Regulations Governing Morphine Prescription in Egypt: An Urgent Need for Modification
2009; Elsevier BV; Volume: 39; Issue: 1 Linguagem: Inglês
10.1016/j.jpainsymman.2009.08.002
ISSN1873-6513
Autores Tópico(s)Pharmacological Effects and Toxicity Studies
ResumoMorphine remains the drug recommended by the World Health Organization (WHO) for moderate to severe cancer pain control,1World Health Organization Cancer pain relief with a guide to opioid availability.2nd ed. World Health Organization, Geneva1996Google Scholar and it is the only strong opioid listed on the WHO model list of essential medicines.2World Health Organization World Health Organization model list of essential medicines.15th ed. 2007http://www.who.int/medicines/publications/essentialmedicines/en/Google Scholar Furthermore, “WHO monitors morphine consumption in individual countries as an index of improvements in pain management”.1World Health Organization Cancer pain relief with a guide to opioid availability.2nd ed. World Health Organization, Geneva1996Google Scholar Since the publication of “Cancer Pain Relief” in 1986,3World Health Organization Cancer pain relief. World Health Organization, Geneva1986Google Scholar global morphine consumption, excluding preparations included in Schedule III, increased from 4.7 to 39.2 tons in 2007.4International Narcotics Control Board Narcotic drugs: Estimated world requirements for 2007; statistics for 2005. United Nations, New York2007Google Scholar, 5International Narcotics Control Board Narcotic drugs: Estimated world requirements for 2009; statistics for 2007. United Nations, New York2009Google Scholar This global increase has been because of morphine consumption in developed countries, which accounted for more than 93% of the global morphine consumption in 2007. Developing countries that have more than 80% of the world's population resulted in only 7% of the global morphine consumption.5International Narcotics Control Board Narcotic drugs: Estimated world requirements for 2009; statistics for 2007. United Nations, New York2009Google Scholar This low consumption of morphine and other opioids in developing countries indicates inadequate cancer pain control and limited accessibility to palliative care.6World Health Organization National cancer control programmes: Policies and managerial guidelines. World Health Organization, Geneva2002Google Scholar The Egyptian morphine consumption figures are very low. For the years 2005–2007, the Egyptian average morphine consumption (excluding preparations in Schedule III) expressed in defined daily doses for statistical purposes (S-DDD) was only three per million inhabitants per day (Fig. 1).5International Narcotics Control Board Narcotic drugs: Estimated world requirements for 2009; statistics for 2007. United Nations, New York2009Google Scholar The Egyptian Narcotics Control Law and the Egyptian health system regulations governing morphine prescription may have contributed significantly to the low morphine consumption in Egypt. To date, oral morphine is not on the Egyptian essential drugs list,7Egyptian Ministry of Health National essential drug list.http://www.mohp.gov.eg/Sec/Drugs/groups.asp?x=1#Google Scholar and the only available registered oral morphine preparation in Egypt is the 30 mg slow-release morphine (SRM) tablet.8Egyptian Ministry of Health Registered priced products.http://www.mohp.gov.eg/Sec/Drugs/drugslaw.asp?x=3Google Scholar According to the Egyptian Narcotics Control Law, the maximum dose limit for tablets of morphine or its salts, which should not be exceeded in a single prescription, is 420 mg and the maximum for ampoules of morphine or its salts is 60 mg.9Narcotics Control Law: No. 182 for the year 1960. Almatabea Alamiria, Giza, Egypt1999Google Scholar According to sections 7 and 8 of the 1997 Egyptian Ministry of Health (MOH) regulations concerned with morphine prescription for cancer outpatients, the maximum dose of oral morphine to be dispensed is 420 mg and only on weekly basis. This means that cancer patients could have a maximum of 14 tablets of the 30 mg SRM per week. For many advanced cancer patients near the end of life, the 420 mg morphine dose may not be enough for only one day.1World Health Organization Cancer pain relief with a guide to opioid availability.2nd ed. World Health Organization, Geneva1996Google Scholar, 10Sykes N. Thorns A. The use of opioids and sedatives at the end of life.Lancet Oncol. 