PHARMACY

GPhA names VP international affairs

BY Michael Johnsen

WASHINGTON — The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs. Marks brings to GPhA more than 20 years of experience, including previous roles within the Department of Commerce. 

"Jonathan’s wide range of experience in trade policy, international intellectual property and international business development are key growth areas for our association and its members as the generic industry expands globally," stated Ralph Neas, GPhA president and CEO. "Jonathan’s expertise will be instrumental in GPhA efforts to promote access to more affordable generic medicines at home and abroad.”

Marks’ areas of focus at GPhA will include ensuring that Trans Pacific Partnership provisions and other international agreements embrace patient access to generics, as well as reinforce the importance of maintaining consistent international nonproprietary names for biosimilars and reference biologics.

During Marks’s tenure at the Commercial Service, he was posted to U.S. Embassies in Russia, Hungary, Germany and Romania, as well as the U.S. Consulate in Guangzhou, China.

He is the recipient of numerous awards from the Department of Commerce for exemplary achievements in the international arena, including the National Export Initiative Award and the Under Secretary for International Trade Award.

Marks, who speaks several foreign languages, graduated from Connecticut College with a major in Chinese and earned a law degree with emphasis on international and tax law from the University of Connecticut School of Law.

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Advocating for childhood immunizations

BY Emily Hensley Shafer, PharmD

Pharmacists and nurse practitioners are trusted healthcare professionals who provide instructions and advice based on peer-reviewed guidelines and clinical data. They have the opportunity and responsibility to educate patients about the benefits of childhood vaccines and to be advocates for immunizations as they relate to public health. Immunizations remain one of the most important public health discoveries of all time and are responsible for the decreased amount of infectious disease.

Patients may ask their pharmacist or nurse practitioner about childhood immunizations, including the safety of vaccines, the use of preservatives, the pediatric vaccination schedule and the potential link between autism and vaccines. Patients may get information from their neighbors, the media or unreliable Internet sources, so it is imperative that pharmacists and nurse practitioners are up-to-date on this information when questions arise. They should start by making sure that patients understand the importance of immunizing their children. Disease prevention — not treatment —  is the key to public health. Babies are born with antibodies from their mother, but not only does this immunity wear off after the first year of life, it also does not protect them against all vaccine-preventable diseases. By being immunized, children are able to develop immunity against disease without having to suffer with the actual disease.  This message needs to be advocated to patients in a clinical and helpful manner.

Before a vaccine can be administered to patients, it undergoes the same process as any other medication. It can take more than a decade and millions of dollars of thorough testing before a vaccine is licensed and put on the market. The safety of each vaccine is continuously monitored through the process of post-market surveillance. One component of this is the Vaccine Adverse Effects Reporting System, or VAERS, which allows people to report symptoms that they think may have been caused by a vaccine. However, since anyone is able to report any symptom, many of the filed reports are coincidental, not causal. This inhibits us from knowing if the vaccine is responsible for the symptoms. Although side effects can occur with vaccines, as with any medication, most are mild, including redness at the site of injection, muscle tenderness where the vaccine is administered and a slight fever.

Vaccines are composed of various ingredients to ensure their potency, prevent contamination from bacteria and viruses, and to encourage the body’s response to the antigens. Some vaccines contain an ingredient called thimerosal, which has been used as a preservative to prevent contamination of multi-dose vials since the 1930s. Thimerosal contains ethyl mercury, which does not have the same chemical properties as methyl mercury, the agent that causes mercury toxicity and potential neurological problems. In the United States, only multi-dose vials of the flu vaccine contain thimerosal.

Parents and caregivers may have questions regarding the current vaccine schedule: Why so many vaccines? Why does it matter when my child gets the vaccine? Why do they need to get some of these if the disease isn’t even around anymore? The current pediatric immunization schedule is recommended by the Centers for Disease Control and Prevention, or CDC; the American Academy of Family Physicians, or AAFP; and the American Academy of Pediatrics, or AAP. It consists of 14 different vaccines — some individual, some combination — and recommends that every child receive 26 shots by the time they are 24 months old, and 34 shots by the time they are 6 years old. While children are receiving more immunizations by the age of 2 years than ever before, they are actually receiving fewer antigens that would challenge the immune system. Overall numbers of antigens have fallen from about 3,000 in 1980 to approximately 150 today. The purpose of the recommended immunization schedule is to protect infants and children by providing immunity as early as possible before they are exposed to potentially life-threatening diseases.  There is no science to support a delayed or alternative immunization schedule. However, if a parent or caregiver chooses to follow an alternative schedule, their children will be at risk of developing diseases during the time that shots are delayed.

