Research Activities to Document Progress During IPPF Aaron M. Gilson, MS, MSSW, PhD Research Program...

Research Activities to Document Progress During IPPF

Research Activities to Document Progress During IPPF

Aaron M. Gilson, MS, MSSW, PhDResearch Program Manager/Senior Scientist

Pain & Policy Studies Group

International Pain Policy Fellowship


WHO Collaborating Center for Pain Policy & Palliative Care

University of Wisconsin Carbone Cancer Center

August 8, 2012

Martha A. Maurer, MSSW, MPH, PhDSenior Researcher/Assistant Scientist


Demonstrate initial needs/problems to government officials and other stakeholders

Document changes as a result of policy improvements policy content increase safe prescribing and dispensing without

contributing to diversion

Begin building an evidence base for patient care Incorporate findings into grant reports and future

publications, as a clear indication of positive changes

Need for ResearchNeed for Research

1. Policy evaluationEstablish justification for efforts to improve policy content in a countryDocument impact of policy change activities

Types of ResearchTypes of Research

2. Collection and analysis of secondary dataMedical use of opioidsInstances of diversion

3. Survey researchAssess knowledge, beliefs, and attitudes of health care professionals

Policy EvaluationPolicy Evaluation

Accuracy of the policy evaluation depends on the types and most current versions of policies collected

Statutes Related to the Federal Constitution National Congress President-issued decrees

Regulations Government health care agencies

Governs organization, power, and function

Types of policies (National)


State policies

Drug control (“Narcotic and Psychotropic Substances Act”)

Medical practice, including prescribing Pharmacy practice, including dispensing

Types of policies

WHO Guidelines (2011) PPSG Global Evaluation

Criteria-based evaluation


Colombia Guatemala Mexico Panama

Current criteria-based evaluations

Addiction (“Dependence Syndrome”)“Physical or psychological dependence understood first as a subjection that obliges a person to take drugs and that after stopping their administration (or use), causes physical and / or bodily disturbances and second as the impulse that requires periodic and continuous administration of drugs to suppress mental distress.”Executive Decree 48-92, Article 2(c)


Comprehensiveness of policies collected Current versions National vs. state policies Translation accuracy Application of evaluation criteria Requires periodic evaluations over time

Considerations and possible challenges


Amount and type of oral opioids prescribed in the last year Amount and type of medication used per patient Number of cancer or HIV/AIDS patients treated with

opioids Frequency with which health care practitioners provide

pain or palliative care Frequency of opioids in health care facilities and

availability for outpatient use Identification of instances of diversion or abuse of opioid

medicines

Examples of data that can be collected

Collection & Analysis of Secondary DataCollection & Analysis of Secondary Data

Should NOT be patient-level data

CAN NOT send identifying patient information Names, dates of birth, ages, etc.

If necessary, code (number) data before sending Clearly indicate what the data represent

In-patient prescription data, outpatient prescription data, hospital stock or purchase data

Quality vs. quantity More important to have complete accurate data from one

institution than incomplete, questionable data from several institutions



Two-year study of medical use of oral morphine at home in rural India and diversion

1,723 patients received palliative care and oral morphine

Noted quantity of morphine received in each shipment; recorded morphine dispensing in stock register, reconciling daily with stock register; return of left-over medication

No instances of abuse or diversion were identified Published in The Lancet:

Rajagopal MR, Joranson DE, Gilson AM. Medical use, misuse, and diversion of opioids in India. The Lancet. 358:139-143.


India Example

HOSPITAL DATA: amount of opioids distributed to hospitals from wholesalers morphine (ampoules, syrup, tablets) fentanyl patches (transdermal) hydromorphone (tablets)

PHARMACY DATA: number of pharmacies that dispense opioids compared with total number of pharmacies

Presented at National Opioid Availability Symposium, April 2010


Serbia Example

680

433

35

18

389

247

20

10

0 100 200 300 400 500 600 700 800

Number of patients whose pain can be treated with the quantities of IR morphine

Tx: 100mg/d * 7 days

Tx: 100mg/d * 4 days

Data from 2009

D

C

B

A

Institutions

Fellow collected morphine consumption data from several hospitals throughout the country

Fellow requested information from manufacturers and importers on the amount of morphine distributed to various hospitals


Nepal Example

Compiled large amount of information, but encountered challenges with standardizing product names, dosage strengths, and formulations across institutions


Nepal Example

Collection & Analysis of Secondary DataCollection & Analysis of Secondary DataNepal Example

Hospital Year Product No. of units (tablets, ampoules)

Total Qty morphine (mg)

