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Prescription Drug Abuse: Emerging Drugs of Abuse Lydia Baltarowich. MD, FACEP, FACMT July 10, 2014 Objectives • Appreciate the significant morbidity and mortality associated with the current prescription drug abuse epidemic • Be familiar with the most common prescription agents and their methods of abuse • Recognize the clinical toxidromes associated with the most common and deadly agents • Know treatment options for overdose Emerging Drugs of Abuse • CDC Data (National Vital Statistics) 1999-2008 showed a dramatic increase in prescription drug abuse, misuse, and overdose deaths (MMWR 2011) • 1999-2008: deaths from opioid prescription pain killers increased 4-fold • Since 2004 Rx opioid analgesics account for more ER visits and deaths than cocaine and heroin; majority listed as “unintentional “We have moved from an era of “illicit” street drug abuse to an era of “legal” prescription drug abuse” (Nelson 2012) Drug Overdose Deaths 1999-2008 CDC 2011 Emerging Drugs of Abuse • The prescription opioid epidemic is a major public health problem and the fastest growing drug problem in the US • CDC Data 1999-2008 showed a parallel increase in overdose deaths, prescription sales, & substance abuse treatment admissions related to opioid prescription pain killers • Top 5 prescriber of opioids to patients < 39yr: EP’s, primary care, pediatricians, dentists • Physician prescriptions are being used as “emerging drugs of abuse” (CDC MMWR 2011) Prescription Drug Deaths Recent Celebrities • Anna Nicole: 39 yr, died in 2007 from an accidental overdose of at least nine different prescription drugs • Heath Ledger: 28 yr died in 2008 from overdose of prescription drugs, including pain-killers, anti-anxiety drugs, and sleeping pills • Michael Jackson: King of Pop died in 2009 from a lethal injection of propofol • Whitney Houston: died 2012, from drowning in a bathtub after she ingested a cocktail of cocaine and prescription drugs: more than 12 prescriptions were found in her hotel room DAWN 2004-2010 Estimated ED visits 2004-2010: • ED visits for misuse/abuse of pharmaceuticals increased 115% • ED visits for non- medical use of narcotic pain relievers increased 156 % : oxycodone, hydrocodone • ED visits for stimulant /ADHD drugs increased 196% • ED visits for benzodiazepines increased 139 % • ED visits for illicit drugs overall showed no significant change, except THC (DAWN Highlights 2012) AAPCC: NPDS DATA 2007-2012 Categories With Largest Numbers of Deaths • Analgesics Opioids > acetaminophen in combination > acetaminophen alone > salicylates • Sedatives- hypnotics/ antipsychotics Alprazolam & quetiapine • Antidepressants Amitriptyline, bupropion, venlafaxine • Cardiovascular drugs: CaChBlockers, digoxin • Stimulants and street drugs Fueling the Prescription Epidemic Healthcare providers: • Prescription overabundance from medical providers • Almost all prescription drugs involved in diversion,abuse, overdoses come directly or indirectly from the original prescriptions • Changing philosophy of pain treatment: subjective pain and patient satisfaction on forefront: JCHO & IOM mandates well- meaning providers • Easier to treat pain than addiction • Aggressive marketing • Economics: dealers, diversion, unscrupulous providers Fueling the Prescription Epidemic Layperson Perceptions about Rx Drugs: Safer than street drugs Not addictive Improve school & athletic performance Decrease stress, help sleep Accessibility: • Easy access in home medicine cabinets, friends, school • Internet marketing & selling of drugs without Rx Cost: • Cheaper, especially if have insurance Legal: Prescription drugs vs Illicit Pill mills, pain clinics and unscrupulous doctors contribute to the illegal distribution of legal prescription drugs. Just about everyone who comes through the doors walks away with the same remedy: a prescription for a month-long supply of powerful opioids Prescription drugs worth millions to dealers Street prices for a single