Commentary: Regulatory means for coping with medicinal adherence-issues in Israel
Zohar Barnett-Itzhaki1,2*, Eli Marom and Eyal Schwartzberg3,4,5
1Public Health Services, Ministry of Health, Jerusalem, Israel
2Bioinformatics department, school of life and health science, Jerusalem College of Technology, Jerusalem, Israel
3Pharmaceutical & Enforcement Divisions, Ministry of Health, 39 Yirmiyahu St., Jerusalem, Israel
4Faculty of Heath Sciences, Ben-Gurion University of the Negev, Beer Sheva, Israel
5Arnold and Marie Schwartz College of Pharmacy, Long Island University, Brooklyn, USA
One of the major goals of governmental health ministries is to focus on the patients' needs; their right for high standard care and empowering their knowledge. The Pharmaceutical Division (PD) in the Israeli Ministry of Health (MoH) is the governing authority for the pharmacy profession in Israel and the regulating body of the pharmaceutical industry. The PD’s goal is to improve patients’ adherence - the process by which patients take their medications as prescribed1. Adherence is composed of several elements: filling the prescription, collecting the prescribed medication, taking the medications according to the instructions, and discontinuation of treatment when needed2. However, approximately 50% of the population does not comply to the physician's orders, according to the world health organization (WHO)1. This worldwide challenge, called “non-adherence”, may stem from lack of understanding of the treatment importance, as well as the lack of reliable medicine information. Non-adherence has direct negative outcomes on patients' health, as well as on the utilization of the health system resources.
There are several strategies to address the challenge of non-adherence, including: disease awareness campaigns (DAC) to raise the public awareness to specific diseases, direct-to-consumer advertisement (DTCA) to raise the public awareness to prescription medicines, specific treatments and over-the-counter (OTC) medications to improve the accessibility of patients to specific medicines. In addition, improved access to highly reliable and scientific pharmaceutical information may also contribute to better adherence3.
Direct-to-consumer advertisement (DTCA).
It was shown that DTCA can influence the public and promote the sales of specific medications4,5. This may lead the patients to request medication that may not benefit, and might even damage their health.
This may influence patients to persuade their physicians to prescribe inappropriate, ineffective and even life-threatening medications. Therefore, DTCA is strictly forbidden in the European Union6, UK7, Australia8 and Canada9. DTCA of pharmaceutical products that require prescriptions is strictly illegal in Israel, unless approved by the director general of the MoH. In comparison, DTCA and promotion of prescription drugs are currently permitted in the USA and New-Zealand10,11.
Disease awareness campaigns (DAC)
DAC can also have the potential to influence patients’ behavior to prefer a specific medicine, and also influence physicians to prescribe specific medications. Some patients may legitimately suffer from a particular disorder that require medicine treatment, however others might be mistakenly diagnosed with a disorder they do not actually have, or start taking medications that might not benefit them and even harm their health12,13. However, DAC may also contribute to the improvement of the public health, for example DAC to promote the use of artemisinin-based combination therapy (ACT) to treat Malaria in rural areas of East Africa, contributed to the increased usage of ACT in children aged 0-5 years14. DAC is allowed in the USA, the European Union, UK, Australia and Canada7,8,9,15,16.
The Israeli MoH has recently established regulations regarding DAC so that consumers can be empowered with information about the availability of treatments for diseases (medications or preventive treatments) in a manner that does not involve promotion of a particular commercial product17. For example, campaigns and information regarding cancer that are provided and run by the Israeli Cancer Association18.
Promotion of adherence for patients with prescribed medications
In 2015, the PD established a procedure that regulates how pharmaceutical companies are allowed to encourage compliance among patients who have been prescribed medications, after the prescription is issued. The patient destined to receive the prescribed drug can receive non-commercial, reliable scientific information in various ways as specified in this procedure, in order to maximize the treatment’s efficiency and to protect the patient’s health. A “medical-information/adherence” center (approved by the MoH and the pharmaceutical company) calls patients (after they gave their consent). This center provides a call center service to supply information regarding the disease and the treatment, and offers in addition home visits for personalized training on appropriate usage of treatment19.
Over the counter (OTC) medications
DTCA of OTC may aid to patient empowerment. It enables the patient to purchase medications, in an informed manner, without the need to visit or consult their physician. OTC-DTCA medication is common in most of the western countries, including the European Union20, and Israel.
Improved access to reliable scientific pharmaceutical information
• A recent initiative to improve the adherence in Israel -which has diverse populations speaking in different languages- was labeling the outer package of every pharmaceutical product in four languages: Hebrew, Arabic, English and Russian. The patient’s leaflets in Israel must be written in three languages as well (Hebrew, Arabic and English).
• Most of the western countries have official websites that provide information regarding the medications registered in these countries, the leaflet, and other relevant information. Similarly to the British website21 and the US website (that is held by the FDA)22, the Israeli drug registry website provides comprehensive data on all the registered medicines in Israel, including the commercial name, manufacturer, active ingredients, dose, indications, a scanned version of the physician leaflet, the patient’s leaflet, a picture of the packaging and an updated medication price23.
• A software application (“Trufa To Go”) launched by the PD aims to promote rational and safe use of OTC medications. The application enables the patient to search the database by product trade name or symptoms experienced, and scan the package barcode for product information. The information available for patients includes: product picture, product information leaflet, indication, package size and price24.
