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Prescription, over-the-counter and in
the post medicinal products
Tim Pfeiffer-Gerschel
DBDD – German Monitoring Centre for Drugs and Drug Addiction
IFT Institut für Therapieforschung, Munich
Lisbon, May 7th, 2009
07.05.2009
1
Introduction
Some data/ studies could be identified from…
 Norway, France (esp. on buprenorphine), Czech Republic,
Germany, Finland (esp. antidepressants) and EMCDDA (drug
users in treatment)
 However, European picture remains fragmented and scattered
 Best data available originate from the USA and Canada
 Limitations to existing research: Terms „misuse“, „abuse“,
„dependence“ and „addiction“ are used in idiosyncratic ways
 Rx drug misuse is defined as the non-medical use of a Rx drug
without a doctor‘s prescription (encompasses self-medication
and recreational use)
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Boyd et al., 2006
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Extent of the problem
 2.1% (12+; 5.2 mio) reported using Rx pain relievers non-medically in
the past month (2007); no significant difference compared to 2002
 NSDUH trends on non-medical use of Rx pain relievers in the past
month: declines among youth (12-17) from 3.2% to 2.7%; increases
among young adults (18-25) from 4.1% to 4.6% and adults (26+)
from 1.3% to 1.6%; is stable for females, increase among males
 Rx opioids: 12M prevalence 4.5-4.8% (18+); of those: 12.9% meet
criteria for abuse/dependence
 Daily use of „tranquilisers“ and „hypnotics“ among the German adult
population (18-79): women: 3.4% (men: 1.4%) and 1.8% (0.7%) resp.
(1998)
 LT prevalence of non-medical use of sedatives and tranquilisers in
the US: 4.1% and 3.4% resp., misuse/dependence: 1.1% and 1.0%;
12M prevalence: 2.3%
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NSDUH Report February 5, 2009; Becker et al., 2008; Tetrault et al., 2008
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Knopf & Melchert, 2003; Huang et al., 2006; Becker, Fiellin & Desai, 2007
Who is at risk?
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Different groups…

Among a sample of unintentional pharmaceutical drug overdose
deaths opioid analgesics have been the most prevalent class of
drugs (93.2%), followed by psychotherapeutic drugs (48.8%);
methadone being the most common drug (40.0%)
 Two main groups: Using diverted drugs (63.1%) vs. „doctor
shopping“(21.4%)
a. Diverted drugs users resemble those traditionally associated with
the abuse of street drugs:

More than two thirds were men, half were <35 years and most were
unmarried or divorced
b. „Doctor shopping“:

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48% women, only 29% <35 years, less likely to have been drinking
when they overdosed, oral drug use
Hall et al., 2008
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Different clients…
Age distribution by primary drug. Clients entering treatment - Percentage
distribution of new outpatient clients by age group for each primary drug
%
Hypnotics and sedatives (m=35.5y)
Cannabis (m=23.8y)
35
Stimulants (m=25.9y)
30
Cocaine (m=30.4y)
25
Opioids (m=31.4y)
20
15
10
5
0
<15
15–19
20–24
25–29
30–34
35–39
40–44
45+
Age
07.05.2009
EMCDDA, 2008
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„Distinct“ groups…
(1) Chronic pain patients
(2) Older adults, elderly
(3) Adolescents, young adults
(4) Street drug users, other SUD
(5) Mentally ill individuals
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(1) Chronic pain patients
 When a patient is in physical or emotional pain, prescribing
controlled substances (Rx drugs) often appears to be the simplest
and most efficient way to relieve suffering and distress
 However, in a minority of cases, this approach leads to Rx drug
abuse and patient harm
 Long-term administration of opioids has been associated with the
development of abuse or addiction in 2.8-18.9% of patients
 However, 87% report at least one indicator of medication misuse
in the prior year
 Predictor LT diagnosis of SUD: Increased likelihood to report
borrowing pain medication from others and requesting an early refill
of pain medication
 Group potentially at risk for addiction is significant
Cowan et al., 2003
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Fishbain et al., 1992
Isaacson et al. 2005
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Morasco & Dobscha, 2008
(2) Older adults, elderly
 Few comparable data on drug abuse in this population
 App. 25% of all Rx drugs are sold to elderly (mainly against
chronic pain, insomnia and anxiety disorders), at least 1 in 4 older
adults uses psychoactive medication with abuse potential
 Estimate: Up to 11% of older women misuse Rx drugs
 In Germany, 80% of prescriptions for benziodiazepiones and in
England 80% of prescriptions for hypnotics are for people 60+
 However, inappropriate medication itself does not seem to be the
major cause of adverse drug reactions in the elderly but the inappropriate use of drugs
 Main preventable factor is the reduction in the number of drugs
given
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Lohse & Müller-Oerlinghausen, 2004; Jahnsen & Glaeske, 2001
Culberson & Ziska, 2008; Drug Ther Bull, 2004
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Laroche et al., 2006; Simoni-Wastila & Yang, 2006
(3) Adolescents, young adults
 9.1% of teens (aged 12-17 years) misused Rx drugs in 2005 and
Rx drugs are the most commonly abused drugs for 12-13 year-olds
 As many new abusers of Rx drugs as new users of marijuana in
2006
 7.4%, 2.2% and 1.2% have misused a Rx pain reliever, Rx sedative
or tranquilizer, or Rx stimulant respectively
 LT prevalence of non-medical use of benzodiazepines among (US)
college students: 7.8% (12M prevalence: 4.5%)
 Prescription and OTC cough and cold medication abuse is rapidly
becoming a national health concern for adolescents
 Significant increases from 2000-2004, while use of all other drugs
decreased
 „Generation Rx“ (Partnership for a Drug-Free America 2005)
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Levine, 2007; McCabe, 2007
Monitoring the Future Study (MTF), Johnston et al., 2004, 2006
National Survey on Drug Use and Health (NSDUH) (SAMHSA),13
2006
(4) Street drug users, other SUD






