The Pharmaceutical Journal
Vol 277 (Supplement) F09-F10
October 2006

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FIP Congress 2006

Innovations that help to improve safety and aid communication with patients

The internet is a remarkable medium that offers unparalleled opportunities for pharmaceutical care and improving the delivery of information about medicines to patients.

So said Eleni Anagnostiadis, of the National Association of Boards of Pharmacy, US, speaking at a session that considered innovative methods of improving communication between patients and health professionals and the impact of good communication on treatment effectiveness and patient safety.

Researching a disease and its treatment online enables patients to ask pertinent questions of their health care providers. Other uses for the internet for patients include submission of self-monitoring results online and making medical appointments.

Many consumers also like to buy medicines on the internet because of ease of access, price, not wanting to visit the doctor and, in some cases, not needing a prescription in order to buy a prescription medicine.

However, they do not see the potential threats in the form of rogue sites and counterfeit drugs, she added.

Quoting figures from the World Health Organization, Ms Anagnostiadis said that counterfeit drugs account for about 10 per cent of the world drug supply. Counterfeits are most common in less developed countries. For example, they account for 30 to 40 per cent of the drug supply in Brazil where, recently, some 20 pregnancies occurred as a result of wheat flour being substituted for the active hormonal ingredients in oral contraceptives.

Turning to counterfeiting in the US, she said that although this accounts for only 1 per cent of the US drugs supply, this is equivalent to 32 million prescriptions each year. Counterfeiting is an extremely lucrative trade and is increasing. By 2010 the worldwide market is projected to be $75bn, an increase of 92 per cent on the 2005 figures.

Counterfeiters are clever and discrepancies can be tiny, she said. Pharmacists, therefore, need to be smart to identify them. But patients must be encouraged to look for them too. Counterfeit investigations opened by the US Food and Drug Administration grew from nine in 1997 to 30 in 2003, before doubling in 2004 to 58. However, many counterfeit drugs are still not detected in the US, she emphasised.

Turning to action on counterfeiting undertaken by the National Association of Boards of Pharmacy (NABP), she described a study conducted during the months of December 2003 and January 2004, when the NABP bought eight different medicines from five suspect internet pharmacy sites. None of the drugs appeared to be sent from the country in which the pharmacy website was registered and all of the drugs were labelled in a foreign language.

In another study in October 2004, the NABP covertly monitored several eBay auctions over a four-week period and bought four products that were purported to be anabolic steroids. All four products were sent from different US sellers without the requirement of a prescription. One product was advertised on eBay as a “Book of test propionate Sustanon” with the explanation that it was a “10 chapter unopened book” of useful information on testosterone propionate 100mg.

All the products were sent for independent analysis and none contained what was expected. As a result of the NABP’s investigation, eBay tightened its rules and its monitoring process to eliminate the illegal sales of steroids on its website.

Ms Anagnostiadis described a further study undertaken in late 2004 when the NABP collaborated with Eli Lilly and the FDA to evaluate websites that were allegedly selling prescription drugs purporting to be branded medicines or “similares” — medicines that claim to be similar to, or identical to, their brand name counterparts. Similares are available in countries all over the world, particularly in Latin America, and are considered in many countries outside the US as legal and inexpensive alternatives to patented drugs. These similares are also threatening to enter, or may already have entered, the US drug distribution system through the internet and other sources, she added.

The NABP ordered several different medicines, including Cialis, Evista and Zyprexa from a total of 13 websites. No prescriptions were required by the sites. The FDA performed an analysis of the submitted medicines, of which two, in particular, were highly suspect. Some of the sampled drugs far exceeded the permitted US levels. The amount of active ingredient present varied widely and, in at least one case, Fenilox (the “generic Evista”), no active ingredient was present.

In May 2005, the FDA issued an advisory note for consumers referring to the Evista that the NABP had purchased. In addition the note referred to the FDA’s results from comparable tests on counterfeit versions of Lipitor and Viagra that were bought in border towns of Mexico. Like the Evista similare in the NABP project, neither the counterfeit Lipitor nor the counterfeit Viagra contained any active ingredient.

She explained that these medicines often reach US consumers when a patient orders the drug from a website, sometimes one alleging to be a US or Canadian site or allegedly connected with the US or Canada, or through the normal distribution system. Many reports of counterfeit medicines are provided to the NABP by patients, although many counterfeits may not be reported because of patients’ concern that they are doing something wrong (eg, importing medicines illegally) or that the reported pharmacy may no longer be allowed to supply drugs.

Turning to action that is being taken against rogue websites, she said that, in 1999, the NABP launched the Verified Internet Pharmacy Practice Sites (VIPPS) programme to evaluate and accredit online pharmacies. To be VIPPS-certified, a pharmacy must comply with the licensing and inspection requirements for each state in which they dispense medicines.

Other features that must be provided include privacy rights for patients, security of prescription orders, adherence to recognised quality assurance policy and provision for consultation between patients and pharmacists. To date, 12 US online pharmacies have gained VIPPS certification, she said.