Manmohan Memorial hospital

2010 Inj.morphine, 15 mg 195 2,925


2010 IR morphine tablet, 10 mg

1,042 10,420


2010 TOTAL FOR ALL PRODUCTS

13,345

Thankot Hospice Center

2010 Injectable morphine, 10 mg

129 1,290


2010 Morphine tablet, 10 mg

717 7,170


2010 TOTAL FOR ALL PRODUCTS

8,460


Sierra Leone Example

In 2008, Shepherd’s Hospice received first-ever shipment of oral morphine powder from low-cost supplier in Scotland

Pharmacist trained in Uganda to learn how to manufacture oral morphine solution

Fellow worked with PPSG to track morphine amounts from import to prescription /administration to patients

Fellow developed safekeeping procedures for how to manage and use the morphine

Second shipment of 1 kg of morphine powder arrived in 2011



Morphine powder imported (500 grams)

Shepherd’s hospice drug store beginning stock balance = 500 grams

Stock Record on MSP WarehouseStock Record on MSP Warehouse

(Amount of morphine sulphate powder requested based on patient load need for morphine for 60 days)

Morphine solution production lab

Stock Record on Production in LabStock Record on Production in Lab

Converted from grams to mls

(Morphine solution is stored on shelf in well ventilated room that serves as laboratory – can last 60 days)

Prescriptions in mls

(All morphine powder went to Shepherds hospice)

Dispensary



Rec No.

Date Qty. MSP received from Warehouse (grams)

Morphine Concentration (mg/ml)

Morphine solution volume prepared (mls)

Supplied to Dispensary (mls)

Supplied to Dispensary (grams)

Qty. MSP remaining in lab (grams)

1 2/11/2009 40 10 4,000 4,000 40 0

2 2/11/2009 4 1 4,000 320 0.32 3.68

3 4/1/2009 80 10 8,000 8,000 80 3.68

Running total 124 120.32 3.68

Stock Record on Production in Lab


Paul Hutson. Pharm.D., M.S.

• Pharmacist Colleague at UW

• Willing to assist with opioid recordkeeping

• Experience with developing databases tailored to specific needs

What information do you want to collect? Who do you want to survey? Length of time to construct survey Validity of survey instrument Low response rate Not generalizable to other institutions or health care

professionals

Survey ResearchSurvey Research



Colombia Example


Colombia Example Survey of officers from each Regional Competent

Authority office (n=31) and Pain and palliative care providers (n=15)

To identify perceptions of opioid availability: Grade the availability of opioids in their region Identify barriers at the institutional and regional levels

Published in the Journal of Pain & Symptom Management Leon et al. Improving availability of and access to opioids

in Colombia: Description and preliminary results of an action plan for the country. Journal of Pain & Symptom Management. 38(5):758-766, 2009.


Guatemala Example


Guatemala Example Survey of physicians (n≈200) who treat patients with

cancer in private practice settings or in four reference teaching hospitals in Guatemala City

Physicians’ Knowledge & Attitudes Regarding the Use of Opioid Analgesics for Cancer Pain Management

• Knowledge and attitudes about treating cancer pain

• Prescription requirements• Opioid prescribing practices• Institutional barriers• Opiophobia

Outcomes• Gender• Age• Year of medical school graduation• Residency program• Hospital• Prescribing experience• Pain management education

Predictor variables


Guatemala Example

Association between reluctance to prescribe and: lack of knowledge about principles of treating cancer pain negative attitudes regarding pain and its treatment exaggerated concerns about “addiction” concern about government oversight

Association between concern about government oversight and lack of knowledge of prescribing requirements

Association between beliefs and attitudes and choice of opioids to prescribe

Year of medical school graduation will not influence attitudes about prescribing and cancer pain treatment

Research Hypotheses


Jamaica Example


Jamaica Example

MoH Survey on Access and Availability of Opioids in Hospitals across Jamaica Conducted by Dr. Verna Edwards, the Chief Dangerous

Drugs Inspector in 2008

Included questions about the availability of specific opioid formulations (Morphine tablets, 10 mg; Injectable Morphine 10mg/ml)


Jamaica Example

Results displayed in a poster indicating the types of opioids available in Jamaica

Placed on every ward in public hospitals across the Island


Jamaica Example Survey on Knowledge, Attitudes and Practices of

Opioid Usage amongst healthcare professionals Conducted in collaboration with the Jamaican Pain

Collaborative Engaged research assistants to enter results data

Sought help for data analysis from MoH statistician Presented results at hospitals Presented results at National Opioid Conference in April

2010

LogisticsLogistics

Getting Started Policy Evaluation

Have you identified all relevant policies? Are they in English?

Data Collection Do you have an institution in mind for data collection? Will it be possible to get a letter of support? What type of data are available? Any questions or concerns?

Surveys (optional) “IRB issues”?

Next StepsNext Steps

Consultation with Martha!!

Research Activities to Document Progress During IPPF Aaron M. Gilson, MS, MSSW, PhD Research Program...

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