Ethics in the provision of information and use of medicines
Gonzalo Herranz, department de Bioética, Universidad de Navarra.
Intervención en roundtable, Jerez, 1996.
1. Reporting on the economic aspects of medication - a new ethical duty?
2. Deontological obligations related to medication monitoring
3. The ethical duty to review polypharmacy periodically
5. Cooperation of doctors and pharmacists
The moderator, Dr. Recalde Manrique, advised me to focus this initial intervention of mine preferably on points and problems concerning the ethics of the use of medicinal products. I will do so. I will try to offer ideas for a discussion on the deontological obligations related to medication monitoring, periodic review of polypharmacy and cooperation in pharmacovigilance. But first I would like to touch briefly on a point related to information, which seems to me to be of interest: the one concerning the cost of medicines.
1. Reporting on the economic aspects of medication - a new ethical duty? 
I have often said, and I repeat it almost over and over again, that the most valuable contribution that contemporary medical ethics has made to the cultural heritage of our time is that it has elevated the patient to the dignity of a mature moral agent, i.e. it has made the patient a free and responsible person. In order to assume this freedom and responsibility, it is a prerequisite that the doctor and the pharmacist provide the patient with clear and honest information on the points he or she needs to know in order to accept the treatment and to commit himself or herself to comply with it. These decisions by the patient are autonomous decisions, i.e. free, rational and well-founded.
Many, including members of Health Care Ethics Committees, have a quaint, libertarian sense of patient autonomy. They reduce it to a mere ability to impose one's own will, to choose on a whim. But true autonomy requires, in addition to independence, knowledge, reflection and commitment, attributes of that uniquely human trait of rationality. This is typical of an adult human being.
For years, I have been saying that it is a natural part of the information to be given to patients that concerns the financial aspects of their medical-pharmaceutical care. Not only in private medicine, where the patient has to pay and therefore needs to know and approve a calculated budget of the costs. I believe that patients should also be given this information in public medicine: not to humiliate them by showing them how much they receive from the national health service, a charitable, paternalistic and generous system that gives them much more than they have contributed. This would reduce the provision of health care to a hypocritical handout. The patient must be informed as part of a programme of personal and social awareness: every patient has the right to know in a clear and definite way the real cost of the services provided, to know, with facts, to what extent the sense of social solidarity that presides over health care is a tangible reality, of which he or she has the right to be both proud and grateful.
Ignorance about the costs of health care, and specifically about the costs of the medicines that each patient receives, is detrimental, as it deprives one of judgement and perspective. It can lead to waste, encourages withdrawal or therapeutic negligence, and leads to disregard for the rules of drug storage. Worse still, it prevents any reasonable cost-saving policy, as it makes any attempt at generic substitution or therapeutic substitution that seeks to maintain therapeutic efficacy at a lower cost almost clandestine. The effort to reduce costs cannot be made with patients' backs turned, as if it were only a question of the responsibility or opportunity of health managers and not of the people as a whole.
There is an extensive task of health education that should aim to demonstrate the falsity of two dominant ideas. One says that the most expensive is always the best, a fallacy, induced by advertising, which forces people to live in luxury and makes them forget that normal is sufficient, that modest is worthy, that efficiency often does not necessarily depend on price. The other idea that needs to be refuted is that what does not cost is worthless. Health services are worth a lot. They must be given with the dignity and respect of someone who is dispensing, not something of their own, but a social treasure. It is information that must be given in a friendly, non-offensive, but clear way. Its time would be the time of prescribing (that would also help the doctor to be aware of the cost of treatments). This information is, in my opinion, not a marginal piece of information to be avoided at the time of dispensing, but an essential component of the information to be given by the pharmacist aware of his or her social and community role.
In conclusion: I believe that doctors and pharmacists should inform their patients about the price of medicines. I am not aware of any study that has tried to correlate treatment adherence with Degree ignorance/knowledge of the cost of medicines. I leave the issue for discussion.
2. Deontological obligations related to medication monitoring
Prescription by the doctor and dispensing by the pharmacist are only the beginning of the medication. The really important phase of therapeutic intervention begins with the implementation of the treatment.
There are several issues here. The first concerns the role of the doctor and pharmacist in encouraging adherence to the treatment plan. It is a well-known fact that many patients do not adhere to treatment. The spectrum of behaviour is very variable. At one extreme, there are patients who do not even come to the pharmacy with their prescriptions; at the other, there are involuntary omissions due to forgetfulness, which are particularly frequent among senile patients. It is very common to withdrawal of a medicine when one of its side effects is perceived or when it is considered that it does not have the expected effect. There may then be more or less prolonged periods of therapeutic withdrawal . And while some chronic patients are able to navigate the pitfalls of unstable disease and complex therapy with skill , others neglect their medication in an irresponsible way, while others are unable to react to the disease.
