Medical Program Director, Palliative Care Baycrest Geriatric Health Care System Professor of Medicine, University of Toronto
Warning: Internet Can Be a Danger to Your Health

Abstract

The process of prescribing medications, explaining the risks and benefits has classically been the role and responsibility of physicians with support from other health care providers such as pharmacists. In the modern age with the phenomenal expansion of the digital world, the world of the internet has become a major player. It is common for physicians to have to contend with and integrate into their practice the common phenomenon of family members looking at the internet and other sources for information about medications proposed for their loved ones.

Introduction

Medical Practitioners are aware of the “black box” warnings of the Federal Drug Administration (FDA) in the United States and the Canadian Health Protection Branch (HPB) drug warnings. These warnings come out when there may exist risks from the use of approved medications, yet do not require their withdrawal from the market-place; a caution to those prescribing the medications to decrease adverse reactions is announced to protect the public and the agency approving the drugs.

In the world of modern medicine and readily available on-line information access  is common. Whenever recommendations are made to older patients, their children will likely Google the medication and come to the doctor with on-line based questions. These invariably focus on side effects listed along with the indications for the drug. Many on-line information sites draw their information directly from FDA or HPB pharmaceutical manufacturer documents where all reported adverse reactions are listed. For many lay people this causes a dilemma.  If the family member concludes that the medication is “too risky” that may impede proper medication therapies, unless the physician is prepared to convincingly counter the concerns. If the medication is rejected, its benefits will not be experienced. Risk assessment is intellectually complex; some people are extremely risk averse.

Case study 1

The daughter of a woman with pronounced Behavioural and Psychological Symptoms of Dementia (BPSD) asked me about the medication prescribed by her mother’s doctor after the usual steps were taken seek aggravating factors for delirium. When she Googled Seroquel (quètiapine) she found the following FDA warning, "Seroquel is not for use in psychotic conditions related to dementia. Seroquel may cause heart failure, stroke, sudden death, or pneumonia in older adults with dementia-related conditions." She wrote me a very concerned email asking “Is this true?  Why would he (the doctor) prescribe it if it is not intended for people with dementia?” I tried to assist by sending  recent peer reviewed articles exploring the medical evidence, much of which has come out since the `black box` warning was added to the Seroquel drug information filed two years previously. The articles I sent put the use of such drugs into a proper medical risk-benefit context so she could understand that all the medications in the newer and older classes had the same risk: mostly related to the underlying disease rather than the medications per se (1). The medication was dispensed with the result that patient became calm enough to remain in the retirement home while alternatives were being pursued; thus avoiding a crisis while a more suitable placement could be found for late stage dementia care which will become the focus of treatments.

Case Study 2

In another case a patient`s daughter would not consent to her mother receiving Aricept® (donepezil) for moderate dementia. After she Googled the medications she was afraid that, according to the listed adverse effects, death was a possibility. To demonstrate such statistics in a recent on-line edition of eHealthMe, “the likelihood of death occurring with the use of Aricept is 2.80%. This is, of course not necessarily cause and effect, but association. [ On Nov, 21, 2013: 14,389 people reported to have side effects when taking Aricept. Among them, 403 people (2.80%) died. (http://www.ehealthme.com/ds/aricept/death)].

Her mother`s cognition declined over the next nine months. With great trepidation and fear of impending doom she agreed to allow the medication. It was started with a cautious very low 2.5 mg. day dose which was gradually increased. Her speaking and interactions improved substantially. It took 3 months with incremental increases in dosage to reach her plateau which lasted about two years. For years the  daughter,  berated herself for relying more on the Internet than direct medical  advice ---I assured her that what she did was not only not `wrong` and, if anything, reflected her deep concern for her mother and was in fact part of the new informatics world. (2, 3)

Why the Quest for Digital information?