2003; 4: 312-318Abstract Full Text Full Text PDF PubMed Scopus (307) Google Scholar The Egyptian Narcotics Control Law dates back to 1960, and the dose limit of morphine per prescription was specified in 1997 according to an amendment decision by the Egyptian Minister of Health. This dose-limiting law, in addition to fears and misconceptions about morphine, has shaped the morphine prescribing regulations of both the MOH and the Health Insurance Organization (HIO). In 1999, the MOH regulations were amended (section 5). Although the maximum dose per prescription remained 420 mg oral morphine, the frequency of dispensing the morphine was not specified. A rather confusing statement (section 5b) was added, stating that “the amount necessary for treatment is dispensed according to the needs of each patient and the decision of the responsible specialized physician.” This statement, in conjunction with the 420 mg dose limit per prescription, can be understood in two different ways. The first way, which is the logical one, is that the amount needed is dispensed but within the 420 mg limit. In the second way, which is not the logical one, the physician has the right to write more than one prescription in a single occasion to supply the patient with enough morphine. Most of the health care facilities follow the first way of understanding, which means that the 1999 amendment failed to improve morphine prescription except in very few centers, such as our center, where physicians insist on following the amendment in the second way mentioned above. The HIO facilities provide health services for civilians working in the government and general organizations, children from birth to school age, and students below the level of university education. It is estimated that the HIO covers 44% of the Egyptian population.11Egyptian Ministry of Health Health Insurance Organization.http://www.hio.gov.eg/Ar/Pages/default.aspxGoogle Scholar Although the MOH regulations should be applied in HIO facilities, in November 2003, the HIO created its own regulations, which further complicated the process of prescribing and dispensing SRM tablets for cancer patients. According to the HIO regulations, “this medication (morphine) is not to be used except after exhausting treatment with ordinary analgesics, so as the drug will not lose its efficacy from the prolonged use.” This is a clear example of how misconceptions about morphine among policymakers may contribute to inadequate cancer pain control. A cancer patient within the HIO system can have a maximum of 28 tablets of the 30 mg SRM every two weeks. In addition, many patients may have no access to these 28 tablets if they did not attend the clinic by themselves and return the empty packs. What makes the process further complicated is that advanced cancer patients for whom no further cancer-modifying treatment is possible are not eligible for transfer to centers outside the HIO system for pain management. With this list of obstacles, access to oral morphine in HIO facilities becomes a difficult mission. In view of the regulations illustrated above, it is not surprising at all to have very low morphine consumption figures in Egypt. Low morphine and other opioid consumption figures indicate very inadequate cancer pain control in Egypt. It is known that there is no standard dose for morphine and that “the right dose is the dose that relieves the patient's pain,” which may be up to thousands of milligrams per day.1World Health Organization Cancer pain relief with a guide to opioid availability.2nd ed. World Health Organization, Geneva1996Google Scholar The oral morphine 420 mg dose limit law should be modified. There should be “NO” dose limit to ensure that the patient is receiving the “right dose” and for enough time. In addition, oral morphine should be on the Egyptian essential drugs list, as it is on the WHO model list of essential drugs.2World Health Organization World Health Organization model list of essential medicines.15th ed. 2007http://www.who.int/medicines/publications/essentialmedicines/en/Google Scholar The Egyptian health system regulations for prescribing and dispensing morphine need to be unified. After modification, the MOH regulations should be implemented in all Egyptian health care facilities. There should not be internal regulations in subdivisions of the Egyptian health system, which are expected to be more stringent, as the current HIO regulations are. Phrases based on misconceptions, like part 1 of the HIO regulations, should be eliminated. It is very difficult for most of the advanced cancer patients, especially near the end of life, to attend outpatient clinics. Consequently, a patient's attendance at the clinic as a prerequisite for dispensing the morphine should not be included in the regulations. Returning the empty packs is not a guarantee for any sound practice and should be cancelled as well. Finally, the patient should have access to amounts of morphine enough for reasonable periods to avoid unnecessary frequent clinic visits, which may increase suffering. In conclusion, there is an urgent need to modify the Egyptian Narcotics Control Law and the Egyptian health system regulations for morphine prescription. Otherwise, Egyptian cancer patients will continue to have poor access to morphine and may suffer significantly because of uncontrolled pain.
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