Specific Aspects of Erectile Dysfunction and Its Treatment for Community Pharmacists

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Specific aspects of erectile dysfunction and its treatment for community pharmacists

JM Vic1*

1Secretary of Technical Information, Madrid Pharmacists Association, Madrid, Spain

We reviewed several topics relating to erectile dysfunction (ED) and its treatment, which are of interest to the community pharmacy. First, we analyze the community pharmacy’s role as a center of health education to the population. Second, we discuss the legal aspects of medical prescription for drugs not financed by the Spanish National Health Service. Finally, we explain how community pharmacists may inform patients on the proper use of prescribed medicines for ED and any medications that may cause interactions or should be avoided with treatment. International Journal of Impotence Research (2004) 16, S50–S52. doi:10.1038/sj.ijir.3901244

Keywords: erectile dysfunction; treatment; prescriptions; pharmacists

The community pharmacy as a center for tional campaigns on the proper use of medicines. In health education the case of ED, this activity could consist of distributing reprints of the Document for the General Public (in this supplement) to community It is highly unlikely for those affected by erectile pharmacies. dysfunction (ED) to ask questions at the community pharmacy, because this topic is often taboo and likely to cause embarrassment. This contrasts shar- The community pharmacy and drug ply with the usual behavior seen in the community prescriptions for ED pharmacy, where people freely ask anything that either directly, or indirectly, affects their health. It has also been noted that patients generally acquire All drugs currently indicated for treatment of ED their treatment for ED from community pharmacy (sildenafil, vardenafil, tadalafil, apomorphine, locations far from their usual surroundings, and, alprostadil [prostaglandin El], testosterone) may be even then, patients infrequently ask questions. dispensed only with a medical prescription. Nevertheless, we should take advantage of the The orally administered drugs sildenafil and potential that the community pharmacy has as an apomorphine are not financed by the Spanish easily accessible center for patients to receive National Health System (NHS). Therefore, in the counseling about health topics. The simplest context of the NHS, the physician must prescribe approach is to distribute educational and informa- them on the so-called ‘form for prescription of tive material that is rigorous, clearly written, and medicines not financed by the National Health concise. This has been a valid approach with other System,’ colloquially known as the ‘white pres- 1 medications and health topics, including the pro- cription’ (Table 1). Moreover, either in private care motion of healthy living habits (quitting smoking, or in the NHS, prescriptions for these drugs require moderation in the consumption of alcohol, getting strict compliance with the law on medical prescrip- 2 physical exercise appropriate for each age, and so tions. According to this law, there are two options on), recommendations for action in specific diseases for prescribing the medication that is not supported (hypertension, diabetes, and so on), and institu- by the NHS.

Standard prescription *Correspondence: JM Vic, BPharm, Secretary of Technical Information, Madrid Pharmacists Association, C/Santa Engracia, no 31, 28010 Madrid, Spain. These prescriptions are usually valid for a single E-mail: [email protected] dispensation, which must be filled within 10 days of Erectile dysfunction for pharmacists JM Vic S51 Table 1 Form for prescription of nonfinanced medicines (White divided dispensations in the community pharmacy Prescription) (except in case of the last dispensation which will be as indicated above). PATIENT (Identification data) PHYSICIAN (Identification data and signature) INSTRUCTIONS FOR PHARMACIST (If appropriate): DATE OF PRESCRIPTION NUMBER OF CONTAINERS The community pharmacy as a patient information PRESCRIPTION: Name of product or INN, pharmaceutical form, center on medicinal use route of administration, number of units/containers, posology and treatment duration POSOLOGY: The dispensing of medicines is a professional act in TREATMENT DURATION: INSTRUCTIONS FOR PATIENT: which the community pharmacist, in addition to NOT INVOICEABLE dispensing the medicines, informs patients about the medication they will be using while also INN ¼ International nonproprietary name. collecting information to detect situations in which there may be problems related to the drugs prescribed. the date indicated on the prescription. One or more products may be listed on each prescription. Each prescription may include 1 or more containers of the product, although the amount corresponding to the Agents for the treatment of ED purpose of the product or to a maximum of 3 months treatment may not be exceeded under any circum- stances. After the medicine is dispensed, the To ensure proper use of the medicines, the commu- prescription remains in the possession of the nity pharmacist should confirm that the patient has dispensing community pharmacist, who must keep enough information about the treatment prescribed it for 3 months. The disadvantage of this option is to him. Basically, the community pharmacist should that it obliges the patient to purchase all the ensure that the patient knows what the medicine is containers prescribed in a single total payment, an for, how it works, what effects it has on erections, amount that the patient is not always able to afford. how it should be taken, how often and for how long it should be taken. In addition, the community pharmacist should assess the information provided by the patient to avoid contraindication and to Prescription for long-term treatments detect situations in which special caution should be taken with the use of the medication. The contra- In the case of prolonged treatments (called long-term indications, precautions, and adverse reactions of treatments in the previously mentioned law), there the medicines indicated for ED are described in the is also the option of using a single prescription to core document. Finally, the community pharmacist obtain the medicine in several dispensations. In this should always offer to answer any questions the case, the 10-day validity period of the prescription is patient may have after reading the leaflets of the calculated from the date indicated on the prescrip- prescribed medicines. tion to the first dispensation. The maximum validity period of the prescription is 3 months. The prescribing physician should clearly indicate Concomitant medications on the prescription the dispensing intervals as well as the number of containers that should be given on each dispensation. The pharmacist should be alert to the use of any Only 1 product may be listed on prescriptions for drug that may interact with ED treatment, and these treatments. advise the patient to see his physician if any are For these prolonged treatments, the community detected. Simultaneous administration of sildenafil pharmacist must stamp, sign, and date each partial with nitrates or nitric oxide donors (eg, isosorbide dispensation, indicating the amount of the partial dinitrate, molsidomine, isosorbide mononitrate, dispensation and return the prescription to the nicorandil, nitroglycerin, sodium nitroprusside) patient. After the last dispensation has been made, is absolutely contraindicated (Table 2).3–5 As its the community pharmacist must retain the prescrip- clearance is reduced when administered concomi- tion and keep it for 3 months. It can be recom- tantly with cytochrome P450 3A4 inhibitors mended that the pharmacist make a photocopy of (CYP3A4) (cimetidine, erythromycin, ketoconazole, the prescription to be kept in the community itraconazole) and HIV protease inhibitors (indinavir, pharmacy records before returning it to the patient, nelfinavir, ritonavir, saquinavir), sildenafil may or record the dispensation in the prescription book interact with drugs that inhibit hepatic metabolism. on a voluntary basis so that there is a record of Although an increased incidence of adverse events