• During 2016, the MoH has established a program of financial support to encourage the health maintenance organizations (HMOs) to enable patient-pharmaceutical counseling, in particular for polypharmacy patients. The counseling can be requested by either the treating physician or the patient himself, and takes place in a designated counseling room within the pharmacy. The program finished the year with significant success and the MoH director has decided to continue the program in the upcoming years.
A major challenge of the MoH is to improve the patients’ health, focus on their needs, and ensure their access to scientific, evidence based and reliable relevant information. Similarly to initiatives enforced world-wide, the MoH uses various approaches to enhance adherence, both on the pre- and post-prescribing phases. These guidelines issued by the MoH, will benefit both the patient and the industry by allowing them to keep investing in marketing and at the same time to empower the patients. The Israeli experience shows that the pharmaceutical industry has quickly and efficiently adopted the regulations and implemented them successfully.
We believe that the personal patient-pharmaceutical counseling may significantly contribute to a better adherence. Much like the advancing means of communication with the treating physician - now available through online application chat or video calls as well as in face-to-face meetings - we find that the patient-pharmaceutical counseling should expand its border into the online world, and offer the patients easy access for professional assistance.
In order to further cope with non-adherence, more research is needed. National surveys and collaborations with the HMOs may aid in revealing the rates of non-adherence and its causes. In addition, the MoH must continue monitoring, and collecting feedbacks regarding the new procedures as well as to keep on developing the adherence enhancement tools and policies.
We thank Sivan Avron (PD, MoH) for her assistance.
The authors declare that they have no competing interests.
- WHO (2003). Adherence to long-term therapies. Evidence for action. http://www.who.int/chp/knowledge/publications/adherence_full_report.pdf?ua=1 Accessed April 9th 2017.
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- EU (1989). Council Directive 89/552/EEC of 3 October 1989 on the coordination of certain provisions laid down by Law, Regulation or Administrative Action in Member States concerning the pursuit of television broadcasting activities http://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELLAR%3A63084a3f-be4a-4415-bf02-ac5f76524348 Accessed April 9th 2017.
- UK Medicines & Healthcare products Regulatory Agency (2014). The Blue Guide: Advertising and Promotion of Medicined in the UK. Third addition. https://www.gov.uk/government/publications/blue-guide-advertising-and-promoting-medicines Accessed April 9th 2017.
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- Health Canada (2010). Guidance Document – Health Canada and Advertising Preclearance Agencies’ Roles Related to Health Product Advertising. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/advert-publicit/pol/role_apa-pca-eng.pdf Accessed April 9th 2017.
- FDA (1999). Guidance for Industry Consumer-Directed Broadcast Advertisements. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070065.pdf Accessed April 9th 2017.
- Every-Palmer S, Duggal R, Menkes DB. Direct-to-consumer advertising of prescription medication in New Zealand. N Z Med J. 2014; 127(1401): 102-10.
- Scientific American (2015). Pharma Watch: Raising Awareness or Drumming Up Sales? https://www.scientificamerican.com/article/pharma-watch-raising-awareness-or-drumming-up-sales/ Accessed April 9th 2017.
- Moynihan R, Henry D. The fight against disease mongering: generating knowledge for action. PLoS Med. 2006; 3(4): e191.
- Opiyo N, Yamey G, Garner P. Subsidising artemisinin-based combination therapy in the private retail sector. Cochrane Database Syst Rev. 2016; 3: CD009926.
- FDA (2014). Guidance for Industry “Help-Seeking” and Other Disease Awareness Communications by or on Behalf of Drug and Device Firms. https://www.fda.gov/OHRMS/DOCKETS/98fr/2004d-0042-gdl0001.pdf Accessed April 9th 2017.
- Health Canada (2011). Regulation of Health Product Advertising in Canada – Overview for Physicians. http://www.hc-sc.gc.ca/dhp-mps/alt_formats/pdf/advert-publicit/pol/overview-apercu-eng.pdf Accessed April 9th 2017.
- Ministry of Health, Pharmaceutical Division (2015). Raising awareness of diseases - Rules for making information accessible to the general public, financed or sponsored by a registrar directly or through a third party. http://www.health.gov.il/hozer/DR_134.pdf Accessed April 9th 2017.
- Israel Cancer Association. http://en.cancer.org.il/ Accessed April 9th 2017.
- Ministry of Health, Pharmaceutical Division (2016). Rules for improving the rational use and adherence to drug treatment in patients with prescribed medications prescription, using non-commercial information. http://www.health.gov.il/hozer/DR_137.pdf Accessed April 9th 2017.
- Dens N, Eagle LC, De Pelsmacker P. Attitudes and self-reported behavior of patients, doctors, and pharmacists in New Zealand and Belgium toward direct-to-consumer advertising of medication. Health Commun. 2008;23(1):45-61.
- http://www.mhra.gov.uk/spc-pil/ Accessed October 26th 2017.
- https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=browseByLetter.page&productLetter=P&ai=0 Accessed October 26th 2017.
- Ministry of Health, Pharmaceutical Administration (2017). The Israeli Drug Registry. https://www.old.health.gov.il/units/pharmacy/trufot/index.asp?safa=e Accessed April 9th 2017.
- MoH PD application for OTC medicines. https://play.google.com/store/apps/details?id=com.onoapps.isradrugregistery Accessed April 9th 2017.