WP7 Implications of the Internet in Relation to Medication Access and Safety Information
Work Undertaken (Deliverables)
- Descriptive cross-sectional survey of E-pharmacies to compare and contrast medication safety information and purchasing procedures from bona fide and non-bona fide e-pharmacy websites selling Isotretinoin and Mistroprostol (Deliverable 30)
- Review of literature on internet medication purchasing
- Review of literature on the online availability and access to information for consumers on teratogenic effects of Isotretinoin
- A web-based survey to develop an understanding of pregnant woman's use of the internet for medication safety information and purchase (Deliverable 31)
- Review of literature on attitudes of women taking medications in pregnancy
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WP7 Results and Foreground
The internet has now become an important source of information and access to products. Research exploring the implications from drug safety and pharmacovigilance is relatively new but rapidly spreading. Work Package 7 (WP7) Implications of the Internet in Relation to Medication Access and Safety Information was a four-phase, multi-method, scoping study conducted at Ulster University between March 2011 and December 2013 as part of the EUROmediCAT project. WP7 combined both quantitative and qualitative research methods to explore the behaviour of pregnant women in their use of the internet for medication safety information and for medication purchase and development recommendations for regulators in relation to the role of the internet in drug safety.
A brief summary of the key points from the literature
- Safety information available online was considerable and there was robust evidence of published and readily available data on the teratogenic effects of medications such as isotretinoin from regulated medicine agency sites, teratology information services and professional networks.
- The literature also indicated that women lacked knowledge about the potential risk of congenital anomalies (CA) from medication use in pregnancy
- Women perceived it was safer to take medication in trimester two and three
- Some women were reluctant to take important prescribed medication because of fear of CA and misconceptions about safety
Evaluation of E-pharmacies (Deliverable 30)
The key term "buy isotretinoin" was keyed into the five most common search engines and the first 10 sites were selected from each. The resultant 50 e-pharmacies were searched to obtain purchasing information on isotretinoin and were evaluated in terms of the general website criteria, e-pharmacy criteria as well as Pregnancy Prevention Programe specific criteria.
Figure 7.1 Location of E-pharmacies
Summary of main findings regarding online purchasing
- It was very easy to purchase prescription only medications without the requisite prescriptions.
- All 7 samples received of 8 purchased from sites not requiring prescriptions were proven by laboratory analysis to be isotretinoin
- None of 7 samples were received in a properly labelled container with an appropriate patient information leaflet
- One of 7 samples had a tiny "Avoid in Pregnancy" symbol on the foil packet, the others no warning at all. All samples came from India
Figure 7.2 Illustration of received isotretinoin sample
Conclusions from the study
Women of childbearing age have the opportunity to self-purchase medications directly from websites that do not provide any form of risk assessment, pregnancy prevention advice, or adequate warnings of the dangers associated with taking these medications nor require a prescription.
The majority of the few sites that required a prescription were prepared to accept a fax or email which is in contravention of the recommendations of the Royal Pharmaceutical Society of Great Britain about what constitutes a valid prescription. None of the purchased medicines were packaged according to the European Council Directive 2001/83/EC. Females obtaining isotretinoin or cytotec from non bona-fide pharmacy sites may be at risk of becoming pregnant and being exposed to known and unknown potential teratogens.
Web-based survey (Deliverable 31)
A web-based survey was undertaken to develop an understanding of pregnant woman's use of the internet for medication safety information and purchase. The survey instrument was developed, adapted and piloted (items from previously validated instruments by Harhi et al; Peterson-Clarke et al 2010; Lagan et al 2011) and ethical approval was obtained from Ulster University Institute of Nursing and Health Research Ethics Filter Committee. Participants had to be 18 years of age or over, currently pregnant or had a baby in the last year, living in the UK and able to understand English. The age distribution was 18-45 (mean 30), 244 women were from England, 21 from Wales, 10 from Scotland and 9 from Northern Ireland. A significant proportion held higher degrees (44% n=125). However, it is important to note, this sample should not be considered representative of the population, but may be considered a wide cross section of women using the internet.
Summary of main findings
Overall, 111 (39.1%) of the study participants were taking at least one medication that was not a mineral or vitamin when they became pregnant and this included: antibiotics, inhalers, anti-depressants, antiepileptics and diabetes medication. The sample selected included women who did not have a chronic condition requiring medication prior to becoming pregnant (60.2% n=171). Chronic conditions suffered by women included asthma, depression, diabetes and epilepsy. Women were asked if they were prescribed medication would they change their medication when planning a pregnancy and 17% (n=47) said "yes", 38% (n=109) "yes" when the pregnancy was confirmed and a small proportion would not change medication in either circumstance (15% n=43).
Women's willingness to take any medication during pregnancy
The majority of women in the study were not happy taking any medication during pregnancy (60% n=169).
Use of the internet for medication safety information in pregnancy
The majority of women use the internet to search for information about medication safety in pregnancy (76% n=217) and health service sites were the most used online source (92.6% n=201) followed by social media (85% n=185) and pharmacy/drug companies (53% n=115). The majority said the information either verified or reassured them it was "ok" to take the medication or influenced their decision not to take the medication. Trustworthiness of sites was an important factor and the majority of women trusted safety information obtained from health service sites (84%). It was surprising to note that 71% (n=180) women had never seen these pregnancy warning symbols.
Figure 7.3 Pregnancy Warning Symbol
The online focus groups
Online focus groups were conducted with two groups of women (n=11 and n=15) using asynchronous messaging to explore online purchasing activities and to seek a deeper understanding of their information seeking behaviour identified. The majority of participants portrayed a similar pattern of behaviour with regard to searching the internet ie. entering a question or the name of the medication into a search engine. The reasons given for accessing information online were "convenience", "accessibility" and "cost savings". Generally speaking the participants mentioned they would trust information they accessed online if it was from a "reputable source" such as the National Health Service (NHS) in the UK. Women were aware of the need to be cautious about the source of the information retrieved:
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"...you can never be 100% sure that the medication you are getting is what you have ordered or where it is coming from"
"You don't know if it is safe"
"May be the wrong medication for you or your illness, something more serious may be missed"
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Many demonstrated the benefits of having the availability of the internet as an information source:
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"...you can purchase medications at a cheaper cost than from retailers"
"...the easiness of it being delivered to your door"
"...cheaper and can get a lot of things online without prescription and get things that you can't get in the UK"
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Those who actually purchased medications were concerned about the "quality of the medication" they purchased from the internet and stated they read the testimonials and blogs provided by customer reviews:
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"I read reviews from other apparent customers"
"I did lots of research about the site from customer's reviews doing a Google search"
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Others demonstrated expertise and entrepreneurial skills:
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"It was just a Google search .... I looked at a lot of pharmacy websites and also Amazon. In the end I actually purchased from someone on eBay that showed an actual photo of the product they had rather than a stock photo. I also spoke with the seller and got some background info on why they were selling etc. Buying this way saved me £30 off the retail price!!"
"I did a Google search and checked out the top 5 sites listed and read reviews in each site about the service. I was wary of buying medication on the internet, it was my first time but I thought if I had a bad experience, I wouldn't bother again but the site I used first time has been good and I am a recurring customer a year on..."
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Conclusions from the study
Data from the online purchasing experience with 50 e-pharmacies demonstrated that it was easy to purchase pure compounds without prescription. The web-based survey indicated that women were using the internet selectively to either find or verify information to enable them to inform their decisions. Women were savvy about the quality of sites accessed and 217/284 accessed bona fide health service sites. The online focus groups substantiated the data from the literature about accessibility, affordability, convenience and the need to check medication safety information online.