tablet of commonly trafficked drugs, compared to their retail prices: • • • • Oxycontin: $50 to $80 on the street, vs. $6 Oxycodone: $12 to $40 on the street, vs. $6 retail Percocet: $10 to $15 vs. $6 Oxymorphone $ 75 • Vicodin: $5 to $25 vs. $1.50; # 30= 750’s $50 • Tramadol: $1-2 for 50 mg Street prices taken from the latest data put out by federal law enforcement agencies; retail prices from pharmacychecker.com. Internet Pharmacies • Ryan Haight On-Line Pharmacy Consumer Protection Act 2008; Implemented 2009 • Amends CSA to prevent illegal distribution of controlled substances by Internet • DEA registration & reporting requirements for all Internet Pharmacies Physician: Responsibility & Dilemma Responsibility: treat pain: 5th Vital Sign • Joint Commission 2000 & patient satisfaction scores • Institute of Medicine Report 2011: pain under-treated Dilemma: • Prevent public health pain killer epidemic • Balance analgesia with drug diversion Teen Drug Abuse: Generation Rx “Generation Rx has arrived” 2004 Teenage illicit drug use declined after it peaked in 1990’s: Ecstasy use declined after peaked in 2001 (PATS 2004) Rx drug use rising among teens & college students (PATS 2005/ MTF 2005, 2007) Generation Rx Cocaine (9%) Heroin (4%) LSD (6%) Ecstasy (9%) Methamph (8%) Ketamine (5%) GHB (4%) PATS 2012/ 2013 • Teen prescription drug misuse and abuse continues to increase since 2008 and is a significant health problem • Currently, 1/4 teens (24 percent) admits to having misused or abused a prescription drug at least once in their lifetime. Prevalence increasing: 18 % (2008)- 24% (2012) • • Increase in the lifetime misuse and abuse of prescription stimulants with 1/8 teens (13%) now misusing Ritalin or Adderall at least once in their lifetime. • • 2013: 4-year increase in the nonmedical use of Adderall by 12th-graders Prevalence of stimulant misuse: 11% (2008) to 13% (2012) 95% CI • 1/3 of parents (29 percent) say they believe ADHD medication can improve a teen’s academic or testing performance • Teen misuse and abuse of prescription pain relievers, Vicodin and OxyContin, has remained stable with one in six (16 percent) teens having misused or abused prescription pain relievers at least once within their lifetime. MTF 2012 MTF Trends: 2008-2012 Monitoring the Future (MTF): “The future is in Adderall” College Students: • Adderall prevalence of use increased from 5.7% 2008 to 11% 2012, higher than non-college age mates • Oxycontin and vicodin declining since 2010 • College students show lower rates of use of illicit drugs except THC Commonly Abused Prescription Drugs • Pain Killers: hydrocodone (vicodin), oxycodone (oxycontin) • Sedatives: alprazolam, diazepam, clonazepam ,zolpidem • Stimulants: Adderall, Ritalin ** 2013: 4-year increase in the non medical use of Adderall by 12th-graders • OTC’s: Dextromethorphan products, antihistamines (PATS 2004-2012 MTF 2005-2012 DAWN 2007-2011) Commonly Abused Prescription Drugs CSA 1970 : Schedules • Schedule 1: high abuse potential; research only • Schedule 2: high abuse potential; written rx, 30 day supply, no refills • Schedule 3 & 4: less abuse potential; verbal rx ; refills limited to 5 refills/ 6 months • Schedule 5: antitussives, antidiarrheals Case 1: “E” or “O” ? 26 yr M found down by friends and could not wake him up. There were green pills around him so they thought he took “ E” ! PE: Lethargic, GCS 9; pupils pinpoint, RR 7, HR 50, BP 90/40 T 35 Neuro: non-focal; Heart/ Lungs/ Abd: + BS Toxidrome: Management: A2 B C2 DE’s Oxycontin Oxycodone :” Oxy” is controlled - release oxycodone 10, 20, 40, 80 mg Oxy’s ,OC’s, Killers, Kicker,Poor Man’s Heroin, Hillbilly Heroin: Appalachia highest traffic Sources: illegal diversion of Rx drug; “doctor shopping”, theft, internet distribution Crush-resistant formulation in 2010 Schedule II Oxycodone Oxycodone: high potency (2x’s morphine), semi- synthetic opioid Top selling narcotic analgesic since 2001 Majority of oxycodone deaths are due to Oxycontin Method: crush