Pill Appearance Research Articles

Impact of Variation in Pill/Package Appearance of Drugs on Patients' Behavior: A Systematic Review.

This systematic review aims to identify and critically evaluate the available evidence on the impact of switches in pill appearance/packaging on patient's behavior. Studies from inception to March 2021 were searched across MEDLINE through PubMed, the Cochrane Library, Embase, and Scopus. Included studies carried out an original evaluation in English or Spanish language that evaluated the impact of switches in pill appearance/packaging on patient's behavior. Two authors independently extracted study data and evaluated studies for methodological quality according to the STROBE guidelines. Ten studies were included, and the mean (SD) number of STROBE criteria satisfied was 17.2 (3.9). Three of 5 studies found a significant association between change in pill appearance and persistence to treatment; the 3 studies that evaluated the impact of a change on adherence to treatment found a significant association; 1 of the 2 studies that evaluated the relationship between a change a clinical outcome found a significant association with the prevalence of uncontrolled blood pressure; and 1 study showed lower rates of switchbacks to the branded product compared with patients who switched to generic drug products, with different appearance. This systematic review showed an impact of the change in pill/package appearance on patients' behavior in 7 of the 10 studies included. Generic switching may lead to unintended consequences on patients' behavior, mainly regarding adherence to treatment.

Community acceptability of dolutegravir-based HIV treatment in women: a qualitative study in South Africa and Uganda

BackgroundDespite concerns about dolutegravir use in pregnancy, most low- and middle-income countries are accelerating the introduction of dolutegravir-based regimens into national antiretroviral treatment programmes. Questions remain about the acceptability of dolutegravir use in women due to the potential risks in pregnancy. This study from South Africa and Uganda explored community values, preferences and attitudes towards the use of dolutegravir-based regimens in women.MethodsThis study employed a qualitative design involving in-depth interviews and focus group discussion conducted between August 2018 to March 2019. The study was conducted in the months following an announcement of a potential risk for neural tube defects with dolutegravir use among women during conception and the first trimester. Participants included HIV positive pregnant and lactating women and their partners. They were selected purposively from urban poor communities in South Africa and Uganda. Data was analysed thematically in NVivo.ResultsForty-four in-depth interviews and 15 focus group discussions were conducted. Most participants had positive views of dolutegravir-based regimens and perceived it to be more desirable compared with efavirenz-containing regimens. There was widespread concern about use of dolutegravir during pregnancy and among women of childbearing age due to publicity around the possible association with neural tube defects. Acceptability was gendered, with nearly all male participants preferring their female spouses of childbearing potential not to use dolutegravir, while most women not planning pregnancy wanted access to contraception alongside dolutegravir. Community awareness and knowledge of dolutegravir was low and characterised by negative information. Women were concerned about HIV-related stigma and wanted the privacy features of dolutegravir to be strengthened with modification of the pill appearance and disguised packaging.ConclusionsDolutegravir-based regimens were found to be generally acceptable for use in women except during pregnancy. Interest in a dolutegravir-based regimen was linked with its perceived potential to enhance health, privacy and reduce stigma while concerns about neural tube defects were the main potential barrier to dolutegravir uptake in women. In order to optimise the community acceptability and uptake of acceptability-based regimen among women it is critical to strengthen community awareness and understanding of dolutegravir treatment, improve contraception services alongside the introduction of dolutegravir, and engage with male partners.

Preferences for and Experiences With Pill Appearance Changes: National Surveys of Patients and Pharmacists

To better understand patients' and pharmacists' preferences for and experiences with changes in pill appearance (size, shape, color, and markings). Cross-sectional. We conducted independent national surveys of patients 50 years and older taking generic drugs for depression, diabetes, epilepsy, HIV, hyperlipidemia, or hypertension and of licensed pharmacists practicing in chain, franchise, or independent pharmacies. Responses were collected between January and April 2016. Of 1000 patient respondents (30% response rate), most reported experiencing changes in pill appearance (51%) and preferred to be notified about them (82%), but less than half recalled being notified (verbally: 36%; via sticker: 45%). Among patients who reported experiencing a change, 12% reported stopping their medication or using it less frequently. Of 710 pharmacist respondents (33% response rate), many reported changes in pill appearance occurring frequently in their pharmacies (47% reported that changes occurred 6 or more times per month) and more than three-fourths reported notifying patients about them often (verbally: 88%; via sticker: 77%). Our findings reveal opportunities to improve patients' experiences with pill appearance changes through better notification practices and patient education.

A Survey of Patients' Perceptions of Pill Appearance and Responses to Changes in Appearance for Four Chronic Disease Medications.

