viernes, 28 de marzo de 2008

Pharmaceutical Compounding in Spain

Publicado en International Journal of Pharmaceutical Compounding. Vol. 12, No. 2, March/April 2008

Pharmaceutical Compounding in Spain

Is compounding permitted in your country?

Compounded medicines in Spain are elaborated in hospital pharmacy services and independent community pharmacies (in the very regulated Spanish’s pharmaceutical market, all pharmacies are “independent community pharmacies”, this is today the only possible pharmacy model). According to a survey of the Consejo General de Colegios Oficiales de Farmacéuticos, in 2003, as much as 85% of the community pharmacies in Spain do perform at least a minimum of pharmaceutical compounding in their laboratories (mainly dermatological preparations). A community pharmacy in Spain is obliged by law to fill all prescriptions for legal medicines (including, of course, prescriptions for compounded medicines)1. When a community pharmacy lacks the equipment, facilities or skills to prepare a given formula, they need to contract its elaboration with another pharmacy, more specialized in compounding. This is known as “elaboración a terceros” (third party compounding) and the requirements, procedure and quality management of the process are regulated by RD 175/2001 – “Good compounding practices and quality control in pharmaceutical compounding”, compulsory from February 2004. The main advantage of this procedure is that it has a tremendous impact on the accessibility of quality pharmaceutical compounding to the patient: all patients in Spain can go to their nearest local pharmacy for a refill of virtually any compounded medicine.

Who regulates compounding in your country?

Pharmaceutical compounding, as well as all other pharmaceutical issues in Spain, is primarily regulated by “Law for the rational use of drugs and therapeutic products” (July 2006). In spite of its “modern” name and recent publication date, this law is in fact a mere update of the 1990 “Medicine’s Act”, with little changes in general, and nothing new concerning pharmaceutical compounding (i.e., the new law has simply ignored all the major advancements experienced by the Spanish pharmacists with respect to pharmacy compounding during the past 16 years!). Compounding activities, laboratories and equipment need also to comply with RD 175/2001 – “Good compounding practices and quality control in pharmaceutical compounding”. The authorities responsible for the enforcement of these regulations are the Pharmacy Department of each Regional Government in Spain.

List some difficulties you have with regulatory agencies regarding compounding:

The Health authorities in Spain show a very restrictive attitude towards pharmaceutical compounding. Compounded medicines are generally regarded as the “last resource” and its use is almost exclusively authorized when all other therapeutic alternative have failed. An example of this is what happens on the event of a drug shortage. All official protocols prioritize importing the drug from abroad, instead of considering the alternative of having it compounded by the community pharmacists (and reimburse the pharmacist in consequence), which in most cases would be a more timely and costly-effective solution to the problem. However, the utility of compounding has been clearly demonstrated in recent events. During 2007 we have experienced sustained drug shortages of a number of very common psychiatric drugs (i.e., amitriptylline, trifluoperazine, primidone, tranylcipromine). These drugs where also temporarily discontinued at the European countries around. Therefore, it proved impossible to access the drug through the usual official “foreign drug import” protocols. Also, the problem turned into a major public health concern, as some of these treatments can not be abruptly discontinued without the appearance of serious adverse events, including suicide. The situation was only solved when the Health administration finally accepted, after not little effort from a few members of the pharmacy profession, reimbursing these drugs elaborated in the compounding pharmacies’ laboratories! After this, we are working together with the health authorities in my region on a protocol to make pharmaceutical compounding the priority alternative on the event of a drug shortage.

Health administrations willing to protect their citizens’ health in the best possible way, should retain the moral of situations like the one described above: if pharmaceutical compounding proves so useful in those extreme cases, what is the scientific/therapeutic rationale to restrict its use so much, thus avoiding a more generalized application of this practice?

What are you allowed to compound?

In Spain we refer to the “freedom of prescription” of the physician to justify the elaboration of virtually any prescription for a compounded medicine that comes into our practices - considering it is in agreement with our professional ethics and knowledge, and with the few limitations listed in the paragraph bellow. However, sometimes the big issue, the true limiting step, is to get the compounded medicine reimbursed by the Social Security. Spanish patients are used to have most prescription medicines for free, or at little cost. Elderly patients, for example, are not used at all to pay for their medicines at the pharmacy. However, compounded medicines are reimbursed according to a list of drugs that is completely out of date (we are really in need of a protocol to update this list regularly, or to change to a different system). It is really hard, if not impossible, to make an elderly patient understand that he needs to pay for the non-lactose version of a drug, or for an oral liquid, when he is used to get all his medicines free of charge.

What are you not allowed to compound?

Spanish pharmacists are not allowed to compound drugs in the same dose, dosage form and with the same excipients as a registered product. Also, we are not allowed to compound medicines that once existed as registered products but where discontinued because of health concerns or safety reasons.

Describe your compounding pharmacy.

