. 