Generic versions of a drug can vary in appearance, which can impact adherence. To assess the preferences, perceptions, and responses of patients who experienced a change in the appearance of a generic medication. Cross-sectional survey of patients from a large commercial health plan. Adults receiving generic versions of lisinopril, fluoxetine, lamotrigine, or simvastatin who experienced a change in the color or shape of their pills between March 2014 and November 2015. Likert-scale responses to questions concerning perceptions of generic drug safety and effectiveness, reliance on and preferences for pill appearance, and responses to pill appearance changes. Multivariable logistic regression-modeled predictors of seeking advice and adjusting use following a pill appearance change. Of 814 respondents (response rate = 41%), 72% relied on pill appearance to ensure they took the correct medication. A similar percentage wanted their pills to remain the same color (72%), shape (71%), and size (75%) upon refill, but 58% would not have paid a $1 premium on a $5 co-pay to ensure such consistency. Most respondents (86%) wanted their pharmacists to notify them about pill appearance changes, but only 37% recalled such notification; 21% thought they received the wrong medication, and 8% adjusted medication use. Younger respondents (18-33 vs. 50-57years) were more likely to seek advice (odds ratio [OR] = 1.91; 95% confidence interval [CI],1.02-3.59), and respondents with lower household income (< $30,000 vs. > $100,000) were more likely to adjust medication use (OR = 3.40; 95% CI,1.09-10.67). Requiring uniform pill appearance may help increase adherence but presents challenges. Standardized pharmacy notification and education policies may be a more feasible short-term solution.

Impact of changes in pill appearance in the adherence to angiotensin receptor blockers and in the blood pressure levels: a retrospective cohort study

ObjectiveTo assess the level of adherence to angiotensin receptor blockers (ARBs) in patients regularly attending a community pharmacy and the influence of a change in patients' adherence to pharmacological treatment.DesignRetrospective...

PHP44 - THE EVALUATION OF GENERIC MANUFACTURUERS’ PRODUCT CHARACTERISTICS IN MAJOR MTM CHRONIC DISEASE MEDICATION CLASSES: A POTENTIAL SOURCE OF NON-ADHERENCE

To characterize the variance in appearance and costs of 16 oral solid generic medications in four major chronic disease/drug management classes. A commercial drug knowledge database was used to identify frequently prescribed oral solid medications that have at least 3 manufacturer sources (excluding repackagers and relabelers) for calendar year 2014. Four drugs from each of the following chronic therapeutic classes were evaluated; 1) antidiabetics (glyburide 5mg, metformin 500mg, acarbose 50mg, glipizide 10mg); 2) statins (simvastatin 40mg, pravastatin 40mg, atorvastatin 40mg, lovastatin 20mg); 3) beta blockers (metoprolol 100mg, atenolol 50mg, carvedilol 25mg, labetolol 100mg); and 4) heart failure drugs (amlodipine 10mg, losartan 50mg, lisinopril 10mg, valsartan 40mg). These classes were chosen because they are included in CMS MTM quality measures. The physical appearance (color, shape, scoring, and size), identifying imprint, and price (WAC) for each manufacturer’s identical strength product was assessed as to similarity to the other generic versions. Database review obtained the following number of manufacturers per class: antidiabetics= 43; statins= 39; beta blockers= 38; and heart failure agents= 53. Overall, for all 16 drugs across all 4 disease states, there was an average of 3 different colors, 2 different shapes, 11 manufacturers, and 4 different images. Individually drugs varied from no differences to 8 differences, with color and shape equally contributing to variation (n=8 for >2 colors and >2 shapes). Differences in dosage scoring and size were minor. There are multiple sources of medications for four chronic conditions. With substantial appearance variation among several generically equivalent products, there is strong possibility that a patient may experience a future drug product switch that could increase the likelihood of significant non-adherence, and ultimately result in adverse disease outcomes through discontinuation of prescribed therapy. Pill appearance variation highlights a potential important focus for future chronic disease/medication therapy management.

What Is the Future of Generics in Transplantation?

Generic immunosuppressive drugs are available in Europe, Canada, and the United States. Between countries, there are large differences in the market penetration of generic drugs in general, and for immunosuppressive drugs in particular. The registration criteria for generic immunosuppressive drugs are often criticized. However, it is unlikely that the criteria for registration of narrow therapeutic index drugs are going to change, and bioequivalence studies, performed in healthy volunteers, will remain the backbone of the registration process. It would be good if the registration authorities would demand that all generic variants of an innovator drug have the same pill appearance to reduce errors and promote drug adherence.To allow for safe substitution, a number of criteria need to be fulfilled. Generic substitution should not be taken out of the hands of the treating physicians. Generic substitution can only be done safely if initiated by the prescriber, and in well-informed and prepared patients. Payers should refrain from forcing pharmacists to dispense generic drugs in patients on maintenance treatment with innovator drug. Instead, together with transplant societies, they should design guidelines on how to implement generic immunosuppressive drugs into clinical practice. Substitutions must be followed by control visits to check if the patient is taking the medication correctly and if drug exposure remains stable. Inadvertent, uncontrolled substitutions from 1 generic to another, initiated outside the scope of the prescriber, must be avoided as they are unsafe. Repetitive subsequent generic substitutions result in minimal additional cost savings and have an inherent risk of medication errors.

Changes in Pill Appearance Increase Drug Discontinuation after MI

According to this study: * The shape and color of pills commonly prescribed to patients after myocardial infarction often differ according to the manufacturer. Such changes increase the likelihood that patients will discontinue use of their prescribed medications. * Patients’ stopping their treatment can lead to significant morbidity or even death.

