Social Pharmacy Lecture 10:

1. Social PharmacyLecture 10: Introduction to Pharmionics. “Drugs don’t work in patients who don’t take them.” JAMASOFT2017

2. TheDrugUseChainincludestheprocessesof: drugacquisition, storage, distribution, prescribing, patientmedicationuse. JAMASOFT2017

3. Study ofmedicationuse • is essential • for pharmacoepidemiology • as well as • for pharmacoeconomics. JAMASOFT2017

4. To becompleted Drug-related problems in Social pharmacy: • Medicationuse(pharmionics -adherence – compliance,...) • InappropriateMedication(MedicationErrors) a. Inappropriateprescribing b. Prescribingerrors c. Dispensingerrors. JAMASOFT2017

5. The International Society for Pharmacoeconomicsand Outcomes Research (ISPOR)(Medication Complianceand Persistence Work Group) • developed definitionsfor compliance and persistence during 3 years • ofinternational review and discussion. JAMASOFT2017

6. Behaviour • Doctor ’s prescribing behaviour Patient’s health behaviour JAMASOFT2017

7. PHARMIONICS • The term pharmionics refers to the investigation of what the patient actuallydoes with the drug after it has been prescribed. JAMASOFT2017

8. Pharmionic - Terminology and Definitions. It is important to understand the terminology ofpharmionics. Compliance is the degree or extent to which patients follow the health advice they receive. Compliance refers to the consistency and accuracy with which a patient follows a recommended medical regimen, usually reffering to a pharmacotherapeutic regimen. The synonyme is Adherence"the extent to which the patient follows medical instructions„ . Adherence is a blanket term for the three phases of ambulatory pharmacotherapy, which are as follows: Acceptance: The first phase is whether the patient accepts the principle and regimen of the prescribed treatment. If acceptance is forthcoming, the patient commences to engage with the drug dosing regimen. Execution: The second phase, measured by compliance, is the extent to which the patient engages with the therapy: that is, how well the dosing history corresponds to the prescribed dosing regimen. Discontinuation: The third phase is when the treatment ceases; this may be because the prescriber called for it to cease, or the patient may have partially or wholly stopped engaging with the dosing regimen; discontinuation is when, for whatever reason, drug intake levels have fallen so low as to be therapeutically inconsequential. Persistence is the length of time between the first-taken dose and the last taken dose in a course of ambulatory pharmacotherapy. Attendance refers to the measurement of the frequency or timing of medical follow-up visits compared to the frequency or timing that should occur based on the physicians‘ plan. JAMASOFT2017

9. Most frequentlyused synonyms: Compliance (Adherence), Concordance, Treatment Persistence, Attendance. JAMASOFT2017

10. Adherence • is defined as the extent to which apatient’s health behavior coincides with their physician’s or pharmacist‘s recommendations, • whether taking medications or following advice for some • type of behavioralchange. JAMASOFT2017

11. Thephenomenonofthecompliancewithdrugtherapyrecommendations has been recognized to represent a complex challenge since its first mentioning by HYPOCRATES about 2400 years ago. JAMASOFT2017

12. People do not takemedicinesproperly. • Approximately half of the medicines prescribed to them for chronic conditions,which undermines their care and leads to increasedhealth care costs, morbidity, and mortality. JAMASOFT2017

13. A recent report by the WHO revealed that 50% of patients with chronic disease do not take their medication as prescribed. Poor medication adherence leads to increasingly poor health outcomes for patients and has a significant negative economic impact on healthcare resources. Readily-available communications technology can provide real-time information and feedback to patients, to support improved medication adherence. JAMASOFT2017

14. Definitions • MedicationCompliance (Adherence) • refers to the consistency and accuracy with which a patient follows a recommendedmedication regimen, usually referring to a pharmacotherapeutic regimen. • Treatment persistence refers to the continued use of the prescribed pharmacotherapeutic regimen. JAMASOFT2017

15. Medication adherence usually refers • to whether patients take their medications as prescribed (eg, twice daily), as well as whether they continue to take a prescribed medication. • Medication non-adherence is a growing concern to clinicians, healthcare systems, and other stakeholders (eg, payers) because of mounting evidence that it is prevalent and associated with adverse outcomes and higher costs of care. JAMASOFT2017

