Top Science-Based Pharmacy Events of the Decade
There have been a few “best of the decade” lists circulating, with both KevinMD and Medpage Today giving their perspective on the biggest medical events of the past ten years. Here’s my own list of what I think influenced or impacted the drive to make pharmacy a more science-based profession. This is a fairly Canadian-centric list: I apologize to all of all SBP’s international readers. I invite your critique and suggestions on anything I missed, or any relevant events/trends in your pharmacy practice. These items are in no particular order.
- Patient Empowerment and Dr. Google – The relationship between the pharmacist and the patient has changed dramatically over the past decade, owing to the ubiquity of the internet, social networking, and the explosion of free medical information (open access) on the web. The typical patient can now access virtually the same drug information as the pharmacist. And when it comes to product warnings, the informed patient tends to know before the pharmacist. In the next decade, the community pharmacist will be challenged to add value beyond the typical “let me tell you about your prescription” script, as the impact of “Dr. Google” will only grow. Even today, the savvy patient has already looked up the patient information on their iPhone while waiting for the prescription to be filled. In the next decade, the pharmacist’s added value won’t come from giving basic information, but from translating and contextualizing drug information into something that’s patient specific. Our current elderly population (pharmacy’s biggest customers) largely missed the age of the internet. But as the tech-savvy Baby Boomer generation moves fully into their chronic disease years (cardiovascular, diabetes, cancer, etc.), they’ll be empowered, they’ll be demanding, and they will challenge the status quo in pharmacist-patient relationships.
- The Vioxx Debacle – Six years ago, one of the world’s bestselling drugs was rofecoxib (Vioxx), one of a class of drugs called COX-2′s that were purported to be safer than traditional anti-inflammatory drugs. While the drugs did seem to be better tolerated by a small number of patients, there were troubling signs that they might cause cardiovascular problems. Despite some pointed criticism of these drugs since they were launched, and significant restrictions placed on use by some drug plans, rofecoxib became a worldwide blockbuster for Merck, driven (in part) by substantial marketing to the public and health professionals. When more data emerged to conclusively demonstrate that the cardiovascular risks were real, and unacceptably high, the drug was pulled from the market, leaving hundreds of thousands of patients without treatment, and furiously demanding answers. There were widespread questions and criticisms raised about the safety of marketed drugs, and the effectiveness of drug regulators like Health Canada and the FDA. And the repercussions sent shock waves that are still being felt today. Some of the consequences of the COX-2 saga have been positive for the science-based use of drugs – more transparency in clinical trial data, more scrutiny of conflicts of interest, and more caution about new drugs. Some complain that Vioxx has made regulators too risk averse – unwilling to give conditional approval to promising drugs where questions remain about the safety profile. Today we have mandatory registration of all clinical trials, pharmaceutical marketing and gift bans, and disclosure of payments to physicians and other health professionals from pharmaceutical companies. And we have health professionals and consumers that are far more wary of the latest “wonder drug” to arrive on the market.
- The End of Routine Hormone Replacement Therapy – The Women’s Health Initiative study was a (US) federally funded study designed to answer a huge number of questions about women’s health: dietary modification, calcium/vitamin D, and hormone replacement, and their effects on heart disease, cancer, and osteoporosis. A massive study, it involves over 160,000 women and has lasted over 15 years (to date). It’s the data on hormone replacement, released in 2002, that has had a huge effect on medical and pharmacy practice. For decades, hormone replacement was thought to present a favourable risk/benefit ratio. Not only was it effective at reducing menopausal symptoms like hot flashes and sleeplessness, it was believed to reduce the risk of osteoporosis, and possibly even heart disease. The data from the study identified that the risks of hormone replacement had been underestimated. While death rates remained unchanged, the risks of heart attack and stroke were higher than expected. Given the ubiquity of hormone replacement, the WHI had a huge public health impact. It is still used, and remains the most effective treatment for menopausal symptoms. Confusion about the WHI data has led to the rise of “bioidentical” hormone replacement, supported by “compounding” pharmacies. Unfortunately, bioidentical hormones, despite the claims, simply do not yet have the data to suggest that they’re any safer than “traditional” hormone replacement. The long term effects of the WHI study have been a reinforcement of the precautionary principle with drug treatment, and a renewed focus to ensure that drugs are used and marketed in accordance with what the science says.
