The natural history of medication compliance in a drug trial: Limitations of pill counts

Rudd, Peter; Byyny, Richard L.; Zachary, Valerie; LoVerde, Mary E.; Titus, Chris; Mitchell, Wayne D.; Marshall, Gary

doi:10.1038/clpt.1989.122

Cited by 174 publications

(85 citation statements)

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“…Finally, the pill count method is subject to possible errors being made by the person who counts the pills. As reported by others (13), our data show that near-optimal average compliance rates may mask con siderable variability within and between subjects. Since it has been demonstrated that compliance may just as well be poor when an excessive number of tablets seems to have been taken {14), we used the frequency of counts yielding devia tions from the prescribed amount of at least 10% in either direction as one of our outcome measures.…”

Section: Discussionsupporting

confidence: 60%

Medication Compliance After Renal Transplantation

Hilbrands

Hoitsma²,

Koene³

1995

Transplantation

108

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Please be advised that this information was generated on 2018-05-10 and may be subject to change. TRANSPLANTATIONVol MEDICATION COMPLIANCE AFTER RENAL TRANSPLANTATION1 L u k a s B. H ilb r a n d s ,2 A n d r ie s J. H o itsm a , a n d R o b e r t A.P. K o e n e Department ofMedicine} Division of Nephrology, University Hospital Nijmegen, NL-6500 HB Nijmegen, The NetherlandsNoncompliance is known to be an important cause of late graft failure after renal transplantation. We inves tigated prospectively the degree of compliance with immunosuppressive and antihypertensive drugs dur ing the first year after renal transplantation by monthly pill counts. In addition, we examined whether noncompliance was related to a number of demographic and clinical variables or to the occur rence of rejections. The study population consisted of 127 patients who were involved in a randomized trial comparing cyclosporine monotherapy with azathioprine-prednisone treatment. Average compliance rates approximated 100%, although considerable vari ability within and between subjects was observed. Us ing an arbitrary lim it to classify patients as compliers or noncompliers, the following frequencies of noncom pliance were observed during the study year: cyclo sporine, 23%; azathioprine, 13%; prednisone, 23%; atenolol, 36%; and nifedipine, 32%. Average compli ance scores for all im m unosuppressive drugs were su perior to those of antihypertensive m edication (P< 0.001). Except for a better com pliance for pred nisone in men as compared w ith wom en, w e found no consistent relationship betw een com pliance on the one hand and several dem ographic variables, graft function, or quality of life on the other hand. Patients who developed one or more acute rejection episodes showed a higher degree of under com pliance, espe cially for prednisone, than patients w ithout rejections (P<0.01). Following the occurrence of a rejection epi sode, compliance scores im proved significantly.Keeping in mind the lim itations of the p ill count method, we conclude that noncom pliance w ith immu nosuppressive drugs is not a huge problem during the first year after renal transplantation. H ow ever, it is likely that noncom pliance contributes to a certain number of acute rejection episodes.Noncompliance with the therapeutic regimen is considered to be a major cause of graft failure after (organ) transplan tation (1-5). Accordingly* efforts to encourage adherence to the medical regimen are regarded as an important aspect of posttransplant patient management (4,5). However, detailed data on the extent of medication noncompliance and on fac tors associated with it in renal transplant patients are scarcely available.We examined medication compliance during the first year after renal transplantation by use of the pill count method, looking for an answer to the following questions: (1) What is the extent of noncompliance with immunosuppressive and antihypertensive drugs after renal transplantation? (2) Can the level of noncompliance be predicted from demographic or cli...

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Section: Discussionsupporting

confidence: 60%

Medication Compliance After Renal Transplantation

Hilbrands

Hoitsma²,

Koene³

1995

Transplantation

108

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“…We compared NPEP regimen completion rates with those of clinic controls, but unmeasured biases limit any conclusion concerning equivalence or superior tolerability. Announced pill counts may result in an overestimation of adherence because social desirability can result in 'pill dumping' before a scheduled visit [32]. However, when used to assess adherence in HIV-positive patients on antiretroviral treatment, pill counts have been shown to correlate with electronic drug monitoring and HIV viral load and provide an objective measure of adherence [33].…”

mentioning

confidence: 99%

Raltegravir‐emtricitabine‐tenofovir as HIV nonoccupational post‐exposure prophylaxis in men who have sex with men: safety, tolerability and adherence

