As much as I support vaccines, I see the short term consequences. Vaccines can be painful. Kids don’t like them, and parents don’t like seeing their children suffer. That this transient pain is the most common consequence of gaining protection from fatal illnesses seems like a fair trade-off to me. But that’s not the case for every parent.
Today’s post isn’t going to focus on the extremes of the anti-vaccination movement. Rather, it’s going to look at ways to make vaccines less painful and more acceptable to children. The pain of vaccines can lead to anxiety, fear, and even nonadherence with vaccination schedules. Fear of needles and injections is not uncommon, it’s estimated that 10% of the population avoids vaccinations for this reason.
The vaccine schedules are intense. Where I live, the public vaccination schedule specifies seventeen injections of six different products over six visits in the first 18 months of life, plus influenza vaccinations and one-offs like H1N1. That’s a lot of visits, and a lot of tears if a child doesn’t handle them well.
In light of what’s known about the prevalence of needle fears, their potential effect on vaccination adherence (that could persist through adult life), and the possible impact on public health because of unvaccinated individuals, it makes sense to do whatever we can to minimize the pain and discomfort of vaccines, increasing their acceptance to children and their parents. But what works? I’ve personally found Smarties (the real ones) and Dora the Explorer stickers are effective distractions and bribes. But I’m not about to call my n=2 trial good science. Nicely, there’s much more evidence to guide our recommendations.
We spend a lot time at SBM discussing different elements of the art and science of medicine, and how we believe that practice can be improve. Yet our science-based intentions can be thwarted at the last possible moment – in the form of dosing errors. The workup may have been comprehensive, the diagnosis could be correct, the most clinically and cost-effective intervention chosen, and whammo. An overdose or underdose, possible toxicity, and a failure to achieve the desired outcome. It’s a completely avoidable, but often overlooked aspect of the practice of medicine.
In my last post, I noted how cough and cold products for children have largely been withdrawn from the market due to their lack of efficacy, and the risks related to toxicity. Today’s post is going to dive a little more deeply into factors that can contribute to toxicity in the pediatric population. Let’s start with a vignette that may be familiar to parents:
The new father is wakened from a blissful, deep sleep by a crying child. Once Dad realizes when and where he is, and the source of the crying, he silently curses the short duration of action of the acetaminophen liquid he gave his child at bedtime. It has probably worn off already, and the fever is back. Stumbling into his child’s room in the dark, he can feel the heat radiating off his body. He fumbles around for the Tylenol, and something to measure it with. He can’t find the dropper bottle, but finds a bottle of syrup. It’s hard to measure the dose in the dark, and the medicine cup he finds is hard to read. “I think the dose is a teaspoon..that’s 5mL”. He pours the medicine into his child’s throat, tucks him back into bed, and both are back asleep within minutes.
As Vaccine Awareness Week draws to a close, I thought it might be instructive to step back and look at the tactics, impact, and successes of the anti-vaccine movement. Yesterday, Orac questioned the best approach to counter the anti-vaccine movement. With today’s post, I’ll summarize two pertinent papers on the effectiveness of their tactics, and suggest some possible approaches.
There’s overwhelming evidence that vaccines have provided us with tremendous health benefits. Smallpox has been eliminated (except, apparently, for homeopathic nosodes), polio is almost gone, and occurrences of diseases like measles or rubella are now rare. In use for over a century, they are a public health triumph: diseases that terrified us a generation ago are now never seen. Epidemiologic evidence demonstrates that vaccines have a remarkable safety record, and are exceptionally cost-effective interventions. Yet in spite of this, concerns about vaccine safety seemingly continue to mount. And as we see time and time again, when vaccination levels drop, diseases reappear. So what’s driving anti-vaccine sentiment, and why is it successful?
The H1N1 pandemic of 2009/10 is now about a year past its peak, and is instructive as a case study on communication on vaccine safety and efficacy. Remember the H1N1 vaccine? Judging by the anti-vaccine rhetoric of just last year, by now we should all have been rounded up by the army, given forced injections, and if the vaccine didn’t kill us right away, or make us walk backwards, we’d be immunosupressed (from the aluminum adjuvant), or have Gulf War Syndrome (from the squalene). And not only did it not work, it doubled our odds of getting H1N1. All we needed was vitamin D and a proprietary supplement formula to avoid the flu, they said.
What evidence standard should exist for health products sold in pharmacies? That’s today’s bleg, and I’m seeking your input.
In most countries, pharmacy is a registered, self-regulated health profession, with a responsibility to optimize the use of drugs. Pharmacist education consists of several years of university-level education and practical training in real-world health care settings. Pharmacists with advanced degrees and post-graduate residencies are common. Not all pharmacists work in community (retail) pharmacies, but that’s where many pharmacists end up, and it’s the public face of the profession.
In most countries, pharmacies are private businesses, either owned by a pharmacist or by a corporation. They are granted a privileged and exclusive right in the provision of health care: certain health products (both prescription and non-prescription) are only available in pharmacies, because pharmacist consultation and availability has been deemed necessary to maximize the safe use of these products. While it’s a setting for health care (and often the first point of contact into the system), retail pharmacy is a business. Pharmacies count on the retail sale of products for revenue and traffic. And in general, pharmacies have the legal right to stock and sell whatever products they want. Tobacco is one exception, where it is no longer sold in most Canadian pharmacies, but remains prevalent in American pharmacies. And as I discussed in a prior post, when we look internationally there can be considerable differences between which drugs are prescription, and these that can be sold over-the counter.
How Much Evidence?
The evidence standard for products sold in pharmacies is facing increasing scrutiny. Concerns have been raised in several countries that pharmacies may be taking advantage of their privileged status as provers of prescription drugs, and are selling products that aren’t supported by good scientific evidence. Some recent examples:
Imagine you’re an FDA reviewer looking at a new drug application. Drug A relieves a symptom, but doesn’t cure any disease. It doesn’t conflict with other medications. It’s considered safe in pregnant and breastfeeding women. At normal doses, there are virtually no side effects. There’s one unfortunate problem: If you take ten times the dose, liver damage is very likely and may be fatal. In other countries, Drug A is the number one cause of acute liver failure.
Should Drug A be available without a prescription?
Now consider another drug. Drug B also treats a symptom, but can also be used to treat a number of acute and chronic conditions, some of which require monitoring by specialist physicians. Drug B should generally be avoided in children, as it is associated with a rare but fatal toxicity. Even at normal doses, it can cause an array of side effects, and severe digestive system toxicity, resulting in hospital admission, is not uncommon. It interacts with other prescription drugs, and can be fatal in overdose situations.
Should Drug B be available without a prescription?
It is my pleasure to announce the addition of a new SBM blogger. Impressed by his dedication to applying scientific principles to the profession of pharmacy, we have recruited Scott Gavura, who is currently best known for his work on Science-Based Pharmacy. You can find out a bit more about his background at his new page on SBM, and his first post is scheduled for Thursday, May 13. In the beginning he will be posting approximately once every four weeks.
Please join me in welcoming Scott to the SBM team.