It is well known that there are risk situations due to problems related to the therapeutic plan: situations of nosological complexity, such as suffering from three or more simultaneous diseases; of posological complexity, such as being treated with more than five different medicines or having to take more than 12 doses a day; changes in the treatment plan, such as modifying it more than three times in the last year; or having a history of disobedience to the therapeutic plan. These risk situations cannot leave doctors and pharmacists indifferent. It is often not enough to give the patient standard information: it is necessary to spend time simplifying and rationalising the plan, persuading the patient to allow him or her to be advised, offering real help so that he or she can follow the treatment accurately. It is not easy sometimes to get the patient's obedience. But it is an important aspect of great preventive significance. We all know the unfavourable results of therapeutic omission.
3. The ethical duty to review polypharmacy periodically
I shall confine myself to transcribing two short stories that reveal the importance of the problem. One focuses on the polypharmacy so typical of the elderly. The other focuses on the care of HIV+ patients.
The first is from a Soundings, by Trisha Greenhalgh, published in the BMJ (Greenhalgh T. Medication review. BMJ 1992;305:1164), which I translate with some liberty.
"Do you really need this? Amiodarone, Co-proxamol, quinine, enalapril, chlorthalidone, Potassium, Digoxin in two dosage levels, ranitidine, lactulose, diazepam, emulsifying bath oil, moisturiser, hydrocortisone ointment, codeine syrup, allopurinol, multivitamins: all that every 60 days, plus eye drops, ear drops, and two pairs of elastic stockings. Well, I'm very sorry: I'm not going to sign this. I don't mind making substitutions for friends, but this patient needs to be seen by a doctor". "But, doctor," says the nurse, "that's what he's always prescribed. He's a very good patient: he always sends a stamped envelope for us to send him his prescriptions...".
This way of starting may seem a bit righteous. But no: I have to admit that I went to see the patient because I simply smelled a story worth telling. He was very surprised to see me. I told him I wanted to talk to him about his medication. A few weeks earlier, he told me, the nurse at the outpatient clinic had told him not to stop taking any medication, that it was important at his age. And he was doing just that. He correctly identified the pills to lower his blood pressure, the ones he needed for his heart. He told me that the ones he took for dizziness (which had been recommended to him one day when he went to the emergency room) were to prevent his head from going out of his head when he stood up. He took a white digoxin every day, and a blue digoxin every other day (which is why I have so many blue pills left over). The various ointments and skin formulas had been recommended by the nurse for the eczema she had from her varicose veins, but the eczema had cleared up a few months ago, but she kept them just in case. Her stomach symptoms had disappeared four or five years ago (they never really hurt again), but she took an occasional pill to keep the ulcer at bay. He brought in a bag of unopened boxes of medicines, saying that when he asked for just a few medicines from the list on his repeated medication chart, they always sent him the wrong ones. He told me that the elastic stockings were for his wife.
The rest can be imagined. The cost of each repeat prescription was about 25,000 pesetas plus dispensing fees. The three medicines that the patient really needed (after adjusting the dosage and without having to use generics) was 1500 pesetas every two months. I took a bag of unused medicines worth 45,000 pesetas. The savings didn't stop there. The truth is that he would no longer need to be transported by ambulance every time he had to see the cardiologist, and, if his general condition continued to improve, he could certainly get by with less than 9 visits a year.
I left the patient and went to make three home visits to three elderly people who cannot leave the house. Back at the outpatient clinic, I had to sign, already drained of enthusiasm for justice and restraint by the expense, something like 30 prescriptions for chronic patients. It was impossible to check the medical records of each case. I signed everything as long as it was not outrageously dangerous. I know the doctor I was replacing very well: he works hard, really sweats the modest salary he earns, and far exceeds in austerity the national average of expense pharmacist. I also know that anyone who is not on the front line of general practice and is unaware of what it is like to go around all day with the language out will argue that the regular review of patients' medication is a contractual duty and not a voluntary and supererogatory activity. But I live in the real world. And to the government, so fond of saying that everything is fine, I have one thing to say: If you really want to reduce the pharmaceutical expense , you have to put the money on the table: you have to get serious about it. You have to organise sessions of doctors, nurses and pharmacists to review patients' medication, you have to give everyone the training they need to do that job seriously. You have to know that, for the health of the patients and for the money you save, it is worth it. But the truth is that it takes time, quite a lot of time. This is the end of Trisha Greenhalgh's vignette.
I add a summary from a letter published in the same journal by a pharmacist and a doctor (Steel S, George R. Wasted drugs in HIV infection and AIDS. BMJ 1992;304:123). After referring to the high cost of caring for HIV+ patients, they profess their belief that a change in prescribing and a reduction in drug wastage could lead to considerable savings, especially in the treatment of patients who are cared for in their own homes. The letter continues: "After the patient's death, a nurse from group collects from the patient's home the medicines that have been dispensed and returns them to the hospital pharmacy, to be destroyed (From agreement with the view of the Royal Pharmaceutical Society of Great Britain, which maintains that, to comply with the Consumer Protection Act, medicines dispensed for one patient cannot be administered to another). In view of the large number of medicines being returned and destroyed, we decided to study the problem. In the 13 months of our study, the value of these medicines amounted to £26504 (about 5.5 million pesetas), about £721 (just over 150,000 pesetas per patient). The medicines recovered were almost always zidovudine, ganciclovir, fluconazole, foscarnet, acyclovir and pentamidine. The wastage may be due to over-prescribing or, more likely, duplicate prescribing by doctors from different hospital services and by general practitioners jointly treating patients. The cost to the country as a whole is very considerable.