The public’s concern about the “risk” from medication use has grown considerably due to the common reporting on such events by the media; some members of media seek to demonstrate the deficiencies in the pharmaceutical industry’s ethical foundations and the inadequate regulatory system which is often attributed to “vested interests”, “corporate influence” and conspiracy theories. The negative result of this perspective includes outbreaks of potentially serious childhood virus illnesses such as measles and chicken-pox because of parental refusal to vaccinate their children based on well documented erroneous associations between autism and vaccination. (4, 5)   

Within the context of palliative care it is not uncommon for family members to be excessively cautious and at times suspicious about opiate use for pain management; such medications are associated with “street drugs” and the concept of addiction often clouds the thinking of the family members who may fear their loved one will “getting hooked” even when the goal is to provide palliative and end-of-life care, often because of serious pain. (6) Another such palliative care example is the reluctance to accept the use of “steroids”, often prescribed to decrease swelling and pressure as in brain and lung tumours and for its potentially elevating effect on mood, sense of well-being and appetite. (7) In these two situations as in others, it takes patience and careful reinforcement and acknowledgement of the person’s fears to achieve one’s goal. Often if the treatment is framed as “a trial of therapy” for a week for example, that is sufficient to observe and then accept or refuse the medication.

When the media focuses on misuse of pharmaceuticals by physicians one of the villains is the “off label” use of medications. This is often erroneously interpreted as meaning “unapproved” and therefore either deceitful, illegal or dangerous. When pharmaceuticals apply to the FDA or HPB (or other national regulatory bodies), they apply for specific indications and provide the proper evidence-based studies upon which the licensing authorities base their decision. Once approved, that medication is then listed within the class of the medication as a therapeutic indication (anti-depressant) or pharmaceutical class of medication (beta-blockers). The drug information and documentation is available from the licensing agencies and myriad secondary sources such as the PDR-Physicians’ Desk Reference in the United States or CPS-Compendium of Pharmaceuticals and Specialities in Canada.

These references provide the information to which physicians turn to for official indications and attributes of the medication. Over time and with increased familiarity the medical literature publishes evidence-based studies that may change clinical prescribing habits by physicians who share the evidence. Eventually many of the uses of the medication may not be what was originally listed in the “labelled” indication of that drug, but have become part of the “standard” use of medication without a revised approved indication for the drug.

Optimal Medication use and the off label designation

A very good example is that of the first effective antidepressant amitriptyline (Elavil®). According to the FDA its indication is, “For the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than are other depressive states.” (8) However since the late 1950’s when this drug made its debut as an anti-depressant, it has gradually entered the practice of pain management and palliative care; it is often successfully used as an adjunct to other analgesics, and is usually effective especially for neuropathic pain. (9)  This is useful in older patients who may have a number of causes of pain including those that are non-malignant such as diabetic neuropathy, radicular or other causes of neuropathic pain.

There is a new enhanced service by the respected digital website ‘ÙpToDate` that is called Practice Changing Updates that physicians may use to maximise their current therapeutic knowledge. The website notes; “this section highlights selected specific new recommendations and/or updates that we anticipate may change usual clinical practice. Practice Changing UpDates focus on changes that may have significant and broad impact on practice, and therefore do not represent all updates that affect practice. These Practice Changing UpDates, reflecting important changes to UpToDate over the past year, are presented chronologically, and are discussed in greater detail in the identified topic reviews.” (10)

Internet Risk

Why might the internet be `dangerous to your health`? When a family member “Googles” a medication on the internet it is common to focus on adverse effects especially the black box” warnings.  This may be a powerful force to cause a refusal of proposed medication therapy.

These concerns of the public are not necessarily “off the wall”. There have been innumerable “scandals” involving pharmaceutical companies and the withholding or miss-representation of important adverse effects as well as even highly regarded physicians including researchers who have miss-represented their views or findings in order to promote their careers or for financial reasons, to the detriment of medical science, the profession and the drug regulating agencies. (11)

