Le strategie per migliorare l’aderenza alla terapia · Mario Polverino Polo Pneumologico ......

Le strategie per migliorare l’aderenza alla terapia

Mario Polverino

Polo Pneumologico Provinciale

Centro Regionale Ad Alta Specializzazione

PO «M. Scarlato», SCAFATI (SA)Scuole di Specializzazione in Pneumologia, Farmacologia

OSMED 2015 report In Italy

Patients with aderence to therapy for pulmonary obstruction

13,6%

C.E. Koop

«The drugs do not work in patients who do not

take them»

Osterberg L et al. N Engl J Med 2005

Cause mancata aderenza

L’ ADERENZA È INVERSAMENTE CORRELATA ALLA FREQUENZA DELLE DOSI

La monosomministrazione giornaliera sia associa ad unapercentuale di aderenza dell’80%

17/11/2016 6

Achieving Asthma Control : the key role of inhalers. Breathe Dec 2008 Vol 5 N° 2

Erogatori…

CCC

Smith IJ, et al. J Aerosol Med Pulm Drug Deliv. 2010; 23(Suppl 2):S25–37

Competence The ability to use a device correctly

• Simpler devices may enable more patients to use them correctly

• MDIs are not simple devices to use

Contrivance Knowing what to do but doing something else

• e.g.: the patient who shows good technique with a spacer and MDI in the clinic, but then does not use the spacer when at home

Compliance Taking medication as recommended

• Patients need to understand

‒ the rationale behind the medication

‒ the consequences of not taking the medication as intended

‒ the consequences of poor inhaler technique

‒ the long-term benefits of taking the medication

Frequency distributionnumber of errors

Relationship number of errors and AIS

Number of errors

0 1 2 3 4 5 6 ≥7

Fre

qu

en

cy %

0

10

20

30

0

1

2

3

4

5

6

AIS u

nits

Numero di errori e stabilità dell’asma

AIS, asthma instability score

Giraud V and Roche N. Eur Respir J. 2002;19:246–51.

DEVICES

Strangely… …any sponsored study concludes that its device is the best

Every mother likes her own beetle

No significant differences between inhaler devices with regards to efficacy and safety, 12

Every mother likes his beetle

Brocklebank et al. Health Technol Assess 2001;5(26)

No significant differences between inhaler devices with regards to efficacy and safety, 12 therefore other case-specific factors should also be taken into account when selecting inhaler device

Wieshammer S, et al. Resp. 2008;75:18–25.

Patient age (years)

Erro

r ra

te (

%)

0

20

60

100

40

80

Severity of airway obstruction

No obstruction

Mild Moderate Severe

Erro

r ra

te (

%)

0

20

60

100

40

80

Errors according patient’s age and obstruction

No significant differences between inhaler devices with regards to efficacy and safety, 12 therefore other case-specific factors should also be taken into account when selecting inhaler device

Ideal device• Patients want an inhaler device that:

– they like, prefer, and are satisfied with1,2

– is easy to use correctly3,4

– is more forgiving of variations in technique3,4

– compensates for any comorbidities that may reduce ability to use devices5,6

– has fewer preparatory steps7

– has an intuitive technique that can be easily picked up with very little or no instructions7

– has positive feedback (such as ‘lactose taste’)8

• Once chosen, it is important that patients receive adequate training on how to use their particular device3,9,10

1. Small M, et al. Importance of inhaler-device satisfaction in asthma treatment: real-world observations of physician-observed compliance and clinical/patient-reported outcomes. Adv Ther 2011;28:202-212.2. Lavorini F, Fontana GA. Inhaler technique and patient's preference for dry powder inhaler devices. Expert Opin Drug Deliv 2014;11:1-3.3. Smith IJ, et al. Inhaler Devices: What Remains to be Done? J Aerosol Med Pulm Drug Deliv 2010;23(Suppl 2):S25-37.4. Papi A, et al. Inhaler devices for asthma: a call for action in a neglected field. Eur Respir J 2011;37:982-985.5. Press VG, et al. Misuse of respiratory inhalers in hospitalized patients with asthma or COPD. Journal of General Internal Medicine 2011:26;635-642.6. Yawn BP, et al. Practical aspects of inhaler use in the management of chronic obstructive pulmonary disease in the primary care setting. Int J Chron Obstruct Pulmon Dis 2012;7:495-502. 7. Svedsater H, et al. Qualitative assessment of attributes and ease of use of the ELLIPTA™ dry powder inhaler for delivery of maintenance therapy for asthma and COPD. BMC Pulm Med 13;13:72.8. Baldrick P and Bamford DG. A toxicological review of lactose to support clinical administration by inhalation. Food Chem Toxicol 1997;35:719-733.9. Press VG, et al. Teaching the use of respiratory inhalers to hospitalized patients with asthma or COPD: a randomized trial. J Gen Intern Med 2012;27:1317-1325.10. Giraud V, et al. Inhaler technique and asthma: feasability and acceptability of training by pharmacists. Respir Med 2011;105:1815-182

