András Fittler

Evaluating aspects of online medication safety in long-term follow-up of 136 Internet pharmacies: illegal rogue online pharmacies flourish and are long-lived.

Background A growing number of online pharmacies have been established worldwide. Among them are numerous illegal websites selling medicine without valid medical prescriptions or distributing substandard or counterfeit drugs. Only a limited number of studies have been published on Internet pharmacies with regard to patient safety, professionalism, long-term follow-up, and pharmaceutical legitimacy verification. Objective In this study, we selected, evaluated, and followed 136 Internet pharmacy websites aiming to identify indicators of professional online pharmacy service and online medication safety. Methods An Internet search was performed by simulating the needs of potential customers of online pharmacies. A total of 136 Internet pharmacy websites were assessed and followed for four years. According to the LegitScript database, relevant characteristics such as longevity, time of continuous operation, geographical location, displayed contact information, prescription requirement, medical information exchange, and pharmaceutical legitimacy verification were recorded and evaluated. Results The number of active Internet pharmacy websites decreased; 23 of 136 (16.9%) online pharmacies ceased operating within 12 months and only 67 monitored websites (49.3%) were accessible at the end of the four-year observation period. However, not all operated continuously, as about one-fifth (31/136) of all observed online pharmacy websites were inaccessible provisionally. Thus, only 56 (41.2%) Internet-based pharmacies were continuously operational. Thirty-one of the 136 online pharmacies (22.8%) had not provided any contact details, while only 59 (43.4%) displayed all necessary contact information on the website. We found that the declared physical location claims did not correspond to the area of domain registration (according to IP address) for most websites. Although the majority (120/136, 88.2%) of the examined Internet pharmacies distributed various prescription-only medicines, only 9 (6.6%) requested prior medical prescriptions before purchase. Medical information exchange was generally ineffective as 52 sites (38.2%) did not require any medical information from patients. The product information about the medicines was generally (126/136, 92.6%) not displayed adequately, and the contents of the patient information leaflet were incomplete in most cases (104/136, 76.5%). Numerous online operators (60/136, 44.1%) were defined as rogue Internet pharmacies, but no legitimate Internet-based pharmacies were among them. One site (0.7%) was yet unverified, 23 (16.9%) were unapproved, while the remaining (52/136, 38.2%) websites were not available in the LegitScript database. Contrary to our prior assumptions, prescription or medical information requirement, or the indication of contact information on the website, does not seem to correlate with “rogue pharmacy” status using the LegitScript online pharmacy verification standards. Instead, long-term continuous operation strongly correlated (P<.001) with explicit illegal activity. Conclusions Most Internet pharmacies in our study sample were illegal sites within the definition of “rogue” Internet pharmacy. These websites violate professional, legal, and ethical standards and endanger patient safety. This work shows evidence that online pharmacies that act illegally appear to have greater longevity than others, presumably because there is no compelling reason for frequent change in order to survive. We also found that one in five websites revived (closed down and reopened again within four years) and no-prescription sites with limited medicine and patient information are flourishing.

Behaviour analysis of patients who purchase medicines on the internet: can hospital pharmacists facilitate online medication safety?

Background Although there are numerous legal and regulated online pharmacies available on the internet, an abundance of illegitimate online pharmacies are offering medications without prescriptions and deliver products with unknown origins worldwide. Despite the fact that the problem has gained the attention of regulatory and health organisations, the awareness of patients and many healthcare professionals is relatively low. Objectives The purpose of this work is to assess the current situation of ordering medicines online, to survey the attitude of patients regarding online drug purchase, promoting the completion of the medication history worksheet and to recommend useful tools for hospital pharmacists to facilitate online medication safety. Methods The attitude of 422 patients regarding purchasing drugs online was evaluated in a hospital environment. Results 8.4% of Hungarian hospital patients have ordered drugs or dietary supplements online and 3.7% of the respondents are considering this option in the future. Most hospital patients (82.8%) are unaware of the quality of these products. Conclusions Patients are not fully aware of the risks of potential hazards associated with purchasing medicines online and presumably cannot differentiate between legal and illegal online pharmacies. Illegal and counterfeit medicines pose a serious public health risk because the origin and quality of these drugs are uncertain and patients typically take these preparations without the knowledge and supervision of physicians or pharmacists. Pharmacists can play an essential role in protecting patient safety and combating counterfeit medicines.