The Marro Pharmacy is placed in Huesca, a little town of 45000 inhabitants in the north of Spain, close to the Pyrenees Mountains. It was founded by my grandfather, Joaquin Marro, in 1941. Today, the director of the Marro Pharmacy is my father, Guillermo Marro, and I am responsible for the laboratories (compounding and cosmetics), the webpage (, and a few other things. There are three other pharmacists working in our pharmacy and we employ a staff of 20 people all together. The Marro Pharmacy opens 12 h a day, 365 days/year. Since 2001, all processes and activities at Marro Pharmacy are ISO 2001 certified, and we are now working towards achieving EFQM. The Marro Pharmacy setting can be considered a “conventional” independent community pharmacy within Spain, but we have always focused our activities towards the service to the patient, mainly through pharmaceutical care and compounding. We have two laboratories within the pharmacy, one is a cosmetic laboratory and the other one is dedicated to pharmaceutical compounding. In the cosmetic laboratory we elaborate our own range of cosmetic products (creams, shampoos, deodorants, etc). With respect to the pharmaceutical compounding laboratory, it is a 80 m2 facility well equipped for its purpose. There is also a clean room, where we elaborate eye drops and injections. The average work-flow in the laboratory is 15 compounds/day, which accounts for approximately 2% of all prescriptions dispensed at the pharmacy counter. We regularly organize meetings with physicians to track their needs and to educate them on the therapeutic possibilities of pharmaceutical compounding.

Can you compound or manufacture large quantities to provide to other pharmacies?

As discussed elsewhere in this article, compounding pharmacies in Spain do have contracts with other pharmacies that need to provide this service to their patients. However, the elaboration of such compounds remains individualized: it is done on a one-by-one basis and the compounding pharmacy needs to file a copy of the prescription for each compound.

How do you assign beyond-use dates, or expiration dates to your compounded preparations?

We refer to bibliography (stability studies published in books and journals) when assigning beyond-use dates. When this is not possible, we apply the USP criteria.

What do you think is unique about the way compounding is done in your country?

In Spain, pharmaceutical compounding activities are integrated within the community pharmacy. There are no “compounding-only” pharmacies, but most community pharmacies do compound. Pharmacists in Spain are the more and more convinced that compounding is an important aspect of the service we provide to our patients, together with pharmaceutical care, counseling and other health-care services. However, we need to fight almost everyday against the unawareness of our authorities with respect to pharmaceutical compounding, to defend its great and unique therapeutic value and its individualized character. In this sense, we get a lot of help and support from AEFF, the Spanish Association of Compounding Pharmacists. AEFF organizes every year, in October, a Scientific Congress on Pharmaceutical Compounding which is a great opportunity to learn new things, to share experiences with colleagues and friends, and to get into contact with how compounding is practiced in the rest of the world. There are always a number of speakers from other countries in Europe, USA and Latin America at the AEFF meetings. In fact, it was through discussions with these international contacts that AEFF Board of Directors realized that the main challenges facing pharmaceutical compounding are not specific to any particular country, but global in nature, and decided in 2004 to promote the creation of the International Society of Pharmaceutical Compounding (ISPhC –, an open forum for compounders from all over the world, were everybody is invited to participate and collaborate in shaping the face of pharmaceutical compounding in the future.

Do all pharmacists have the ability to compound? Or, does it take additional special training?

You don’t need any additional special training to be a compounding pharmacist in Spain. However, there is an increasingly good offer of post-graduated and training courses from Schools of Pharmacy and other institutions in my country.

Are you allowed to compound nonprescriptions medications for sale?

Pharmacists in Spain are allowed to compound nonprescription medications for sale in their own pharmacy. These preparations are called preparados oficinales. The only limitation is that they must be described in the Formulario Nacional (National Formulary). However, in spite of its recent publication (2003) most preparados oficinales listed in the Formulario Nacional are old topical preparations with little interest in today’s therapeutics.

Other information you would like to share with compounding pharmacists around the world about compounding in your country?

One of the main barriers that limit the development of pharmaceutical compounding in Spain is its little presence in most of the university curricula of pharmacy and medicine. The potential of pharmaceutical compounding is not explained at all to the future physicians in Spain. Also pharmacy students, although they are correctly taught the technical skills to elaborate and dispense a drug, they often leave the University thinking that pharmaceutical compounding is something of the past, ignoring its increasing role in modern pharmacotherapy and its true potential in today’s healthcare systems, the more and more focused on the individualization of products and services.

The other main barrier opposing the development of pharmaceutical compounding has already been discussed elsewhere in this article: the need to convince our Health administrations that pharmaceutical compounding exists, provides a quality and individualized therapeutic alternative, and is worth for the improved healthcare of our patients.

Finally, these and other barriers that restrict the development of pharmaceutical compounding can be surely analysed from a global perspective: they are not exclusive to Spain or any other country in particular. They are certainly global in nature and therefore should be considered and evaluated by pharmacists discussing from an international perspective.

Diego Marro

Publicado en International Journal of Pharmaceutical Compounding. Vol. 12, No. 2, March/April 2008

2 comentarios: