The Philippine National Drug Policy & Rational Drug Use of Medicines 1. ". %. (.

Briefly discuss the development of the PND ! its goal and its five pillars. Distinguish the term #drug$ from the term #medicines$ Define rational medicine use. &ite e'amples of irrational medicine use. Discuss the follo)ing program initiatives to promote rational medicine use* R+ ,,-. /0eneric1s +ct of 12334 5 goal & 6ey revisions! advantages of using 7NN8generic name Define 9ssential Medicine &oncept! essential medicines list! access to essential medicines Discuss the :uality +ssurance &ycle for Rational Medicine Use activities 5 standards! ;ualitative and ;uantitative assessment of performance! diagnosis of reasons for inade;uate performance! target interventions.

7t )as during the time )hen democracy )as <rought <ac6 in the Philippines in 123, )hen the Philippine National Drug Policy )as esta<lished. 7t )as through a series of multi=sectoral consultation and participation of the drug industry! academe! professional organi>ations! government agencies and consumers that it )as formed in the hope of providing solutions to pro<lems and the clamoring need to provide essential drugs to the people. ?ed <y the Tas6 orce on Pharmaceuticals! PNDP )as created to attain the goal of promoting the rational use of essential drugs in the country 7n 123-! &ora>on &. +;uino declared pu<licly the Philippine National Drug Policy /PNDP4 together )ith its four pillars! i.e.! :uality +ssurance! Rational Use of Drugs! @elf=Reliance! and Tailored Procurement. Based on the issuance of 9.A. Nos. 1-( and 1-. amendments to R.+. .2"1 BThe Pharmacy ?a)B and R.+. %-"C B ood! Drug! and &osmetic +ctB respectively. +t present! the PNDP has five pillar components )hich address the pro<lem of inade;uate provision of good ;uality essential drugs to the people. These pillars )ere created to <ring a<out the availa<ility and afforda<ility of safe! effective! and good ;uality drugs for all sectors of the country especially the poor ones. The five pillars of PNDP are /14 assurance of the safety! efficacy and usefulness of drug products through quality control /"4 promotion of the rational use of drugs <y health professionals and the general pu<lic /%4 development of self reliance in local pharmaceutical industry /( ) targeted procurement of drugs <y government and /.4 people empowerment. QUALITY ASSURA !" #UR"AU $% %$$& A & &RU'S (#%A&) )ISI$ The B +D is a )orld=class regulatory agency and center of scientific e'cellence composed of professionally competent! legally ;ualified! efficient! and confident staff )ith unfettered enforcement capa<ilities *ISSI$ To ensure the safety! efficacy! purity! and ;uality of processed foods! drugs! diagnostic reagents! medical devices! cosmetics and household ha>ardous su<stances through state=of=the art technology! as )ell as the scientific soundness and truthfulness of product information for the protection of pu<lic health. The functions of B +D are as follo)s* 9nsure the safety! purity and ;uality of food! drugs and cosmetics Dandles the policy formulation and sector monitoring arm of the minister on matters pertaining to food! drugs! traditional medicines! cosmetics and household products. Prescri<es general standards and guidelines )ith respect to the veracity of nutritional and medicinal claims in the advertisement of food! drugs and cosmetics in various media Provide consultative! training and advisory services to all agencies and organi>ations involved in food and drug manufacturing and distri<ution )ith respect to assuring safety and efficacy of food and drugs Maintain a corps of specially trained food and rugs inspectors for assignment to the various field offices of the Ministry /of Dealth4 &onduct studies and research related to food and drug safety

RATI$ AL &RU' US" + component of the Philippine national Drug Policy that attempts to correct and limit inappropriate and )asteful utili>ation of pharmaceuticals in the community through thorough legislation and strategies /pu<lic education program4 that tries to reach prescri<ers! dispensers and the consumers so they can use drugs properly! correctly and sanely. The goal of this pillar is fulfillment the @+N9 criteria in drug use* safety! afforda<ility need and efficacy The rational use of drugs means that patients receive medicines appropriate for their clinical needs! in doses that meet their individual re;uirements! for an ade;uate period of time! and at the lo)est cost to them and their community. 7rrational drug use <y prescri<ers and consumers is a very comple' pro<lem! )hich calls for the implementation of many different interventions at the same time. 9fforts to promote rational drug use should also cover the use of traditional and her<al medicines. Eey policy issues are* development of evidence=<ased clinical! as the <asis for training! prescri<ing! drug utili>ation revie)! drug supply and drug reim<ursementF esta<lishment and support of drugs and therapeutics committeesF promotion of the concepts of essential drugs! rational drug use and generic prescri<ing in <asic and in=service training of health professionalsF the need and potential for training informal drug sellersF continuing education of health care providers and independent! un<iased drug informationF consumer education! and )ays to deliver itF financial incentives to promote rational drug useF regulatory and managerial strategies to promote rational drug use 'eneral 'uidelines for proper drug use The essential drugs concept is central to a national drug policy <ecause it promotes e;uity and helps to set priorities for the health care system. The core of the concept is that use of a limited num<er of carefully selected drugs <ased on agreed clinical leads to a <etter supply of drugs! to more rational prescri<ing and to lo)er costs. The reasons are clear. 