Drug insurance schemes are systems that provide access to medicines on a prepaid basis and could potentially improve access to essential medicines and reduce out-of-pocket payments for vulnerable populations.

To assess the effects on drug use, drug expenditure, healthcare utilisation and healthcare outcomes of alternative policies for regulating drug insurance schemes.

We searched CENTRAL, MEDLINE, Embase, nine other databases, and two trials registers between November 2014 and September 2020, including a citation search for included studies on 15 September 2021 using Web of Science. We screened reference lists of all the relevant reports that we retrieved and reports from the Background section. Authors of relevant papers, relevant organisations, and discussion lists were contacted to identify additional studies, including unpublished and ongoing studies.

We planned to include randomised trials, non-randomised trials, interrupted time-series studies (including controlled ITS [CITS] and repeated measures [RM] studies), and controlled before-after (CBA) studies. Two review authors independently assessed the search results and reference lists of relevant reports, retrieved the full text of potentially relevant references and independently applied the inclusion criteria to those studies. We resolved disagreements by discussion, and when necessary by including a third review author. We excluded studies of the following pharmaceutical policies covered in other Cochrane Reviews: those that determined how decisions were made about which conditions or drugs were covered; those that placed restrictions on reimbursement for drugs that were covered; and those that regulated out-of-pocket payments for drugs.

Two review authors independently extracted data from the included studies and assessed risk of bias for each study, with disagreements being resolved by consensus. We used the criteria suggested by  Cochrane Effective Practice and Organisation of Care (EPOC)  to assess the risk of bias of included studies. For randomised trials, non-randomised trials and controlled before-after studies, we planned to report relative effects. For dichotomous outcomes, we reported the risk ratio (RR) when possible and adjusted for baseline differences in the outcome measures. For interrupted time series and controlled interrupted time-series studies, we computed changes along two dimensions: change in level; and change in slope. We undertook a structured synthesis following the EPOC guidance on this topic, describing the range of effects found in the studies for each category of outcomes.

We identified 58 studies that met the inclusion criteria (25 interrupted time-series studies and 33 controlled before-after studies). Most of the studies (54) assessed a single policy implemented in the United States (US) healthcare system: Medicare Part D. The other four assessed other drug insurance schemes from Canada and the US, but only one of them provided analysable data for inclusion in the quantitative synthesis. The introduction of drug insurance schemes may increase prescription drug use (low-certainty evidence). On the other hand, Medicare Part D may decrease drug expenditure measured as both out-of-pocket spending and total drug spending (low-certainty evidence). Regarding healthcare utilisation, drug insurance policies (such as Medicare Part D) may lead to a small increase in visits to the emergency department. However, it is uncertain whether this type of policy increases or decreases hospital admissions or outpatient visits by beneficiaries of the scheme because the certainty of the evidence was very low. Likewise, it is uncertain if the policy increases or reduces health outcomes such as mortality because the certainty of the evidence was very low.

The introduction of drug insurance schemes such as Medicare Part D in the US health system may increase prescription drug use and may decrease out-of-pocket payments by the beneficiaries of the scheme and total drug expenditures. It may also lead to a small increase in visits to the emergency department by the beneficiaries of the policy. Its effects on other healthcare utilisation outcomes and on health outcomes are uncertain because of the very low certainty of the evidence. The applicability of this evidence to settings outside US healthcare is limited.

Prescription drugs contribute to increased healthcare expenditures in the United States (U.S.). Use of generic drugs has been recognized as an effective tool to control rising prescription drug costs. This study aimed to evaluate the impact of U.S. federal and state generic drug policies on drug use, spending, and patient outcomes.

A systematic search was performed in June 2017, using PubMed, Web of Science, PsycINFO, and Business Source Premier. Search was limited to published articles in English language, including human subjects in the U.S., and with at least one outcome measure related to health service utilization, spending, or patient outcomes.

Thirty-four studies constituting seven key policy domains were included. Medicaid/Medicare Prior Authorization (PA) policies (n = 4) led to increased generic use, reduced patient and payer's spending on prescriptions without causing deterioration in patient's health-related quality of life. Medicare prescription plan's generic drug benefits (n = 4) had impact on increased generic use and generated savings, but the limited access to branded drugs may increase medication use gaps and risks of hospitalizations. State generic substitution laws (n = 3) caused increased generic use and cost savings for both consumers and states. Medicare/Medicaid coverage cap policies (n = 3) were associated with increased patient's out-of-pocket spending (OOP) and reduced prescription spending for payers. Policies lowering cost-sharing (n = 7) were associated with increased patient's medication use and adherence, but the impact varied by therapeutic classes. Existing evidence evaluating Medicare Part D (n = 12) suggested decreased prescription spending for beneficiaries and Medicare. Generic gap coverage reduced patient's OOP and Medicare spending. Finally, early evidence showed reduced consumers' OOP prescription spending after the ACA (n = 2).

