Guest Post: Practicing what I preach about generic drugs

- Kathleen "Cook" Uhl, MD

In 2015, I was treated for stage 3 colorectal cancer. All of my cancer medications – from the chemotherapy right down to the anti-nausea medications – were generics.

Why did I take only generic medicines? Through my work at the U.S. Food and Drug Administration (FDA), I know that FDA-approved generic drugs meet the Agency’s high standards for safety, efficacy, and quality. So when my doctors at Walter Reed National Military Medical Center prescribed me generic cancer medications, I was confident that the generic prescriptions were as high-quality as brand-name medications, and could be substituted for the brand-name drug with no difference in safety or efficacy.

The generic drug approval process is supported by solid scientific research and review. Generic drug manufacturers must demonstrate their product is pharmaceutically equivalent and bioequivalent to the brand-name product before it can be approved. They also must demonstrate that the generic drug can be reliably and consistently manufactured in a way that maintains this equivalence and quality.

Pharmaceutical equivalence means that the generic has the same active ingredient, strength, dosage form, and route of administration as the brand-name drug. Formulations may differ in inactive ingredients, provided that the generic drug manufacturer shows the inactive ingredients are safe and do not change the way the active ingredients are delivered to the body. Generic drugs may also have differences in characteristics such as size, shape, or color.

FDA standards of bioequivalence often require companies to conduct in vivo bioequivalence studies. Typically, volunteers take the brand-name and generic drug products to demonstrate that there is no significant difference between the rate and extent of absorption of the active ingredient. A bioequivalent drug will behave the same way in patients as its brand-name counterpart. FDA scientists compare data from these studies to ensure that a generic drug can be substituted for its brand-name counterpart and will behave the same way in patients.

Makers of generic drugs also submit data to FDA to show how the processes of combining the active and inactive ingredients to make the generic drug meet the same standards as the brand-name drug. It is only when a generic drug manufacturer has demonstrated that it can reliably make a high-quality, pharmaceutically equivalent and bioequivalent product that it can be made available to patients.

I am a cancer survivor. I am alive today because of the love and support of my family, friends, and co-workers. I am alive because of the incredible doctors and medical staff at Walter Reed. I am also alive because of generic drugs. Generic drugs saved my life.

**

Dr. Kathleen "Cook" Uhl is Director of the Office of Generic Drugs in the Center for Drug Evaluation and Research at the U.S. Food and Drug Administration. Her editorial "How the FDA Ensures High-Quality Generic Drugs" appeared in the June 1 issue of AFP.

Tips for caring for persons with developmental disabilities

- Jennifer Middleton, MD, MPH

Two articles in the current issue of AFP, along with other recent primary care literature, contain a wealth of practical tips and techniques for successfully - and respectfully - caring for persons with developmental disabilities.

"Adults with Developmental Disabilities: A Comprehensive Approach to Medical Care" provides an overview of office accessibility pointers, communication techniques, approaches to preventive care and acute illnesses, and end-of-life planning. It also includes a discussion on the medical versus neurodiversity models of diversity, asserting that accepting patients as they are is preferable to trying to "normalize" them:

The goal of health care for patients with developmental disabilities is to improve their well-being, function, and participation in family and community. It is not always necessary or desirable to try to change a person's traits and characteristics to make them appear or behave more normally. 

Along those lines, the patient in this issue's Close-up, "Persons with Disabilities: I'm the Expert About the Body," says, "[T]here are many things they cannot know about me just by observing the way I look or the way I communicate." Avoiding the temptation to make assumptions can go a long way toward communicating respect. This website, quoted within the feature article, includes brief video examples of engaging with patients with no or limited speaking ability. An AFP Curbside Consultation from 2017 reinforces the importance of grounding medical decision making within the patient's definition of quality of life - which may not always align with physicians' assumptions.

Improving our ability to care for persons with developmental disabilities is critically important to reducing health care disparities between them and the non-disabled population. A 2017 statewide study across Ohio found that, compared with persons with no disability, persons with a disability (and/or their supporters) were more likely to report their health status as being "fair" or "poor," had more hospital and Emergency Department (ED) visits, and had more problems "getting needed care." Disabled persons reported more frequent "delayed treatment[s]," problem[s] getting care," and "problem[s] seeing a specialist." A study from the United Kingdom examining hospital admissions found similarly: hospitalizations were double that of non-disabled persons, even after controlling for "higher levels of comorbidity." The authors of both studies call for further studies to explore solutions to minimize these disparities; improving communication between persons with developmental disabilities and physicians, as detailed in the AFP articles above, may be an important first step.

These AFP articles also include a collection of online toolkits and resources on "Supported Decision Making." You can read more in the AFP By Topic on Care of Special Populations. Since family physicians often care for supporters, too, the CDC has tips for caregivers of persons with a disability, and so does FamilyDoctor.org.

Few family physicians are delivering babies, and few women are having VBACs. What's stopping them?