9ssential drugs that is selected on the <asis of safe and cost=effective clinical! give <etter ;uality of care and <etter value for money. The procurement of fe)er items in larger ;uantities results in more price competition and economies of scale. :uality assurance! procurement! storage! distri<ution and dispensing are all easier )ith a reduced num<er of drugs. Training of health )or6ers and drug information in general can <e more focused! and prescri<ers gain more e'perience )ith fe)er drugs and are more li6ely to recogni>e drug interactions and adverse reactions. +romotion of Rational &rug use R"+U#LI! A!T $. ,,-. /'eneric Act of /011) The 0eneric +ct of 1233 )as passed <y the @enate and the Douse Representatives on +ugust ".! 1233 and +ugust %1! 1233! respectively and )as approved <y President &ora>on &. +;uino! @eptem<er 1% of the same year. This +ct consisting of 1. sections )as created to uphold! necessitate and ensure the production of an ade;uate supply! distri<ution! use and acceptance of drugs and medicines recogni>ed <y their generic names in the Philippines. +s stated in @ection ". @tatement of the Policy! the +ct )as specifically /14 to promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing drugs; /"4 to ensure the adequate supply of drugs with generic names at the lowest possible cost and endeavor to make them available for free to indigent patients; /%4 to encourage the extensive use of drugs with generic names through a rational system of procurement and distribution; /(4 #to emphasize the scientific basis for the use of drugs; in order that the health professionals may become more aware and cognizant of their therapeutic effectiveness; and /.4 #to promote drug safety by minimizing duplication in medications and/or use of drugs with potentially adverse drug interactions The follo)ing terms )hich are essential to <e understood in relation to the +ct )ere defined*

Generic Name or Generic Terminology ! is the identification of drugs and medicines <y their scientifically and internationally recogni>ed active ingredients or <y their official generic name as determined <y the Bureau of ood and Drugs of the Department of Dealth. Active Ingredient! is the chemical component responsi<le for the claimed therapeutic effect of the pharmaceutical product. Chemical Name! is the description of the chemical structure of the drug or medicine and serves as the complete identification of a compound. Drug Product 5 is the finished product form that contains the active ingredients generally <ut not necessarily in association )ith inactive ingredients. Drug Establishment! is any organi>ation or company involved in the manufacture! importation <ut not necessarily in association )ith inactive ingredients. Drug Outlets! means drugstores! pharmacies! and any other <usiness esta<lishments )hich sell drugs or medicines. Essential Drugs List or National Drug Formulary ! is a list of drugs prepared and periodically updated <y the Department of Dealth on the <asis of health conditionings o<taining in the Philippines as )ell as on internationally accepted criteria. 7t shall consist of a core list and a complimentary list. Core List " is a list of drugs that meets the health care needs of the maGority of the population. Com lementary List! is a list of alternative drugs used )hen there is response to the core essential drug or )hen there is hypersensitivity reaction to the core essential drug or )hen! for one reason or another! the core essential drug cannot <e given. !rand Name 5is the propriety name given <y the manufacturer to distinguish its product from those of competitors. Generic Drugs! are drugs not covered <y patent protection and )hich are la<eled solely <y their international non=proprietary or generic name. +2ILI++I " ATI$ AL &RU' %$R*ULARY The Philippine National Drug ormulary is an integral component of the National Drug Policy /NDP4. 7t is a maGor strategy in the promotion of rational drug use! <y assuring the availa<ility and accessi<ility of essential drugs of proven efficacy! safety and ;uality at afforda<le cost. 7t is formulated <y the Department of Dealth through the National ormulary &ommittee /N &4! mandated <y the R.+. ,,-. also 6no)n as the 0enerics +ct of 1233. 7t )as formulated utili>ing su<mitted evidence ta<les! documentations and a series of deli<eration meetings )ith a panel of e'perts and resource persons consisting of representatives from medical schools! Philippine Medical +ssociation /PM+4! academic! specialty and su<=specialty societies! drug industry! government and private hospitals! and other sta6eholders. 