107.05.2009 blurred lines prescription, over-the-counter and in the post medicinal products tim...
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107.05.2009
Blurred linesBlurred linesPrescription, over-the-counter and in Prescription, over-the-counter and in
the post medicinal productsthe post medicinal productsTim Pfeiffer-Gerschel
DBDD – German Monitoring Centre for Drugs and Drug AddictionIFT Institut für Therapieforschung, Munich
Lisbon, May 7th, 2009
307.05.2009
IntroductionIntroduction
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)
Boyd et al., 2006
507.05.2009
Extent of the problemExtent 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%
NSDUH Report February 5, 2009; Becker et al., 2008; Tetrault et al., 2008Knopf & Melchert, 2003; Huang et al., 2006; Becker, Fiellin & Desai, 2007
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Who is at risk?Who is at risk?
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Different groups…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“: 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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0
5
10
15
20
25
30
35
<15 15–19 20–24 25–29 30–34 35–39 40–44 45+
Age
%
Hypnotics and sedatives (m=35.5y)
Cannabis (m=23.8y)
Stimulants (m=25.9y)
Cocaine (m=30.4y)
Opioids (m=31.4y)
Different clients…Different clients…
Age distribution by primary drug. Clients entering treatment - Percentage distribution of new outpatient clients by age group for each primary drug
EMCDDA, 2008
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„„Distinct“ groups…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(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 significantCowan et al., 2003
Fishbain et al., 1992 Isaacson et al. 2005
Morasco & Dobscha, 2008
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(2) Older adults, elderly(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 inappro-priate use of drugs
Main preventable factor is the reduction in the number of drugs given
Lohse & Müller-Oerlinghausen, 2004; Jahnsen & Glaeske, 2001Culberson & Ziska, 2008; Drug Ther Bull, 2004
Laroche et al., 2006; Simoni-Wastila & Yang, 2006
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(3) Adolescents, young adults(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)
Levine, 2007; McCabe, 2007Monitoring the Future Study (MTF), Johnston et al., 2004, 2006
National Survey on Drug Use and Health (NSDUH) (SAMHSA), 2006
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(4) Street drug users, other SUD(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, non-medical 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
Davis & Johnson, 2008Havens et al., 2009; Haydon et al., 2005
Hall et al., 2008; Tetrault et al., 2008Sung et al., 2005
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(5) Mentally ill individuals(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
Edlund et al., 2008Huang et al., 2006
2007.05.2009
Over-the-counter medication (OTC)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)
Williams & Kokotailo, 2006Sheridan et al., 2007
Szkolnicka 2005Wazaify, Hughes & McElnay 2006
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Reasons?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. stimu-lants) 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
INCB, 2007Zacny et al., 2003
Forman et al., 2006
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What do we see in Europe?What do we see in Europe?
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Tip of the iceberg…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 dis-charge
EMCDDA, 2008 Boeuf & Lapeyre-Mestre, 2007
Küfner & Rösner, 2008 Oertle & Mouton, 2006
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Misuse of substitution drugsMisuse of substitution drugs
2,13,6
7,1
13,1
16,2
4,3
2,3
8,07,0
10,5
0
2
4
6
8
10
12
14
16
18
2002 2003 2004 2005 2006
% m
isu
se
Methadone
Buprenorphine
Phar-Mon sample of clients with opiate-use-disorder (OUD)in outpatient treatment (2006)
Küfner & Rösner, 2008Rösner & Küfner, 2007
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Polydrug usePolydrug use
Primary drug Opioids CocaineOther
stimulantsHypnotics/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
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 drug
EMCDDA, 2008
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EU Challenges…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
2707.05.2009
Thank you very much! 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 04-40e-mail: [email protected]