Transcript Drug Diversion - University of the Sciences in

Drug Diversion
Chaitali Chheda, PharmD candidate 2008
Dr. Grace Earl, PharmD, Assist. Professor
University of the Sciences in Philadelphia
Philadelphia College of Pharmacy
January 10, 2008
1
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
2
Objectives
1a Define drug diversion
1b List various schedules of controlled substances
1c Identify the popular drugs diverted
1d Describe ways of drug diversion
3
Objectives cont.
2a Discuss monitoring programs employed by the states
2b Explain role of Drug Enforcement Agency
2c State role of FDA’s office of criminal investigations
3a Understand pharmacists’ responsibility and intervention
3b Summarize offenses and penalties
4
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
5
What is Drug
• 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
(1)
Diversion?
16
14
12
10
1992
2003
8
6
4
2
0
1992
2003
Use of Scheduled Drugs
(in millions)
6
15.1 million people reported using
Scheduled Drugs in 2003
• Approximately equal to 2 times the
population of New York City
7
Question
• Opioid drugs like morphine, oxycodone, and
hydrocodone have which of these effects?
•
•
•
•
Enhance alertness, or wakefulness
Relieve pain
Cause euphoria or “high”
Amnesia, or forgetfullness
• Click here for the answer …..☼
8
The Answer IS…..
• Opioid drugs have these effects:
• Relieve pain
• Cause euphoria or “high”
9
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®
10
Abuse Potential and Schedules
Schedule
Examples
• I - marijuana, heroin, no medical usage
• II - morphine, oxycodone (OxyContin®), hydromorphone
Most Abusive
(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)
Less Abusive
11
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 ☼
12
The Answer IS…. (1)
• The top 3 most abused substances in
America are:
• Alcohol
• Marijuana
• Tobacco
13
How Are These Drugs Diverted?
14
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
15
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
16
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
17
The Failure of Practice
• Ronald McIver, 63 years old, and a doctor. He is
now in jail following a conviction for drug
trafficking.
• One patient with a severe pain condition was
given high doses of OxyContin 40 mg from the
start of therapy and was allowed to control her
own dosing.
• She didn’t bring any medical records explaining
her past history (She had been addicted to crack
cocaine in the past).
Tina Rosenberg, The New York Times Magazine, June 17, 2007.
18
Methods of Drug Diversion III
• Pharmacist as a source(1)
• not checking for the accuracy of physicians’
DEA number
• receiving phone orders and dispensing or
giving out medications based on incomplete
information on prescription
19
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)
20
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.
21
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.
22
Regulation and Control
23
Regulation and Control (1)
• All new drugs and their marketing activities have to be
approved by The Food and Drug Administration (FDA)
• The Controlled Substances Act (CSA) of 1970 created a
system for classifying prescription drugs according to their
medical use and potential for abuse
• Prescriptions written for scheduled drugs must meet
certain criteria
• Professional boards such as the State Board of Pharmacy
provides licenses and can take action against members
within their profession
• State bureaus of narcotics and local law enforcement are
important in controlling diversion
• Twenty states have implemented Prescription Drug
Monitoring Programs to control diversion and abuse.
24
Monitoring Programs Employed by States (2)
• State-administered prescription monitoring
programs are very effective in controlling
diversion of scheduled substances at retail
pharmacy.
25
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.
26
Does Pennsylvania have MCPP?
• For more information visit:
• http://oig.hhs.gov/oei/reports/oei-12-9100490.pdf
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?
28
Drug Enforcement Administration (6)
• The Drug Enforcement Administration (DEA)
overlooks distribution of controlled prescription
drugs to control diversion.
• It monitors shipping of legal controlled substances
across United States borders, and gives permits for
imports/exports.
29
More Conspiracies Uncovered (4)
• Counterfeit Lipitor®: Three businesses and eleven
individuals were indicted for their involvement in a $42
million dollar conspiracy to sell counterfeit, smuggled, and
misbranded Lipitor®, and other drugs, and for
participating in a conspiracy to sell stolen drugs. The case
resulted in nine convictions, $2.8 million in forfeitures, and
12 others are under indictment awaiting trial, $10,000,000
more in alleged proceeds are to be forfeited. In June 2006,
one of the defendants was sentenced to nine years and six
months in federal prison and ordered to pay $1,806,905 in
restitution to Pfizer, Inc.
• California Man Arrested on Counterfeit Drug Charges:
California man was arrested on June 2006 for distributing
fake drugs purchased over internet from a Chinese supplier
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.
31
Q: What over-the-counter drug is
used to make illegal
methamphetamine?