et al. 2013

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ObjectivesThree-drug nonoccupational post-exposure prophylaxis (NPEP) typically includes co-formulated emtricitabine-tenofovir (FTC-TDF) and a protease inhibitor. However, protease inhibitors can cause significant toxicities, can interact with prescribed and illicit drugs, and work late in the viral cycle. Agents that act before viral integration into host DNA may have efficacy advantages. Raltegravir (RAL) is a good candidate for NPEP as it has few side effects or drug interactions and acts prior to HIV integration. The objective of this study was to investigate the use of RAL in 3-drug NPEP in terms of safety, adherence and tolerability. MethodsWe evaluated 28 days of RAL-FTC-TDF treatment in 86 men and FTC-TDF treatment in 34 men eligible for three-and two-drug NPEP, respectively. We assessed adherence (compared between groups and with nonstudy controls) and clinical and adverse events at weeks 1, 2 and 4, and efficacy at week 12. Analyses were by intention to treat, excluding from the adherence analysis subjects who ceased NPEP because their source was HIV-uninfected. ResultsNo participant became infected with HIV. For RAL-FTC-TDF and FTC-TDF, regimen completion rates were 92% and 91% and medication adherence rates were 89% and 90%, respectively. Eight (9%) RAL recipients developed mild myalgias, with four developing transient grade 4 elevations in creatine kinase (two developed both), all of which improved to grade 2 or less by week 4 without RAL discontinuation. Eight prescribed and 37 potential illicit drug interactions with a protease inhibitor were avoided by use of RAL. ConclusionsRAL-FTC-TDF is well tolerated as NPEP, results in high levels of adherence and avoids potential drug−drug interactions. Patients and clinicians should be aware of the potential for acute muscle toxicity when RAL is used as NPEP. ORIGINAL RESEARCH13 randomized study of ART as pre-exposure prophylaxis in men who have sex with men (MSM); and a randomized trial of ART as prevention in HIV-serodiscordant, heterosexual couples [5][6][7][8][9]. PEP does not always prevent HIV transmission [10][11][12]. Longer time to first PEP dose, incomplete PEP adherence, continued HIV risk behaviour and primary ART drug resistance have each been linked to failure [11,12]. In seven PEP studies published since 2001, 51% of the total 1009 participants reported at least one adverse event (AE) and around 20% failed to complete the 28-day course [13][14][15][16][17][18][19].The use of three antiretroviral agents in PEP is common [1-4] but based solely on standard-of-care treatment of HIV infection. The most commonly used third drug is a protease inhibitor [1][2][3][4]. Protease inhibitors prevent mature HIV protein formation within cells in which HIV is already integrated into host-cell DNA. Agents that act before viral integration may have efficacy advantages by preventing rather than limiting infection. In addition, some prescribed and proscribed drugs have potentially dangerous interactions with protease inhibitors.Raltegravir (RAL) is an HIV inte...

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“…14 Pill counts, requiring patients to return unused pills at each visit so that the number of missed doses can be calculated, have also been shown to overestimate the number of pills actually taken. 15,16 Patients may throw away missed doses to avoid being viewed as nonadherent. Nonetheless, pill counts are often used as an adjunct to self-report.…”

Section: Indirect Methods Of Measuring Adherencementioning

confidence: 99%

Assessment and Measurement of Adherence to Oral Antineoplastic Agents

Spoelstra¹,

Given²

2011

Seminars in Oncology Nursing

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OBJECTIVES:The increase in oral anticancer medications with complex regimens creates a need to assure patients are taking therapeutic dosages as prescribed. This article reviews the assessment and measurement of adherence to oral antineoplastic agents. DATA SOURCE:Research and journal articles from CINAHL and Pub Med. CONCLUSION:Assessing and measuring adherence to oral antineoplastic should include three dimensions: the percentage of medications taken, the duration, and the timing of taking the medication. IMPLICATIONS FOR PRACTICE:Clinicians need to conduct ongoing assessment and measurement of adherence to oral antineoplastic agents. This includes eliciting patient report of adherence, pill counts, drug diaries, and pharmacy or medical record audits.

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The natural history of medication compliance in a drug trial: Limitations of pill counts

Cited by 174 publications

References 0 publications

Medication Compliance After Renal Transplantation

Medication Compliance After Renal Transplantation

Raltegravir‐emtricitabine‐tenofovir as HIV nonoccupational post‐exposure prophylaxis in men who have sex with men: safety, tolerability and adherence

Assessment and Measurement of Adherence to Oral Antineoplastic Agents

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