A Sensitive Method for Thin-Layer Chromatographic Detection of Amphotericin B

Thin-layer chromatography with microbiological detection (direct bioautography) of amphotericin B. has never been reported. The combination of these methods can be used advantageously, especially when not only chemical identification of samples is required, but also when antifungal activity is of interest. In this paper a fast and easy-to-perform method is introduced in which major (RF 0.46) and minor (RF 0.31) components can be separated from amphotericin B, which itself is not a homogenous substance but mixture of polyenes. Thin-layer chromatography is performed on silica gel layers with chloroform-methanol-borate buffer 4:5:1 (v/v) as optimized mobile phase, and the microbiological activity of amphotericin B can be measured sensitively by direct bioautography. Candida albicans (ATCC 90028) and Saccharomyces cerevisiae (ATCC 9763) fungus strains were tested. Among the detection methods investigated, direct bioautography with Candida albicans proved to be the most sensitive, with a detection limit of 0.8 ng per spot. For densitometric evaluation of plates with (385 nm) ten times more substance is required, and with a UV lamp (366 nm) as much as 50 ng AmB per spot is needed to visualize the main component.

Attitude of patients and customers regarding online drug purchase – a Hungarian community pharmacy survey

Az internet terhoditasaval szabadon elerhetőve valtak a betegek es fogyasztok szamara olyan termekek, igy a gyogyszerek is, amelyek korabban kizarolag korlatozott hozzaferessel, orvosi rendelesre voltak csak elerhetők. Tanulmanyunkkal az internetes gyogyszerrendeles helyzetet kivantuk felmerni a gyogyszertarakba beterő, azaz az egeszsegugyi ellatast mar igenybe vevő hazai betegek es fogyasztok koreben. Ot magyar varos kilenc gyogyszertaraban 434, specifikusan a gyogyszer- es gyogyhatasu keszitmenyek termekkorre iranyulo kerdőiv segitsegevel gyűjtottunk adatokat. Felmeresunk alapjan a valaszadok 6,2%-a rendelt mar gyogyszert vagy gyogyhatasu termeket interneten keresztul, es meg legalabb ugyanennyien tervezik ezt a kozeljovőben. Interneten keresztul gyogyszert jellemzően a 30–49 ev kozottiek, a felsőfoku vegzettseggel rendelkezők es a nők rendeltek. Tobbseguk előtt nem volt ismert az ilyen modon forgalmazott es a gyogyszertarban kaphato termekek kozotti esetleges minősegi elteres. Ezek az adatok arra figye...As internet is now available to nearly everyone in Hungary, the accessibility of websites offering pharmaceutical products is also increasing. The national and international regulation of these sites is currently an unsolved problem worldwide, thus potentially harmful, counterfeit and prescription only medicines are easily accessible on the market. We aimed to measure and estimate the current situation of the ordering of online medicines. In 5 Hungarian cities 434 self-administered questionnaires were collected in community pharmacies. Our results show that 6.2% of the respondents have already ordered drugs or dietary supplements online and approximately same amount of people are considering this option in the near future. Based on our survey mostly the educated, the 30-49 year old people and women are likely to buy drugs online. Every fifth respondent reported willingness to buy drugs online from abroad if lower prices were offered. Most people do not know that the quality of medicines purchased online could be different from the ones purchased from community pharmacies. We would like to draw attention of healthcare professionals to the rising popularity and potential risks of drugs available online.

A challenge for healthcare but just another opportunity for illegitimate online sellers: Dubious market of shortage oncology drugs

Introduction Drug shortages mean a challenge to healthcare systems. Exposed patients or health care providers may seek alternative resources for these products online. The purpose of our study was to analyze the online availability of oncology shortage drugs at national and at international levels in 2014 and 2016. Methods We tested the online accessibility of oncology shortage drugs by simulating the Internet search method of patients. Search results were evaluated according to operational, distributional, and patient safety characteristics. Results In 2014 and 2016 all (100%) antineoplastic agents affected by shortages were available on the Internet without medical prescription. The number of relevant websites among search engine results has decreased from 112 to 98, while online vendors actually offering oncology shortage drugs for sale has risen from 66.1% to 80.6% within relevant websites in the two evaluated years. None of the online sellers were classified as legitimate or accredited by LegitScript and VIPPS online pharmacy verification databases. Conclusion According to our findings shortage oncology drugs are widely available online. To manage shortages and illegal Internet trade national and international standardized shortage reporting and information systems, regularly updated Internet pharmacy verification databases are needed. As well, institutional procurement and medication use review policies are required.

