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Section 505-1 of the FDCA authorizes FDA to require the submission of a risk evaluation and mitigation strategy (REMS) if FDA determines that such a strategy is necessary to ensure that the benefits of the drug outweigh the risks. Spotting drug diversion within the current reporting system is a major challenge due to limited information on the offending product. Close surveillance of drugs that could be used criminally to immobilize victims is particularly crucial.

Drug-facilitated sexual assault (DFSA) is a sexual activity that occurs either without the victim’s consent or with consent that cannot be considered valid due incapacitation of the victim by alcohol or drugs. The term pro-active DFSA is used in situations when a perpetrator spikes the victim’s drinks covertly [1]. Opportunistic DFSA is carried out once the victim has been rendered unconscious. In addition to alcohol, the most frequently used drugs to perpetrate DFSA are flunitrazepam (Rohypnol), gamma-hydroxybutyrate (GHB), gamma-butyrolactone (GBL), carisoprodol (Soma) and ketamine. Ecstasy (MDMA) and other benzodiazepines are also occasionally used. These drugs rapidly induce somnolence, sedation and muscle relaxation and decrease inhibition. Most are odorless and tasteless; GBL has a bitter taste that can be masked. Affected people usually have little to no recollection of the assault [2].

The total number of DFSAs is difficult to estimate, mainly due to the reluctance of the victims to report them. There are some indications that the numbers are on the increase [3], [4]. Due to the nature of the drugs, the victims recall little or nothing, may feel embarrassed or guilty, do not want to become stigmatized further, or feel they do not have enough evidence to support the claim confidently. Forensic evidence is difficult to obtain and often lost after first urination the morning after the assault. All drugs used for DFSA are metabolized rapidly by the body, rendering them undetectable within 24 to 48 hours after ingestion [5].

The most common ways of obtaining these drugs is through the darknet [6]. Benzodiazepines, GHB (Xyrem) and ketamine (anesthetic used in human and veterinary medicine) are often diverted from legitimate medical use for illicit purposes. Xyrem (GHB) was subject to an interesting legal dispute regarding pharmaceutical advertising. U.S. v. Caronia (2012) became one of the landmark cases in the promotion of prescription drugs for unapproved (off-label) indications [7]. Physicians who prescribe Xyrem have to pass special certification to ensure safe prescription, handling, and storage of the drug [8].

Flunitrazepam is still legally manufactured in Europe and some countries in Latin America, where it is used as a sedative or tranquilizer. It has been reformulated so it imparts an easily identifiable blue color to clear beverages and haziness to colored beverages [9]. Naturally, this effect is absent in drugs that were obtained from illegal manufacturing sources. An example from Campania Region in Italy shows how important it is to classify correctly cases of misuse, abuse and diversion as cases of any non-normal use are likely to come in unclassified or misclassified. This failure to classify cases correctly at entry has a relevant impact on signal detection activities [10].

In 2010, the FDA published guidance intended to address provisions set forth in Section 505D of the FDCA regarding standardized numerical identifiers (SNIs) for prescription drug packages, the first step in the development and implementation of measures to secure the drug supply chain. The FDA considers the prescription drug package to be the smallest unit that requires an SNI. The SNIs should be applied to each package in both human-readable and machine-readable form and can be encoded into a 2D barcode or radio-frequency identification (RFID) (FDA, 2010). Inclusion of a package-level SNI, where available in an adverse drug event case report would make detection of diversion significantly easier to spot.

Example of SNI on packaging (Amlodipine and Atorvastatin, Mylan)

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[1] Gautam, L., Sharratt, S., & Cole, M. (2014). Drug Facilitated Sexual Assault: Detection and Stability of Benzodiazepines in Spiked Drinks Using Gas Chromatography-Mass Spectrometry. Plos ONE, 9(2), e89031. doi: 10.1371/journal.pone.0089031

[2] West Virginia Foundation for Rape Information and Services, W. (2019). Drug Facilitated Sexual Assault | Sexual Violence | West Virginia Foundation for Rape Information and Services (WV FRIS). Retrieved from http://www.fris.org/SexualViolence/DrugFacilitated.html

[3] Bureau of Justice Statistics. (2019). Bureau of Justice Statistics (BJS) – Rape and Sexual Assault. Retrieved from https://www.bjs.gov/index.cfm?ty=tp&tid=317

[4] FBI. (2016). January to June 2015–2016 Offenses Reported to Law Enforcement by State by City 100,000 and over in population. Retrieved from https://ucr.fbi.gov/crime-in-the-u.s/2016/preliminary-semiannual-uniform-crime-report-januaryjune-2016/tables/table-4/table_4_january_to_june_2015_offenses_reported_to_law_enforcement_by_state_by_city_100-000_and_over_in_population/view

[5] U.S. Department of Justice – Drug Enforcement Administration. (2017). Drug-Facilitated Sexual Assault. Drug Enforcement Administration. Retrieved from https://www.dea.gov/sites/default/files/2018-07/DFSA_0.PDF

[6] United Nations Office on Drug and Crime. (2016). World Drug Report. Vienna, Austria: UNODC. Retrieved from https://www.unodc.org/doc/wdr2016/WORLD_DRUG_REPORT_2016_web.pdf

[7] Recent cases. First Amendment – Commercial speech Second Circuit holds that prohibiting truthful off-label promotion of FDA-approved drug by pharmaceutical representatives violates First Amendment. United States v. Caronia, 703 F.3d 149 (2d Cir. 2012). (2013). Harvard Law Review, 127, 795-802. Retrieved from http://cdn.harvardlawreview.org/wp-content/uploads/pdfs/vol127_united_states_v_caronia.pdf

[8] Jazz Pharmaceuticals, Inc. (2015). Xyrem REMS Document. NDA 21-196 XYREM® (SODIUM OXYBATE) ORAL SOLUTION. FDA. Retrieved from https://www.fda.gov/media/90866/download

[9] SCHWARTZ, R., MILTEER, R., & LeBEAU, M. (2000). Drug-Facilitated Sexual Assault (‘Date Rape’). Southern Medical Journal, 93(6), 558-561. doi: 10.1097/00007611-200093060-00002

[10] Sessa, M., di Mauro, G., Mascolo, A., Rafaniello, C., Sportiello, L., Scavone, C., & Capuano, A. (2018). Pillars and Pitfalls of the New Pharmacovigilance Legislation: Consequences for the Identification of Adverse Drug Reactions Deriving From Abuse, Misuse, Overdose, Occupational Exposure, and Medication Errors. Frontiers In Pharmacology, 9. doi: 10.3389/fphar.2018.00611

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