Federal and state policies regarding generic drugs have resulted in reduced spending for consumers and payers. However, the overall impact on patient outcomes remains unclear.

To update a past systematic review on whether Medicare Part D changed drug utilization and out-of-pocket (OOP) costs overall and within subpopulations, and to identify evidence gaps.

Published and gray literature from 2010 to 2015 meeting prespecified screening criteria, including having a comparison group, and utilization or OOP cost outcomes.

We conducted a systematic literature review with a quality assessment.

For each study, we extracted information on study design, data sources, analytic methods, outcomes, and limitations. Because outcome measures vary across studies, we did a qualitative synthesis rather than meta-analysis.

Sixty-five studies met screening criteria. Overall, Medicare Part D enrollees have increased drug utilization and decreased OOP costs, but coverage gaps limit the program's impact. Beneficiaries whose insurance becomes more generous after enrollment had disproportionately increased drug utilization and decreased OOP costs. Outcomes among dual-eligibles were mixed.

There is strong evidence on how Medicare Part D and the donut hole coverage gap affect utilization and OOP costs, but weak evidence on how effects vary among dual-eligibles or across diseases. Findings suggest that the Affordable Care Act's provisions to expand coverage and reduce the donut hole should improve patient outcomes.

Access barriers to effective medication treatment have been a persistent issue for millions of older Americans despite the establishment of Medicare Part D.

We aimed to assess the prevalence rate of cost-related medication non-adherence (CRN) and the patterns of CRN behaviors in Medicare-Medicaid dual eligibles with diabetes.

We used data from the 2011 Medicare Current Beneficiary Survey, a nationally representative sample of Medicare beneficiaries. Multivariate logistic regression analysis was performed to assess CRN rate, controlling for demographics and types of Medicare Part D plans.

The CRN rate in dual-eligible diabetes patients was 21%, compared to 16% in non-dual-eligible diabetes patients (p<0.01). In 2011, the standardized prevalence rate of CRN in dual-eligible diabetes patients was 21%, of those with CRN 29% reported three or more types of CRN behaviors.

Contrary to the common belief that dual eligibles have better insurance coverage for medication due to the assistance from Medicaid to pay some of the out-of-pocket payments, the CRN rate among dual eligibles is high and patients often report multiple types of CRN behaviors. This demonstrates that cost is a significant access barrier for dual-eligible diabetes patients. More research is needed to improve the insurance benefit design and expand insurance coverage for this high-need, high-cost subpopulation.

The Medicare prescription drug program (Part D) standard benefit includes deductible, initial coverage, coverage gap and catastrophic coverage phases. As beneficiaries enter each phase, their out-of-pocket medication costs change discontinuously. The benefit cycle restarts on 1 January of the next year. Taking advantage of variation in drug coverage, we study how individuals reinitiate discontinued medications in response to the non-linear price schedule. Because some beneficiaries who receive low-income subsidies (LIS) have zero or fixed small copayments throughout the year, we perform a difference-in-difference analysis by using the LIS group as a comparison. We find that individuals delay reinitiating important medications in December and are significantly more likely to reinitiate in January than in other months. Although we find some evidence that reinitiation is lower in the final months of the year, it is mostly driven by those who face higher prices due to the coverage gap. Our study suggests that individuals respond more to the current price of medications and do not anticipate future prices as well as theory would suggest.

To evaluate the effects of the Medicare Part D coverage gap on pharmacy use among a national sample of Medicare beneficiaries and on medication adherence among 2 subsamples with heart failure and/or diabetes.

Pre-post design, with comparison group and propensity score weighting.

We used a 5% random sample of elderly Medicare beneficiaries enrolled in stand-alone Part D plans in 2007. The comparison group had full coverage in the gap, whereas the 2 study groups had either no coverage or generic-only coverage in the gap. Main outcomes included probability of filling a prescription, monthly pharmacy spending and number of prescriptions filled, and adherence measured by medication possession ratios.