• Only feedback that dose has been taken is a sweet taste, which may simply indicate high oropharyngeal deposition

• Too many manoeuvres

• Blisters frequently changed and the device cleaned before refill

• If high resistance, it may be difficult to generate high enough inspiratory flow to disaggregate particles sufficiently

• Device must be kept upright until loaded

• Base must be turned fully in both directions

• Patient must shake before use, and drug may escape if the patient exhales into the device2

1. Lavorini F, et al. Respir Med. 2008;102:593–604; 2. O’Connor BJ. Respir Med 2004;98(Suppl 1):S10–6

Features "unfriendly" to the correct use

Corticophobia

Zedan et al. Iran J Allergy Asthma Immunol 2010;9: 163-168.

Rubin et al. Chest 1990; 97:959-61

Perché il paziente dovrebbe essere

aderente se…

Decisioni senza contesto clinico

Affidare la diagnosi…

• …a un questionario

• …solo all’E.O.

• …solo alla funzione

• …solo alla clinica

41FEV1/VC: 57; FEV1= 23.5% del

teorico

BPCO: DEFINIZIONE

La broncopneumopatia cronica ostruttiva

(BPCO) è un quadro nosologico

caratterizzato da una persistente

ostruzione al flusso aereo.

2005

COPD, a common preventable and

treatable disease, is characterized by

persistent airflow limitation that is

usually progressive and…

2014

A Review of Available National Guidelines of Treatment of COPD in Europe. Miravitlles,

Vogelmeier, Roche, Halpin, Cardoso, Chuchalin, Kankaanranta, Sandström, Śliwiński, Zatloukal, Blasi

[in press]1. Czech Republic: CZ

2. England: EN

3. Finland: FI

4. France: FR

5. Germany: GE

6. Italy: IT

7. Poland: POL

8. Portugal: POR

9. Russia: RU

10. Spain: SP

11. Sweden: SW

Diagnosis

• FEV1/FVC < 70: EN, FR, GE, FI, PO, RU

• FEV1/FVC < LLN: CZ, IT, POL, and SW

Stratification of Disease Severity

• CZ, EN, FR, GE, POL, POR and RU: GOLD (FEV1)

– IT: Stage 3 and Stage 4 in a single “severe” category.

• FI: low risk (FEV1 ≥50%) and high risk (FEV1

<50%)

• SW: GOLD (FEV1) + EX

• SP: BODE

Symptoms

• FI and SP: CAT

• CZ, POL and POR: CAT and mMRC

• FR: episodic/daily symptoms and mMRC

• RU and SW: CAT, mMRC, and Clinical COPD Questionnaire (CCQ);

• EN: mMRC, systemic symptoms, BMI, CAT, 6’WT and PaO2

Phenotypes

• CB/E: CZ, EN, POL, RU, SP and SW

• Frequent exacerbator: CZ, EN, FI, POL, POR, RU, SP and SW

– ≥2 EX: CZ and FR

– ≥2 EX or ≥1 SEVERE (hospitalization): FI, RU, POR and SP

– ≥2 EX or ≥1 SEVERE (hospitalization) + FEV1 <50%: POL

• ACOS: CZ, FI, RU, SP, FR and SW

Treatment Goals • CZ, FI, FR, POL, POR and SW: reducing

symptoms, averting the natural progression of the disease, improving QoL, enhancing PA, preventing complications and adverse consequences, and increasing life expectancy

• GE and SP: improvement of symptoms, exercise capacity, and QoL; and reduction of exacerbation frequency

• RU: short-term (symptom relief and improvement of exercise tolerance and QoL) and long-term (preventing disease progression and exacerbations and decreasing mortality

• IT: not explicitly stated:

Treatment according patient phenotype

• BC: PDE4in, mucoactive agent, and/or macrolide added to bronchodilators (CZ)

• E: theophylline (CZ)

• ACOS: ICS + LABA or ICS + LABA + LAMA (CZ, FI and SP)

• EX: regular treatment +

PDE4in

ICS

mucoactive drugs

antibiotics

Ass. %teor.