7n 122%! <y virtue of 9'ecutive Arder No. (2 s.122% and the Philippine Dealth 7nsurance +ct of 122.! the PND )as officially adopted as the <asis for procurement of drug products )ithin the entire DAD. 'eneral 'uidelines for "sta3lis4ing t4e +4ilippine ational &rug %ormulary Drug selection for the Philippine National Drug ormulary must <e <ased on the follo)ing* 1. Relevance to disease )hich is indicated in the treatment of prevalent diseases. ". 9fficacy and safety o<Gectively o<tained on pharmacologic studies! )hich includes at least e'panded Phase 77 clinical trials and8or additional Phase 777 studies among ilipinos. %. :uality control standards! including sta<ility! and )hen necessary! <ioavaila<ility have to <e met. The suppliers of pharmaceutical products must provide documentation of the product1s compliance )ith the re;uested specifications. (. &ost of the treatment regimen. .. +ppropriateness to the capa<ility of health )or6ers at different level of health care must <e considered. ,. ?ocal health pro<lems! the prevalent diseases or conditions on pharmaco6inetic and pharmacodynamic parameters modifying therapeutic response have to <e considered. -. Most favora<le <enefit8ris6 ratio is selected )hen several drugs are availa<le for the same therapeutic indication. 3. Preferential factors for evaluating therapeutically e;uivalent drugs* a. Drug )ith <est understood <eneficial properties and limitations <. Drug )ith clinical utility for treating more than one condition

c. Drug )ith most favora<le pharmaco6inetic properties d. Drugs in a dosage form easily dispensed <y health staff or safely administered to the patient e. Drugs )ith greater accepta<ility f. Drugs )ith favora<le sta<ility g. Drugs for )hich local relia<le manufacturing facilities e'ist for its production 2. ormulation as single compounds and fi'ed=ratio com<inations are accepta<le only )hen* a. Use of more than one drug is clinically documented <. 7ts therapeutic <enefit is greater than the sum of each individual component c. 7t is safer than the use of a single compound drug d. 7t is cheaper or does not e'ceed the cost of the sum of individual products e. Patient compliance is improved f. @atisfaction of maGority of the population is maintained 1C. Period revie) of significant ne) therapeutic advances and information is necessary. 11. 7nternational Non=propriety Names for drugs should <e used. The PND is a component of the National Drug Policy )hich see6s to <ring a<out the availa<ility of safe! efficacious! and ;uality drugs at afforda<le cost. Through the 9ssential Drug &oncept! it is a step to rationali>e drug production! distri<ution! procurement and consumption. +4ilippine ational &rug %ormulary (+ &%) 7s the 9ssential Drug ?ist for the Philippines prepared <y the National Drug &ommittee /ND&4 )ith consultation to different e'perts in the field of pharmaceutics! )hich is updated every year! consisting of* a. &ore ?ist 5 drugs that are essential and are needed <y the maGority of the population and should <e availa<le at all times in appropriate dosage forms and in sufficient ;uantities. <. &omplimentary ?ist 5 drugs that are needed for treating rare disorders! drugs )ith special pharmaceutical properties and alternative drugs to <e used )hen there is no response in medicating &ore list drugs or )hen &ore list drugs cannot <e administered for a reason or situation. S"L%5R"LIA !" 7t is very important that the drug policy defines the future supply system. + )ell=coordinated supply system )ill ensure that pu<lic funds availa<le for drug purchases are used effectively to ma'imi>e access! to o<tain good value for money and to avoid )aste. The most important o<Gective should <e to get ;uality essential drugs to the people )ho need them! at prices that the ilipinos can afford. Production of drugs should <e <ased on a careful situation analysis and on a realistic appraisal of the feasi<ility of domestic production. Pharmaceutical production can <e classified into three levels* Primary production = includes the manufacture of active pharmaceutical ingredients and intermediatesF @econdary production =includes the production of finished dosage forms from e'cipients and active su<stancesF Tertiary production= is limited to the pac6aging of finished products or repac6aging of <ul6 finished products. The government hopes to provide a regular supply of lo)=cost drugs to pu<lic health programmes aimed at disease control! through government=o)ned drug manufacture rather than through overseas procurement. 7n ma6ing the decision a<out <eing involved in pharmaceutical production of the government is <ased on a thorough situation analysis through determining its feasi<ility and the ;uality and prices )ith )hich the locally produced drugs )ill compete in the mar6et. The main goal of this pillar is to* manufacture pharmaceutical needs of most important drug locally and drug development from medicinal plants and other indigenous sources. ilipino Pharmaceutical +ssociation 5 promoted self reliance and encourages production especially of generic drugs. +n achievement of <eing a<le to increase in the percent share of un<randed generics in the mar6et )as attained )ith "H /12334 and 1CH /122%4.

