"The future belongs to those who believe in the beauty of their dreams." - Eleanor Roosevelt
What dreams can we imagine for drug safety? Perhaps, in an idealized future, patients would experience only benefit, never harm, from their medications. This overview presents current problems in drug safety and glimpses of possible solutions, based on the three main categories of adverse drug reactions (ADRs): medication errors/drug misuse; adulteration; and inherent toxicity.
Mediation Errors/Drug Misuse
Much energy has been focused on the first type of ADR; medication errors. These are essentially problems in the way in which drugs are used. Problems range from obvious errors in drug administration to more complex societal concerns, as demonstrated by these examples:
In theory, these types of problems are all preventable by using the drugs properly. Current solutions mandate improvements at every step of the medication pathway: prescribing, monitoring, labelling, storage and verification procedures. A good resource for these details exists at ISMP-Canada. For the future, experts on medication errors place improving undergraduate education of medical students high on their list of ways to increase awareness of drug safety issues.4 These experts also recommend using bar codes to ensure that the right drug is always given to the right patient. Electronic prescribing will reduce illegibility and rule-based errors.5 In 2009, only 27 percent of Canadian general practitioners were able to prescribe electronically.6 Public health issues also need to be addressed, such as providing more resources for the treatment of drug addiction.
Adulteration of Drug Products
A second cause of adverse drug reactions is adulteration of the drug product; the presence of an impurity which can be harmful. Adulteration can occur intentionally or unintentionally, as in these examples:
This type of ADR is also preventable. It can occur with conventional medicines, as in the nabilone example, but usually occurs with health supplements that lack adequate regulation, especially those purchased over the internet. Possible solutions in the future require increased regulation of dietary supplements, and increased staffing of government inspectors. For now, be suspicious if a patient describes unusual effects from a product, or if there is a change in the physical characteristics of a product that might suggest counterfeiting. The globalization of the pharmaceutical industry due to cost pressures has resulted in a high percentage of drugs that are imported. In the US, it has been estimated that 80 per cent of active ingredients and 40 per cent of the final drug products are imported. Quality control is harder to enforce.10
Inherent Toxicity of Drug Chemicals
Even if no medication error occurs or impurity exists, ADRs can still happen because of an inherent chemical property of the drug molecule. The common inherent toxicities of a drug may be revealed in pre-marketing studies, and post-marketing surveillance adds to our knowledge of less common reactions.
The third type of ADR is not as easily preventable. In the future, some degree of prevention might be attained though an increased understanding of the genetics of drug-induced injury. By identifying specific individuals at risk, we can avoid giving them a potentially toxic drug. Leveraging the current voluntary reporting system for ADRs with systems such as the FDA's proposed Sentinel Initiative will help to identify new ADRs. Sentinal will link existing healthcare databases, such as those already used for administration and insurance, to create a national monitoring process that is continuous and operates in real time.14 For now, increased use of the existing Health Canada reporting system for ADRs will add to the available knowledge.
The problems are multifaceted and thus require a wide variety of solutions. Technology will help, but education, reallocated funding, improved staffing, increased attention to safety issues, and wider us of existing processes will all play a role in making drug safety a reality.
Written by Barbara Cadario, B.Sc.(Hon), B.Sc.Phm., M.Sc., BC Drug and Poison Information Centre
©2011 B.C. Drug and Poison Information Centre
A version of this document was published in BCPhA's The Tablet. 2010; 19(2): 8-9.