16. The term “adherence” • is preferred by many health care providers, because “compliance” suggests that the patient is passively following the doctor's and pharmacist’s orders and that the treatment plan is not based on a therapeutic alliance or contract established between the patient and the physician or pharmacist. JAMASOFT2017

17. Definitions Medication Compliance (Adherence)“…extent to which a patient acts in accordance with the prescribed interval and dose of a dosing regime“ in contrast Medication Persistence is „the accumulation of time from initiation to discontinuation of therapy” JAMASOFT2017

18. We speak: Compliance with (or adherence to) a medication regimen. JAMASOFT2017

19. Adherence is a more accurate termthan compliance: compliance suggests a process in which dutiful patients passively follow the adviceoftheir physicians or pharmacists. Adherence, in contrast, better fitshow most patients actively participate in their careand decide for themselves when and whether tofollowtheirdoctor’s or pharmacist‘sadvice. JAMASOFT2017

20. Compliancewith ...or Adherence to... • a medication regimen is generally defined as the extent to which patients take medications asprescribed by their health care providers – physician and pharmacist. JAMASOFT2017

21. Medication compliance and medication persistence • are two different constructs. • Medication compliance (synonym: adherence) refers to the degree or extent of conformity to the recommendations about day-to-day treatment by the provider with respect to the timing, dosage, and frequency. It may be defined as "the extent to which a patient acts in accordance with the prescribed interval, and dose of a dosing regimen." Medication persistence refers to the act of continuing the treatment for the prescribed duration. It may be defined as "the duration of time from initiation to discontinuation of therapy." No overarching term combines these two distinct constructs. • Providing specific definitions for compliance and persistence is important for sound quantitative expressions of patients' drug dosing histories and their explanatory power for clinical and economic events. • Adoption of these definitions by health outcomes researchers will provide a consistent framework and lexicon for research. JAMASOFT2017

22. Adherence is a multidimensional phenomenon • determined by the interplay of five sets of factors termed “dimensions” by the WHO: • Adherence is the extent to which a person’s behavior (in) taking medication … corresponds with agreed recommendations from a health care provider (WHO 2003). • Poor adherence to treatment regimens has long been recognizedas a substantial roadblock to achieving better outcomes forpatients. • Data show that as many as half of all patients donot adhere faithfully to their prescription-medication regimens. JAMASOFT2017

23. Non-adherence • Non-adherence to medicationsreduces treatmentbenefits and can confoundthe clinician’s assessment of therapeutic effectiveness, • and is thought to account for 30% to 50% ofcases where drugs fall short of their therapeutic goals. JAMASOFT2017

24. Non-adherence Medicationnon-adherenceencompasses a range of behaviors, bothintentional and unintentional, and can lead to eitherunderuse oroveruse of medications. JAMASOFT2017

25. Non-adherence Underuseincludes not initially filling a prescription, skippingdoses, splitting pills, and stopping a medicationsooner than the physician intended. There are studies focusing on medication underuse due to patients’delay or failure to fill a prescription, which has been termed “primary medication non-adherence“. JAMASOFT2017

26. Non-adherence to medicationregimens also affects the quality and length of life; for example,it has been estimated that better adherence to antihypertensivetreatment alone could prevent premature deaths. JAMASOFT2017

27. Generally: A major reason for poor compliance is negligence. JAMASOFT2017

28. Patient - Physician Concordance • - the extent to which patients and their physiciansagree on whether, when, and how a medicationshould be taken—is also associated withmedication adherence. • Furthermore, the costof medications and lack of adequate prescription • drug coverage influences whether people take prescribed medications. JAMASOFT2017

29. Medication non-adherenceeither willful or inadvertent, • can include: • Failing to initially fill or refill a prescription, • Discontinuing a medication before the course of therapy is complete, • Taking more or less of a medication than prescribed, • Taking a dose at the wrong time. JAMASOFT2017