Some parents question the need to give their child a vaccine for diseases that are uncommon in the United States. Polio, for example, has not occurred in this country since 1979, but remains prevalent in India, Africa, Southeast Asia and the Middle East. An unvaccinated child from the United States could easily receive the infection while abroad, or a foreign person who is unknowingly shedding the poliovirus could expose an unvaccinated child while in the United States. The bottom line is each and every vaccine added to the list of recommended immunizations will save lives and/or reduce the number of disabilities in children.

One of the most delicate topics concerning vaccines is the idea that vaccines may cause autism. Autism is a chronic developmental disorder, usually first identified in children around 2 years of age. Since the measles-mumps-rubella vaccine is administered just before the peak age of onset of autism symptoms, some parents mistakenly assume a causal relationship between the disease and the vaccine. However, it is crucial that patients know that studies continue to show that vaccines are not associated with autism spectrum disorders.

Also, pharmacists and nurse practitioners can talk with parents about adult immunizations. A survey released by the National Consumers League found that more than 1-in-5 (22%) U.S. parents surveyed admitted they’ve never received a flu shot, and only half (53%) of parents with children ages 17 years and younger have received a flu vaccination within the last year. The CDC recommends all adults receive an influenza immunization annually, particularly parents of infants younger than 6 months of age.

Patients identify pharmacists and nurse practitioners as a professional resource — enthusiastic about understanding their questions and concerns, and striving to give them all the information necessary to make the right choice in the health of their child. There are a number of resources from the CDC, AAFP and AAP to help pharmacists and nurse practitioners do this. With patience and compassion for parents’ concerns, they can help the patients keep their own child and other children healthy for years to come. 

To view the immunization schedules, click here.

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Counseling the vaccine-hesitant patient

BY Susan M. Cooley

What’s at the root of most morbidity and mortality from influenza and other vaccine-preventable diseases? Under-immunization. Retail clinicians (i.e., nurse practioners, physician assistants and doctors) are in a unique position to influence immunization rates by educating patients on the benefits of appropriate vaccines. While myths surrounding vaccines — like the idea that the flu shot leads to contracting influenza and misguided information that vaccines lead to autism or mental retardation — have been dispelled by rigorous scientific investigation, people of all ages appear to be “skipping out” on vaccines.

With the current influenza season in full swing, retail clinicians should remain vigilant about offering the vaccine through March. Of those children who died of influenza last year, 90% had not received a flu vaccine. In contrast to previous flu seasons, the current flu strain has proven especially harmful to young adults who have not received the vaccine.

In counseling the vaccine-hesitant parent or patient, it is important to understand the basis for their stance against vaccines. Parental fears and concerns regarding vaccines often stem from misconceptions, including the belief that vaccine-preventable diseases no longer pose a risk, doubts about vaccine safety and beliefs that certain ingredients in vaccines are dangerous.

Vaccine-hesitant patients or parents can be categorized into five categories:

  1. Uninformed, but educable and seeks information to counter anti-vaccine information;
  2. Misinformed, but correctable and not fully aware of vaccine benefits;
  3. Well-read and open-minded, willing to discuss the issues with consideration of pros and cons;
  4. Strongly vaccine-resistant, willing to listen to both sides of the argument, but unlikely to change viewpoints soon; or
  5. Strong-willed and committed, attempts to convince provider to agree with the argument against vaccines. Parents in this last group are difficult to counsel.

Remembering that the goal is increased adherence (i.e., decreased morbidity and mortality from vaccine-preventable diseases), non-judgmental communication is the key to counseling around vaccines. As with any emotionally charged issue, clinician attitude can help or hinder shared decision-making. Vaccine Information Sheets, or VIS, given early in the exam can help parents or patients formulate questions. Clinicians should take time to solicit questions, acknowledging both benefits and risks. Respectful listening requires eye contact and refrains from patronizing behaviors. It is most important that clinicians not get offended, nor offend the patients, around issues of disagreement. Use of clear, simple language is of utmost importance.

With practice, clinicians can develop an attitude that is respectful of the parent or patient’s authority while encouraging vaccine adherence.

For resources, visit CDC.gov/Flu/Professionals/Vaccination/ and Immunize.org.

 

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