Understanding Drug Diversion: Agencies, Regulations, and Prevention Strategies, Slides of Criminal Law

Download Understanding Drug Diversion: Agencies, Regulations, and Prevention Strategies and more Slides Criminal Law in PDF only on Docsity! 1 Drug Diversion Docsity.com 2 Goals 1. Define what drug diversion means and what it encompasses 2. Identify regulatory agencies and regulations that cover drug diversion 3. Understand pharmacists’ responsibilities and interventions to prevent drug diversion Docsity.com 5 What is Drug Diversion? (1) • Drug diversion is the use of legal drugs for illegal purposes or the use of prescription drugs for recreational purposes • According to a study by the National Center On Addiction and Substance Abuse (CASA) at Columbia University, between 1992 and 2002, prescriptions written for unscheduled and scheduled drugs increased by 56.6% and 154.3% respectively Docsity.com 6 What is Drug Diversion?(1) • In 1992 and 2003, 7.8 million and 15.1 million people respectively, admitted using scheduled drugs. This increase of 94 % was seven times faster than the increase in US population 0 2 4 6 8 10 12 14 16 1992 2003 1992 2003 Use of Scheduled Drugs (in millions) Docsity.com 7 15.1 million people reported using Scheduled Drugs in 2003 • Approximately equal to 2 times the population of New York City Docsity.com 10 Most Frequently Abused Drugs (1) • To relieve pain: opioids like OxyContin® and Vicodin® • To relieve anxiety: sedatives like Valium® and Xanax® • To boost attention and energy: medicines that speed up physical and mental processes like Ritalin®, Adderall® and Dexedrine® • To improve athletic performance: steroids like Anadrol® and Equipoise® Docsity.com 11 Abuse Potential and Schedules Examples • I - marijuana, heroin, no medical usage • II - morphine, oxycodone (OxyContin®), hydromorphone (Dilaudid®) • III - methylphenidate (Ritalin®), hydrocodone (Vicodin®, Lortab®), anabolic steroids (Anadrol® ) • IV - benzodiazepines such as diazepam (Valium®) and alprazolam (Xanax®) • V - Medications having limited opioids in combination with other substances (codeine containing analgesics, cough and cold preparations) Most Abusive Less Abusive Schedule Docsity.com 12 Question (1) • What are the top 3 most abused substances in America? • Alcohol • Diazepam (Valium®) • Marijuana • Methylphenidate (Ritalin®) • Oxycodone (OxyContin®) • Tobacco • Click here for answer ☼ Docsity.com 15 Methods of Drug Diversion I • Patients as a source of drug diversion(1) • changing writing on prescriptions • obtaining prescriptions for a single drug from multiple doctors concurrently • forcing or influencing physicians to write prescriptions • using deceptive prescriptions • patients acting like physicians Docsity.com 16 Double-Take! • A woman walks into a pharmacy with a prescription from the ER. The pharmacist recognizes the doctor’s name and signature because the pharmacist receives prescriptions from him often. The pharmacist overlooks the fact that the prescription has a “1” marked in the refill area of the prescription, because this medication is rarely issued refills. The patient picks up the prescription, and then later calls the pharmacy to inform them that her refill has not been entered. The pharmacist tells the patient to return to the pharmacy for a new label, and calls the ER doctor to see if the patient should receive refills. The doctor informs the pharmacist to call the police. E. Emma, Community Pharmacist, June 2007 Docsity.com 17 Methods of Drug Diversion II • Healthcare professionals as a source(1) • lacking skills and failing to recognize diversion • Physicians as a source(2) • using the wrong drug for diagnosis • not having the ability to make good decisions • addicted to drugs affecting mental health • engaged in illegal drug trafficking activities Docsity.com 20 Method of Drug Diversion IV • Internet pharmacies: unregulated and illegal, not requiring a prescription, offering online consultation (1) • Pharmaceutical companies: not adding antagonists in drugs with high abuse potential, vigorously using promotional activities to influence patients (1) • Theft from: physicians, pharmacies, (2) and residential properties(3) • Losses: during transportation (2) or from pharmacies(3) Docsity.com 21 Case of Pharmacy Theft (4) • There was a theft on Sunday at a local pharmacy in Pennsylvania. The suspect went behind the pharmacy counter and demanded OxyContin® and oxycodone. The suspect warned the employees not to call for help and said he had several accomplices in the store. The suspect took the drugs and left the store, grabbing a soda on way out. Docsity.com 22 Risky Business (5) • There was a robbery on Monday at a grocery store pharmacy located within a supermarket in Connecticut. The suspect reached the pharmacy counter and passed a note on paper which stated “I have a gun pointed at you, I want Xanax® and Klonapin® “ The pharmacist grabbed a couple of bottles and gave them to suspect. Later it was found that suspect was given one bottle of Xanax® 0.5 mg off the shelf and another sealed bottle, also one and a half bottles of clonazepam. Docsity.com 25 Monitoring Programs Employed by States (2) • State-administered prescription monitoring programs are very effective in controlling diversion of scheduled substances at retail pharmacy. Docsity.com 26 Monitoring Programs Employed by States (2) • Multiple copy prescription programs (MCPPs): Prescriber writes prescription for schedule II (in certain states III, IV, and V) substance on a state issued, preprinted, serialized double or triple form. Copies of the prescription are kept with the pharmacist, state agency and physician. • Electronic data transmission system (EDT): Prescriber writes prescription for schedule II (in certain states III, IV, and V) substance on a prescription form, retains original prescription and sends the information either electronically or using a claim form to the state’s agency. Docsity.com 27 Pharmacist Guilty: (4) • Kentucky pharmacist pleads guilty to illegally selling prescription drug samples and agrees to pay $10.5 million • A conspiracy was uncovered by the Office of Criminal Investigation. It was found that a Kentucky pharmacy owner, along with other people, obtained drug samples, repackaged them, and sold them illegally to public • What agency oversees controlled drugs? Docsity.com 30 Office of Diversion Control (6) • DEA Office of Diversion Control is responsible for: diversion of controlled pharmaceuticals and diversion of controlled chemicals • It’s activities include: coordinating investigations; writing and putting laws into effect; controlling imports and exports of drugs and chemicals; monitoring distribution of certain controlled drugs; providing distribution intelligence to the states. Docsity.com 31 Q: What over-the-counter drug is used to make illegal methamphetamine? Docsity.com 32 Diversion of Controlled Chemicals (6) Is it….. a. Acetaminophen (Tylenol) b. Glucosamine c. Potassium chloride (KCl) d. Pseudoephedrine (Sudafed) Click here for answer: ☼ Docsity.com 35 Diversion of Controlled Pharmaceuticals (6) • Goal is to control abuse and illegal use of controlled substances and at the same time make sure that they are easily available for medical use. • Under federal law, manufacturers, distributors, dispensers, administers, or prescribers of controlled substances, and all pharmacies must register with DEA. Registrants must act in accordance with requirements related to drug security and maintenance of standards and records. Docsity.com 36 FDA’s Office of Criminal Investigations (OCI) (4) • FDA believes that a closed drug supply chain is very important to prevent illegal drugs from reaching consumers • OCI focuses its action on investigations of illegal drug diverters and others who threaten the security of drug supply chain Docsity.com 37 Examples of Significant Counterfeit Drug Cases (4) A package containing several thousand fake Viagra® and Cialis® tablets was mailed from China, seized, and a case was started by OCI and U. S. Immigration and Customs Enforcement (ICE). In May 2006, the pharmacist was guilty of conspiracy and was awaiting sentencing. The OCI investigation of illegal medical products diversion, which defrauded Medicaid and Medicare programs of more than $45,000,000, led to arrest of two owners of a Florida pharmaceutical wholesale distributor on more than 247 criminal counts, on March 2006. Docsity.com 40 Truth or Consequence • A pharmacist receives a prescription from an ER physician with a small quantity intending to last the patient