30. Adherence is defined as the extent to which apatient’s health behavior coincides with their physician’srecommendations, whethertakingmedicationsor following advice for some type of behavioralchange. Adherence is a more accurate termthan compliance: compliance suggests a process in which dutiful patients passively follow the advice oftheir physicians or pharmacists. JAMASOFT2017

31. Adherence, in contrast, better fitshow most patients actively participate in their careand decide for themselves when and whether tofollow their doctor’s and pharmacist‘sadvice. Medication non-adherenceencompasses a range of behaviors, bothintentional and unintentional, and can lead to eitherunderuse or overuse of medications. Underuseincludes not initially filling a prescription, skippingdoses, splitting pills, and stopping a medicationsooner than the physician intended. JAMASOFT2017

32. It is quite reasonable to believe that thequalityof patients’ relationship • with their physicians alsoinfluences their decisions about filling prescriptions,just as doctor-patient relationships affectadherenceto preventive care recommendations andbehavioral change advice. JAMASOFT2017

33. It is quite reasonable to believe that the qualityof patients’ relationship Trust and confidence inone’s physician improves medication adherence. Not much is known, however, about thespecific aspects of patients’ relationships with theirdoctors that influence medication adherence, suchas the importance of trust and confidence beyondsimply having a physician one regularly sees, orwhether satisfaction with care received from thatphysician further promotes adherence beyond thatpromoted by trust. JAMASOFT2017

34. Dosing Frequency and Medication Adherence in Chronic Diseases. Thereexists a significant inverse relationship between dosing frequency andadherence when comparing twice-daily versus once-daily dosing. JAMASOFT2017

35. Fig.1. Negative correlation between frequency of daily doses and compliance level JAMASOFT2017

36. Patients with chronic diseasesappear to be more adherent with once-daily compared with more frequently scheduled medication regimens. JAMASOFT2017

37. Manychronicdiseasesrequire patients to take 1 or more maintenance medications,often more than once daily. JAMASOFT2017

38. The consequences of medication non-adherence • in older adults may be more serious, less easily detected, and less easily resolved than in younger age groups. • Medication non-adherence accounts for more than 10% of older adult hospital admissions, nearly one-fourth of nursing home admissions, and 20% of preventable adverse drug events among older persons in the ambulatory setting. • It is estimated that medication non-adherence results in more deaths annually, and costs • the health care system billions per year. JAMASOFT2017

39. The inability of many elderly to afford theirmedications. JAMASOFT2017

40. What is less clear is why adherence to the prescriptionswritten every year is so poor. Out-of-pocket costs for medicationclearly affect adherence; people use more drugs when the pricesof the drugs are lower. But even if drugs were free, non-adherencewould persist: one recent study showed that even among patientswho have health plans with no cost sharing for medications,rates of non-adherence were nearly 40%. JAMASOFT2017

41. Lack of coordination of care • is another major factor. • Thereis much more that could be done at the time a physician prescribesa medication to optimize and tailor regimens for individualpatients. JAMASOFT2017

42. For patients with coexisting conditions • who take multiplemedications prescribed by multiple physicians, there is a vitalneed to reconcile the prescribed regimen with what a patientis actually taking and to understand why there is a differencebetween the two. • But optimizing and reconciling medicationsrequire substantial investments of time by a skilled healthcare practitioner, as well as electronic data sharing amongpractitioners — neither of which is widely available intoday’s model of health care delivery. JAMASOFT2017

43. There are also numerous factors that affect adherence at theindividual level, including lifestyle,psychological issues,health literacy, support systems, and side effects of medications. Indeed, patients’ personal attributes probably have the strongestinfluence on adherence. Engaging and supporting patients inimproving their adherence are critical to improving health outcomes.In today’s system, however, there are neither the incentivesnor the support systems to do so. JAMASOFT2017

44. Taken together, • these findings suggest that improved adherencewill require changes in health care delivery, particularly inthe area of primary care, along with continued investment ininformation-technology systems and new health plan designs thatfocus on achieving improved health outcomes. • Fortunately, thereare a number of real-world examples that teach important lessonsabout how to improve medication adherence. For instance, twowell-known integrated health care delivery systems, and studies point to improvedadherence and outcomes among patients with particular conditions,such as HIV infection, AIDS, and heart failure. • The successstories are there, though they are still scattered. JAMASOFT2017