Burden of changes in pill appearance for patients receiving generic cardiovascular medications after myocardial infarction: cohort and nested case-control studies.

Generic prescription drugs made by different manufacturers may vary in color or shape, and switching among these drug products may interrupt medication use. To determine whether nonpersistent use of generic drugs among patients with cardiovascular disease after myocardial infarction (MI) is associated with inconsistent appearance of their medications. Cohort and nested case-control studies. Claims from a commercial health insurance database in the United States. Patients discharged after hospitalization for MI between 2006 and 2011 who initiated treatment with a generic β-blocker, angiotensin-converting enzyme inhibitor, angiotensin II-receptor blocker, or statin. Case patients discontinued their index medication for at least 1 month; control patients continued treatment. Control patients were matched to case patients on therapeutic class, number of dispensings before nonpersistence, sex, and age. Rates of changes in pill color and shape during the year after MI were calculated. Next, 2 refills preceding nonpersistence were evaluated to determine whether pill color or shape had changed. Odds of discordance among case and control patients were compared using conditional logistic regression. A total of 29% of patients (3286 of 11,513) had a change in pill shape or color during the study. Statins had the most changes in appearance, whereas β-blockers had the fewest. A total of 4573 episodes of nonpersistence was matched to 19,881 control episodes. The odds of nonpersistence in case patients increased by 34% after a change in pill color (adjusted odds ratio, 1.34 [95% CI, 1.12 to 1.59]) and 66% after a change in pill shape (adjusted odds ratio, 1.66 [CI, 1.43 to 1.94]). Only 3 categories of drugs indicated after MI were evaluated, and clinical outcomes were not addressed. Variation in the appearance of generic pills is associated with nonpersistent use of these essential drugs after MI among patients with cardiovascular disease. Agency for Healthcare Research and Quality and the Harvard Program in Therapeutic Science.

Generic substitution of antidiabetic drugs in the elderly does not affect adherence.

The possibility that variation in packaging and pill appearance may reduce adherence is a reason for concern, especially for chronic diseases. The objectives of the study were to quantify the extent of switches between generic antidiabetics and to verify whether switching between different products of the same substance affects adherence. All elderly residents of the Umbria Region who received at least 2 prescriptions of antidiabetics in 2010 and 2011 were included in the study. Switching was defined as the dispensing of two different products of the same substance in a series of two prescriptions. Single and multiple switchers were identified according to the number of switches during 2011. Switching relevant to the three off-patent substances with generic use ≥ 5% (metformin, gliclazide and repaglinide) was quantified. The effect of switching on adherence, defined as the proportion of days in 2011 covered by prescriptions (Medication Possession Ratio, MPR), was estimated. Among the 15 964 patients receiving antidiabetics (14.4% of the elderly population) 9211 were prescribed at least one of the generic substances. Of these patients, 23.3% experienced a single switch and 15.7% were multiple switchers (61.0% never switched). The proportion of multiple switchers increased with the number of prescriptions, reaching 26% among patients with ≥ 11 prescriptions. MPR was 62%, 62% and 72%, respectively among non-switchers, single and multiple switchers. In elderly patients treated with antidiabetics, the substitution between branded and unbranded products (as well as between generics) of the same substance, did not negatively affect adherence.

Variations in Pill Appearance of Antiepileptic Drugs and the Risk of Nonadherence

Generic prescription drugs are bioequivalent to brand-name versions but may not have consistent color or shape, which can cause confusion and lead to interruptions in medication use. We sought to determine whether switching among different-appearing antiepileptic drugs (AEDs) is associated with increased rates of medication nonpersistence, which can have serious medical, financial, and social consequences. We designed a nested case-control study of commercially insured patients in the United States who initiated an AED. Cases were patients who became nonpersistent, defined as failure to fill a prescription within 5 days of the elapsed days supplied. Controls had no delay in refilling and were matched by sex, age, number of refills, and the presence of a seizure disorder diagnosis. We evaluated the 2 refills preceding nonpersistence and determined whether pill color and/or shape matched ("concordant") or did not match ("discordant"). We compared the odds of discordance among cases and controls using multivariate conditional logistic regression, adjusting for baseline characteristics, and drug type. We repeated our analysis among patients with a seizure diagnosis. The AEDs dispensed had 37 colors and 4 shapes. A total of 11,472 patients with nonpersistence were linked to 50,050 controls. Color discordance preceded 136 cases (1.20%) but only 480 controls (0.97%) (adjusted odds ratio [OR], 1.27 [95% CI, 1.04-1.55]). Shape discordance preceded 18 cases (0.16%) and 54 controls (0.11%) (OR, 1.47 [95% CI, 0.85-2.54]). Within the seizure disorder diagnosis subgroup, the risk of nonpersistence after changes in pill color was also significantly elevated (OR, 1.53 [95%, CI 1.07-2.18]). Changes in pill color significantly increase the odds of nonpersistence; this may have important clinical implications. Our study supports a reconsideration of current regulatory policy that permits wide variation in the appearance of bioequivalent drugs.