Statement on the ethics of prescribing and generic substitution of medicines

Foundation: Comisión Central de Deontología de la Organización Médica Colegial Española.
sourceSpanish: Comisión Central de Deontología de la Organización Médica Colegial Española.
language original: Spanish.
Approval: General Assembly of 25-III-2000.
Publication: Revista OMC, April 2000.
Copyright: No.
Checked on 16 May 2002.

Declaration of the WTO Central Commission of Deontology on the ethics of prescribing and generic drug substitution

I. Introduction

1. In recent years, the urgent problem of reducing the health care expensehas been intensely debated in Spain within society and in the medical and pharmaceutical professions. Following the experience gained in other advanced countries, generic prescribing and generic substitution of medicines have been proposed by different bodies as practices that can help to substantially lighten the financial burden of the pharmaceutical expense.

2. A generic prescription is given when the physician completes the prescription for the medicine he/she is recommending to his/her patient by writing the generic name of the medicine. This leaves it up to the pharmacist to dispense the prescribed medicine as a generic product from among the various existing generics or, if out of stock and if the patient agrees, as a branded product.

Generic substitution occurs when the pharmacist dispenses a generic product (or possibly another brand name product) instead of the brand name product prescribed by the physician.

3. Both generic dispensing and substitution impose some ethical requirementsstemming from the basic mandate to do no harm. Assuming the correct indication of the drug, the use of generics is justified by the fact that they are equivalent to the corresponding branded products. This equivalence requirement necessarily includes equivalence Chemistry(generic and branded product contain the same amount of the same therapeutically active component and at the same dose); biological equivalence (generic and branded product achieve identical bioavailability when administered at the same dose to the same individuals); and therapeutic equivalence (generic and branded product, when administered at the same dosage regimen to the same individuals, produce the same therapeutic efficacy and cause identical toxicity).

4. It is the responsibility of the health authorities to control the quality of medicines, regardless of whether they are generic or branded. The authorisation to market generic medicines is equally demanding and legally entails identical responsibilities and effects for both generic and branded medicines subject.

II. Generic prescription

5. As stated in the recent Declaration of the Central Deontology Commission on Freedom of Prescription, the physician has a duty to prescribe rationally and with good economic sense. Prescribing the least expensive medication when its equivalent efficacy and safety are guaranteed is an act managerand ethically required, as this is usually the explicit or implicit will of the patient or of the institutions, public or private, that have to pay for it. In contrast, prescribing an equivalent but higher-priced medicine is ethically reprehensible, if there is no reasonable and convincing justification for such an action. Such conduct is contrary to the rules of rational drug use, which require, in addition to efficacy and safety, cost-effectiveness.

6. The Central Ethics Commission therefore supports the concept of prescribing lower-priced medicines and medical devices, including generic prescriptions, when their efficacy and safety are preserved. A physician can, and should, prescribe generics when he/she is satisfied that they comply with the ethical requirements of requirements.

III. Generic substitution

7. The above recommendation in favour of generic prescribing does not amount to a blank cheque in favour of generic substitution. Under ordinary conditions, the physician bears the ultimate responsibility for the patient's care, so the choice or selection of the medicine cannot be outside the physician's control.

8. That the physician has obtained the patient's informed consent to the therapeutic plan means that this plan is the one that has been authorised by the patient. A drug substitution, even if only generic, can never be introduced without the patient's consent. And even if most patients consider the generic substitution justified by the reduction of the pharmaceutical expenseas reasonable, they have the right, after having received from the pharmacist the relevant information in understandable terms about the treatment alternatives (Art. 10.5, Law 14/1986, General Health) to choose freely among the options presented to them (Art. 10.6 of the same Law), which also implies the right, before making their decision, to have the substitution known and authorised by the physician.

9. For the pharmacist to impose generic substitution without the doctor's authorisation could create high-risk ethical and legal situations, in the event of undesirable effects resulting from such substitution. In any case, such substitution may not be carried out without the authorisation of the patient and the physician, especially in cases where the adjustment of the therapeutic plan has been very laborious, or when the medicines have a very small therapeutic margin. The legal rules and regulationsrecognises this fact and has published lists of medicines that cannot be substituted by other medicines in dispensing. Art. 10.6 of the above-mentioned General Health Law states that it should be the managerdoctor in charge of the case who offers treatment options to the patient.

10. Generic substitution should be a matter of cooperation, not confrontation, between doctor and pharmacist. The pharmacist, despite his status as an expert in medicines, cannot invade the doctor's legitimate areaand change the therapeutic plan that the doctor has recommended to his patient: this would be tantamount to appropriating the doctor's exclusive prescribing authority. He must, when he has reason to do so, communicate the relevant points to the doctor, so that the latter can approve them and record them in his patient's medical record. And the physician is obliged to accept and welcome the pharmacist's reasonable and justified proposals.

11. The Central Ethics Commission is deeply convinced that genuine and fruitful cooperation between doctors and pharmacists, both in primary care and in hospitals, must be guided by two principles: the traditional principle of separation of functions (doctors prescribe, pharmacists dispense), in force since the Edict of Salerno and in all advanced societies, and the principle of interprofessional cooperation which enables the skills and knowledge of doctors and pharmacists to be used to the best advantage in the service of patients. For while pharmacists are obliged by their profession to be good connoisseurs of medicines, they cannot forget that doctors are the good connoisseurs of patients and ultimately responsible for their health care.

Madrid, 28-29 May 1999.