The NABP has also established the Verified Accredited Wholesale Distributors’ (VAWD) programme. She explained that this accredits wholesale distributors that demonstrate compliance with the VAWD criteria, which include licensure, quality of the facility, personnel, record-keeping, authentication/verification, the return of damaged and outdated products, and supported policies and procedures.

The VAWD programme provides assurance to the state boards of pharmacy and to patients that the wholesale distribution facility operates legitimately, is validly licensed and is employing security and best practices for safely distributing prescription drugs from manufacturers to pharmacies and other institutions.

Improving adherence

Continuing on the theme of patient communication, Hanne Herborg, director of research and development at Pharmakon, Danish College of Pharmacy Practice, presented findings from a Danish research programme whose aim was to improve adherence and self-management among patients on antihypertensive medication. Adherence to long-term therapies is a complex issue, whose study requires a complex approach, she said.

Adopting a narrative approach is key to the problem of non-adherence and a clear distinction should be made intentional and non-intentional non-adherence. Of particular importance is the development of a close partnership with the patient, built up through story telling and individual counselling and coaching.

Going on to describe the elements of the research programme, she said the first stage is a quick screening of the patient for non-adherence and identification of problem types, with patients telling their own stories. Following assessment, drug therapy is adjusted as appropriate. Through a process of motivational interviewing techniques, the patient is then individually coached to tailor adherence solutions to individual need. Information can be provided in written form, internet-based or in the form of a videotape.

Relevant reminder technologies (eg, dose dispensing aids, mobile telephone text reminders, telephone reminders, electronic medicine monitors, blood pressure measurement, patient diaries) are offered and patients choose which reminders they think will be useful. The patient is also followed up and there is close collaboration with the patient’s GP.

Mrs Herborg explained that the programme is supported by a number of instruments and tools of which the “systems model” based on the WHO approach is core. In this model, non-adherence can be identified as a problem of lack of knowledge, poor motivation or behaviour choice. If it turns out to be none of these, the “outer circle” of the model must be consulted. This looks at patients’ symptoms, lifestyle issues, personal networks, including patient interaction with health systems, all of which can influence non-adherence.

Without “digging deep” it is easy for pharmacists to miss non-adherence and the reasons for it, said Mrs Herborg. Superficial questioning may fail to elicit problems and it is important to ask questions that get to the patient’s story. Narrative medicine is a method for getting information from patients that they may not have identified. Anyone’s story can be told in different ways and from different angles. Information that could provide solutions to issues of, say, non-adherence, can therefore potentially be found.

Presenting results from the study to date, Mrs Herborg said that of 1,426 participants taking antihypertensive medicines, 563 (39 per cent) had signs of non-adherence (eg, elevated blood pressure, dissatisfaction with the GP or the medication, adverse effects, drugs not taken on some days). Of these, 240 were selected for pharmacist intervention (either brief or comprehensive).

Elevated blood pressure was found significantly more often in patients who experienced side effects and those who said they stopped taking their medicines or were unsure of how to take their medicines or had problems reading instructions for use. The study identified a wide range of drug-related problems, of which the most common were adverse effects (34 per cent of problems), too low a dosage (15.2 per cent), untreated indication (8.8 per cent) and an adherence problem causing under use of the medicine (8.8 per cent).

She went on to explain that interventions used most frequently were “low tech”. These included information and counselling (75 per cent of interventions),the provision of written materials (51 per cent), patient education (36 per cent), coaching (30 per cent) and recommendation to contact the GP (22 per cent). High-tech reminder systems, such as dosing aids, e-mail and text messaging were less popular, she added.

In conclusion, Mrs Herborg said that the study had shown that integrating the management of prescription and patient risk factors is possible in a Danish community pharmacy, using either brief or comprehensive versions of the programme. The comprehensive version appears to have more potential but the brief version may be more economical, she said.

Health promotion

Kwok-Cho Tang, of the WHO, Geneva, Switzerland, discussed the role of pharmacists in making health promotion a key focus in communities. He explained that the changing context of global health, including the growing double burden of communicable and chronic diseases and widening health inequalities has changed the focus of health promotion from health education to identification and influencing the root causes of ill health

He highlighted a new Bangkok charter for health promotion (adopted in August 2005) which identifies actions, commitments and pledges required to address the determinants of health through health promotion. Progress towards a healthier world requires strong political action, sustained advocacy, broad participation and partnership across public, private, non-governmental and international organisations and civil society.

Investment in sustainable policies to tackle the root causes of ill health, together with regulation and legislation are necessary to ensure a high level of protection from harm and opportunity for health and well being for all people, he said.

Pharmacists have long been active in health promotion, from direct patient care and immunisation management to promoting access to essential drugs, recycling medicines and providing information for disadvantaged groups. He pointed out that a key goal in health promotion for pharmacists in the future is to win community support and secure state support through advocacy, media influence and community mobilisation. They should engage more rigorously in policy and health systems changes, he said.

Turning to health promotion activities which pharmacists could be more involved in, he identified compliance issues, screening, evaluating traditional medicine, improving access to affordable, quality drugs and improving standards of practice. “To tackle the underlying causes of poor health, pharmacists must work with both systems and individuals. There is a need for ongoing review of pharmacists’ health promotion activities with the understanding that pharmacists should be advocates for health and not just health educators.”