Relative to the comparison group, beneficiaries without drug coverage in the gap reduced the number of prescriptions filled per month by 16.0% (95% confidence interval [CI], 15.5%-16.5%); those with generic drug coverage in the gap reduced it by 10.8% (95% CI, 10.3%-11.4%). Most of the reduction was attributable to reduced use of brand-name drugs. Beneficiaries with heart failure reduced adherence to heart failure drugs by 3.6% (95% CI, 2.9%-4.2%) and beneficiaries with diabetes reduced antidiabetic medication adherence by 10.3% (95% CI, 9.4%-11.3%).

Medicare beneficiaries reduced medication use (mainly brand-name drugs) after entering the coverage gap. This result suggests that while beneficiaries' financial burden would continue because of the coverage gap, the gap would not result in a large reduction in medication adherence for essential drugs for diabetes and heart failure.

Despite the rollout of Medicare Part D, cost-related nonadherence (CRN) among older adults remains a problem.

To examine the rate and correlates of self-reported CRN among a population of older persons with diabetes.

Cross-sectional.

A total of 1264 Part D patients with diabetes, who entered the coverage gap in 2006.

Initial administrative medication lists were verified in computer-assisted telephone interviews, in which participants brought their medication bottles to the phone. Medications were classified into cardiometabolic (diabetes, hypertension, cholesterol-lowering), symptom relief, and "other." Participants were asked if they had any CRN during 2006, and if so to which medication/s. We used the person-medication dyad as the unit of analysis, and tested a multivariate random effects logistic regression model to analyze the correlates of CRN.

Approximately 16% of participants reported CRN. CRN was more frequent for cholesterol-lowering medications (relative risk, 1.54; 95% confidence interval, 1.01-2.32) compared with medications taken for symptom relief. CRN was reported less frequently with increasing age above 75 years, compared with patients between 65 and 69. In addition, compared with those with incomes of ≥$40,000, CRN risk for those with incomes of <$25,000 was markedly higher (relative risk, 3.05; 95% confidence interval, 1.99-4.65).

In summary, we found high rates of CRN among Medicare beneficiaries with diabetes, particularly those with lower incomes. We observed more frequent CRN for cholesterol-lowering medications as compared with medications for symptom relief. Efforts to ensure medication affordability for this population will be important in boosting adherence to key medications.

The use of generic antiepileptic drugs (AEDs) in patients with epilepsy is controversial. The purpose of this study is to identify patient characteristics associated with increased odds of receiving a generic AED product. A large commercial database was used to identify patients with a primary diagnosis of epilepsy who were prescribed an AED during a three-month window. Data analysis found that those ≥65 years old had 15.7% greater odds of receiving a generic AED (OR = 1.157; 95% CI = 1.056-1.268). Patients with Medicaid were found to have 2.44 times the odds of having had a generic AED prescription (OR = 2.44; CI = 2.168-2.754). Patients residing in the Northeast had 12.6% decreased odds of receiving a generic AED (OR = 0.874; C I= 0.821-0.931). These patient characteristics could signify certain health care disparities and may represent potential confounders to future observational studies.

Increasing the awareness and use of generic drug discount programs (GDDP) may improve access to essential prescription drugs. However, little is known about public perceptions of GDDPs. The purpose of this study is to understand the perceptions and utilization patterns of low-income women regarding GDDP.

Using a purposive sampling strategy, we conducted seven focus groups with a total of 50 participants using a semistructured guide to assess awareness and utilization of GDDP. Transcripts of the focus groups were systematically analyzed across groups with a general inductive approach for qualitative data analysis.

Five major categorical themes emerged from the focus group content analysis: 1) Perceived differences between generic and brand-name prescription drugs, 2) barriers to utilizing GDDP, 3) lack of adequate communication between pharmacy, physician and patient about GDDP, 4) perceived health impact of utilizing GDDPs, and 5) perceived health care savings. Most participants indicated that they perceive no difference between generic and brand-name prescription drugs. Lack of awareness was indicated as a barrier to utilization. There was general agreement among participants that GDDP can help to maintain health while saving money.

Study participants demonstrated generally favorable perceptions regarding GDDPs. Our findings underscore the need for policies that encourage expansion of the GDDP formulary and increasing awareness and utilization of GDDP.

Maintenance antidepressant pharmacotherapy in late life prevents recurrent episodes of major depression. The coverage gap in Medicare Part D could increase the likelihood of reducing appropriate use of antidepressants, thereby exposing older adults to an increased risk for relapse of depressive episodes.