- The Treatment of HIV – A HIV diagnosis used to mean a fairly rapid death sentence. When I graduated pharmacy in 1993 there were three drugs available: AZT, ddI and ddC. The innovation that’s been delivered in the HIV treatment world has been astonishing. Mortality rates have dropped, and life expectancy has jumped by over a decade, in less than a decade. Why? There are now dozens of highly effective treatment options, and HIV is now managed more like a chronic disease due to the astounding effectiveness of combination therapy. If you’re looking for a positive example of the power of science, and of the beneficial role of pharmaceuticals, look no further than the treatment of HIV.
- SARS, H1N1, and the Role of the Pharmacist in Public Health – H1N1 is the current public health scare in North America, but the memories of SARS are still fresh in Canada, especially to those that were in Toronto in 2003, where the outbreak was substantial. Not only have SARS and H1N1 reinforced the critical importance of a well-financed public health infrastructure, it’s also finally occurred to public health officials that pharmacies and pharmacists have pivotal roles in advocating for, and delivering, public health measures. Today, many pharmacists can give vaccines, pharmacists are important, accesible sources of information on H1N1, and monitoring of sentinel drug sales in pharmacies [PDF] takes place to help detect public health issues. I see this as a critical role for pharmacy practice, and yet another reason why “make believe medicine” and other nostrums have no place in pharmacies.
- Personalized Medications and Targeted Therapies – There has been no evolution in disease treatment so dramatic than what’s been seen in cancer chemotherapy: from crude therapies like nitrogen mustard decades ago, to much more biologically specific treatments that maximize their effects on cancer cells while minimizing toxicity. In the last decade, we’ve seen the rise of molecular oncology: Specialized, patient-specific, treatments based on tumor characteristics. Herceptin (trastuzumab) has transformed adjuvant breast cancer treatment, and Gleevec (imatinib) is highly specific therapy that is astonishingly effective in treating chronic myelogenous leukemia. More research into the molecular basis of disease is leading to remarkably innovative treatments. The challenge in the next decade will be finding ways to pay for these incredibly expensive drugs.
- The Rise and Fall of Canadian Internet Pharmacies – A giant sucking sound was heard in Canada in the 2000′s: It was the sound of lower-priced brand-name drugs being shipped across the border to Americans seeking relief from expensive prescription drugs. Canadians were understandably concerned: Canada has a drug supply and pricing system that (while imperfect), largely meets the needs of Canadians. It’s not designed to support a pool of uninsured Americans that is larger than the entire Canadian population. Responding to American consumer demand, internet-based pharmacies sprung up, and started shipping drugs over the border, sometimes even with state government endorsement. 2003 sales by internet pharmacies peaked at over $600 million, but then started dropping dramatically after that. What happened? The biggest factor was the disappearance of the foreign exchange advantage. As the Canadian dollar rose in value, the savings for many Americans evaporated. At the same time, new measures to help with drug costs in the US (e.g., Medicare Part D) offset the cost burden. Canadian manufacturers tightened shipping restrictions, in an attempt to limit exporting. And growing concerns about the safety of purchasing drugs over the internet likely had an effect. While the Canadian internet pharmacy industry still survives, it’s a shell of its glory days. And that’s a good thing.
- The Changing Reimbursement Model for Pharmacists - Canadian pharmacies are largely paid based on a fee-for-service model that compensates based on the number prescriptions filled. Professional services provided by pharmacists are, in general, not directly compensated. It’s a model that doesn’t work to align pharmacist, patient, prescriber, and insurer interests. Many provinces experimented with changing the pharmacy reimbursement model in the 2000′s, with some success in reducing the cost of drugs while introducing new payment models for patient-focused services. More changes are expected in the next decade, as drug utilization climbs, new generic drugs arrive, and chronic disease management becomes a bigger focus for health ministries. A better model will fairly compensate pharmacists for professional services provided. while ensuring pharmacies remain viable and accessible to patients. Change will not be easy, and it is pharmacy’s challenge to lead these changes. A new reimbursement model could enhance the role of the pharmacist and leverage the pharmacist’s expertise to improve drug utilization and support patient care. Will it happen in the next ten years? I won’t make any bets.
- Regulation of Natural Health Products – As I blogged last week, Canada entered this decade without appropriate regulation of herbals and other natural health products. As we enter 2010, full implementation of the Natural Health Products Regulations is delayed, but looming. It’s not perfect (not even close) but it’s better than no regulation, like the American model. At a minimum, we should soon have the assurance that what’s on the label is actually in the bottle. The challenge for science-based pharmacy advocates will be to press for higher standards for products sold in pharmacies – starting with getting homeopathy out of pharmacies.
Number 10? I’ll leave that up to you. Please add your comments below.
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