tablets to defeat time-release matrix, then snort or inject Immediate Release: lower dose formulations: roxicodone or generic oxycodone/: 5,10,20 mg APAP: percoset, roxicet, tylox ASA: percodan, roxiprin Oxycontin mimics • Analysis of the tablets indicated that they were a mix of heroin, caffeine, and lactose: green coating over a compressed light brown powder. Actual OxyContin tablets have a light green coating over a compressed white powder • Dangers of contraband products: you don’t know what you are getting 26 Clinical Pearls • Opioid toxidrome: miosis, CNS/ respiratory depression • UDS: opiate immunoassay: Natural Opiates: + morphine, codeine, heroin Semi-synthetics: variable, assay sens & drug concentration Synthetics: not detected • Treatment : narcan low dose 0.4 mg IV, IM; titrate dose or infusion • Long Acting formulations: relapse expected; admit, narcan drip • Partial response to naloxone: more narcan or co-ingested sedative • Addiction/ withdrawal: GI, agitation, diaphoresis, gooseflesh Oxymorphone: Opana • • • • Slang: stop signs, biscuits, octagons, O bomb, blues “The new oxycontin”: crushed: snort & IV Formulations: initial: OPANA ER was crushable Reformulated 2012 but generics exist • • • • Oxycodone metabolite, semisynthetic Efficacy & tolerability like morphine ETOH+ ER formulations: increase oxymorphone levels TTP associated with IV use Vicodin: Hydrocodone + APAP • • • • • • Most popular Rx “pain killer” abused by teens Second to marijuana as the ‘drug of choice’ Street prices: $5- $ 25 vs $1.50 (# 30- 750mg $50) About 50% of teens feel there is no great risk to its use Potential for APAP toxicity Vicodin 5mg/ 325 apap; Vicodin ES 7.5mg/ apap 750mg Lortab, Lorcet, Norco • Schedule III • Opioid ototoxicitiy: methadone and hydrocodone Acetaminophen • Most common cause of ALF in US: APAP- opioid combination analgesics • FDA limits acetaminophen in prescription combination products at 325 mg and requires liver toxicity warnings: January 2014 • Combination acetaminophen-opioid products: no more than 3gm/ 24h; patient education regarding dosing should be stressed • FDA final rule in 2009 on the labeling of all OTC drugs containing acetaminophen to warn of the risk of liver damage. effective April 2010. • “Liver warning: Severe liver damage may occur if you take • more than 4,000 mg of acetaminophen in 24 hours • with other drugs containing acetaminophen • 3 or more alcoholic drinks every day while using this product.” Pure Hydrocodone • • • • • ZohydroER:10,15,20-50 mg No APAP !!! Abuse potential similar to morphine and oxy Schedule 2 Capsule Formulation lacks abuse-deterrents, so allows it to be crushed, chewed, dissolved, snorted, injected • Extremely potent, hydrocodone opioid that is between five and 10 times the strength of Vicodin. One capsule could be fatal to a child Methadone • CDC: 1/ 3 of annual Rx drug overdose deaths are from methadone (1/3 of 15,000) WHY ? • Cheap generic used for pain management, not substance abuse rx • Long ½ life: 8-60 hrs( 24hrs): • opioid naïve: must titrate doses up from 10-20 mg • can take 5 days to achieve pain control so patient self medicates • analgesic effect lasts 4-8 hrs, resp depression longer • Drug interactions: P450 metabolism • Dose –dependent QT prolongation > 500msec: torsade,sudden death • Ototoxicity: tinnitus & hearing loss Buprenorphine • Suboxone: buprenorphine and naloxone: prevents IV use • Tablet or dissolvable sublingual film: “ prison heroin ‘ 2 -12 mg buprenorphine with 0.5-3 mg naloxone, • • • • Subutex: no naloxone Schedule III Better safety profile than methadone, no QT prolongation Children: delayed, prolonged toxicity Tramadol • Tramadol, as synthetic opioid, marketed as a non-controlled analgesic since1995 under the trade name of Ultram®. Generic, combination, and extended release tramadol products exist. • July 2, 2014, DEA final rule placing tramadol into schedule IV of the Controlled Substances Act. Will become effective August 18, 2014 • Induces psychic and physical