32
Diversion of Controlled Chemicals (6)
Is it…..
a. Acetaminophen (Tylenol)
b. Glucosamine
c. Potassium chloride (KCl)
d. Pseudoephedrine (Sudafed)
Click here for answer: ☼
33
The answer is…
d.
Pseudoephrine can be used to make
methamphetamine
34
Diversion of Controlled Chemicals
• Until recently there were no laws to control
distribution of chemicals needed to synthesize
illegal drugs.
• The Chemical Diversion and Trafficking Act of
1988 applied the concept of commodity control to
chemicals commonly used for manufacturing and
synthesizing drugs of abuse.
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.
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
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.
38
More Examples (4)
An Investigation was conducted by the OCI and ICE
which helped the Chinese authorities in determining the
source of counterfeit drugs. This joint effort resulted in the
arrest of 11 individuals. They will be prosecuted by the
Chinese government for their involvement in making and
distributing fake Lipitor, Viagra, and Cialis.
• For more examples got to:
http://www.fda.gov/ola/2006/appendixa0711.html
39
What Are Your Responsibilities?
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
41
• Approximately what percent of pharmacies will
call a physician if they suspect a fake prescription?
a.
b.
c.
d.
30%
55%
78%
93%
Click here: ☼
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%
43
Pharmacist responsibility (7)
• Share responsibility for controlling prescription drug abuse
and diversion
• Ethics: support laws to protect society from abuse
• Professional: prescribe and dispense controlled substances
using standard practices, make sure that medications are
available for legal use to patients and simultaneously
prevent abuse of medications
• Personal: have knowledge of ways of drug diversion and
actions that can be taken to prevent diversion
• Legal: be familiar with the state and federal laws regarding
dispensing of controlled substances
• Link to PA State Board of Pharmacy:
http://www.dos.state.pa.us/bpoa/cwp/view.asp?a=1104&q
=432995
44
Actions taken or would be taken by pharmacists if
suspected a professional colleague of drug diversion (1)
• Document it: 62.9%
• Confront colleague: 50.1%
• Report colleague to professional
association: 49.5%
• Contact police: 11.7%
• Take no action: 0.7%
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.
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
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
48
Offenses and Penalties
49
Offenses and Penalties
• The Office of Diversion Control’s Title 21 “Unites States
Code (USC) Controlled Substances Act, Part D - Offenses
and Penalties” lists the various unlawful acts and the
penalties
• Penalties could be imprisonment, fines, or both
• For specific examples go to:
http://www.deadiversion.usdoj.gov/21cfr/21usc/21idusct.htm
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
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.
52
Question
• What percentage of pharmacists received
post graduate instruction in….
• dispensing controlled drugs?
• Preventing drug diversion?
• Identifying prescription drug abuse and
addiction?
53
(1)
Answer
• What percentage of pharmacists received
post graduate instruction in….
• dispensing controlled drugs? 56%
• Preventing drug diversion? 48%
• Identifying prescription drug abuse and
addiction? 50%
54
References
1.
2.
3.
4.
5.
6.
7.
8.
Under the counter: the diversion and abuse of controlled prescription drugs in the
U. S. July 2005. The national center on addiction and abuse at Columbia University.
Forgione DA, Neuenschwander P, Thomas E Vermeer. Diversion of prescription
drugs to the black market: what states are doing to curb the tide. J Health Care
Finance. 2001: 2001;27(4):65
Inciardi JA, Surratt HL, Jurtz SP, Cicero TJ Mechanisms of prescription drug
diversion among drug-involved club- and street- based populations. Pain Med. 2007
Mar; 8(2):171-83
Efforts of FDA’s office of criminal investigations. Appendix A-FDA testimonyJuly 11, 2006; [cited 2007 July 1]. Available from:
http://www.fda.gov/ola/2006/appendixa0711.html
Naddi.org [homepage on the Internet]. National Association of Drug Diversion
Investigators; c2006 [cited 2007 July 1]. Available from: http://www.naddi.org/
Deadiversion.usdoj.gov [homepage on the internet]. Office of diversion control.
U.S. department of justice. Drug enforcement administration. [cited 2007 July 1].
Available from: http://www.deadiversion.usdoj.gov/prog_dscrpt/index.html
A pharmacist’s guide to prescription fraud. Office of diversion control. U.S.
department of justice. Drug enforcement administration. 2000 Feb; 1(1); [cited
2007 July 1]. Available from
Federal trafficking penalties U.S. Drug enforcement administration. [cited 2007 July
1]. Available from: http://www.usdoj.gov/dea/agency/penalties.htm
55