FEV1 2.78 124

FVC 3.35 118

ITFVC 83

Ass. %teor.

FEV1 2.42 110

FVC 2.77 106

ITFVC 87

Ass. %teor.

FEV1 2.64 80

FVC 3.31 82

ITFVC 80

Paz. sesso femminile, a. 70

• Fumatrice (45 pack/years), dispnea e tosse

Ass. %teor

FEV1

0.92 40

FVC 2.10 72

IT 55

SIGN?

BTS?

BBC?

ERS?

GOLD?

CNN?ATS?

Come calibrare la terapia?

Uso CSI limitato stadi più avanzati o a pazienti con

almeno 2 R / anno

1

2

3

4

Riacutizzazioni

anno

≥ 2

< 2

MRC2 +

CAT 10 +

MRC 0 1 CAT < 10

Trattamento farmacologico

S

T

A

D

I

SABA o

SAMA2a opzione

LAMA o

LABAo

SABA +

SAMA

LAMA oLABA

2a opzione

LAMA + LABA(

A)

(B)

ICS + LAMA

o

ICS+LABA+

LAMA

ICS/LABA+

PDE4

LAMA+LABA

;

LAMA +

PDE4

ICS + LABA

o LAMA2a opzione

LAMA + LABA

(C)

(D)

GOLD 2013

I broncodilatatori sono il trattamento cardine della

BPCO e gli unici indicati negli stadi lievi/moderati (

<2 riacutiz/anno )

FARMACOTERAPIA DELLA BPCO

STABILE (17/20)

60

%

<2

>2

r

i

a

c

u

t

i

z

z

a

z

i

o

n

i

/

a

n

n

o

80% 50%

VEMS % del

predetto

LAMA o

LABA

SABA

o

SAMA

(LAMA O LABA?)

LABA o LAMA

(LABA+ ICS)

LABA + ICS

LAMA + LABA + ICS

LAMA o LABA +

roflumilast

LAMA + LABA

LABA o LAMA

sintomi

LABA +

LAMA

?20%

30%

Person

e con

BPCO

%

50%

SABA o

SAMA

LABA o

LAMA

LABA +

LAMA

LABA

+ CSI

TRIPLI

CE

LABA o

LAMA

LABA + CSI

TRIPLICE

LABA o

LAMA

LABA o

LAMA

+ CSI o

PDE4

LABA +

LAMA

+ CSI o

PDE4

LABA +

LAMA

+ CSI +

PDE4

Perché il paziente dovrebbe essere aderente se…

Perché il paziente dovrebbe essere aderente se…

…i medici non sono d’accordo fra loro?

AFT 3 e 4

DOCENTI

Verificare la diagnosi in pazienti che assumevano BD

ANAMNESI FISIOLOGICA

Età - Sesso

ANAMNESI

Esposizione a sorgenti

inquinanti - Fumo

COMORBIDITA'

SINTOMISpirometria

ESITO SPIROMETRIA

TERAPIA POST VALUTAZIONE

Conferma Terapia

PRE

POST

TERAPIA POST VALUTAZIONE

Report I Trim. 2014

Dati

FEBBRAIO 2016

Report I TRIMESTRE 2016Tot. € 7026 Conf. Tot. 288

Gennaio

Febbraio

Marzo



13,6%



13,6%BEN il aderente

Conclusioni

1. LG uniformi, chiare, inequivocabili, facilmente intuibili e applicabili

Conclusioni

1. LG uniformi, chiare, inequivocabili, facilmente intuibili e applicabili

2. Comunicazione

Arch Bronconeumol. 2016 Apr;52(4):179-180. Epub 2016 Mar 10

Appello finale

QUESTIONARIO DELL’AMORE

Grazie

dell’attenzione

CENSURA

Il relatore a 9 mesi Il relatore oggi

Le strategie per migliorare l’aderenza alla terapia · Mario Polverino Polo Pneumologico ......

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