dependence similar to morphine (μopioid) • Associated with craving, tolerance, and withdrawal symptoms if discontinued • Seizures are more likely at high doses > 400 mg/ day • Serotonergic agent which can cause Serotonin Syndrome, especially after naloxone administration, which can unmask serotonergic effect Long- Octing/ ER Opioids • No place in ED as 1st line treatment for pain • Not for acute pain or for opiate naïve patient: dose must be titrated, and can take 5 days to achieve pain control • Patients tend to self medicate Abuse: high abuse potential • ER Formulations desirable: large doses • Crushed: IV or snorted: rapid onset & rapid fatality • Tamper-resistent formulations limit crush but you can still swallow pills Formulations: • OxyContin: Purdue Pharma created a crush-resistant formulation in 2010; FDA blocked generic version of crushable oxy • Oxymorphone: tamper resistent OPANA but generics: available Case 2: Smart Drugs 19 yr F student, brought to ED by friends with headache and palpitations. She had been studying hard for past 2 weeks during U of D (Dopamine) finals. Today became restless, talkative, started cleaning everything in her dorm & then felt like her heart & head were going to explode. PE: restless, scratching legs constantly, O X 3 HR 160, BP 160/90, T 37 RR 22 Pupils 6mm Talking to self, speech mumbling, paranoid behavior Neuro exam: non-focal, no tremor or rigidity Heart/lungs/ abd: +BS What is the Toxidrome? DDx: Management: Epidemiology • MTF, PATS, DAWN show increased abuse, misuse of stimulant ADHD drug: “The future is in Adderall” Smart Drugs • Performance-enhancing off-label use, rather than abuse as a recreational drug, is the primary reason that students use stimulants: • memory enhancement, tests, and study marathons • Market push behind diagnosis of adult ADHD, similar to that used for pain killers • Increased prescribing rates: increased diversion, abuse, misuse, overdose Prescription Stimulants • Dextroamphetamine/ Amphetamine: Adderall / XR • Slang: Smart Pills, Smurfs, Blue Betties Blueberries, A-bombs, Black Beauties • Lisdexamfetamine (Vivanse): pro drug to dextroamphetamine • Methylphenidate (Mph): Ritalin, Concerta Ritalin = “kiddee cocaine” / “Vitamin R”/ “R ball” • Not an amphetamine • Abuse Methods: ingest or crush tablets: snort or inject • Schedule II: high potential for abuse Prescription Stimulants Mechanism: Mph & Dextroamphetamine: Enhance release and block reuptake of NE, D, 5HT *MPH has little effect on 5HT Increased dopamine: improves wakefullness, attention & focus decreases appetite, increases energy ***advantage: “ clean dorm rooms ” Clinical Pearls • Sympathomimetic toxidrome: • • • Alpha/ beta adrenergic: tachy, htn, mydriasis, seizures DA & 5HT: hyperthermia, rigidity: SS psych: agitation, hallucinations, paranoia, psychosis • • Chronic use: vasculitis, cardiomyopathy, neuropsychstereotypical behavior/ Tweaking: compuslive behavior associated with amphetamine abuse • ER Formulations have delayed , prolonged symptoms • UDS: amph + : phenethylamine structure, but not methylphenidate • • • Treatment: aggressive benzos & cooling Interrupt CV/CNS sympathomimetic toxidrome with benzos Hyperthermia increase mortality: cooling • Addiction/ withdrawal: fatigue, hypersomnia, hyperphaghia Adderall May Not Make You Smarter, But It Makes You Think You Are • Controversial: According to a study from the University of Pennsylvania (2010), students who took Adderall didn’t actually perform better on tests of cognitive function — they only thought they did Malenka RC, Nestler EJ, Hyman SE (2009): Molecular Neuropharmacology: "Therapeutic (relatively low) doses of psychostimulants, such as methylphenidate and amphetamine, improve performance on working memory tasks both in in normal subjects and those with ADHD. Dopamine and norepinephrine, but not serotonin, produce the beneficial effects of stimulants on working memory “ High on Cough Syrup Case 3: “Robo-Tripping” 14 yr M brought to ED from school