Consumers Turning to the Internet Pharmacy Market: Cross-Sectional Study on the Frequency and Attitudes of Hungarian Patients Purchasing Medications Online

Background During the past two decades, the internet has become an accepted way to purchase products and services. Buying medications online are no exception. Besides its benefits, several patient safety risks are linked to the purchase of medicines outside the traditional supply chain. Although thousands of internet pharmacies are accessible on the web, the actual size of the market is unknown. Currently, there is limited data available on the use of internet pharmacies, the number, and attitude of people obtaining medications and other health products from the internet. Objective This study aims to gather information on the frequency and attitudes of patients purchasing medications online in a nationally representative sample of outpatients. Attitudes towards main supply chain channels, perceived benefits, and disadvantages of influencing online medication purchase are evaluated. Methods A cross-sectional explorative study using a personally administered survey was conducted in a representative sample of Hungarian outpatients in 2018. Results A total of 1055 outpatients completed the survey (response rate 77.23%). The mean age was 45 years, and 456 (43.22%) reported having chronic health conditions. The majority (872/1055, 82.65%) of the respondents were aware that medications could be obtained online, but only 44 (4.17%) used the internet for previous medication purchases. Attitudes towards the different pharmaceutical supply chain retail channels showed significant differences (P<.001), respondents accepted retail pharmacy units as the most appropriate source of medications while rejected internet pharmacies. Respondents were asked to evaluate 9 statements regarding the potential benefits and disadvantages about the online medicine purchase, and based on the computed relative attitude rate there is a weak still significant tendency toward rejection (P<.001). Correspondence of demographic factors, internet usage behavior, and prospective online drug purchase attitude was evaluated. Respondents who use the internet more and purchase goods online will be more likely to buy medications online. Furthermore, youth and education will determine the medication purchase behavior. Conclusions Many patients will purchase medications on the internet in the future. Currently, there is an increased risk of patients buying products from illegal sites because these dominate the global online pharmacy market. Consequently, improved patient-provider communication and promotion campaigns are needed to inform the public about the safe use of internet pharmacies, as these initiatives can directly prevent patient safety threats.

5PSQ-124 Medicines and dietary supplements purchased outside the traditional supply chain raise patient safety concerns in hospital and clinical settings

Background The growing market of online pharmacies has caused numerous patient- and medication-safety concerns for health systems. Our previous study in 2013 showed that a high rate of Hungarian hospital patients (8.4%) ordered drugs or dietary supplements online. Purpose A complex methodology called Risk Based Safety Mapping of Online Pharmaceutical Market has been developed to evaluate patient safety threats. The aim of our current study is to evaluate actual patient safety risks in an outpatient setting and integrate this data into this methodology. Material and methods A pilot online survey was developed using Google Forms and distributed via social media (Facebook) between 4 October 2017 and 11 October 2017. The target population was Hungarian citizens from the southern Transdanubian region who use outpatient health service for chronic or acute conditions. Three sections were created: demographics, medication and dietary supplement use, and medication and dietary supplement purchase. Results are used to form a questionnaire to collect detailed information in a large (n=1,000) sample size. Study protocol was approved by the Regional Committee for Research Ethics. Results The sample of the present study consisted of 111 participants (81 females, 30 males). The mean age of our sample was 28.32 years (SD=10.48). Thirty-one (27.9%) responders reported taking medications regularly and 83 (74.8%) taking medications in acute cases, meanwhile 42 persons (37.8%) use dietary supplements. The participants (95.2%) reported buying the medications exclusively in a pharmacy, three (3,5%) buying them in a pharmacy or in a store and 1 (1,1%) to buying medications only on the Internet. Among the participants taking dietary supplements (42), 26 (61.9%) reported buying these products in a pharmacy, 23 (54,8%) to buying them in a store and 12 (28.6%) to getting them from the Internet. Conclusion There is a high risk of patients consuming dietary supplements or counterfeit medications purchased over the Internet. This complex methodology can help to identify high-risk patients. Targeted interventions by clinical pharmacists (medication reconciliation, standardised purchasing policies) are the main prevention strategies against the harm caused by health products purchased outside the traditional supply chain. Conflict of interest Corporate-sponsored research or other substantive relationships: Supported by the UNKP-17–4. New National Excellence Programme of The Ministry Of Human Capacities.

DD-023 Evaluation of information content and characteristics of publicly available drug shortage information sources

Background As drug shortages continue to pose an international problem almost every country has implemented a shortage information source in the form of a catalogue or database system. The aim of these systems is to collect and provide information about supply disruptions and therefore help mitigate the effect on the healthcare system and patient care. Unfortunately, these databases are heterogeneous which raise difficulties for hospital pharmacists. Purpose Our aim was to assess the information content and characteristics of publicly available shortage databases to identify and draw attention to the problem. The signalling function (collection mechanism, source of data and frequency of update) was also evaluated as a key parameter in everyday practice. Material and methods 6 European and 4 oversea s (South America and Australia) online available drug shortage information sources (catalogue, database) were evaluated according to the following characteristics: (1) product information: product name, name of active ingredient, dosage form, unit size, identification number/marketing authorisation number, marketing authorisation holder, ATC code or therapeutic category; (2) shortage information: duration–beginning and estimated end, reason/background, recommendations; and (3) database structure: language, status, variety of pharmaceuticals included, owner, references, updates, searching options. Results Every database (100%) contained data about the product, active ingredient, dosage form, notification or beginning of the shortage event and the reason or background of the supply disruption. Special features were observed in some databases, such as the representation of information source (40%), alternative product recommendation (20%), patient safety precautions (10%) and information for patients (10%). All of the databases contained information about the notification system but it was represented as separate information. Conclusion The national drug shortage databases show a high degree of diversity in information content and structure. A standardised reporting system is advisable at international, national and institutional levels. The required and presented information may vary regarding the location and level of health service provision, but inclusion of product identification information, duration (beginning and estimated end) and comprehensive signalling function is highly recommended for the efficient management of supply disruptions. No conflict of interest.