Conclusion

To deal with the new world of information technology and the challenges to our clinical judgement we have to learn to deal with Internet addiction and “Googlemania.” We must not denigrate the desire of loved ones to “search`` the internet for information about important decisions. We can direct family members to the most reliable sites possible; if what is found is contrary to our understanding of the evidence, we need to explain our experience without becoming `defensive` if our authority or knowledge is questioned. It is often useful to explain that “Google” searches may not be adequate to get to the bottom of the information load. It is  useful to help family members and patients understand the difference between data, information, knowledge and wisdom—hopefully it is the latter two which come with keeping up with the field and combining the results of studies with our clinical experience—something which the internet alone cannot do. Patience and open listening rather than “bombarding” the family with more information will eventually achieve our goal. Sometimes it is just the natural unfolding of the story and the clinical condition that leads to the change of mind or someone else’s experience that clinches the decision one way or the other. Quite often things develop with time and sometimes bringing up the options again in the future might be helpful. Provide peer-reviewed medical evidence articles to support our position. This may help family members understand why we are making our recommendation; if the recommendation is rejected, that is just part of clinical practice and we carry on doing the best we can.



References

1.   Lopez OL, Becker JT, Chang YF, Sweet RA, Aizenstein H, Snitz B, Saxton J, McDade E, Kamboh MI, DeKosky ST, Reynolds CF 3rd, Klunk WE.The long-term effects of conventional and atypical antipsychotics in patients with probable Alzheimer's disease. Am J Psychiatry. 2013 Sep 1;170(9):1051-8. doi: 10.1176/appi.ajp.2013.12081046. http://www.ncbi.nlm.nih.gov/pubmed/23896958

2. Cholinesterase inhibitors (ChEIs), donepezil, galantamine and rivastigmine are efficacious for mild to moderate Alzheimer's disease. Cochrane Database of Systematic Reviews: Plain Language Summaries. This version published: 2012. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0013575/

3. Dev H, Agius M, Zaman R.The dramatic effects of Galantamine in a patient with early-onset Alzheimer's disease.   Psychiatr Danub. 2010; 22:367-9. http://www.ncbi.nlm.nih.gov/pubmed/20562785

4. Fellet M. The Menace of Vaccine Avoidance. March 28, 2011. University of California, Santa Cruz. http://scicom.ucsc.edu/publications/essays-profiles-pages/essay-fellet.html

5. Garty E. Vaccination avoidance – the natural choice or a deadly game? Weizmann Institute of Science, Israel    http://davidson.weizmann.ac.il/en/online/database/med_and_physiol/vaccination-avoidance-%E2%80%93-natural-choice-or-deadly-game
 
6. WHO Pain and Palliative Care Communication Program
Fear of Addiction: Confronting a Barrier to Cancer Pain Relief. Volume 11, #3, 1998
http://whocancerpain.wisc.edu/?q=node/244

7. Melissa Vyvey, Steroids as pain relief adjuvants. Can Fam Physician December 2010 56: e415-417
http://www.cfp.ca/content/56/12/1295.full

8. Amitriptyline HCL USP.Drugs.Com (FDA information of indications)
http://www.drugs.com/pro/amitriptyline.html#indications

9. E Med Expert. Amitriptyline HCL (Elavil)
http://www.emedexpert.com/facts/amitriptyline-facts.shtml

10. Practice Changing Updates: UpT oDate.
 http://www.uptodate.com/contents/practice-changing-updates?utm_source=bronto&utm_medium=email&utm_term=View+current+Practice+Changing+UpDates.&utm_content=UpToDate+Practice+Changing+UpDates&utm_campaign=Expert+User+Series+-+Practice+Changing+UpDates+-+English+-+Copy+1&_bta_tid=3.MWY.BxD8VA.CuKl.AUDg_w..Aqv9Eg.b..l.BLuP.a.Uo5KIA.Uo51Sw.oqyDPA&_bta_c=eg1erces762uzvgnfipxq1h5l157d 

11. Dr. Sidney Wolfe: GlaxoSmithKline Settlement Still Not Enough to Deter Illegal Behavior by Pharmaceutical Industry.  YubaNet.com. Jul 3, 2012
http://yubanet.com/opinions/Dr-Sidney-Wolfe-GlaxoSmithKline-Settlement-Still-Not-Enough-to-Deter-Illegal-Behavior-by-Pharmaceutical-Industry.php