45. METHODS TO MEASUREMENTS • Electronic monitoring method is a measurement of the frequency and timing of doses taken by the patient compared to the frequency or timing that should occur based on the physician’s prescription. Measurement is made by microprocessor driven devices that record the date and time of events. Data are transformed into patients’ logs by special software. • Pill count method is a measurement of the amount of a drug remaining unused in the patient’s possession compared to the amount that should be left based on the physician’s prescription. This method is less accurate than electronic monitoring because patients often forget to return all of a medication. • Prescription refill rate refers to the measurement of the frequency or timing of prescription refills compared to the frequency or timing that should occur based on the physician’s prescription. This method is less accurate than electronic monitoring because patients may obtain prescription refills without taking the medication. • Attendance refers to the measurement of the frequency or timing of medical follow-up visits compared to the frequency or timing that should occur based on the physician’s plan. JAMASOFT2017

46. The concept of adherence can be summarized as havingstages: Adherence = Acceptance  Execution  Persistence EXPLANATION Adherence on the part of the patient is dependent on a series of factors that represent the burden of treatment. This burden encompasses adverse effects, the complexity of the treatment regimen ( i.e. , multiple dose times , requirements ). To avoid or take food, diet change, etc),as well as capacity to perform the tasks. The patient’s readiness and willingness to undertake the treatment or lifestyle change separates patients into four broad categories: Non-compliers: Those who do not accept the diagnosis and need for treatment at this time. Partial compliers: Those who accept the diagnosis and need for treatment but cannot fulfill the recommended actions sufficiently to reach targeted improvements in their health. Over-compliers: Those who take more than the recommended amount of medication or who diet or exercise in excess (These patients are rare). Adequate compliers: Those who follow the health advice adequately (i.e., enough medication, diet, exercise to improve or control their medical disorder). JAMASOFT2017

47. Partial adherence and non-adherence are important considerations for several reasons: • 1.The target outcome can be affected as much by adherence as by the selection of treatment. • Non-adherence means that the patient’s health will not improve and will probably worsen. This can result in costly short- or long-term medical care. • Partial adherence means that the patient’s health is not adequately managed. This can result in a stepped-care spiral into ever more complex and costly treatments that might not have been necessary if the patient had followed the initial regimen. • In contrast, adequate compliers do not necessarily need to take 100% of doses, diet or exercise to achieve the desired results. Health care providers need to understand both the limitation of their knowledge to determine the optimum dose or therapy for an individual and the patient’s ability to follow the regimen completely. Electronic monitoring of dosing has demonstrated that there is no magic number that represents the appropriate adherence rate for all patients or all disorders. JAMASOFT2017

48. Partial adherence and non-adherence are important considerations for several reasons: • 2. Inadequate adherence may result in high follow-up costs during stepped care. Increased costs are incurred with extra outpatients visits, diagnostic tests to determine the reason for treatment failure, hospital admissions if the condition worsens, decreased work productivity, increased family burden, or increased mortality. JAMASOFT2017

49. Partial adherence and non-adherence are important considerations for several reasons: • 3. Inadequate adherence may result in a waste of resources if prescriptions for • Medications have been filled but not used. When the doctor who is unaware of the degree of compliance with theregimen thinks that the medication has not been effective, higher doses, alternative drugs, or multiple drugs are prescribed. JAMASOFT2017

50. Methods to measure compliance (adherence). • The standard methods of asking the patient (self-reporteddata), counting unused tablets, or observing the prescription refill rate all have inherent flaws. • The gold standard of adherence measurement is electronic monitoring. • Various devices, reminders ( e.g., bottle cap, inhaler, and liquid dispenser monitors, reminders based on RFID) are available that collect continuous data based on dosing. The data can be downloaded to a computer for display. The data describe the dates and times of doses taken, a pattern of doses taken and missed, and calculations of overall adherence rates. • The devices are widely used in clinical trials and in some clinical care situations. JAMASOFT2017