DI-043 Biologics are a new challenge for hospital pharmacists - pilot study of patient adherence

Background Dispensing biological drugs has become an exclusive competency of hospital pharmacists both to in- and outpatients in recent years in Hungary. Biologicals are the most important treatment for patients with rheumatoid diseases, but poor adherence can undermine the effectiveness of these medicines. Although routine monitoring have been recommended, there are no standardised methods to track adherence to biologicals. Purpose Pilot study to measure rheumatology outpatients’ adherence to biologicals, to identify medicines errors, to improve storage and use so they are safe and effective and to identify critical intervention points for hospital pharmacists. Material and methods A 31-item questionnaire using a four point Likert scale was developed based on the Rheumatology Compliance Questionnaire. Questions focused on factors modifying treatment and adherence. Patients were interviewed by a hospital pharmacist. The data were evaluated by descriptive analysis and chi-square test. Results 106 rheumatology patients filled in our questionnaire; 21.7% of respondents were identified as non-adherent. Neither side effects (p = 0.303), therapeutic switch (p = 0.578) nor complexity of treatment (p = 0.712) correlated significantly with adherence category. Patient-centred care significantly influenced adherence (p = 0.057). A higher rate of adherence was measured amongst patients receiving an infusion in the hospital (67%), than those self-administering biologicals at home (59%, p = 0.260). Numerous medicines use errors were detected during the personal interviews. 29% of responders found patient education ineffective, 19% emphasised the lack of patient-centred care. Conclusion Adding a pharmacist to the healthcare team has many benefits in improving adherence. Based on our findings hospital pharmacists must focus on: identification of non-adherent patients during personal interviews providing information about storage and administration of biologicals at home the elderly, who do not accept the invasive nature of administration As an outcome of our study a specific patient leaflet has been developed aiming to optimise outcomes and minimise risks of biologicals used in rheumatoid diseases. References and/or acknowledgement No conflict of interest.

DD-010 Online availability of oncology drugs affected by shortages

Background There has been a sharp rise in the number of drug shortages during the past few years and they present a daily challenge for hospitals worldwide. According to the EAHP survey carried out in 2013 99% of hospital pharmacists have experienced problems with medicine supplies. Shortage issues are typical in the area of oncology. Currently numerous antineoplastic agents are frequently unavailable and delays in treatment have their consequences. Inaccessibility and the growing demand for necessary medicines increases the demand to purchase them outside the traditional supply chain. Thus, patients more and more often obtain these drugs from unreliable online suppliers. Due to ineffective international legislation and law enforcement illegitimate online medicines are a serious safety problem. Purpose To survey the online availability of oncology drugs during shortages and to assess the indicators of patient safety hazards (no prescription requirement, illegitimacy of vendors and lack of product information). Materials and methods We tested how easily patients could access out-of-stock oncology drugs online. We documented the characteristics of online vendors, prescription requirement, contact and product information, the drug prices, and the legitimacy of the sellers. As there are no European data on drug shortages, we looked at the official drug shortage list of the Hungarian National Institute of Pharmacy, which may also represent the shortages experienced in Europe. We searched with Google for the English and Hungarian terms of 43 products, including 16 antineoplastic agents (ATC L01) in October 2013. Results Of the 16 antineoplastic agents, 15 (93.8%) were available online. A total of 121 web links were examined, including internet pharmacies, intermediary sites (n = 26) and social media links (n = 36). Oncology drugs were marketed by 31 internet pharmacies, nearly half (n = 14, 45.2%) of these were classified as illegitimate (“rogue”) by LegitScript internet pharmacy verification standards. Numerous vendors offered multiple drugs in short supply for sale; significant (occasionally ten-fold) differences in drug prices were observed. In 72.2% of the cases no prescription was required. The medical information on the effects, dose and side effects was typically incomplete or missing. Only a small proportion of the patients (n = 5, 16.1%) were offered the opportunity to consult with healthcare professionals. The contact information of the vendor was often (n = 11) concealed. Conclusions Patients can easily purchase most scarce anti-cancer drugs online without prescription. The lack of expert advice and unreliable information during this type of procurement pose great risks to patients’ health. During the management of today’s shortage crisis health professionals need to proactively highlight the dangers of illegitimate online drug sources. No conflict of interest.