To determine whether (1) beneficiaries reduce antidepressant use in the gap, (2) the reduction in antidepressant use is similar to the reduction in heart failure medications and antidiabetics, (3) the provision of generic coverage reduces the risk of reduction of medication use, and (4) medical spending increases in the gap.

Observational before-after study with a comparison group design.

A 5% random sample of US Medicare beneficiaries 65 years or older with depression (n = 65,223) enrolled in stand-alone Part D plans in 2007.

Antidepressant pharmacotherapy, physician, outpatient, and inpatient spending.

Being in the gap was associated with comparable reductions in the use of antidepressants, heart failure medications, and antidiabetics. Relative to the comparison group (those who had full coverage in the gap because of Medicare coverage or low-income subsidies), the no-coverage group reduced their monthly antidepressant prescriptions by 12.1% (95% CI, 9.9%-14.3%) from the pregap level, whereas they reduced use of heart failure drugs and antidiabetics by 12.9% and 13.4%, respectively. Those with generic drug coverage in the gap reduced their monthly antidepressant prescriptions by 6.9% (95% CI, 4.8%-9.1%); this decrease was entirely attributable to the reduction in the use of brand-name antidepressants. Medicare spending on medical care did not increase for either group relative to the comparison group.

The Medicare Part D coverage gap was associated with modest reductions in the use of antidepressants. Those with generic coverage reduced their use of brand-name drugs and did not switch from brand-name to generic drugs. The reduction in antidepressant use was not associated with an increase in nondrug medical spending.

Medication use among Medicare beneficiaries has increased and adherence has improved since the implementation of the Medicare Part D prescription drug benefit in 2006. However, the structure of the benefit, particularly, the coverage gap, is still problematic. It is critical to understand how beneficiaries with coexisting conditions respond to the coverage gap and whether their response differs by type of medications.

The paper aims to evaluate the effects of Medicare Part D's coverage gap on drug regimens among beneficiaries with coexisting depression and heart failure (HF).

Drug utilization patterns and medication adherence of a 5% random sample of Medicare Part D beneficiaries with depression and HF in 2007 were observed. Drug utilization patterns were measured on the basis of reported drug claims and medication adherence was defined as the proportion of days of medication possession in a given period. We compared pre-post drug use patterns and medication adherence across three groups: no coverage, generic coverage, and full coverage due to low-income subsidies (LIS) and used propensity score weighting to adjust for difference across groups.

Beneficiaries with some drug coverage in the gap were more likely to enter the gap: 82% for LIS, 79% for generic-only and 58% for no coverage. Beneficiaries without drug coverage reduced their use of antidepressants by 5.0% (95% CI 1.7%-8.2%), and HF drugs by 9.4% (95% CI 7.2%-11.5%) after they entered the coverage gap. Those with generic coverage cut their brand-name drugs more than generic drugs but did not shift to generic drugs. However, adherence to antidepressants did not change; adherence to HF drugs reduced slightly, 2.5% (95% CI 1.2%-3.7%) in the no-coverage group and 2.6% (95% CI 1.3%-3.9%) in the generic-coverage group.

The coverage gap was associated with a modest reduction in number of prescriptions filled for depression and HF but it was not associated with a significant effect on adherence.

We found that beneficiaries with coexisting depression and HF were less likely to reduce their drug use than beneficiaries in general. In addition, the gap was not associated with a large reduction in adherence. It suggests that concerns about the coverage gap's harmful effects on medication adherence, or comorbidities might be overstated.

Further studies on how people make medication use decisions in the face of changes in benefits and how the coverage affects non-drug medical outcomes are warranted.

In 2006, the US Centers for Medicare and Medicaid Services implemented Medicare Part D to provide outpatient prescription drug insurance to disabled and older adults. In creating Part D, a key provision to address quality included medication therapy management (MTM) programmes designed to increase proper and safe use of medications among targeted Part D beneficiaries. A preponderance of evidence shows that Part D has increased medication affordability and accessibility; however, what remains less clear is whether it has improved the quality of medication use and optimized health outcomes. Now in its sixth year, Part D is undergoing its first major revision, with the gradual elimination of the coverage gap by 2020. Therefore, now is a good time to review the accumulated evidence on the impact of Part D and MTM programmes on the quality of medication use to help inform future policy decisions and research directions. In this review, we found that Part D's net effect on quality of medication use has mainly been positive. Cost-related medication nonadherence improved moderately and there were fewer than expected treatment interruptions. However, vulnerable subgroups, such as sicker and dual-eligible beneficiaries, experienced lags in improvement. Beneficiaries who entered the coverage gap consistently experienced interruptions and displayed worsening medication adherence after entering the gap, with generic-only gap drug coverage offering limited benefit. Such findings can serve as baseline information as the coverage gap phases out. Limited availability of data is the greatest barrier to research into Part D. Part D's overall effect on health outcomes and adverse medical events, such as hospitalizations, is inconclusive because of inadequate evidence to date. Similarly, no evaluation of quality of medication use is available with respect to utilization management strategies and MTM programmes delivered under Part D. Future research will need to further examine the added value of Part D and address whether Part D optimizes health outcomes in the Medicare population. As the current economic recession increases the pressure to cut costs, the effect of future spending restrictions, such as restrictions on coverage subsidies, will also be of special concern.