+lso the use of traditional medicine )as encourage in this pillar )hich implies that there should <e continuous use of traditional or her<al medicine that must <e )idely practiced and its place in health care should <e considered in the <roader development of health policy. Traditional and her<al medicines are usually 6no)n <y local names. 7t should <e ta6en note that the use of the IDA guidelines for the assessment of her<al medicines is recommended. TAR'"T"& +R$!UR"*" T Procurement is an activity involving ac;uisition of goods! consulting services! contracting for infrastructure proGects and lease of goods and real estate. 7n the procurement of drugs in the Philippines it is scientifically <ased on mor<idity patterns! cost effectiveness considerations and the essential drugs concept. 7t is mandatory in all government agencies under 9.A. (2 s. 122% to use the Philippine National Drug ormulary Jol.1 as sole <asis for procurement of essential drugs. The former President idel J. Ramos ordered that the Therapeutics &ommittee8 Physician in charge of the clinic or infirmary8Procurement officer shall <e responsi<le for determining )hich products and the corresponding ;uantity to <e procured <y the government! every re;uisition and issue voucher or any re;uest to purchase drug shall <e accompanied <y a certification signed <y the re;uisitioning officer that the drug products <eing re;uisitioned or procured fall )ithin and conform )ith PND vol. 1! the commission on audit shall instruct all unit auditors8 heads of auditing unit to monitor compliance )ith this order and to disallo) in audit claims8 disim<ursment either from regular <udget local and 8or trust funds ! for drugs not listed in PND a )ritten re;uest )ith corresponding Gustification addressed to the head of the national drug policy office )ho may approve or disapprove the re;uest. The goal of the department of health is to procure drugs satisfy the needs of the maGority of the population and therefore should <e availa<le at all times! in ade;uate amounts in appropriate dosage forms and at a price the individual and the community can afford. 7t is should <e scientifically <ased on mor<idity patterns! cost effectiveness and the essential drug concept. The Department of health has a Procurement and ?ogistic @ervice unit )hich have many functions. The role of this unit is to formulate plans! policies! standards and guidelines related to procurement and logistics management of the Department of DealthF procures! maintains and manages supplies! materials and services to support the logistical re;uirements of the Department of DealthF advises the @ecretary of Dealth on matters pertaining to the procurement of goods and services and logistics management. The Procurement division specifically develops an annual procurement program for the Department of DealthF provides assistance to field offices of the Department on matters pertaining to procurement of drugs! medicines! medical supplies! health e;uipment and other general supplies and materialsF ensures that all offices8units adhere to procurement processes and procedures. The materials or management division specifically ensures proper handling and storage! ade;uate and timely distri<ution of drugs! medicines! medical supplies health e;uipment and other general office supplies and materialsF maintains and updates inventory of goods! supplies and materials. The department allo)s yearly <iding procedures in the procurement of drugs. They invite companies in the <idding procedure or companies )ill apply for it. +fforda<ility is necessary or a prere;uisite in the access of a drug. The department must find drugs )hich are afforda<le to the lo)er masses! <ut also they must put to mind that even if it is afforda<le it is still effective in the treatment of a disease. +"$+L" "*+$6"R*" T People1s participation is the core principle of Primary Dealth &are. +s PD& agency of our country! Department of Dealth plays a catalyst role in sustaining and accelerating health care program implementation through active and collective participation of the community. This strategy is referred to as people empo)erment. People empo)erment is the process of gaining mastery and po)er over one1s community to produce change. &hanging peopleKs <ehavior or ha<its is not an easy tas6 and generally re;uires a long term strategy <ased on the <ehavioral principles. + <ehavioral modification intervention has to <e underta6en )ith 6no)ledge of the social and cultural conte't in )hich it is <ased. Thus! empo)erment is not merely an information campaign <ut a deli<erate! planned strategy that uses various means and approaches to elicit needed action among those )ho can contri<ute to solving or reducing an identified pro<lem in the community.

