1. Research Activities to Document Progress During IPPF Aaron M. Gilson, MS, MSSW, PhD Research Program Manager/Senior Scientist Pain & Policy Studies Group International Pain Policy Fellowship Pain & Policy Studies Group WHO Collaborating Center for Pain Policy & Palliative Care University of Wisconsin Carbone Cancer Center August 8, 2012 Martha A. Maurer, MSSW, MPH, PhD Senior Researcher/Assistant Scientist Pain & Policy Studies Group

2.  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 Research

3. 1. Policy evaluation  Establish justification for efforts to improve policy content in a country  Document impact of policy change activities Types of Research 2. Collection and analysis of secondary data  Medical use of opioids  Instances of diversion 3. Survey research  Assess knowledge, beliefs, and attitudes of health care professionals

4. Policy Evaluation Accuracy of the policy evaluation depends on the types and most current versions of policies collected

5.  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) Policy Evaluation State policies

6.  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 Policy Evaluation

7.  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) Policy Evaluation

8.  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 Policy Evaluation

9.  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 Data Should NOT be patient-level data

10.  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 Collection & Analysis of Secondary Data Considerations and possible challenges

11.  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. Collection & Analysis of Secondary Data India Example

12.  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 Collection & Analysis of Secondary Data Serbia Example

14. 680 433 35 18 389 247 20 10 0100200300400500600700800 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

15.  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 Collection & Analysis of Secondary Data Nepal Example

16.  Compiled large amount of information, but encountered challenges with standardizing product names, dosage strengths, and formulations across institutions Collection & Analysis of Secondary Data Nepal Example

17. Collection & Analysis of Secondary Data Nepal Example HospitalYearProductNo. of units (tablets, ampoules) Total Qty morphine (mg) Manmohan Memorial hospital 2010Inj.morphine, 15 mg1952,925 Manmohan Memorial hospital 2010IR morphine tablet, 10 mg 1,04210,420 Manmohan Memorial hospital 2010TOTAL FOR ALL PRODUCTS 13,345 Thankot Hospice Center 2010Injectable morphine, 10 mg 1291,290 Thankot Hospice Center 2010Morphine tablet, 10 mg 7177,170 Thankot Hospice Center 2010TOTAL FOR ALL PRODUCTS 8,460

18. Collection & Analysis of Secondary Data Sierra Leone Example

19.  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 Collection & Analysis of Secondary Data Sierra Leone Example

20. Morphine powder imported (500 grams) Shepherd’s hospice drug store beginning stock balance = 500 grams Stock 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 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

21. Collection & Analysis of Secondary Data Sierra Leone Example Rec No. DateQty. 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) 12/11/2009 40104,000 400 22/11/2009 414,0003200.323.68 34/1/2009 80108,000 803.68 Running total124120.323.68 Stock Record on Production in Lab

22. Collection & Analysis of Secondary Data Paul Hutson. Pharm.D., M.S. Pharmacist Colleague at UW Willing to assist with opioid recordkeeping Experience with developing databases tailored to specific needs

23.  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 Research Considerations and possible challenges

24. Survey Research Colombia Example

25. Survey Research 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.

26. Survey Research Guatemala Example

27. Survey Research 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

28. Survey Research 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

29. Survey Research Jamaica Example

30. Survey Research 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)

31. Survey Research 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

32. Survey Research 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

33. Logistics 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”?

34. Next Steps  Consultation with Martha!!