Prescription opioids are an important component of street drug
users‘ drug-taking regimes
Illicit drug involvement and psychiatric symptoms may be driving
the high rates of Rx opiate misuse among rural stimulant users
Rx medication (mainly: opioids, but also benzodiazepines and
stimulants) plays an increasing role in black markets
Diverted drugs users resemble those traditionally associated with
the abuse of street drugs
(Illicit) drug use (alcohol, cocaine, cannabis, hallucinogen, nonmedical stimulant and sedative/tranquilizer use associated with
non-medical use of Rx opioids use
Use of other illicit drugs is the strongest predictor of non-medical
use of Rx opioids
07.05.2009
Davis & Johnson, 2008
Havens et al., 2009; Haydon et al., 2005
Hall et al., 2008; Tetrault et al., 2008
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Sung et al., 2005
(5) Mentally ill individuals
 Higher rates of opioid abuse problems among users of
prescribed opioids at least partially mediated by
depression and anxiety disorders
 Hypothesis: Mental disorders leading to substance
abuse among prescription opioid users rather than
prescription opioids themselves prompting substance
abuse iatrogenically
 SUD due to Rx drug use frequently associated with other
axis I/II
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Edlund et al., 2008
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Huang et al., 2006
Over-the-counter medication (OTC)
 OTC substances are the predominantly overlooked type
of substance abuse by adolescents and young adults
 Phenomenon of legal party pills (piperazine-containing –
BZP, mCPP)
 OTC medication plays a considerable role in deliberate
self-poisoning
 Study to test intervention model to minimise OTC drug
misuse in Ireland in community pharmacies (difficulties
encountered, e.g. no client proceeded to completion of
the follow-up phase)
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Williams & Kokotailo, 2006
Sheridan et al., 2007
Szkolnicka 2005
Wazaify, Hughes & McElnay 2006
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Reasons?
 Growing availability? Marked increases in the numbers of
prescriptions written for opioids in the USA
 Internet? The emergence of „no prescription web sites“ introduces a
new vector for unregulated access to opioids – However, no parallel
increases in problems associated with other Rx drugs (e.g. stimulants) observed
 Societal norm that Rx drugs are ubiquitous and universally
beneficial - misuse of Rx drug to obtain a specific pharmacological
purpose
 Emphasis on primary care physicians for care of patients with pain
conditions rather than physicians who specialize in pain treatment
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INCB, 2007
Zacny et al., 2003
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Forman et al., 2006
What do we see in Europe?
07.05.2009
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Tip of the iceberg…
 Expansion in the prescription of substitution drugs has been
paralleled by increasing reports of the misuse of these drugs
 Opioids other than heroin are reported as the primary drug by
about 5% (up to 15%) of clients entering drug treatment in Europe
 Between 2001-2004 among „abnormal prescription forms“ in France
the most frequently involved drugs were benzodiazepines,
benzodiazepine analogues or opioids
 Switzerland: On average, patients were taking 5 drugs on admission
to hospital which increased to 12 during their stay and to 6 on discharge
07.05.2009
EMCDDA, 2008
Boeuf & Lapeyre-Mestre, 2007
Küfner & Rösner, 2008
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Oertle & Mouton, 2006
Misuse of substitution drugs
Phar-Mon sample of clients with opiate-use-disorder (OUD)
in outpatient treatment (2006)
18
16,2
% misuse
16
14
Methadone
12
Buprenorphine
13,1
10
8
8,0
6
4
2
7,0
3,6
2,1
4,3
2,3
0
2002
07.05.2009
10,5
7,1
2003
2004
2005
2006
Küfner & Rösner, 2008
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Rösner & Küfner, 2007
Polydrug use
All clients entering outpatient treatment: primary drug type combined
with a secondary drug type; percentage distribution of secondary drug by
primary drug for the EU overall
Secondary drug
Primary
Primary drug
drug Opioids
Cocaine
Other
Hypnotics/
stimulants sedatives
Hallucinogens
Cannabis
Alcohol
Opioids
23,1
25,1
5,3
9,0
1,4
17,9
8,5
Cocaine
9,9
5,9
8,3
2,8
1,3
24,5
26,5
Cannabis
3,6
9,6
12,4
1,7
2,1
19,6
21,2
Stimulants
7,6
13,9
37,3
5,1
5,2
35,8
19,2
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EMCDDA, 2008
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EU Challenges…
 Different group(s) (age, gender, background) – how to access and
distinguish these?
 Which group should be monitored to which extent; no systematic
data e.g. from homes for the aged nor primary care physician
 Specialised treatment centres for drug/substance users only reach
parts of the total Rx drugs using population; partly „very“ hidden
populations, difficult to access and to get in contact with
 Information partly available for clients in specialised treatment
centres – specific but sensitive group (representative?)
 Frequently, misuse of pharmaceuticals remains undiscovered or is
regarded as less problematic even among clients with SUD (implicit
hierarchy of substances)
 Difficulties if registration is solely based on ICD-10 codes
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Thank you very much!
Tim Pfeiffer-Gerschel, Dr. Dipl. Psych.
DBDD, c/o IFT Institut für Therapieforschung
Parzivalstrasse 25 - D-80804 Munich, Germany
Tel: +49 (0)89 36 08 04-40
e-mail: [email protected]
07.05.2009
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