The main goal of people empo)erment is to ma6e people committed to health )or6 since they ta6e responsi<ility for their o)n health. 7n drug utili>ation! it helps consumers on their decision of purchase of an efficacious! afforda<le! safe and good ;uality drugs. 7t provides the consumer )ith a <etter understanding of the <enefits and the potential dangers of drug use! and safe sources of drug information and supply. +chievement of this goal )ill produce informed and empo)ered consumers )ho are a<le to act in their o)n and in their communityKs <est interests. 7RR+T7AN+? M9D7&7N9 U@9 +R$#L"*S R"LAT"& T$ &RU' US" I T2" +2ILI++I "S The factors that influence drug use are many and interrelated. &hanging comple' practices that are em<edded in cultural and social <eliefs and shaped <y 6no)ledge! attitudes! infrastructure and economic interests is very difficult. No single approach is li6ely to )or6! and some interventions may produce unintended effects. + com<ination of strategies tailored to the needs of the different groups and different environments is needed. Ta6ing drug is a component of health see6ing <ehavior in all communities. &urrently! the local mar6et is s)amped )ith thousands of pharmaceutical preparation. MaGority of ilipinos are not a<le to afford essential drugs. ?imited resources put aside for medicine are <eing utili>ed to purchase irrational products as influenced <y political! cultural! and economic factors revolving around the lives of many ilipinos. 7n many parts of the country! o<Gective information on drugs is scarce. Dealth )or6ers receive limited <asic training or continuing education on drugs. Eno)ledge! on the other hand! is only a component of the crisis. Moreover! pro<lems of access to ;uality drugs and rational use persist. +lthough fe) hard data are availa<le! it is li6ely that in the rural parts of the Philippines )here more than half the population still lac6s access to essential drugs. +nd there are ne) challenges that may have an impact on access! such as the e'pansion of the private sector1s role in pharmaceuticals! health sector reforms and the effects of glo<ali>ation. The changing pattern of diseases! antimicro<ial resistance and emerging ne) diseases are other factors. Particularly important is the current trend of governments to reduce health care spending <ecause of inade;uate resources! despite increasing health needs. $7eruse and misuse of drugs occurs as a consequence of prescri3ing more t4an enoug4 medicine needed and consumption of medicine w4ic4 is more t4an t4e amount required . Drugs are <eing used even )hen not indicatedF some are prescri<ed inappropriately for non=specific and self limiting illness. 7ncorrect drug use occurs in the sense of incorrect prescri<ing as )ell as inappropriate use of consumers. Thus! duplication in medications and consumption of drugs )ith potentially adverse drug reactions are unavoida<le. &rugs are insufficiently prescri3ed and ta8en . Due to poverty and more important necessities in life! patients have a propensity to Gust <uy multivitamins! cough and cold preparations to relieve the e'isting illness they are e'periencing. +lso! other patients do not complete their antimicro<ial treatment leading to much cases of drug resistance. Drugs li6e anti<iotics! anti=diarrheas! and pain6illers e'ceed the incidence of the disease they are supposed to treat. Prescri<ing and dispensing patterns are influenced <y socio=cultural factors such as patients1 demand! the attitude of the prescri<ers! and previous prescri<ing e'periences and drug promotions. "9tra7agant use of drug products . Physicians have the tendency to prescri<e e'pensive drug products and treatments of choice for common illness are not usually prescri<ed. This may <e influenced <y the e'tensive mar6eting done on the part of the pharmaceutical companies )herein physicians as )ell as the ilipino people are <linded <y the colorful advertisements and famous cele<rities as endorsers of the drugs. Inappropriate promotion of medicinal drugs remains a pro3lem in our country . Pro<lems relate to scientific accuracy and <alance of information! improper inducements to prescri<ers or dispensers! lac6 of full product information! misleading presentations <y medical representatives! and promotional activities disguised as educational or scientific e'ercises. on5compliance of t4e patients also affi9 to t4e issues related to drug use . &orrect prescri<ing does not guarantee that drugs are used properly. Non adherence to doctors1 prescription is very common. 7nade;uate drug information! insufficient la<eling! lac6 of money! and cultural perception on drugs are Gust some of the many reasons of patients )ho do not conform to )hat their physicians advise them. Self medication is very rampant in the Philippine setting and this is compounded )ith the inclination of dispensing drugs over the counter. Ather health professionals may recommend drug even if they are

not authori>ed to do so. @uggestions of friends and relatives also contri<ute nota<ly to self medication. This can lead to inappropriate use and to delays in the correct diagnosis and treatment. Unrestricted availa<ility can also contri<ute to the emergence of drug resistance! drug interactions and adverse effects! and inefficient use of scarce household resources. +DJ+NT+09@ A U@7N0 7NN809N9R7& N+M9 1. Rationali>es drug use +voids drug duplication there<y preventing over dosage or to'icity Minimi>es drug=drug interaction Minimi>es medical error ". 7nternationally understood and accepted 5 ensures continued administration of drugs in long term therapy %. Jalua<le teaching tool for doctors! dentists! vets! pharmacists and nurses at various stages of training and practice (. Reduces the total cost of drug treatment