until they can visit their regular doctor. The pharmacist notices that the “15” written on the prescription, has been changed to a “45” with different ink. The pharmacist contacts the physician to clarify the prescription, makes a copy of the prescription, instructs the customer to wait, and contacts the police. E. Emma, Community Pharmacist, June 2007 Docsity.com 41 • Approximately what percent of pharmacies will call a physician if they suspect a fake prescription? a. 30% b. 55% c. 78% d. 93% Click here: ☼ Docsity.com 42 Actions taken or would be taken by pharmacist if suspected a patient of drug diversion (1) • Call prescribing physician: 92.8% • Refuse to fill prescription: 76.6% • Confront patient with suspicions: 32.3% • Tell patient to leave pharmacy: 16.3% • Take no action: 1.7% Docsity.com 45 What Can You Do to Help Impaired Co-Worker? (7) • Talk to them about their deteriorating performance at work • Let them know that they may loose job • Encourage joining drug treatment assistance programs • A number of state licensing boards, employee assistance programs, state diversion programs, and peer assistance organizations direct individuals to appropriate counseling and treatment services. These services try to keep the confidentiality of individuals needing assistance. Docsity.com 46 Strategies for Assessing Questionable Prescriptions(1) • Examine for mistakes or irregularities • Verify with prescribing physician, provider number • Observe patient nervousness, unusual behavior, paying by cash • Appropriateness of dosage, number of refills and refill date • Handwriting too legible, different ink used • Acceptable standard abbreviations • Prescription for antagonist drugs such as depressants and stimulants at the same time • A number of people coming within a short time with similar prescriptions from the same physician Docsity.com 47 Who’s On “Candid Camera” • Two customers arrive at a pharmacy on the same day with almost identical prescriptions for OxyContin 20mg, #90, one tablet TID, from the same doctor. Both pay cash and the prescriptions are filled by two different pharmacists on different shifts. The pharmacy manager notices the similarity at night during an audit. • He called the doctor the next day who verified that neither patient was hers and was unaware that she was missing pages from her prescription pad. The manager pulled the pick up time from each prescription from the pharmacy computer, and matched those times to the camera over the pick up counter, and gave copies of the video to the police. E. Emma, Community Pharmacist, June 2007 Docsity.com 50 Federal Trafficking Penalties (8) • Vary depending upon the drug, schedule of drug, quantity, number of prior offenses, harm caused, and number of individuals involved • Penalties for trafficking Fentanyl (Schedule II)- 400 gms or more mixture: – First Offense: ≥ 10 yrs, and ≤ life. If death or serious injury: ≥ 20 yrs and ≤ life. Fine of ≤ $4 million if an individual, ≤ $10 million if not an individual. – Second Offense: ≥ 10 yrs, and ≤ life. If death or serious injury life imprisonment. Fine of ≤ $8 million if an individual, ≤ $20 million if not an individual. – Two or More Prior Offenses: Life imprisonment • For more information go to http://www.usdoj.gov/dea/agency/penalties.htm Docsity.com 51 Summary • Drug diversion involves the use of legal drugs for illegal purposes and can occur through patients, physicians, internet pharmacists, pharmaceutical companies, thefts and losses. • Agencies and programs such as the FDA, DEA, OCI, MCPP and EDT help to prevent drug diversion by the use of various regulations and acts such as the CSA, chemical diversion act, and trafficking act. • Pharmacists have an ethical, professional, personal, and a legal responsibility to control prescription drug abuse and diversion. They can use various strategies to assess questionable prescriptions. • The penalties for trafficking ranges from fines, to life imprisonment, and depend upon the schedule of drug, quantity, harm caused, number of prior offenses and individuals involved. Docsity.com 52 Question • What percentage of pharmacists received post graduate instruction in…. • dispensing controlled drugs? • Preventing drug diversion? • Identifying prescription drug abuse and addiction? Docsity.com