because of bizarre behavior: appears to be in a trance, says he’s floating VS HR 120, BP 150/80, T 37, RR 20 pupils 5mm Alert, oriented X 1, blank stare, visual hallucinations, slurred speech, cannot move his extremities Asymptomatic in 12 hrs Parents later found empty boxes of Coricidin HBP in his room. Toxidrome: hallucinogen, dissociative, anticholinergic “Robo-Tripping” Toxidrome: hallucinogenic & dissociative • First plateau: 1.5 to 2.5 mg/kg – Slight stimulant: restless or drowsy, mydriasis, tachy • Second plateau: 2.5 to 7.5 mg/kg – “Stoned”: drowsy or agitated, slurred speech, ataxia, euphoria, LSD hallucinations, memory disrupted • Third plateau: at 7.5 to 15mg/kg, – Strong intoxication, LSD hallucinations • Fourth plateau: > 15mg/kg (Sigma plateau) – Similar to ketamine & PCP: trance-like, catatonic state, dissociative effect Dextromethorphan • Over-the-counter cough suppressant: easy access, cheap, legal • Substitute for illicit Hallucinogens, Dissociative Agents: PCP/ Ketamine • Serotonin receptor agonist: blocks 5HT re-uptake: hallucinogen, SS • NMDA glutamate receptor antagonism results in: PCP 1 site: dissociative effects (PCP, ketamine) PCP 2 site: NE, D, 5HT re-uptake inhibition • UDS: False positive PCP • Most Popular: Coricidin HBP Cough & Cold – 30 mg DXM HBr – 4 mg chlorpheniramine (anticholinergic ) CCC” “Triple C” “ Concentrated DXM Sources • DexAlone gelcaps: 30 mg • DXM/ guaifenesin tablets: Mucinex DM (ER): 30 mg • DXM syrups: Delsym:extended release suspension:12 hrs 30 mg DXM/ 5ml (150 ml) Dextromethorphan Slang terms DXM/DM Robo Tussin DEX Triple C Red Devils Skittles Robo-ing or Robo -Tripping Robo-shuffle Prescription Cough Syrup Promethazine 6.25 mg / Codeine 10 mg per 5 ml – Codeine is mainly responsible for the euphoria – Promethazine causes motor impairment, drowsiness • Highest abuse in South: Texas to Florida • Schedule V • “Causes a slow trip, gives u a leaned out kinda feelin” • Slang: Purple drank, Lean, Texas Tea, Purple Jelly, White Cup, Styrofoam Cup, Promethazine, Codeine (Urban Dictionary) “Sizzurp” The original formula: Promethazine w/Codeine = Sizzurp Original Sprite Soda ( fruit flavor soda) A jolly rancher (flavor additive) Put it all in a styrofoam cup and enjoy Styrofoam cups, an iconic symbol of sizzurp Wayne raps, “You know what’s in my Styrofoam “ Sizzurp is well known in the hip-hop/ rap culture, specifically in Houston, since 1990’s Three 6 Mafia's “Sippin' on Some Sizzurp” and Lil' Wayne's “Me and My Drank Case 4: The “Red Pop” Case 18 yr M brought to ED in PEA cardiac arrest after he was found unresponsive at a party where he was noted to be drinking a red pop all night mixed with “lean” . Patient was resuscitated, after 5 days was extubated, but had sequelae of anoxic cerebral injury: non-verbal, minimally communicative. Transferred to Neuro rehab facility. Drug Screen: opiate positive Prescription Cough Syrup Promethazine (Phenergan): phenothiazine antihistamine • Clinical effects: sedation; anticholinergic, EPS Codeine • Opioid agonist • Metabolism: inactive, requires demethylation to morphine • 5-7% of caucasian population unable to convert: no CYP2D6 Promethazine and codeine combinations are contraindicated in pediatric patients < 16 yr Administration of promethazine with other respiratory depressants has been associated with respiratory depression and death, in pediatric patients (FDA Medwatch) Case 5: Found Down 32 y/o F found unresponsive with an empty bottle of vodka and unmarked pill bottles next to her She was last seen yesterday PE: lethargic, moans and withdraws to pain VMAS 1 GCS 10 pupils 4 mm BP 100/60 HR 90 T 36 RR 10 POx 90% Neuro: non-focal, normal tone; DTR’s 2+ Heart/ Lungs: clear Abd: soft, BS decreased Skin: normal UDS: ETOH 0.20 Toxidrome: Gaba Receptor Agonists Sedative-Hypnotic Toxidrome Benzodiazepines Z drugs Alcohols, GHB Valproic acid Carisoprodol, meprobamate Barbiturates Chloral hydrate Propofol, Etomidate “Trinity ” “Holy Trinity” or “ Houston Cocktail” • Soma (carisoprodol)350mg • Alprazolam / Xanax®/ Valium • Hydrocodone/ Oxycontin/ Tramadol “Vicosomapraz” Clinical Pearls: SOMA • • • Centrally acting muscle relaxant, sedative; meprobamate metabolite Sedative-hypnotic toxidrome (meprobamate) Serotonergic: tachy, htn, shivering, tremors, myoclonic jerks, hyperreflexia, clonus,especially after narcan • • Onset of action of carisoprodol is rapid No awakening; partial response after narcan if “trinity” • Lab: neg tox screen, unless “trinity” • GABA agonist: addiction/ withdrawal • DEA: carisoprodol continues to be one of the most commonly diverted drugs and abuse is prevalent • Schedule IV Case 6:The Pharm Party These guys went Pharming… 13 & 14 yr M brought to ED after falling at “the pharm”. They keep repeating that they took some “coffins” PE: Bp 110/60, HR 80, T 36 Drowsy, Ox3,pupils 3mm, slurred speech, ataxic Toxidrome? What are “coffins” Benzodiazepines Alprazolam: Xanax 2mg Zanny bars, coffins, french fries Blue footballs: 1mg round Swallowed or crushed/ snorted/ injected Diazepam, Klonopin: K-pins Alone or in combination with: etoh, stimulants, soma, heroin Toxidrome: cerebellar incoordination/ Sedative-hypnotic Flumazenil reversal Lab: poor detection on UDS Schedule IV Addiction & withdrawal: occult dependence is common “Z” Drugs Non-benzodiazepine hypnotics Zolpidem: Ambien, Ambien CR Zaleplon: Sonata Zopiclone/ Eczopiclone: Lunesta Most commonly prescribed sleep aid 2013 FDA approved label changes specifying new dosage recommendations for zolpidem products because of concerns regarding next-morning impairment (especially women) Schedule IV Bind to benzo receptors at GABA A complex Respond to flumazenil High toxic to therapeutic ratio Flumazenil • Competitive antagonist at BZ receptor on GABA A complex • Effective for benzo and “Z” drug overdose • Flumazenil 2 hr half-life: shorter than most benzodiazepines • Dose:0.2/ 0.3/ 0.5 mg q 30 sec max 3 mg • Selective Indications: – pure benzo induced coma or resp depression – reversal of conscious sedation or anesthesia – pediatric benzo overdose • Avoid if: – chronic benzodiazepine use – co-ingestants that are proconvulsant, TCA – if BZD used to control seizures Other Rx Meds Abuse • • • • • • • Seroquel (Quetiapine): antipsychotic Benadryl: anticholinergic; TCA-like Flexeril: anticholinergic; TCA-like Clonidine: central alpha2 agonist opioid toxidrome Baclofen: sedative Fentanyl patches Quetiapine: Seroquel • Atypical antipsychotic:abused as anxiolytic & sleep aid • Antihistamine, antimuscarinic, alpha blockade: sedation, tachy, hypotensive • K Ch Blocker: “QT iapine “ : QT prolongation • Dystonic reaction, NMS • UDS: false + TCA • 30% of jailed LA inmates in psych services malinger symptoms to obtain quetiapine – Sedative, calmative, anxiolytic Quiz 1) Name the dissociative hallucinogens of abuse DXM, PCP, Ketamine 2) Which agents have recently been associated with tinnitus and hearing loss? Opioids: methadone, hydrocodone 3) Which cough syrup can result in dystonic reactions? Promethazine/ Codeine 4) Flumazenil is safe in chronic benzo users. False Quiz 5) Is Aderrall a scheduled drug? Schedule II 6) Which opioid is associated with SS? Tramadol 7) Which sedative is associated with SS? Soma (Carisoprodol) 8) Which cough syrup ia associated with SS? DXM 9) Will methylphenidate produce a positive amphetamine result on UDS ? Not an amphetamine Quiz 10) What is concern for treating acute pain in ED with LA opioids? Delayed pain control, therapeutic overdose 11) Which neurotransmitters do amphetamines affect ? Dopamine, Norepi, Serotonin 12) What are best treatment options for agitation from prescription stimulants? Benzodiazepines Quiz 13) What is Tweaking ( not Twirking) ? Compulsive behavior associated with amphetamine abuse 14) What is difference between Schedule 2 and Schedule 3 category? Schedule 2: high abuse potential; written rx, 30 day supply, no refills Schedule 3 & 4: less abuse potential; verbal rx ; refills limited to 5 refills/ 6 months