International Journal of Impotence Research Erectile dysfunction for pharmacists JM Vic S52 Table 2 Nitrate-containing or nitric oxide-donating drugsa some patients have experienced vasovagal symp- toms and significant resting blood pressure Marketed in Spain Not marketed in Spain decreases when apomorphine was administered at higher than the recommended dose (5 mg).3,6 Isosorbide dinitrate Linsidomine Apomorphine should not be administered in Iso Lacer Amyl nitriteb Molsidomine Propatyl nitrate combination with other centrally acting dopamine Corpea Tenitramine agonists (such as bromocriptine, lisuride, pergolide, Molsidain Erytrityl tetranitrate pramipexole, ropinirole) or dopamine antagonists Isosorbide mononitrate Pentaerithrityl tetranitrate (such as sulpiride, thiapride, clozapine, olanzapine, Cardionil Trolnitrate Cardiovas quetiapine, haloperidol, zuclopentixol, metoclopra- Coronur mide, thioridazine, etc) because of the potential Dolak for pharmacodynamic interactions. Simultaneous Isonitril intake of apomorphine and alcohol may cause an Olicard increase in the incidence and extent of hypoten- Pertil 3,6 Uniket sion. Patients treated with anticoagulants, such as Nicorandil heparin or warfarin, may be more prone to bleeding Dancor after the injection of alprostadil.3 Nitroglycerine As an estimated 25% of ED cases have been Cafinitrina Cordiplast patch related to the use of drugs, it is advisable for the Diafusor (patch) community pharmacist to check whether the patient Minitran (patch) is under treatment with drugs that cause ED (see the Nitradisc (patch) core document).3 If these problems are detected, the Nitro Dur (patch) community pharmacist should refer the patient to Nitroderm Matrix Nitroderm Tts (patch) the physician for reassessment of the patient’s Nitroplast (patch) treatment. Solinitrina Finally, because good control and treatment of Solinitrina Ts (patch) other diseases such as diabetes mellitus or high Trinipatch (patch) Trinispray blood pressure may contribute to worsening of ED, Vernies the community pharmacist should cooperate with Sodium nitroprusside the physician in the follow-up of treatment com- Nitroprussiat Fides pliance in these patients.

a This list was prepared with the BOT database of the Spanish National Council of Pharmacists (updated 6/9/2001).7 This list does not include generic drugs. b References In Spain, medicinal products containing amyl nitrate have been withdrawn from the market. There is an illicit circulation of products based on this substance. 1 Informacioń sobre medicamentos no financiados. R.D. 1663/ 1998, de 24 de julio. Insalud 1998. 2 Royal Decree. 1910/1984 and Ministerial Order of 30 April was not observed when sildenafil was administered 1986; Real Decreto 1910/1984, de 26 de septiembre, de receta concomitantly with CYP3A4 inhibitors, an initial medica; Orden de 30 de abril de 1986 sobre especialidades dose of 25 mg should be considered in these farmaceúticas. Normalizacioń de recetas me´dicas y modelos patients. Concomitant administration of sildenafil oficiales de receta especial para medicamentos que incluyan sustancias psicotro´picas o estupefacientes. with ritonavir, an HIV protease inhibitor that 3 Drugdex Drug Evaluations: Alprostadil; Apomorphine; Silde- exhibits potent inhibitory action on cytochrome nafil. Micromedexs Healthcare Series. Vol. 109, 2001. P450, is not recommended, and a maximum dose 4 Parfitt KM. The Complete Drug Reference. 32 edn. Pharma- ceutical Press: London, 1999. of 25 mg of sildenafil should not be exceeded in a s 3,5 5 Viagra Ficha Tećnica de la especialidad. 48-h period. It is recommended that caution be 6 Uprimas Ficha Tećnica de la especialidad. taken when administering apomorphine to patients 7 BOT. Base de Datos del Medicamento. Versioń septiembre treated with nitrates (previously listed) because 2001. Consejo General de Colegios Oficiales de Farmaceúticos.

International Journal of Impotence Research