Despite extensive use of prescription medications in ESRD, relatively little is known about the participation of Medicare ESRD beneficiaries in the Part D program. Here, we quantitated the sources of drug coverage among ESRD beneficiaries and explored the Part D plan preferences of ESRD beneficiaries with regard to deductibles, coverage gaps, and monthly premiums. We obtained data on beneficiary sources of creditable coverage, characteristics of Part D plans, demographics, and residence from the Centers for Medicare and Medicaid Chronic Condition Data Warehouse and identified beneficiaries with ESRD from the US Renal Data System. We found that a substantial proportion (17.0%) of ESRD beneficiaries lacked a known source of creditable drug coverage in 2007 and 64.3% were enrolled in Part D. Of those enrolled, 72% received the Medicare Part D low-income subsidy. ESRD beneficiaries who enrolled in standalone Part D plans without the assistance of the low-income subsidy tended to prefer more comprehensive coverage options. In conclusion, more outreach is needed to ensure that beneficiaries who lack coverage obtain the coverage they need and that ESRD beneficiaries join the best plans for managing their disease and accompanying comorbid conditions.

This paper reviews articles from 2010 that examined medication mishaps (ie, medication errors and adverse drug events [ADEs]) in the elderly.

The MEDLINE and EMBASE databases were searched for English-language articles published in 2010 using a combination of search terms including medication errors, medication adherence, medication compliance, suboptimal prescribing, monitoring, adverse drug events, adverse drug withdrawal events, therapeutic failures, and aged. A manual search of the reference lists of the identified articles and the authors' article files, book chapters, and recent reviews was conducted to identify additional publications. Five studies of note were selected for annotation and critique. From the literature search, this paper also generated a selected bibliography of manuscripts published in 2010 (excluding those previously published in the American Journal of Geriatric Pharmacotherapy or by one of the authors) that address various types of medication errors and ADEs in the elderly.

Three studies focused on types of medication errors. One study examined underuse (due to prescribing) as a type of medication error. This before-and-after study from the Netherlands reported that those who received comprehensive geriatric assessments had a reduction in the rate of undertreatment of chronic conditions by over one third (from 32.9% to 22.3%, P < 0.05). A second study focused on reducing medication errors due to the prescribing of potentially inappropriate medications. This quasi-experimental study found that a computerized provider order entry clinical decision support system decreased the number of potentially inappropriate medications ordered for patients ≥ 65 years of age who were hospitalized (11.56 before to 9.94 orders per day after, P < 0.001). The third medication error study was a cross-sectional phone survey of managed-care elders, which found that more blacks than whites had low antihypertensive medication adherence as per a self-reported measure (18.4% vs 12.3%, respectively; P < 0.001). Moreover, blacks used more complementary and alternative medicine (CAM) than whites for the treatment of hypertension (30.5% vs 24.7%, respectively; P = 0.005). In multivariable analyses stratified by race, blacks who used CAM were more likely than those who did not to have low antihypertensive medication adherence (prevalence rate ratio = 1.56; 95% CI, 1.14-2.15; P = 0.006). The remaining two studies addressed some form of medication-related adverse patient events. A case-control study of Medicare Advantage patients revealed for the first time that the use of skeletal muscle relaxants was associated significantly with an increased fracture risk (adjusted odds ratio = 1.40; 95% CI, 1.15-1.72; P < 0.001). This increased risk was even more pronounced with the concomitant use of benzodiazepines. Finally, a randomized controlled trial across 16 centers in France used a 1-week educational intervention about high-risk medications and ADEs directed at rehabilitation health care teams. Results indicated that the rate of ADEs in the intervention group was lower than that in the usual care group (22% vs 36%, respectively, P = 0.004).

Information from these studies may advance health professionals' understanding of medication errors and ADEs and may help guide research and clinical practices in years to come.