To address the problem we are piloting a medication management tool card for HIV-infected patients. It is a simple card that records prescription and dispensing history that can be used by patients, doctors and pharmacists. The cards are inexpensive and, judging from anecdotal experience in the paediatric and obstetric area, well received by patients.
The cost of the drugs needed to treat HIV infection and the need for long-term maintenance of treatment raises the need for rational prescribing and review mechanisms. In particular, there is a need for good communication between prescribing physicians and dispensing pharmacists.
So much for Steel and George's letter. I know that things are going well between us and that there is good control of prescribing for HIV+ patients. But the situation is not unique to HIV infection. Spanish medicine cabinets are overflowing with surplus drugs. Third World drug distributions collect bulky plastic bags with the annual surplus of unused drugs: many of them come from polypharmacy that is not regularly checked.
Since the Edict of Salerno by Emperor Frederick II, the traditional principle of separation of the roles of prescribing and dispensing has been in force for doctors and pharmacists. Exceptionally, however, the doctor dispenses: he gives medication directly to the patient: in emergencies, on discharge from hospital. And the pharmacist prescribes, not only when advising on over-the-counter medicines, but also when practising generic substitution and therapeutic substitution. Old prescriptions (and in Germany this is still common) carried the words aut simile, aut idem next to the name and dosage of the prescribed medicine.
On generic substitution, there is very little to say: it must be fully in line with rational use. It cannot merely mean a reduction of the pharmaceutical expense , but must first fulfil the mandate to do no harm. The quality requirements of the generic is identical to that of the registered medicine: from the most Materials pharmacodynamic characteristics to the civil liability for the quality of the product.
Switching to generics requires particular attention: patient information. Recent studies have shown that patients' complaints do not stem from the fact of switching. They understand the desire to save money, no one complains that it is irrational to prescribe the cheaper alternative: but they demand to be told. When properly informed, they are the first to accept that there are reasons to switch.
The problem of therapeutic substitution arises much less frequently and should not be a problem in primary care pharmacy, where the contact between pharmacist and physician is easy and immediate. Firstly, because therapeutic substitution can only be authorised for certain families of drugs, for certain therapeutic classes, which offer both minimal or small differences in chemical structure and a large price difference. This is the case, for example, among certain antibiotics such as cephalosporins, oral antacids, antihistamines, topical antifungals, oral and parenteral iron formulations, etc.
It takes a great deal of clinical pharmacology to practise therapeutic substitution on a sound basis. The conditions for therapeutic substitution must be as demanding in the outpatient setting as in the inpatient setting, but it must be borne in mind that monitoring mechanisms are more complex and weaker in the home setting than in the inpatient setting. In other words, a well-agreed and rationally founded form must be available. It always requires the prior authorisation of the prescribing physician, so that any subsequent arrangement practice should be proscribed. It always requires knowledge of the concurrent therapy the patient is receiving, his or her "pharmacological" history of previous drug reactions. It requires the authorisation of the responsible physician to be documented in the medical record. Above all, it requires vigilance to check for therapeutic equivalence or adverse reactions. The appearance of signs of inequivalence is to be feared when a patient has been well stabilised on one drug, in cases where a patient is receiving multiple therapy, in children, and in patients with limited capacity to absorb, metabolise and eliminate drugs.
Recently, general practitioners argue against generic substitution: harm to pharmaceutical firms that cannot exploit their patents long enough, serious economic damage that can break research and innovation capacity, and the pharmaceutical industry's sponsorship on the continuing education of doctors. A very difficult problem to solve. Perhaps a reduction of dividends. Case by case study.
Substitution is made to cheaper, but equally effective products, equivalent in everything but price. Otherwise, there can be no question of substitution. The reduction of expense can never become merely a benefit for the hospital, which, by reducing its costs, increases its profits, or for the doctor, but must be for the patient, for the community. When physicians and pharmacists choose a drug from among several, their primary concern must be clinical efficacy, reduction of toxicity, and adequate pharmacokinetics. Savings come into consideration when these three other conditions have been met.
5. Cooperation of doctors and pharmacists
It ensures that the professional skill of doctors and pharmacists can be used to best advantage when the public has independent and separate access to the two professionals. Today, there is hope that if doctors and pharmacists come closer to the patient, things will be better.
Working closely together as members of a Primary Care team, with mutual critical support, forming a team that shares values and goals, and protected from the vicissitudes of a competitive business environment, is a possibility worth exploring.
Ford and Jones in an article, in my view, very important, published just over a year ago (Ford S, Jones K. Integrating pharmacy fully into the primary care team. BMJ 1995;310:1620-1621), said that areas of collaboration could be established in areas such as:
establish and maintain up-to-date Primary Care Centre forms;
audit the price of identical medicines;
establish targeted purchasing systems;
monitor more complex or costly treatment regimens;
to exercise post-marketing surveillance;
keeping records of adverse reactions.