- Kenny Lin, MD, MPH

In 2017, fewer than one in five members of the American Academy of Family Physicians (AAFP) reported providing obstetric care. In a previous Graham Center Policy One-Pager in AFP, Dr. Tyler Barreto and colleagues reported that between 2009 and 2016, the percentage of family physicians practicing high-volume obstetrics (more than 50 deliveries per year) fell from 2.1% to 1.1%. A subsequent study in Family Medicine by Dr. Sebastian Tong and colleagues found that 51% of recent family medicine residency graduates intended to provide prenatal care, and 23% intended to deliver babies; however, less than 10% were delivering after 1 to 10 years in practice.

In a recent policy brief in the Journal of the American Board of Family Medicine, Dr. Barreto and colleagues analyzed data from the 2016 Family Medicine National Graduate Survey to identify barriers faced by residency graduates who stated interest in delivering babies but did not do so in practice. Almost 60% of respondents cited the lack of opportunity to do deliveries in the practice they joined and lifestyle considerations as the most important factors. Fewer than 10% felt that inadequate training or reimbursement were major issues.

Although these recent studies did not specifically focus on family physicians who perform surgical deliveries, prior research has established that Cesarean delivery outcomes are comparable whether performed by family physicians or obstetrician-gynecologists. To support women who choose to attempt labor and vaginal birth after Cesarean delivery (VBAC), the AAFP published a 2015 guideline that was largely based on an Agency for Healthcare Research and Quality review of the benefits and harms of VBAC versus elective repeat Cesarean. I summarized the key findings of this review in AFP's "Tips From Other Journals":

The risk of uterine rupture was statistically higher in women undergoing a trial of labor (0.47 percent) compared with women undergoing an elective repeat cesarean delivery (0.026 percent). Fourteen to 33 percent of women who experienced a uterine rupture underwent a hysterectomy. Maternal mortality was rare, but higher in women undergoing an elective repeat cesarean delivery (13.4 deaths per 100,000 deliveries) than in those undergoing a trial of labor (3.8 per 100,000). In contrast, trial of labor was associated with higher perinatal mortality (1.3 deaths per 1,000 deliveries) than elective repeat cesarean delivery (0.5 per 1,000). ... The evidence suggests that most of the differences in maternal and perinatal outcomes between these delivery options are statistically, but not clinically, significant.

As mentioned previously on the Community Blog, access to VBAC remains limited or nonexistent in many parts of the U.S., and debates continue about its safety for mothers and babies. This month in CMAJ, Dr. Carmen Young and colleagues analyzed a Canadian hospital database containing information on women with a single prior Cesarean between 2003 and 2015 and a second singleton birth at 37 to 43 weeks gestation. They found that rates of the composite outcomes "severe maternal morbidity and mortality" and "serious neonatal morbidity and mortality" were significantly higher after attempted VBAC compared to elective repeat Cesarean. However, absolute differences in these outcomes were low, with NNTs of 184 and 141, respectively.

This new study may give some hospitals and maternity care providers pause about continuing to support women who desire VBAC, and, together with the dwindling numbers of family physicians providing delivery services, could push the overall U.S. Cesarean rate of 32% higher in future years.

Supporting our patients' health outside of the office

- Jennifer Middleton, MD, MPH

Our patients' incomes, neighborhoods, and educational levels impact their health at least as much, if not more, than the interventions we discuss with them within our practice settings. Identifying patients who are struggling with housing, bills, child care, and/or safety might feel like a daunting task, though, and connecting them to helpful resources can feel overwhelming. A new toolkit released by the AAFP can make these tasks manageable; The EveryONE Project provides screening tools to help family physicians screen for social determinants of health (SDOH) and also connect patients to local resources.

The EveryONE Project website contains links to screen patients for SDOH challenges, a guide to patient resources, and planning tools for your office (or practice setting) to implement these changes. Each of these links provides more in-depth background material, a robust list of specific suggestions, and references to resources like Aunt Bertha, an online search engine that lists social services by zip code. These resources simplify connecting individual patients to local resources. (If you're interested in community planning tools, check out the CDC's Tools for Putting Social Determinants of Health into Action.)

A 2017 AFP editorial, "Acting on Social Determinants of Health: A Primer for Family Physicians," includes additional suggestions to implement SDOH interventions and also gives examples of how doing so can benefit patients:

Rather than simply recommending that a patient eat better and exercise more, care teams can connect patients to a local community garden, low-cost exercise resources (e.g., YMCA), or neighborhood walking groups. As another example, knowing that a patient lives in a neighborhood with old housing may prompt a physician to proactively screen for lead exposure based on elevated community risk. 

Perhaps a staff member in your office, or a visiting nursing or medical student, might compile a list of local resources where you practice, starting with tools like Aunt Bertha. Perhaps your practice might identify a champion to work through The EveryONE Project's assessment checklist. Or, perhaps your practice has a best practice to share with other Community Blog readers - please do so in the comment section below. The AFP By Topic on Health Maintenance and Counseling includes tools to deepen your understanding of your patients' unique situation via an in-depth family history and spiritual assessment as well.

If our goal is whole person health, then including SDOH assessment into our practices is essential. No advanced training in public health or social work is necessary to use these tools. As Sir Michael Marmot said, quoted in the The EveryONE Project Guide to Social Needs Screening Tool and Resources, "Why treat people and send them back to the conditions that made them sick in the first place?"