Irrational use of drugs is a major problem worldwide. The World Health Organization (WHO) estimates that over half of all drugs are prescribed, dispensed or sold inappropriately. Inappropriate drug prescriptions have a negative impact on quality and safety of treatment, promote drug resistance, diminish patient trust in the healthcare system and increase the economic burden on the patient and the healthcare system at large.
A lucrative business
Inappropriate prescribing practices for certain prescription drugs is a common problem in Lebanon. A recent study by the Ministry of Public Health (MoPH) and the WHO shed light on the serious issue of antimicrobial resistance which was attributed to the inappropriate use of antimicrobials, overuse of injections and failure to prescribe in compliance with clinical guidelines and inappropriate self-medication of prescription-only medicines (WHO, 2015). Another study found that 40 percent of all prescriptions in seven hospitals in Lebanon contained an error, of which 9 percent were unnecessary medication prescription, 7 percent were non-indicated medication, 6 percent had a deficiency in the prescribed medication dosage, 3.5 percent had an inadequate duration and 2.8 percent had an inadequate rate. All rates have been found to be high compared to other countries such as Germany (Al-Hajje, 2012).
These inappropriate prescribing practices have contributed to the high costs of pharmaceuticals in Lebanon. For instance, the National Health Accounts published by the MoPH in 2012 shows that almost 33 percent of the total health expenditures in Lebanon is spent on pharmaceutical goods. The per capita spending on pharmaceuticals is considered one of the highest in the Middle East and the seventh highest globally at 3.1 percent (International Federation of Pharmaceuticals Manufacturers, 2012; Sobeh and Sobroneva, n.d.; The Lebanon Brief, 2012). In addition, the pharmaceutical sector is dominated by imported medicines and patented brand names, which constitute more than 80 percent of the total market (WHO, 2010).
Drug promotion gone wrong
One of the main factors contributing to poor prescribing quality and pattern of drugs in Lebanon is unrestricted drug promotion and advertising to health professionals. Currently, there are no laws or legislation regulating drug promotion and advertising to health professionals, qualification and training of medical representatives, conferences and scientific meetings, post-marketing scientific studies, speakers’ fees and consultancies, and restrictions and limits on gifts and promotions. This gives physicians a “quasi-absolute” freedom in prescribing medications which in turn increases their power over the demand side. In addition, it gives pharmaceutical organizations a vast influence over post-university medical education and sponsorship of seminars and medical conferences, which may create a conflict of interests. The situation is aggravated by the negative attitudes of health professionals, patients and the public towards generic drugs.
Although it can be claimed that physicians may benefit from their relationship with the pharmaceutical industry through access to information and evidence on new medicines and products, there is a growing body of evidence which suggests that even gifts of minimal values can hold powerful influence on physician behavior in the spirit of reciprocity. Indeed, the evidence from several systematic reviews suggests all forms of physician-pharmaceutical industry interactions have an impact on increased prescribing frequency for newer and more expensive drugs, “irrrational” prescribing and lower prescribing quality. Similarly, there is concern that industry-sponsored continuing education will influence physicians’ behaviors for the financial benefit of the industry.
Regulating the pharmaceutical industry: A global perspective
As a result of these concerns, countries worldwide have tried to regulate and improve the transparency of relationships between healthcare professionals and the pharmaceutical industry. These include measures at the governmental, organizational and individual level.
At the governmental level regulations include outright or selective bans on gifts to healthcare professionals, disclosure of interactions between healthcare professionals and the industry on publicly accessible websites, limits on the sale of prescribing data for marketing purposes and public funding of academic detailing programs (Grande, 2010). The Sunshine Act, enacted in the US in 2010, marked the first Congressional involvement in regulating the disclosure of payments made by pharmaceutical and device companies to physicians and teaching hospitals. The law requires manufacturers to annually report on payments or transfers of values exceeding $10 per instance or $100 per year along with the receiver’s identity and the payment purpose on a publicly accessible website. Although government regulation may not be a perfect solution, the pharmaceutical industry and medical profession have fallen short in decreasing the influences of industry gifts through self-regulation (Grande, 2010).
At the organizational level, the Institute of Medicine (in 2009) and the Association of American Medical Colleges (in 2008) both recommended eliminating industry gifts, meals and speakers’ bureaus as well as urged strict control of industry payments for consulting, honoraria and educational purposes. Restrictive institutional policies governing the interactions of healthcare professionals with the industry have been shown to positively affect the prescription behavior of healthcare professionals and increase their support for banning contacts with pharmaceutical representatives.
At the individual level, interventions to educate healthcare professionals and raise their awareness on how industry interactions could influence their behavior have been recommended. Specifically, well-designed seminars, role-playing, focused curricula and evaluations of pharmaceutical representatives’ presentations have been shown to enhance the awareness of health professionals of such influences, increase their skepticism toward information presented by the industry and influence their behaviors to some extent. Equally important are empowering and raising awareness of patients and the general public on how such interactions can affect health providers’ prescription behaviors with subsequent negative implications on the quality and cost of care.
Implications for Lebanon
In Lebanon, regulatory measures to restrict, control and improve the transparency of relationships between healthcare professionals and the pharmaceutical industry have neither been implemented nor enforced. However, a proposed code of ethical standards for drug promotion has been posted on the MoPH website in 2011 and updated by the general director of the ministry in 2014. The code will allow for surveillance of promotional and prescribing patterns and for appeal mechanisms as well as provide for disclosure of complaints and non-compliance files to the MoPH and health professional associations in case corrective measures are not taken.
Approval and subsequent implementation of the proposed code of ethics is crucial as it could provide an opportunity to address some of the challenges pertaining to drug promotion and advertisement targeted at healthcare professionals in Lebanon.
Another regulatory measure worth highlighting in Lebanon is the recently implemented unified prescription form law, which allows pharmacists under certain conditions to give patients the choice between a patented medicine and a matching generic, as it has implications for rational prescribing. Specifically, it is critical to monitor such an initiative to ensure it does not act as a “game changer” by shifting the focus of pharmaceutical promotional activities from physicians to pharmacists.