107.05.2009 Blurred lines Prescription, over-the-counter and in the post medicinal products Tim Pfeiffer-Gerschel DBDD – German Monitoring Centre for Drugs.

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

607.05.2009

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

807.05.2009

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

1007.05.2009

„„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

1107.05.2009

(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

1907.05.2009

(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?

2307.05.2009

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

2507.05.2009

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

2607.05.2009

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]